Patent Docs: Patent Office Rules & Procedures

Patent Office Rules & Procedures

January 05, 2009

January 04, 2009

December 23, 2008

USPTO News: Patent Prosecution Highway Pilot with CIPO Is Extended

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

Posted at 11:11 PM in Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

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.

Posted at 11:07 PM in Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

December 12, 2008

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.

Posted at 11:51 PM in Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

December 11, 2008

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 M onsanto 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.

Posted at 11:59 PM in Patent Office Rules & Procedures | Permalink | Comments (1) | TrackBack (0)

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.

Posted at 11:59 PM in Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

December 10, 2008

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

Posted at 10:54 PM in Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

December 09, 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

Posted at 09:31 AM in Patent Office Rules & Procedures | Permalink | Comments (9) | TrackBack (0)

December 08, 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.

Posted at 11:59 PM in Federal Circuit, Patent Office Rules & Procedures | Permalink | Comments (6) | TrackBack (0)

December 04, 2008

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.

Posted at 11:44 PM in Patent Office Rules & Procedures | Permalink | Comments (9) | TrackBack (0)

December 03, 2008

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

Posted at 05:24 PM in District Court, Patent Office Rules & Procedures | Permalink | Comments (5) | TrackBack (0)

December 02, 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

Posted at 11:38 PM in District Court, Patent Litigation, Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

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/.

Posted at 11:04 PM in Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

Sun	Mon	Tue	Wed	Thu	Fri	Sat
			1	2	3	4
5	6	7	8	9	10	11
12	13	14	15	16	17	18
19	20	21	22	23	24	25
26	27	28	29	30	31

Authors

Contributors

About the Authors

E-mail Newsletter

Contact the Docs

Foreign Correspondents

Docs on Twitter

Recent Posts

Disclaimer

Patent Office Rules & Procedures

January 05, 2009

January 04, 2009

December 23, 2008

December 12, 2008

December 11, 2008

December 10, 2008

December 09, 2008

December 08, 2008

December 04, 2008

December 03, 2008

December 02, 2008

March 2023

Google Search

Patent Resources

Patent Search

Patent Blogs & Sites

Biotech & Pharma Blogs & Sites