Patent Docs

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 magdalen.greenlief@uspto.gov.

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

USPTO to Appeal Wyeth v. Dudas

    By Donald Zuhn --

Last Friday, U.S. Patent and Trademark Office Director Jon Dudas filed a Notice of Appeal in the District Court for the District of Columbia appealing the Court's September 30th decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit.  Director Dudas challenges District Judge James Robertson's grant of summary judgment to plaintiffs Wyeth and Elan Pharma International Ltd. and denial of summary judgment to Director Dudas.

As we reported in October, the Wyeth decision could have a significant impact on the manner in which Patent Term Adjustment (PTA) determinations are made.  In particular, the Wyeth Court determined that the U.S. Patent and Trademark Office had misconstrued 35 U.S.C. § 154(b)(2)(A), and as a result, had denied Wyeth a portion of patent term to which it was entitled under U.S. Patent Law.

At issue in the case was the interplay, under § 154(b)(2)(A), between the patent term guarantee provision of § 154(b)(1)(A) that provides a one-day extension of patent term for every day that the issuance of a patent is delayed by the failure of the USPTO to comply with various enumerated statutory deadlines ("A delay") and the patent term guarantee provision of § 154(b)(1)(B) that provides a one-day term extension for every day greater than three years after the filing date that it takes for the patent to issue ("B delay").  According to the Patent Office's interpretation of § 154(b)(2)(A), the start of the B delay period is an application's filing date rather than the date occurring three years after the application's filing date, and as a result, any A delay occurring during the first three years of prosecution would overlap with any B delay the application might accumulate.  Thus, under the USPTO's procedure for determining PTA, "the applicant gets credit for 'A delay' or for 'B delay,' whichever is larger, but never A + B."  The Wyeth Court determined, however, that the proper formula for determining PTA is:

A delay plus B delay less A delay that overlaps with B delay less applicant's delay

In November, we reported that two patentees had followed in Wyeth's footsteps by filing complaints in the District Court for the District of Columbia against Director Jon Dudas for similar PTA "miscalculations."  On September 5th, San Francisco-based Napo Pharmaceuticals, Inc. filed a complaint asserting that the correct PTA for U.S. Patent No. 7,341,744 (issued March 11, 2008) is 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) is 702 days rather than the 411-day period determined by the Office.  Both complaints question the Office's interpretation that the B delay period begins on the date of an application's filing.

We thank the Patent Docs reader who brought the Director's Notice of Appeal to our attention.

For additional information regarding this and other related topics, please see:
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008

USPTO News: USPTO e-Commerce Update

    By Christopher P. Singer --

The U.S. Patent and Trademark Office sent out an e-Commerce e-Alert on December 2, 2008 that included information regarding its recent announcements about the Priority Document Exchange (PDX) Program with the Korean Intellectual Property Office (KIPO); preventing Digital Certificates from expiring; and using the EFS-Web with Adobe 9.0

PDX with Korean Intellectual Property Office (KIPO)

On October 14, 2008, the USPTO announced that KIPO was added as a participant in the Priority Document Exchange (PDX) program, which allows for the exchange of priority documents electronically at no cost to the applicant.  Patent Docs previously reported on the Office's initial announcement.  In its e-Commerce e-Alert, the Office reminds applicants interested in participating in this program that the proper forms (PTO/SB/01 or PTO/SB/39) that permit release of priority documents can be found on the Office's website.  More information about the program can be found here, and specific questions regarding the PDX program can be sent by e-mail to PDX@uspto.gov.

Digital Certificate Maintainence

As previously reported by Patent Docs, digital certificates can expire if registered practitioners fail to maintain them.  As the Office reminds practitioners, steps can be taken to prevent digital certificates from expiring, including:

1.  Within 120 days of receipt, applicants must use the authorization code and reference number received from the Electronic Business Center (EBC) to create and download a digital certificate.  After 120 days, the authorization code and reference number will expire and require replacement.

2.  Immediately after downloading a digital certificate, applicants should go to https://sas.uspto.gov/ptosas/ to create digital certificate self-recovery codes.  These codes, which allow applicants to immediately recover a certificate should any problem occur, should be saved in a secure location.  Applicants are reminded that without self-recovery codes, certificates can only be recovered with the help EBC, and that the process will take several business days.

3.  Active digital certificates are automatically renewed for indefinite access.  This renewal occurs automatically while you are using your certificate.  Therefore, it is important to use your certificate regularly, at least every 90 days.

4.  If you have copied your digital certificate on multiple computers, be sure to document the locations of each copy.  After automatic renewal, only the copy in use at that time of renewal will be valid; all other copies must be updated separately.  If you experience problems with your certificate, try the following steps before contacting the EBC:  review the modification dates of all certificate copies; determine the most current copy; and then simply replace all outdated copies with the most recent certificate.

Adobe 9.0 and EFS-Web

Practitioners who submit filings via the EFS-Web can use the latest version of Adobe® Reader®, version 9.0, to complete EFS-Web fillable PDF forms.  Using the fillable PDF forms provides auto-loading of data directly into USPTO databases.  Certain forms for "e-Petitions" including the SB66 Petition to Accept Unintentionally Delayed Payment of Maintenance Fee in an Expired Patent (37 CFR 1.378(c)) and SB130 Petition to Make Special based on Age provide real-time automatic processing.  These forms are still compatible with previous versions of Adobe® Reader® including versions 7.0.8, 7.0.9, 8.1.1, and 8.1.2.

Additional Reminder

The biotechnology, chemical, and pharmaceuticals (BCP) technology groups at the U.S. Patent and Trademark Office are holding their quarterly customer partnership meeting on Wednesday, December 3rd.  The agenda can be viewed here, and can be viewed over the web at https://uspto.connectsolutions.com/bcp120308/.

Pinkos Appointment Provokes Allegations - Updated

    By Kevin E. Noonan --

Maybe Hal Wegner (at right) is surprised by the continuing shenanigans of the current Patent Office administration.  Maybe he is genuinely offended by their many actions and appointments made with seemingly little or no heed of the legal requirements for holding positions of authority in the Office.  Or maybe he has finally just had enough.

But in a series of e-mails sent to members of his extensive mailing list, Mr. Wegner, the dean of U.S. patent commentators, uncharacteristically excoriated the appointment of Stephen M. Pinkos (at left) to a position on the Patent Public Advisory Committee (P-PAC).  He begins his commentary by noting that "[h]eretofore, the principle concern with the Pinkos P-PAC appointment" was that he might be in a position to "whitewash" his own performance as Under Deputy Secretary for Intellectual Property and Deputy Director of the Office from 2004-2007.  This, of course, would be bad enough.  But now it seems that Mr. Pinkos, like Margaret Peterlin before him, may lack the statutory requirements for holding the position.

These requirements include someone "chosen so as to represent the interests of diverse [patent] users of the United States Patent and Trademark Office" under 35 U.S.C. § 5(b)(1) or qualified to "represent . . . applicants located in the United States" under 35 U.S.C. § 5(b)(2) or with "substantial background and achievement in finance, management, labor relations, science, technology, and office automation" under 35 U.S.C. § 5(b)(3).

Mr. Pinkos has been a lobbyist since leaving the Patent Office, according to the website of his company, PCT Government Relations LLC.  Although he is a graduate of the DePaul University School of Law, he is not licensed to practice law (according to Martindale-Hubbell) nor is there any record that he has passed the registration examination to practice before the Patent Office.  The website for the International Intellectual Property Institute (where Mr. Pinkos is a member of the Board of Advisors) reports that he is a member of the Virginia bar.

Mr. Pinkos' experience is as a Capitol Hill staffer, specifically as counsel for the House Judiciary Committee.  His appointment as Under Secretary and, presumably his current post, is reportedly nothing more than a political reward for his efforts in support of House Republicans' benighted and ultimately futile attempt to remove President Clinton from office through impeachment.

The motivation for placing Mr. Pinkos on the P-PAC, according to Mr. Wegner, is part of an effort to "whitewash" the incompetence of the current management.  This impression is reinforced by the 2007 P-PAC Annual Report, which is a glowing encomium to the Office's success in promoting patent "quality."  Also praised in the report are efforts to coerce applicants to make statements on the relevance of cited references, shifting the burden of examination from examiners to applicants, placing patent applicants at risk for charges of inequitable conduct, and producing an ethical conflict of interest between patent practitioners and their clients.

It is one thing when Greg Aharonian, known to be occasionally intemperate in his criticism of Patent Office officials, makes similar charges.  It is another thing entirely when someone with the experience and gravitas of Mr. Wegner is compelled to come to the same conclusions.  And it is a testament to how thoroughly current Patent Office management has poisoned the relationship between the Office, applicants, and their representatives, that Mr. Pinkos' appointment has produced this reaction.  If we (and the Office) are lucky, things will begin to change with the commencement of the new administration.  It cannot come too soon.

UPDATE:  Lest anyone think Patent Docs doesn't appreciate Greg Aharonian's tireless efforts in combating Patent Office shenanigans, we refer you to our post on his (ultimately unsuccessful) attempt to have judicial review of the Peterlin appointment (see "Margaret Peterlin Gets to Keep Her Job").  Greg was one of the first members of the patent community to recognize the qualitatively different approach of the current administration, particularly its penchant for doing whatever it wants with little regard for the procedural or statutory requirements.  And whatever you think about his methods or his rhetoric, in these times "occasional intemperance" in defense of the U.S. patent system is no vice.

USPTO News: Patent Office Issues Appeals Rules Clarification

    By Donald Zuhn --

Yesterday, the U.S. Patent and Trademark Office published a notice in the Federal Register (73 Fed. Reg. 70282) clarifying the new appeals rules scheduled to take effect on December 10, 2008.  The Patent Office also posted a statement regarding the clarification on its website.  As we reported last summer, the USPTO set forth amended rules of practice before the Board of Patent Appeals and Interferences (BPAI) in ex parte appeals that would take effect six months from their June 10, 2008 publication date (see "New Appeals Rules Published"). 

The Office's clarification involves the format of appeal briefs submitted prior to the December 10 effective date.  In particular, the Office has indicated that it will accept appeal briefs that are submitted in the new format prior to the effective date of the new appeals rules.  The Office noted that it had discovered that a number of appeal briefs have been submitted in the new format, and that these briefs were being rejected as non-compliant.  The Office stated that the rejection of such briefs was unintended, and that it "will not hold an appeal brief as non-compliant solely for following the new format even though it is filed before the effective date."  Appellants who have received a notice of non-compliant brief under such circumstances may request withdrawal of the notice.

The Office noted that information regarding the new appeals rules, including a list of Frequently Asked Questions about the new rules and checklists for ensuring that briefs comply with the new rules, can be found on a dedicated webpage the Office has set up for the new appeals rules.

The Office's clarification may be somewhat surprising in view of two other Federal Register notices the Office has published on the new appeals rules.  In the first notice (73 Fed. Reg. 32559), published on June 9, 2008, the Office requested that interested members of the public comment on the Office's estimates for any additional burdens imposed on applicants by the new appeals rules.  As we noted in July, in addition to publishing the notice for comment only one day before the final version of the new appeals rules were published, the Office curiously neglected to list the June 9 notice on its website -- in contrast to the June 10 notice setting forth the final appeals rules which was posted on the Office's website (see "USPTO Rulemaking Practices Being Called into Question (Again)").  The Office published a second notice (73 Fed. Reg. 58943) on October 8, 2008, inviting public comments on paperwork burdens associated with the new appeals rules (see "Unhappy with the Ex parte Appeal Rule?  Read This Now").  The publication date of this notice was significant, since the Office of Management and Budget requires 60 days in which to review comments regarding the paperwork burdens of new rules (it does not appear that the OMB has completed its review of the new appeals rules; see ICR regarding new appeals rules).  Interested applicants and patent practitioners will now await the OMB's decision regarding the appeals rules.

For additional information regarding this topic, please see:

• "More on Ex parte Appeal Rule," October 10, 2008
• "Unhappy with the Ex parte Appeal Rule?  Read This Now," 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
• "New Appeals Rules Published," June 10, 2008
• "Patent Office to Publish New Appeals Rules on Tuesday," June 9, 2008

USPTO News: Annual Fee Announced for Registered Practitioners

    By Christopher P. Singer --

In a Notice published in the Federal Register (73 Fed. Reg. 67750) on Monday, November 17, 2008, the U.S. Patent and Trademark Office announced a new rule that would institute an annual fee for all registered practitioners.  The fee will be required for practitioners to maintain active status to practice before the Office.  As other commentators have mentioned, and as the Notice informs, the rule change is based on a prior Notice published on December 12, 2003 which discussed proposed amendments to 37 C.F.R. § 11 that include an annual practitioner fee (see, e.g., Patently-O, "Patent Practice: Annual Practitioner Maintenance Fee").  The Office rationalizes the motivation for the rule change based on an interest in "maintaining a roster of registered practitioners, including affording practitioners due process, protecting the public, preserving the integrity of the Office, and maintaining high professional standards" as well as protecting the general public interest in having an up-to-date roster of registered patent attorneys and agents.  The fee is currently scheduled to be $118 per year, and as Hal Wegner, a partner at Foley & Lardner LLP and professor at George Washington University Law School, noted in a Monday newsletter to his e-mail subscribers "since the final rules are effective in the new fiscal year (in December) the payment is due September 30, 2009."

The rules describe the protocol the Office plans to implement regarding notifying registered practitioners when the fee is due, as well as consequences for non-payment (administrative suspension) and how practitioners who are suspended, if suspended in good faith, can be placed back on active status.  These fees, according to the Notice, are designed to recover the Office's estimated annual cost of maintaining the active practitioner roster, which includes additions and removals from the roster, updating contact information, conducting investigations regarding allegations of practitioner misconduct, and conducting disciplinary proceedings against practitioners.

Perhaps what is most disturbing about this Notice is that it comes on the heels of the USPTO's recent announcement that the recent rule changes to Markush claims and IDS practice will not go into effect under the current administration (see "PTO Announces No IDS or Markush Rules During Bush Administration").  Hopefully, this action will prove to be the single exception to the current Administration's stated intention of not making any further changes to the patent rules and regulations.

USPTO News: USPTO Announces "Highest Performance Levels in Agency’s History" in 2008

    By Donald Zuhn --

The U.S. Patent and Trademark Office released its FY 2008 Performance and Accountability Report yesterday and announced that the Office had for the first time "met 100 percent of its Government Performance and Results Act (GPRA) goals."  According to the Patent Office, the year-end numbers "demonstrate the agency’s commitment to sustaining high performance in the quality and timely examination of patent and trademark applications."

The Performance and Accountability Report indicates that the Office examined 448,003 applications in 2008 -- the highest number of applications the Office has ever examined in a year (the Office's previous high of 362,227 examined applications was set last year).  The report also notes that 72.1% of patent applications were filed electronically via the EFS-Web in 2008, which is up from about 50% last year and less than 2% in 2005.  Not surprisingly, the Office also received a record number of application filings via the EFS-Web in 2008 (332,617).  Despite the significant increase in the number of applications that the Office examined in 2008, the report states that the total number of applications awaiting action rose from 760,924 in 2007 to 771,529 in 2008, and the total number of applications under examination rose from 1,112,517 in 2007 to 1,208,076 in 2008.

The report indicates that while the Office had more patent application disposals (396,228) in 2008 than in any of the four previous years, the Office allowed fewer applications (187,607) in 2008 than it did in 2007.  The percent of application disposals constituting allowances in 2008 was 47.3%, down from 54% in 2007, 56.1% in 2006, 61% in 2005, and 64.2% in 2004.  Last year, the Office indicated that the dropping allowance rate supported its assertion that patent quality was on the rise.  In the 2008 report, the Office instead focuses on its higher than expected allowance compliance rate of 96.3 percent when speaking of increased patent quality.  (The allowance compliance rate is the percentage of reviewed applications allowed by examiners that did not have any errors.)

Turning from the (ever) dwindling allowance rate, Tech Center 1600 (biotechnology and organic chemistry) offered biotech and pharma applicants and practitioners some good news, as that Group was once again able to reduce the average pendency to a first Office Action.  The average pendency to a first Office Action dropped (for the second year in a row) from 22.7 months in 2007 to 19.9 months in 2008.  Unfortunately, the average total pendency in Tech Center 1600 rose slightly to 34.8 months from 34.4 months in 2007.  As a point of comparison, the average pendency to a first Office Action for all Tech Centers combined jumped from 25.3 months in 2007 to 25.6 months in 2008, and the overall average total pendency increased from 31.9 months in 2007 to 32.2 months in 2008.

For additional information regarding this and other related topics, please see:
• "USPTO Announces 'Record Breaking' 2007 Performance," November 15, 2007
• "BIO Issues Statement Regarding USPTO Performance Report," December 6, 2007
• "Patent Office Announces Record-Breaking Year," December 27, 2006

USPTO News: New PCT Transmittal and Search Fees Effective in January

    By Christopher P. Singer --

In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Wednesday, November 12, 2008, the U.S. Patent and Trademark Office announced new fees for the transmittal and search for international applications filed under the Patent Cooperation Treaty (PCT).  The fees are designed to recover the estimated average cost to the Office of processing PCT international applications and preparing international search reports and written opinions for PCT international applications.  The new PCT transmittal fee will be $240 (adjusted from the current fee of $300), and the new search fee where the USPTO is acting as the International Searching Authority will be $2,080 (up from the current fee of  $1,800).  The supplemental search fee for each examined additional invention, which applicants have the option of requesting will also increase to $2,080, from the current fee of $1,800.  The fees will apply to international applications having a receipt date that is on or after January 12, 2009.