By Donald Zuhn --
On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance"), to implement a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012). At a biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting in April, the Office announced that it would be hosting a public forum on the Guidance in May to receive public feedback on the Guidance, and at that forum encouraged shareholders to submit written comments on the Guidance. Since the forum, the Office has encouraged the patent community to provide further feedback regarding the Guidance (despite the Office's announced deadline of July 31 for submitting comments).
Comments regarding the Guidance, including at least three received after the July 31 deadline, have been posted on the USPTO website. The comments are divided into seven groups (with the number of submissions in each group also provided): Intellectual property organizations and other associations (21), government agencies (0), academic and research institutions (4), law firms (7), companies (8), individuals (43), and comments received after August 1, 2014 (3). Today, we examine the joint comment submitted on October 14, 2014 by the Biotechnology Industry Organization, the Coalition for 21st Century Medicine, five companies (GlaxoSmithKline, Novartis AG, Novo Nordisk Inc., PharmaMar S.A., and Verenium Corp.), and six individuals (Nancy J. Linck, Gladys H. Monroy, Kate H. Murashige, Kenneth H. Sonnenfeld, Suzannah K. Sundby, and Warren D. Woessner).
The BIO joint comment letter begins by "strongly recommend[ing] that the USPTO . . . publish its proposed revisions and provide an opportunity for public feedback before the Revised Guidance is finalized and implemented by examiners," stating that "[a]dditional opportunities for input by the interested public would at any rate be more likely to increase acceptance of such a Revised Guidance by the patent user community." The letter also suggests that "[o]nce the Revised Guidance is promulgated, claims that were first rejected under the March Guidance should not get a second action final rejection under the Revised Guidance."
The rest of the 9-page joint letter addresses seven substantive issues that the signatories argue would benefit from public comment before any Revised Guidance is finalized and implemented. Among these issues are the use of additional case law, a closer reading of Supreme Court and other case law, the use of "function" to demonstrate patent-eligibility, examiners' use of claim interpretation, the possibility of limiting § 101 analysis to claims "directed to" (as opposed to merely "reciting" or "incorporating") a judicial exception, the use of preemption, and the possibility of implementing a "unified" analysis.
With respect to the use of additional case law, the letter states that:
In framing the March Guidance, the USPTO seems to have focused only on selected Supreme Court cases and has not drawn on all available precedent. Despite being extensively briefed, the Supreme Court has not overruled or distinguished Parke-Davis, Merck v Olin Mathieson, In re Kratz, In re Bergstrom and other cases. To the extent these and other cases are not clearly inconsistent with recent Supreme Court decisions, they remain good law until the courts say otherwise, and it should not fall to the PTO to administratively abrogate them by giving them the "silent treatment."
The letter also states that "[a]dditional insight can be gleaned by a closer reading of those Supreme Court cases on which the USPTO has focused." In particular, the signatories suggest that "Supreme Court cases dealing with patentable subject matter are generally framed in broad conceptual brushes, but they are decided on the specific facts presented," and therefore "urge[s] the USPTO to closely scrutinize the particular claims at issue in each precedential case, and where necessary analyze the record to appreciate the scope of the claimed subject matter considered by the Supreme Court." By doing so, the letter contends that the Office will be able "to more accurately put the Court's decisions in context and properly apply the concepts they set forth."
As for the Office's suggestion that applicants will be able to establish patent eligibility using functional differences, the signatories note that they are "greatly intrigued by this concept and would much appreciate further clarification of what the USPTO means and how it expects such evidence is to be used in the analysis." Referring to the Guidance's amazonic acid example (Example B), the letter asks whether:
[T]he USPTO mean[s] by considering "function" that purifying amazonic acid allows skilled persons to formulate it into tablets, to administer it at a precise dose with a predictable pharmacokinetic and pharmacodynamic profile, and for the first time to treat human disease while avoiding side-effects, and that in this sense purifying it conferred a new "function" as disease-treating agent?
The letter then answers that question by expressing the signroties' belief that the conclusion is supported in the case law, and adding that:
Case law also supports the concept that even if a function is known for a natural substance, patent eligibility may be further buttressed by evidence that any "function" is enhanced by purification or enrichment, such as an IC50 that is greatly increased over raw preparations out of a bacterial fermentate, or the absence of impurities (specified or not) that would otherwise make cruder preparations unsuitable for human administration.
With respect to establishing patent eligibility using functional differences, the letter suggests that:
The Revised Guidance should emphasize that even absent chemical modifications, purification or enrichment can give rise to preparations that are every bit as "distinctive" in "name, character, or use," having characteristics "markedly different" from the natural state, or demonstrating an "enlargement in the range of . . . utility." We recommend that the USPTO seek inspiration in the case law when developing additional examples to illustrate this point. Good fodder for such examples can be found in Parke-Davis' remarkable distinctions between purified adrenaline salt vs. the older medicinal powders of shriveled adrenal glands, or in the great advantages of enriched preparations of pure vitamin B12 which the Merck court contrasted to the disgusting earlier raw beef liver extracts that had, up to that time, been the only treatment for pernicious anemia.
As for the Office's proposal to limit § 101 analysis to claims "directed to" a judicial exception (as opposed to merely "reciting" or "incorporating" that exception), the signatories indicate that "as communicated the concept still seems to be very much in flux, and is poorly understood at least by the patent user community." The letter suggests that problems with the above analysis may be overcome if examiners were "required, as a first step, to define precisely what they regard as the applicable judicial exclusion and where it is recited in the claim."
The BIO joint letter closes by focusing on the possible implementation by the Office of a "unified" analysis. The letter contends that:
Alice provides guidance as to how to analyze process claims based on abstract ideas. But, Alice set forth only "a" (not "the") framework for an eligibility analysis that was particularly suited for the kind of claimed subject matter at issue. Its mode of analysis does not necessarily apply in the same way to compositions or manufactures, which have their own line of case law. None of the cases dealing with compositions and manufactures -- Myriad, J.E.M. Ag-Supply, Chakarabrty, Funk Bros. -- has applied an "inventive concept/significantly more" analysis.
The letter also points out that:
The Supreme Court may have applied an "inventive concept" / "add enough" analysis when it discerned abstract ideas, laws of nature and natural phenomena in disembodied methods and processes. But when it encountered physical compositions and articles, it engaged in a less intrinsic, and more comparative analysis that queried whether the claimed thing has a "distinctive name, character or use" compared to the natural thing, has "markedly different characteristics," or enlarges its "range of utility."
The BIO joint letter concludes by reiterating that the issues discussed in the letter "would benefit from further public dialogue with the USPTO before the Revised Guidance is finalized." It will be interesting to see whether the Office follows the letter's suggestion to release the revised Guidance as a draft and to seek public comment on the draft before implementing the revised Guidance or proceeds to release and implement the revised Guidance first and collect public feedback later.
For additional information regarding this topic, please see:
• "USPTO Outlines Changes to Myriad-Mayo Guidance at BIO Symposium," September 30, 2014
• "USPTO Expected to Issue Revised Myriad-Mayo Guidance in October," September 17, 2014
• "Guest Post: Myriad-Mayo Guidance -- Consistency With International Harmonization and TRIPS," August 26, 2014
• "Examination of Myriad-Mayo Guidance Comments -- AUTM, COGR, AAU, and APLU," August 21, 2014
• "Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations," August 11, 2014
• "Examination of Myriad-Mayo Guidance Comments -- ACLU," August 5, 2014
• "Guest Post: Overview of First Published Comments on Myriad-Mayo Patent Eligibility Guidance," July 13, 2014
• "Guest Post: USPTO Public Forum on Patent Guidance: My Thoughts as a Speaker and Attendee," June 11, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part IV," May 22, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part III," May 15, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part II," May 14, 2014
• "Guest Post: How to Patent Grapefruit Juice -- The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour," May 13, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part I," May 12, 2014
• "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
• "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014