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

Comments

[David Boundy]

Interestingly, stories number 1, 2, 4 and number 5 are about the PTO ignoring laws it finds inconvenient.

The Obviousness Guidelines and Written Description materials are "economically significant guidance documents." As such, they should have been run through notice and comment, and posted on a web page of significant guidance documents - see instructions from the President:

http://www.whitehouse.gov/omb/memoranda/fy2007/m07-07.pdf

[Noise above Law]

Thank you David for your tireless guardianship.

I believe that the USPTO avoids at all costs the instructions and executive orders of the President because they would have to acknowledge that the Office in large part is causing the problems.

[EG]

Kevin,

New "Top Story" for 2009: Dudas has announced his resignation (apparently effective January 12). See Patently-O.

[Suzanne Sutton, Ph.D]

Mr. Boundy,

Your dedication and unremitting effort has once more yielded outstanding and unsurpassed results. I believe this is one of, if not the most, important patent law events of the past year. Congratulations on an yet another superlative accomplishment!

Dr. Suzanne Sutton, NYC

[Anne Byars]

I am new to your blog. Thanks for the outstanding work!