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  • Conference & CLE Calendar

    Calendar_7
    November 8, 2007 – Trilateral Cooperation: Successes, Opportunities, and Challenges (Intellectual Property Owners Association) – Washington, D.C.

    November 13-15, 2007 – Pharma and Biotech Collaborative Agreements (American Conference Institute) – New York, NY***

    December 3, 2007 – 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice – PTO Day (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

    January 9, 2008 – Patent Claim Construction (Law Seminars International) – San Francisco, CA

    January 30-February 1, 2008 – Pharma/Biotech IP Due Diligence (American Conference Institute) – New York, NY***

    February 15, 2008 – Patent Claim Construction (Law Seminars International) – Chicago, IL

    ***Patent Docs is a media sponsor of this conference or CLE.

  • LSI Patent Claim Construction Workshops

    San Francisco #4 Law Seminars International (LSI) will be holding two one-day workshops on Patent Claim Construction on January 9, 2008 in San Francisco, CA and on February 15, 2008 in Chicago, IL.  The workshops will cover key issues in claim construction, including a case law overview and update, recent developments from the Federal Circuit, litigation strategies, and effective appellate advocacy.  In particular, each workshop will offer presentations on the following topics:

    • Current Federal Circuit Developments in Claim Construction
    • Litigation Strategies from Plaintiff and Defendant Perspectives
    • Adapting to the Changes in the Law: Tips for Successful Claim and Specification Drafting: Implications of Patent Office Rule Changes
    • Views From the Bench
    • In-House Strategies for Addressing the Key Issues in Claim Construction Today: Managing the Prosecution Process for the Most Effective Claim Drafting on a Portfolio-wide Basis
    • Using Graphics to Help Win Claim Construction Disputes
    • Handling Claim Construction on Appeal

    An agenda for the San Francisco workshop can be found here.  A complete brochure for the San Francisco workshop, including an agenda, list of speakers, and registration form can be downloaded here.

    An agenda for the Chicago workshop can be found here.  A complete brochure for the Chicago workshop, including an agenda, list of speakers, and registration form can be downloaded here.

    LSI - Law Seminars International - blue The registration fee for each workshop ranges from $347.50 (students and new employees) to $695 (regular tuition).  Discounts are available for government employees and groups of two or more registrants.  Those interested in registering for the San Francisco workshop can do so here and those interested in registering for the Chicago workshop can do so here.

  • IPO PTO Day

    Washington Monument #1 Last week, we reported that the Intellectual Property Owners Association (IPO) and the U.S. Patent and Trademark Office will be co-sponsoring the 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) on December 3, 2007 in Washington, D.C.  At the time, a program for the conference was not yet available.  The IPO has now released a program for the conference.  The patent portion of the conference will address the following topics (although it will be interesting to see whether some of the scheduled topics will change in view of the recent decision in the consolidated cases of Tafas v. Dudas and SmithKline Beecham Corp. v. Dudas):

    • Introduction and State of Patent Operations
    • Understanding the New Patent Rules on Continuations and Claims
    • Strategies for Operating Under the New Patent Rules on Continuations and Claims
    • USPTO Guidelines for Determining Obviousness in View of the Supreme Court Decision in KSR International Co. v. Teleflex Inc.
    • Federal Circuit Opinions Affecting USPTO Patent Practice: Key Cases of the Past Year
    • Current Intellectual Property Rights Developments (Luncheon Presentation by Commissioner for Patents John Doll)

    Patent-related breakout sessions will address the following topics:

    • Questions and Answers on the Continuations and Claims Rules
    • Practicing Before the Board of Patent Appeals and Interferences
    • Professional Responsibility for Intellectual Property Practitioners

    Ipo_2
    The registration fee for the conference ranges from $200 (government/academic) to $600 (general registration).  Those interested in registering can do so here.  While the program indicates that there will be a live webcast of the conference, the online listing notes that the live webcast has been cancelled.

  • Post-GSK: Where Do We Go from Here? – Annuities

        By Kevin E. Noonan —

    Uspto_seal
    A day after the day of rejoicing for inventors, patent practitioners, examiners, and seemingly all of civilization, fair-minded people will concede that the U.S. Patent and Trademark Office faces a daunting task.  After years of neglect – from Congress raiding the users’ fees, an inadequate number of examiners, technology-driven increases in the number of applications filed, and a "count" system that has not rewarded a style of examination that encourages prosecution to a definitive end point – the Office is facing a massive backlog of applications without sufficient resources to process them in a timely manner.

    If the patent bar is gladdened by District Court Judge Cacheris’ decision enjoining implementation of the new rules – representing an attempt, albeit a misguided one, on the part of the Office to address the pendency and backlog problems – it behooves us to propose alternatives.  Patent Docs will be posting a series of such proposals, and we invite our readers to provide their own ideas.  As they used to say in the days of the counterculture, "if you are not part of the solution, you are part of the problem."  Patent Office management clearly thinks the patent bar is part of the problem; it would be satisfying to prove them wrong.

    Annuities

    To start things off, consider the advantages of requiring an annuity payment to keep an application pending.  This device is used in many countries, particularly in Europe, to encourage applicants to maintain only those applications pending that are considered worth the cost of the annuity.  Adapting this concept to the American patent system would require a few modifications, however.  Small entity applicants would be exempt from the requirement, so as to not put individual inventors, universities, and small businesses at a disadvantage.  Divisional applications would require an annuity based on a schedule starting not at the priority date but on the filing date.  This would be consistent with divisional applications having claims to patentably-distinct inventions, and not the result of strategic decision-making by the applicant that could be manipulated to extend pendency.  What must be avoided is the requirement in Europe that a continuation or divisional application pay the accumulated annuities previously paid in the parent case, which would represent a significant disincentive to serial divisional filing and would exacerbate the backlog problem by encouraging "early" divisional filing.

    An additional advantage of this proposal is that it would increase Patent Office revenues in a way tied directly to applicants who file and maintain multiple related applications.  Since the Patent Office contends that these applicants are responsible for increased pendency and the backlog, the annuity would have these applicants pay for the privilege.  An added benefit would be that over time some of the more controversial assumptions the Patent Office made with regard to the new rules would be put to the test, since it would be expected that if a significant portion of continuation applications represent "gaming the system" or planting potential traps for competitors, adding a cost to the process should shift the cost/benefit analysis in the direction of discouraging unnecessary continuation filings.

  • PLI CLE on GSK v. Dudas Fall-Out

    Practising Law Institute (PLI) #1 Practising Law Institute (PLI) will be offering an audio-only webcast entitled "New USPTO Claims and Continuation Rules Enjoined: What Is the Fall-Out?" on Friday, November 2, 2007 from 1:00-2:00 PM (EST).  Speakers Robert J. Spar, former Director of the Office of Patent Legal Administration of the U.S. Patent and Trademark Office, and John M. White, Director of Patent Professional Development of the Practising Law Institute, will address Wednesday's decision in the consolidated cases of Tafas v. Dudas and SmithKline Beecham Corp. v. Dudas
    .  While the original program schedule called for a discussion of the new continuation and claims rules, the revised program schedule calls for a discussion of the Court's decision and the impact of this decision on patent practice.

    The registration fee for this webcast is $299.  Those interested in registering for the webcast, can do so here.

  • Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)

        By Kevin E. Noonan —

    Glaxosmithkline_gsk
    Judge James C. Cacheris, Senior Judge sitting in the U.S. District
    Court for the Eastern District of Virginia, delivered what is perhaps
    the most significant ruling in U.S. patent law this year (and this
    includes the Supreme Court’s KSR Int’l Co. v. Teleflex, Inc.
    opinion).  He granted GlaxoSmithKline’s (GSK) motion for temporary
    restraining order (TRO) and preliminary injunction (PI) to prevent the
    U.S. Patent and Trademark Office from implementing its new continuation
    and claims rules entitled "Changes to Practice for Continued
    Examination Filings, Patent Applications Containing
    Patentably-indistinct Claims and Examination of Claims in Patent
    Applications; Final Rule" (New Rules).  The New Rules were set to be
    implemented tomorrow, November 1st, and the notice on the Patent Office
    website remained up until well after close of business today (see "USPTO Late to Its Own Party").

    Ikonisys_3
    The New Rules were opposed in separate lawsuits filed by GSK and
    earlier by Triantafyllos Tafas, a sole inventor, and supported by amicus curiae briefs from the American Intellectual Property Lawyers Association (AIPLA) (see "AIPLA Supports GSK’s Lawsuit Against the Patent Office’s New Rules");
    Elan Pharmaceutical Corp.; HEXAS, LLC, The Roskamp Institute, and
    Tikvah Therapeutics, Inc.; the pharmaceutical manufacturer’s trade
    organization (PhRMA); the Biotechnology Industry Organization (BIO); as
    well as a letter from Senator Charles Schumer of New York asking Jon
    Dudas, Undersecretary of Commerce and Director of the Patent and
    Trademark Office, to delay implementation of the New Rules (see "Senator Schumer Sends a Signal").
    GSK’s motion was further supported by declarations from Harry F.
    Manbeck, Jr., Commissioner of Patents during the first Bush
    Administration (see "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules");
    Bert Magen of the Vierra Magen lawfirm; David J. Kappos, Vice President
    and Assistant General Counsel, Intellectual Property Law, IBM (an early
    corporate supporter of the New Rules); Joseph F. Hetz of the Brinks
    Hofer law firm; and Samson Helfgott, a patent attorney formerly
    employed by the General Electric Co.  These declarants and amici were uniformly opposed to the New Rules, a fact that the Court found important in its determination.

    In a thorough and well-reasoned opinion (especially in view of the
    compressed time frame that saw parties filing briefs as late as
    yesterday), the Court made some preliminary findings that formed the
    basis for its decision.  Most important of these is that the Court was
    persuaded, over vigorous albeit contradictory assertions from Patent
    Office counsel, that the Office’s implementing statute, 35 U.S.C. §
    2(b)(2)(A), did not grant the Office substantive rulemaking authority.
    Particularly persuasive for the Court was the evidence, adduced by GSK,
    that Congress had included provisions granting the Office just such
    substantive rulemaking authority in patent "reform" legislation
    introduced in 2005, and included in legislation recently passed by the
    House of Representatives (H.R. 1908) (see "Patent ‘Reform’ Bill Passes House of Representatives").
    Not unreasonably, the Court concluded that Congress would not be trying
    to grant the Patent Office authority it already had.

    The Court also voiced "serious concerns" that the New Rules are contrary to the Patent Act, citing In re Henricksen
    which held that the Patent Office did not have the power to restrict an
    applicant from filing a continuation application under 35 U.S.C. §
    120.  In this regard, the Court was unpersuaded by the Patent Office’s
    reliance on In re Bogese, which dealt with prosecution laches.  The Court cited in particular dicta from the Federal Circuit in Symbol Technologies Inc. v. Lemelson Med. Educ. & Research Found. that prosecution laches should be used sparingly lest it "vitiate" applicant’s rights contained in § 120.

    The Court applied the law of the Federal Circuit in deciding GSK’s
    TRO/PI motion, although it noted in a footnote that 4th Circuit law was
    substantially the same.  The Court applied the familiar test for
    deciding such a motion:

    • The likelihood that GSK would prevail on the merits;
    • Whether GSK would suffer irreparable harm if the New Rules were implemented;
    • The balance of the hardships between the parties; and
    • The public interest.

    With regard to the question of the likelihood that GSK would prevail
    on the merits, the Court found that GSK had demonstrated a likelihood
    of success that:

    • The New Rules exceed the Patent Office’s statutory authority;
    • The New Rules are contrary to the Patent Act;
    • Application of the New Rules to pending applications implicates the
      prohibition on retroactive application of agency regulations; and
    • The standards for submitting an examination support document are impermissively vague.

    The Court found that neither party demonstrated a likelihood of
    success on the questions of whether the limitations of requests for
    continuing examination (RCEs) were contrary to 35 U.S.C. § 132; or that
    the Patent Office was entitled to Chevron deference with regard
    to the claims limitations rules.  The Court also held that the Patent
    Office had demonstrated that promulgation of the New Rules was not
    arbitrary and capricious, mostly on the basis of Patent Office computer
    modeling showing that the New Rules would have an impact on the backlog
    despite the Office’s admission that only 2.7% of pending applications
    (11,000) would be impacted by the New Rules.

    The Court also found that GSK had shown sufficient evidence of
    irreparable harm, despite the Patent Office’s argument that GSK had not
    provided evidence of any particular patent that would be negatively
    affected.  The Court found the harm to be in the uncertainty that the
    New Rules would create, and the negative impact on investment that
    would follow from such uncertainty.

    Uspto_seal_no_background
    On the question of the balance of the harm, the Patent Office
    asserted that it would cost "millions" to reconfigure its computer
    network and to re-train examiners (asserting that the examiner corps
    could not be relied upon to remember its training on the New Rules
    should implementation be delayed).  GSK responded, and the Court
    agreed, that the costs in question were "sunk" costs, already incurred
    for implementing rules the Office knew might not go into effect.  The
    Court found that while the costs and harm to the Patent Office were not
    "nonexistent," the harm to GSK due to "uncertainty and loss of
    investment suffered immediately" by GSK was the deciding factor in
    finding this prong of the test in GSK’s favor.

    Finally, the public interest question pitted the Patent Office’s
    general (and generic) assertion that the public interest was best
    served by a efficient and timely patenting process against not only
    GSK’s assertions, but the evidence from the amici and declarants that a significant portion of the relevant public did not
    believe that its interests would be served by implementation of the New
    Rules.  Patent Office statements regarding the importance of certainty
    in the patenting process were countered by GSK’s assertions of the need
    for investor certainty that a technology-dependent company like GSK
    would be able to protect its technology with patents.  The Court was
    evidently convinced by the argument that such companies relied on the
    current patent system to protect their interests, and that the changes
    proposed by the Office "changes those companies’ calculus and
    immediately decreases their ability to pursue costly new innovations."
    The Court also noted the harm to the public in permitting the New Rules
    to be implemented while the Court was considering GSK’s complaint on
    the merits, in view of the irrevocable decisions some applicants would
    have to make under rules that could be later overturned.

    Despite its statements on likelihoods, the Court did not address the
    merits of the parties’ positions, and so this decision merely (and
    thankfully) preserves the status quo.  Before GSK filed its complaint
    and its case was consolidated with the Tafas action, the Patent Office
    and Dr. Tafas had agreed on an accelerated briefing schedule for
    summary judgment motions in exchange for Dr. Tafas withdrawing his
    request for preliminary injunction.  In view of the Court’s decision
    today, this agreement has been terminated, and the Court asked the
    parties to submit a briefing schedule in the near future.  Accordingly,
    the Court’s determination on the merits of whether and to what extent
    the New Rules will ever be implemented has been delayed indefinitely.
    For most patent prosecutors, however, the important thing is that the
    New Rules will not go into effect tomorrow.

    For additional information on this topic, please see:

  • USPTO Late to Its Own Party

        By Sherri Oslick —

    Trick or treat, USPTO.  An injunction from Eastern District of Virginia for your goodie bag.

    Shortly after 12 noon EDT on Halloween day, October 31, Judge James C. Cacheris granted GSK’s motion for preliminary injunction, enjoining the USPTO from implementing its new rules.  And yet, throughout the entirety of the afternoon, the PTO’s "Reminder: Claims and Continuations Rules Effective Nov. 1" posting remained emblazoned on the front page of the USPTO website.  It took the PTO a full five hours, until shortly after 5 pm EDT, to remove this post from its site.  And it wasn’t until a full hour later, shortly after 6 pm EDT, that the PTO posted a notice regarding the injunction.

    2007aug20finalruleclaimscont
    That makes the USPTO five hours late to its own party.  And in this Patent Docs reporter’s opinion, the PTO’s failure to at least pull its "Reminder" post shortly after grant of the PI is just plain irresponsible.  The new rules represent, shall we say, a "significant" change in patent practice, and the public should have been timely informed of the return to status quo.  It is almost certainly safe to say that many patent practitioners and applicants were anxiously awaiting the results of the PI hearing; those unaware of the patent blog coverage of the hearing were undoubtedly expecting the PTO to make a timely announcement.  Alas, not only did the PTO fail to make an affirmative statement within a reasonable amount of time, they also left inaccurate information on their website for the entire afternoon.  Insert governmental inefficiency joke of your choice here.

    Anyway, for those of you who have not yet seen the PTO announcement, here are the relevant passages:

    On October 31, 2007, the United States District Court for the Eastern District Court of Virginia, however, issued a Preliminary Injunction enjoining the USPTO from implementing the changes in the Claims and Continuations Final Rule.  Therefore, the changes to the rules of practice in the Claims and Continuations Final Rule will not go into effect on November 1, 2007.

    USPTO employees are to continue processing and examining patent applications under the rules and procedures in effect on October 31, 2007, until further notice.

    This Web site will be updated and USPTO employees will be notified with further information as it becomes available.

    For the PTO’s full announcement, see its "Notice Regarding Claims and Continuations Rules."

  • Patent Profile: Nventa Biopharmaceuticals Corp. Announces Grant of U.S. Patent 7,262,014 to HPV-Fusion Technology

        By Christopher P. Singer —

    Nvn_to_logo
    Nventa Biopharmaceuticals Corporation     announced on October 29, 2007 that U.S. Patent 7,262,014, titled "Immune responses against HPV antigens elicited by compositions comprising an HPV antigen and a stress protein or an expression vector capable of expression of these proteins" has been granted by the U.S. Patent and Trademark Office.  The ‘014 patent relates to compositions and methods for inducing or enhancing immune response to human papillomavirus (HPV) with or without adjuvant.  According Nventa’s press release, the patent provides a method for treating a tumor expressing HPV antigen by administering an effective amount of a composition of an HPV antigen fused to a stress protein, and additionally provides exclusivity for HspE7, an investigational therapeutic vaccine.

    The ‘014 patent issued from U.S. Application No. 10/938,695 (filed September 10, 2004) and claims priority through a number of divisional and continuation applications as well as to a provisional application, filed on August 5, 1997.  The patent contains a total of 15 claims relating to methods of treatment.  Representative independent Claims 1 and 3 recite:

    1.  A method of treating a tumor exhibiting an HPV protein antigen, the method comprising administering to a subject having the tumor an effective amount of an expression vector that encodes and is capable of directing expression of a fusion protein comprising the HPV protein antigen fused to a stress protein.

    3.  A method of treating a tumor expressing an HPV protein antigen, the method comprising administering to a subject an effective amount of a composition comprising the HPV protein antigen joined to a stress protein.

  • GSK Secures Injunction

    Us_seal
    Judge James C. Cacheris of the Eastern District of Virginia has issued his Order, Memorandum and Opinion, and Minute entry for proceedings
    following today’s hearing in the consolidated cases of SmithKline Beecham Corp. v. Dudas and Tafas v. Dudas.  Patent Docs will provide additional coverage of the Court’s Order and Opinion later today.

  • Senator Schumer Sends a Signal

        By Kevin E. Noonan —

    Dudas_jon
    As reported earlier today on the PLI Patent Blog, Senator Charles Schumer (D-NY) last Thursday sent a letter
    to U.S. Patent and Trademark Office Director Jon Dudas (at right), asking the Director to delay implementation of the new continuation and claims rules (see 72 Fed. Reg. 46716).

    In his letter, Sen. Schumer (below) cites both the opposition of inventor and other groups, and the pending lawsuit in the Eastern District of Virginia brought by GlaxoSmithKline, as reasons for delaying implementation of the rule.  The Senator’s letter cites the potential for disparate impact of the new rules on different technologies, as well as the potential for unintended consequences 1_4
    including harming American innovation.  The Senator also raises the issue that the costs of filing an Examination Support Document (ESD) could require inventors to make choices between financial resources devoted to additional claims necessary to protect their inventions, and the costs of preparing an ESD.  He also noted that ESD practice could undermine "core principles" of candor in making disclosures to the Patent Office and the public.

    The significance of the Schumer letter is that the Senator is a co-sponsor of the patent "reform" bill languishing (fortunately) in the Senate.  Some have speculated that the Senator’s letter may be merely a signal to the Office that they should wait until the "reform" bill, which contains (in the versions passed by the House of Representatives, H.R. 1908) provisions authorizing the Patent Office to make substantive rules with regard to continuations.  Another possibility is that the Senator (or one of his staffers) listened to constituents like Gene Quinn who have provided the Senator’s office with information regarding the new rules.  And it cannot be forgotten that under Senate rules any Senator can put a "hold" on any measure that, while not binding, will frequently be respected and prevent a bill from coming to a vote.  The Senator’s belated interest in the inadvisability of the new rules just might be a signal that some on Capitol Hill are beginning to understand that the push for "reform" has less to do with a broken patent system than it has to do with the unenlightened self-interest of certain technology sectors looking to stifle competition (you know who you are).  It may behoove readers to send their own signals to their Senators to derail the disaster of "reform" before there is nothing of any value left in the U.S. patent system.