• IPO #2 The Intellectual Property Owners Association (IPO) will be co-sponsoring a conference entitled: "Trilateral Cooperation: Successes, Opportunities, and Challenges" on November 8, 2007 in Washington, D.C.  The conference, which is Uspto_seal_no_background_4
    being held in conjunction with the 25th Annual Meeting of the Trilateral Patent Offices (U.S. Patent and Trademark Office, Japan Patent Office, and European Patent Office), will seek to foster and expand international collaboration and address the challenges associated with increased use of world patent systems.  The conference will cover the following topics:

    • The Business Imperative for Close Trilateral Cooperation in a Global Economy
    • Patent Office Insights on the Trilateral Process . . . Past Successes and Future Challenges
    • Perspectives of Owners and Advocates on Trilateral Cooperation

    Japanese_patent_office_jpo_seal_2
    Conference speakers will include Jon Dudas, Under Secretary of Commerce for IP and Director of the U.S. Patent and Trademark Office; Masahiro Koezuka, Commissioner of the Japan Patent Office; and Alison Brimelow, President of the Epoepc
    European Patent Office.  The program for the conference can be found here.

    The registration fee for the conference is $50.  Those interested in registering can do so here.

  • IPO #2 The Intellectual Property Owners Association (IPO) and 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.  While a program for the conference is not yet available, the IPO has announced that the conference will include several presentations on the new patent continuation and claims rules.

    The registration fee for the conference is $600.  Those interested in registering can do so here.

  •     By Kevin E. Noonan

    Glaxosmithkline_gsk
    Like the most popular kid at a high school dance being the first to take the floor, GlaxoSmithKline’s (GSK) lawsuit against John Dudas and the U.S. Patent and Trademark Office’s new continuation and claims rules entitled "Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably-indistinct Claims and Examination of Claims in Patent Applications; Final Rule" (New Rules), seems to have broken the ice.  The American Intellectual Property Lawyers Association (AIPLA) has filed an amicus curiae brief with the Court hearing GSK’s temporary restraining order and preliminary injunction motion, and it has been joined by some expected and unexpected bedfellows.

    Aipla
    The AIPLA brief focuses on two of the requirements for a preliminary injunction:  irreparable harm and the public interest (the other two are the balance of the hardships between the parties and the likelihood of success on the merits).  In doing so, the brief concentrates on the retroactive application of the rules to applications filed prior to the time the rules were promulgated (and, if the Patent Office’s backlog statistics can be believed, before the rules were even proposed for the majority of pending applications).  AIPLA states the case for the injunction succinctly:  imposition of the rules would affect great hardship on applicants, while the Court’s granting a stay on implementing the new rules "should not adversely impact" the Office.

    The brief sets up the argument with regard to contrasting patent protection and trade secret protection.  Patent applicants, rather than disclosing their inventions to the public attendant on applying for patent protection, had the option of holding their inventions as trade secrets.  The decision-making involved in choosing patent protection over keeping the technology as a trade secret was made in reliance on the rules as they existed when the applications were filed, and applying the new rules retroactively frustrates the legitimate expectations patent applications had in reliance thereupon, according to the brief.  The brief argues that the public interest is served by
    encouraging invention disclosure through patenting, since patent protection is
    given for only limited times and the technology falls into the public domain
    upon patent expiry (and earlier should the patent maintenance fees not be paid).

    The hardships on patent applicants, according to the brief, will be "immediate, widespread and irreparable" should the new rules be permitted to come into effect on November 1st.  This is an important point made in the brief, since the aim is to convince the Judge that the rules should be stayed pending judicial resolution of the allegations of unlawfulness in GSK’s complaint.  The brief asserts that permitting the new rules to come into effect will make it "impossible to return to the status quo . . . important intellectual property rights will be permanently lost."  The brief references case law, treatises, and other reference works to demonstrate that filing patentably-distinct claims for what may be more than a single invention has been both routine and useful for applicants, particularly new business concerns, that are formed to commercialize "emerging technology," a type of technology cited by the Office as intended to benefit from the new rules.  The brief asserts that it is just the applications in these technologies that "almost inevitably" contain more than the 5 independent claims and 25 total claims that are the maxima permitted under the new rules.  Having filed and prosecuted applications under the former rules of practice, implementation of the new rules will, according to the brief, require companies to file a Suggested Restriction Requirement (SRR) document or an Examination Support Document (ESD).  The deficiency of the first option is that the Office is not obliged to grant such requests, and such a failure would cause an applicant to abandon claims to previously-disclosed inventions and lose intellectual property rights as a result.  This is "profoundly unfair" and constitutes a "forfeiture" of rights for inventions disclosed publicly (by publication of an application) and then preclusion from pursuing claims to such invention(s).  ESDs fare no better in the brief’s analysis, citing the risks attendant to filing such a document (including "inadvertent misstatements") and the costs, which even the Office now admits can cost over $13,000 in some instances and not the $2,500 it originally estimated the average cost to be.  The brief makes the interesting point that, by shifting the burden from the Examiner to the applicant, the new rules are "at variance with counsel’s role as ‘an advocate’ for her client."  And the alternatives to filing an ESD or cancelling claims and losing valuable intellectual property rights in the process is rightly termed a Hobson’s Choice in the brief.

    The same can be said, in another portion of the brief, for requiring applicants to make the types of representations regarding patentable-distinctiveness between claims of related, co-pending applications in order to avoid having to cancel claims or entire applications filed under a different regulatory regime.

    A portion of the brief is spent exposing the Office’s proffer of petitioning for additional claims, RCEs, or continuation applications for what it is — a red herring, a sham, and a ruse, because according to the Office’s own words there are so few situations that would constitute an adequate showing to have a petition granted.  Also noted are the costs attendant upon the filing and rearranging of claims in existing applications, as well as the reporting requirements discussed above.  All these efforts are expected to take "extraordinary amounts of time" and "incur unjustifiably excessive costs" in order to comply.

    Magen_burt
    The AIPLA brief is supported by a declaration from Burt Magen (at right), a partner at the Vierra Magen Marcus & DeNiro firm who represents SanDisk; Mr. Magen testifies on behalf of their interests and the effects he expects the new rules to have on his client’s interests.  Not surprisingly, these effects will be bad.  Mr. Magen focuses his testimony on the retroactive application of the rules to pending applications.  He testifies that SanDisk has 235 applications pending for which his firm provides representation in patent prosecution matters and that have not yet received a "first action on the merits" (FAOM).  According to Mr. Magen, there are 142 patent families represented by these 235 applications.  By his calculations, the claims of 174 of the 235 pending applications will need to be combined into 81 patent applications to comply with the rules, requiring SanDisk to abandon 93 of these applications, and another 8 applications where other members of the family have received a FAOM.  Mr. Magen testifies that the cost of abandoning these applications alone amounts to almost $200,000 in wasted filing fees (which, unlike claims fees, are not going to be refunded by the Office).  In addition, adding the claims from these 101 applications will incur an additional cost in excess of $130,000, according to Mr. Magen’s calculations.  Mr. Magen then adds the expected costs of the divisional applications that SanDisk will file as a consequence of restriction of the claims (by the Office, or more likely, consistent with a Suggested Restriction Requirement (SRR) submission), which he estimates to be about $150,000.  The grand total is almost half a million dollars.  Mr. Magen then goes on to testify as to the consequences of the Office not granting SanDisk’s SRR, which will be irrevocable loss of intellectual property rights.

    Anticipating the Office’s counterargument regarding the filing of a petition and showing, or an Examination Support Document (ESD), Mr. Magen testifies that this option is "not only expensive, but also provides statements on the record that can potentially be used by an accused infringer" for both invalidity and inequitable conduct defenses.  With regard to Requests for Continued Examination (RCEs), Mr. Magen testifies that the limitation of only one per patent family disrupts the "normal back-and-forth" with an Examiner that occurs during patent prosecution, and also prevents an applicant from complying with the duty of disclosure under Rule 56 in instances where an applicant files international applications, as Mr. Magen testifies SanDisk does routinely, and receives a search report containing relevant prior art that is not known to the applicant nor received in time to be filed in the ordinary course.  RCE practice permits an applicant to submit such art under the current rules, and this procedural avenue is foreclosed under the new rules.  "This situation will create irreparable harm to SanDisk," according to Mr. Magen.

    Kappos_david
    Perhaps most surprising is the declaration of David J. Kappos (at left), Vice President and Assistant General Counsel, Intellectual Property Law, of IBM.  IBM, like many information technology (IT) companies, has been a strong supporter of "patent reform," including the new rules.  Despite previous statements in support of the rules, Mr. Kappos’ declaration is filed in support of the AIPLA’s amicus brief.

    Mr. Kappos’ declaration focuses on the retroactive application of the rules to pending applications, and specifically references the "related application" disclosure requirements imposed by new rules 37 C.F.R. §§ 1.78(f)(1) and 1.78(f)(2).  Mr. Kappos testifies that IBM has 25,000 pending applications and, after preliminary review, would need to identify more than 30,000 related patents and patent applications in order to comply with the rules.  Mr. Kappos further testifies that, should the Patent Office refuse to accept IBM’s bases for its assertions of patentable distinctiveness, the only remedy would be to cancel claims and thus lose rights to patentable inventions.  (No doubt the Patent Office rejoinder to this assertion will be the Examination Support Document (ESD) option; the lunacy of this course of action is not addressed in Mr. Kappos’ declaration.)

    The bottom line, according to Mr. Kappos, is a cost of "over 10 million dollars" in legal fees and internal costs, not counting the loss of intellectual property rights that may be occasioned by the rules.  These costs, according to Mr. Kappos, will be incurred to the detriment of IBM’s abilities to protect its new intellectual property; this allegation strikes directly at one of the (largely spurious) Patent Office grounds for the new rules, that examination of "old" technology (represented by continuation applications) detracts from the Office’s ability to examine "new" technology.

    It remains to be seen whether all this activity will be "too little, too late" or whether GSK and its amici will be able to convince the Judge that they satisfy the preliminary injunction standard.  It would be sweet irony if the Judge recognizes the Patent Office’s postponement of the hearing to the day before implementation is slated to occur for what it is – an attempt to tie his hands and make it more likely that he will deny the motion.  The brief and declarations submitted today bolster GSK’s argument that it has fulfilled the requirements for an injunction.  Let’s hope the Judge is listening.

    For additional information on this topic, please see:

  •     By Donald Zuhn

    Over the past week, Patent Docs has reported on two challenges to new IDS rules proposed by the U.S. Patent and Trademark Office ("Changes to Information Disclosure Statement Requirements and Other Related Matters," 71 Fed. Reg. 38,808).  The USPTO’s new IDS rules would require applicants to, inter alia, provide detailed explanations of all references when more than 20 references are cited and explain cited references that are at least 25 pages long or in foreign languages.

    Ip_logo_2
    Interestingly, while the USPTO attempts to force U.S. applicants to jump through even more hoops in complying with their duty to disclose "all information known . . . to be material to patentability" under 37 C.F.R. § 1.56, IP Australia announced on October 18, 2007 that it was "substantially remov[ing] the requirement for applicants and patentees to inform the Commissioner of Patents of the results of documentary searches by, or on behalf of, foreign patent offices" (see "Changes to regulations made under sections 27(1), 45(3) and 101D of the Patents Act 1990).  Thus, as of October 22, 2007, Australian patent applicants will no longer have to inform IP Australia of documentary search results — with one exception:

    if the final date by which an applicant or patentee was required to inform the Commissioner of the results of a search under the regulations was before 22 October 2007, and the Commissioner was not informed of the results of the search by that final date, the results of that search remains outstanding.  The amending legislation does not excuse any past failure to comply with the disclosure obligations.

    In a corresponding position paper, IP Australia provided an overview of the feedback it received in response to its May 16, 2007 consultation paper regarding the elimination of the obligation to lodge search results.  In the position paper, IP Australia noted that it received comments indicating:

    a general level of consensus that the existing search result disclosure provisions were onerous and costly for applicants and other users of the patent system.  There was also a level of doubt expressed as to the value or the benefits arising from the present provisions.

    One can only hope that the USPTO will look to the changes in Australian disclosure requirements, and the reasons offered for such changes by IP Australia, as it continues in its efforts to reshape the U.S. disclosure requirements.

    Related reading:

  •     By Suresh Pillai —

    Epigenomics
    Epigenomics AG
    of Frankfurt, Germany has been awarded U.S. Patent No. 7,229,759 ("Highly sensitive method for the detection of cytosine methylation patterns," issued June 12, 2007).  The ‘759 patent, covering a method for the detection of cytosine methylation in genomic DNA samples, is the fourteenth U.S. patent to be awarded to the Frankfurt, Germany-based biotech company.

    DNA methylation is a naturally occurring means by which cells regulate gene transcription.  Methylation occurs when cytosine is modified via the addition of a DNA methyl group.  The methyl group subsequently interferes with the binding of transcription factors and allows for chromatin condensation, thereby terminating gene activity.  Specific methylation at cytosines throughout the genome results in the specific targeted reduction for gene transcription.  Methylation patterns also form genetic fingerprints specific to various disease states, including cancer, that correspond to the regulation of genes important in disease pathogenesis.

    The newly issued patent covers Epigenomics’ HeavyMethyl® and MethyLight® technology (see below) as well as their proprietary line of DNA methylation biomarkers.  Through the use of established real-time quantitative PCR techniques, the technology can differentiate between genomic DNA that is either methylation-modified or unmodified.  This technology can be used for the high-throughput methylation detection of cancer biomarkers, thereby providing a clinical diagnostic tool for the early detection of cancer at the genetic level.

    The ‘759 patent issued from U.S. Application No. 10/229,370, which was filed on August 27, 2002, and which claims the benefit of International Application No. PCT/EP02/02572, filed March 8, 2002.  Independent claim 1 recites:

    1.  A method for the detection of cytosine methylation in DNA samples, characterized in that the following steps are conducted:
        a genomic DNA sample, which comprises the DNA to be investigated as well as background DNA, is chemically treated in such a way that all unmethylated cytosine bases are converted to uracil, while 5-methylcytosine bases remain unchanged;
        the chemically treated DNA sample is amplified with the use of at least 2 primer oligonucleotides, as well as a polymerase and at least one blocking oligonucleotide or PNA oligomer which preferentially binds to a 5′-CG-3′ dinucleotide or a 5′-TG-3′ dinucleotide or a 5′-CA-3′ dinucleotide on the background DNA, whereby the DNA to be investigated is preferentially amplified over the background DNA as the template, and
        the amplified products are analyzed and the methylation status in the DNA to be investigated is concluded from the presence of an amplified product and/or from the analysis of the amplified product.

    Suresh Pillai, Ph.D., is a molecular biologist and a third-year law
    student at DePaul University College of Law.  Dr. Pillai
    was a member of MBHB’s 2007 class of summer associates, and is currently working as a law clerk at MBHB.

  •     By Donald Zuhn

    Office_of_management_budget_omb_sea
    Yesterday, we reported on a second letter that was sent to the Office of Management and Budget (OMB) criticizing the IDS rules proposed by the U.S. Patent and Trademark Office on July 10, 2006 (see "Changes to Information Disclosure Statement Requirements and Other Related Matters," 71 Fed. Reg. 38,808).  The letter was prepared by Dr. Richard Belzer on behalf of clients he declined to identify, and accompanying Dr. Belzer’s letter was a 21-page Declaration from a unidentified registered patent attorney having over 20 years of experience in the field of intellectual property.  The Declarant estimates that the cost of complying with the proposed IDS Rule will be between $7.3 and $7.9 billion per year.

    Profile
    In addition to this cost of compliance estimate, the Declarant provides a number of other interesting "observations."  For example, the Declarant presents a significantly different picture regarding the percentage of applications that would be impacted by the proposed IDS rule.  While the Patent Office analyzed allowed applications over an unidentified six-week period of time and then concluded that 15% of all patent applications would be affected by the "more than 20 reference" provision of the IDS rule, the Declarant analyzed a random sample of 25 patents selected from the 2,896 patents that issued during the week of the report and found that 44% contained citations to more than 20 references.  As a result of this discrepancy, the Declarant urges the OMB "to examine the PTO data supporting the comment in the rule proposal very carefully, including checking its methodology for possible bias."

    The percentage of affected applications rises even higher when the "+25 page/foreign-language reference" provision of the IDS rule is considered.  Among the 25 patents from the Declarant’s random sample, only three of the fourteen patents that were not impacted by the "more than 20 reference" provision were also not impacted by the "+25 page/foreign-language reference" provision.  Thus, 85% of the 25 patents from the Declarant’s random sample would have been required to comply with one of these two provisions (a far cry from the Patent Office’s estimate that only 15% of all patent applications will be impacted).

    Moreover, the Delcarant suggests that when faced with the consequences of performing a search (i.e., complying with the above provisions):

    some practitioners might respond . . . by adopting a "head in the sand" approach and failing to search for or find possibly pertinent references, to avoid the risk of filing reports of this nature.  To the extent that this occurs, there would be extra costs [for the proposed IDS rules] as well.  Such costs include the extra cost arising from the examiners needing to search for references without applicant searches, extra costs to the public from some patents issuing unjustifiably because less searching was done, and extra costs on applicants arising from unprotected inventions (temporarily or permanently) or wasted application fees because applications were written without adequate investigation of prior art to focus them on the true inventive aspects.

    In opining on the Patent Office’s "Certification Analysis Under the Regulatory Flexibility Act" of June 29, 2007, which relates to cost estimates for the preparation of Examination Support Documents (ESDs), the Declarant "consider[s] that report’s quality as easily falling within the term ‘junk science’ (to the extent that the report qualifies for use of the term ‘science’ at all)."  [The Declarant offers an analysis of the ESD cost estimate because the Patent Office failed to provide a cost estimate for the preparation of Patentability Justification Documents (PJDs) under the proposed IDS rule.]  In addition, the Declarant notes (not surprisingly) that:

    [t]he PTO’s consultant who sought to estimate practitioner costs for ESDs did not report speaking with or gathering information from any practitioners, much less taking any valid and reliable sample of practitioners who have studied the nature of the tasks they would be required to perform under the proposed IDS rule.

    According to the Declarant, the Patent Office’s flawed methodology does not end with its failure to consult with patent practitioners and applicants.  In fact, the Declarant points out numerous instances in which the Office failed to present or identify data or information that the Declarant deems necessary to a proper analysis of the proposed IDS rule’s impact, including the Office’s failure to:

    • identify the dates of the allowed applications in its six-week study (see above);
    • report the average number of independent or total claims found in the 15% of applications in its sample in which applicants cited more than 20 references;
    • report the average number of dependent claims in applications;
    • produce actual data on the number of applications that are amended and the percentage of patents that are the subject of litigation;
    • determine the amount of time examiners expend reviewing large IDS’s;
    • estimate the fraction of references cited that exceed 25 pages and the fraction of references cited that are in a foreign language;
    • determine the percentage of foreign-language references submitted in IDS statements that have been translated in full;
    • provide data as to how often references are cited after a first Office action;
    • provide the amount of revenue the Office collects for the filing of late IDS’s.

    With respect to the impact of the IDS rule on allegations of inequitable conduct (a topic on which the Declaration provides a thorough analysis), the Declarant states that:

    based on my experience with inequitable-conduct litigation, it is my opinion that, for those applications that result in patents that are litigated, inequitable conduct would be alleged in essentially 100% of cases in which a "patentability justification" document was filed.  This is perhaps the easiest estimate that I have made in this declaration.

    Finally, in summarizing the impact of the proposed IDS rules, the Declarant concludes that:

    [t]his is a particularly cumbersome set of rules that the public is being asked to follow.  The paperwork requirements are extreme and quite expensive.  The PTO’s entire strategy is flawed, because (a) it seeks to shift duties from the examiners, who can perform such duties cheaply and without paperwork, to applicants, who are positioned to perform such duties more expensively and who must submit the paperwork only in the most careful fashion, and (b) it places applicants and practitioners in a "Catch-22" situation by, under an existing rule, mandating disclosure of material, known prior art references, while simultaneously, under the proposed new rule, mandating high extra cost and grave risks in instances where there is a duty to disclose many references or references that are relatively lengthy or written other than in English.

  •     By Kevin E. Noonan

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

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

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

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

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

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

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

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

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

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

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

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

  •     By Donald Zuhn

    Office_of_management_budget_omb_sea
    Last week, we reported on a letter that David Boundy, the Vice President of Intellectual Property for Cantor Fitzgerald L.P., sent to the Office of Management and Budget (OMB) on behalf of twenty-five companies and organizations, criticizing the IDS rules proposed by the U.S. Patent and Trademark Office on July 10, 2006 (see "Changes to Information Disclosure Statement Requirements and Other Related Matters," 71 Fed. Reg. 38,808).  Yesterday, Mr. Boundy alerted Patent Docs to a second letter that has been sent to the OMB challenging the proposed IDS Rule.

    The second letter was prepared by Dr. Richard Belzer on behalf of clients he declined to identify.  In explaining the need for confidentiality, Dr. Belzer writes that "[my clients] have persuaded me that there is a reasonable expectation that revealing their identities could result in financially devastating retaliation with respect to patent applications now in process or which they would submit to USPTO in the future."

    Accompanying Dr. Belzer’s 11-page letter is a 21-page Declaration from a registered patent attorney having over 20 years of experience in the field of intellectual property and the unedited comments of "four experienced patent attorneys with skills across multiple practice areas" who reviewed the Declaration.  Although the affiant was willing to be identified, Dr. Belzer states that "to ensure that the affiant has the same protection from retaliation that my clients reasonably fear, I have redacted all personally identifiable information from the declaration."

    Based on the affiant’s estimate that the cost of complying with the proposed IDS Rule will be between $7.3 and $7.9 billion per year, Dr. Belzer concludes that the IDS rule would have an "economically significant" effect.  [Patent Docs readers are reminded that Mr. Boundy’s letter included an estimate from San Luis Obispo, CA patent attorney Philip Steiner that the cost of complying with the proposed IDS Rule would be $1.9 billion.]

    With respect to the impact of the proposed IDS rule, Dr. Belzer begins by stating that:

    [b]ased on my expertise in regulatory analysis, and more than 20 years’ experience reviewing such analyses (including 10 while employed as an economist at OMB), I am virtually certain that the proposed IDS Rule is economically significant and thus warranted the preparation of an RIA [Regulatory Impact Analysis] in accordance with the guidelines set forth in OMB Circular A-4.

    Uspto_seal
    Dr. Belzer then adds that "based on my governmental experience it is inconceivable that USPTO could be unaware of the approximate magnitude of these costs, or that it employed any reasonable economic method or logic to determine that the proposed rule was ‘not significant,’" and that "[o]ne can infer with reasonable certainty that USPTO deliberately evaded the requirements of Executive Order 12,866 [which mandated that the Patent Office perform an RIA]" (emphasis added).  Dr. Belzer continues his harsh criticism of the Patent Office’s efforts to gain OMB approval for the proposed IDS rule by noting that the:

    USPTO is required, pursuant to OMB’s and is own information quality guidelines, to adhere to the principles of substantive and presentational objectivity in the dissemination of influential information.  The proposed IDS Rule was covered by these guidelines, but USPTO did not disclose any credible information about its cost.  This is per se a violation of both substantive and presentational objectivity.  The agency could not reasonably have believed that the costs of the proposed IDS Rule were trivial and thus not worth mentioning, and its failure to disclose an unbiased cost estimate was knowingly misleading.

    Determining that the Patent Office has failed to credibly estimate the costs of complying with the proposed IDS Rule, Dr. Belzer concludes his letter by offering to assist the Patent Office and the OMB in the development of credible burden estimates for the proposed IDS rule.

  •     By Sherri Oslick

    Genzyme
    Genzyme Corporation of Cambridge, MA has announced that Bioenvision, Inc. (New York, NY) stockholders approved the acquisition of the company by Genzyme for roughly $345 million in cash.  The acquisition suffered from a number of bumps in the road, starting with disapproval of the deal by a key stockholder who raised issue with the fact that Genzyme’s proposed takeover followed closely behind a share value dilution used to pay for new clinical trials, believing that Genzyme’s offer undervalued the company.  In the end, Genzyme and Bioenvision had to seek court approval to reopen the original stockholders’ vote on the acquisition in order to ensure that all stockholders had the opportunity to vote.  The acquisition will be effective on Wednesday, October 24.

    Bioenvision
    Bioenvision is a biopharmaceutical company focused on compounds for the treatment of cancer, autoimmune disease, and infection.  Included in Bioenvision’s pipeline is clofarabine, a purine nucleoside analog cancer therapeutic.  Genzyme initially retained the rights to clofarabine in an exclusive sublicense from Bioenvision.  Marketed as Clorar® in the U.S. and Canada, clofarabine was approved by the FDA in December, 2004 for the treatment of relapsed and refractory pediatric patients with acute lymphoblastic leukemia (ALL).  The FDA also granted orphan drug status to clofarabine as well as an additional six month pediatric exclusivity for clofarabine in pediatric ALL.

    Bioenvision’s product portfolio also includes, among others, Modrenal® (trilostane), a selective steroid receptor marketed in the U.K. for the treatment of post-menopausal advanced breast cancer following relapse to initial hormone therapy, and Suvus® (methylene blue), which yielded positive results in the treatment of hepatitis C viral infection in Phase II trials.  Bioenvision’s patent portfolio includes at least three published patent applications directed to its methylene blue therapeutic.

    For more information, please see:

  •     By Kevin E. Noonan

    Practising_law_institute_pli
    Resistance to the U.S. Patent and Trademark Office’s new continuation and claims rules continues to grow (although how effective that resistance will be less than two weeks before the rules are implemented is a problematic question).  The latest salvo comes from the Practising Law Institute’s Patent Blog, in the form of back-to-back posts by Gene Quinn (see "A Call to Action Against the Patent Office") and John White (see "Time to Get Involved & Stop the USPTO").

    Quinn_gene
    Mr. Quinn’s (at left) post speaks frankly of "revolution" and a "call to action."  Lawsuits are recommended as the implement of choice in this fray, and in particular the lawsuit filed by GlaxoSmithKline in the Eastern District of Virginia last week (see "Horray! – (Finally) the Big Dogs Have Joined the Hunt").  Mr. Quinn agrees that pharma will be the hardest hit by the rules, but thinks that all high-tech patenting should be included in the list of technologies put at risk by the rules, including software.

    Mr. Quinn points out that the Patent Office has asked the Court to wait until the night before the implementation deadline (fittingly, Halloween) to hear GSK’s motion for a TRO and preliminary injunction, clearly hoping that the Court will not be able to respond "on the spot" and, of course, then setting up its next argument that the new rules are a fait accompli and that granting GSK’s motion would prejudice those applicants who have already complied with the rules.

    Mr. Quinn doesn’t think filing separate lawsuits will be effective (in the short term, at least), but he does think that others can help the Court understand the gravity of the situation and the equities involved in granting the preliminary injunction motion until the Court can consider the issues on the merits.  He suggests that interested parties – everyone from individual inventors, small businesses, small cap, large cap, or Fortune 500 companies – should file amicus briefs with the Court to explain how the rules will negatively impact them.  The idea is for the Court to recognize that this isn’t just one company disagreeing with the Patent Office, but that GSK’s suit represents a large, even overwhelming, proportion of those entities most interested and invested in patents and patenting.

    Recognizing that some groups may not have the time or the wherewithal to effectively mount such as effort – and cautioning against a letter-writing campaign to the Court that may backfire – Mr. Quinn suggests that anyone having any arguments or evidence against the new rules send them to him at: gquinn@ipwatchdog.com.  He asks for specifics, preferably with citations to relevant case law, statutes or the rules, and in any event, complete arguments rather than rants.  Mr. Quinn  proposes to use his blog to publicly vet the arguments and to make them available to others.  Anonymity is offered but not required  – after all, who (or what lawyer, at least) wouldn’t want to take credit for the argument that persuades the Court to rule in "our" favor?

    White_john
    Mr. White (at left) is kinder in some ways to the current Patent Office administration, positing that the negative effects of the new rules are merely unintended consequences.  (As readers of Patent Docs will recognize, we feel that view is naïve – the Office cares about nothing other than reducing the backlog, and will do whatever it takes to do so.)  He recognizes that the comments provided to the Office merely "softened the blow" of the new rules (and as hard as it may be to comprehend, the rules as originally proposed were even worse than the rules as promulgated this August).  Like Mr. Quinn, Mr. White believes it’s time to "rally the troops" and "grab the pitchforks" (whether analogizing the Patent Office with Frankenstein or Dracula is not specified).  His reasoning is the same as Mr. Quinn’s:  not much time, and irrevocable loss of property rights.

    Uspto_seal
    Both authors correctly state the widespread beliefs of the vast majority of the patent bar (absent a few litigators who are willing to gut the patent system to kiss up to their patent-infringing clients):  the new rules are an illegal grab of executive power without consideration to the limitations of the enabling statute, done with scant factual support and supported by specious arguments (sound familiar?).  No one disputes that 20 years of Patent Office underfunding during an era of exponentially-increasing innovation (anyone at the PTO ever heard of Moore’s Law?) has left the Office with a crushing backlog, but what is misunderstood (or misrepresented) is that this represents innovation, and the new rules are willing to force applicants to abandon protection for that innovation to satisfy merely bureaucratic goals.  Don’t be surprised if one-quarter to one-third of the Patent Office backlog of applications are abandoned in the next twelve months (which is precisely what the new rules are intended to encourage if not force applicants to do).  And don’t be surprised if we start feeling the consequences in the next few years.  Let’s hope some of that abandoned innovation doesn’t relate to new drugs that Americans will need as a large bolus of us get to the age where we wish we had all the pharmaceutical help we can get.  The Patent Office will be content with reducing its backlog on the backs of those with such needs.