Patent Docs

Kubin Panel Questions Motivation behind Reversal in New Written Description Training Materials

    By Donald Zuhn --

As we reported yesterday, the Federal Circuit heard oral argument today in In re Kubin (see "In re Kubin to Be Argued before the Federal Circuit on Thursday").  Kevin Noonan will be providing a complete analysis of the oral argument in this case in a subsequent post.  One interesting aside, however, involved an exchange between the Court (specifically Circuit Judge Rader) and USPTO Associate Solicitor Janet Gongola regarding Example 11 of the new Written Description Training Materials.

Last March, the Patent Office announced that it had updated the training materials to be used by examiners in the examination of patent applications for compliance with the written description requirement.  The revised training materials replaced the previous set of training materials issued by the Office in 1999.  Perhaps the most interesting of the seventeen examples in the new training materials is Example 11, which concerns claims that are directed to a polynucleotide or polypeptide sequence that shares percent identity with another sequence  (see "An Analysis of the New Written Description Training Materials - DNA Hybridization & Percent Identity").

Example 11 is divided into two sections, one in which there is no art-recognized structure-function correlation for the claimed sequence (Example 11A), and one in which there is an art-recognized structure-function correlation for the claimed sequence (Example 11B).  Both subparts present identical exemplary claims reciting an isolated nucleic acid that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2, and nearly identical exemplary claims reciting an isolated nucleic acid that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2; wherein the polypeptide has a recited activity.  The only difference between the hypothetical specification of Example 11A and the hypothetical specification of Example 11B is that the latter identifies two domains -- a binding domain and a catalytic domain -- that are critical to the recited activity.  The training materials specify that the first exemplary claim in each subpart satisfies the written description requirement.  The training materials also state that while the second exemplary claim in Example 11B satisfies the written description requirement, the second exemplary claim in Example 11A does not.

Last June, during a presentation at BIO 2008, Group 1600 Director Dr. George Elliott acknowledged that Example 11 represented a reversal in the Office's position (see "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.").  In particular, Dr. Elliott noted that the Office's position had previously been that claims lacking functional language (such as the first exemplary claim in Examples 11A and 11B) failed to comply with the written description requirement and that claims possessing such language (such as the second exemplary claim in Examples 11A and 11B) complied with the requirement.  Dr. Elliott contended that claims with functional language (where the specification lacks any teaching regarding the amino acid residues that are tolerable to change) do not satisfy the written description requirement because "the minute you add function, you've limited the claim to a subset of species, and you don't know which species are in the subset and which species aren't."  In other words, absent any teaching of structure/function relationships, the Patent Office's position is that one cannot determine the species that share at least 85% sequence identity with the recited sequence and also possess the recited function.  For a more thorough discussion of the rationale behind the USPTO's reversal on functional limitations, Dr. Elliott recommended that attendees read Ex parte Porro, which involved an application filed in June of 2003 (for a discussion of the Porro decision, see "The Written Description Training Materials and Ex parte Porro").

With respect to today's oral argument in Kubin, the Court speculated that the Patent Office may have reversed its position on the fact pattern set forth in Example 11 in order to support its argument that Kubin lacked an adequate written description despite the recitation in claim 73 of an activity limitation (i.e., binding CD48).  A transcript of the exchange between the Court and Associate Solicitor Gongola follows:

Gongola:  I'd like to move now -- if the Court has no more questions on obviousness -- into the written description area.  This Court found that written description was not satisfied under the only two tests that Kubin ever raised before the Board:  the representative number of species test and the structure-function correlation test.  Now, the Board found, at Finding of Fact 20 and 21, that the specification only taught how to make cDNA molecules that encode NAIL identically.  That's one subgenus.  The Board found, at Finding of Fact 22, that the specification did not teach anything about any variants.

Court:  What about the conservative substitutions set forth at page 63?

Gongola:  The language on conservative substitution, using the Board's own findings, does not demonstrate -- Finding of Fact 23 -- which 20% of the amino acid residues should be changed to maintain function.  So that discussion of conservative substitution may teach how to make the variants, but it doesn't teach what those variants are.  It doesn't describe them so that a person of skill in the art would understand that Kubin possessed the variants.  There -- the Board Finding of Fact 25 says that there are a very large number of modifications that can be made.  One in five amino acids can vary.  We have no idea which of the 21 to 220 -- 22 to 221 portion of NAIL to change and maintain binding -- which amino acids have to remain and which can be substituted.  But more than that, even if this Court would accept the discussion that the conservative substitution could somehow provide written description support for variants, it wouldn't still do so for the full scope of the genus.  That discussion would only apply to variants made by substitution.  Applicant -- Kubin has defined a variant to be made by a substitution, an insertion, or a deletion.  Conservative substitution dialog doesn't speak to anything about variants made by insertions, or variants made by deletions.  So therefore, Applicant Alonso still has -- I'm sorry, Kubin . . .

Court:  Yes, but the description of the variations is also linked to a protein having activity Y.  Therefore, this satisfies the function-structure alternative test for written description, doesn't it?

Gongola:  No, your Honor.  The function-structure test requires an identification of a structure common to all members of the genus.  We do not have that identification of a common structure.  Twenty percent . . .

Court:  I'm quoting almost out of PTO's manual on written description -- verbatim -- when I give my example there, am I not?  The variations plus the activity Y -- protein having activity Y -- isn't that exactly the PTO's manual on written description?

Gongola:  Are you referring to the training materials?

Court:  Yes, I am.

Gongola:  That language may be found in the training materials, but it is not -- it's guidance.  It's -- each case of written description has to be decided on its own facts.

Court:  The Patent Office is guiding applicants on how to do things wrong?

Gongola:  No, your Honor, but guidance provided in a training document cannot be taken and applied to each case.  Each case has to be decided on its own facts.

Court:  So it's just guidance to examiners on how to do it wrong?

Gongola:  No, your Honor -- respectfully -- it is guidance to the public as well, but . . .

Court:  But if we take that guidance, we don't get to your result, do we?

Gongola:  No, your Honor, I respectfully disagree; we do.  In Carnegie Mellon, this Court has explained that when there's substantial variation within a genus, an applicant has to describe a sufficient number of species to reflect the variation.  Kubin has not done that here.  Kubin hasn't described any variation.  If we want to look at the training materials, the Board only . . .

Court:  It's interesting that this was revised immediately after Kubin -- the Kubin result -- wasn't it?

Gongola:  That . . .

Court:  Which is kind of an admission that the example did track Kubin and was detrimental to your position, wasn't it?

Gongola:  No, your Honor.

Court:  So, despite your smiling defense, the facts tend to give us a different conclusion.

Gongola:  No, your Honor, that's not correct.  The training materials were not revised post-Kubin to somehow capture Kubin.  The revisions have been in the works for a very long time.

Court:  I see, okay.

Gongola:  So it's just coincidence that Example 11 may seem to look like the Kubin fact pattern.  But if we actually look at Example 11, it is distinguishable from the facts here.  Example 11 goes to a nucleic acid that encodes a polypeptide that has certain homology -- 85% homology -- and a certain activity.  Now here's where -- that sounds a lot like Kubin's claim.  I agree with that.  But here's where the difference resides:  the specification in Example 11 disclosed two specific domains that were responsible for the activity.  Kubin's specification here doesn't contain any similar disclosure.  So the fact pattern here is different from the fact pattern in the revised training materials.  But I also want you to know -- these materials, as you point out, were not even in existence when the Board rendered its decision.  So it really isn't proper to be considering them right now, since the Board didn't have a chance to consider them in the first instance.  And on top of that, they're only guidance.  They're not a rigid rule.

BIO Gives President-elect Obama Its Ideas on Patent Reform

    By Kevin E. Noonan --

A change of administration always gives stakeholders a chance to make their policy views known, in an effort to influence the new people and policies taking power in Washington.  This is particularly true in this season of (welcome) change, and even more important for U.S. patent law, in view of the proposed (legislative), actual (judicial), and thwarted (administrative) changes in patent law and practice over the past few years. 

James Greenwood (at right), President and Chief Executive Office of the Biotechnology Industry Organization (BIO), took this opportunity to share BIO's views on patent reform in a letter recently sent to President-elect Obama.  In his letter, Mr. Greenwood reminds the President-elect of the importance of patents to the members of his organization, comprising "more than 1,250 biotechnology companies, academic institutions, state biotechnology centers and related enterprises across the United States and in more than 30 other countries."  These companies are on the cutting edge not only in the traditional fields of pharmaceuticals and medicine, but also in agriculture, energy, and environmental sciences.  According to Mr. Greenwood, "[s]trong patent protection is essential to the success and, in some instances, survival of biotechnology in this country.  Patents allow biotechnology companies and their life science partners to transfer technology, attract capital, and make business decisions that lead to the development of medicines and diagnostics for intractable diseases, and agricultural, energy, and environmental products to meet growing global needs."

In view of the importance of strong patent protection for biotechnology, BIO and its members have a unique interest in making U.S. patent law more effective in promoting innovation.  However, one of the most important players in U.S. patenting, the Patent and Trademark Office, is an "agency in crisis," according to Mr. Greenwood.  The problem:  the more than 1.2 million patent applications currently pending in an examiner corps of 6,000.  Despite large increases in the number of examiners (four-fold) and the PTO's budget (10-fold) over the past 10 years, Mr. Greenwood asserts that the Office has not been able to cope with the "ever-growing influx" of new applications, resulting in a backlog of unexamined applications and a 50% increase in pendency.  And it can be expected to get worse, according to Mr. Greenwood, in view of Patent Office statistics showing a 6% increase in patent application filings expected to continue for several years.

Mr. Greenwood does not believe that current Patent Office efforts have been effective in addressing these problems.  He cites "aggressive" production goals for examiners that have increased examiner attrition, and the inconsistencies in the amount of time allotted for examination of applications that have become "more and more complex."  The inappropriate production goals are also having the expected bureaucratic effect of increasing the rate of rejection to "historically-high levels."  Even in the face of these trends, which might under other circumstances increase confidence in those patents that are granted, Mr. Greenwood rightly stated that there is an "erosion of confidence in the quality of U.S. patents."  (He neglects to mention the political motivations of groups like the Coalition for Patent Fairness that tout the lack of patent quality because it fits with their anti-patent agenda.)

Mr. Greenwood also thinks that the efforts in the last two Congresses to "reform" U.S. patent law were ill-advised for focusing on "patent litigation and other divisive back-end changes to the patent system" rather than PTO problems.  He also notes that many of the policy drivers for legislative reform have been addressed by the courts, in cases such as KSR Int'l Co. v. Teleflex Inc., eBay Inc. v. MercExchange L.L.C., and In re Seagate.  In view of these changes in the law that have already effectuated much of what the proponents of patent reform legislation asserted as the bases for legislation, Mr. Greenwood posits that the proper place for patent reform is in the Patent Office using administrative remedies.

And Mr. Greenwood has a number of such remedies that he proposes in his letter.  These include the following:

• Reassessment of examiner compensation, retention, and production goals and incentives (citing the fact that the Office's production system in use today was established in 1976 and has not been fundamentally changed since):   Mr. Greenwood proposes that production goals and time per application should be adjusted for complexity of the subject matter, and that the Office should not treat all applications equivalently, recognizing that examiners should receive more "credit" for examining applications of greater complexity that require more time and effort for proper examination.  He also mentions reforms that would reduce incentives for examiners to elicit practices, such as requests for continued examinations, that some patent reform proponents have characterized as being improper applicant behavior (not taking into account the incentives in the current system for examiners to desire RCE filings).

• PTO branch offices and other measures to facilitate hiring and access to talent:  BIO and Mr. Greenwood recognize that the complex applications examined by the Office today require individuals with the appropriate science and engineering backgrounds, and that the Office should have all the tools available to recruit and retain these people.  Thus, he proposes that the Office establish (or at least consider establishing) branch offices outside the Washington, D.C. area, using technology (PAIR, teleconferencing) in combination with branch offices to ensure consistency and adequate examiner supervision.

• Pre-first action interviews and issuance of "short form" search reports:  BIO and Mr. Greenwood propose expansion of certain features now used during "accelerated examination" that provide opportunities for applicants and examiners to have "informal" pre-examination conferences.  The advantages of such conferences would be that "applicants and examiners could meet for an informal pre-examination conference to discuss the application, explain the underlying technology, and agree on ways the application could be improved for more efficient substantive examination."  The goal would be to streamline the examination process by identifying art and amendments to overcome such art early in examination.  (An unspoken corollary of such a system would be that the examiner or applicant make expressly of record the substance of such pre-examination activities.)

• Reassessment of current restriction practice in light of the European unity-of-invention concept:  One of the unacknowledged (by the Office) inconsistencies of the now-enjoined new continuation rules was that divisional applications constituted a major portion of the applications vilified as "rework" in the Office's philosophical justification for the rules.  Mr. Greenwood and BIO propose that the Office consider using international standards for restriction practice, to reduce the incentive or capacity for examiners to "restrict . . . an invention down to every patentably distinct embodiment" and producing divisional applications in the process that increase the backlog of unexamined applications.

• Incentives for applicants to abandon obsolete applications:  BIO and Mr. Greenwood recognize that there are instances where the importance of patent applications diminishes over time, whether because the underlying technology is never commercially viable, the technology becomes obsolete, or the applicant simply runs out of time due to the patent term limit of twenty years from the earliest priority date.  Mr. Greenwood cites Patent Office statistics that over 10% of applications are abandoned for failure to respond to a first office action, and posits that this represents a waste of Office resources.  However, Mr. Greenwood also wants to ensure that there is no disincentive for an applicant to wait until receiving a first office action to make the decision to abandon an application.  One way to address this situation, according to Mr. Greenwood, would be to require an applicant to affirmatively request examination, noting that "up to 30% of all patent applicants decide that they no longer want to seek a patent on their application" in foreign jurisdictions imposing this requirement.  BIO's letter also suggests that the Office offer incentives for abandoning applications on obsolete technology, such as "offering a partial refund of search and/or examination fees for withdrawn applications" or advancing examination of "other, commonly-owned applications in the examination queue for every obsolete application that is withdrawn before substantive examination."  An additional proposal is to provide accelerated or deferred examination at an applicant's option, citing the use of such practices in the EU, Japan, China, Canada, Germany, and Korea.

• International work sharing:  This proposal is in line with current efforts by the Office to "workshare" patent search and examination with patent offices in Australia, Japan, Korea, and elsewhere.  The advantage is that almost half (45%) of all patent applications pending in the Office were filed from abroad, and that international patent filing strategies are "routinely" used by U.S. businesses as well.  In these efforts the Office has recognized the inefficiencies in having essentially the same application subjected to patent searching by multiple patent offices worldwide.  Technology, such as electronic file sharing, could be used to promote consistency and efficiency in these efforts.  Mr. Greenwood also suggests adopting strategies employed in countries like Australia and Israel where an applicant can elect to accept a patent having "identical scope" as a granted foreign counterpart patent.

• Transparency and public assistance in patent examination process:  Public PAIR and the decision to open patent prosecution records to the public for published applications are the types of "transparency" reforms supported by Mr. Greenwood and BIO, and this type of transparency in the patenting process should be expanded, including permitting third parties to submit prior art to the Office to "improve the patent examination process."

• USPTO fees:  Finally, BIO and Mr. Greenwood propose that the fee structure of the Office be modified to permit examination fees to be "more directly proportional" to the amount of effort required for adequate examination work required.  As part of these reforms, Mr. Greenwood proposes that the Office be allowed to "retain and reinvest its revenues" and that fee diversion be permanently prohibited.

Who is appointed as Patent Office Director, and the direction the Office takes under the Obama administration has been the subject of wide speculation since the election.  The recent withdrawal by Governor Richardson from consideration as Commerce Secretary has made these questions even less clear.  BIO and Mr. Greenwood attests that the organization is "eager to engage constructively in the continuing debate on improving the timeliness, quality, transparency, and efficiency of the patent system."  It will be refreshing if the new administration proves to be more willing to listen to the ideas proposed by BIO and others, rather than to seek justification and support for policies produced by Patent Office bureaucrats without the benefit of input from the companies and other stakeholders most invested in solving the real problems facing the Office, patent applicants and the public.

Top Stories of 2008: #5 to #1

    By Donald Zuhn --

Yesterday, we counted down stories #9 to #6 of the top stories covered at Patent Docs in 2008 (see "Top Stories of 2008: #9 to #6"), and on New Year's Day, we listed stories #13 to #10 (see "Top Stories of 2008: #13 to #10").  Today, we conclude our second annual list of top stories by counting down the top five stories of 2008.  In case you missed the articles the first time around or wish to go back and review them, we have also provided links to our coverage of these stories (as well as a few links to articles on related topics).  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our rankings, please let us know.


#5 -- Examination of Obviousness in Group 1600

Obviousness-related stories took the #5 (obviousness guidelines) and #4 (Supreme Court KSR decision) spots on our 2007 list of top stories.  With respect to the USPTO's issuance of guidelines for making obviousness determinations, we "predicted" that it would take some time for patent practitioners to discover the extent to which the new obviousness guidelines might impact patent prosecution.  For practitioners in the biotech and pharma arts, it didn't take too long.  As we reported in March, Bruce Kisliuk, a former Director with USPTO Technology Center 1600, informed attendees at an American Conference Institute (ACI) conference that most of the rationales set forth in the new obviousness guidelines applied to "classical mechanical situations" rather than biotech and pharma applications.  As a result, TC 1600 examiners were being taught to analyze obviousness using eleven key cases (consisting of seven CAFC, three district court, and one board decision).  One of these cases, the board decision in Ex parte Kubin, is scheduled for oral argument before the Federal Circuit on Thursday.

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

• "Docs at BIO: Panel Discusses IP Strategies after KSR," June 26, 2008
• "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.," June 22, 2008
• "Briefs for In re Kubin filed by Amgen and BIO," June 12, 2008
• "USPTO's Bruce Kisliuk Addresses ACI Conference," March 3, 2008

#4 -- New Written Description Guidelines Issued

Obviousness was not the only requirement for patentability that garnered special attention at the Patent Office last year.  At the end of March, the USPTO released revised training materials for use in the examination of patent applications for compliance with the written description requirement.  The new training materials, which replace the training materials issued by the Office in 1999, provide seventeen examples, of which fourteen are specifically related to biotech inventions.  While many of the examples should be of interest to biotech/pharma practitioners (as shown below, analyses of the majority of these examples were provided on Patent Docs), the most interesting example may be Example 11, which concerns claims reciting a polynucleotide or polypeptide sequence that shares percent identity with another sequence.  The new training materials give the impression that claims reciting both percent identity and functional limitations can create more of a written description problem than claims reciting just a percent identity limitation (while the training materials note that the latter class of claims could present an enablement problem, this advice comes by way of a separate practice note).  During a BIO 2008 presentation, TC 1600 Director Dr. George Elliott explained that the rationale behind Example 11 could be found in Ex parte Porro.  Unfortunately, with respect to Example 11, the training materials appear to neglect case law that allows for the recitation of a genus containing some inoperative species.

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

• "In re Alonso (Fed. Cir. 2008)," November 3, 2008
• "The Written Description Training Materials and Ex parte Porro," July 8, 2008
• "Docs at BIO: 'Gotcha' Games Continue at USPTO," June 25, 2008
• "An Analysis of the New Written Description Training Materials – Protein Variants," June 24, 2008
• "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.," June 22, 2008
• "An Analysis of the New Written Description Training Materials – Antisense," May 13, 2008
• "An Analysis of the New Written Description Training Materials – Antibodies to a Single Protein & Antibodies to a Genus of Proteins," May 12, 2008
• "An Analysis of the New Written Description Training Materials - ESTs & Partial Protein Structures," May 8, 2008
• "An Analysis of the New Written Description Training Materials - DNA Hybridization & Percent Identity," May 6, 2008

#3 -- Patent Reform Stalls in the Senate

No story on this year's list received more coverage on Patent Docs -- as evidenced by the list below -- than the story that moved from #6 on last year's list to #3 on this year's list:  patent reform.  But for the fact that the Senate patent reform bill never reached the floor for a vote (the bill was removed from the Senate calendar last spring), this story might have reached #2 on our list.  The year started out with the release of a draft of the Senate Judiciary Committee's report on the Patent Reform Act of 2007 (S. 1145), saw a better-late-than-never movement by biotech and pharma companies and organizations against biotech/pharma-unfriendly provisions of the bill, and ended with the announcement by Senator Jon Kyl (D-AZ) of a (possibly) more biotech/pharma-friendly patent reform bill to compete with Senator Patrick Leahy's (D-VT) bill.  Both bills are expected to be re-introduced when the 111th Congress gets down to business this month.  As with follow-on biologics legislation, however, whether the new Congress will be able to devote much attention to patent reform in view of the current economic crisis remains to be seen.

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

• "BIO Praises Senator Kyl's Patent Reform Bill," September 26, 2008
• "Senator Kyl’s Patent Reform Bill Introduced Today," September 25, 2008
• "BIO Discusses Legislative Accomplishments," September 3, 2008
• "Senate Patent Reform Legislation -- One Old Bill and One New Bill," August 11, 2008
• "Patent Reform Critic Says Legislation Would Be Costly and Counterproductive," July 30, 2008
• "Wall Street Journal: Current Patent System Suppresses Innovation," July 14, 2008
• "Evolution of Inequitable Conduct," May 27, 2008
• "Patent Hypocrisy," May 22, 2008
• "Bush Administration Continues Attempt to Destroy U.S. Patent System," May 18, 2008
• "Senate Patent Reform Bill: R.I.P.?" May 5, 2008
• "New York Times to Innovation: Drop Dead," April 30, 2008
• "No End to Fee Diversion?" April 21, 2008
• "BIO Commends Senator Specter for Patent Reform Stance," April 10, 2008
• "Commerce Secretary 'Entirely Wrong' on Inequitable Conduct Reform," April 8, 2008
• "Last Call to Voice Your Opposition to AQS Provision," April 4, 2008
• "Department of Commerce Sends Senators Second Letter on Patent Reform Bill," April 3, 2008
• "IPO Distributes 'Urgent' Legislative Alert on Applicant Quality Submissions," March 30, 2008
• "Amendments to S. 1145," March 17, 2008
• "Harry Manbeck on Inequitable Conduct," March 13, 2008
• "It's Getting to Be Crunch Time for S. 1145," March 13, 2008
• "U.S Patent 'Reform' Bill Worries Israelis," February 22, 2008
• "Judge Michel Doesn't Think Much of Senate Bill S. 1145, Either," February 20, 2008
• "The (Un)Intended Consequences of the Law," February 18, 2008
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part I," February 14, 2008
• "BIO Report Indicts 'Patent Reform' Proponents," February 13, 2008
• "Patent Reform and Infringement Damages: Some Economic Reasoning," February 5, 2008
• "Department of Commerce Sends Letter on Patent Reform to Senator Leahy," February 4, 2008
• "Biotech and Pharma Opposition to Senate Patent Reform Bill," February 3, 2008
• "The Letters Keep Coming Over the Senate Transom," January 30, 2008
• "Draft Report on Senate Patent Reform Bill: Interlocutory Decisions & Venue," January 29, 2008
• "Draft Report on Senate Patent Reform Bill: Damages," January 28, 2008
• "Draft Report on Senate Patent Reform Bill: Applicant Quality Submissions & Micro-Entities," January 25, 2008
• "U.S. Senate Mailbox Filling with Letters against Passage of Patent 'Reform' Bill: An Update," January 23, 2008
• "Draft Report on Senate Patent Reform Bill: Post-Grant Procedures," January 22, 2008
• "Draft Report on Senate Patent Reform Bill: Inequitable Conduct Provisions," January 21, 2008
• "U.S. Senate Mailbox Filling with Letters against Passage of Patent 'Reform' Bill," January 18, 2008
• "Draft Report on Senate Patent Reform Bill: First Inventor to File Provisions," January 17, 2008
• "Draft Report on Senate Patent Reform Bill: Assignee Filings, Mandatory Publication, and Third Party Submissions," January 16, 2008
• "Draft Report on Senate Patent Reform Bill: Late Patent Filings," January 15, 2008
• "Draft Report on Senate Patent Reform Bill Circulated," January 14, 2008

#2 -- The Rise and Fall of Other USPTO Rules Packages

The USPTO spent most of 2008 defending four major rules packages:  the claims and continuations, IDS, Markush, and appeal rules.  The enjoinment of the claims and continuations rules is currently at issue in the Tafas v. Dudas appeal.  The other three rules packages, however, have been (at least for now) tabled by the USPTO.  A significant amount of the credit for forcing the USPTO to postpone (perhaps indefinitely) the implementation of these rules packages must go to David Boundy, the Vice President of Intellectual Property for Cantor Fitzgerald L.P., and Dr. Richard Belzer, a former civil service staff economist in the Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB).  Mr. Boundy and Dr. Belzer regularly reminded (and encouraged patent practitioners and applicants to remind) the OMB that the Patent Office was not playing by the rules in trying to secure approval for each of the rules packages.  Whether the Obama Administration picks up the rules packages where the Bush Administration left off remains to be seen (as we have noted before, Obama advisor and Duke University School of Law Professor Arti Rai, co-signed one of only two amicus briefs in support of the USPTO in the Tafas v. Dudas appeal).

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

• "Patent Office Announces Delay for New Appeals Rules," December 10, 2008
• "Patent Office to Publish Notice Delaying New Appeals Rules," December 9, 2008
• "Patent Office Issues Appeals Rules Clarification," November 21, 2008
• "PTO Announces No IDS or Markush Rules During Bush Administration," October 27, 2008
• "More on Ex parte Appeal Rule," October 10, 2008
• "Unhappy with the Ex parte Appeal Rule? Read This Now -- Updated," October 8, 2008
• "Patent Office Posts Comments on New Appeals Rules," September 11, 2008
• "More on USPTO Rulemaking Practices," July 21, 2008
• "USPTO Rulemaking Practices Being Called into Question (Again)," July 20, 2008
• "Docs at BIO: Panel Discusses Impact of USPTO Rules Changes and Patent Reform Legislation on Biotech Patenting," June 23, 2008
• "New Appeals Rules Published," June 10, 2008
• "Patent Office to Publish New Appeals Rules on Tuesday," June 9, 2008
• "USPTO Posts Comments on New Rules for Alternative Claiming," April 23, 2008
• "Cantor Fitzgerald VP Comments on Markush Rules," April 10, 2008
• "You Can't Fight the USPTO -- or Can You?" March 11, 2008
• "Patent Office Publishes Notice Regarding Impact of Proposed Markush Claims Rules on Small Entities," March 10, 2008
• "Federal Register Notice Regarding Markush Claims to Publish on Monday March 10, 2008," March 7, 2008
• "OMB Receives Additional Submission Regarding PTO Rules Packages," February 21, 2008

#1 -- Continuation and Claims Rules Enjoined in GSK/Tafas v. Dudas; USPTO Appeals Injunction

Stories related to the new claims and continuations rules took the #3 (promulgation of new rules), #2 (USPTO clarification of new rules), and #1 (new rules preliminarily enjoined) spots on our 2007 list of top stories.  Not surprisingly, the Tafas case once again takes the top spot on this year's list of top stories.  On April 1st, Judge James C. Cacheris of the District Court for the Eastern District of Virginia granted Dr. Tafas' and GSK's motions for summary judgment and voided the claims and continuation rules as "otherwise not in accordance with law" and "in excess of statutory jurisdiction [and] authority," and thus, in contravention of the Administrative Procedure Act (APA).  The Patent Office responded by appealing the District Court's decision in May, and the Federal Circuit held oral argument on the appeal on December 5th.  In view of the panel's questioning of USPTO General Counsel James Toupin (and the quantity of amicus briefs supporting Dr. Tafas and GSK -- thirteen of the fifteen amicus briefs supported the appellees), one might guess that the Federal Circuit will affirm the District Court's decision.  However, stranger things have happened (and if the CAFC does lift the injunction, the Tafas case will almost certainly take the top spot again next year).  

For information regarding this topic, please see:

• "Federal Circuit Hears Oral Argument on Tafas Appeal," December 8, 2008
• "Law Professors Back USPTO in Tafas v. Dudas Appeal," October 23, 2008
• "PTO Files Reply Brief in Tafas v. Dudas Appeal," October 15, 2008
• "Dr. Tafas Files Brief in New Rules Appeal," September 20, 2008
• "GSK Files Brief in Tafas v. Dudas Appeal," September 25, 2008
• "Tafas v. Dudas Update," September 2, 2008
• "Enjoined Rule Will Not Be Applied Retroactively . . . If PTO Prevails in Tafas v. Dudas," August 7, 2008
• "Public Interest Groups Back USPTO in Tafas v. Dudas Appeal," August 5, 2008
• "USPTO Files Opening Brief in Tafas v. Dudas Appeal," July 22, 2008
• "Save the Date -- Initial Scheduling of the Tafas/GSK v. Dudas Appeal," May 21, 2008
• "USPTO to Appeal Tafas/GSK v. Dudas," May 7, 2008
• "BIO Responds to Events of the Day," April 1, 2008
• "No April Fool's Joke -- Tafas and GSK Win on Summary Judgment," April 1, 2008
• "PLI's John White Discusses Tafas/GSK v. Dudas," February 11, 2008
• "Judge Cacheris Takes GSK Case under Advisement," February 8, 2008
• "GSK Summary Judgment Hearing Set for Friday Morning," February 7, 2008

Top Stories of 2008: #9 to #6

    By Donald Zuhn --

On New Year's Day, we counted down the first four of the top thirteen stories covered on Patent Docs in 2008 (see "Top Stories of 2008: #13 to #10").  Today, we count down stories #9 to #6, and tomorrow, we will count down last year's top five stories.  In case you missed the articles the first time around or wish to go back and review them, we have provided links to our coverage of these stories (as well as a few links to articles on related topics).  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our rankings, please let us know.

#9 -- The USPTO Tightens Its Grip on Practitioners

We kicked off 2008 by reporting on the comments made by Harry Moatz (at right), USPTO Director of the Office of Enrollment and Discipline (OED), at an Intellectual Property Owners (IPO) meeting in New York.  At that meeting, Mr. Moatz made it clear that the Office planned to discipline registered practitioners who did not comply with the new claims and continuations rules (despite the fact that the rules had been preliminarily enjoined less than three months before his address).  Then Robert Clarke, USPTO Director of the Office of Legal Administration, announced at a panel discussion on patent reform that the OED also planned to "investigate" attorneys who file a "large number" of references that "could be used" to reject "a substantial number" of the claims presented in an application.  By appealing the Tafas decision and abandoning (at least for now) the new IDS, Markush, and appeals rules, the USPTO has put some of the OED's plans on hold.  The OED has kept busy, however, by announcing the creation of online registration system for registered practitioners, initiating an online Continuing Education for Practitioners (CEP) pilot program (expected to eventually be expanded to all registered practitioners), and relying on a December 12, 2003 Federal Register Notice to institute a $118 annual fee for all registered practitioners.

For information regarding this topic, please see:

• "Patent Office Reminds Patent Practitioners to Update Contact Information," December 12, 2008
• "Annual Fee Announced for Registered Practitioners," November 19, 2008
• "Patent Office Seeking Volunteers to Test Continuing Education System," September 1, 2008
• "EFS-Web Customer Satisfaction Survey & New Online Contact Information System for Practitioners," July 25, 2008
• "New Rules, New Threats: More on the Office of Enrollment and Discipline," January 14, 2008


#8 -- Impact of Presidential Election on U.S. Patent Practice

On November 4th, Senator Barack Obama was elected the 44th president of the United States.  The impact of Senator Obama's election on U.S. patent policy will have to await the President-elect's commerce secretary and USPTO director appointments (interestingly, New Mexico Governor Bill Richardson, President-elect Obama's selection for commerce secretary, withdrew his name from consideration earlier today; see New York Times report).  In October, we provided a hint of what patent practitioners and applicants could expect from an Obama Administration in our coverage of a panel discussion between representatives of Senator Obama and Senator McCain.  Representing Senator Obama's campaign were Professor Arti Rai, from the Duke University School of Law, and Associate Professor Christopher Sprigman, from the University of Virginia School of Law.  While the panel discussed the Obama campaign's gold-plated patent plan, we noted that all mention of the concept had been removed from the campaign's official website.  We subsequently noted that Prof. Rai co-signed one of only two amicus briefs in support of the USPTO in the Tafas v. Dudas appeal.  On a more positive note, Harold Wegner, a partner at Foley & Lardner LLP and professor at George Washington University Law School, noted this fall that the Obama Administration was also listening patent practitioners such as Chicago-based Foley partner Sharon Barner.  The direction that the new Administration takes the USPTO will likely be a top story in 2009.

For information regarding this topic, please see:

• "New Administration Will Act Quickly to Jump-Start Stem Cell Research," November 11, 2008
• "Reaction to Historic Presidential Election," November 5, 2008
• "A Second Look at President-elect Obama's Technology Platform," November 4, 2008
• "Presidential 'Debate' on U.S. Patent Policy," October 14, 2008

#7 -- Follow-on Biologics Debate Continues

While innovator and generic companies have reached a consensus regarding the need for a follow-on biologics regulatory pathway, they have been unable to reach consensus on the primary sticking point holding up passage of a follow-on biologics bill:  an appropriate exclusivity period.  Over the past twelve months, both sides issued reports and press releases supporting their particular stances.  For example, a Teva-funded study released in November suggested that a data exclusivity period of seven years would be "sufficient for maintaining strong incentives to innovate while fostering a competitive marketplace."  Another Teva-funded study released in September questioned the need for exclusivity provisions that would tack on an extra 7-12 years of protection.  Meanwhile, innovator companies have supported bills providing 12-14 years of exclusivity.  Five follow-on biologics bills were introduced during the 110th Congress:  H.R. 1956 (which provides twelve years of data exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data exclusivity and eight years of market exclusivity), and S. 623 and H.R. 1038 (which do not address data/market exclusivity).  Whether the 111th Congress will be able to devote much attention to a follow-on biologics bill in view of the current economic crisis, and if it does, what type of bill makes it to the White House, will also be a top story in 2009.

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

• "BIO Says CBO Estimate of Follow-on Biologics Savings Is Based on 'Troubling Assumption'," December 29, 2008
• "Medco Predicts Follow-on Biologics Regulatory Pathway by 2011," November 25, 2008
• "Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient," November 20, 2008
• "Follow-on Biologics in the News," September 23, 2008
• "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation," September 18, 2008
• "BIO Discusses Legislative Accomplishments," September 3, 2008
• "Congressional Fact-finding on Follow-on Biologics," August 13, 2008
• "Insmed's Follow-on Biologics Campaign Continues," August 13, 2008
• "JEC Holds Hearing on Drug Pricing; GPhA Lobbies for Follow-on Biologics Pathway," July 31, 2008
• "Insmed Announces Bioequivalent G-CSF Biologic," July 10, 2008
• "CBO Releases Report on Senate Follow-on Biologics Bill; BIO Calls for Congress to Pass Biologics Bill in 2008," July 1, 2008
• "Follow-on Biologic Drugs and Patent Law: A Potential Disconnect?" March 25, 2008
• "New Follow-on Biologics Bill Introduced in the House," March 18, 2008
• "Dr. Robert Shapiro Discusses Follow-on Biologics Report," February 19, 2008
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part II," February 14, 2008
• "Insmed Announces National Awareness Campaign Regarding Follow-on Biologics," February 13, 2008

#6 -- The USPTO Comes under Attack

In February, we reported on a USPTO oversight hearing held by the House Subcommittee on Courts, the Internet, and Intellectual Property.  In addition to hearing from USPTO Director Jon Dudas, the Subcommittee also heard from Robin Nazzaro, the Director of National Resources and Environment for the U.S. General Accountability Office; Robert Budens, the President of the Patent Office Professional Association (POPA); and Alan Kasper, the First Vice President of the American Intellectual Property Law Association (AIPLA) and a partner with Sughrue, Mion, PLLC.  Some of the most interesting testimony was provided by the POPA president, who indicted the Office's antiquated production system, which has remained essentially unchanged since it was put in place in 1976, for much of the Office's pendency problems.  In May, we reported that the Subcommittee's Chairman, Congressman Howard Berman (D-CA) (at right), sent a letter to Director Dudas requesting "additional information" regarding the Director's earlier testimony, and in June, we analyzed the Director's response to Congressman Berman's letter.  The Subcommittee's inquiry may have helped stall the Patent Office's efforts to enact some of the most sweeping changes to U.S. patent practice that have been proposed or promulgated in recent memory.  More on that tomorrow.

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

• "Pinkos Appointment Provokes Allegations - Updated," November 24, 2008
• "Deputy Director Peterlin Announces Resignation," July 29, 2008
• "Docs at BIO: Panel Discusses Impact of USPTO Rules Changes and Patent Reform Legislation on Biotech Patenting," June 23, 2008
• "What the Director's Letter Didn't Say," June 15, 2008
• "Director Answers House Subcommittee's Questions," June 12, 2008
• "Maybe It's Finally Time They Went Home," May 28, 2008
• "Maybe It Isn't Going to Get Much Better," May 21, 2008
• "Congressman Berman Is on the Case," May 14, 2008
• "IPO Disagrees with Director Dudas," May 11, 2008
• "GAO Testimony Supports POPA's Position on Examiner Attrition," March 13, 2008
• "POPA President Critical of USPTO During House Subcommittee Oversight Hearing," March 4, 2008
• "More on House Subcommittee USPTO Oversight Hearing," February 28, 2008
• "House Subcommittee Holds USPTO Oversight Hearing," February 27, 2008

USPTO News: Patent Prosecution Highway Pilot with CIPO Is Extended

    By Donald Zuhn --

Yesterday, the U.S. Patent and Trademark Office announced that the USPTO and Canadian Intellectual Property Office (CIPO) will be extending the Patent Prosecution Highway (PPH) pilot program between the Offices for an additional two years to January 28, 2011.  The USPTO and CIPO will evaluate the results of the PPH pilot program at the end of the two-year period to determine whether and how the program should be fully implemented.

As we reported earlier this year (see links below), the USPTO and CIPO initiated the one-year PPH pilot on January 28, 2008.  The objective of the PPH is to share the results of each Office's searches in order to make examination more efficient.  The PPH allows an application that has allowable/patentable claims as determined in the Office of first filing (OFF) to have a corresponding application in the Office of second filing (OSF) to be advanced out of turn for examination, and give the OSF access to the search and examination results from the OFF.  Thus, the applicant can enjoy accelerated examination in the OSF, which is based on the art and examination already dealt with in the OFF.

Inquiries regarding the PPH pilot program should be directed to Magdalen Greenlief at 571-272-8800 or via e-mail (Magdalen.greenlief@us~to.gov).

For additional information regarding this topic, please see:
• "Patent Prosecution Highway Network Expands to Canada & Korea," January 29, 2008
• "USPTO Announces Two Additional Partners in the Patent Prosecution Highway Pilot Program," January 17, 2008

USPTO News: Patent Office Closed on December 26th

    By Donald Zuhn --

Yesterday, the U.S. Patent and Trademark Office (USPTO) announced that the USPTO will be closed on Friday, December 26, 2008.  The USPTO notice states that because December 25th is a federal holiday, the Office will consider December 26th to be a "Federal holiday within the District of Columbia."  As a result, any action or fee due on December 25th or December 26th will be considered timely if the action is taken or the fee is paid on Monday, December 29, 2008 (i.e., the next business day on which the Office is open).  Applicants are reminded that any correspondence sent to the USPTO via United States Postal Service (USPS) Express Mail will be considered filed on the date of deposit with the USPS, and any correspondence transmitted electronically to the USPTO will be considered filed with the USPTO on the date the USPTO received the electronic transmission.

USPTO News: Patent Office Reminds Patent Practitioners to Update Contact Information

    By Donald Zuhn --

On Thursday, the U.S. Patent and Trademark Office issued a reminder notice to all registered patent attorneys and agents to update their contact information via the Office's new online registration system.  Patent Docs first reported on the new online registration system last summer.

According to the Patent Office's notice, each patent practitioner should begin by checking the "Patent Attorney/Agent Search" page of the USPTO website before March 1, 2009 to ensure that the practitioner's business mailing address is correct.  If a practitioner's business address is incorrect, the practitioner should download and complete a "Change of Address for Registered Patent Attorneys and Agents" form and mail the completed form to:  Mail Stop OED, Director, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, Virginia 22313-1450.

If a practitioner does not find his or her name on Office's roster of registered attorneys and agents, the reminder notice states that the practitioner is not authorized to practice before the USPTO in patent cases, and notes that the practitioner's name may have been removed pursuant to 37 C.F.R. §§ 10.11(b) or 11.11 for lack of response to a previous survey or communication from the OED.  The Office's reminder notice contains detailed instructions for resolving situations in which a practitioner believes he or she should be listed on the roster.

In the second phase of online registration, the OED will separately mail passwords and user identifications to all practitioners for which it has a correct (or corrected) mailing address.  The two mailings will be sent out after March 1, 2009.  Once practitioners have received their password and user identification, they will be able to change their address, telephone number, and e-mail address by signing in at the "On-Line Change of Address for Practitioners" page of the USPTO website.  The Office notes that to avoid unsolicited spamming and communications, practitioner e-mail addresses will not be made public by the Office.

The Office's notice states that the new online registration system is being implemented in order to help eliminate processing errors associated with the practitioner roster, reduce losses due to mailings to incorrect addresses, and ensure that practitioners receive critical notices and confirmations from the USPTO.  The Office intends to use the collected contact information to communicate with practitioners -- including providing information about future annual practitioner maintenance fees (see "Annual Fee Announced for Registered Practitioners").  The notice also reminds practitioners that under 37 C.F.R. § 11.11(a), they are required to update their contact information on the roster within 30 days of any change.

With respect to the annual practitioner maintenance fee the Office will begin assessing next year, the Office reminder notes that in response to suggestions from law firms and companies, such entities will be able to make a single payment of the annual fee for all practitioners who are members of their firms or companies.  In order to ensure that firm and company payments are properly attributed to the correct practitioners, the Office is recommending that all practitioners within a particular firm or company use the same name in their contact information.  Additional information regarding annual practitioner fee payments by law firms and companies can be found in the Office's reminder notice.

Personalized Medicine: A Patent Office Perspective

By Kevin E. Noonan --

On December 3rd, the biotechnology, chemical, and pharmaceuticals (BCP) technology groups at the U.S. Patent and Trademark Office held their most recent quarterly customer partnership meeting.  During one of six presentations, Kathleen Bragdon, a Quality Assurance Specialist from Technology Center 1600, presented "A Look at Personalized Medicine."  In prior years, this talk may have been anticipated to be a prospective look at a developing technology area, or represent the Office's attempt to open a dialog with applicants and their representatives.  But these have not been normal times, and the presentation contained a few unpleasant but not entirely unexpected surprises.

The majority of the presentation was a competent, but by no means comprehensive, review of personalized medicine (referencing scientific journal articles and Wikipedia) and pharmacogenetics.  Warfarin, and the use of genetic screening of single nucleotide polymorphisms (SNPs) to determine patients for whom warfarin treatment may be contraindicated, was used as a case study.  Ms. Bragdon also reviewed FDA approval of genetic testing of two human genes (VKORC1 and CYP2C9) having SNPs predictive for warfarin sensitivity.

The talk featured several examples of how these relationships between genotype and drug treatment could be claimed, including the following:

3. A method for determining whether a human subject having breast cancer will be effectively treated with "breast cancer drug X", said method comprising:
a) considering data in a database comprising genetic patient information about the ERBB2 gene at position 101 of SEQ ID NO:1; and
b) correlating the presence of a cytosine at position 101 of SEQ ID NO:1 with effective treatment of the human subject with "breast cancer drug X".

This is an invalid claim, according to Ms. Bragdon, for failing to qualify as statutory subject matter under the Bilski decision, because it is neither tied to a machine or apparatus nor performs a transformation (see ".  The following claim, on the other hand, would be statutory subject matter:

4. A method for treating a human subject having breast cancer, said method comprising:
a) obtaining a nucleic acid sample from said human subject;
b) subjecting the sample to PCR and identifying the nucleotide present at position 101 of SEQ ID NO:1; and
c) treating the human subject with "breast cancer drug X" when a cytosine is detected at position 101 of SEQ ID NO:1.

A comparison between these claims illustrates the Office's solution to how Bilski (or whatever form a future LabCorp decision may take regarding these kinds of claims) may be applied to biotechnology (or more specifically, molecular diagnostic) claims (see "The Relevance of In re Bilski to the Patentability of the Metabolite Claim").  By casting the claim as a method of treatment, and tying the step of identifying patients bearing a diagnostic SNP to a treatment step, the policy and philosophical problems presented by the LabCorp case are apparently solved.  While the identification step can still be interpreted to be either a "mental step" or a mere recitation of a natural principle, treatment methods are clearly statutory subject matter (in the U.S.).

One difficulty with this solution, however, is that it may frequently be the case that the actor who performs the diagnostic step of determining whether a patient bears a diagnostically-relevant SNP is a different actor than the one who performs the method of treatment step.  This dichotomy of action then directly implicates the principle enunciates in the Muniauction case, that a claim cannot be infringed by joint tortfeasors unless there is one actor exercising direction and control over the others (see "Adequate Method Claiming Requirements:  Muniauction, Inc v. Thomson Corp.").  This situation may frequently be the case in the practice of claims such as claim 4 in the presentation.  However, there may be instances when it is not the case.  In these cases, the Office's solution to the LabCorp problem will be unavailing.  The introduction of method of treatment claims in this regard is also problematical insofar as it implicates the infringement exemption embodied in 35 U.S.C. § 287(c) for physicians and other medical personnel.

The presentation also discusses the Office's interpretation of how the enablement requirement may be implicated in personalized medicine claims.  In this regards, Ms. Bragdon discussed the following claim:

5. A method for treating a human subject having breast cancer, said method comprising:
a) obtaining a nucleic acid sample from said human subject;
b) subjecting the sample to PCR and identifying the nucleotide present at position 101 of SEQ ID NO:1; and
c) treating the human subject with "breast cancer drug X" when a cytosine is detected at position 101 of SEQ ID NO:1.

The presentation supplies the (putative) disclosure from the specification supporting this claim, that SEQ ID NO:1 is a variant of the ERBB2 gene having an A (adenine) to C (cytosine) mutation at position 101 (A101>C).  This mutation (A101>C) is typically found in breast cancer patients, according to the hypothetical, and it correlates with a significantly better response to treatment with "breast cancer drug X" versus placebo (i.e., without the mutation, breast cancer drug X is ineffective).  Finally, the hypothetical specification does not distinguish among patient populations tested, but teaches that variability in treatment responses among patient populations may be an unpredictable (emphasis in original) factor in SNP correlation studies (presumably, this factor in the analysis could also be something within the skill of one having ordinary skill in the art).

The enablement issue arises under this hypothetical because post-filing data establishes that there is a patient population that does not show the claimed correlation between the mutation in the ERBB2 gene and responsiveness vel non to breast cancer drug X.  Ms. Bragdon did not assert that under these circumstances the claim would necessarily be invalid for lack of enablement, but suggested that "[t]he appropriateness of making any enablement rejection should be considered based on the foregoing facts."

While it is certainly the case that post-filing evidence can be used to show that a claim is not enabled, here it seems that the more appropriate question would be whether the specification provided sufficient guidance to enable the skilled worker to determine whether a particular patient (as opposed to a patient population) would bear a predictive SNP, and whether the practice of the claimed invention with a particular patient having a particular SNP to predict drug sensitivity would require undue experimentation.  Perhaps Ms. Bragdon was performing her analysis in view of the Federal Circuit's Monsanto Co. v. Syngenta Seed, Inc. case, where the Court found invalid claims reciting genetic transformation of plant cells where certain plant cells (monocots) could not be transformed at the time the application was filed, and the specification provided neither any teaching regarding how to transform monocot cells nor disclaimer or limitation to transformable dicot cells.  However, the Office appears to be suggesting that claims like claim 5 may be per se unpatentable in the face of after-filing evidence that not all patients fall within the scope of the claim.  This seems an unnecessary conclusion and extension of the requirements for enablement under 35 U.S.C. § 112, first paragraph.

A copy of Ms. Bragdon's presentation can be obtained here.

Additional BCP presentations will be discussed in future posts.  For information regarding other BCP posts, please see:

• "USPTO Implements New Program to Teach Examiners How to Read and Understand Case Law," December 4, 2008.

USPTO News: Additional Application Types Eligible for Participation in PPH Between USPTO and EPO

By Christopher P. Singer --

In a memorandum dated December 10, 2008, the USPTO announced that, in response to comments from its customers, it has modified the requirements for requesting participation in the patent prosecution highway (PPH) pilot program.  The changes will take effect on December 22, 2008, and will allow certain U.S. applications based on PCT filings to participate in the program.  We reported the prior announcement detailing the more restrictive original requirements for participation in the PPH pilot program between the USPTO and the EPO here.

Under the new requirements, a U.S. application may be eligible to participate in the PPH program if it falls within any of the three following categories:

(a) a Paris Convention application which either (i) validly claims priority under 35 U.S.C. § 119(a) and 37 C.F.R. § 1.55 to one or more applications filed in the EPO; or (ii) validly claims priority under 35 U.S.C. § 119(a) or § 365(a) to a PCT application that contains no priority claims.

(b) a national stage application under the PCT (an application which entered the national stage in the U.S. from a PCT international application after compliance with 35 U.S.C. § 371), which PCT application (i) validly claims priority under 35 U.S.C. § 365(b) to an application filed in the EPO; (ii) validly claims priority under 35 U.S.C. § 365(b) to a PCT application that contains no priority claims; or (iii) contains no priority claim.

(c) a so-called bypass application filed under 35 U.S.C. § 111(a) which validly claims benefit under 35 U.S.C. § 120 to a PCT application, which PCT application (i) validly claims priority under 35 U.S.C. § 365(b) to an application filed in the EPO; (ii) validly claims priority under 35 U.S.C. § 365(b) to a PCT application that contains no priority claims; or (iii) contains no priority claim.

The Notice provides some graphical depictions of applications which fall under these categories, which may be helpful in determining whether an application you are handling is eligible under these new requirements.  Questions concerning the Notice or the PPH program can be directed to Magdalen Greenlief, Office of the Deputy Commissioner for Patent Examination Policy, at 571-272-8800 or at [email protected].

USPTO News: Patent Office Announces Delay for New Appeals Rules

    By Donald Zuhn --

Yesterday, we reported on a Notice published by the U.S. Patent and Trademark Office in today's Federal Register announcing a delay in the effective date of the new rules relating to Practice before the Board of Patent Appeals and Interferences in Ex Parte Appeals (Appeals rules).  Today, the Patent Office placed announcements regarding the appeals rules delay on the home page and "News and Notices" page of the Office's website.  The Office's announcement indicates that new effective and applicability dates for the appeals rules will be identified in a subsequent announcement.  The Office also states that it will continue to accept appeal briefs that comply with either the current or new rules.

As suggested by Ron Katznelson (at right) in a comment to our earlier report:

It is important that practitioners not follow USPTO's invitation to use the new rules' option when filing an appeal and that they make clear in their transmittal that the appeal is filed under the 2004 rules.  Because the public record on the extent of paperwork burdens imposed by the new appeal rules is incomplete, this is important for three reasons:

(a) The USPTO will likely use the fact that some filings are made under the new rules to later argue that the public does not really care much which rules are used - thereby making a false point about lack of incremental burdens.

(b) It is also clear that appeal cases that would be most negatively impacted by the new rules would naturally be filed under the old rules and therefore the voluntary filings under the new rules would be heavily biased towards the simple and short cases. The USPTO will most likely use their "junk science" methods to characterize the ensemble of appeals filed under the new rules based on this voluntary highly biased population. This will enable the USPTO to falsely characterize all appeals if filed under the new rules.

(c) It is unlikely that the new appeal rules will survive proper OMB PRA review. As numerous comments show, certain features of the new rules would have to be withdrawn or modified substantially. Therefore, practitioners' "learning curve benefits" from attempting to follow rules that may never survive are doubtful at best.

Dr. Katznelson was one of twelve parties to submit comments in response to the Patent Office's June 9th request for comments on the Office's estimates for additional burdens imposed on applicants by the new appeals rules (see "Patent Office Posts Comments on New Appeals Rules").  Dr. Katznelson, the President of Bi-Level Technologies, is also a named inventor on a number of U.S. patents.

For additional information regarding this topic, please see:

• "Patent Office to Publish Notice Delaying New Appeals Rules," December 9, 2008
• "More on Ex parte Appeal Rule," October 10, 2008
• "Patent Office Posts Comments on New Appeals Rules," September 11, 2008
• "More on USPTO Rulemaking Practices,"July 21, 2008
• "USPTO Rulemaking Practices Being Called into Question (Again)," July 20, 2008
• "New Appeals Rules Published," June 10, 2008
• "Patent Office to Publish New Appeals Rules on Tuesday," June 9, 2008

USPTO News: Patent Office to Publish Notice Delaying New Appeals Rules

    By Christopher P. Singer --

In a Notice to be published in tomorrow's Federal Register, the U.S. Patent and Trademark Office announced that the new rules relating to Practice before the Board of Patent Appeals and Interferences in Ex Parte Appeals (Appeal rules) will not take effect on December 10, 2008, as originally scheduled.

The primary reason for the delay, according to the Notice, is that the Office of Management and Budget (OMB) has not yet had a chance to complete its review of all the information submitted in response to the information collection under the Paperwork Reduction Act (PRA).  As previously reported by Patent Docs, the public must be afforded an opportunity to submit comments directed to the burden impact of any proposed rule change to the OMB under the PRA.  The OMB uses the information provided by the agency advancing the rule change as well as the comments provided by the public and assesses the ultimate burden impact of the proposed rule changes.  This helps to insure that any rule changes advanced by a particular governmental agency are not unduly burdensome on the public.

Patent Docs will monitor the status of the Appeal rules and provide an update as appropriate.

For additional information regarding this topic, please see:

• "More on Ex parte Appeal Rule," October 10, 2008
• "Patent Office Posts Comments on New Appeals Rules," September 11, 2008
• "More on USPTO Rulemaking Practices,"July 21, 2008
• "USPTO Rulemaking Practices Being Called into Question (Again)," July 20, 2008
• "New Appeals Rules Published," June 10, 2008
• "Patent Office to Publish New Appeals Rules on Tuesday," June 9, 2008

Federal Circuit Hears Oral Argument on Tafas Appeal

    By Donald Zuhn --

Last Friday, the Federal Circuit heard oral argument in the Tafas v. Dudas appeal.  Arguing on behalf of Defendants-Appellants Director Jon Dudas and the U.S. Patent and Trademark Office was USPTO General Counsel James Toupin.  Plaintiffs-Appellees SmithKline Beecham Corp., SmithKline Beecham plc, and Glaxo Group Ltd. (GSK) were represented by John Desmarais, a partner with Kirkland & Ellis LLP, and Plaintiff-Appellee Dr. Triantafyllos Tafas was represented by Steven Moore, a partner with Kelley Drye & Warren LLP.

Mr. Toupin argued first, and for seventeen and a half minutes, the Patent Office's General Counsel was peppered with questions from the panel, which consisted of Circuit Judges Rader, Bryson, and Prost.  Mr. Desmarais went next, addressing the Court for just over eighteen minutes, followed by Mr. Moore, who argued for almost eight minutes.  Mr. Toupin closed oral argument with another twelve and a half minutes of rebuttal.  An audio recording of the oral argument can be found here.  For practitioners and applicants who have not had a chance to listen to the nearly one-hour long oral argument in this case, a few highlights are offered below.

Mr. Toupin (at right) began by stating that "[a]ll of the regulations at issue here fit squarely within the plain meaning of governing the conduct of proceedings before the Office, and seek to expedite the process of patent applications," adding that Lacavera v. Dudas, 441 F.3d 1380 (Fed. Cir. 2006), and Bender v. Dudas, 490 F.3d 1361 (Fed. Cir. 2007), indicate that "the PTO's interpretation of [35 U.S.C.] § 2 is entitled to Chevron deference."  The Court, however, reminded Mr. Toupin that whether the PTO was entitled to Chevron deference was "kind of the issue here."  Questioning the Office's counsel on the issue of deference, the Court asked:

Court:  You want Chevron deference, but you only get that deference if you're acting within the scope of your authority, and [if not,] that's a matter on which there is no deference, right?

Mr. Toupin:  No.  Under Bender and Lacavera, the Court accorded the agency Chevron deference with respect to . . .

Court:  Under Borlem, we said very clearly:  only if you're within your statutory mandate, and the courts decide whether you're within the scope of your authority.

On the issue of deference, the Court concluded by "asking" whether Mr. Toupin was "arguing that we ought to allow the [agencies] to themselves define their own limits of their power and receive deference for that?"

Moving on to the limits on continuation applications imposed by the new rules, the Court stated that:

Court:  The question remains, and I think you alluded to this earlier, that it's still . . . what you've done [with the continuation and claims rules] still has to be in accordance with law, and my concern there goes to the [35 U.S.C. §] 120 and the continuation issue.  It seems to me, and tell me if you disagree, that [§] 120 sets out quite clearly certain criteria for when an application is entitled to a priority date.  And as I read your proposed regulations, they create a very explicit exception.  In other words, they say an application -- except for the third or more application that doesn't involve new matter -- you don't get the priority date.  And that bumps up, in my view, to the language in the statute.

Mr. Toupin:  First, that's not an accurate interpretation of the rule itself because additional continuations are permissible on a showing that with reasonable diligence one could not have brought the matter previously.

The Court, not satisfied with Mr. Toupin's reply, snapped back that "[t]he statute says 'shall have the same effect' -- shall have the same effect whether it's the third, the fifth, or the first, as long it's copending at the time [applicants] make the request."  The Court then asked:

Court:  Do you disagree that the statute is absolutely clear that there's no exception or exclusion for third and fourth applications that do not provide anything that wasn't otherwise available?

Mr. Toupin:  What the Court held in . . .

Court:  Can you just answer the question as to whether you think the statute is clear?

Mr. Toupin:  No, your Honor.  What the Court held in the Henricksen case was that it was not clear on the face of the statute, unequivocally clear on the face of the statute, that an applicant [could not be] limited to two continuations, and it therefore held the Board erred in finding that it was clear.

Leaving the issue of continuation limits behind, the Court then turned to claims limits imposed by the new rules:

Court:  Looking at the other rule, the 5/25 rule, do you read [35 U.S.C. §] 112 as -- the "or more" language -- as creating some kind of limit?

Mr. Toupin:  [A]s the Court held in Rubinfield, "or more" requires an applicant to submit at least one claim.

Court:  "Or more."  Does "or more" have a limit in it?  How many is "or more"?  Is six "or more"?

Mr. Toupin:  Six is literally "or more."

Court:  Thank you.

Mr. Toupin reminded the Court that "[t]he agency, of course, has not here imposed a limit on the number of claims," and instead had "only imposed a requirement that over a certain number of claims the applicant should provide additional information to assist in the examination."  One of the oral argument's most interesting exchanges followed:

Court:  Well, there's a little problem with that too.  Wouldn't you be crazy to use that [Examination Support Document (ESD)] procedure and subject yourself to inequitable conduct if you make a slightly wrong comment in the wrong place?

Mr. Toupin:  To the contrary, your Honor . . .

Court:  You're going to go out and advise your clients to use the ESD procedure routinely?  . . .  You're advising a pharma company now, and you've got clinical trials under way, and you know you're going to need to, down the road  . . .  identify your species that are the best ones.  You're going to need continuations to cover your real inventions.  You're going to need more claims because you're not only claiming the species but the various formulations and the administration methods.  . . .  And you're going to say:  "Well it's okay, we can go beyond five and we can go beyond the continuations limit because, ahhh, we can clarify it all with ESDs?"  That's the advice you're going to give your client?

Mr. Toupin:  Well, look, first, your Honor . . .

Court:  "Yes" is your answer?  I bet you're not going to be hired by very many pharmaceutical companies.  I just think you sent yourself to the electronics industry.

The Court concluded its questioning of the Patent Office's counsel by pointing out that in promulgating the new rules, the PTO had "shifted the burden here . . . that the burden is kind of shifted to [an applicant] not only to prove that you deserve the extra claims, but that you deserve the patent based on your own reading of the prior art, which if you [make a] mistake in the slightest, it's going to cost you your head."

By any comparison, the Court's questioning of Mr. Desmarais and Mr. Moore was much less contentious.  With Mr. Desmarais (at left), the Court probed the issue of prosecution laches and whether its decision in In re Bogese informed the current appeal.  Using the facts in Bogese, the Court posed the following hypothetical:

Court:  Could the PTO issue a rule that says applicants who file twelve continuations over an eight-year period without advancing prosecution when given the opportunity will forfeit their patent right?

Mr. Desmarais:  This Court made it clear in the prosecution laches trilogy -- in Symbol II, In re Bogese, and Symbol IV -- that mechanical rules aren't the way to handle this.

The Court noted, however, that unlike in Bogese, the new rules give applicants "an out," stating that "[t]hey say just explain your reasons, or why you shouldn't have done it earlier, and you can have more [continuations]."  Mr. Desmarais countered by stating:

That's the problem with the current rules.  They're saying now with the current rules [that] when you get to the third [continuation], you have to sign a declaration that says you cannot have done this earlier.  That's not what [§] 120 says.

On the issue of whether the new rules would actually address the PTO's growing backlog of applications, the Court and GSK's counsel engaged in the following exchange:

Court:  What do you do with the factual predicate here?  [The PTO is] falling behind at least 100,000 applications a year.  Something's got to happen.

Mr. Desmarais:  Yeah, something absolutely should happen, and that analysis and what should happen is something for Congress to deal with.  . . .  So what has Congress been doing?  Since 2005, Congress has been debating patent reform.  They have been considering should we give the PTO authority to mess with § 120.  They have been considering should we give the PTO substantive rulemaking authority.  They debated it in 2005, 2006, 2007, 2008 -- it hasn't passed yet, but they know it's their job and they're attending to it.  It's not for the PTO to say we're tired of waiting for Congress, and to come in, grab the law themselves, and start to change it.  They can't do that.

The difference in the tenor of the Court's questioning of Mr. Toupin and Mr. Desmarais was no more apparent than when the Court asked Mr. Desmarais whether pharmaceutical companies "could well need" more than the two continuations, five independent claims, and 25 total claims provided by the new rules.  GSK's counsel responded with an impassioned plea on behalf of the pharmaceutical industry:

You will, in my view, cripple the pharmaceutical industry with these rules.  . . .  The problem for the pharmaceutical industry, and why these rules are so problematic, is [a pharmaceutical company] come[s] up with a class of compounds -- which is a big genus of compounds, that's what they invent in the laboratory -- it then takes them literally a decade, literally a decade and millions of dollars, to find the species that works.  Many of [these species] fail along the way.  They go into clinicals, phase I, phase II, whatever, and [a pharmaceutical company] may put in $100 million, or $200 million, or $300 million, and [the species] may fail in the clinic.  [The company has] to go back and pick another one and try again.  If you limit them to two continuations, and the third only if they couldn't have done it earlier, you're going to cripple them because they're going to get into the process, multi-years into the process, hundreds of millions of dollars into the process, and then they're going to find the compound that actually works and saves human lives, and they're not going to be able to patent it.  And you know what happens if they can't patent it?  They're not going to take it to market.

The Court then turned to Mr. Moore (at right), asking Tafas' counsel whether there should be any limits on the numbers of claims an applicant can file:

Court:  Do you think if someone came in with 1,000 claims, and said to the examiner:  "Get busy"?  . . .  Do you think the examiner could say, or the PTO could say as a policy matter:  "No, that's just too many claims.  There's no way that you need a thousand claims.  We're just not going to look at a thousand claims"?

Mr. Moore:  Under the law today, no.  They could not say that.  But we do know what they do.  I mean, we all know what they do.  They will restrict those 1,000 claims into 1,000 applications.

As to whether the Office could address the problem with additional claims fees, the Court queried:

Court:  Could they ask you to pay an extra fee if you want more than 25 claims?  Could they double, or triple, or quadruple the fee?

Mr. Moore:  Under the current statutes, the fees are set by Congress.  So I don't think they can set fees.

On rebuttal, Mr. Toupin covered the issues of retroactivity and the vagueness of the ESD rule (both of which had been first addressed by Mr. Moore), and then the Court tossed a few more questions Mr. Toupin's way:

Court:  I know we're straying a little into policy here rather than direct law, but Mr. Desmarais made the point that this could be crippling for the pharmaceutical industry.  Was that considered as part of the notice and comment period and was that considered by the Office in [promulgating the new rules] in the first place?

Toupin:  Absolutely, your Honor.  Our original proposal was one continuation or RCE as of right, and any additional [continuation or RCE] would require a showing.  We changed that explicitly in response to concerns about the effect [of the new rules] on commercialization to 2+1 [i.e., two continuations plus one RCE].

The Court concluded by asking Mr. Toupin if he knew whether the use of delayed examination would "affect patent term restoration under the Hatch-Waxman Act," to which Mr. Toupin responded that he did not.

Patent practitioners, applicants, and assignees will now await the Federal Circuit's decision.

USPTO Implements New Program to Teach Examiners How to Read and Understand Case Law

    By Donald Zuhn --

On Wednesday, the biotechnology, chemical, and pharmaceuticals (BCP) technology groups at the U.S. Patent and Trademark Office held their most recent quarterly customer partnership meeting.  During the last of six presentations, Associate Solicitor Janet Gongola outlined a new training module that the Office has begun using to instruct examining corps about case law.  Ms. Gongola noted that the new training module had been first used on November 18th, and that the examiners in Tech Center 1600 (biotechnology and organic chemistry) would receive their case law training sometime in December.

The new training module has been designed by the Office to provide examiners with a basic understanding of case law, including the components of an opinion, the meaning of precedent, and how to cite cases, so that examiners will be better able to respond to the use of case law by patent practitioners.  The case law training module being used by the Office consists of a pair of two-hour sessions, the first session constituting a lecture by an attorney from the Office of the Solicitor and the second session constituting a series of four laboratory exercises in which trainees split off into small groups to address hypothetical situations involving §§ 101, 102, 103, and 112 rejections.

Reviewing a number of slides from the first session of the training module, Ms. Gongola informed attendees that examiners are taught to always consult the MPEP first when attempting to ascertain the Office's policy regarding the meaning of a cited case.  In the event that the MPEP provides no information regarding the cited case, examiners are then taught to focus on the portion of the case that has been cited by the practitioner, and then, if necessary, to read other parts of the case that may be pertinent the issue.  The training module also helps examiners understand, identify, and distinguish holdings and dicta.  (Ms. Gongola noted, however, that examiners were being taught to avoid debates with practitioners over whether particular statements in a case constitute holdings or dicta.)  In addition, examiners are instructed on the difference between the headnotes/syllabus and the opinion itself and the difference between majority and plurality opinions, concurrences, and dissents.

During her presentation, Ms. Gongola recommended that when citing cases, practitioners should always cite to the U.S.P.Q. reporter, as it is the only reporter to which examiners have access.  In view of the limited amount of time that examiners are allowed to spend examining applications on their dockets, this recommendation appears to be a good one.

In an interesting aside, Ms. Gongola noted during her presentation that the Patent Office had hired 1192 new examiners in 2008, of which 32 had been assigned to TC 1600 and 207 had been assigned to TC 1700 (chemical and materials engineering).  The Associate Solicitor also noted that in 2007, 1196 new examiners had been hired, of which 62 had been assigned to TC 1600 and 154 had been assigned to TC 1700.  For the patent practitioners in the audience, who one might assume deal mostly with TC 1600 examiners, this does not come as particularly good news -- especially since the average total pendency in YC 1600 rose to 34.8 months in 2008 from 34.4 months in 2007 (see "USPTO Announces 'Highest Performance Levels in Agency’s History' in 2008").

A copy of Ms. Gongola's presentation can be obtained here.

More Patentees Follow Wyeth's Lead in Seeking Additional PTA

    By Donald Zuhn --

As we reported yesterday, Director Jon Dudas of the U.S. Patent and Trademark Office filed a Notice of Appeal in the District Court for the District of Columbia on November 28th, appealing the Court's decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit (see "USPTO to Appeal Wyeth v. Dudas").  As we noted earlier this fall in our summary of the Wyeth case, the decision could significantly impact the manner in which the Patent Office makes Patent Term Adjustment (PTA) determinations (see "Wyeth v. Dudas (D.D.C. 2008)").

The Wyeth decision, however, has already had a significant impact in that a number of suits have been filed against Director Dudas asserting improper PTA determinations.  In November, we reported on the first two patentees to follow in Wyeth's footsteps by filing complaints against Director Jon Dudas for similar PTA "miscalculations" (see "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA").  In particular, on September 5th, San Francisco-based Napo Pharmaceuticals, Inc. filed a complaint in the District Court for the District of Columbia, asserting that the correct PTA for U.S. Patent No. 7,341,744 (issued March 11, 2008) should be 1007 days rather than the 453-day period calculated by the Patent Office.  On November 7th, Ironwood Pharmaceuticals, Inc. of Cambridge, MA filed a complaint asserting that the correct PTA for U.S. Patent No. 7,371,727 (issued May 13, 2008) should be 702 days rather than the 411-day period determined by the Office.

Recently, four more patentees filed complaints against USPTO Director Jon Dudas contending that the Patent Office's PTA determinations were incorrect.  On the same day that Director Dudas filed his Notice of Appeal, Solvay Pharmaceuticals GmbH of Hannover, Germany, filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,729 (issued June 3, 2008) should be 633 days rather than the 534-day period calculated by the Patent Office (see complaint).  And on Monday, three more patentees followed suit.  These patentees include:

• Biogen Idec Inc. of Cambridge, MA, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,560 (which issued June 3, 2008) should be 2,058 days rather than the 1,409-day period determined by the Office (see complaint);

• Purac Biochem B.V. of the Netherlands, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,410,556 (which issued August 12, 2008) should be 949 days rather than the 386-day period determined by the Office (see complaint); and

• Molecular Insight Pharmaceuticals, Inc. of Cambridge, MA, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,399 (which issued June 3, 2008) should be 1303 days rather than the 634-day period determined by the Office (see complaint).

Because 35 U.S.C. § 154(b)(4)(A) specifies that "[a]n applicant dissatisfied with a [PTA] determination made by the Director . . . shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent," three of the four patentees above had little choice but to file complaints seeking additional PTA (while Purac had until February 8, 2009 to file its complaint, the other three patentees had until Sunday, November 30th to file their complaints).  And now that the Patent Office has decided to fight Judge Robertson's decision in Wyeth, patentees facing similar situations will be forced to file complaints to obtain additional PTA.  Patent Docs will continue to monitor newly filed actions in the District Court for the District of Columbia in order to identify other patentees seeking corrected PTA determinations.

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

• "USPTO to Appeal Wyeth v. Dudas," December 2, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008