Patent Docs

USPTO Holds First Hearing on "Second Opinion" Genetic Testing

    By Kevin E. Noonan --

The U.S. Patent and Trademark Office held the first of two planned hearings aimed at fulfilling one of the reporting provisions of the Leahy-Smith America Invents Act (see "USPTO to Hold Hearing on Genetic Diagnostic Testing").  Section 27 of the Act requires the Office to conduct a study regarding the advisability of permitting "second opinions" for patented genetic diagnostic tests without patent infringement liability:

SEC. 27. STUDY ON GENETIC TESTING.

(a) IN GENERAL.—The Director shall conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.

(b) ITEMS INCLUDED IN STUDY.—The study shall include an examination of at least the following:

(1) The impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses.

(2) The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test.

(3) The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures.

(4) The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

(c) CONFIRMING GENETIC DIAGNOSTIC TEST ACTIVITY DEFINED.—For purposes of this section, the term ''confirming genetic diagnostic test activity'' means the performance of a genetic diagnostic test, by a genetic diagnostic test provider, on an individual solely for the purpose of providing the individual with an independent confirmation of results obtained from another test provider's prior performance of the test on the individual.

(d) REPORT.—Not later than 9 months after the date of enact- ment of this Act, the Director shall report to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on the findings of the study and provide recommendations for establishing the availability of such independent confirming genetic diagnostic test activity.

In acting to satisfy this Congressional mandate, the Office invited public testimony and published in the Federal Register a list of questions to be addressed by such testimony (77 Fed. Reg. 3748).

At the hearing, the Patent Office was represented by Deputy Director Teresa Stanek Rea; Janet Gongola, Patent Reform coordinator; Stuart Graham, Chief Economist (who has taken responsibility for preparing the Report) and George Elliot, Group 1600 (Biotechnology) Director.  Deputy Director Rea opened the proceedings, setting forth the overarching goal of the undertaking:  trying to find a balance between protecting innovation through the patent system and providing the "best" patient care possible.  Janet Gongola next explained the structure of the meeting, and introduced a video welcome from Congresswoman Debbie Wasserman Schultz (D-FL), the author of the AIA provision introduced in lieu of a more extensive draft provision introduced and then withdrawn after furious opposition by the ACLU and others (see "House Judiciary Committee Approves H.R. 1249").  Rep. Wasserman Schultz explained her personal involvement with this issue, being both a cancer survivor who bears one of the BRCA2 mutations.  Although for her the test was definitive, in doing her research Rep. Wasserman Schultz became aware that not all instances of the Myriad test were as unambiguous as her mutation, and because of its patent position, Myriad could (and generally did) prevent any other testing lab from performing its patented test.  The significance of BRCA gene mutation detection (and the extensive surgical prophylaxis recommended for BRCA mutation bearers) convinced Rep. Wasserman Schultz that women should have the opportunity to obtain a "second opinion."  (While generally not an unreasonable position, it is unclear whether the basis for any diagnostic ambiguity is how Myriad performs the test or that certain mutations/variants found in the BRCA gene sequence are "polymorphisms of uncertain significance," i.e., nucleotide sequence polymorphisms not yet unambiguously associated with disease -- in the latter case, of course, no number of "second," "third," or "nth" opinions would provide any greater degree of diagnostic certainty.)

After Rep. Wasserman Schultz's video, the first witness offering testimony was Thomas Kowalski of Vedder Price LLP.  Mr. Kowalski provided the most extensive testimony, referencing the AMP v. USPTO (Myriad) case and the deficiencies in the plaintiffs' arguments (and the wisdom of the Federal Circuit's opinion), saying that the study mandated by § 27 of the AIA was in the nature of a "do-over," a legislative attempt to avoid patent infringement for BRCA testing that the plaintiffs had not been able to obtain in the lawsuit.  He also contended that any legislative action to provide a patent infringement exemption for "second opinion" genetic diagnostic testing would be an "unconstitutional, unrecompensed taking" of the patentee's property right.  It perhaps goes without saying that Mr. Kowalski urged the Office to provide Congress with a report that did not recommend such an exemption.

The panel next heard from Mercedes Meyer, a member of the Board of Directors of the American Intellectual Property Law Association.  Like Mr. Kowalski, Dr. Meyer urged the Office to carefully consider the risks to innovation that could arise from passage of an patent infringement exemption for "second opinion" testing.

The first witness to speak in favor of such an exemption was Mary Williams, Executive Director of the Association of Molecular Pathologists.  Ms. Williams repeated most of the arguments advanced by the ACLU in the Myriad case, reminding the Office that her Association was the lead plaintiff in the case; these arguments included AMP's position that neither genes nor genetic diagnostic tests should be patented.  She also noted that the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) of the Department of Health and Human Services had produced an extensive (~400 page) Report in April 2010 (see "BIO Comes out Swinging against SACGHS Report").  She urged the Office to consider that Report in preparing its own, citing the four years the Committee spent in producing the Report and the limited time Congress provided the Office to do its work.  She also urged the Office to adopt the SACGHS Report's recommendation, failing to mention that the recommendations of the SACGHS Report were in many instances either unsupported or contradictory of the evidence set forth in the body of the Report.

Lori Pressman, an independent technology transfer consultant testified next.  She referenced her own studies on the effects of patents on technology transfer and providing diagnostic testing to patients, and suggested that patent protection would be more important for future testing that it had been in the past.  Like other witnesses, she did not recommend legislation providing an infringement liability exemption for "second opinion" genetic diagnostic testing.

Hans Sauer, Associate General Counsel for IP for the Biotechnology Industry Organization (BIO) spoke next.  Dr. Sauer provided the Office with some demographic information about BIO (including the fact that Myriad is not a member) and explained the frustration of BIO's members who see a threat to their intellectual property (in agricultural genetics, for example) in the ACLU's lawsuit that many feel was prompted (and has been somewhat successful if only in the court of public opinion) due to Myriad's aggressive assertion of its patent rights.  Interestingly, Dr. Sauer told the Office panel that anecdotal reports from physicians was that patients don't want a "second opinion" on the test as much as they want a second opinion on their medical options (which of course is not impacted by the Myriad patents).

Lisa Schlager, Vice President for Community Affairs and Public Policy of FORCE, a cancer patient advocacy group, testified regarding the need for patient access to their genetic information and opposing patents on human genes, genetic information (which is not patented), and genetic diagnostic testing.

The next witness, Kristin Neuman, Executive Director of Librassay™, a division of MPEG LA, testified that MPEG LA (which began in response to establishment of the MPEG2 video program/playback standard) has established a "clearinghouse" for licensing rights to patented genetic sequences.  This clearinghouse, named Librassay™, will provide a "one stop shop" for obtaining rights to include patented sequences, for example, on a gene chip.  She said the Internet interface was undergoing beta testing and that the company was working to obtain sublicensing rights for university-owned gene sequence IP.

Ellen Jorgensen then testified regarding her organization, Genspace.  She advocated "at-home" or "do-it-yourself" DNA testing, asserting that individuals could perform their own testing much more inexpensively.  Genspace provides the technology and the lab space for performing such tests, and she suggested that soon performing whole genome sequencing would be as common in high school laboratories as dissecting a frog had been in earlier, simpler times.  She did not discuss any dangers in errors that might arise from such "at-home" genetic diagnostic testing, nor precautions in interpreting results (especially concerning the emotional consequences of finding a genetic mutation in an individual's BRCA genes).

[Patent Docs author Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP concluded the scheduled testimony portion of the hearing.  Dr. Noonan's testimony can be found here.  Ed.]

After taking one comment from the audience (from another patient advocacy group opposed to gene patenting and patented genetic diagnostic assays), Ms. Gongola thanked the witnesses and informed the audience that a transcript of the hearing would be available on the USPTO AIA microsite.  The second hearing on genetic diagnostic testing will be held in San Diego on March 9, 2012.  The Office will accept written comments until March 26, 2012, and the Report is due on June 16, 2012.

Although this was just the first hearing, the panel of Office officials and their questions provided a few indications of the direction of their inquiry.  First, Stuart Graham is in charge of the exercise, and asked many of the witnesses for further information, statistics and other evidence supporting their testimony.  His questions seemed directed to garnering hard evidence (which may not exist in some instances) on the effects of patents on innovation and patient access to testing.  Several witnesses mentioned the interaction with the healthcare system and the role of public and private insurance in promoting or hindering access to genetic diagnostic testing (and the likelihood that second opinion testing would not be reimbursed in many cases because it would be deemed to be duplicative).  But it may be safe to presume that Dr. Graham will bring an economist's objectivity to his work, and thus that the testimony and written comments should include as much evidence as possible in support of the advocated position.  It would be prudent that those who advocate the position that patenting supports innovation in genetic diagnostic testing make the Office aware not only of their views but the factual grounds for them.

It is also reasonable to presume that the Office will be sensitive to Rep. Wasserman Schultz's passion for this issue and will be certain that whatever its recommendations they include the possibility for some accommodation to "second opinion" genetic diagnostic test providers.  The form and extent of this accommodation will depend on the strength of the evidence pro and con regarding the need and wisdom of "second opinion" genetic diagnostic testing.

Patent Docs Author Testifies at Genetic Diagnostic Testing Hearing

Patent Docs author Dr. Kevin Noonan (at right) gave the following testimony at today's USPTO hearing on genetic diagnostic testing:

I want to thank the organizers for inviting me to testify today.

This study by the PTO is important because it should give the Office the opportunity to determine whether there is any evidence that "patents are the problem" with regard to patient access to genetic diagnostic testing.  It has become fashionable in some quarters (mostly the medical and legal academies) and in some industries to question the value of patenting in promoting innovation.  Those that do so analogize patents to a tax on innovation and even contend that patenting can retard innovation.  Judges and even some Justices have proposed that there needs to be a balance between patenting; like a judicial Goldilocks, there is abroad the idea that we need just the right amount of patenting, and that steps, like the "second opinion" exemption we are discussing today are ways to achieve that golden mean.

These ideas are current under circumstances where there is little evidence that patents are responsible for preventing patients from enjoying the benefits of the new genetic technology.  There is also little evidence that current genetic diagnostic test providers are beset by rampant error in the test results they provide.  It isn't as if no one has looked for these effects, but in every case the reports and studies are forced to begrudgingly admit that there is no apparent effect of patents on either access or quality, even while remaining steadfast that there could be or might be in the future.  This includes many academic studies as well as official U.S. government agencies including the Department of Health and Human Services SACGHS report.  I know of no study showing that limitations on patient access are not the consequence of behaviors and policies of private and government insurers, payors and providers rather than patents.  After all, in America, the one right patients don't have when it comes to medical treatment or diagnosis is an economic one.  Healthcare in this country depends on what each individual patient can afford, or if they have benefits through their employer, what their employer provides.  If an insurer won't pay for a genetic diagnostic test, it doesn't mean the test is too expensive -- it means the insurer has decided that it, and its insureds, can wait until the price comes down.  The patent system didn't create this situation and weakening patenting won't solve it.

So we are left again with a discussion of what might be done with patents, that supporters contend will facilitate patient access and diagnostic reassurance even in view of a dearth of evidence that patents are the problem.  I propose that if we are willing to do that, we would be remiss if we didn't consider all of the consequences of such actions and to inquire whether patient access or test quality would improve or not (particularly if our efforts are not taken in parallel with reforms in other areas of healthcare system).

It is unlikely that the future will resemble the past, but it would also be a mistake to ignore the past.  And the record of the past 30 years is that biotechnology has been an extraordinarily fruitful and successful industry.  This is remarkable, if you remember that the industry is only about 30 years old.  As Judge Rader noted in his "additional views" in the Classen case, and Judge Moore in her concurring opinion in the Myriad case, biotechnology has prospered in large part because it was supported by the U.S. patent system.  And the reasons for that outcome are two-fold:  technology transfer from university research under the Bayh-Dole Act, and investment in the technology because of the existence of patent protection.

As an example of the importance of university tech transfer, since the passage of the Bayh-Dole Act, 6,000 new companies were founded on university inventions, more than 4,000 new products came on the market (including 153 new drugs, vaccines, or medical devices), at least 279,000 new jobs were created just in the period between 1996 and 2007, and over $457 billion was added to the country's gross national product.

Universities and research institutes have performed the basic scientific research, and the potential to protect the practical applications of that research through patenting have provided the incentives (and the economic benefits to those universities and research institutes) for companies to commercialize them.  This partnership has propelled the U.S. to the forefront of biomedicine, providing biologic drugs and diagnostic methods for important and previously intractable diseases.

These foundations of success may be negatively influenced by proposals that permit unfettered (and uncompensated) "second opinion" testing.  This is because of another reality:  while the Human Genome Project created the largest amount of scientific information in the shortest time in human history, in many ways it was what Bob Weinberg of MIT has called "the race to the beginning of the road."  The next 50-100 years will be consumed with a much more difficult task -- understanding how this genetic information interacts with environmental factors to cause disease.  And in doing this we will be faced with another reality:  there will be very little "low hanging fruit" of unrecognized single-gene genetic mutations associated with human disease.  Most common diseases like cancer and diabetes involve genetic and other changes in multiple genes, unlike Myriad's BRCA test and other existing genetic tests.

In other words, complexity will be the rule.  And when something is complex, it is harder to reverse engineer.  That reality produces the danger of proposals to weaken patent protection for genetic diagnostic testing.  I haven't picked up a pipette in 25 years, but even I can envision ways for a company to produce a genetic diagnostic test for a multivariate disease that can be protected without patenting.  Simply identify the genetic variants from the 6-12 genes involved and put diagnostic sequences on a gene chip along with probes for 10,000 other genes.  Encrypt each chip so that the diagnostic patterns -- the diagnostically informative positions -- cannot be identified without the encryption key, and then provide the public with the test.  No patents, no problem -- and no disclosure and no end to the ability to charge whatever a provider wants, limited only by the time it takes for someone to independently make the same discovery.

But in such a world the partnership between universities and business that fueled the biotechnology revolution is broken, because universities cannot -- and should not -- fail to disclose the results of their research.  While not everything that university research has produced over the past 30 years has been patented, it has been disclosed (whether patented or not).  And support for some of that research has been provided by investors and companies translating that technology from the lab bench to the clinic, and the basis for that support will be diminished if not extinguished if genetic diagnostic methods lose the ability to be fully protected.

While such a scenario could also arise under present law, there is little incentive for it to do so, since the public can eat its cake and have it too -- basic university research can proceed as it always has, being directed to science instead of technology.  Important technologies have resulted from such basic research, from Cohen and Boyer's identification of restriction enzymes to Fire and Mello's siRNA; these inventions were arose unexpectedly from basic scientific research based on new biological discoveries.  Such discoveries don't always have clinically or commercially useful applications, but where they do they can be protected by patenting.  If that is changed, investment behavior may change, and it may not take a dramatic change in the scope of patent protection to change the incentives that exist today.  Permitting "second opinion" genetic diagnostic testing for some applications of biotechnology may be enough to make patenting less attractive compared with the effort necessary to protect genetic diagnostic methods by non-disclosure.

If there were no alternatives to legislating some sort of exemption from patent infringement liability for "second opinion" genetic diagnostic tests, then perhaps public policy concerns would tip the scales in favor of some form of the legislation as has been proposed.  But there are at least the following possible ways to prevent this outcome in the patent arena (and I'm sure many unexplored ways in the insurance and general healthcare space).

First, we can recognize that under Federal Circuit case law and PTO practice the written description and enablement requirements have limited the scope of medical and genetic diagnostic claims over the past decade or so -- it is unlikely that a broad claim to detecting any mutation associated with a particular gene for a particular disease would be granted or enforced today.  So the specter of broad, overarching claims that inhibit all research on genetic mutations in a particular gene associated with a particular disease is and has been a strawman in the debate.

Second, other robust patent principles -- such as patent exhaustion -- can be employed to the problem if it arises.  The Supreme Court has extended patent exhaustion principles to method claims in the Quanta case.  Here, for example, an individual could be given the right to a "second opinion" test provide that she can show that she has obtained the first test from the patent holder or her licensee.

Third, as we heard from MPEG LA there are ways to avoid "patent thickets" even if they were to arise -- and the possibility for them to arise is low, if only because many underlying gene patents will expire.  The telecommunication industry has used standard setting and other means to avoid patent thickets, and the biotechnology industry can as well.

Fourth, in egregious circumstances, the U.S. government can exercise "march-in" rights to encourage non-exclusive commercialization (although this option should be exercised sparingly).

Under any scenario in which second opinion genetic diagnostic testing is performed, a critical requirement must be that the lab that provides such a second opinion be at least as competent and provide at least as accurate a diagnosis as the patent holder or her licensee or an important reason for even considering unrecompensed second opinion testing will be unfulfilled.  One of the aspects of genetic diagnostic methodology is that implementing it with actual patient samples isn't as simple as performing an experiment in a lab -- providing the required quality control is one of the things patent protection funds, so that the public gets the benefits of genetic testing in the first place.  Permitting any genetic testing without such safeguards would be irresponsible.

Finally, in addition to upsetting the settled expectations of a highly successful industry, any action to carve out an exemption from patent infringement liability for "second opinion" genetic diagnostic testing would amount to a taking that would need recompense.  Any legislation or policy change that would permit such second opinion testing -- which would amount to a compulsory license -- would need to take the public cost into account.  The same impetus underlying some of these proposals -- the coming age of personalize medicine and widespread genetic diagnostic testing -- will multiply and exacerbate the cost of any policy that permits someone other than the patentee from performing a patented genetic diagnostic test, and it is disingenuous not to consider the cost.  We will also need to factor in the cost to the economy in general if loss of patent protection leads to job losses in states like Massachusetts and California that have a disproportionately large number of biotech companies.

In addition, these costs must be balanced with impending patent expiry, since any benefit to the public will be short lived in many cases and, if the result is unpatented but undisclosed genetic tests, any such benefit will likely be overwhelmed by increased costs from such unpatented tests.

These considerations, in my mind, make any proposal for permitting "second opinion" genetic diagnostic testing to be unnecessary, premature and ill-advised, and I urge the Office to include these reservations in its report to Congress.

Thank you.

USPTO to Hold Hearing on Genetic Diagnostic Testing

By Donald Zuhn --

On Thursday, the U.S. Patent and Trademark Office will hold the first of two hearings on independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests.  The Office is holding the hearings to collect information for the preparation of a report to Congress pursuant to § 27 of the Leahy-Smith America Invents Act (see "USPTO News Briefs," January 26, 2012).  Thursday's hearing will take place in the USPTO's Madison Auditorium located at 600 Dulany Street in Alexandria, Virginia, with a second hearing scheduled for March 9, 2012 in San Diego.

Agendas for both public hearings can be found here (February 16) and here (March 9).  WebEx and teleconference numbers and passwords or access codes for each hearing can be found on the agendas.  On Thursday, a USPTO panel consisting of Deputy Director Teresa Stanek Rea; Dana Robert Colarulli, Director, Office of Governmental Affairs; Janet Gongola, Patent Reform Coordinator; Stuart Graham, Chief Economist; and George Elliott, Director, Technology Center 1600 will hear testimony between 9:35 am and 12:05 pm from the following individuals:

• Thomas Kowalski, Shareholder, Vedder Price, P.C.
• Mercedes Meyer, Member, Board of Directors, American Intellectual Property Law Association
• Mary Williams, Executive Director, Association for Molecular Pathology
• Lori Pressman, Independent Consultant on Technology Transfer
• Hans Sauer, Associate General Counsel for Intellectual Property, Biotechnology Industry Organization
• Ellen Jorgensen, President, Genspace
• Lawrence Horn, CEO, MPEG LA, LLC and Kristin Neuman, Executive Director, Librassay, MPEG LA, LLC
• Lisa Schlager, Vice President, Community Affairs & Public Policy, FORCE
• Kevin Noonan, Patents Docs author and Partner, McDonnell Boehnen Hulbert & Berghoff LLP

Prior to this testimony, the panel will hear (via video) from Rep. Debbie Wasserman Schultz (D-FL) (at left) who introduced an amendment to H.R. 1249 that would have exempted from infringement a "genetic diagnostic tester's performance of a confirming generic diagnostic test activity" that would otherwise constitute infringement under §§ 271(a) or (b).  H.R. 1249 was eventually passed by both the House and Senate -- without Rep. Wasserman Schultz's amendment (see "House Judiciary Committee Approves H.R. 1249") -- and signed into law as the Leahy-Smith America Invents Act.  USPTO Chief Economist Stuart Graham will also give an overview of the genetic diagnostic testing study.  Unscheduled testimony will be taken beginning at 1:30 pm.

In addition to the public hearings, the Office is also seeking written comments, which must be submitted by March 26, 2012.  Additional information regarding the submission of written comments can be found here and in the Office's Federal Register notice (77 Fed. Reg. 3748).

USPTO Proposes More Rules for Implementing AIA Provisions

By Donald Zuhn --

Last November, officials from the U.S. Patent and Trademark Office indicated that ten notices of proposed rulemaking to implement various provisions of the Leahy-Smith America Invents Act were being drafted and vetted by the Office, and that the notices would be published in January 2012 (see "USPTO News Briefs").  By the end of its self-imposed deadline, the Office had released five notices offering proposed rulemaking regarding:

• Changes To Implement Miscellaneous Post Patent Provisions of the Leahy-Smith America Invents Act (77 Fed. Reg. 442) -- Patent Docs report;
• Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act (77 Fed. Reg. 448) -- Patent Docs report;
• Implementation of Statute of Limitations Provisions for Office Disciplinary Proceedings (77 Fed. Reg. 457) -- Patent Docs report;
• Changes To Implement the Inventor’s Oath or Declaration Provisions of the Leahy-Smith America Invents Act (77 Fed. Reg. 982) -- Patent Docs report; and
• Changes To Implement the Supplemental Examination Provisions of the Leahy-Smith America Invents Act and To Revise Reexamination Fees (77 Fed. Reg. 3666) -- Patent Docs report.

On Thursday, the Office released a set of seven notices requesting comments and/or providing additional proposed rulemaking.  Among the recent set of notices were the following:

• Practice Guide for Proposed Trial Rules (77 Fed. Reg. 6868);
• Rules of Practice for Trials Before the Patent Trial and Appeal Board and Judicial Review of Patent Trial and Appeal Board Decisions (77 Fed. Reg. 6879);
• Changes To Implement Derivation Proceedings (77 Fed. Reg. 7028);
• Changes to Implement Inter Partes Review Proceedings (77 Fed. Reg. 7041); and
• Changes To Implement Post-Grant Review Proceedings (77 Fed. Reg. 7060).

As with the first set of proposed rules, Patent Docs plans to discuss each of the notices published last week, beginning with the notice to implement the derivation proceedings provisions of the AIA.  Subsequent posts will address the other notices.

Section 3(i) of the Leahy-Smith America Invents Act amends 35 U.S.C. § 135 to provide for derivation proceedings in which an applicant may seek a determination that "an inventor named in an earlier application derived the claimed invention from an inventor named in the petitioner's application and, without authorization, the earlier application claiming such invention was filed" (see "AIA Overview: First-Inventor-to-File Provisions").  The 14-page notice of proposed rulemaking on derivation proceedings addresses the manner in which the Patent Trial and Appeal Board will resolve disputes as to which of two applicants is a true inventor.  In addition to the derivation proceedings provisions provided in AIA § 3(i), the notice indicates that:

Derivation proceedings will be conducted in a manner similar to inter partes reviews and post-grant reviews.  Unlike patent interferences, derivations will be conducted in a single phase without the use of a "count."  An inventor seeking a derivation proceeding must file an application.  35 U.S.C. 135(a).  An inventor, however, may copy an alleged deriver's application, make any necessary changes to reflect accurately what the inventor invented, and provoke a derivation proceeding by the timely filing of a petition and fee.

Pursuant to § 135(a), the Director shall determine whether to institute a derivation proceeding in response to a petition demonstrating that the standards for instituting a derivation proceeding have been met.  However, the notice states that "[a] derivation is unlikely to be declared even where the Director thinks the standard for instituting a derivation proceeding is met if the petitioner's claim is not otherwise in condition for allowance."

Under new § 135(f), the Director is not precluded from determining the patentability of the claimed inventions involved in the proceeding.  The notice indicates that "[t]he Director will delegate to the Board authority to resolve patentability issues that arise during derivation proceedings when there is good cause to do so."

Following a discussion of the changes to 35 U.S.C. § 135, the notice provides a discussion of specific rules for instituting and conducting derivation proceedings before the Board.  In particular, the notice proposes adding new subpart E to 37 C.F.R. part 42 to provide rules specific to derivation proceedings.  In three of the other notices issued last week, the Office proposes adding subpart A to 37 C.F.R. part 42, which sets forth the policies, practices, and definitions common to all trial proceedings (including derivation proceedings) before the Board; subpart B, which provides rules specific to inter partes review; subpart C, which provides rules specific to post-grant review; and subpart D, which provides rules specific to transitional program covered business method patents.

A brief discussion of the proposed rules for instituting and conducting derivation proceedings can be found on pages 7030-31 of the notice, and the text of the new rules can be found on pages 7039-41 of the notice.

Comments regarding the notice can be submitted by e-mail to derivation@uspto.gov; by regular mail addressed to:  Mail Stop Patent Board, Director of the United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Lead Judge Michael Tierney, Derivation Proposed Rules; or via the Federal eRulemaking Portal.  The deadline for submitting comments is April 10, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 7028).

USPTO Issues Proposed Rulemaking for Supplemental Examination Provisions of AIA

By Andrew Williams --

On January 25, 2012, the U.S. Patent and Trademark Office published its notice of proposed rulemaking to implement the supplemental examination provisions of the Leahy-Smith America Invents Act ("the AIA") (77 Fed. Reg. 3666).  This is one of the ten notices that the Office plans to publish to implement the various provisions of the AIA, and specifically deals with § 12 of the Act, which amends chapter 25 of title 35, United States Code by adding new § 257 "Supplemental examinations to consider, reconsider, or correct information."  We provided an overview of the supplemental examination provisions of the AIA last fall (see "AIA Overview: Supplemental Examination').  In short, this new provision permits "a patent owner to request supplemental examination of a patent by the Office to consider, reconsider, or correct information believed to be relevant to the patent."  77 Fed. Reg. 3666.  The Office is required by statute to determine within three months of a request whether it raises a substantial new question of patentability, and if so, the Director is required to order an ex parte reexamination of the patent.  Such a reexamination follows the same rules as a normally requested reexamination, except that the patent owner does not get the opportunity to submit a statement pursuant to section § 304 after the reexamination is ordered, and the reexamination is not limited to patents and printed publications.  In addition to providing notice of rules for implementing this new procedure, the Office also proposed fees for both supplemental examination and various reexamination fees.  Notably, the Office is proposes raising the cost for filing a request for ex parte reexamination to $17,750!  Written comments related to these proposed rules must be received by March 26, 2012.

In general, the proposed rules track the provisions of § 12 of the AIA, but there are a few notable exceptions.  The AIA did provide the Office with the authority to implement some of its own procedures, but otherwise the Office took the opportunity to interpret some sections of the AIA and propose its own rules when the AIA was silent on an issue.  This report will mainly focus on the unique aspects of the Office's proposed implementation of supplemental examination, but where necessary to provide context, the provisions of § 12 of the AIA and the reasons for its enactment will be described.  In addition, even though this report provides an overview of some of the more interesting aspects of the proposed rule, it is not meant to be exhaustive.    

As may be self-evident, one of the purposes of the new supplemental examination procedure is to help cure an application from potential future allegations of inequitable conduct.  Therefore, one of the most significant differences between this procedure and ex parte reexamination is that supplemental examination is not limited to patents and printed publications.  The Office recognizes that the type of information that can come from a variety of new sources, and some of these types of information may be difficult for the Office to review, especially in the view of the imposed three-month deadline.  Moreover, in addition to raising issues of novelty or obviousness, the patent owner is allowed to raise issues of patentablility under 35 U.S.C. §§ 101 and 112.  As a result, the Office is proposing specific rules to ensure that the determination of whether there is a substantial new question of patentability can be made within this three-month time frame.  First, the Office is proposing setting a limit of ten (10) "items of information" that can be included with such a request.  According to the Office, the rationale for such a number is that allegations of inequitable conduct during patent litigation typically concern fewer than ten items of information.  Moreover, the Office reasons, if a patentee has more than ten items, more than one supplemental examination request can be filed at the same time.  This limit on the number of items, however, is irrelevant to whether the items need to be combined, for example, where the request includes an issue of obviousness.  In such a case, it is easy to see where the limit of ten items could be reached.  Second, the Office is proposing an additional fee for any document submitted with the request that is in excess of 20 pages, as well as requiring a summary of the relevant portions of document over 50 pages.  The Office does suggest that overly long documents can be redacted, provided that no relevant information is excluded.  However, it is probably not advisable to submit a redacted portion of a document, especially if the document was responsible for the determination to file supplemental examination in the first place.  Finally, the Office is proposing that the request must include (1) an identification of each issue raised by each item of information, (2) a detailed explanation for each issue, and (3) an explanation of how each item of information is relevant to each aspect of the patent to be examined and how each item raises each identified issue.  It is clear that these requirements are meant to assist the Office in meeting its deadline.  However, even though it might be advisable for a patent holder to alert the Office to reasoning as to why it is citing an item of information in its request, patent holders will likely be weary of providing too much information, and therefore will need to approach such a task cautiously.

And, for clarification, the proposed rules do define what an "item of information" is.  For example, an item can be a document that is submitted as part of the request.  Examples of these items include journal articles, patents, affidavits, declarations, and transcripts of recordings (in fact, it appears that as long as it is written, it can be an item of information).  However, an item need not be a document, as documentary evidence may not be available for some issues, such as issues related to satisfying 35 U.S.C. § 101.  In these cases, the Office is proposing that the "item of information" be the discussion of the issue within the body of the request.  However, the proposed rules are clear that if the item is text within the request (or even another "document" reproduced in the request), the patentee still must count that item as one of the ten.  And, the Office is proposing that the item of information must be in writing.  As such, audio or video recordings must be submitted in the form of a written transcript.     

An interesting provision of the AIA as it relates to supplemental examination involves what happens if the Director becomes aware that "material fraud" on the Office was committed in connection with a patent.  In such a case, the Director is authorized to take certain actions, such as the cancellation of claims.  However, the Director is required to refer the matter to the Attorney General.  As a result, the Office stated clearly in the proposed rules that the standard for "material fraud" is narrower than for inequitable conduct as defined by the Federal Circuit in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011).  No further explanation of how much narrower was provided, however.    

The Office has proposed several other interesting rules in connection with supplemental examination.  First, the patentee cannot file any amendments with the request for supplemental examination.  In fact, because the patentee does not get an opportunity to submit a statement should a reexamination be declared, the first opportunity to file claim amendments is after the first Office action on the merits.  The Office is also proposing a prohibition on interviews during the supplemental examination proceedings.  However, this does not preclude a call to the Office to confirm receipt of a request or to discuss procedural questions.  In addition, the Office is proposing a rule that prohibits third parties from participating or filing papers in a supplemental examination proceeding.  Of course, this proposal isn't that surprising, because third parties are also prohibited from participating in any ex parte reexamination proceeding, should one be ordered.

One of the more shocking aspects of the proposed rules is the size of the proposed fees for both requesting supplemental examination and for filing a request for ex parte reexamination.  Currently, the fee of the reexamination request is $2,520.  However, the Office is proposing that this fee be raised to $17,750, with a subset of the fee refunded should the request be refused.  In addition, the proposed fee for a supplemental examination request is $5,180, but such a request must also include the fee for reexamination should it be ordered, in this case $16,120.  Therefore, provided there are no documents over 20 pages submitted with the request (because documents over 20 pages require an additional fee), the fee that must accompany a request for supplemental examination is $21,300.  The Patent Office acknowledges that it is not following the provisions of the AIA that set out the process for setting or adjusting fees, allegedly because it is not feasible to have these fees in place by September 16, 2012 under that scheme.  Therefore, the Office is relying on 35 U.S.C. § 41(d)(2) for its authority, which allows the Office to set fees to recover the estimated average cost to the Office of processing, services, or materials.  The notice does discuss the analysis of how these estimated numbers were derived, and refers the reader to the Patent Office website.  Still, considering the onerous requirements that the AIA placed on the Office in relation to supplemental examination (for example, requiring a decision within three months), one can't help but wonder whether the Office is proposing these new fees as a way to deter patent holders from filing such a request, rather than an effort to recoup their ultimate costs.

Similar to the other notices of rulemaking, comments can be submitted by e-mail to supplemental_examination@uspto.gov; by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Cynthia L. Nessler, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.  Again, the deadline for submitting comments is March 26, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 3666).

For information regarding the Office's implementation of other AIA provisions, please see:

• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Oath or Declaration Provisions," January 30, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Statute of Limitations Provisions for Office Disciplinary Proceedings," January 16, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Preissuance Submissions Provision," January 12, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Miscellaneous Post Patent Provisions," January 11, 2012

USPTO Extends PCT-PPH Programs with EPO & JPO

By Donald Zuhn --

Last month, the U.S. Patent and Trademark Office announced that it was extending its Patent Prosecution Highway (PPH) pilot program based on Patent Cooperation Treaty (PCT) work products (i.e., PCT-PPH pilot program) with the European Patent Office for two more years.  The USPTO similarly announced that it was extending the PCT-PPH pilot program with the Japan Patent Office for two more years.  Both pilot programs are now scheduled to end on January 12, 2014, although either program may be further extended past that date.

Under the PCT-PPH framework, an applicant receiving a positive written opinion or a positive international preliminary examination report in a PCT application where the EPO or JPO was the International Searching Authority (ISA) or the International Preliminary Examination Authority (IPEA) may request that the USPTO fast track the examination of corresponding claims in the corresponding U.S. application.  A positive written opinion or IPER is one in which at least one claim in an International application is determined to have novelty, inventive step, and industrial applicability.  Both programs were extended in order to collect more information before any formal decision on the programs is made.

Since implementing its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) on July 3, 2006, the U.S. Patent and Trademark Office has established a total of twenty PPH programs with other patent offices.  Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Patent Office (HPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Spanish Patent and Trademark Office (SPTO), the Austrian Patent Office (APO), the Mexican Institute of Industrial Property (IMPI), and the Israel Patent Office (ILPO), the Taiwan Intellectual Property Office (TIPO), the Norwegian Industrial Property Office (NIPO), China's State Intellectual Property Office (SIPO), and the Icelandic Patent Office (IPO).  The USPTO has also established eleven PCT-PPH programs with other patent offices:  IP Australia, APO, SIPO, EPO, NBPR, JPO, KIPO, the Nordic Patent Institute (NPI), ROSPATENT, SPTO, and the Swedish Patent and Registration Office (PRV).  Additional information regarding the various PPH and PCT-PPH programs can be found here.

PPAC to Hold Public Hearings on Proposed Fee Schedule

By Donald Zuhn --

On Monday, the U.S. Patent and Trademark Office issued a notice in the Federal Register (77 Fed. Reg. 4509) announcing that the Patent Public Advisory Committee (PPAC) will be holding two public hearings in February regarding proposed patent fees.  The public hearings are being held pursuant to § 10 of the Leahy-Smith America Invents Act, which concerns the Office's fee setting authority.  Under that section, the Director is permitted to set or adjust any fee established, authorized, or charged under Title 35 (but "only to recover the aggregate estimated costs to the Office for processing, activities, services, and materials relating to patents").

AIA § 10 also outlines the process whereby the Director is allowed to set or adjust such fees.  In particular, the Director must submit a proposed fee change to the PPAC not less than 45 days before publishing the proposed fee in the Federal Register, after which the PPAC shall have 30 days to deliberate, consider, and comment on the proposal as well as hold a public hearing on the proposal.  The Director shall then consider and analyze the PPAC's comments, advice, or recommendations before setting or adjusting the fee.  AIA § 10 also requires that the Director provide the public with a 45-day period in which to comment on any fee change, and specifies that fee changes shall not become effective until 45 days after the final rule regarding such change is published in the Federal Register (in order to give Congress an opportunity to enact a law disapproving of the fee change).

In Monday's notice, the Office indicated that it is planning to set or adjust fees pursuant to its § 10 fee setting authority.  In order to comply with the requirements of § 10, the Office will be holding two public hearings on proposed patent fees.  The hearings will take place on from 8:00 am to 3:00 pm (EST) on February 15 in the Madison Auditorium, 600 Dulany Street, Alexandria, Virginia 22314; and from 8:00 am to 3:00 pm (PST) on February 23, 2012 at the Sunnyvale Public Library, 665 W. Olive Avenue, Sunnyvale, California 94086.  Both public hearings will be made available via webcast (details forthcoming).

The notice indicates that the Office will publish a proposed patent fee schedule and related supplementary information for public viewing on the USPTO's AIA webpage no later than February 7, 2012.  Following the public hearings, the Office intends to publish a notice of proposed rulemaking in the Federal Register setting forth the proposed patent fees, after which the public will be afforded an opportunity to comment on the fees again.

Individuals wishing to present oral testimony at either hearing must request an opportunity to do so in writing no later than February 8, 2012.  Requests to testify must be submitted by e-mail to Jennifer Lo at Jennifer.Lo@uspto.gov, and should include:  (1) the name of the person wishing to testify; (2) the person's contact information (telephone number and e-mail address); (3) the organizations the person represents, if any; and (4) an indication of the amount of time needed for the testimony.

Those wishing to submit written comments must do so on or before February 29, 2012.  Written comments can be sent by e-mail to fee.setting@uspto.gov or by regular mail addressed to:  United States Patent and Trademark Office, Mail Stop CFO, P.O. Box 1450, Alexandria, VA 22313–1450, ATTN: Michelle Picard.

USPTO Proposes Rules Changes for Implementing AIA Provisions -- Oath or Declaration Provisions

By Donald Zuhn --

Last November, officials from the U.S. Patent and Trademark Office indicated that ten notices of proposed rulemaking to implement various provisions of the Leahy-Smith America Invents Act were being drafted and vetted by the Office, and that the notices would be published in January 2012.  With January drawing to a close, the Office has thus far published five of these notices.  In previous posts, we have discussed three of the notices (concerning implementation of the AIA's miscellaneous post patent provisions, preissuance submissions provision, and provisions on disciplinary proceedings -- see links below).  A subsequent post will address a recently published notice concerning the implementation of the AIA's supplemental examination provisions (77 Fed. Reg. 3666).  Today, we address the Office's notice on "Changes To Implement the Inventor’s Oath or Declaration Provisions of the Leahy-Smith America Invents Act " (77 Fed. Reg. 982).

The 22-page notice proposes changes that are intended to revise and clarify the rules of practice relating to the inventor's oath or declaration, assignments containing oath or declaration statements from inventors, and oaths or declarations signed by parties other than the inventors, as well as revise and clarify the rules of practice for powers of attorney and prosecution of an application by an assignee.  In particular, the notice proposes changes to the rules to implement AIA § 4, which amends 35 U.S.C. §§ 115 and 118 to change the practice regarding an inventor's oath or declaration, and AIA § 20, which amends, inter alia, 35 U.S.C. §§ 116, 184, 251, and 256 to remove the "without any deceptive intention" language.  A list of the specific changes to each of these sections can be found on pages 982-84 of the notice.

Following the list of specific changes to Title 35, the notice provides a general discussion regarding the implementation of AIA §§ 4 and 20.  With regard to these changes, the notice indicates that amended § 115 permits the required inventor statements (i.e., that the application was made or was authorized to be made by the affiant or declarant, and that the individual believes himself or herself to be the original inventor or an original joint inventor of a claimed invention in the application) to be made in an oath or declaration under 35 U.S.C. § 115(a), a substitute statement under 35 U.S.C. § 115(d), or an assignment under 35 U.S.C. § 115(e).  Because amended § 115 no longer requires an inventor to identify his or her country of citizenship, the Office will no longer require this information to be included in the oath or declaration.

The Office also proposes changes to the rules that will allow an assignee, a party to whom the inventor is legally obligated to assign the invention, or a party who otherwise has a sufficient proprietary interest to provide a substitute statement with respect to an inventor who is deceased, is legally incapacitated, cannot be found or reached after diligent effort, or refuses to sign the oath or declaration.  The Office further proposes changes to the rules to allow inventors to make the required statements in an assignment executed by the inventor and recorded in the Office (including a proposal to require that the assignment cover sheet identify the assignment as also being an oath or declaration).

While the AIA permits the Office to delay requiring an oath or declaration until allowance, the Office determined that it would be "better for the examination process and patent pendency to continue to require the oath or declaration during preexamination."  For example, the Office noted that it "must know the identity of the inventors to determine what prior art may be applied against the claimed invention or whether to issue a double patenting rejection."  The notice indicates that the Office considered discontinuing the practice of charging a surcharge for late filing of an oath or declaration, but states that "the cost of the special processing required for such applications should be borne by those applicants who require special processing and not by applicants whose applications are complete on filing."

With regard to powers of attorney, the Office proposes changes to the rules that will:

• Provide for the carryover of a power of attorney in continuation and divisional applications, and in continuation-in-part applications where inventorship is the same as in the immediate prior application;
• Permit practitioners who have acted only in a representative capacity in an application to change the correspondence address after a patent has issued;
• Accept the signature of a practitioner of record on a statement under 37 C.F.R. § 3.73(b) on behalf of an assignee without requiring further evidence of the practitioner's authority to act on behalf of the assignee;
• Provide a procedure for handling conflicts between different purported assignees attempting to control prosecution; and
• Harmonize the practice regarding foreign and domestic priority claims by requiring both types of claims to be set forth in an application data sheet.

A lengthy discussion of the specific changes to the rules to implement the above changes can be found on pages 985-96 of the notice.  Additional discussion of the rules changes, as well as revised versions of the affected rules (see pages 998-1003) can be found in the Office's Federal Register notice (77 Fed. Reg. 982).

Comments regarding this notice can be submitted by e-mail to oath_declaration@uspto.gov; by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Hiram H. Bernstein, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.  The deadline for submitting comments is March 6, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 982).

For information regarding the Office's implementation of other AIA provisions, please see:

• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Statute of Limitations Provisions for Office Disciplinary Proceedings," January 16, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Preissuance Submissions Provision," January 12, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Miscellaneous Post Patent Provisions," January 11, 2012

USPTO News Briefs

By Donald Zuhn --

USPTO Schedules Hearings and Seeks Comments on Genetic Diagnostic Testing

In a press release and corresponding notice in Wednesday's Federal Register (77 Fed. Reg. 3748), the U.S. Patent and Trademark Office announced that it would begin gathering information on independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests.  The Office is collecting such information in order to prepare a report to the Committee of the Judiciary for both the Senate and House pursuant to § 27 of the Leahy-Smith America Invents Act.  As part of the information gathering process, the Office noted that it would be holding two public hearings on the matter, with the first hearing to be held from 9:00 am to 4:00 pm (EST) on February 16, 2012 in the USPTO's Madison Auditorium located at 600 Dulany Street in Alexandria, Virginia, and the second hearing to be held from 9:00 am to 4:00 pm (PST) on March 9, 2012 at the Joan B. Kroc Institute for Peace & Justice at the University of San Diego.  The Office is also seeking written comments on genetic diagnostic testing.

Pursuant to AIA § 27, the Office's report to Congress must include an examination of the following topics:

(1)  The impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing, and on inhibiting innovation to existing testing and diagnoses;

(2)  The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test;

(3)  The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures; and

(4)  The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

The Office's notice also includes a number of additional issues (see pages 3748-49) on which the public is invited to comment.

Those wishing to present oral testimony at either hearing must do so in writing by February 8, 2012 by e-mailing the following information to Saurabh Vishnubhakat at saurabh.vishnubhakat@uspto.gov:  (1) The name of the person wishing to testify; (2) the person's contact information (telephone number and email address); (3) the organization(s) the person represents, if any; (4) an indication of the amount of time needed for the testimony; and (5) a preliminary written copy of the testimony.  The Office noted that the public hearings would be made available via a webcast (with details to be provided at a later date).

Those wishing to submit comments must do so by March 26, 2012 by sending such comments by e-mail to genetest@uspto.gov or by regular mail addressed to Saurabh Vishnubhakat, Attorney Advisor, Office of Chief Economist, United States Patent and Trademark Office, Mail Stop External Affairs, P.O. Box 1450, Alexandria, VA 22313–1450.  Comments sent by e-mail should include "Genetic Testing Study" in the subject line.

USPTO Issues Reminder Regarding Deadline for Commenting on Locations of Satellite Offices

The U.S. Patent and Trademark Office issued a press release today reminding the patent community that the deadline for submitting written comments on potential locations for additional USPTO satellite offices is 11:59 pm (ET) on January 30, 2012.  The Office noted that this deadline would not be extended.  Last November, the Office issued a notice in the Federal Register outlining the specifics of its request for comments (see "USPTO News Briefs," December 15, 2011).  In that notice, the Office noted that:

    Comments should provide information that supports the USPTO's purposes of establishing satellite offices, including that the location will:
    (1) Increase outreach activities to better connect patent filers and innovators with the USPTO, including the number of patent filings and grants by the city/region as well as other information that provides insight into the region’s innovation activity;
    (2) Enhance patent examiner retention, including quality of life indicators such as average household income, cost of living factors, and other factors related to employee retention;
    (3) Improve recruitment of patent examiners, including data on employment rates and other economic factors in the area, science and technology professionals, as well as legal professionals in the workforce and other related information;
    (4) Decrease the number of patent applications awaiting examination; and
    (5) Improve the quality of patent examination.

In today's release, USPTO Director David Kappos stated that the Office was "looking forward to reviewing community feedback on locations for Satellite Offices to recruit and retain top talent, and to better serve our applicant community," adding that the Office was "committed to conducting an open and transparent selection process that will ultimately yield the best locations for the USPTO and its user community."

USPTO Establishes Retention Period for Patent-Related Papers

In a notice published in Wednesday's Federal Register (77 Fed. Reg. 3745), the U.S. Patent and Trademark Office announced that it is establishing a one-year retention period for patent-related papers that:  (1) began on September 1, 2011, for papers scanned into IFW or SCORE prior to September 1, 2011; or (2) began or begins on a paper's submission date, for papers scanned into IFW or SCORE on or after September 1, 2011.  The Office originally proposed the retention plan in a Federal Register notice in August (see "USPTO News Briefs," September 1, 2011).

Under the new retention plan, the USPTO will dispose of papers after the expiration of the one-year retention period unless, within sufficient time prior to disposal of the paper, an applicant, patent owner, or reexamination party files a bona fide request to correct the electronic record of the paper in IFW or SCORE, and the request remains outstanding at the time disposal of the paper would have otherwise occurred.  Previously, the Office retained papers indefinitely.  Additional information regarding the retention plan, as well as the Office's response to the lone comment it received in response to its earlier notice, can be found in the latest notice.

According to the notice, the Office will continue to accept comments regarding the new retention plan, which can be sent by e-mail to IFWPaperRetention@uspto.gov or by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450.

USPTO Issues Memo on Use of Non-Patent Literature During Examination

By Donald Zuhn --

Last week, the Office of the General Counsel for the U.S. Patent and Trademark Office issued a memorandum in response to several inquiries the Office has received concerning copyright infringement and the use of non-patent literature (NPL) in the examination process.  The memo, which was sent by USPTO General Counsel Bernard Knight, Jr., discusses the application of the fair use doctrine to the use of NPL during examination.

The memo begins by stating three issues involving the use of NPL:

1.  Whether it is fair use for the USPTO to make copies of copyrighted non-patent literature (NPL) and provide such copies to an applicant in the course of patent examination?

2. Whether it is fair use for the USPTO to provide certified copies of entire file histories, including copyrighted NPL, to members of the public, for a fee?

3. Whether it is fair use for an applicant to make a copy of a piece of copyrighted NPL and submit it to the USPTO?

With respect to the first issue, the memo notes that the Office "currently obtains much of its NPL through licenses, and has ensured that its licenses permit it to make copies of copyrighted NPL that is used in examination."  For unlicensed NPL, the memo states that the Office considers the copying and providing of such references to applicants to be protected by the doctrine of fair use.  In order to prevent copyrighted NPL from being copied "for reasons unrelated to patent matters," such references are not provided on PAIR.  As for the second issue, the Office considers that providing certified copies of entire file histories, including copyrighted NPL, to members of the public for a fee to also be protected by the doctrine of fair use.  Finally, with regard to the third issue, the Office considers the copying of copyrighted NPL by patent applicants and their attorneys and the submission of those copies to the USPTO "pursuant to the USPTO's disclosure requirements," to be protected by the doctrine of fair use.  The memo adds, however, that "[t]he USPTO takes no position on whether additional copies of such NPL made by an attorney or applicant during the course of patent prosecution (e.g. for the client, for other attorneys, for the inventor, or for the law firm's future reference) qualifies as fair use."  The memo also warns that "[t]o the extent applicants have obtained copyrighted NPL pursuant to a license, applicants are responsible for ensuring that the license is not inconsistent with fair use."

The memo explains that the Copyright Act provides four factors for assessing whether a particular use is a fair use, and thus considered not to be an infringement of a copyright.  Citing § 107 of the Copyright Act, the memo states that these factors are:

(1) the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes; (2) the nature of the copyrighted work; (3) the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and (4) the effect of the use upon the potential market for or value of the copyrighted work.

Applying the four factors to the first issue, the Office notes that "[i]n the 1960s, as part of an initiative to expedite the examination process, the USPTO began providing copies of cited prior art to applicants."  With respect to copying and providing unlicensed NPL to applicants, the Office notes that the first factor "weighs in favor of fair use because the USPTO is not using the work for a commercial purpose."  The Office also cites "several cases dealing with use of copyrighted works in connection with non-commercial, government functions [that] favor[] fair use."  As to the second factor, the memo states that "the USPTO and the applicants are interested in the NPL only for its factual, rather than its expressive, content," and notes that NPL typically consists of published works, which "receive less protection than unpublished works."  The Office acknowledges that the third factor "tends to be neutral in this case," because "[i]n many cases . . . an entire publication (e.g., an entire journal article) is considered relevant."  With regard to the fourth factor, the memo states that:

There is no basis for concluding that the USPTO' s provision of copyrighted NPL to patent applicants in the course of patent examination impairs the marketability of the copyrighted NPL.  The NPL at issue has typically been published several years before the USPTO's use and by the time of the USPTO's use usually has only limited commercial value.  In addition, by not providing copies of copyrighted NPL in its Public PAIR system -- and thereby preventing any possibility of systematic infringement through access to USPTO's databases -- the USPTO has taken steps to ensure that copies of NPL used in examination do not become freely available on the internet.

The memo therefore concludes that the Office's copying and providing of copyrighted NPL to applicants constitutes fair use.

On the second issue, the memo contends that "[t]he fair use analysis for providing file wrappers to the public for a fee (pursuant to 35 U.S.C. 9 and 37 C.F.R. 1.19( a)) is similar to the analysis for providing copies of the NPL during examination."  The Office states that "[t]he fact that the USPTO charges a fee for the certified file wrapper does not alter the conclusion that the use of the work is not for profit," noting that "[t]he fee is calibrated to reflect cost recovery, and the USPTO does not profit from making copies of any particular copyrighted work."  The memo therefore concludes that "the incidental inclusion of copies of copyrighted NPL in a copy of a certified file wrapper offered to the public for a fee" also constitutes fair use.

The memo next applyies the four factors to applicants' copying and submission of copyrighted NPL.  The memo contends that "[t]he fair use analysis for an applicant's IDS submission is very similar to, and reaches the same result as, the fair use analyses for the USPTO uses [specified in the first two issues]."  With respect to the first factor, the memo states that "[t]he case for fair use . . . might be even stronger for the applicant, because the applicant is required by law to submit the prior art to the patent office."  In particular, the memo explains that "[g]iven that the applicants here are not 'exploiting' the copyrighted work, and are instead merely submitting it, pursuant to a legal requirement, based on its factual, rather than its expressive, content, the first factor weighs heavily in favor of fair use."  As to the fourth factor, the memo states that "it is also worth noting that the copies of NPL that law firms typically submit to the USPTO have been obtained through legitimate, licensed databases, and thus have already been paid for once," adding that "[t]he copyright holder has already been compensated for that use (which would not typically have occurred but for the legal requirement imposed by the patent system)."  The memo therefore concludes that "it is fair use for an applicant to make copies of NPL and submit those copies to the USPTO during examination in an IDS."  The memo provides a bit of a disclaimer, however, reminding applicants that "to the extent they have obtained copies of NPL through licenses, they should consult those licenses to ensure that any proposed use of the NPL is within the scope of the license."

Hat tip to Greg Aharonian for alerting the readers of his e-mail newsletter to the Office's memo on the use of NPL during examination.

USPTO News Briefs

By Donald Zuhn --

USPTO Selects Site of Detroit Satellite Office

In a press release issued earlier this month, the U.S. Patent and Trademark Office announced that it had entered into a five-year lease agreement on a 31,000 square foot space at 300 River Place Drive in Detroit, where the Elijah J. McCoy USPTO will be located.  The Detroit satellite office was so designated pursuant to § 24 of the Leahy-Smith America Invents Act (see "USPTO News Briefs," December 15, 2011).  According to the announcement, the Office intends to open the Detroit satellite office no later than July 2012, and the satellite office is expected to create more than 100 new jobs during its first year.  The Office asks prospective employees to send e-mail inquiries to detroithiring@uspto.gov for more information.  The Office also reminded applicants and practitioners that it is currently in the process of collecting information on potential locations for future satellite offices.  Written comments regarding possible locations must be submitted by January 30, 2012 (see "USPTO News Briefs," December 15, 2011, for information regarding the Office's Federal Register notice requesting comments).

 
USPTO to Hold Seven AIA Roadshows

In a press release issued on January 9, the U.S. Patent and Trademark Office announced that it would be hosting a public series of educational "roadshows" regarding the Leahy-Smith America Invents Act.  The roadshows will allow the public to speak with USPTO officials about the new patent law and its implementation.  Seven roadshows have been scheduled, to be held at the following locations:

Friday, February 17
USPTO Campus
Alexandria, VA

Friday, February 24
Sunnyvale Public Library
Sunnyvale, CA

Monday, February 27
Marriott Library, University of Utah
Salt Lake City, UT

Wednesday, February 29
Dallas Public Library
Dallas, TX

Friday, March 2
Broward County Main Library
Ft. Lauderdale, FL

Monday, March 5
Boston Public Library
Boston, MA

Wednesday, March 7
Chicago Public Library
Chicago, IL

USPTO Patent Reform Coordinator Janet Gongola commented that "[t]he USPTO hopes that the public will find the roadshows to be an ideal forum to engage with the Office about our various proposed rules implementing provisions of the America Invents Act," adding that "[t]he roadshows also give the agency the opportunity to visit members of the patent community in different parts of the country as part of our ongoing effort to create a 21st century patent and trademark office."

According to the USPTO's Leahy-Smith America Invents Act Implementation webpage, the agenda of the roadshows will be as follows:

Welcoming Remarks -- 10:00 – 10:30 am
Patent Related Provisions -- 10:30 – 11:15 am
Break -- 11:15 – 11:30 am
Patent Related Provisions -- 11:30 am – 12:30 pm
Lunch -- 12:30 – 1:30 pm
Contested Case Provisions -- 1:30 – 3:00 pm
Break -- 3:00 – 3:15 pm
Contested Case Provisions -- 3:15 – 4:30 pm 

Patent Docs intends to attend and report on the Chicago roadshow.

USPTO Issues AIA-Mandated Reports

In a press release issued yesterday, the U.S. Patent and Trademark Office announced that it had submitted to Congress two reports mandated by the Leahy-Smith America Invents Act.  The first report concerns the scope of prior user rights defense in industrialized countries (see "USPTO Issues Report on Prior User Rights"), and the second report (prepared pursuant to AIA § 31) concerns international patent protections for small businesses.

According to the Office's announcement, the International Patent Protections for Small Businesses Report "considers how to best help small businesses with patent protection overseas, including whether a loan or grant program should be established to help small businesses cover the costs of application, maintenance, and enforcement fees or related technical assistance."

The Office noted that the AIA mandates that the USPTO conduct five more studies in the coming months.  Next on the Office's agenda is the report on secondary genetic testing; the Office will be hosting public hearings and seeking written public comments as it did for the first two reports.

USPTO Issues Report on Prior User Rights

By Kevin E. Noonan --

The U.S. Patent and Trademark Office on Friday released a "Report on the Prior User Rights Defense" provisions of the Leahy-Smith America Invents Act.  This Report was prepared as part of a mandate by Congress in §§ 3(m) and 31 of the Act that the Office perform studies relating to the effects of the Prior User Rights Defense (PURD) of the Act including:

(1)  comparison(s) between the patent laws of the U.S. and the laws of other industrialized countries;

(2)  the effect of prior user rights on innovation rates;

(3)  the correlation, if any, between prior user rights and start-up enterprises as well as the ability to attract venture capital to start new companies;

(4)  the effect of prior user rights, if any, on small businesses, universities, and individual inventors;

(5)  legal and constitutional issues with placing trade secret law in patent law; and

(6)  whether or not the change to a first-to-file patent system creates any particular need for prior user rights.

The Report, attributed to Director David Kappos and Assistant Director Teresa Stanek Rea, addresses these questions, making a number of findings and recommendations.

Findings:

1. The AIA strikes the right balance by limiting the prior user rights defense to those parties that can prove commercial use at least one year prior to the filing date of the patent application by clear and convincing evidence.

2. The scope of the prior user rights defense includes limitations on the type of continued activities, the transfer of the personal rights, and the enforcement of said right, such that the patentee's rights are not unjustly impinged and the university community may benefit, since the defense is not available in patent actions by universities.

3. There is not substantial evidence that prior user rights as established in the AIA will have a negative impact on innovation.

4. There is no substantial evidence showing that prior user rights as established in the AIA will have a disproportionately negative impact on venture-capital investments to small businesses and start-ups.

5. There is an insufficient basis to recommend a change to the scheme chosen by Congress with respect to the application of prior user rights to universities.

6. There is no substantial evidence that the limited prior user right defense as established by the AIA will have a negative impact on small businesses or independent inventors.

7. A prior use defense to patent infringement is both Constitutional and lawful and the defense is consistent with the Constitution and Supreme Court precedent recognizing that trade secret law and patent law can, and do, legally co-exist in the United States, and indeed have co-existed since our Constitution was created.

8. Trade secret protection is of considerable value to United States businesses and the United States economy, and as such, there are compelling economic and policy justifications for providing a prior user rights defense to patent infringement.

9. Providing limited prior user rights in a first-inventor-to-file system addresses the inherent inequity such a system creates between an earlier commercial user of the subject matter and a later patentee. A prior user rights defense is pro-manufacturing and pro-jobs, as it rewards businesses that put new technology promptly into commercial use, and provides protection for early commercial use when challenged by the later filing of patent applications by other entities.

10. Because the availability of a prior user rights defense to patent infringement is a fundamental aspect of many patent regimes throughout the industrialized world, there is a strong preference that United States businesses be afforded the same advantages in terms of prior use protections in the United States that their competitors enjoy abroad.

Recommendations:

1. The prior user rights defense provisions set forth in the AIA are generally consistent with those of major trading partners and need not be altered at this time.

2. The prior user right defense under the AIA should be maintained with no change at the present time because there is no substantial evidence that it will have a negative impact on innovation, venture funding, small businesses, universities, or independent inventors.

3. The USPTO should reevaluate the economic impacts of prior user rights as part of its 2015 report to Congress on the implementation of the AIA, when better evidence as to these impacts might be available.

4. United States patent law should provide for a prior user rights defense as an appropriate balance between trade secret protection and patent law, which legally co-exist to provide competitive advantages for United States businesses.

5. United States patent law should provide for a prior user rights defense to patent infringement in order to address a systemic inequity inherent in a first-inventor-to-file system and to ensure United States businesses are (i) able to protect their investments in the event of a later issued patent, and (ii) placed on similar footing as competitors in other jurisdictions.

The Report, in Section III, contains a detailed comparison of the prior user rights defense in Japan, Canada, Australia, and countries in the European Union (Denmark, France, Germany, and the UK), as well as Korea, Brazil, Mexico, China, and Russia.  The results are contained in an informative table comparing these rights across these different countries:

The Report was based on testimony at an October 25, 2011 hearing and written comments; testimony was provided by Gary Griswold (on his own behalf; Mr. Griswold is a long time supporter of these provisions, see, Gary L. Griswold & F. Andrew Ubel, Prior User Right—A Necessary Part of a First-to-File System, 26 J. MARSHALL L. REV. 567, 572 (1993)); Alan Kasper (from the American Intellectual Property Law Association); Thomas Kurkowski (on his own behalf); Dan Lang (Cisco) and MaCharri Vorndran-Jones (American Bar Association-IP Group).  In addition, Intellectual Property Organizations (including the AIPLA, ABA-IP Group, Coalition for Patent Fairness, Computer and Communications Industry Association, Institute of Patent and Trade Mark Attorneys of Australia, International Federation of Intellectual Property Attorneys (FICPI), Japan Intellectual Property Association Innovation Alliance, Japan Patent Attorneys Association, and New Zealand Institute of Patent Attorneys), Academic and Research Institutions (including the Wisconsin Alumni Research Foundation, Berkeley Center for Law and Technology and Greentech Industries, Regents of University of California Board and Higher Education Associations); companies (including Belz Consulting, Cisco, Google and Verizon (Joint Comments), Hospira, Inc., Lex Machina, Microsoft Corp., Space Exploration Technologies Corp., and Telstra Corporation) and individuals (including Stephan Freischem, Asamichi Kato, Thomas E. Kelley, Thomas Kowalski, Paul Morgan, Tony Tether, and Neil Thomas) provided written comments.  Conspicuously absent from this list are biotechnology or innovative pharmaceutical companies.

While comprehensive, some of the language of the Report seems to bear little logical relationship to the Findings and Recommendations.  For example, regarding the impact on the PURD on "innovation, start-up enterprises, small businesses, individual inventors and universities," the Report notes that "[t]he extent of benefits and harm flowing from the availability in the U.S. of a prior user rights defense is, in the end, an empirical question best answered by comprehensive data on the true impacts revealed over time" and that "[u]nfortunately, formal statistical study of prior user rights has been extremely limited, largely because the full effect of this type of policy change is inherently difficult to measure."  In view of these circumstances, and despite the admittedly limited experience with the assertion of the PURD both under 35 U.S.C. § 273 and in foreign jurisdictions, the Report finds (Finding 3) that "[t]here is no substantial evidence that prior user rights as established in the AIA will have a negative impact on innovation."  Of course, there is just as clearly no substantial evidence that prior user rights as established in the AIA will not have a negative impact on innovation, making the nature of the finding a political, rather than a factual, statement.

Similarly, while acknowledging the mixed nature of the written comments and testimony ("the potential for secret uses in a market would make it more difficult for investors to estimate markets and value invention, thereby depressing the attractiveness of a later patenting start-up to venture-capital funding" versus "without the prior user rights defense, the company which lost the 'race to the USPTO' in a first-to-file environment would lose all investment returns for that project") and the lack of any empirical evidence ("[a] search of the existing economic literature yielded no empirical study of the impact of prior user rights within the U.S. venture-capital investment context"), the Report concludes that "[t]he best available evidence shows, however, that the U.S. venture-capital investment environment has grown and thrived in a context of uncertainty over property rights in innovation, especially as regards patents and trade secrets" and "if prior user rights are likely to be rarely exercised in the U.S. (as is suggested by the European experience), then it is reasonable to conclude that 'switching' from patent to trade secret protection as a result of the availability of this defense may be limited in nature."  Thus, Finding 4 states that "[t]here is no substantial evidence that prior user rights as established in the AIA will have a disproportionately negative impact on venture-capital investments to small businesses and start-ups" and on equally absent evidence, Finding 5 states that "[t]here is an insufficient basis to recommend a change to the scheme chosen by Congress with respect to the application of prior user rights to universities," a finding that at least properly recognizes the "first make no recommendation for change" attitude adopted by the Office in the Report.  Throughout the Report, the Office concedes that there is no evidence one way or the other on an issue (such as whether the PURD will harm innovation), or on the other hand postulates scenarios where patenting would not be important to an innovator (without much supporting evidence of the likelihood of such scenarios), and concludes that the absence of evidence supports the conclusion that no changes are necessary in the statutory scheme.

The question of constitutionality of the PURD provisions is answered almost entirely by citation of Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470 (1974), which held that the existence of patent and trade secret protection was not contradictory or incompatible with one another.  (Interestingly, the Report notes that the Court's conclusion was based on the idea that "the ideas protected by trade secrets will likely be discovered by others in a similar time frame," wherein the Court stated that "[n]or does society face much risk that scientific or technological progress will be impeded by the rare inventor with a patentable invention who chooses trade secret protection over patent protection [because] if a particular person had not made a discovery others would have, and in probably a relatively short period of time."  The basis for the Court's thinking is this regard is unexplained.)

The Report also states that the PURD existed between 1839 and 1952, citing (anomalously) Eldred v. Ashcroft, 537 U.S. 186, 199-205 (2002), in support of this proposition.  Specifically, the Report cites Act of 1839, ch. 88, § 7, 5 Stat. 353, 354 (repealed 1952), "[t]hat every person or corporation who has, or shall have purchased or constructed any newly-invented machine, manufacture, or composition of matter, prior to the application by the inventor or discoverer of a patent, shall be held to possess the right to use and vend to others to be used, the specific machine, manufacture, or composition of matter, so made or purchased, without liability therefore to the inventor, or any other person interested in such invention; and no patent shall be held invalid by reason of such purchase, sale, or use prior to the application for a patent as aforesaid, except on proof of abandonment of such invention to the public, or that such purchase, sale, or prior use has been for more than two years prior to such application for a patent" and McClurg v. Kingsland, 42 U.S. 202, 208-09 (1843), wherein the Court held that "[t]he object of this provision is evidently twofold; first, to protect the person who has used the thing patented, by having purchased, constructed, or made the machine, etc., to which the invention is applied, from any liability to the patentee or his assignee.  Second, to protect the rights, granted to the patentee, against any infringement by any other persons.  . . .  [I]t puts the person who has had such prior use on the same footing as if he had a special license from the inventor to use his invention; which, if given before the application for a patent, would justify the continued use after it issued without liability."  Of course, each example is clearly directed to continued use of a "newly-invented machine, manufacture, or composition of matter" prior to the patenting thereof, and not the continued practice of methods, including methods for producing the patented machine, manufacture, or composition of matter.  While patent law and trade secret law may be compatible, the citations do not support the contention that U.S. patent law ever contained a PURD of the type embodied in the AIA.

The "real" reason behind the PURD may be contained in one paragraph of the Report:

A related issue is the consequence that, by filing a patent application, the technology is disclosed to competitors in other countries where the innovator may not, for lack of resources, have sought patent protection, or where patents are difficult to enforce.  Several comments pointed out that this can have drastic effects on American businesses and jobs.  A representative from a small United States company commented that the company's use of trade secret protection enables it to provide services at a price level that its Chinese competitors admitted they cannot match.  Several representatives of "green" technology companies based in the United States noted that disclosure of new technologies via a patent application would allow foreign competitors to copy the innovation, using cheaper labor and with the assistance of foreign government subsidies, to undercut their businesses, at the expense of "creating much-needed jobs for American workers."

While these sentiments are powerful incentives for establishing the PURD, and it is understandable that the Office would want to fulfill the statutory mandate, presumably Congress wanted something more than a rubberstamp.  If in the exercise of its "special expertise" the Office was unable to find evidence supporting the PURD (or not), it seems that this is the conclusion:  it is too early to tell, not that "all is well" in the absence of any evidence.  While the Report's conclusions may reflect political realities, they serve Congressional purposes only facially and do not provide any basis for deciding whether the PURD will support or inhibit innovation.  The public (and those members of the public whose representatives are not satisfied with the rhetoric of job creation that swept the bill through this Congress after several years of failure to enact "patent reform") are not well served by such facile conclusions.  Perhaps we will all have to wait to assess whether the PURD has these predicted beneficial effects or inhibits innovation to our detriment.  But it should not be too much to ask that policymakers face that fact and simply say so.

USPTO Proposes Rules Changes for Implementing AIA Provisions -- Statute of Limitations Provisions for Office Disciplinary Proceedings

By Donald Zuhn --

Earlier this month, the U.S. Patent and Trademark Office published four Federal Register notices as part of its efforts to implement the Leahy-Smith America Invents Act.  Last week, we discussed the Office's notice regarding implementation of the AIA's miscellaneous post patent provisions and preissuance submissions provision (see links below).  Today, we address the Office's notice regarding "Implementation of Statute of Limitations Provisions for Office Disciplinary Proceedings" (77 Fed. Reg. 457).

Section 32 of Title 35, which concerns the suspension or exclusion from practice, reads as follows

The Director may, after notice and opportunity for a hearing, suspend or exclude, either generally or in any particular case, from further practice before the Patent and Trademark Office, any person, agent, or attorney shown to be incompetent or disreputable, or guilty of gross misconduct, or who does not comply with the regulations established under section 2(b)(2)(D) of this title, or who shall, by word, circular, letter, or advertising, with intent to defraud in any manner, deceive, mislead, or threaten any applicant or prospective applicant, or other person having immediate or prospective business before the Office.  The reasons for any such suspension or exclusion shall be duly recorded.  The Director shall have the discretion to designate any attorney who is an officer or employee of the United States Patent and Trademark Office to conduct the hearing required by this section.  The United States District Court for the District of Columbia, under such conditions and upon such proceedings as it by its rules determines, may review the action of the Director upon the petition of the person so refused recognition or so suspended or excluded.

Section 2(b)(2)(D) permits the Office to require "agents, attorneys, or other persons representing applicants or other parties before the Office,  . . . to show that they are of good moral character and reputation and are possessed of the necessary qualifications to render to applicants or other persons valuable service, advice, and assistance in the presentation or prosecution of their applications or other business before the Office."

Section 3(k) of the AIA amends § 32 by adding the following sentence before the last sentence:

A proceeding under this section shall be commenced not later than the earlier of either the date that is 10 years after the date on which the misconduct forming the basis for the proceeding occurred, or 1 year after the date on which the misconduct forming the basis for the proceeding is made known to an officer or employee of the Office as prescribed in the regulations established under section 2(b)(2)(D).

Prior to the AIA's amendment of § 32, disciplinary actions for violations of the USPTO Code of Professional Responsibility were generally understood to be subject to a five-year statute of limitations pursuant to 28 U.S.C. § 2462.  The Office notes that with passage of the AIA, "Congress provided the Office with five additional years to bring an action, thus ensuring that the Office had additional flexibility to initiate 'a [disciplinary] proceeding for the vast bulk of misconduct that is discovered, while also staying within the limits of what attorneys can reasonably be expected to remember'" (quoting the Congressional Record S1372–1373 (daily ed. March 8, 2011) (statement of Sen. Kyl)).  The Office also notes that "[t]he one-year limitation period in the AIA reflects that disciplinary actions should be filed in a timely manner from the date when misconduct forming the basis of a disciplinary complaint against a practitioner is made known to 'that section of PTO charged with conducting section 32 proceedings.'"

The Office's Federal Register notice implementing the statute of limitations provisions set forth in AIA § 3(k) specifies the date on which the one-year statute of limitations period begins for the three types of disciplinary complaints:

1.  Complaints predicated on the receipt of a probable cause determination from the Committee on Discipline -- the one-year period begins on the date on which the Director for the Office of Enrollment and Discipline (OED Director) receives a complete, written response to a request for information and evidence from the practitioner.

2.  Complaints seeking reciprocal discipline -- the one-year period begins on the date on which the OED Director receives a certified copy of the record or order regarding the practitioner being publicly censured, publicly reprimanded, subjected to probation, disbarred, suspended, or disciplinarily disqualified.

3.  Complaints seeking interim suspension based on a serious crime conviction -- the one-year period begins on the date on which the OED Director receives a certified copy of the record, docket entry, or judgment demonstrating that the practitioner has been convicted of a serious crime.

Additional discussion of the rules changes, as well as revised versions of the affected rules, can be found in the Office's Federal Register notice (77 Fed. Reg. 457).

Comments regarding this notice can be submitted by e-mail to OED_SOL@uspto.gov; by regular mail addressed to:  Mail Stop OED -- Ethics Rules, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, Virginia 22313–1450, marked to the attention of William R. Covey, Deputy General Counsel for Enrollment and Discipline and Director of the Office of Enrollment and Discipline; or via the Federal eRulemaking Portal.  The deadline for submitting comments is March 5, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 457).

For information regarding the Office's implementation of other AIA provisions, please see:

• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Preissuance Submissions Provision," January 12, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Miscellaneous Post Patent Provisions," January 11, 2012

USPTO Proposes Rules Changes for Implementing AIA Provisions -- Preissuance Submissions Provision

By Donald Zuhn --

Last week, the U.S. Patent and Trademark Office published four Federal Register notices as part of its efforts to implement the Leahy-Smith America Invents Act.  Yesterday, we discussed the Office's notice regarding implementation of miscellaneous post patent provisions in the AIA (see "USPTO Proposes Rules Changes for Implementing AIA Provisions -- Miscellaneous Post Patent Provisions").  Today, we address the Office's notice regarding implementation of the AIA's preissuance submissions provision ("Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act," 77 Fed. Reg. 448).

 Section 8 of the AIA amends 35 U.S.C. 122 by adding 35 U.S.C. 122(e), which lists certain conditions that apply to a third-party preissuance submission to the Office in a patent application.  In particular, AIA § 8 permits any third party to submit for the Office's consideration and inclusion in an application's file "any patent, published patent application, or other printed publication of potential relevance to the examination of the application," provided that the submission is made:

before the earlier of --
    (A) the date a notice of allowance under section 151 is given or mailed in the application for patent; or
    (B) the later of --
        (i) 6 months after the date on which the application for patent is first published under section 122 by the Office, or
        (ii) the date of the first rejection under section 132 of any claim by the examiner during the examination of the application for patent.

The submission must also "set forth a concise description of the asserted relevance of each submitted document."  This provision of the AIA takes effect on September 16, 2012, and will apply to any patent application filed before, on, or after that date.

In implementing the preissuance submissions provision of the AIA, the Office notes that such submissions may filed in paper or electronically via the EFS-Web, but that such submissions "would not be automatically entered into the electronic image file wrapper (IFW) for an application," but instead, "would be reviewed to determine compliance with 35 U.S.C. 122(e) and new 37 CFR 1.290 before being entered into the IFW."  The Office also notes that "[n]on-compliant third-party preissuance submissions would not be entered into the IFW of an application or considered and would be discarded," and further, that the Office would not provide a refund of the fee required for making a preissuance submission in the event that the submission was found to be non-compliant.  The notice indicates that the Office "may attempt to notify the third party submitter of such non-compliance," if the submitter has provided an e-mail address, but that the statutory period for making the submission would not be tolled.

The notice states that "third-party submissions will not create a duty on the part of the applicant to independently file the submitted documents with the Office in an information disclosure statement (IDS)."  The notice also states that examiners will "consider the documents and concise descriptions submitted in a compliant third-party preissuance submission in the same manner that the examiner considers information and concise explanations of relevance submitted as part of an IDS."

Noting that 37 C.F.R. § 1.99 currently provides for a third-party submission of up to ten documents for the fee set forth in 37 C.F.R. § 1.17(p), which is currently $180.00, and with the expectation that the processing costs of preissuance submissions under new 37 C.F.R. § 1.290 will be similar, the notice indicates that the fee set forth in 37 C.F.R. § 1.17(p) will also be applicable to third-party preissuance submissions of no more than ten documents.  The fee will be waived for a preissuance submission that "lists three or fewer total documents and is the first preissuance submission submitted in an application by a third party or a party in privity with the third party."  Besides noting that 35 U.S.C. 122(e) will be implemented as new rule 37 C.F.R. § 1.290, the notice also indicates that current § 1.99 will be eliminated.  (The notice also indicates that the public use proceeding provisions of 37 C.F.R. § 1.292 will be eliminated because AIA § 6 makes available a post-grant review proceeding in which prior public use may be raised.)

Additional discussion of the rules changes, as well as revised versions of the affected rules, can be found in the Office's Federal Register notice (77 Fed. Reg. 448).

Comments regarding this notice can be submitted by e-mail to preissuance_submissions@uspto.gov; by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Nicole D. Haines, Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy.; or via the Federal eRulemaking Portal [http://www.regulations.gov/#!home].  The deadline for submitting comments is March 5, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 448).

USPTO Proposes Rules Changes for Implementing AIA Provisions -- Miscellaneous Post Patent Provisions

By Donald Zuhn --

Last fall, the U.S. Patent and Trademark Office announced that it would be releasing a number of a Federal Register notices in January as part of the Office's efforts to implement the Leahy-Smith America Invents Act (see "USPTO News Briefs").  On Friday, the Office issued a press release noting that four notices of proposed rulemaking regarding implementation of various provisions of the AIA had been published in the Federal Register on January 5.  These four notices concern:

• Changes To Implement Miscellaneous Post Patent Provisions of the Leahy-Smith America Invents Act (77 Fed. Reg. 442);
• Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act (77 Fed. Reg. 448);
• Implementation of Statute of Limitations Provisions for Office Disciplinary Proceedings (77 Fed. Reg. 457); and
• Changes To Implement the Inventor’s Oath or Declaration Provisions of the Leahy-Smith America Invents Act (77 Fed. Reg. 982).

The Office noted that the publication of the proposed rules commenced a 60-day period for public comment.  The Office also noted that proposed rules on supplemental examination, inter partes review, post-grant review, the transitional program for covered business methods, and derivation would be published later this month.

Patent Docs will discuss each of the four notices published last week, beginning with the notice to implement miscellaneous post patent provisions of the AIA.  Subsequent posts will address the other notices.

In the notice entitled "Changes To Implement Miscellaneous Post Patent Provisions of the Leahy-Smith America Invents Act," the Office notes that AIA provisions result in the following changes to Title 35:

• AIA § 6(g) amends 35 U.S.C. § 301 to expand the information that can be submitted in the file of an issued patent to include written statements made by a patent owner before a Federal court or the Office regarding the scope of any claim of the patent;
• AIA § 6(a) and (d) contain provisions in new 35 U.S.C. §§ 315(e)(1) and 325(e)(1) that estop a third party requester from filing a request for ex parte reexamination where the third party requester filed a petition for inter partes review or post grant review and a final written decision under 35 U.S.C. §§ 318(a) or 328(a) has been issued;
• AIA § 6(h)(1) amends 35 U.S.C. § 303 to expressly identify the authority of the Director to initiate reexamination based on patents and publications cited in a prior reexamination request under 35 U.S.C. § 302;
• AIA § 3(i) replaces interference proceedings with derivation proceedings;
• AIA § 3(j) replaces the "Board of Patent Appeals and Interferences" with the "Patent Trial and Appeal Board" in 35 U.S.C. §§ 134, 145, 146, 154, and 305;
• AIA § 6(a) replaces inter partes reexamination with inter partes review of a patent;
• AIA § 6(d) provides for post-grant review of patents; and
• AIA § 7 amends 35 U.S.C. § 6(b) to define the duties of the Patent Trial and Appeal Board.

To implement these changes, the Office proposes a number of rules changes, including the following:

• Rule 1.501 -- rewritten to allow for the submission of "statements of the patent owner filed in a proceeding before a Federal court or the Office in which the patent owner took a position on the scope of any claim of a particular patent";
• Rule 1.501(f) -- limits the use of statements of the patent owner and accompanying information for determining the proper meaning of a patent claim in an ex parte reexamination proceeding that has been ordered pursuant to 35 U.S.C. § 304, an inter partes review proceeding that has been instituted pursuant to 35 U.S.C. § 314, or a post grant review proceeding that has been instituted pursuant to 35 U.S.C. § 324;
• Rule 1.510(b)(6) -- requires a certification that the estoppel provisions of inter partes review and post grant review do not bar the third party from requesting ex parte reexamination, as well as a statement identifying the real parties in interest to allow for a determine as to whether an inter partes review or post grant review filed subsequent to an ex parte reexamination bars the third party from maintaining a pending ex parte reexamination (the requester can remain anonymous by providing the identification and requesting that the Office seal it);
• A number of rules would be rewritten to replace "Board of Patent Appeals and Interferences" with "Patent Trial and Appeal Board," add specific references to trial proceedings before the Patent Trial and Appeal Board, and add specific references to derivation proceedings.

Additional discussion of the rules changes, as well as revised versions of the affected rules, can be found in the Office's Federal Register notice (77 Fed. Reg. 442).

Comments regarding this notice can be submitted by e-mail to post_patent_provisions@uspto.gov; by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Kenneth M. Schor, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.  The deadline for submitting comments is March 5, 2012.  Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 442).

USPTO Proposes Change to PTA Provisions Regarding Appellate Review

By Donald Zuhn --

On December 28, the U.S. Patent and Trademark Office issued a notice of proposed rule making regarding certain patent term adjustment (PTA) provisions in the Federal Register (76 Fed. Reg. 81432).  In particular, the Office has proposed that the period of adjustment for applications involved in appellate review begin when jurisdiction over the application passes to the Board rather than the date on which a notice of appeal to the Board is filed.  According to the notice, jurisdiction of an appeal passes to the Board at the earlier of the filing of the reply brief or upon the expiration of the time in which to file a reply brief.  While the Office acknowledges that "the impact of the rule change would be to reduce the amount of patent term adjustment awarded for successful appeal under 35 USC 154(b)(1)(C)(iii)," the Office also notes that in certain circumstances, "the impact may be offset by potentially increasing the amount of patent term adjustment awarded for failing to issue the patent within three years of the actual filing date in the United States under 35 USC 154(b)(1)(B)."  The notice explains that one such situation could be where the examiner reopens prosecution after a notice of appeal has been filed and the patent issues thereafter.

According to the notice, the proposed rule making is based on comments the Office received in response to a Federal Register notice the Office published in April 2011 (see "USPTO Proposes Changes to PTA and PTE Provisions").  In particular, the Office noted that several comments suggested that the appellate review period should be treated as beginning when jurisdiction passes to the BPAI, rather than on the date a notice of appeal to the BPAI was filed, so that applicants could obtain patent term adjustment under 35 U.S.C. 154(b)(1)(B) (i.e., delay arising from the USPTO's failure to issue a patent within three years of an application's actual filing date).  Currently, "B" delay does not include the period of appellate review by the BPAI or a Federal court, and the period of appellate review begins with the filing of a notice of appeal.  The Office's notice provides a detailed explanation as to how the Office arrived at the new interpretation of the start of the appellate review period (see page 81434).

Comments regarding the proposed change should be sent e-mail to AC63.comments@uspto.gov; by regular mail to Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Kery A. Fries, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.  The deadline for submitting comments is January 27, 2012.

Top Stories of 2011: #12 to #10

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its fifth annual list of top biotech/pharma patent stories.  For 2011, we identified a dozen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  Today, we count down stories #12 to #10, and then throughout the week, we will work our way towards the top three stories of 2011.  As with our other lists (2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

12.  Europe Seeks Unified Patent System

In February, the European Parliament approved a request to use "enhanced cooperation" to launch a reform of the European patent system.  At the time, it seemed to be the last major hurdle to reaching agreement on a unified patent system and court in Europe.  By April, this view appeared to have been too optimistic, as the European Court of Justice ruled that a separate European patent court would violate EU law by taking powers away from courts in EU countries.  Despite the adverse ruling on a unified patent court, the European Commission moved ahead with its plans to create a unified EU patent.

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

• "European Patent Reform Suffers Another Setback," April 27, 2011
• "European Parliament Approves Enhanced Cooperation Procedure to Create Unified EP Patent System," March 1, 2011

11.  FDA Drug Approvals at Decade High (Almost)

Trying to counter some of its critics, the U.S. Food and Drug Administration announced in November that the agency approved 35 new drugs in FY 2011, which, with the exception of 2009 when 37 new drugs were approved, constituted the most approvals in the past decade.  Criticism of the FDA has centered around the agency's tougher safety standards, which some argue have slowed down the pace of drug approvals and have hurt the drug industry.  Despite the increase in drug approvals, a Health Affairs paper (published in November 2010, but discussed here in January 2011) contends that extending "data exclusivity" for conventional "small molecule" drugs from the present 5 years under the Hatch-Waxman Act to 12 years (the term given biologic drugs under the Affordable Care Act of 2010) would provide a net benefit in new drugs and increased longevity.

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

• "FDA Approves 35 New Drugs in FY 2011," November 20, 2011
• "FDA Drug Approvals for 2011 on Pace to Surpass 2010 Despite New Safety Standards," July 13, 2011
• "Authorized Generics Again under Fire in Senate Bill," February 23, 2011
• "Academic Study Supports Longer Data Exclusivity Term for Conventional Drugs," January 17, 2011

10.  Deficit Debate Delays USPTO Plans

During the first few months of the year, the U.S. Patent and Trademark Office announced a number of new initiatives aimed at decreasing application pendency and increasing examination quality.  However, by April the USPTO announced that the programs, including both Track I examination and the Detroit satellite office, were being put on hold due to budgetary constraints following enactment of the budget for FY 2011 on April 15.  The good news is that several of the initiatives that were delayed last spring were part of the Leahy-Smith America Invents Act (a story for another day).  Of course, securing appropriate funding to implement the new programs will be an entirely different matter (despite Congress' promises to the contrary).  Despite the ups and downs of 2011, the USPTO was able to close the year on a good note when it announced that the number of unexamined patent applications had been reduced to 669,625, which constituted a five-year low.

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

• "U.S. Application Backlog Falls to Five-Year Low," October 24, 2011
• "USPTO Publishes Notice Regarding Prioritized (Track I) Examination Delay," May 1, 2011
• "USPTO News Briefs," April 27, 2011
• "USPTO Satellite Offices on Hold," April 25, 2011
• "USPTO News Briefs," April 21, 2011
• "USPTO to Launch Prioritized Examination on May 4th," April 10, 2011
• "USPTO Provides More Details Regarding "Three Track" Examination Proposal," February 7, 2011

USPTO News Briefs

By Donald Zuhn --

USPTO Declines to Extend Patent Application Backlog Reduction Stimulus Plan

In a Federal Register notice published earlier this month (76 Fed. Reg. 77979), the U.S. Patent and Trademark Office announced that it had decided not to extend the Patent Application Backlog Reduction Stimulus Plan, which was implemented in November 2009 (see "USPTO Implements Patent Application Backlog Reduction Stimulus Plan").  Under the plan, an applicant would be able to have an application accorded special status for examination after expressly abandoning another copending unexamined application.  In explaining its decision not to extend the program, the Office stated that the "plan has fulfilled its purpose."  While the notice provided no data on the number of applications that were abandoned under the program, the Office stated that "[f]ilings under this plan reached a peak in late 2010 and have since steadily decreased."

USPTO Begins Delivery of Search Results to EPO

On Thursday, the U.S. Patent and Trademark Office announced that it had begun providing the European Patent Office with search results for all publicly available U.S. patent applications.  According to the USPTO, the delivery of search results is intended to assist applicants filing in the EPO to comply with amended Rule 141(1) of the EPO’s implementing regulations to the European Patent Convention (EPC).  The amended rule, which took effect on January 1, 2011 and applies to all European patent applications filed after that date, requires applicants to file a copy of search results from a patent application to which the European patent application claims priority.  The Office noted that it would also deliver search results for unpublished U.S. patent applications to the EPO provided that the U.S. patent application has cleared national security review and the applicant has submitted Form PTO/SB/69 (note: practitioners who attempt to access this form directly from the USPTO Forms page will find that the link for this form is broken; the link above, however, functions properly).  The USPTO has not instituted a fee for delivery of search results to the EPO.

USPTO Adds Two New ePetitions

Last week, the U.S. Patent and Trademark Office announced in a Patents Alert e-mail that beta versions of two new ePetitions had been made available via the EFS-Web.  The new ePetitions are a Petition for Revival of an Abandoned Patent Application Abandoned Unintentionally (37 CFR 1.137(b)) (For Cases Abandoned After 1st Action and Prior to Notice of Allowance) and a Petition to Correct Assignee After Payment of Issue Fee (37 CFR 3.81(b)).  The new additions bring the total of ePetitions to ten.  For more information regarding ePetitions, practitioners should consult the Office's ePetitions Resource Page.

USPTO's Extended Missing Parts Pilot Program Is Extended

By Donald Zuhn --

In a Federal Register notice published last week (76 Fed. Reg. 78246), the U.S. Patent and Trademark Office announced that the Extended Missing Parts Pilot Program that was implemented last year will be extended for another year.  The pilot program "effectively provides a 12-month extension to the existing 12-month provisional application period, providing applicants additional time to find financial help, evaluate a product's worth in the marketplace or further develop the invention for commercialization."  In particular, the pilot program modifies the Office's current missing parts practice -- which permits an applicant to pay the filing fees and submit an executed oath or declaration after the filing of a nonprovisional application within a two-month time period that is extendable for an additional five months on payment of extension of time fees -- such that applicants can file a nonprovisional application with at least one claim within the 12-month statutory period after the provisional application has been filed (as well as pay the basic filing fee, submit an executed oath or declaration, and not file a nonpublication request) and then be given a 12-month period within which to decide whether the nonprovisional application should be completed by paying the required surcharge and the search, examination, and any excess claim fees.

Applicants wishing to participate in the pilot program must file a nonprovisional application within twelve months of the filing date of a provisional application, directly claim the benefit of the provisional application, and submit a certification and request to participate in the program with the nonprovisional application.  In the Office's notice regarding the extension of the pilot program, the Office:

[C]autions all applicants that, in order to claim the benefit of a prior provisional application, the statute requires a nonprovisional application filed under 35 U.S.C. 111(a) to be filed within twelve months after the date on which the corresponding provisional application was filed.  See 35 U.S.C. 119(e).  It is essential that applicants understand that the Extended Missing Parts Pilot Program cannot and does not change this statutory requirement.

The pilot program is not without its drawbacks; for example, the form for requesting participation in the program (PTO/SB/421) outlines the PTA effects of participation in the program, stating that:

Any patent term adjustment (PTA) accrued by applicant based on certain administrative delays by the USPTO is offset by a reduction for failing to reply to a notice by the USPTO within three months.  See 37 CFR 1.704(b).  Thus, if applicant replies to a notice to file missing parts more than three months after the mailing date of the notice, the additional time that applicant takes to reply to the notice will be treated as an offset to any positive PTA accrued by the applicant.

In addition, under the pilot program, nonprovisional applications are still published according to the existing eighteen-month publication provisions.  Most importantly, the Office has advised applicants that:

[T]he extended missing parts period does not affect the twelve-month priority period provided by the Paris Convention for the Protection of Industrial Property.  Thus, any foreign filings must still be made within twelve months of the filing date of the provisional application if applicant wishes to rely on the provisional application in the foreign-filed application or if protection is desired in a country requiring filing within twelve months of the earliest application for which rights are left outstanding in order to be entitled to priority.

Where an applicant participating in the program fails to pay the basic filing fee, provide an executed oath or declaration, or submit application papers that are in condition for publication -- i.e., comply with the requirements for participation in the program (which are essentially the requirements for publication of the application) -- the applicant is given a two-month (extendable) time period within which to supply those items.  In the notice regarding the extension of the pilot program, the Office notes that applications that are not filed electronically will still be assessed a $400 additional fee (or $200 for small entities) pursuant to the Leahy-Smith America Invents Act, that this fee will be due within the two-month (extendable) time period to reply to the Notice to File Missing Parts of Nonprovisional Application, and that applicants will not be given the 12-month time period under the pilot program to pay this fee.

The pilot program has been extended until December 31, 2012.

For additional information regarding the pilot program, please see:

• "USPTO Implements Pilot Program Extending Provisional Application Period," December 13, 2010
• "USPTO Seeks to Effectively Double Provisional Application Period," April 4, 2010

USPTO News Briefs

By Donald Zuhn --

USPTO Updates "Track I" Program

On Monday, the U.S. Patent and Trademark Office announced that it had issued a final rule, changing the Track I prioritized examination program.  Under the new rule, applicants can request prioritized examination for "any patent application in which a proper request for continued examination (RCE) has been filed before, on, or after December 19, 2011."  Additional information regarding the change was provided in a notice published Monday in the Federal Register (76 Fed. Reg. 78566).  After postponing the launch of the Track I program due to funding limitations, the Track I program was finally implemented on September 26 as part of the Leahy-Smith America Invents Act (see "USPTO Implements Prioritized Examination Track under AIA").

USPTO and Rospatent Announce PCT Agreement

On Monday, the U.S. Patent and Trademark Office announced the implementation of an agreement with the Russian Federal Service for Intellectual Property (Rospatent), in which Rospatent will act as an available International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) for international applications filed with the USPTO as the Receiving Office.  The agreement will take effect on January 10, 2012.  According to the Office's notice on the agreement, "[t]he addition of Rospatent as an available ISA/IPEA choice will allow applicants additional flexibility in choosing a given international authority based on the technology disclosed in the international application, speed of services provided and cost of obtaining searches and examinations of international applications."

Applicants selecting Rospatent as the ISA will pay a search fee of $415, as compared with $2,080 for searches conducted by the USPTO.  Applicants selecting Rospatent as the IPEA will pay an international preliminary examination fee of RUB 5400 ($169.41 at the current exchange rate) and a handling fee of $219 when Rospatent was the ISA, as compared with $600 for an examination conducted by the USPTO when the USPTO was the ISA.  For examinations conducted by Rospatent where it was not the ISA, the examination fee will RUB 8100 ($254.11 at the current exchange rate), as compared with $750 for an examination conducted by the USPTO when the USPTO was not the ISA.

USPTO Director Davis Kappos noted that "[t]he collaboration between the USPTO and Rospatent will be beneficial for US applicants as it will provide additional choices at a lower cost."

USPTO and IPO Establish PPH Pilot Program

Last month, the U.S. Patent and Trademark Office announced the establishment of a new Patent Prosecution Highway (PPH) pilot program with the Icelandic Patent Office (IPO).  As with other PPH programs, the USPTO-IPO PPH will permit an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from either the USPTO or IPO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office.

The USPTO-IPO PPH pilot program, which began on December 1, 2011, is scheduled to expire on November 30, 2012, but may be extended for up to one year or terminated earlier depending on volume of activity and other factors.  USPTO requirements for participation in the USPTO-IPO PPH pilot program can be found here, and IPO requirements can be here.

Since implementing its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) on July 3, 2006, the U.S. Patent and Trademark Office has established a total of twenty-two PPH programs with other patent offices.  Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Patent Office (HPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Spanish Patent and Trademark Office (SPTO), the Austrian Patent Office (APO), the Mexican Institute of Industrial Property (IMPI), the Swedish Patent and Registration Office (PRV), Nordic Patent Institute (NPI), and the Israel Patent Office (ILPO), the Taiwan Intellectual Property Office (TIPO), the Norwegian Industrial Property Office (NIPO), China's State Intellectual Property Office (SIPO), and the Icelandic Patent Office (IPO).

In other PPH news, the USPTO issued a follow-up notice regarding its launch of new Paris Convention ("Paris Route") and Patent Cooperation Treaty (PCT) Patent Prosecution Highway (PPH) pilot programs with China’s State Intellectual Property Office (SIPO) (see "USPTO News Briefs," November 17, 2011).

USPTO Launches New Website Design

The U.S. Patent and Trademark Office launched a new home page design today.  According to a notice regarding the new design, the redesigned website "better presents the activities and services of the USPTO to the public, and is more accessible to [the agency's] user community."  The Office noted that the old design, which was launched in June 2009 (see "USPTO Issues Beta Release of New Website"), was criticized as being "too text heavy," and the new site places a greater reliance on graphic cues to help visitors find what they’re looking for.  To help users transition to the new site, the old home page will be available until February 29, 2012.  The Office is also accepting comments regarding the website at newhomepage@uspto.gov.