Patent Docs

USPTO Issues Memo on AMP v. Myriad to Examining Corps

By Donald Zuhn --

On the same day that the Supreme Court handed down its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Patent and Trademark Office issued a one-page memorandum to its Patent Examining Corps to provide preliminary guidance on the decision.  The memo from Andrew Hirshfeld, the Deputy Commissioner for Patent Examination Policy, notes that in Myriad, "the Supreme Court held that claims to isolated DNA are not patent-eligible under 35 U.S.C. § 101," and that the decision "significantly changes the Office's examination policy regarding nucleic acid-related technology" (emphasis in original).  The memo advises the examining corps that:

As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated.  Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.  Claims clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally-occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible.  Other claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.

(emphasis in original).

The memo concludes by noting that "[t]he USPTO is closely reviewing the decision in Myriad and will issue more comprehensive guidance on patent subject matter eligibility determinations, including the role isolation plays in those determinations."

Patent Docs thanks Hal Wegner for alerting the patent community to the memorandum.

USPTO Proposes Rules Changes to Implement Patent Law Treaty

By Donald Zuhn --

In April, the U.S. Patent and Trademark Office published a notice in the Federal Register (78 Fed. Reg. 21788) proposing changes to the rules of practice for consistency with the Patent Law Treaty (PLT) and title II of the Patent Law Treaties Implementation Act of 2012 (PLTIA), which amends the Title 35 to implement the provisions of the PLT.  The PLT, which harmonizes and streamlines formal procedures pertaining to the filing and processing of patent applications, only applies to applications that can be filed as international applications under the Patent Cooperation Treaty (PCT), and therefore, does not apply to design, plant, provisional, or reissue applications.

Although the PLT entered into force on April 28, 2005, and was ratified by the Senate on December 7, 2007, because the PLT is not a self-executing treaty it did not enter into force in the U.S. until the PLTIA was enacted on December 18, 2012 -- the PLTIA, however, does not take effect until December 18, 2013, or one year after the date of enactment.  The PLTIA will apply to any patent issued before, on, or after December 18, 2013, and to any application pending on or filed after December 18, 2013.  The PLTIA, however, will have no effect with respect to any patent that is the subject of litigation in an action commenced before December 18, 2013.

According to the notice, there are three notable changes resulting from the PLT and PLTIA, which involve:

(1) The filing date requirements for a patent application; (2) the restoration of patent rights via the revival of abandoned applications and acceptance of delayed maintenance fee payments; and (3) the restoration of the right of priority to a foreign application or the benefit of a provisional application via the permitting of a claim to priority to a foreign application or the benefit of a provisional application in a subsequent application filed within two months of the expiration of the twelve-month period . . . for filing such a subsequent application.

With respect to the filing date requirements, the Office is proposing changes to the rules to provide (a) that a claim is not required for a nonprovisional application to be entitled to a filing date, and (b) to allow for the filing of a nonprovisional application "by reference" to a previously filed application in lieu of filing the specification and drawings.  Under the revised rules, when a nonprovisional application is filed without at least one claim or without referencing a previously filed application in lieu of submitting the specification and drawings, the applicant will be given a period of time to provide one or more claims or a copy of the specification and drawings of a previously filed application.

To prevent an applicant from taking advantage of the opportunities to delay the examination process provided by the PLT and PLTIA (i.e., by filing an application without at least one claim or without referencing a previously filed application), the Office is also proposing changes to the rules to provide for a reduction of patent term adjustment (PTA) if an application is not in condition for examination within eight months of its filing date (or date of commencement of national stage in an international application).

With respect to the first change resulting from the PLT and PLTIA, the notice indicates that:

An application whose disclosure satisfies only the requirements of 35 U.S.C. 111(a) to be entitled to a filing date may nonetheless not meet the requirements of 35 U.S.C. 112 and 113 necessary for the applicant to be entitled to a patent for any claimed invention presented in the application, or even for the application to effectively serve as a priority or benefit application for an application subsequently filed in the United States or abroad.  Therefore, the ability to file an application without a claim or drawing should be viewed as a safeguard against the loss of a filing date due to a technicality and not as a best practice.

With regard to the second change resulting from the PLT and PLTIA, the Office is proposing changes to the rules to provide for the revival of abandoned applications and acceptance of delayed maintenance fee payments solely on the basis of "unintentional" delay.  The notice indicates that the PLTIA eliminates patent law provisions relating to the revival of abandoned applications or acceptance of delayed maintenance fee payments on the basis of a showing of "unavoidable" delay.  In particular, the PLTIA amends 35 U.S.C. §§ 122(b)(2)(B)(iii), 133, 151, 364(b), and 371(d) to delete the reference to an unavoidable standard.

As for the third notable change, the Office is proposing changes to the rules to allow an applicant to restore the right to priority to a prior-filed foreign application or a provisional application if a subsequent application (nonprovisional or international application) is filed after the expiration of the twelve-month period set forth in 35 U.S.C. § 119(a) or (e), but within two months from the expiration of the twelve-month period, provided that the delay in filing the subsequent application was unintentional.

The Office's notice provides a detailed discussion of the specific rules changes at pages 21792-800, and a listing of the revised rules at pages 21803-09.  For additional information regarding the proposed rules changes, readers are encouraged to consult the 22-page Federal Register notice.

Written comments regarding the proposed rules changes can be submitted until June 10, 2013 by e-mail to AC85.comments@uspto.gov; by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Robert W. Bahr, Senior Patent Counsel, Office of Patent Examination Policy; or via the Federal eRulemaking Portal.

USPTO News Briefs

By Donald Zuhn --

USPTO Modifies After Final Consideration Pilot Program

Earlier this month, the U.S. Patent and Trademark Office published a notice in the Federal Register (78 Fed. Reg. 29117) regarding modifications to the After Final Consideration Pilot Program (AFCP).  The AFCP, which was implemented in April 2012, provides examiners with a limited amount of non-production time -- three hours for utility and reissue applications -- to consider responses filed following a final rejection (see "USPTO to Assess After Final Consideration Pilot Program").  When the program was originally implemented, the Office indicated that when an examiner determines that "the nature and extent of the amendments or arguments presented in the response can be fully considered within the limited amount of time authorized by the [AFCP]," the examiner should consider the after final response, and when the examiner determines otherwise, the examiner "should treat the response according to current practice, without non-production time authorized."

In implementing the original AFCP, the Office described six "limited situations [in which] further amendments or arguments may be considered" under the AFCP:

1.  The amendment places the application in condition for allowance by canceling claims or complying with formal requirement(s) in response to objection(s) made in the final office action.
2.  The amendment places the application in condition for allowance by rewriting objected-to claims in independent form.
3.  The amendment places the application in condition for allowance by incorporating limitations from objected-to claims into independent claims, if the new claim can be determined to be allowable with only a limited amount of further consideration or search.
4.  The amendment can be determined to place the application in condition for allowance with only a limited amount of further search or consideration, even if new claims are added without cancelling a corresponding number of finally rejected claims.
5.  The amendment can be determined to place the application in condition for allowance by adding new limitation(s) which require only a limited amount of further consideration or search.
6.  The response comprises a perfected 37 CFR 1.131 or 37 CFR 1.132 affidavit or declaration (i.e. a new declaration which corrects formal defects noted in a prior affidavit or declaration) which can be determined to place the application in condition for allowance with only a limited amount of further search or consideration[.]

The Office's notice regarding the modified program, otherwise known as the After Final Consideration Pilot Program 2.0 (AFCP 2.0), indicates that there are three main differences between the original AFCP and the AFCP 2.0:  (1) an applicant must file a request to participate in the AFCP 2.0; (2) a response after final rejection under the AFCP 2.0 must include an amendment to at least one independent claim; and (3) when a response does not result in a determination that all pending claims are in condition for allowance, the examiner will request an interview with the applicant to discuss the response.  The notice also specifies that the requirements for participating in the AFCP 2.0 are:

(1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434);
(2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect;
(3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the notice, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant);
(4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and
(5) the required papers must be filed via the EFS-Web.

The AFCP 2.0 took effect on May 19, 2013, and the pilot program will run until September 30, 2013.  The Office notes that the AFCP 2.0 is intended "to reduce pendency by reducing the number of Requests for Continued Examination (RCE) and encouraging increased collaboration between the applicant and the examiner to effectively advance the prosecution of the application."

USPTO Announces Patent for Humanity Winners

Last month, the U.S. Department of Commerce announced the winner of the USPTO Patents for Humanity pilot program.  The Patents for Humanity pilot program, which was launched in February 2012, is a competition recognizing patent owners and licensees who address global challenges in health and standards of living.  The competition was divided into four categories:  medical technology (with separate subcategories for medicines & vaccines and diagnostics & devices), food and nutrition, clean technology, and information technology.  Winners received accelerated processing of select matters at the USPTO in addition to recognition for their work.  The 2012 winners were as follows:

Medical – Medicines & Vaccines
• Gilead Sciences, for making HIV drugs available to the world's poor using a network of generics manufacturers in Asia and Africa.
• University of California, Berkeley, for developing research and license agreements to provide a lower-cost, more reliable way to produce anti-malarial compounds.

Medical – Diagnostics & Devices
• SIGN Fracture Care International, for distributing low-cost fracture implants to speed healing in developing world hospitals.
• Becton Dickinson (BD), for creating a fast, accurate TB diagnosis machine and placing 300 systems in 22 High Burden Countries.

Food & Nutrition
• DuPont Pioneer, for developing an improved strain of sorghum fortified with more protein and vitamins for use in sub-Saharan Africa.
• Intermark Partners Strategic Management LLP, for extracting edible protein and vitamins from waste rice bran in Latin America.

Clean Tech
• Procter & Gamble, for distributing a small chemical packet which removes impurities and contaminants from drinking water and has purified nearly 5 billion liters worldwide.
• Nokero, for delivering solar light bulbs and phone chargers for off-grid villages through local entrepreneurs.

Information Tech
• Sproxil, Inc, for deploying a system to identify counterfeit drugs with an ordinary cell phone in sub-Saharan Africa.
• Microsoft Corporation, for providing machine learning tools that allow health researchers to better analyze large data sets.

USPTO Publishes Final Rule Adopting New Rules of Professional Conduct

By Andrew Williams --

The U.S. Patent and Trademark Office ("USPTO") published its final rule in the April 3, 2013 Federal Register (78 Fed. Reg. 20180) in preparation for adopting new USPTO Rules of Professional Conduct ("USPTO Rules").  As we reported previously when the proposed rules were announced (see "USPTO Proposes Update to Code of Professional Responsibility"), the new USPTO Rules seek to conform the ethical obligations for representing others before the USPTO to the ABA Model Rules of Professional Conduct, which have been adopted in some form by every state (except California) and the District of Columbia. 

The adoption of the new USPTO Rules is significant for any patent practitioner that has a USPTO registration number.  On the one hand, the updated USPTO Rules are welcome news for attorney practitioners, because currently such individuals are required to know and abide by the ethics rules of the state or jurisdiction in which they practice.  Because the USPTO had been operating under the Patent and Trademark Office Code of Professional Conduct, which was based on the former ABA Model Code from 1980, patent attorneys were required to maintain adherence to two different sets of ethical obligations.  On the other hand, non-lawyer patent practitioners (patent agents) will now be subject to the new USPTO Rules, even though they may not be aware of the differences and subtleties of the ABA Model Rules.  It will be important for these individuals to become accustomed to the new USPTO Rules, especially where they differ from the previous Patent Office Code.  In fact, Dennis Crouch, Associate Professor of Law at the University of Missouri School of Law and author at the Patently-O blog, submitted a comment expressing the concern that the Patent Office not unduly focus on the experience of attorneys at the expense of these non-lawyer patent practitioners.  The USPTO Rules will go into effect on May 3, 2013.

Confidentiality of Information

After the proposed rules were promulgated on October 18, 2012, nineteen individuals or organizations submitted comments to USPTO.  This author submitted a comment on behalf of Patent Docs regarding concerns about the new disclosure-of-confidential-information rules, as outlined in a previous post (see "USPTO Proposes Update to Code of Professional Responsibility").  These concerns were echoed by the four organizations that filed comments:  the Intellectual Property Owners Association (IPO), the American Bar Association (ABA), the American Intellectual Property Law Association (AIPLA), and the Minnesota Intellectual Property Association.  Even though each of these comments addressed the problem slightly differently, the underlying concerns were still the same.

In a nutshell, new rule § 11.106, which is based on ABA Model Rule 1.6, states that a practitioner shall not reveal a client's confidential information without informed consent, implied authorization, or permission under the rules.  Both the new USPTO Rules and the ABA Model Rules include circumstances in which a practitioner "may" reveal such confidence, such as disclosing information that may prevent death, bodily harm, or fraud.  However, even in the cases where death, bodily harm, or fraud may result, the practitioner is still not required to reveal such information, but rather has permission to do so.  The new USPTO Rules diverge from the ABA Model Rules in one important respect:  the new USPTO Rules at § 11.106(c) include a type of information that is mandatory to reveal:  "A practitioner shall disclose to the Office information necessary to comply with applicable duty of disclosure provisions."  In other words, under this proposed rule, a finding that relevant information was intentionally withheld by a practitioner involved in the prosecution of an application will not only subject a patent to becoming unenforceable, it will result in an ethical violation by the practitioner.

Of course, this requirement has the possibility of trapping a patent practitioner between two ethical obligations -- a proverbial rock and a hard place.  Importantly, this obligation to disclose is not limited to the confidential information from the particular prosecution client, but instead extends to any confidential information belonging to any other client, provided it is material to the first client's application.  To be fair, a similar quandary may have already existed, because if a patent attorney is aware of such third-party confidential information, there was already a requirement to disclose it in order to prevent the patent from becoming unenforceable.  Nevertheless, most clients would prefer that confidential information not be made publically accessible in another client's patent file because the practitioner was required to satisfy his or her ethical obligation to the other client.

The biggest concern expressed in the comments about this issue was whether an attorney in such an ethical quandary would be able to withdraw from the case, and thereby discharge the ethical obligation.  In the published final rule, the USPTO addressed these comments, but did not change the proposed rule.  The USPTO's response provided some justification for the rule as drafted.  For example, the USPTO appears to suggest that such an ethical quandary is unlikely because the restrictions on conflicts of interest "would generally prevent a practitioner from accepting clients who may have potentially adverse interests."  Of course, this is not the test for whether there is a conflict of interest under ABA Model Rule 1.7 or USPTO Rule 107.  Instead, a concurrent conflict of interest exists where the representation of two clients would be directly adverse, or where there would be a significant risk that the representation of either client would materially limit the representation of the other.  Indeed, a requirement to disclose confidential information can arise when a current client discloses information to a practitioner that happens to be material to the patentability of another client's application.  Conflict screening will generally not prevent these ethical quandaries.

This does, however, bring up another interesting issue regarding the interplay between the duty to disclose and the rules on whether a conflict exists.  The USPTO Rules include a version of ABA Model Rule 1.10, in which the existence of a conflict of interest is imputed to everyone at a firm.  In other words, if another attorney at a firm is performing legal services for a client, then every attorney at that firm is thought to be working for that client, even if the other attorneys at the firm have no knowledge of that client.  Moreover, unless the conflict arises from an association with another firm, it is generally not possible to "screen" or "wall" those attorneys off to avoid the conflict.  Instead, in such instances where a conflict would arise, the firm is forced to decline the work that would cause the conflict.  This is not true of the duty of disclosure.  Whether a practitioner is aware of a reference that is material to the patentability of an application is personal to that patent attorney or agent.  Knowledge of a material reference is not imputed, so different attorneys representing different clients in similar spaces could be aware of art that would be material to the other client's application and not be required to disclose it.  This is because that attorney needs to have actual knowledge of the reference.

Nevertheless, whether those attorneys had actual knowledge of such a reference is a factual matter, and the consequences of a court finding such knowledge can be catastrophic for a client.  Therefore, firms can take precautions to avoid even the appearance of impropriety.  For example, firms can obtain separate USPTO customer numbers for use with specific clients.  That way, if one client's reference becomes relevant to another client's application, as long as the attorneys of the second client are not associated with the first client's customer number, a presumption could be drawn that they never had knowledge of the reference in the first place.  The only problem with this approach, however, is that clients often hire a firm because of the firm's experience prosecuting particular types of applications.  Unfortunately, it is this experience that can potentially give rise to these conflicts, or requirements to disclose information.

Ultimately, the USPTO did respond to the expressed concern by noting that a practitioner in such a situation could be able to withdraw from representation.  In the response to this comment, the USPTO pointed to § 1.116 of the new Rules, which provides that in certain situations, a practitioner may seek to withdraw to avoid a conflict of interest.  Moreover, in the "Discussion of Specific Rule," the USPTO specifically stated that "if a practitioner has a conflict of interest in a given matter, arising from a different client, timely withdrawal by the practitioner from the given matter would generally result in OED not seeking discipline for conflicts of interest under part 11."  Even though the use of the word "generally" is troubling in this explanation, this is probably the best practical solution short of amending the rules.

USPTO Issues Rules to Implement AIA Technical Corrections

By Donald Zuhn --

In the past week, the U.S. Patent and Trademark Office has published two Federal Register notices to implement technical corrections to the Leahy-Smith America Invents Act.  On Monday, the Office issued an interim final rule (78 Fed. Reg. 19416) that revises the rules of practice to implement changes to the patent term adjustment (PTA) provisions as provided in § 1(h) of the Technical Corrections Act, which was enacted on January 14, 2013.  Section 1(h) of the Technical Corrections Act specifies that the fourteen-month period within which the Office must issue a notice of rejection under 35 U.S.C. § 132 or notice of allowance under 35 U.S.C. § 151 (see 35 U.S.C. § 154(b)(1)(A)(i)(II)) and the three-year application pendency period provided by 35 U.S.C. § 154(b)(1)(B) are to be measured from the same date, i.e., the date of commencement of national stage under 35 U.S.C. § 371.

Section 1(h) also revises the provisions for notifying applicants of PTA determinations and for requesting reconsideration and judicial review of the Office's PTA determinations.  With regard to notifying applicants of PTA determinations, the interim rule changes the rules of practice to eliminate the need for the Office to provide an initial PTA determination with the notice of allowance, before the PTA under 35 U.S.C. §§ 154(b)(1)(A)(iv) (for not issuing a patent within four months following payment of the issue fee) and 154(b)(1)(B) (for not issuing a patent within three years after the actual filing date) can be determined.  Although the Office will no longer provide an initial PTA determination with the notice of allowance, under 37 C.F.R. § 1.705(c) Applicants must still file a request for reconsideration prior to the issuance of a patent in order to reinstate PTA reduced pursuant to 37 C.F.R. § 1.704(b) for failing to reply to a rejection, objection, argument, or other request within three months of the date of mailing of the Office communication.  With regard to requesting reconsideration of the Office's PTA determinations, the rules of practice are also being changed to allow applicants to extend the two-month period for filing a request for reconsideration of the PTA indicated on a patent by an additional five months after the date that the patent was granted under the provisions of 37 C.F.R. § 1.136(a).

The changes to 37 C.F.R. §§ 1.702, 1.703, and 1.705 provided by the interim rule apply to any patent granted on or after January 14, 2013, and the change to 37 C.F.R. § 1.704 applies to any application for which a notice of allowance was mailed on or after April 1, 2013.  The Office will be accepting comments regarding the interim rule until May 31, 2013.  Comments can be sent by e-mail to AC84.comments@uspto.gov; by regular mail addressed to:  Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Kery A. Fries, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.

Last week, the Office also issued a final rule (78 Fed. Reg. 17871) to implement technical corrections to the AIA with respect to inter partes review proceedings.  In particular, the final rule eliminates the nine-month "dead zone" for filing an inter partes review petition challenging a first-to-invent patent or reissue patent by permitting a petitioner to file an inter partes review petition challenging a first-to-invent patent or reissue patent upon issuance.  Revised 37 C.F.R § 42.102 provides, in part, that:

A petition for inter partes review of a patent must be filed after the later of the following dates, where applicable:
    (1) If the patent is a patent described in section 3(n)(1) of the Leahy-Smith America Invents Act, the date that is nine months after the date of the grant of the patent;
    (2) If the patent is a patent that is not described in section 3(n)(1) of the Leahy-Smith American Invents Act, the date of the grant of the patent[.]

The effective date provision of AIA § 3(n)(1) states that:

Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18-month period beginning on the date of the enactment of this Act [i.e., March 16, 2013], and shall apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time--
    (A) a claim to a claimed invention that has an effective filing date as defined in section 100(i) of title 35, United States Code, that is on or after the effective date described in this paragraph; or
    (B) a specific reference under section 120, 121, or 365(c) of title 35, United States Code, to any patent or application that contains or contained at any time such a claim.

Thus, 37 C.F.R § 42.102(1) encompasses first-inventor-to-file (FITF) patents and 37 C.F.R § 42.102(2) encompasses first-to-invent patents.

The final rule implementing technical corrections with respect to inter partes review proceedings took effect on March 25, 2013.

USPTO News Briefs

By Donald Zuhn --

USPTO Extends Comment Period on Notice Regarding Preparation of Patent Applications

In January, the U.S. Patent and Trademark Office published a notice in the Federal Register (78 Fed. Reg. 2960) requesting public comment regarding potential practices that applicants can employ in the drafting of patent applications to facilitate examination and bring more certainty to the scope of issued patents.  The notice set forth a list of nine "potential practice changes that applicants can employ to augment the quality of issued patents" and sought input as to whether any of the practices should be used by applicants during the preparation of an application to place the application in a better condition for examination.

On March 15, the Office published a new notice in the Federal Register (78 Fed. Reg. 16474) extending the comment period by one month from March 15, 2013 (when many application drafters were likely preoccupied with a more significant deadline) to April 15, 2013.  Comments can be sent by e-mail to QualityApplications_Comments@uspto.gov, or by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Nicole D. Haines.

In the Office's initial notice, the potential practice changes were divided into two groups, one group related to clarifying the scope of the claims and one group related to clarifying the meaning of claim terms in the specification.  The first group of potential practices included:

1.  Presenting claims in a multi-part format by way of a standardized template that places each claim component in separate, clearly marked, and designated fields (e.g., preamble, transitional phrase, and individual claim limitations).

2.  Identifying corresponding support in the specification for each of the claim limitations (e.g., using a claim chart).

3. Indicating whether examples in the specification are intended to be limiting or merely illustrative.

4.  Identifying whether the claim preamble is intended to be a limitation on claim scope.

5.  Expressly identifying clauses within particular claim limitations for which the inventor intends to invoke 35 U.S.C. § 112(f) (which pertains to means-plus-function limitations for applications filed on or after September 16, 2012) and pointing out where in the specification corresponding structures, materials, or acts are disclosed that are linked to the identified § 112(f) claim limitations.

6.  Using textual and graphical notation systems known in the art to disclose algorithms in support of computer-implemented claim limitations, such as C-like pseudo-code or XML-like schemas for textual notation and Unified Modeling Language (UML) for graphical notation.

The second group of practices included:

1.  Indicating whether terms of degree -- such as substantially, approximately, about, essentially -- have a lay or technical meaning and explaining the scope of such terms.

2.  Including in the specification a glossary of potentially ambiguous, distinctive, and specialized terms used in the specification and/or claims.

3.  Designating, at the time of filing the application, a default dictionary or dictionaries to be used in ascertaining the meaning of the claim terms.

USPTO Implements PCT-PPH with IPOPHL

On March 5, the U.S. Patent and Trademark Office announced that it was establishing a patent prosecution highway (PPH) pilot program based on Patent Cooperation Treaty (PCT) work products (PCT-PPH) with the Intellectual Property Office of the Philippines (IPOPHL).  Under the new pilot program, which went into effect on January 29, an applicant receiving a written opinion or international preliminary examination report in a PCT application that indicates at least one claim in the PCT application has novelty, inventive step, and industrial applicability, where the USPTO was the International Searching Authority or the International Preliminary Examining Authority, may request that the IPOPHL fast track the examination of corresponding claims in an application filed with the IPOPHL.  The USPTO- IPOPHL PCT-PPH pilot program is scheduled to expire on January 28, 2014, but may be extended if necessary to adequately assess the feasibility of the program.

USPTO Upgrades to PPH 2.0 with IPOPHL

On the same day that the U.S. Patent and Trademark Office announced the implementation of a PCT-PPH with the IPOPHL, the USPTO announced that it was upgrading its PPH with the IPOPHL to a PPH 2.0 program, with the upgrade commencing on January 29.  The PPH 2.0 program with IPOPHL supersedes the prior PPH program with that office.  The upgrade with the IPOPHL brings the number of PPH 2.0 participating offices to twelve, including the USPTO, Canadian Intellectual Property Office (CIPO), European Patent Office (EPO), Japan Patent Office (JPO), IP Australia (IPAU), Korean Intellectual Property Office (KIPO), National Board of Patents and Registration of Finland (NBPR), Portugal National Institute of Industrial Property (INPI-PT), Federal Service on Intellectual Property, Patents & Trademarks of Russia (Rospatent), Spanish Patent and Trademark Office (SPTO), and United Kingdom Intellectual Property Office (UKIPO).

In order to participate in any of the PPH 2.0 programs in the USPTO, applicants must satisfy the following requirements:

1.  One of the other PPH 2.0 participating offices has determined that at least one claim is allowable/patentable (under the PPH 2.0 program, applicants no longer need to submit a copy of the allowed claim or any English translation thereof).

2.  The application before the PPH 2.0 participating office (i.e., containing the allowable/patentable claim) and the U.S. application for which participation in the PPH 2.0 program is being requested must have the same priority/filing date (the Annex to the USPTO's notice on the PPH 2.0 program provides fifteen schematics outlining situations in which this requirement would be satisfied).

3.  All claims on file, as originally filed, or as amended in the U.S. application must sufficiently correspond to one or more of the claims indicated as allowable in the application filed in the PPH 2.0 participating office (the USPTO notice states that "[a] claim is considered to 'sufficiently correspond' where, accounting for differences due to translations and claim format, the claim in the U.S. application is of the same or similar scope as a claim indicated as allowable in the application filed in the PPH 2.0 participating office").  Under the PPH 2.0 program, applicants must submit a claims correspondence table (in English), indicating how all the claims in the U.S. application correspond to the allowable/patentable claims in the application filed in the PPH 2.0 participating office.

4.  Examination of the U.S. application for which participation in the PPH 2.0 program is being requested has not yet begun.

5.  The applicant has filed a request to participate in the PPH 2.0 program.

6.  The applicant must submit a copy of the office action issued just prior to the "Decision to Grant a Patent" (along with an English translation, which may be a machine translation) for the application before the PPH 2.0 participating office (under the PPH 2.0 program, applicants no longer need to submit a statement that the English translation is accurate).

7.  The applicant must submit an information disclosure statement listing all documents cited in the office action of the PPH 2.0 participating office.

8.  All of the documents described above must be filed via the EFS-Web and indexed using the document description:  "Petition to make special under Patent Pros Hwy."

Additional information regarding the PPH 2.0 program with the IPOPHL can be found here.

USPTO Continues PPH with SIPO

Earlier this month, the U.S. Patent and Trademark Office announced the continuation of the PPH pilot program with the State Intellectual Property Office of the People's Republic of China (SIPO).  As with other PPH programs, the USPTO-SIPO PPH permits an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from either the USPTO or SIPO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office.  The USPTO-SIPO PPH pilot program is now scheduled to expire on November 30, 2013, but may be extended thereafter.

USPTO News Briefs

By Donald Zuhn --

USPTO Modifies PKI Subscriber Agreement

On February 11, the U.S. Patent and Trademark Office distributed a Patents Alert e-mail in which the Office noted that the Public Key Infrastructure ("PKI") Subscriber Agreement had been modified such that PKI certificate holders are strictly prohibited from using Private PAIR to access any nonpublic patent application or documents owned by another, absent specific authorization.  In particular, the PKI Subscriber Agreement states that:

Any inadvertent or other disclosure of nonpublic documents shall in no way be construed as authorized access to such documents. Disclosure of other’s nonpublic documents constitutes involuntary unauthorized access and I understand that I must immediately destroy all such material without dissemination to anyone else, retrieve and destroy any such material if disseminated, notify the USPTO of the nature and extent of the unauthorized use, and certify that I have destroyed such material, that I have not granted rights to others to access such material, and that I will not otherwise make use of such material.

The Agreement also states that the Office may immediately revoke PKI certificates at any time without prior notice if, inter alia, "there is unauthorized use such as attempting or gaining access to nonpublic information or inadvertently disclosed nonpublic information," a PKI holder "use[s] Private PAIR to view another applicant's unpublished application without authorization," or the PKI holder "refuse[s] to destroy, cease dissemination, and/or retrieve any dissemination of any inadvertently disclosed or other nonpublic documents."

The Office's e-mail indicated that continued use of the system following the posting of the notice constituted agreement to the updated terms.  The new version of the PKI Subscriber Agreement can be found here.

The changes in the PKI Subscriber Agreement are likely related to an issue with the Private PAIR system between September 15-19, 2012.  In response, the USPTO issued Notices of Erroneous Access to Certain Patent Application Information Between September 15 and September 19, 2012 to applicants whose applications were erroneously accessed.  The Notices stated, in part:

Between September 15, 2012 and September 19, 2012, registered users of the Private Patent Application Information Retrieval (PAIR) system were able to access certain data regarding unpublished applications other than their own.  This unauthorized access was caused by a software error that was corrected on September 19, 2012, the day it was detected.  The United States Patent and Trademark Office (USPTO) immediately fixed the problem, quickly identified and addressed its root cause, and is putting measures in place to prevent future occurrences and notifying the affected applicants.  The USPTO takes the security of our IT systems very seriously, and this letter reports the results of our ongoing investigation.

USPTO Upgrades to PPH 2.0 with KIPO and INPI-PT

In February 2012, the U.S. Patent and Trademark Office implemented a new version of the enhanced Patent Prosecution Highway (PPH) pilot program known as PPH MOTTAINAI.  Under the new version of the PPH MOTTAINAI program -- known as PPH 2.0 -- the European Patent Office (EPO) joined the original seven MOTTAINAI offices -- the USPTO, Canadian Intellectual Property Office (CIPO), Japan Patent Office (JPO), IP Australia (IPAU), National Board of Patents and Registration of Finland (NBPR), Federal Service on Intellectual Property, Patents & Trademarks of Russia (Rospatent), Spanish Patent and Trademark Office (SPTO), and United Kingdom Intellectual Property Office (UKIPO) -- to bring the total number of participating offices at that time to nine.

On February 12, the USPTO announced that the Office had implemented PPH 2.0 programs with both the Korean Intellectual Property Office (KIPO) and the Portugal National Institute of Industrial Property (INPI-PT), with each program commencing on January 29.  The PPH 2.0 program with KIPO supersedes the prior PPH program with that office, but does not affect the USPTO-KIPO PCT-PPH program.

In order to participate in any of the PPH 2.0 programs in the USPTO, applicants must satisfy the following requirements:

1.  One of the other PPH 2.0 participating offices has determined that at least one claim is allowable/patentable (under the PPH 2.0 program, applicants no longer need to submit a copy of the allowed claim or any English translation thereof).

2.  The application before the PPH 2.0 participating office (i.e., containing the allowable/patentable claim) and the U.S. application for which participation in the PPH 2.0 program is being requested must have the same priority/filing date (the Annex to the USPTO's notice on the PPH 2.0 program provides fifteen schematics outlining situations in which this requirement would be satisfied).

3.  All claims on file, as originally filed, or as amended in the U.S. application must sufficiently correspond to one or more of the claims indicated as allowable in the application filed in the PPH 2.0 participating office (the USPTO notice states that "[a] claim is considered to 'sufficiently correspond' where, accounting for differences due to translations and claim format, the claim in the U.S. application is of the same or similar scope as a claim indicated as allowable in the application filed in the PPH 2.0 participating office").  Under the PPH 2.0 program, applicants must submit a claims correspondence table (in English), indicating how all the claims in the U.S. application correspond to the allowable/patentable claims in the application filed in the PPH 2.0 participating office.

4.  Examination of the U.S. application for which participation in the PPH 2.0 program is being requested has not yet begun.

5.  The applicant has filed a request to participate in the PPH 2.0 program.

6.  The applicant must submit a copy of the office action issued just prior to the "Decision to Grant a Patent" (along with an English translation, which may be a machine translation) for the application before the PPH 2.0 participating office (under the PPH 2.0 program, applicants no longer need to submit a statement that the English translation is accurate).

7.  The applicant must submit an information disclosure statement listing all documents cited in the office action of the PPH 2.0 participating office.

8.  All of the documents described above must be filed via the EFS-Web and indexed using the document description:  "Petition to make special under Patent Pros Hwy."

Additional information regarding the PPH 2.0 program with KIPO can be found here, and with INPI-PT can be found here.

USPTO Implements PCT-PPH with INPI-PT

Since implementing its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) in 2006, the U.S. Patent and Trademark Office has established close to forty PPH programs with more than twenty other patent offices.  Earlier this month, the USPTO increased the number of PPH programs (full or pilot) by one with the announcement that the Office was establishing a PPH pilot program based on Patent Cooperation Treaty (PCT) work products (PCT-PPH) with the Portugal National Institute of Industrial Property (INPI-PT).

Under the USPTO-INPI-PT PCT-PPH, which went into effect on January 29, an applicant receiving a positive written opinion or a positive international preliminary report in a PCT application where the USPTO or INPI-PT was the International Searching Authority or the International Preliminary Examination Authority may request that the other office fast track the examination of corresponding claims in corresponding applications.  The USPTO-INPI-PT PCT-PPH pilot program is scheduled to expire on January 28, 2014, but may be extended if necessary to adequately assess the feasibility of the program.

USPTO Issues First-Inventor-to-File Examination Guidelines and Final Rule

By Donald Zuhn --

In a press release issued earlier today, the U.S. Patent and Trademark Office announced that examination guidelines and the final rule for implementing the first-inventor-to-file (FITF) provisions of the Leahy-Smith America Invents Act (AIA) would be published in the Federal Register on February 14 -- thirty days before the FITF provisions take effect on March 16, 2013.  According to the Office's announcement, the move to a FITF system is "one of the hallmarks of the AIA," and constitutes "a major step towards harmonization of the U.S. patent system with those of the United States' major trading partners, allowing greater consistency in the prosecution and enforcement of U.S. patents."

Although the two notices will not be published in the Federal Register until Thursday, unpublished copies of the "Examination Guidelines for Implementing the First Inventor To File Provisions of the Leahy-Smith America Invents Act" can be found here, and the final rule entitled "Changes To Implement the First Inventor To File Provisions of the Leahy-Smith America Invents Act" can be found here.  The unpublished notices come in at 120 and 160 pages, respectively.

The Office's announcement indicates that the examination guidelines "set[] forth the agency's interpretation of how the first-inventor-to-file provision alters novelty and obviousness determinations for an invention claimed in a patent application," and in particular "inform the public and patent examiners how the AIA's changes to the novelty provisions of law alter the scope of what is prior art to a claimed invention and how the new grace period operates."  Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the USPTO Teresa Stanek Rea stated that the "[m]igration to a first-inventor-to-file system will bring greater transparency, objectivity, predictability, and simplicity to patentability determinations and is another step towards harmonizing U.S. patent law with that of other industrialized countries."

The press release also noted the Office would be providing more information on the first-inventor-to-file final rules and examination guidelines at a public training session to be held on Friday March 8, 2013 at the Office's headquarters in Alexandria, VA.  The training session will be webcast (with details about the webcast to be announced).

Given the length of the two notices, we will present an overview of the final rule today and will address the examination guidelines in a subsequent post.  The final rule notes that AIA § 3 amends U.S. patent law to:

(1) convert the U.S. patent system from a "first to invent" system to a "first inventor to file" system;
(2) treat U.S. patents and U.S. patent application publications as prior art as of their earliest effective filing date, regardless of whether the earliest effective filing date is based upon an application filed in the United States or in another country;
(3) eliminate the requirement that a prior public use or sale be "in this country" to be a prior art activity; and
(4) treat commonly owned or joint research agreement patents and patent application publications as being by the same inventive entity for purposes of 35 U.S.C. 102, as well as 35 U.S.C. 103.

While the above changes take effect on March 16, 2013, the final rule points out that the changes "apply only to certain applications filed on or after March 16, 2013."  This is due to the effective date provision of AIA § 3(n)(1), which states that:

Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18-month period beginning on the date of the enactment of this Act [i.e., March 16, 2013], and shall apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time--
    (A) a claim to a claimed invention that has an effective filing date as defined in section 100(i) of title 35, United States Code, that is on or after the effective date described in this paragraph; or
    (B) a specific reference under section 120, 121, or 365(c) of title 35, United States Code, to any patent or application that contains or contained at any time such a claim.

AIA § 3(a) defines the "effective filing date" for a claimed invention in a patent or application for patent as:

(A) if subparagraph (B) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(B) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under section 119, 365(a), or 365(b) or to the benefit of an earlier filing date under section 120, 121, or 365(c).

According to the final rule notice, the rules of practice in title 37 of the Code of Federal Regulations (C.F.R.) are being revised "for consistency with, and to address the examination issues raised by, the changes in section 3 of the AIA."  Among the changes to the rules of practice are the following:

• Where a U.S. patent or U.S. patent application publication has a prior art effect as of the filing date of a foreign priority application, a certified copy of the foreign application or an interim copy of the foreign application must be filed within the later of four months from the actual filing date of the application filed under 35 U.S.C. 111(a) or sixteen months from the filing date of the prior foreign application.  Under some circumstances, the above requirement will not apply -- e.g., the foreign application was filed in a foreign intellectual property office participating with the USPTO in a bilateral or multilateral priority document exchange agreement (such offices currently consist of the European Patent Office (EPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), and the World Intellectual Property Organization (WIPO)).

• For a nonprovisional application filed on or after March 16, 2013 that claims the benefit of the filing date of an application (i.e., foreign, provisional, or nonprovisional application, or international application designating the U.S.) filed prior to March 16, 2013, wherein the nonprovisional application filed on or after March 16, 2013 contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013, the applicant must provide a statement to that effect.  Such statement must be provided within the later of:

(a) four months from the actual filing date of the later-filed application,
(b) four months from the date of entry into the national stage in an international application,
(c) sixteen months from the filing date of the prior-filed application, or
(d) the date that a first claim to a claimed invention that has an effective filing date on or after March 16, 2013 is presented in the application.

According to the final rule, "[t]his procedure will permit the Office to readily determine whether the nonprovisional application is subject to the changes to 35 U.S.C. 102 and 103 in the AIA."

As a result of public input regarding the Office's notices of proposed rulemaking and proposed examination guidelines, the Office made some changes to the Office's proposed rules of practice pertaining to the FITF provisions of the AIA.  With respect to the requirement to submit a certified copy of the foreign application, the final rule indicates that the requirement will not apply in some circumstances, and that applicants will be permitted to submit an interim copy within the required time frame and then submit a certified copy before a patent is granted.

With respect to the requirement that the applicant provide a statement regarding the effective filing date of the claims in an application, the final rule indicates that "a statement is required only if a transition application contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013."  The final rule defines a "transition" application as "a nonprovisional application filed on or after March 16, 2013, that claims priority to, or the benefit of the filing date of an earlier application (i.e., foreign, provisional, or nonprovisional application, or an international application designating the United States) filed prior to March 16, 2013."  The proposed rulemaking had also required a statement if a transition application discloses subject matter not also disclosed in the prior-filed foreign, provisional, nonprovisional application, or international application designating the U.S. but did not ever contain a claim to a claimed invention that has an effective filing date on or after March 16, 2013.  The final rule eliminates the requirement to make this latter statement.

As for the changes made to the proposed rules, the Office states that it "sought to address the concerns of its stakeholders as expressed in the public comment, and plans to seek additional public comment on the rules of practice pertaining to the first inventor to file provisions of section 3 of the AIA after the Office and the public have gained experience with the rules of practice pertaining to the first inventor to file provisions in operation."

In addition to a discussion of the specific rules changes (on pages 17-59 of the notice), the final rule also addresses the nearly seventy written comments the Office received in response to its notice of proposed rulemaking (primarily on pages 60 to 106).  Although several comments opposed or expressed concerns with the statement requirements in the proposed rulemaking, the final rule maintains the requirement to provide a statement in a transition application "if the application contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013."  A statement is no longer required if a transition application discloses subject matter not also disclosed in the prior-filed foreign, provisional, nonprovisional application, or international application designating the U.S.

For the statement that is still required, the final rule states that "this statement is needed to assist the Office in determining whether the application is subject to AIA 35 U.S.C. 102 and 103 (an AIA application) or pre-AIA 35 U.S.C. 102 and 103 (a pre-AIA application)."  The final rule asserts that "if the Office must determine on its own the effective filing date of every claim ever presented in an application filed on or after March 16, 2013, that claims priority to or the benefit of an application filed prior to March 16, 2013, examination costs will significantly increase."  The final rule notes that applicants will not have to indicate the specific claims that have a post March 16, 2013 effective filing date, or the effective filing date of each claim, as the Office does not need this information to determine whether the application is an AIA application or a pre-AIA application.  In addition, the final rule specifies that "no statement is required if the applicant reasonably believes on the basis of information already known to the individuals identified in § 1.56(c) that the nonprovisional application does not, and did not at any time, contain a claim to a claimed invention that has an effective filing date on or after March 16, 2013."

In response to several comments regarding the mechanism for making the statement, the Office noted that it is revising the application data sheet to include a check box to allow applicants to easily indicate whether a transition application contains or ever contained a claim to a claimed invention having an effective filing date that is on or after March 16, 2013.

A number of the Office's other responses were particularly enlightening.  For example, in response to a comment that questioned how long the statement requirement would be applicable, the Office responded that (emphasis added):

The requirement for a statement for certain transition applications in §§ 1.55 and 1.78 as adopted in this final rule is implicated whenever an application filed on or after March 16, 2013, claims a right of priority to or the benefit of the filing date of an application filed prior to March 16, 2013.  This requirement, however, should not affect continuation or divisional applications because a continuation or divisional application discloses and claims only subject matter also disclosed in the prior-filed application.  See MPEP § 201.06 (defines divisional application), and § 201.07 (defines continuation application).  In addition, an application claiming a right of priority to a foreign application or the benefit of a provisional application must be filed within one year of the filing date of the foreign or provisional application.  See 35 U.S.C. 119(a) and 119(e).  In view of the one-year filing period requirement in 35 U.S.C. 119(a) and 119(e), this requirement should not affect applications filed after May 16, 2014, that claim only a right of priority to one or more foreign applications, or that only claim the benefit of one or more provisional applications (the critical date is May 16, 2014, rather than March 16, 2014, in view of the changes to 35 U.S.C. 119 in section 201(c) of the [] Patent Law Treaties Implementation Act of 2012, Pub. L. 112-211 (2012)).  Therefore, after March 16, 2014, (or May 16, 2014, the statement required by §§ 1.55 and 1.78 as adopted in this final rule for certain transition applications should be necessary only in certain continuation-in-part applications.

In response to several comments requesting that the Office clarify that an amendment to the claims that lacks support under 35 U.S.C. 112(a) does not convert that application into an AIA application, the Office responded as follows (emphasis added):

For an application filed on or after March 16, 2013, that discloses and claims only subject matter also disclosed in a previously filed pre-AIA application to which the application filed on or after March 16, 2013, is entitled to priority or benefit under 35 U.S.C. 119, 120, 121, or 365, an amendment (other than a preliminary amendment filed on the same day as such application) seeking to add a claim to a claimed invention that is directed to new matter would not convert the application into an AIA application.  35 U.S.C. 132(a) prohibits the introduction of new matter into the disclosure and thus an application may not actually "contain" a claim to a claimed invention that is directed to new matter.  The Office notes that the MPEP sets forth the following process for treating amendments that are believed to contain new matter: (1) a new drawing should not be entered if the examiner discovers that the drawing contains new matter (MPEP § 608.02); and (2) amendments to the written description or claims involving new matter are ordinarily entered, but the new matter is required to be cancelled from the written description and the claims directed to the new matter are rejected under 35 U.S.C. 112(a) (MPEP § 608.04).  This process for treating amendments containing new matter is purely an administrative process for handling an amendment seeking to introduce new matter into the disclosure of the invention in violation of 35 U.S.C. 132(a) and resolving disputes between the applicant and an examiner as to whether a new drawing or amendment to the written description or claims would actually introduce new matter.

In response to one comment suggesting that the rules should provide recourse in the situation where there has been an inadvertent addition of a claim, or a specific reference to a prior-filed application, that causes the application to be subject to AIA 35 U.S.C. §§ 102 and 103, the Office responded as follows (emphasis added):

There is no provision in the AIA for an application (or any patent issuing thereon) that contains, or contained at any time, such a claim or specific reference to be subject to pre-AIA 35 U.S.C. 102 and 103 instead of AIA 35 U.S.C. 102 and 103 on the basis of the claim or specific reference being submitted by inadvertence . . . .  As discussed previously, however, for an application filed on or after March 16, 2013, that discloses and claims only subject matter also disclosed in a previously filed pre-AIA application to which the application filed on or after March 16, 2013, is entitled to priority or benefit under 35 U.S.C. 119, 120, 121, or 365, an amendment (other than a preliminary amendment filed on the same day as such application) seeking to add a claim to a claimed invention that is directed to new matter would not convert the application into an AIA application.

In response to a related comment suggesting that the Office provide an applicant with the opportunity to cancel any claims to a claimed invention having an effective filing date before March 16, 2013 from the application, and file a divisional application directed to the cancelled subject matter to permit applicants to have the claims in the divisional application examined under pre-AIA 35 U.S.C 102 and 103, the Office responded as follows (emphasis added):

If an application on filing contains at least one claim having an effective filing date before March 16, 2013, and at least one claim having an effective filing date on or after March 16, 2013, the application will be examined under AIA even if the latter claims are cancelled.  However, if a pre-AIA parent application is pending and an applicant inadvertently files a continuing application with claims having an effective filing date on or after March 16, 2013, the applicant could file a continuation or divisional application from the pre-AIA parent application without any claim to the benefit of the AIA application and without any claim to a claimed invention having an effective filing date on or after March 16, 2013.  In this situation, the continuation or divisional application would be examined as a pre-AIA application under pre-AIA 35 U.S.C. 102 and 103.

The above responses from the Office suggest that if an applicant wants to have a transition application examined as a pre-AIA application under pre-AIA 35 U.S.C. §§ 102 and 103, the applicant must include claims directed only to subject matter disclosed in a previously filed pre-AIA application.  For this reason, applicants may also want to consider filing only one claim with a transition application.  In view of the Office's responses, any other claims or claim amendments should be presented after the filing date and not in a preliminary amendment filed on the same day as the transition application.  This is because claim amendments or new claims presented in an amendment other than a preliminary amendment filed on the same day as such application that are not supported by a pre-AIA application would be treated as new matter.  As the Office indicates in the final rule notice, "an application may not actually 'contain' a claim to a claimed invention that is directed to new matter," and therefore, "a claim to a claimed invention that is directed to new matter would not convert the application into an AIA application."  The final rule makes clear that if an application on filing contains at least one claim having an effective filing date on or after March 16, 2013, the application cannot be examined as a pre-AIA application under pre-AIA 35 U.S.C. §§ 102 and 103 simply by cancelling the claim having an effective filing date on or after March 16, 2013.  The final rule notice also makes clear that if a claim having an effective filing date on or after March 16, 2013 is inadvertently presented on filing, the application cannot be examined as a pre-AIA application under pre-AIA 35 U.S.C. §§ 102 and 103.

The final rule concludes with a discussion of rulemaking considerations (pages 106-128) and the text of the changed rules (pages 128-160).

USPTO Extends Comments Deadline, Will Hold Roundtables on RCE Practice

By Donald Zuhn --

In December, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 72830) seeking public feedback on Request for Continued Examination (RCE) practice.  The notice provided a series of questions for which the Office specifically was seeking comment:

(1) If within your practice you file a higher or lower number of RCEs for certain clients or areas of technology as compared to others, what factor(s) can you identify for the difference in filings?

(2) What change(s), if any, in Office procedure(s) or regulation(s) would reduce your need to file RCEs?

(3) What effect(s), if any, does the Office’s interview practice have on your decision to file an RCE?

(4) If, on average, interviews with examiners lead you to file fewer RCEs, at what point during prosecution do interviews most regularly produce this effect?

(5) What actions could be taken by either the Office or applicants to reduce the need to file evidence (not including an IDS) after a final rejection?

(6) When considering how to respond to a final rejection, what factor(s) cause you to favor the filing of an RCE?

(7) When considering how to respond to a final rejection, what factor(s) cause you to favor the filing of an amendment after final (37 CFR 1.116)?

(8) Was your after final practice impacted by the Office’s change to the order of examination of RCEs in November 2009? If so, how?

(9) How does client preference drive your decision to file an RCE or other response after final?

(10) What strategy/strategies do you employ to avoid RCEs?

(11) Do you have other reasons for filing an RCE that you would like to share?

According to the notice, feedback regarding RCE practice could be provided by submitting written comments by e-mail to rceoutreach@uspto.gov; by regular mail to the United States Patent and Trademark Office, Mail Stop Comments -- Patents, Office of Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Raul Tamayo; or by using the web-based collaboration tool IdeaScale®, which allows users to post comments, view and respond to others' comments, and indicate agreement or disagreement with particular comments.  At the time the notice was published, the deadline of submitting comments was February 4, 2013.  However, as indicated on the Office's RCE Outreach webpage, the deadline for submitting comments has now been extended to March 11, 2013.

In addition to requesting comments on RCE practice, the notice also indicated that the Office would be holding five roundtables on the topic.  The dates and locations of the roundtables have now been announced:

• February 20 -- Santa Clara University School of Law, Santa Clara, CA -- Roundtable from 9:00 to 11:00 am (PT) and focus session from 2:00 to 4:00 pm (PT)

• February 26 -- Southern Methodist University, Dedman School of Law, Dallas, TX -- Roundtable from 9:00 to 11:00 am (CT) and focus session from 2:00 to 4:00 pm (CT)

• February 28 -- New York University School of Law, New York, NY -- Roundtable from 9:00 to 11:00 am (ET) and focus session from 2:00 to 4:00 pm (ET)

• March 6 -- USPTO Headquarters, Alexandria, VA -- Roundtable from 9:00 to 11:00 am (ET) and focus session from 2:00 to 4:00 pm (ET)

• March 8 -- Chicago-Kent College of Law, Chicago, IL -- Roundtable from 9:00 to 11:00 am (CT) and focus session from 2:00 to 4:00 pm (CT)

The RCE Outreach webpage includes an invitation to participate in the roundtable and focus sessions on RCE practice.  According to the invitation, the Office's current analysis of RCE practice is aimed at "learn[ing] more about the root causes for RCE filings as a basis for the consideration and design of procedural modifications and educational initiatives to promote compact prosecution."  The Office notes that "[t]he purpose of this effort is not to eliminate RCE practice, or in any way disadvantage it, [b]ut rather, the purpose is to enable applicants to use RCE practice when needed, while avoiding it where equal or better options are available."  The roundtable/focus session portion of the RCE Outreach program consists of a series of roundtable discussions (of 75-100 people) and focus sessions (of 10-15 people) to "share ideas, feedback, experiences, and insights on RCE related prosecution strategies."

Those interested in participating in any of the roundtables or focus sessions can register by sending an e-mail message to rceoutreach@uspto.gov and providing the following information:  (1) Your name, title, and if applicable, company or organization, address, phone number, and e-mail address; (2) which event you wish to attend; (3) which session you wish to attend (i.e., roundtable and/or focus session); and (4) if you wish to make an oral presentation at the roundtable, the specific topic or issue to be addressed and the approximate desired length of your presentation.  Registration for the roundtables/focus sessions is requested by the following dates:  Santa Clara, CA -- February 15; Dallas, TX -- February 22; New York, NY --February 22; Alexandria, VA -- March 1; Chicago, IL -- March 1.

Although the Office has implemented several programs aimed at reducing the RCE backlog (which currently numbers more than 103,000; see Patents Dashboard), the Office's request for comments and its announcement of roundtables/focus sessions on the topic suggests that the Office may now be turning to its stakeholders for ways to decrease the RCE backlog.  Of course, the Office's efforts to decrease the backlog by raising the cost of filing a first RCE to $1,200, and further raising the cost of filing subsequent RCEs to $1,700 (see "USPTO Publishes Final Rule Setting Patent Fees"), despite the fact that the Patent Public Advisory Committee (PPAC) called such fees "illogical" (see "PPAC Issues Report on USPTO Patent Fees Proposal"), might leave some stakeholders with doubts.

Additional information regarding the Office's efforts to address the RCE backlog can be found on the RCE Outreach webpage and in the Office's Federal Register notice (see also "USPTO Seeks Public Feedback on RCE Practice").

USPTO News Briefs

By Donald Zuhn -- 

USPTO Seeks Comments on Patent Law Harmonization

Last week, the U.S. Patent and Trademark Office issued a notice in the Federal Register (78 Fed. Reg. 7411) seeking comments on matters related to the harmonization of substantive patent law.  In particular, the Office indicated that it was seeking input from the public regarding four topics:

(1) The grace period,
(2) publication of applications,
(3) the treatment of conflicting applications, and
(4) prior user rights.

The notice also indicated that the Office would be holding a public hearing from 8:30 am to 12:00 pm (EDT) on March 21, 2013, to permit members of the public to testify on the above issues.  The hearing will be held at the Madison Auditorium on the USPTO campus in Alexandria, Virginia.  Those wishing to testify at the hearing can request an opportunity to do so by e-mailing IP.Policy@uspto.gov no later than February 28, 2013.  Requests to testify at must include: (1) The name of the person desiring to testify; (2) the person's contact information (telephone number and e-mail address); (3) the organizations the person represents, if any; and (4) a preliminary written copy of their testimony.  The Office plans to webcast the public hearing, and information regarding the webcast will be made available closer to the hearing date.

With respect to the submission of comments, the Office noted that while separate written comments would be accepted, the Office encouraged interested stakeholders to complete an electronic questionnaire relating to the above issues instead.  Written comments can be sent by e-mail to IP.Policy@uspto.gov, or by regular mail addressed to:  Mail Stop OPEA, P.O. Box 1450, Alexandria, VA 22313–1450, ATTN: Bijou Mgbojikwe, with the text "Harmonization issues" in the subject line of the e-mail or regular mailing.  The deadline for submitting written comments is February 28, 2013.  However, in lieu of written comments, the Office is asking the public to complete a questionnaire that is available here.

The USPTO's effort to obtain stakeholder input on patent law harmonization arises out of a July 2011 meeting in Tegernsee, Germany of representatives from the patent offices of Denmark, France, Germany, Japan, the United Kingdom, the United States, and the European Patent Office -- or the "Tegernsee Group" -- to discuss international harmonization of substantive patent law.  The Tegernsee Group mandated detailed studies on the four topics above and collaboratively developed a joint harmonization questionnaire to aid in the acquisition and analysis of stakeholder views across jurisdictions on these issues.

USPTO Releases Patent Term Calculator

In January, the U.S. Patent and Trademark Office announced the release of the beta version of a patent term calculator, which allows for the estimation of the expiration date of a utility, plant, or design patent.  The calculator, which is in the form of an Excel spreadsheet, can be downloaded here.  Guidance as to how to best use the tool, including a guide for locating information to be entered into the calculator, can be found on the patent term calculator webpage.

In its press release, the Office notes that the calculator "provides a best estimate of a patent's expiration date, based on a comprehensive list of factors than can be found in USPTO records," and that "[b]efore relying on an expiration date, individuals should always carefully inspect all relevant documents available through the USPTO, court records and elsewhere, and consult with an attorney."

Patent Docs thanks Kery Fries of the USPTO's Office of Patent Legal Advisor and Office of Deputy Commissioner for Patent Examination Policy for alerting us to the new tool.

USPTO Extends PPH with IPO

Last month, the U.S. Patent and Trademark Office announced that the Patent Prosecution Highway (PPH) pilot program with the Icelandic Patent Office (IPO) would be extended indefinitely.  As with other PPH programs, the USPTO-IPO PPH permits an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from either the USPTO or IPO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office.

The USPTO currently has twenty-two PPH programs (full or pilot) in place with IP Australia (IP AU), the Austrian Patent Office (APO), the Canadian Intellectual Property Office (CIPO), China's State Intellectual Property Office (SIPO), the Colombian Superintendence of Industry and Commerce (SIC), the Industrial Property Office of the Czech Republic (IPOCZ), the Danish Patent and Trademark Office (DKPTO), the European Patent Office (EPO), the National Board of Patents and Registration of Finland (NBPR), the German Patent and Trade Mark Office (DPMA), the Hungarian Intellectual Property Office (HIPO), the Icelandic Patent Office (IPO), the Israel Patent Office (ILPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the Mexican Institute of Industrial Property (IMPI), the Norwegian Industrial Property Office (NIPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Intellectual Property Office of Singapore (IPOS), the Spanish Patent and Trademark Office (SPTO), the Taiwan Intellectual Property Office (TIPO), and the United Kingdom Intellectual Property Office (UK IPO).  The USPTO has also established twelve PCT-PPH programs with other patent offices:  IP AU, APO, SIPO, EPO, NBPR, ILPO, JPO, KIPO, the Nordic Patent Institute (NPI), ROSPATENT, SPTO, and the Swedish Patent and Registration Office (PRV).  Additional information regarding the various PPH and PCT-PPH programs, as well as links to the appropriate request forms to be used for each program, can be found here.

USPTO Publishes Final Rule Setting Patent Fees

By Donald Zuhn --

Last Friday, the U.S. Patent and Trademark Office published a final rule in the Federal Register (78 Fed. Reg. 4212) setting and adjusting certain patent fees pursuant to the Office's fee-setting authority under § 10 of the Leahy-Smith America Invents Act.  The publication of the 80-page final rule (nearly) culminates a process that began last February when the Office submitted a proposed fee schedule to the Patent Public Advisory Committee (PPAC).  PPAC the held two public hearings on the proposed schedule, and in September issued a report on that schedule.  Following consideration of PPAC's report, the published a notice of proposed rulemaking setting and adjusting certain patent fees, which initiated a 45-day comment period that ended in November.  Although the AIA allows the new fee schedule to take effect 45 days after publication (i.e., March 4, 2013), in order to give Congress an opportunity to review the schedule, the notice indicates that the final rule will take effect on March 19, 2013, except for the following amendments, which will take effect on January 1, 2014:

§ 1.18(a)(1), (b)(1), (c)(1), and (d)(1) – patent issue and publication fees
§ 1.21(h)(1) – fee for recording a patent assignment electronically
§ 1.482(a)(1)(i)(A), (a)(1)(ii)(A), and (a)(2)(i) – international application filing, processing and search fees)
§ 1.445(a)(1)(i)(A), (a)(2)(i), (a)(3)(i), and (a)(4)(i) – international application transmittal and search fees

In September, we posted several tables listing the fees for large entities that were proposed to change (see "More on USPTO's Proposed New Fees - Part II").  One table sorted the fees as they might be paid during the course of prosecution, another sorted the fees by amount, and a third table sorted the fees by dollar and percent change.  Because only seven of the patent fees for large entities changed from the notice of proposed rulemaking to the final rule, the table below lists the fees as they might be paid during the course of prosecution, with the current fee, proposed fee, final fee, and dollar change from the proposed fee to the final fee (click on table to enlarge):

USPTO Seeks Public Input on Application Drafting Practices

By Donald Zuhn --

The U.S. Patent and Trademark Office published a notice in the Federal Register (78 Fed. Reg. 2960) earlier today requesting public comment regarding potential practices that applicants can employ in the drafting of patent applications to facilitate examination and bring more certainty to the scope of issued patents.  Although the instant notice is directed to potential practices that applicants can employ, the notice indicates that the Office intends to issue a separate notice identifying potential practices that the Office can employ to also facilitate examination and bring more certainty to the scope of issued patents.

Today's notice sets forth a list of nine "potential practice changes that applicants can employ to augment the quality of issued patents" and seeks input as to whether any of the practices should be used by applicants during the preparation of an application to place the application in a better condition for examination.  The list of practices is divided into two groups, one group related to clarifying the scope of the claims and one group related to clarifying the meaning of claim terms in the specification.  The first group of potential practices includes:

1.  Presenting claims in a multi-part format by way of a standardized template that places each claim component in separate, clearly marked, and designated fields (e.g., preamble, transitional phrase, and individual claim limitations).

2.  Identifying corresponding support in the specification for each of the claim limitations (e.g., using a claim chart).

3. Indicating whether examples in the specification are intended to be limiting or merely illustrative.

4.  Identifying whether the claim preamble is intended to be a limitation on claim scope.

5.  Expressly identifying clauses within particular claim limitations for which the inventor intends to invoke 35 U.S.C. § 112(f) (which pertains to means-plus-function limitations for applications filed on or after September 16, 2012) and pointing out where in the specification corresponding structures, materials, or acts are disclosed that are linked to the identified § 112(f) claim limitations.

6.  Using textual and graphical notation systems known in the art to disclose algorithms in support of computer-implemented claim limitations, such as C-like pseudo-code or XML-like schemas for textual notation and Unified Modeling Language (UML) for graphical notation.

The second group of practices includes:

1.  Indicating whether terms of degree -- such as substantially, approximately, about, essentially -- have a lay or technical meaning and explaining the scope of such terms.

2.  Including in the specification a glossary of potentially ambiguous, distinctive, and specialized terms used in the specification and/or claims.

3.  Designating, at the time of filing the application, a default dictionary or dictionaries to be used in ascertaining the meaning of the claim terms.

Comments can be sent by e-mail to QualityApplications_Comments@uspto.gov, or by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Nicole D. Haines.  The deadline for submitting comments in response to the notice is March 15, 2013.

USPTO Extends Missing Parts Pilot Program Again

By Donald Zuhn --

In a Federal Register notice published earlier today (78 Fed. Reg. 2256), the U.S. Patent and Trademark Office announced that the Extended Missing Parts Pilot Program that was implemented two years ago would be extended for another year.  The pilot program allows applicants to request a twelve-month extension to pay the search fee, examination fee, any excess claim fees, and surcharge for late submission of the search and examination fees in a nonprovisional application.  The notice indicates that the pilot program benefits applicants by providing additional time to determine if patent protection should be sought and focus on commercialization efforts, benefits the public by adding publications to the prior art, and benefits the Office by removing nonprovisional applications that applicants decline to pursue from its workload.  The pilot program has been extended through December 31, 2013.

In December 2010, the Office implemented the Extended Missing Parts Pilot Program, noting that it would "effectively provide a 12-month extension to the existing 12-month provisional application period, providing applicants additional time to find financial help, evaluate a product's worth in the marketplace or further develop the invention for commercialization" (see "USPTO Implements Pilot Program Extending Provisional Application Period").  The Office initially sought comments regarding the program in April 2010 (see "USPTO Seeks to Effectively Double Provisional Application Period").  Under the pilot program, the Office modified its missing parts practice -- which permits an applicant to pay the filing fees and submit an executed oath or declaration after the filing of a nonprovisional application within a two-month time period that is extendable for an additional five months on payment of extension of time fees -- such that applicants would file a nonprovisional application with at least one claim within the 12-month statutory period after the provisional application was filed (as well as pay the basic filing fee, submit an executed oath or declaration, and not file a nonpublication request) and then be given a 12-month period within which to decide whether the nonprovisional application should be completed by paying the required surcharge and the search, examination, and any excess claim fees.

Applicants wishing to participate in the pilot program must satisfy the following requirements:

(1) submit a certification and request to participate in the program at the time of filing of a nonprovisional application (preferably using Form PTO/AIA/421);
(2) the application must be an original (not reissue) nonprovisional utility or plant application filed under 35 U.S.C. 111(a);
(3) the nonprovisional application must directly claim the benefit under 35 U.S.C. § 119(e) and 37 C.F.R. § 1.78 of a prior provisional application filed within the previous twelve months, with the specific reference to the provisional application being made in an application data sheet; and
(4) the applicant must not have filed a nonpublication request.

The pilot program was first extended in December 2011 (see "USPTO's Extended Missing Parts Pilot Program Is Extended").  In today's notice regarding the extension of the pilot program, the Office:

[C]autions all applicants that, in order to claim the benefit of a prior provisional application, the statute requires a nonprovisional application filed under 35 U.S.C. 111(a) to be filed within twelve months after the date on which the corresponding provisional application was filed.  See 35 U.S.C. 119(e).  It is essential that applicants understand that the Extended Missing Parts Pilot Program cannot and does not change this statutory requirement.

The form for requesting participation in the program (PTO/AIA/421) also outlines the PTA effects of participation in the program, stating that:

Any patent term adjustment (PTA) accrued by applicant based on certain administrative delays by the USPTO is offset by a reduction for failing to reply to a notice by the USPTO within three months.  See 37 CFR 1.704(b).  Thus, if applicant replies to a notice to file missing parts more than three months after the mailing date of the notice, the additional time that applicant takes to reply to the notice will be treated as an offset to any positive PTA accrued by the applicant.

In addition, under the pilot program, nonprovisional applications are still published according to the existing eighteen-month publication provisions.  More importantly, the Office "advises" that:

[T]he extended missing parts period does not affect the twelve-month priority period provided by the Paris Convention for the Protection of Industrial Property (Paris Convention).  Thus, any foreign filings must still be made within twelve months of the filing date of the provisional application if applicant wishes to rely on the provisional application in the foreign-filed application or if protection is desired in a country requiring filing within twelve months of the earliest application for which rights are left outstanding in order to be entitled to priority.

Perhaps in a nod to the first-inventor-to-file (FITF) provisions of the Leahy-Smith America Invents Act -- and in particular to AIA § 3(n), which applies the FITF provisions to any application filed on or after March 16, 2013 that contains or contained at any time a claim having an effective filing date that is on or after March 16, 2013 -- the Office's most recent notice states that:

While only one claim is required in a nonprovisional application for filing date purposes and applicant may file an amendment adding additional claims later during prosecution, applicant should consider the benefits of submitting a complete set of claims on filing of the nonprovisional application.  This would reduce the likelihood that any claims added later during prosecution might be found to contain new matter.

Where an applicant participating in the program fails to pay the basic filing fee, provide an executed oath or declaration, or submit application papers that are in condition for publication -- i.e., comply with the requirements for participation in the program (which are essentially the requirements for publication of the application) -- the applicant is given a two-month (extendable) time period within which to supply those items.  In the notice regarding the second extension of the pilot program, the Office notes that applications that are not filed electronically will still be assessed a $400 additional fee (or $200 for small entities) pursuant to the AIA, that this fee will be due within the two-month (extendable) time period to reply to the Notice to File Missing Parts of Nonprovisional Application, and that applicants will not be given the 12-month time period under the pilot program to pay this fee.

USPTO News Briefs

By Donald Zuhn --

USPTO and EPO Announce Formal Launch of Cooperative Patent Classification System

On January 2, both the U.S. Patent and Trademark Office and European Patent Office announced the formal launch of the Cooperative Patent Classification (CPC) system, a global classification system for patent documents (see USPTO press release and EPO press release).  In September, the two offices has announced the publication of an advanced version of the CPC scheme and some final CPC definitions ahead of the last week's official launch (see "USPTO and EPO Announce Launch of Cooperative Patent Classification System").

The CPC is a detailed classification system that includes approximately 250,000 classification symbols based on the International Patent Classification (IPC), which is administered by the World Intellectual Property Organization (WIPO).  The new classification system, which incorporates the best classification practices of both the U.S. and European systems, will enable efficient prior art searches to be conducted and is also expected to enhance efficiency by supporting work-sharing initiatives designed to reduce unnecessary work duplication.  The USPTO noted that the CPC "will be used by the USPTO and more than 45 patent offices -- a user community totaling more than 20,000 patent examiners -- all sharing the same classifications helping to establish the CPC as an international standard."

Building on the CPC launch package, which included the complete CPC scheme, 59 of the 625 final CPC definitions, and a CPC-to-IPC concordance, the USPTO and EPO provided updates to the CPC definitions on November 9 and December 17, 2012.

USPTO Establishes Permanent PPH Program with TIPO

Last month, the U.S. Patent and Trademark Office announced that it was establishing a permanent Patent Prosecution Highway (PPH) program with the Taiwan Intellectual Property Office (TIPO), effective as of September 1, 2012.  The establishment of the permanent PPH program comes one year after the USPTO announced the establishment of a PPH pilot program between the USPTO, as the designated representative of the American Institute in Taiwan (AIT), and the Taiwan Intellectual Property Office (TIPO), as the designated representative of the Taipei Economic and Cultural Representative Office (TECRO) in the United States (see "USPTO News Briefs," September 1, 2011).

As with other PPH programs, the USPTO-TIPO PPH permits an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from either the USPTO or TIPO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office.  Information regarding the full implementation of the USPTO-TIPO PPH can be found here.

USPTO Selects Site of Dallas-Fort Worth Satellite Office

In a press release issued in November, the U.S. Patent and Trademark Office announced that it had selected the Terminal Annex Federal Building as the site of the Dallas-Fort Worth satellite office.  The Dallas-Fort Worth satellite office is one of three satellite offices the USPTO plans to open in addition to the satellite office that was opened in Detroit in July (see "USPTO to Open Three More Satellite Offices").  In opening the additional satellite offices, the USPTO is exercising its authority under to § 23 of the Leahy-Smith America Invents Act to establish three or more satellite offices in the United States by September 16, 2014, subject to available resources.  The USPTO noted that the Terminal Annex Federal Building is located along the southern edge of Dealey Plaza, which was the location of the assassination of President John F. Kennedy on November 22, 1963 (see image at right; the Terminal Annex Federal Building is the building in the lower right hand corner).  Last August, the USPTO announced that the Denver satellite office would be located in the Byron G. Rogers Federal Building.

Image of Dealey Plaza in Dallas, TX from 1995 or 1996 (above) by Father of Nehrams2020, from the Wikipedia Commons under the Creative Commons Attribution-Share Alike 3.0 Unported license.

Top Three Stories of 2012

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  On Monday, Tuesday, and Wednesday we counted down stories #15 to #4, and today we count down the top three stories of 2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

3.  Implementation of Leahy-Smith America Invents Act Continues

The U.S. Patent and Trademark Office began the year by publishing five notices of proposed rulemaking in January to implement various provisions of the Leahy-Smith America Invents Act.  Another four notices of proposed rulemaking and a practice guide for proposed trial rules were published in February.  Over the summer, the Office issued three more notices of proposed rulemaking and a guidance document on the first-inventor-to-file (FITF) provisions of the AIA.  In July, the Office began issuing final rules to implement AIA provisions, with the final rules corresponding to the notices of proposed rulemaking issued earlier in the year.  By mid-August, the Office had issued eight final rules and a patent trial practice guide.  The Office also held a roundtable in September to obtain public input on issues relating to the Office's proposed rules to implement the first-inventor-to-file provisions of the AIA.  In February, the Office started to exercise its new fee setting authority under the AIA by submitting a proposed fee schedule to the Patent Public Advisory Committee (PPAC), with the PPAC holding two public hearings on the proposed schedule.  In September, the PPAC issued a report on the proposed schedule, which the Director considered before publishing a notice setting and adjusting certain patent fees.  The publication of the proposed fee schedule initiated a 45-day comment period, which ended in November.  The Office is expected to publish a final notice on fees in the coming weeks, with the fee schedule taking effect 45 days after publication (to provide Congress with an opportunity to review the schedule).  Earlier in the year, the Office issued AIA-mandated reports on the prior user rights defense provisions of the AIA and on international patent protections for small businesses.  While the Office collected public comments on genetic diagnostic testing and held two public hearings on the matter, the Office was unable to meet the deadline for submitting its AIA-mandated report on genetic diagnostic testing to Congress (and, in fact, has scheduled a roundtable on January 10 to discuss the topic further).  The Office also opened its first satellite office in Detroit, and after considering public input on locations for additional satellite offices, announced that it would be opening three additional offices in Dallas, TX; Denver, CO; and California's Silicon Valley.  Throw in a series of AIA roadshows, webinars, and a Twitter chat, and it has been a busy year for the Office as it implements changes brought about by the AIA, and for applicants and practitioners as they try to keep up with these changes.  And FITF is only 72 days away.

For information regarding this and other related topics, please see:

• "USPTO Issues Final Rule Implementing Micro Entity Status," December 26, 2012
• "USPTO News Briefs," December 20, 2012
• "USPTO to Hold Roundtable on Genetic Diagnostic Testing," December 4, 2012
• "IPO Submits Comments on Proposed Fees," November 14, 2012
• "USPTO Holds Live Chat on AIA," November 13, 2012
• "USPTO News Briefs," October 30, 2012
• "PPAC Issues Report on USPTO Patent Fees Proposal," October 9, 2012
• "Rules Changes Implementing the Inventor's Oath or Declaration Provisions of the AIA," October 4, 2012
• "More on USPTO's Proposed New Fees - Part II," September 19, 2012
• "More on USPTO's Proposed New Fees," September 11, 2012
• "USPTO Proposes New Patent Fees and CPI Adjustments to Certain Fees," September 6, 2012
• "USPTO News Briefs," September 5, 2012
• "USPTO News Briefs," August 27, 2012
• "USPTO Issues Several Final Rules for Implementing AIA Provisions," August 15, 2012
• "USPTO Issues Final Rule to Implement Miscellaneous Post Patent Provisions of AIA," August 8, 2012
• "USPTO Issues Final Rule for Implementing Statute of Limitations Provisions for Office Disciplinary Proceedings," July 31, 2012
• "USPTO Issues Final Rule for Preissuance Submissions," July 25, 2012
• "USPTO to Open Three More Satellite Offices," July 2, 2012
• "Docs at BIO: Session on Prior User Rights as a New IP Option," June 20, 2012
• "USPTO Report on Genetic Testing Delayed," June 18, 2012
• "BIO International Convention 2012 Preview - Part III: BIO and the America Invents Act," June 14, 2012
• "USPTO Issues Proposed Rules for Implementing Micro Entity Status," June 4, 2012
• "USPTO News Briefs," May 23, 2012
• "USPTO Posts Comments on Genetic Diagnostic Testing," May 22, 2012
• "USPTO Posts Comments on Proposed Fees Changes," March 19, 2012
• "A Glimpse under the Hood: How the USPTO Proposes to Adjust Patent Fees," March 14, 2012
• "USPTO Proposes Fees Changes," March 1, 2012
• "USPTO News Briefs," February 20, 2012
• "USPTO Holds First Hearing on "Second Opinion" Genetic Testing," February 16, 2012
• "Patent Docs Author Testifies at Genetic Diagnostic Testing Hearing," February 16, 2012
• "USPTO to Hold Hearing on Genetic Diagnostic Testing," February 15, 2012
• "USPTO Proposes More Rules for Implementing AIA Provisions," February 13, 2012
• "USPTO Issues Proposed Rulemaking for Supplemental Examination Provisions of AIA," February 8, 2012
• "PPAC to Hold Public Hearings on Proposed Fee Schedule," February 1, 2012
• "Interpreting 35 U.S.C. § 102 under the America Invents Act," January 31, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Oath or Declaration Provisions," January 30, 2012
• "USPTO News Briefs," January 26, 2012
• "USPTO News Briefs," January 18, 2012
• "USPTO Issues Report on Prior User Rights," January 17, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Statute of Limitations Provisions for Office Disciplinary Proceedings," January 16, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Preissuance Submissions Provision," January 12, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Miscellaneous Post Patent Provisions," January 11, 2012

2.  Supreme Court Grants Certiorari in AMP v. Myriad

Six days after issuing its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court issued an Order granting the petition for writ of certiorari in Association for Molecular Pathology v. Myriad, vacating the judgment, and remanding the case back to the Federal Circuit for further consideration in light of the Mayo decision.  As we noted yesterday, the Federal Circuit decided on remand that claims to isolated human DNA satisfy the requirements of 35 U.S.C. § 101, with each member of the panel issuing opinions that tracked their earlier opinions (the Federal Circuit's decision placed #5 on our 2012 list of top stories).  In September, the American Civil Liberties Union (ACLU) and Public Patent Foundation (PubPat) again filed a petition for certiorari with the Supreme Court, which the Court granted on November 30.  The Court's grant was limited to the first question presented -- whether human genes are patent-eligible -- and the Court denied certiorari on the other two questions (thus letting stand the Federal Circuit's determination that screening methods using genetically transformed cells are patent-eligible under the Court's Mayo v. Prometheus precedent, and that a declaratory judgment plaintiff must cite actual injury to have standing).  The Supreme Court's grant of certiorari in AMP v. Myriad ensures that this case will be a top story again in 2013.

For information regarding this and other related topics, please see:

• "Supreme Court Grants Cert in AMP v. Myriad," November 30, 2012
• "Myriad Files Responsive Brief Opposing Certiorari," November 29, 2012
• "AMP v. Myriad Briefed and Distributed for Conference - Update," November 19, 2012
• "AMP v. Myriad Briefed and Distributed for Conference," November 13, 2012
• "Plaintiffs (Again) File Certiorari Petition in Myriad Case," September 25, 2012
• "Patent Eligibility and Biology," August 23, 2012
• "The Proper Scope of DNA (or 'Gene') Patent Claims," August 1, 2012
• "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29, 2012
• "The Aussies Are At It Again," June 14, 2012
• "Supreme Court Remands Myriad Case," March 26, 2012

1.  Supreme Court Issues Decision in Mayo v. Prometheus

On March 20, the Supreme Court unanimously held in Mayo Collaborative Services v. Prometheus Laboratories, Inc. that claims directed to the relationship between the concentrations of blood metabolites and response to a therapeutic drug were invalid for "effectively claim[ing] underlying laws of nature themselves."  In the nine months since the Supreme Court issued its decision, applicants and practitioners have tried to gauge the impact of the decision and have asked whether claims perceived to be directed to "laws of nature" can, in fact, be written to pass Constitutional muster.  The U.S. Patent and Trademark Office responded to the Mayo decision by issuing preliminary guidance on the day after the decision, and then followed up with interim guidance in July.  It did not take the lower courts long to apply Mayo, with the District Court for the District of Columbia in SmartGene, Inc. v. Advanced Biological Laboratories SA invalidating diagnostic method claims in view of Mayo only ten days after the Supreme Court issued its decision.  In November, the Federal Circuit made its "first" attempt to implement the Supreme Court's jurisprudence on the scope of patent eligibility for diagnostic method claims in PerkinElmer, Inc. v. Intema Ltd. (we did not count the Federal Circuit's decision on remand in AMP v. Myriad, as the diagnostic method claims in that case had already been held patent-ineligible under the "machine-or-transformation" test set forth in In re Bilski).  As we wrote at the time, PerkinElmer stands as the most recent cautionary tale of how diagnostic methods claims must be crafted -- narrow, specific, encompassing particular assaying and detection steps, and encompassing some (any) patentable feature other than the naturally occurring correlation between a marker and disease.  Whether this will be sufficient to render the subject matter of such claims as patent-eligible remains an open question.

For information regarding this and other related topics, please see:

• "PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)," November 20, 2012
• "Patent Eligibility and Biology," August 23, 2012
• "Chief Judge Rader (Not Surprisingly) Gets it Right about Chimerical 'Tragedy of the Anti-Commons,'" August 6, 2012
• "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29, 2012
• "USPTO Issues Interim Guidance Regarding Mayo v. Prometheus," July 5, 2012
• "BIO International Convention 2012 Preview: BIO and the Prometheus Supreme Court Case," June 5, 2012
• "Do Diagnostic Method Claims Fall under the Safe Harbor of 35 U.S.C. § 287(c)?" April 11, 2012
• "SmartGene, Inc. v. Advanced Biological Laboratories SA (D.D.C. 2012)," April 10, 2012
• "USPTO Issues Preliminary Guidance on Mayo v. Prometheus," March 27, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories -- What Should We Do? (or Can These Claims Be Saved?)," March 26, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories -- What the Court's Decision Means," March 22, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories -- What the Supreme Court Said," March 21, 2012
• "Early Reaction to Supreme Court Decision in Mayo v. Prometheus," March 20, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)," March 20, 2012

Image of New Year's Eve ball drop for 2012 in Times Square (above) by Replytojain, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.

Top Stories of 2012: #8 to #11

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  Yesterday, we counted down stories #15 to #12, and today we count down stories #11 to #8 as we work our way towards the top three stories of 2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

11.  Patent Law Changes Abroad

In December, the European Parliament adopted two draft regulations on the creation of the unitary patent, and an agreement establishing the Unified Patent Court (UPC), a specialized court having exclusive jurisdiction over infringement and validity questions related to unitary patents, is expected to be signed next month.  The European Union, however, was not the only governing body making patent news abroad.  In Australia, significant amendments were made to that country's patent laws through enactment of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, with the new provisions scheduled to take effect on April 15, 2013.  Those provisions will raise Australia's patentability threshold and specification requirements, and are intended to raise the quality of granted patents in Australia to a level that is more consistent with the standards set in the U.S., Japan, and Europe.  In Israel, the adoption of a set of amendments to the Israel patent statute establish 18-month publication, submission of prior art by third parties, and third party requests for expedited examination of patent applications.

For information regarding this and other related topics, please see:

• "Parliament Approves EU Unitary Patent Package," December 17, 2012
• "European Parliament Adopts Draft Regulations on Unitary Patent," December 12, 2012
• "Unitary Patent & Unified Patent Court," December 12, 2012
• "Progress for Single European Patent and Litigation System," November 12, 2012
• "Australia Reforms Its Patents Act 1990," August 29, 2012
• "Recent Amendments to the Israel Patent Statute: Pulling the Pace of Prosecution from the Purview of the Applicant," August 7, 2012
• "EU Patent Is Finally Born," July 2, 2012

10.  Federal Circuit Issues Fractured En Banc Decision on Divided Infringement Cases

On August 31, the Federal Circuit issued its en banc decision in Akamai Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc. v. Epic Systems Corp., reversing the District Court in both cases and remanding for reconsideration.  A majority consisting of Chief Judge Rader and Circuit Judges Lourie, Bryson, Moore, Reyna, and Wallach (with Circuit Judges Newman, Linn, Dyk, Prost, and O'Malley dissenting) expressly overruled BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007), which held that there must be a single actor (or a second actor acting under the control of another) for infringement to lie.  According to the majority, all the steps of the claimed method still need to be performed, but it is not necessary to prove a "single entity" performed them.  The majority opinion, if upheld, would be a boon for biotechnology, if only because it would provide another way for claim drafters to protect diagnostic method claims.  However, it is unlikely that the Supreme Court will deny certiorari in a case of statutory construction where the Federal Circuit is so plainly fractured.  (According to the Supreme Court's website, the deadline for filing a petition for a writ of certiorari was December 28, 2012.)

For information regarding this and other related topics, please see:

• "Akamai Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc. v. Epic Systems Corp. (Fed. Cir. 2012) (en banc)," September 4, 2012

9.  More USPTO PTA Interpretations Questioned

In 2012, the District Courts for the District of Columbia and the Eastern District of Virginia sided with a number of patentees in determining that certain practices used by the U.S. Patent and Trademark Office in determining Patent Term Adjustment (PTA) were improper.  In ArQule, Inc. v. Kappos, the District Court for the District of Columbia found that the Office's practice of counting weekends and holidays as applicant delay under 37 C.F.R. § 1.704(b) (while permitting responses filed by the next business day to be considered timely under 35 U.S.C. § 21(b)) was improper.  In Exelixis, Inc. v. Kappos, the Eastern District of Virginia disagreed with the Office's practice of negating B delay in circumstances where an applicant had responded to a final rejection by filing a request for continued examination (RCE).  According to the District Court, the statute "makes [it] clear that once the three year clock has run, PTA is to be awarded on a day for day basis regardless of subsequent events" in the Court's view.  As a result, RCEs filed after the three-year date should not toll the amount of B-Delay to be awarded to the patentee.  The District Court for the District of Columbia adopted the rationale of the Eastern District of Virginia in Novartis AG v. Kappos, finding that PTA should not be reduced by time attributable to an RCE where the RCE is filed after the expiration of the three year guarantee period specified in the statute.  The Court in Novartis, however, refused to toll the 180-day after issuance deadline for filing suit against the USPTO Director to challenge a PTA determination (for one of 23 patents at issue in the case, where the Office had failed to issue a determination on reconsideration within the 180-day period of 35 U.S.C. § 154(b)(4)(A), but Novartis had filed suit within 180 days of the Office's determination on reconsideration, the Court did toll the start of the 180-day period).  The Court issued a warning to patentees that may be dissatisfied with PTA determinations by the Office that are based on different theories than those presented in Wyeth, ArQule, or Exelixis, stating that "Novartis was free to raise the same issues that Wyeth and Abbott Laboratories raised in their lawsuits within the 180 days after their patents were granted."

For information regarding this and other related topics, please see:

• "Novartis AG v. Kappos (D.D.C. 2012)," November 27, 2012
• "Exelixis, Inc. v. Kappos (E.D. Va. 2012)," November 8, 2012
• "ArQule v. Kappos: Enjoy Your Weekend, or What a Difference a Day (or Two or Three) of PTA Can Make," October 1, 2012
• "USPTO Proposes Change to PTA Provisions Regarding Appellate Review," January 9, 2012

8.  Supreme Court to Resolve Circuit Split on Reverse Payment Settlement (Pay-for-Delay) Agreements

Last month, the Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with certiorari petitions before the Court relating to reverse payment settlement (or pay-for-delay) agreements in ANDA litigation under the Hatch Waxman Act.  The Court's decision to grant certiorari marks the culmination of almost a decade of effort by the Federal Trade Commission to get a reverse payment case before the Court.  What clinched the effort this time was the decision in the K-Dur case by the Third Circuit in favor of the FTC's position, finding such settlements to be presumptively anticompetitive and subject to a "rule of reason" antitrust analysis.  This result was contrary to decisions in the 11th Circuit (Valley Drug Co. v. Geneva Pharmaceuticals, Inc., 344 F.3d 1294 (11th Cir. 2003) and Schering-Plough Corp. v. Federal Trade Commission, 402 F.3d 1056 (11th Cir. 2005)); 2nd Circuit (In re Tamoxifen Citrate Antitrust Litigation, 466 F.3d 187 (2d Cir. 2006) and Arkansas Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98, 105 (2d Cir. 2010)); and the Federal Circuit (In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323 (Fed. Cir. 2008)) that such agreements are legal provided that they stay within the legitimate bounds of the patent grant (applying the "scope of the patent" test).  (It should be noted that the lone appellate exception (before K-Dur), In re Cardizem CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003), involved different facts leading to the conclusion that there was anticompetitive behavior.)

For information regarding this and other related topics, please see:

• "Supreme Court to Review Reverse Payment Settlement Agreements," December 9, 2012
• "FTC Moves as Amicus in Effexor Litigation, and Gets Its (Well-Earned) Comeuppance," October 18, 2012
• "FTC Asks Supreme Court to Play Favorites in Reverse Payment Settlement Agreement Cases," October 16, 2012
• "Amici File Briefs Supporting Certiorari in K-Dur Case -- Part II," October 10, 2012
• "Amici File Briefs Supporting Certiorari in K-Dur Case," October 8, 2012
• "GPhA Files Amicus Brief in K-Dur Case," October 3, 2012
• "Bayer Files Amicus Brief in K-Dur Case," September 27, 2012
• "PhRMA Files Amicus Brief in K-Dur Case," September 26, 2012
• "Should Presumptions Be Avoided in the Reverse Payment Debate?" September 21, 2012
• "Generic Defendant Petitions for Certiorari in K-Dur Litigation," September 17, 2012
• "Merck Asks Supreme Court to Review Third Circuit K–Dur Decision," August 28, 2012
• "The Federal Trade Commission Finally Wins One," July 18, 2012
• "Federal Trade Commission v. Watson Pharmaceuticals, Inc. (11th Cir. 2012)," April 30, 2012
• "Latest Legislative Attempt on Reverse Payment ANDA Settlements," February 27, 2012

Image of New Year's Eve ball drop for 2012 in Times Square (above) by Replytojain, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.

Top Stories of 2012: #12 to #15

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  Today, we count down stories #15 to #12, and then throughout the week, we will work our way towards the top three stories of 2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

15.  USPTO Continues Efforts to Cut Application Backlog and Pendency

In November, the U.S. Patent and Trademark Office released its Performance and Accountability Report for Fiscal Year (FY) 2012, which indicated that the Office had met all of its annual performance targets.  For one of those targets -- average total pendency -- the Office not only hit its target by achieving a 32.4-month pendency (versus the target of 34.7 months), but it surpassed the average pendency achieved in each of the three previous fiscal years.  The Office also noted that despite an increase in application filings (565,566 in FY 2012 versus 537,171 in FY 2011), the number of applications awaiting action dropped from 690,967 in FY 2011 to 633,812 in FY 2012 (the fourth consecutive year that the number of applications awaiting action had dropped) and the total number of pending applications decreased from 1,168,928 in FY 2011 to 1,157,147 in FY 2012.  However, despite the improving numbers, the Office has continued to seek ways in which to cut the application backlog and application pendency.  One issue on which the Office has focused its attention recently is the rising number of Requests for Continued Examination (RCEs).  Earlier this month, the Office published a notice in the Federal Register (77 Fed. Reg. 72830) seeking public feedback on RCE practice.  The notice, which indicated that the Office has a backlog of more than 90,000 applications that have not been examined since an RCE was filed, described some of the Office's efforts to reduce the RCE backlog, including the Quick Path Information Disclosure Statement (QPIDS) pilot program and the After Final Consideration Pilot (AFCP).  Not surprisingly, the notice does not discuss the Office's efforts to decrease RCE filings by raising the cost of filing a first RCE to $1,200 (from the current fee of $930), and further raise the cost of filing subsequent RCEs to $1,700, a proposal that the Patent Public Advisory Committee (PPAC) has called "illogical."  Comments to the Office's notice can be submitted until February 4, 2013 (see link below for information regarding the submission of comments).

For information regarding this and other related topics, please see:

• "USPTO Seeks Public Feedback on RCE Practice," December 13, 2012
• "USPTO News Briefs," June 21, 2012
• "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program," May 10, 2012
• "USPTO to Assess After Final Consideration Pilot Program," April 5, 2012

14.  USPTO and Applicants Deal with Intersection of Patent and Copyright Law

In January, the Office of the General Counsel for the U.S. Patent and Trademark Office issued a memorandum in response to several inquiries the Office had received concerning copyright infringement and the use of non-patent literature (NPL) in the examination process.  In that memo, USPTO General Counsel Bernard Knight, Jr. deemed the following practices to be protected by the doctrine of fair use:  (1) the Office's practice of making copies of copyrighted NPL and providing such copies to an applicant in the course of patent examination; (2) the Office's practice of providing certified copies of entire file histories, including copyrighted NPL, to members of the public for a fee; and (3) the copying of copyrighted NPL by patent applicants and their attorneys and the submission of those copies to the USPTO pursuant to the USPTO's disclosure requirements.  The memo was timely given separate lawsuits brought by a publishing company against two law firms in February.  (Because one of the firms is McDonnell Boehnen Hulbert & Berghoff LLP, where the Patent Docs authors and contributors work, Patent Docs has not provided any coverage of these cases.  However, former MBHB attorney Dennis Crouch has covered the cases on his Patently-O weblog; see here and here, for example.)

For information regarding this and other related topics, please see:

• "USPTO Issues Memo on Use of Non-Patent Literature During Examination," January 23, 2012

13.  Congress Works to "Correct and Improve" Leahy-Smith America Invents Act

On November 30, Rep. Lamar Smith (R-TX) introduced a bill (H.R. 6621) entitled "To correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code."  Demonstrating that you cannot judge a bill by its title, the legislation contained provisions having nothing to do with any of the AIA's provisions, including one that would have effectively eliminated patent rights for the ~200 pending U.S. patent applications having a filing date prior to June 7, 1995 (when legislation enabling the provisions to the Uruguay Rounds of the General Agreement on Tariffs and Trade (GATT) were enacted).  This section, however, was replaced with a provision requiring a report to Congress on the status of pre-GATT applications before the House passed the bill by a 308-89 vote, and even that changed section was replaced with a clerical amendment in the Senate version of the bill.  Following passage of the further amended bill by the Senate, the bill stalled back at the House when Rep. Bobby Scott (D-VA) objected to a vote on the grounds that a quorum was not present.

For information regarding this and other related topics, please see:

• "The Status Quo Reigns in Senate's Version of H.R. 6621," December 30, 2012
• "Congressional Corrections Regarding H.R. 6621," December 20, 2012
• "Congressional Misunderstandings (Apparently) Motivate H.R. 6621," December 20, 2012
• "The Plot Thickens around H.R. 6621," December 18, 2012
• "Pre-GATT Patent Applications Threatened by Lamar Smith's H.R. 6621," December 6, 2012

12.  Federal Circuit Defines Presumption of Enablement for Prior Publications

On July 27, the Federal Circuit issued a decision in In re Antor Corp. that increased the burden on proving patentability created by prior art references for patent applicants and patentees by defining a presumption of enablement not only for prior patents and published patent applications but also for all prior printed publications, regardless of source of provenance.  The Antor decision is likely to have important implications for practitioners attempting to provide patent protection for biotechnology-based inventions.  This is because the inventiveness of biotechnology inventions is often assessed in view of prior art produced by university researchers, and it is a feature of some of this art that portions therein are reserved for what can most kindly be called discussions of possible future implications and applications of a scientific result (or unkindly, unsupported flights of fancy).  However, the presence of such language in scientific references such as journal articles not expressly provides a much more robust source of prior art, insofar as anything said in a prior art printed publication now falls expressly within the presumption that it is enabled.  While in many cases this will not pose an insurmountable challenge, it can be expected at the very least to increase the difficulties and cost of obtaining patents, and to open up a host of new prior art for use in invalidity defenses.

For information regarding this and other related topics, please see:

• "In re Antor Media Corp. (Fed. Cir. 2012)," August 20, 2012

Image of New Year's Eve ball drop for 2012 in Times Square (above) by Replytojain, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.

USPTO Issues Final Rule Implementing Micro Entity Status

By Donald Zuhn --

Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 75019) issuing the Office's final rule implementing the micro entity provision of § 10 of the Leahy-Smith America Invents Act.  The notice concerns rules changes that provide procedures for claiming micro entity status, paying patent fees as a micro entity, notifying the Office of loss of micro entity status, and correcting fees paid erroneously in the micro entity amount.  According to the notice, the rules changes implementing the micro entity provision of the AIA will take effect on Tuesday, March 19, 2013 (the first-inventor-to-file provisions of AIA § 3 take effect on Saturday, March 16, 2013).

With respect to the payment of fees as a micro entity, the notice indicates that "[c]ertain patent fees set or adjusted under the fee setting authority in the AIA will be reduced by seventy-five percent for micro entities" (emphasis added).  In other words, as the notice explains, "[t]he micro entity provisions of 35 U.S.C. 123 are currently in effect," but "no patent fee is currently eligible for the seventy-five percent micro entity reduction as no patent fee has yet been set or adjusted under section 10 of the Leahy-Smith America Invents Act."  Thus, under the AIA's fee setting authority provisions, micro entities would have to wait until 45 days after the Office issues its final rule on the fee schedule to obtain the benefit of a 75% reduction in fees.  Given the effective date for the rules changes implementing the micro entity provision of the AIA, a final rule on the new fee schedule is likely to be published prior to February 1, 2013.

As for the rules changes, the notice indicates that a provision is being added to the rules that specifies the requirements to qualify as a micro entity, and that this provision tracks the statutory requirements for a micro entity set forth in § 10 of the AIA.  The notice also indicates that the provision also specifies procedures relating to micro entity status that largely track the regulatory requirements and procedures in 37 C.F.R. § 1.27 for small entity status.  In particular, applicants claiming micro entity status will be required to file a certification of entitlement to micro entity status (for which forms will be provided by the Office).  Such certification will only need to be filed once in an application -- although an applicant must be entitled to such status on the date that any fee is paid.  Procedures for notifying the Office of loss of micro entity status and correcting payments of patent fees paid erroneously in the micro entity amount will track the corresponding small entity provisions for notifying the Office of loss of small entity status and correcting payments of patent fees paid erroneously in the small entity amount.

While the notice states that "[t]he Office does not plan to provide advisory opinions on whether a particular entity is entitled to claim micro entity status," the notice provides some discussion of the requirements contained in 35 U.S.C. § 123 at pages 75021-22.  A discussion of the specific rules changes is provided next (at pages 75022-25), and is followed by comments submitted in response to the Office's notice of proposed rulemaking (see "USPTO Issues Proposed Rules for Implementing Micro Entity Status") and the Office's responses to those comments.

USPTO News Briefs

By Donald Zuhn --

USPTO to Hold Roundtable on Recordation of Real-Part-in-Interest Information

Last month, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 70385) indicating that the Office will be holding a roundtable from 8:30 am to 12:00 pm (EDT) on January 11, 2013 to obtain public input regarding changes to the Office's rules of practice for collecting and providing patent and application ownership information and making such information publicly available.  The roundtable will be held in the Madison Auditorium on the USPTO campus (600 Dulany Street, Alexandria, Virginia 22314).

Those wishing to participate in the roundtable must submit requests by Friday, December 21, 2012.  Requests can be submitted by e-mail to saurabh.vishnubhakat@uspto.gov, and should include the name of the person wishing to participate, the person's contact information (telephone number and e-mail address), and the organizations that the person represents.  The notice indicates that the roundtable will be webcast, and that information regarding accessing the webcast will be made available prior to the roundtable.

The Office is also seeking written comments on the issue.  Written comments, which must be submitted by January 25, 2013, can be sent by e-mail to saurabh.vishnubhakat@uspto.gov or SMEpatenting@uspto.gov, or by regular mail to:  Saurabh Vishnubhakat, Expert Advisor, Office of Chief Economist, United States Patent and Trademark Office, Mail Stop External Affairs, P.O. Box 1450, Alexandria, VA 22313–1450.

The Office is seeking comment regarding whether the definition of real-party-in-interest (RPI) information should be broad (RPIs would correspond to those entities having the legal right to enforce the patent and would likely require the disclosure of exclusive licensees) or limited (RPIs restricted to legal title holders and "ultimate parent entities"), and the timing of and mechanism for collecting such information.

USPTO Requests Comments on Grace Period Study

Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 73452) inviting the public and other Federal agencies to submit comments regarding the Office's grace period study.  The notice states that:

The United States' grace period, which permits exceptions to absolute novelty, figures centrally in the international discourse on patent law harmonization.  The grace period allows individuals to improve upon their ideas by sharing them with the research and business communities without jeopardizing their intellectual property interests.  Many European countries, however, lack adequate grace periods.  The consequences of this are not fully understood.  Few studies in the past ten years have dealt with the grace period, and none of them have quantified the effects of premature disclosure on researchers’ failure to apply for or receive patents.

To examine this issue, the Office will be conducting a study "to estimate the commercial opportunities lost as a result of the lack of grace periods."  As part of the study, the Office will survey scientific researchers affiliated with certain European universities who have published journal articles disclosing potentially patentable materials during a five-year period.

Written comments regarding the collection of information with respect to the grace period study, which must be submitted by February 8, 2013, can be sent by e-mail to InformationCollection@uspto.gov (those submitting comments by e-mail should include "0651–00xx Grace Period Study comment" in the subject line of the message); by regular mail to:  Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450; or using the Federal Rulemaking Portal.  Additional information, including the specific topics for which the Office has invited comment, can be found in the Federal Register notice.

USPTO Seeks Comments on Patent Small Claims Proceedings

On Tuesday, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 74830) seeking comments as to whether a small claims proceeding for patent enforcement should be developed.  The Office is particularly interested in obtaining comments regarding whether there is a need and desire for this type of proceeding, the circumstances for which such proceedings would be needed, and the features such proceedings should have.  The Office is also interested in collecting comments regarding the characteristics of such proceedings, including subject matter jurisdiction, venue, case management, appellate review, available remedies, and conformity with the U.S. constitutional framework.  The Office's notice provides a list of additional topics and questions for which the Office is seeking comments.

Written comments regarding patent small claims proceedings, which must be submitted by March 18, 2013, can be sent by e-mail to ip.policy@uspto.gov, or by regular mail to:  Mail Stop OPEA, P.O. Box 1450, Alexandria, VA 22313–1450, ATTN: Elizabeth Shaw.

USPTO Seeks Public Feedback on RCE Practice

By Donald Zuhn --

Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register (77 Fed. Reg. 72830) seeking public feedback on Request for Continued Examination (RCE) practice.  The notice indicates that the Office currently has a backlog of more than 90,000 applications that have not been examined since an RCE was filed, and states that this backlog diverts Office resources from the examination of new applications.  While the Office notes that several programs have been implemented to reduce the need to file an RCE, and thereby reduce the RCE backlog, the Office is now turning to its stakeholders "in an effort to better understand the full spectrum of factors that impact the decision to file an RCE."  The Office plans to use the information it gathers to design additional programs and initiatives aimed at reducing RCE filings and the RCE backlog.

The Office describes some of its efforts to reduce the RCE backlog in the notice, pointing to the Quick Path Information Disclosure Statement (QPIDS) pilot program and the After Final Consideration Pilot (AFCP) as two examples (see "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program"; "USPTO to Assess After Final Consideration Pilot Program"; and "USPTO News Briefs," June 21, 2012).  The notice does not, however, discuss the Office's efforts to decrease RCE filings by raising the cost of filing a first RCE to $1,200 (from the current fee of $930), and further raise the cost of filing subsequent RCEs to $1,700 (see "More on USPTO's Proposed New Fees - Part II"), a proposal that the Patent Public Advisory Committee (PPAC) has called "illogical" (see "PPAC Issues Report on USPTO Patent Fees Proposal").  On the topic of RCE filings, PPAC has previously explained that:

[A]pplicants rely on RCEs to continue the prosecution and eventually (and justly) receive a patent on their invention.  RCEs are mostly filed by applicants genuinely attempting to move prosecution forward and get a patent and not generally, it is believed, simply to delay the prosecution (applicants have the ability to file further continuation applications to proceed with other claim sets or to keep a particular patent family in prosecution in any case).  RCEs are a source of frustration for both the Office and the applicants, with both parties contributing to the problem.  However, from both casual conversation and also in public statements, the USPTO seems to place the blame for the rapid growth in RCE applications solely and squarely on applicants.  The change several years ago to move RCEs to the special new case docket (rather than an examiner’s amended docket) causes (as one would expect) significant delays in acting on RCEs.  That the Office has proposed significant increases in the RCE fees adds salt to an existing wound:  applicants must pay more for what most perceive as a reduction in service.  Thus, the proposed increase in fees for RCEs was not well received by the public.

Noting that "[t]he USPTO acknowledges that the cost of completing an RCE is less than that required for an original utility application," PPAC has also contended that "the increased costs to applicant being proposed to treat an RCE (and particularly a second and subsequent RCE) compared to the fees proposed for a utility or continuation application seems illogical."  Instead, PPAC has suggested that:

[A] small increase in the fee for an RCE might be appropriate but it should align more closely to the associated required work, and certainly be less than the fees for new or continuation applications.  The higher fee for second and subsequent RCEs should be eliminated because these become easier and cheaper to examine and any number of continuations may be filed at the same cost per continuation.  Rather than punishing applicants for pursuing their inventions by filing an RCE, it is suggested that the USPTO continue to find ways to reduce applicants' need for the RCEs in the first place.

The Office's request for comments on RCE practice also notes that a webpage devoted to its efforts to decrease the RCE backlog has been created on the USPTO website.  Data regarding RCE filings can be found at this webpage, including a chart showing the rise in the RCE backlog from just under 20,000 RCE filings awaiting an Office action in the fourth quarter of fiscal year (FY) 2009 to the current level of nearly 100,000.

The Office also provides data on RCE filings by technology, noting that the fraction of applications containing RCE filings is generally the same across technologies.

According to the notice, the public can provide feedback regarding RCE practice by submitting written comments by e-mail to rceoutreach@uspto.gov; by regular mail to the United States Patent and Trademark Office, Mail Stop Comments -- Patents, Office of Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Raul Tamayo; or using the web-based collaboration tool IdeaScale®, which allows users to post comments, view and respond to others' comments, and indicate agreement or disagreement with particular comments.  Comments must be submitted by February 4, 2013.  The Office also plant to hold a series of roundtables on RCE practice.

The notice provides a series of questions on which the Office is particularly seeking comment:

    (1) If within your practice you file a higher or lower number of RCEs for certain clients or areas of technology as compared to others, what factor(s) can you identify for the difference in filings?
    (2) What change(s), if any, in Office procedure(s) or regulation(s) would reduce your need to file RCEs?
    (3) What effect(s), if any, does the Office’s interview practice have on your decision to file an RCE?
    (4) If, on average, interviews with examiners lead you to file fewer RCEs, at what point during prosecution do interviews most regularly produce this effect?
    (5) What actions could be taken by either the Office or applicants to reduce the need to file evidence (not including an IDS) after a final rejection?
    (6) When considering how to respond to a final rejection, what factor(s) cause you to favor the filing of an RCE?
    (7) When considering how to respond to a final rejection, what factor(s) cause you to favor the filing of an amendment after final (37 CFR 1.116)?
    (8) Was your after final practice impacted by the Office’s change to the order of examination of RCEs in November 2009? If so, how?
    (9) How does client preference drive your decision to file an RCE or other response after final?
    (10) What strategy/strategies do you employ to avoid RCEs?
(11) Do you have other reasons for filing an RCE that you would like to share?