GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules

    By Kevin E. Noonan --

As reported recently by Patent Docs (see "Hooray! - (Finally) the Big Dogs Have Joined the Hunt"), GlaxoSmithKline (GSK) filed suit on October 9th in the U.S. District Court for the Eastern District of Virginia against John Dudas and the U.S. Patent and Trademark Office, asking for preliminary and permanent injunctions staying implementation of the PTO's new continuation and claims rules entitled "Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably-indistinct Claims and Examination of Claims in Patent Applications; Final Rule" (New Rules).  A hearing is set for October 31st (the delay being the result of the Patent Office's request, perhaps hoping the judge wouldn't be willing to stay implementation of the New Rules at the 11th hour).  GSK is asking for a stay in implementation of the New Rules and a permanent injunction enjoining Defendants from issuing new regulations relating to the number of continuations, requests for continuing examination (RCEs), or claims permitted in an application, and to vacate the New Rules and declare them arbitrary, capricious, an abuse of agency discretion, contrary to law, constitutional right, power privilege or immunity, and in excess of the Office's statutory authority.

GSK has filed a declaration from none other than Harry F. Manbeck, Jr. (at left), former Patent Office Commissioner under President George H.W. Bush and now a member of the Rothwell Figg firm in Washington, D.C.  In addition to his government service, Mr. Manbeck served as general patent counsel to the General Electric Company, which enhances the credibility of his testimony regarding the New Rules.  The Patent Office has filed a motion to strike this declaration, which will come as no surprise once the declaration has been read and appreciated.

Mr. Manbeck makes a number of relevant assertions (under penalty of perjury) in his declaration.  First, he testifies that the Patent Office has only limited (non-substantive) rulemaking authority, specifically precluding the Office from interpreting the Patent Act.  He cites Federal Circuit authority (including Merck & Co. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996) for the proposition that the statute (35 U.S.C. § 2(b)(2)(A) - previously 35 U.S.C. § 6(a) - authorizes the Office to make rules "directed only to the conduct of proceedings in the PTO; it does NOT grant the Commissioner the authority to issue substantive rules."  Id. at 1549-50  (emphasis in original); accord, Eli Lilly & Co. v. Board of Regents of the Univ. of Washington, 334 F.3d 1264, 1269 n.1 (Fed. Cir. 2003).  He frankly disputes the assertion that Congress expanded the PTO's rulemaking authority when the statute was amended in 2000 and codified as 35 U.S.C. § 2(b)(2)(A); he cites unsuccessful Congressional efforts on two occasions since the 2000 amendments to grant expanded rulemaking power to the PTO, as well as the provisions of H.R. 1908 (see "Patent 'Reform' Bill Passes House of Representatives") that do grant such powers to the Office, as evidence that Congress did not intend to give such power to the PTO by the 2000 amendments.  He also notes that the provisions of the House bill give Congress the ability to reverse any such action by the Office within 60 days, as well as the absence of provisions for expanding the PTO's rulemaking authority in the Senate version of the bill (which he notes has not been passed).

Mr. Manbeck also provides the Court with a brief synopsis of the history of continuation practice (a wise undertaking in view of the judiciary's relative lack of experience with the minutiae of Patent Office regulations), as well as the case law supporting unfettered continuation application filings.  In this he affirms many of the allegations contained in GSK's complaint relating to the importance of continuations in protecting innovation and the statutory provisions ensuring the availability of continuation application practice.  In particular, Mr. Manbeck disputes any claim that the amendments to 35 U.S.C. § 120 made as part of the American Inventors Protection Act in 2000 gave the Director (formerly Commissioner) any power to substantively limit applicant access to continuation applications.  Mr. Manbeck also discusses claiming under 35 U.S.C. § 112, second paragraph, and request for continuing examination practice under 35 U.S.C. § 132.  He also debunks the idea that the New Rules are intended to address the problem of "submarine patents," made largely obsolete in view of the changes in patent term enacted as part of U.S. implementing law related to accession to the GATT treaty.

Turning to the heart of the matter, Mr. Manbeck sets forth the following reasons why an applicant would file a continuation application:

• To differentiate claims over art cited in prosecution;
• To present evidence of unexpected advantages (that may not have been available beforehand);
• To add new claims directed to aspects of an invention disclosed but not earlier claimed;
• To disclose newly-discovered prior art (particularly art contained in a search report produced by a foreign patent office or in an international application).

Moreover, Mr. Manbeck cites Patent Office statements that the following reasons would not satisfy the "sufficient reason" standard for the petition and showing option "offered" by the Office:

• Attempts to submit newly-discovered prior art (citing Response to Comment 85);
• An unusual interpretation of the claims by an examiner only belatedly understood by the applicant;
• Applicant's recent discovery of a commercially-viable product, or financial resources, or a competing product;
• Significant applicant disability.

In making these statements, Mr. Manbeck reminded the Court that the Federal Circuit has expressly prohibited the Office from denying an applicant's right to file a continuing application absent evidence of abusive and repetitive practices.  Symbol Technologies, Inc. v. Lemelson Med., Educ. And Research Found., 422 F.3d 1378 (Fed. Cir. 2005); it is clear that the prohibitions on continuation filings contained in the New Rules address far more instances than prosecution laches as held by the Court.

Mr. Manbeck also addresses the aspects of the New Rules that are to be applied retroactively for both continuations and claim numbers and that they create an ethical conundrum for practitioners to the detriment of their clients based on the "physical impossibility" interpretation the Office has placed on the "could not have earlier" requirement for a showing sufficient to obtain an additional continuation or RCE.  (This tracks the allegations in GSK's complaint.)  He particularly points out the deficiencies of the Examination Support Document rule (37 C.F.R. § 1.265) including allegations of vagueness and failure to inform applicants on how to comply with the rule (also aspects of GSK's allegations in its complaint).

Mr. Manbeck concludes that "it is my opinion that the Director and the PTO have exceeded their statutory authority in promulgating the [New] Rules, that the [New] Rules exceed the plain language of the Patent Act, and that the [New] Rules' ESD requirement hopelessly lacks guidance.

It will be interesting to see how the Office attempts to rebut Mr. Manbeck's informed opinion.

Comments

[step back]

Thank you for posting the PDF of Manbeck's declaration. I personally was disappointed in Manbeck not relating how a Commissioner of the USPTO is sworn in (I assume they are, aren't they?) to uphold "the law" and what that means with regard to "facilitating" the processing of patents and how the new reg's do just the opposite.

[Inquiring Mind]

I'm not a litigator, and I know this *is* litigation, but if the PTO was really acting in good faith in implementing these rules and acting in the public interest, would they really move to strike a declaration like this? Wouldn't they instead explain clearly to the court why the rules were correct, well-founded, etc., rather than resorting to the tactics and technicalities of litigation to win their case? It just appears to me to be further evidence that the PTO is not acting in the public interest, and instead is intent on carrying out its own perplexing agenda no matter what the cost.

[just interested]

Just as a heads up, the court ORDERED that all references to Mr. Manbeck's declaration be removed from GSK's exhibits.

[Kevin E. Noonan]

Dear Just:

That's not up on PACER yet, but if true it does not bode well for GSK. Did the Court give any basis for its ruling?

Thanks for the comment.

[J. Horn]

If that is in fact the ruling it may only be a partial preclusion to prevent Manbeck from providing impermissible expert opinion as to the proper interpretation of the patent statutes, which is the exclusive province of the court -- Evidence 101. Will be interesting to see and hope all eggs are not in this one basket.