USPTO's Bruce Kisliuk Addresses ACI Conference

    By Donald Zuhn --

At last week's American Conference Institute (ACI) Pharma/Biotech Patent Claim Drafting and Prosecution conference, Bruce Kisliuk, the Director of the U.S. Patent and Trademark Office's Technology Center 1600, gave an interesting address in which he touched on a number of topics, and then opened the floor to questions from conference attendees.  Perhaps alluding to the Tafas/GSK v. Dudas case, Mr. Kisliuk began his talk by stating that he had "good news" -- namely that he didn't have anything new to report.  In view of the unexpected shortage of news regarding the GSK case (and thus, the lack of any new information about the continuation and claims rules and IDS rules), the TC 1600 Director focused instead on patent reform, his Group's implementation of the new obviousness examination guidelines, and the Office's other rules initiatives (besides the continuation and claims rules and IDS rules).

Patent Reform

Mr. Kisliuk (at left) reiterated that the Patent Office does not support the Senate patent reform bill, stating that "we don't believe that some of the proposals are fixing the problems the right way."  In particular, the Group Director declared that "the PTO doesn't want tolerating infringement to become the cost of doing business."  As to how the Senate could report such a heavily criticized bill, Mr. Kisliuk speculated that "the reality is that most of the discussions [taking place on Capitol Hill] are not high level."

The Group Director, however, did not hesitate to point out the portions of the Senate bill that the Patent Office found to be acceptable.  Not surprisingly, he began with the dreaded Applicant Quality Submissions (AQSs), which he called "fundamental pieces" of the Office's effort to promote "shared responsibility" between patent applicants and the Patent Office.  Somewhat refreshingly, Mr. Kisliuk did not turn a blind eye to the significant problems these "fundamental pieces of shared responsibility" would cause in view of current inequitable conduct jurisprudence.  Acknowledging that patent attorneys and applicants have been unable to discuss AQSs apart from inequitable conduct, the Director noted that the Patent Office supported inequitable conduct reform.  According to Mr. Kisliuk, the Office supported separate analyses of materiality and intent, an adoption of the pre-1992 materiality standard (both of which have been included in the Senate bill), and a lessening of the "all of nothing" impact of an inequitable conduct finding (presumably so claims not touched by a finding of inequitable conduct might remain enforceable).

As for the other portions of the Senate bill with which the Patent Office finds favor, Mr. Kisliuk mentioned fee setting authority and post-grant review.  With respect to the latter, the Group Director noted that the Office supported both a first and second window of review, but wanted to see some revisions to the second window.  According to Mr. Kisliuk, the Office is "uncomfortable" about letting anyone challenge a patent during the entire length of its term.

When asked to opine on the possible fate of the Senate bill, Mr. Kisliuk deferred to the grapevine, stating that "most people in the know believe the window [for passage] is closing."

Examination Guidelines for Determining Obviousness

The Group Director spent the bulk of his talk discussing the implementation of the new obviousness examination guidelines in TC 1600.  Before addressing the details of this implementation, Mr. Kisliuk declared that neither the Supreme Court's decision in KSR Int'l Co. v. Teleflex, Inc. nor the Patent Office's issuance of examination guidelines last October represented a "sea change."  Instead, "the basic approach [for examining applications for compliance with 35 U.S.C. § 103] remains the same," and was focused, as always, on the analysis outlined in Graham v. John Deere.  In addition, Mr. Kisliuk believed that most of the rationales set forth in the new obviousness examination guidelines would apply to "classical mechanical situations," but he wasn't sure how applicable these rationales would be to the examination of biotech and pharma applications.

As for implementing the new guidelines, the Group Director noted that "high-level" obviousness training (consisting of a 2-hour session with some small-group follow-up sessions) was nearly complete in TC 1600, with less than 50 examiners remaining to be trained.  Moreover, instead of teaching the guidelines' rationales as bright-line rules (since Mr. Kisliuk believed the Supreme Court had cautioned against the use of rigid, bright-line rules in KSR), the Group Director noted that TC 1600 examiners were being taught to analyze the issue obviousness using eleven key cases as tools.  The eleven cases are:

1.  Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007) - as we discussed here;
2.  Pfizer, Inc. v. Apotex, Inc. (Fed. Cir. 2007) - as we discussed here;
3.  Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd. (Fed. Cir. 2007) - as we discussed here;
4.  McNeil-PPC, Inc. v. Perrigo, Co. (S.D.N.Y. 2007);
5.  In re Omeprazole Patent Litigation (S.D.N.Y. 2007);
6.  Ex parte Kubin (B.P.A.I. 2007) - as we discussed here;
7.  In re Sullivan (Fed. Cir. 2007) - as we discussed here;
8.  Daiichi Sankyo Co. v. Apotex, Inc. (Fed. Cir. 2007) - as we discussed here;
9.  Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. 2007) - as we discussed here;
10.  Forest Labs., Inc. v. Ivax Pharm., Inc. (Fed. Cir. 2007) - as we discussed here;
11.  Syngenta Seeds, Inc. v. Monsanto Co. (D. Del. 2004)

The Group Director stressed that he wanted the examiners to focus on the facts of each case (since the issue of obviousness is very fact specific), and more specifically, on the "science behind the case."  Addressing the most controversial of the eleven cases (i.e., Ex parte Kubin), Mr. Kisliuk stated that TC 1600 examiners were not being taught to think of In re Duell as being dead, but rather, were being taught that Kubin illustrates that advances in the state of the art may render something previously unpredictable to be predictable.

Mr. Kisliuk closed his obviousness discussion by predicting that the Office would soon be facing an influx of Rule 132 declarations on the issue of obviousness, and indicated that examiners were currently being trained to properly consider and weigh the probative value of this expected influx of declarations.

Rules Initiatives

Although he spent little time discussing the proposed appeal rules, the Group Director did note that TC 1600 had the lowest percent of pre-appeal conference requests, the lowest success rate (i.e., lowest percent of cases reopened or allowed) on pre-appeal, and the lowest success rate on appeal.  With respect to the first measure, Mr. Kisliuk conceded that he didn't know whether this indicated that his Group was doing a better job at issuing rejections or whether biotech and pharma patent attorneys were simply not using the pre-appeal process as a tool.  The Group Director couldn't explain the low pre-appeal and appeal success rates, but sees the low rates "as a good sign, not a bad one."

On the topic of the proposed alternative claiming rules, Mr. Kisliuk noted that few comments had been submitted in response to the proposed rules, but acknowledged that "people have been distracted" by other events.  In defending the need for the alternative claiming rules, the Group Director provided an example in which a claimed formula encompassed some 2.63 x 10(14) variants, and asked the conference attendees where an examiner should start examining such a claim.

Tafas/GSK v. Dudas

The Group Director closed his discussion by briefly touching on the GSK case (even though he had admitted at the start of his talk that he had no news to report).  Mr. Kisliuk reported that he had attended both the October and February hearings, and felt that as to the issues of continuation limitations, claims limitations, RCE limitations, and retroactivity, "neither side is going to win it all."  Acknowledging that he was only speculating, the Group Director suggested that "the PTO may move forward with what it does get."  When asked when he expected the Court to reach a decision, Mr. Kisliuk conceded that he knew little more than the conference attendees, but stated that "insiders" were thinking the Court would announce its decision in about a month from the date of the hearing (February 8th).  If his prediction holds true, patent attorneys and applicants could see a decision by the end of this week.

Comments

[anon]

Thanks for all the great posts. However, my browser is not showing the contents of this article for some reason.

[Donald Zuhn]

Anon:

The post should be displayed now.

Don

[Derek]

On the alternative claiming rules, it's easy to see why people have been distracted. But let's face it - how necessary are they? If a claim covers 10(14) compounds, that (a) makes it really easy for an examiner to find a 102 reference, and (b) ought to make the claim a prime candidate for a 112 enablement over the scope of the claim rejection. And if neither of these is feasible, maybe the claim is good and should be allowed.

[Kevin E. Noonan]

Did anyone think to ask Mr. Kisliuk why this "problem" suddenly exists? For decades, applicants have been able to claim generic chemical compounds that encompassed hundreds of millions of possible species, and the patent office was able to deal with them. Isn't this just another manifestation of the office deciding "there are too many patents" or that "patents are too easy to obtain" in the face of political pressure, and looking for ways to dramatize the problem?

It seems to be simple: either the claims are not patentable due to prior art or 112 issues, as in Derek's comment, or they are patentable given the best information available at the time they are examined. The office will never be able to grant a perfect patent that can never be challenged, and that shouldn't be the standard. Applicants and the office want the most "bullet-proof" patents (each for their own reasons), expecially in the biotech area where a patent may be the only asset a company has. All the rest of this is political philosophy masquerading as policy, and bad policy at that.