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  • Draft Report on Senate Patent Reform Bill: Interlocutory Decisions & Venue

        By Mark Chael —

    Senate_seal
    As we reported two weeks ago, a draft of the Senate Judiciary Committee’s report on the Patent Reform Act of 2007 (S. 1145) has been circulated on the internet.  The 106-page draft report
    contains sections on the background and purpose of the bill, the
    legislative history of the bill, a section-by-section summary of the
    bill, a placeholder for a cost estimate, a regulatory impact
    evaluation, and a list of the changes to Titles 15, 28, and 35 that
    would result if the Senate bill were passed into law.  The circulation
    of the draft report suggests that Senator Patrick Leahy,
    Chairman of the Senate Judiciary Committee, intends to keep his
    mid-December patent reform bill pledge to seek "favorable Senate action
    as early as the floor schedule permits" (see "Patent Reform Discussed on Senate Floor").  In view of the length of the draft report, Patent Docs
    has been
    providing a discussion of selected sections of the bill since the draft
    report began to circulate.  Today, in the final article in this series, we address section 8 of the bill.

    Section 8 of the Senate patent reform bill amends section 1292 of title 28 to require that the U.S. Court of Appeals for the Federal Circuit accept all interlocutory appeals of claim construction orders certified by the district courts.  New § 1292(c)(3) reads as follows:

    § 1292.  Interlocutory decisions

    (c) The United States Court of Appeals for the Federal Circuit shall have exclusive jurisdiction —

    ***

    (3) of an appeal from an interlocutory order or decree determining construction of claims in a civil action for patent infringement under section 271 of title 35.

    Application for an appeal under paragraph (3) shall be made to the court within 10 days after entry of the order or decree.  The district court shall have discretion whether to approve the application and, if so, whether to stay proceedings in the district court during the pendency of such appeal.

    Also, section 8 of the draft bill amends the patent venue provisions of § 1400(b) and adds new §§ 1400(c) and (d).  The amended sections of 35 U.S.C. § 1400 are as follows:

    § 1400.  Patents and copyrights, mask works, and designs

    (b) Notwithstanding section 1391 of the title, in any civil action arising under and Act of Congress relating to patents, a party shall not manufacture venue by assignment, incorporation, or otherwise to invoke the venue of a specific district court.
    (c) Notwithstanding section 1391 of this title, any civil action for patent infringement or any action for declaratory judgment may be brought only in a judicial district —

    (1) where the defendant has its principal place of business or in the location or place in which the defendant is incorporated or formed, or, for foreign corporations with a United States subsidiary has its principal place of business or is incorporated or formed;
    (2) where the defendant has committed substantial acts of infringement and has a regular and established physical facility that the defendant controls and that constitutes a substantial portion of the operations of the defendants;
    (3) where the primary plaintiff resides, if the primary plaintiff in the action is —

    (A) an institution of higher education as defined under section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)); or
    (B) a nonprofit organization that —

    (i) qualifies for treatment under section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3);
    (ii) is exempt from taxation under section 501(a) of such Code; and
    (iii) serves as the patent and licensing organization for an institution of higher education as defined under section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)); or

    (4) where the plaintiff resides, if the sole plaintiff in the action is an individual inventor who is a natural person and who qualifies at the time such action is filed as a micro-entity pursuant to section 123 of title 35.

    (d) If a plaintiff brings a civil action for patent infringement or declaratory judgment relief under subsection (c), then the defendant may request the district court to transfer that action to another district or division where, in the court’s determination —

    (1) any of the parties has substantial evidence or witnesses that otherwise would present considerable evidentiary burdens to the defendant if such transfer were not granted;
    (2) such transfer would not cause undue hardship to the plaintiff; and
    (3) venue would be other wise appropriate under section 1391 of this title.

    Finally, section 8 of S. 1145 makes some technical amendments concerning venue for actions against the USPTO.  As indicated in the Senate Judiciary Committee’s draft report, the American Inventors Protection Act (AIPA) of 1999 determined that the venue of the USPTO is the district in which it resides (see 35 U.S.C. § 1(b)).  However, in enacting the AIPA, Congress failed to make this determination consistent throughout the entire patent statute, thereby allowing certain court challenges to particular USPTO actions to be brought in the District of Columbia, where the USPTO resided decades ago.  These technical amendments to USPTO venue statute would make it clear that all court actions against USPTO decisions, where applicable, shall be brought in the U.S. District Court for the Eastern District of Virginia.

    In commenting on the venue amendments, the drafters alleged that in VE Holding Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574 (Fed. Cir. 1990) and Beverly Hills Fan Co. v. Royal Sovereign Corp., 21 F.3d 1558 (Fed. Cir. 1994), the Federal Circuit had "virtually eliminated any meaningful distinction between the patent venue provision [28 U.S.C. § 1400] and general venue."  According to the draft report, "[t]he effect of these decisions is that venue for a patent infringement defendant is proper wherever an alleged infringing product can be found."  And, "since [many] products are sold nationally, a patent holder can often bring a patent infringement action in any . . . judicial district in the [U.S.]."  The drafters, and others, allege that this leads to forum shopping in patent cases.

    Professor, now CAFC Judge, Kimberly Moore concluded in her seminal paper, Forum Shopping in Patent Cases: Does Geographic Choice Affect Innovation? 79 N.C. L. Rev. 889 (2001), that about half of all patent infringement cases are filed in only ten of the 94 judicial districts in the U.S.  This trend is only expected to continue and perhaps worsen (see, e.g., R.R. McKelvie, Forum Selection in Patent Litigation: A Traffic Report for 2006, 19 Intell. Prop. & Tech. L.J. 1 (2007)).  It is black-letter law that venue exists, in part, to protect defendants that have no more than minimal contacts in a forum of the plaintiff’s choosing.  And, it is common sense that judicial economy is best served in a venue close to witnesses and evidence.  Finally, if only a few districts are asked to handle the majority of patent infringement actions, their dockets will be unnecessarily overcrowded.

    The Senate patent reform bill also provides for interlocutory appeals of patent claim constructions after Markman hearings, provided that the appeal is taken within 10 days following entry of the Markman ruling.  The Judges of the Federal Circuit, in particular Judge Michel, have spoken out against the propriety of interlocutory appeals of this type.  However, the Senate Judiciary Committee alleged that "[n]umerous studies have shown that the Federal Circuit’s reversal rate of district court claim construction decisions is unusually high" (citing P.M. Schoenhard, Reversing the Reversal Rate: Using Real Property Principles to Guide Federal Circuit Patent Jurisdiction, 17 Fordham Intel. Prop. Media & Ent. L.J. 299 (2007)).  Testimony before the Senate Committee on the Judiciary by the Chief Intellectual Property Counsel at Goldman Sachs, Mr. John A. Squires, further alleged that "the manner [in which] claim construction determinations are currently reviewed increases litigation costs, decreases certainty and predictability, and can prolong settlement discussions."

    The amendments found in S. 1145 will provide district court judges with the discretion to certify a challenged Markman ruling for appeal to the Federal Circuit.  According to the Committee, it is the district court judges who are in the best position to decide when and if an appellate review of claim construction is appropriate.

    Interestingly, as Patent Docs (and others) have reported, at least five Senators are opposed to the current draft patent reform legislation and have written a letter to Senator Leahy, the Committee Chairman, stating that additional information and hearings are necessary (see "Patent Reform Bill to Be Delayed?").  Although, S. 1145 is on the Senate’s schedule this year (see Patent Docs report), swift passage is by no means certain.

    For additional information on the draft report, please see:

    For additional information regarding this topic, please see:

  • USPTO News: Patent Prosecution Highway Network Expands to Canada & Korea

        By Christopher P. Singer —

    Uspto_seal
    As reported on Patent Docs earlier this month, the U.S. Patent and Trademark Office announced in a January 28, 2008 notice that the Canadian Intellectual Property Office (CIPO) and the Korean Intellectual Property Office (KIPO) have now entered Patent Prosecution Highway (PPH) pilot projects with the USPTO.  The idea behind the PPH is to leverage fast-track patent examination in each office so that applicants can obtain corresponding patents faster and more efficiently in each country.  Further, each Office should benefit from work previously done by the other Office, accordingly reducing examination workload and improving patent quality.  Participants in the PPH who receive a determination from either the CIPO or KIPO that at least one claim in an application is patentable may request that the USPTO fast track the examination of corresponding claims Canadian_flag_4
    in the corresponding application.  Similarly, if the USPTO determines that at least one claim is patentable, the applicant may request accelerated processing of corresponding applications filed at the CIPO or KIPO.

    These pilot programs are designed to assess general interest in these programs and are scheduled to last until January 28, 2009, but could be Korean_flag_2
    extended beyond, or terminated prior to, that date.  Full requirements for participation in each trial program through the USPTO can be found at these here (for the PPH with the CIPO) and here (for the PPH with the KIPO).

    For additional information of this and other related topics, please see:

  • Draft Report on Senate Patent Reform Bill: Damages

        By Donald Zuhn —

    Senate_seal
    As we reported two weeks ago, a draft of the Senate Judiciary Committee’s report on the Patent Reform Act of 2007 (S. 1145) has been circulated on the internet.  The 106-page draft report
    contains sections on the background and purpose of the bill, the
    legislative history of the bill, a section-by-section summary of the
    bill, a placeholder for a cost estimate, a regulatory impact
    evaluation, and a list of the changes to Titles 15, 28, and 35 that
    would result if the Senate bill were passed into law.  The circulation
    of the draft report suggests that Senator Patrick Leahy,
    Chairman of the Senate Judiciary Committee, intends to keep his
    mid-December patent reform bill pledge to seek "favorable Senate action
    as early as the floor schedule permits" (see "Patent Reform Discussed on Senate Floor").  In view of the length of the draft report, Patent Docs
    has been
    providing a discussion of selected sections of the bill since the draft
    report began to circulate.  Today, we address section 4 of the bill.

    Senate_floor
    Before addressing section 4, however, there are two recent developments concerning the Senate’s patent reform bill that are worth noting.  First, the Senate Judiciary Committee reported the bill last Friday.  Patent Docs has not had a chance to review the final report on the patent reform bill, but according to the Intellectual Property Owners Association (IPO), the report "includes minority and additional views."  Second, Gene Quinn of the PLI Patent Blog informs us that Robert Clarke, the Director of Legal Administration at the USPTO, announced during a webcast today that the Patent Office does not support the Senate’s patent reform bill.  At this time, the Office’s specific objections to the bill are unclear (we will leave it to our readers to speculate as to which provisions most disturb the Patent Office).

    But back to the damages provisions of S. 1145.  Section 4, entitled "Right of the inventor to obtain damages," addresses perceived deficiencies in the current damages statute, particularly the reasonable royalty standard, the willfulness statute, prior user rights, and marking requirements.  The draft report states that because the Senate Judiciary Committee "has heard no concerns expressed with current determinations of lost profits," the Senate bill introduces no changes with respect to lost profits.

    Reasonable Royalty

    With respect to the calculation of a reasonable royalty, the draft report states that the S. 1145 seeks "to bring clarity and guidance to the application of the law of damages" by codifying the analysis the judge and jury should perform in determining an appropriate reasonable royalty.  Under the provisions of the section 4, the judge would determine whether the case falls within the "entire market value" rule, the "marketplace licensing" rule, or neither rule, and then identify for the jury only those factors that are relevant in determining a reasonable royalty.

    According to new § 284(c)(1)(A), the entire market value rule may be applied if the patented invention’s contribution over the prior art is the predominant basis for the market demand of the infringing product or process.  According to new § 284(c)(1)(B), a reasonable royalty may be based on other comparable, nonexclusive licenses of the patented invention (the marketplace licensing rule) when there have been a sufficient number of licenses to indicate a general marketplace recognition of the reasonableness of the licensing terms.  According to new § 284(c)(1)(C), if neither of the above sections applies, the reasonable royalty calculation is to be applied "only to the portion of the economic value of the infringing product or process properly attributable to the claimed invention’s specific contribution over the prior art."  This section, however, does not set forth a specific methodology for use in making this calculation.  The draft report explains that "specific contribution over the prior art" means "the reason the patent was allowed in view of the existing information at the time of the invention."  The draft report further explains that none of these provisions precludes a court from considering, or directing a jury to consider, other relevant factors in calculating the reasonable royalty, including, for example, the fifteen Georgia-Pacific factors.

    The draft report suggests that the provisions described above were designed to address an increasing number of reasonable royalty cases brought on by an increase in the number of patent holders who do not produce products.  According to the report, this situation arises because:

    the patent holder is focused on research and development rather than production (which is the case for many small inventors and universities), or because the patent at issue had been purchased, not for the purpose of manufacture, but for the purpose of licensing (or litigation), or because the infringed patent is so new to the marketplace that there has yet to be any real competition to it.

    The report notes that several "alarming" cases "have captured the attention of the public and the Congress, [and] not surprisingly, involve out-sized damages awards."  The draft report contends that because modern patents often claim combinations, and the typical invention is no longer a "sui generis creation," juries may improperly award damages based on the value of the entire product, resulting in a damages award that is disproportionate to the infringing harm.

    Willfulness

    Under the Senate patent reform bill, willfulness is to be decided by the judge (rather than jury) and only after there is a finding of validity and infringement (as opposed to being plead at the outset of the action).  The draft report argues that the provisions of section 4 "should greatly reduce unwarranted allegations of willfulness, as well as unnecessary costly discovery."

    To raise the notice threshold, the Senate bill requires that the patent holder present the accused infringer with more than mere "conclusory allegations" that the accused infringer is infringing one or more of the patent holder’s patents. According to new § 284(e)(2)(A), the patent holder must instead "allege acts of infringement sufficient to give the alleged infringer an objectively reasonable apprehension of suit, and the patent holder must also plead with particularity which products or processes allegedly infringe which claims of the patent, as well as the basis for such a belief."

    In addition, the draft report notes that § 284(e)(3) provides a "meaningful" good faith defense to willfulness when an infringer can show "reasonable reliance on the advice of counsel; evidence that the infringer sought to modify its conduct to avoid infringement once it had discovered the patent; or other evidence a court may find sufficient."  The report explains that such a defense is needed because "[t]he question of whether a patent is valid or infringed can often be a close question with colorable arguments on both sides," and because the pleading of willfulness gives the patent holder "significant litigation advantages, including breaching the attorney client privilege, necessitating different trial counsel, and resulting in costly additional discovery."  The draft report also explains that the threat of willfulness often leads to imbalanced settlement negotiations that are "not reflective of the compensation owed the patentee due to the alleged infringement."

    The draft report contends that the changes to the willfulness statute were necessitated by the statute’s lack of guidance regarding what activities constitute willful infringement.  The changes to the willfulness statute are intended to reduce excessive pleading, inappropriate findings of willfulness, and inflated litigation and transaction costs and damage awards.

    Prior User Rights

    The draft report notes that the Senate patent reform bill, as introduced, would have extended the prior user rights statute from encompassing just business methods to covering all types of subject matter.  However, as a result of the "persuasive outcry from the university and tech transfer communities," the bill only modifies § 273(b)(6) to clarify that "affiliates" of the prior user may also assert the defense.  The draft report also notes that the bill would require the Director of the USPTO to provide Congress with recommendations on prior user rights within two years of the Act’s enactment.

    Notice and Marking

    The draft report notes that "neither marking nor actual notice is required to begin the accrual of damages if the patented invention is not made or sold by the patentee or someone acting under its authority," and further, that certain types of subject matter (e.g., business methods) are exempt from notice and marking requirements.  The draft report then states that the Senate Judiciary Committee considered "extreme recommendations" to improve the disparity in notice and marking requirements between different types of subject matter and different types of patent holders, but instead chose "a more modest approach."  That approach:  reducing the maximum period for which damages can be recovered for infringing patents not covered by the marking requirements from 6 years to 2 years from the date of actual notice.

    For additional information on the draft report, please see:

    For additional information regarding this topic, please see:

  • Monsanto Co. v. Bayer Bioscience N.V. (Fed. Cir. 2008)

        By Kevin E. Noonan —

    Even as the Senate may be preparing to vote on a patent "reform" bill that contains (for the first time) provisions codifying a standard for inequitable conduct, the Federal Circuit continues to develop its own inequitable conduct jurisprudence.  The draft Senate report on the proposed bill, S. 1145, rejects the Federal Circuit’s approach on determining materiality of a reference, but consideration of the circumstances under which the courts must apply current law (which approach is unlikely to change) at least suggests that such criticism misses many relevant issues.

    Monsanto
    The most recent case illustrating these principles is Monsanto Co. v. Bayer Bioscience N.V.  In response to Monsanto’s declaratory judgment action, Bayer asserted infringement of four patents (U.S. Patent Nos. 5,545,565 ("the ‘565 patent"), 5,767,372 ("the ‘372 patent"), 6,107,546 ("the ‘546 patent"), and 5,254,799 ("the ‘799 patent")) which were found on summary judgment to be invalid, not infringed (specifically, the asserted ‘565 patent claims), and unenforceable because Bayer was guilty of inequitable conduct during prosecution.  The Federal Circuit reversed the original claim construction of the District Court and vacated the invalidity and inequitable conduct judgment, in part because there were genuine issues of material fact inappropriate for summary determination.  On remand, Bayer dismissed its claims with regard to the ‘799, ‘372, and ‘546 patents, filing a Statement of Non-liability as to those patents, so the claims based on the ‘565 patent alone went to trial.

    The claims at issue relate to genetically-engineered corn plants transformed with an expression construct that expressed a protein encompassing the amino terminal portion of an insecticidal toxin from Bacillus thuringiensis.  Monsanto produces a genetically-modified corn product that expresses a Bt toxin having the same amino acid sequence as the claimed toxin.  On remand, a jury found the asserted claims of the ‘565 patent to be not infringed and invalid for obviousness and anticipated by Monsanto’s own prior invention.  The District Court then found the ‘565 patent to be unenforceable due to inequitable conduct, a judgment affirmed by the Federal Circuit, which did not reach Bayer’s appeal on the invalidity and non-infringement judgments.

    Bayer_ag_logo_2
    The basis for the District Court’s inequitable conduct decision was Bayer’s failure during prosecution to disclose its full knowledge of the subject matter of an abstract ("the Barnes Abstract") from a poster presentation made at a scientific conference.  The subject matter of the presentation was production of a chimeric gene comprising an amino terminal portion of Bt toxin fused to a selectable marker protein (conferring kanamycin resistance) that could be used to select recombinant cells.  In prosecution of the ‘565 patent, the Examiner rejected Bayer’s claims (directed to a genus of Bt toxin-encoding constructs) for obviousness over several prior art references including the Barnes Abstract.  In particular, the Examiner asserted that Barnes provided motivation to produce genetically-engineered plant cells comprising a truncated Bt toxin gene, since the art recognized that this portion was sufficient for the insecticidal activity of the toxin.  In response, Bayer argued that the Barnes reference failed to show that the fusion protein was biologically active, or that the amino terminal fragment of the protein was toxic.  In addition, Bayer argued that the Barnes Abstract was not enabling, since while it asserted that the fusion gene "may" be inserted into a plant vector and that the resulting protein "should" express the insecticidal and kanamycin-resistant phenotype, "no concrete evidence [of function] was provided."

    However, the Barnes Abstract was not the only information regarding Dr. Barnes’ work known to Bayer.  One of its employees, Dr. Celestina Mariani, attended the conference and took extensive notes.  These notes reflected the poster contents, specifically that Barnes had in fact determined that his amino terminal fragment retained insecticidal activity and had produced a vector encoding the fusion protein.  Moreover, the poster showed that the construct conferred kanamycin resistance in a bacterial system, and when the protein was applied to plants showed insecticidal activity.  The poster also showed that Barnes had made a recombinant construct in an Agrobacterium T-DNA plant expression vector where expression of the fusion protein was controlled by a plant-specific promoter.  At her deposition, Dr. Mariani testified that the Barnes laboratory "surely w[as] busy with introducing in plants this cassette" since there was no other reason to insert the fusion protein sequence into the Agrobacterium construct.

    In addition to this testimony, the District Court heard undisputed evidence that these notes were "widely distributed" to the scientists working on the Bt project at Bayer.  Most significantly, the notes were also known to Dr. Wouter Meulemanns, who was responsible for prosecuting the four Bayer patents in suit.  Although Dr. Meulemanns testified that he spoke with Dr. Mariani about the Barnes poster, he asserted that she did not remember "anything" about the presentation.  In view of the clear recollection of the notes and poster Dr. Mariani exhibited during her deposition testimony, the District Court did not find Dr. Meulemanns’ testimony to be credible.  The District Court found the notes to be material to patentability, both under the "reasonable examiner" test and because they would have established a "prima facie case of unpatentability."  Coupled with the District Court’s skepticism regarding Dr. Meulemanns’ testimony, it found the requisite intent to deceive the Patent Office, and that Bayer had committed inequitable conduct in obtaining the ‘565 patent.  In addition, the District Court found that the other three patents originally asserted were also unenforceable for inequitable conduct.

    Federal_circuit_seal
    The Federal Circuit affirmed, in a unanimous decision written by Judge Gajarsa, based on finding no clear error in the District Court’s analysis.  The Federal Circuit held that the information on the Barnes Abstract was material because it "refutes, or is inconsistent with, a position the applicant takes in . . . an argument of unpatentability relied on by the Office" under 37 C.F.R. § 1.56(2)(i).  Although the amino terminal fragment of the Bt toxin disclosed by Barnes was different from the fragment in Bayer’s ‘565 patent claims, the scope of those claims pending when Bayer made its argument was broader and encompassed a genus of fragments that would include the one disclosed by Barnes.  The Federal Circuit found that Bayer knew that Barnes’ recombinant fusion protein showed insecticidal properties when applied to a plant leaf, and yet argued that the unpredictability of plant recombinant genetics precluded the skilled worker from having a reasonable expectation of success in producing a functional recombinant Bt toxin fragment.  In addition, the Federal Circuit noted Bayer’s argument that there was "no concrete evidence" that the Barnes construct had been made, when Dr. Mariani’s notes clearly showed that the poster contained positive information that Barnes had made the construct.  The CAFC was careful to circumscribe the rubric in enunciated in making its materiality finding:

    We do not suggest that all internal documents of potential relevance must be submitted to the PTO as a matter of course.  Rather, it is the particular circumstances that render the internal documents material in this case.

    The Federal Circuit easily dismissed Bayer’s challenges to the District Court’s findings with regard to its intent to deceive, stating:

    Intent is easily inferred when, as here, an applicant makes arguments to the PTO that it knows, or obviously should have known, are false in light of information not before the examiner, and the applicant knowingly withholds that additional information.

    The Federal Circuit also affirmed the District Court’s holding that the ‘799, ‘372, and ‘546 patents were also unenforceable due to inequitable conduct.  Here, Bayer had asserted a jurisdictional challenge to the judgment, based on it having dismissed the infringement claims as to these patents.  But the Federal Circuit held that Monsanto’s motion for attorneys’ fees under 35 U.S.C. § 285 was sufficient to bring these patents within the scope of the District Court’s jurisdiction, and that the Statement of Non-liability was not sufficient to exempt these patents from the lower court’s scrutiny.  The CAFC noted that its decision in Nilssen v. Osram Sylvania, Inc. (Fed. Cir. 2007) would also support the District Court’s jurisdiction on a theory of infectious unenforceability, but that here "the outcome is even clearer as there is no dispute that the court had an independent grant of jurisdiction under § 285 to consider inequitable conduct relating to the withdrawn patents."

     Monsanto Co. v. Bayer Bioscience N.V. (Fed. Cir. 2008)
    Panel: Circuit Judges Bryson, Gajarsa, and Dyk
    Opinion by Circuit Judge Gajarsa

    Additional information regarding this case can be found at Patently-O.

  • Court Report

        By Sherri Oslick —

    Gavel_35
    About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Monsanto Co. et al. v. Markert et al.
    3:08-cv-03022; filed January 23, 2008 in the Central District of Illinois

    Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendant’s use of soybean seed produced from earlier planted Roundup Ready® soybean seed.  View the complaint here.


    Validus Pharmaceuticals Inc. v. Actavis South Atlantic LLC et al.
    1:08-cv-00036; filed January 17, 2008 in the District Court of Delaware

    Infringement of U.S. Patent No. 6,977,253 ("Methods for the Treatment of Bipolar Disorder Using Carbamazepine," issued December 20, 2005) following a paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Validus’ Equetro® (carbamazepine extended-release capsules, used for the treatment of acute manic to mixed episodes associated with Bipolar I disorder).  View the complaint here.

  • Patenting Life (Part III)

        By Kevin E. Noonan —

    J_craig_venter_institute
    Craig Venter’s colleagues at the J. Craig Venter Institute show no signs that vocal criticism of their work in synthetic biology has made a dent in their determination to "create life" (see "Playing the Bioterror Card in the Synthetic Biology Debate").  They report in this week’s Science Express (an online journal of pre-publication posted papers) that by successfully chemically synthesizing an entire bacterial chromosome, they have taken the next step in their efforts to create "life" in a test tube (see Gibson et al., "Complete Chemical Synthesis, Assembly, and Cloning of a Mycoplasma genitalium Genome," abstract – full version of article available to subscribers only).

    The bacterial chromosome in question comprises about 385 "essential" genes from the 485-gene Mycoplasma genitalium genetic complement (see below).  The researchers had determined the identity of the 100 "non-essential" genes using conventional genetic techniques, but are not yet certain whether these genes can all be deleted simultaneously.  The synthesis reported this week is directed at making that determination.

    The synthesis was not completely synthetic, in the sense that the final chromosome was not produced solely from in vitro chemical synthesis.  Rather, chemically-synthesized oligonucleotides of 5 to 7 kilobases in length were ligated to produce intermediates of 24, 36, 72 and 144 kilobases.  These intermediates were cloned into bacterial artificial chromosomes (BACs) and sequenced, and then the final chromosomes were assembled by transformation-associated recombination in yeast (S. cerevisiae) using yeast artificial chromosome vectors (YACs).  This final assembly was isolated and clones with the correct sequence identified.  The size of the completed genome was 582,970 basepairs (about 3 kb larger than the native bacterial chromosome).

    This synthetic chromosome also contained what the researchers termed "watermarks," insertions of transposable element sequences at intergenic sites.  These markers were diagnostic for the artificial chromosome, as was the insertion of an antibiotic resistance element in a gene (MG408) that acts as a virulence factor, thus in one step permitting selection of the artificial chromosome and eliminating human pathogenicity.

    This work complements earlier work where the group was able to transplant the genome of one Mycoplasma species into another (see links below).  It sets the stage for determining which of the 100 non-essential genes can be deleted simultaneously, and for the project’s ultimate goal of complete synthetic reconstruction of a living organism.

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

  • USPTO News: “New Route” Created between USPTO and JPO

        By Donald Zuhn —

    New_route
    The U.S. Patent and Trademark Office (USPTO) and the Japan Patent Office (JPO) have announced that the two Offices will begin a new work-sharing pilot program on January 28, 2008.  The pilot program, which the Offices are calling the "New Route," will allow each Office to benefit from examinations and searches performed in the other Office.  In particular, the Office in which an application is first filed will provide translations, search results, and examinations to the Office in which the application is subsequently filed.

    According to the USPTO, the New Route program will allow the Offices to "reduce overall workload, minimize duplication of search efforts, and increase examination quality."  While acknowledging that the New Route program is similar to the Patent Cooperation Treaty (PCT), the Offices contend that the program will offer applicants lower costs and more targeted filings.

    Uspto_seal_no_background_2
    The foundation for the New Route pilot program was laid last fall during the 25th Annual Trilateral Conference (see Patent Docs report), where the USPTO and JPO agreed on the pilot program’s parameters.  Because a permanent version of the New Route program, as envisioned by the two Offices, would require changes to U.S. and Japan patent law, the Offices will be testing the New Route concept using two filing scenarios that are currently available under each country’s patent law.  These scenarios include:

    1.  A priority application is filed in Office #1.  A PCT application claiming the benefit of the priority application is filed in Office #1.  The PCT application enters national stage in Office #2 and the search and examination results of the priority application are available within 26 months from the filing date of the priority application.

    2.  A PCT application having no benefit claims is filed in Office #1.  The PCT application enters national stage in Office #1 earlier than it enters national stage in Office #2, the latter occurring at the 30th month.  The search and examination results of the national stage in Office #1 are available within 26 months from the international filing date.

    Japanese_patent_office_jpo_seal_2
    Applicants interested in participating in the New Route pilot program must file a request with the first Office (and then subsequently with the second Office).  Because a request filed with the USPTO (when it is the first Office) will not guarantee that search and examination results will be available within the 26-month period described above, the USPTO is encouraging applicants to utilize the provisions of 37 C.F.R. § 1.102 (Advancement of examination) and M.P.E.P. § 708.02(a) (Accelerated Examination).  The USPTO will notify U.S. applicants as to whether their applications have been selected for the pilot program, and during the course of the pilot program, will periodically send a list of candidate applications to the JPO.  The New Route pilot program will run until January 28, 2009 or until each Office selects 50 candidate applications.

    The USPTO notice provides specific guidelines for entering the New Route pilot program.  Where the USPTO is the first Office in which the application is filed (i.e., the USPTO is Office #1), the following criteria must be met:

    1.  The PCT application must be filed with a single priority claim to a nonprovisional application (scenario #1 above) or without a priority claim (scenario #2 above).
    2.  The PCT application has not yet entered national phase in the JPO.
    3.  A first action on the merits must be issued by the USPTO on the nonprovisional application within 26 months of its filing date (scenario #1 above) or on a U.S. national stage application within 26 months of the international filing date (scenario #2).

    Applicants interested in participating in the New Route program and having applications meeting the above criteria must fax a letter to the Office of the Commissioner for Patents, directed to the attention of Magdalen Greenlief (571-273-0125), notifying the USPTO that the applicant wishes to participate in the New Route pilot program, identifying the U.S. and PCT application numbers, and informing the Office whether a first action on the merits will be issued within 26 months of the nonprovisional or international filing date.

    Where the USPTO is the second Office in which the application is filed (i.e., the USPTO is Office #2), the following criteria must be met:

    1.  The U.S. application is a national stage application of a PCT application filed with the JPO Receiving Office.
    2.  The PCT application must be filed with a single priority claim to a Japanese patent application (scenario #1 above) or without a priority claim (scenario #2 above).
    3.  Search and examination results must be issued by the JPO on the Japanese patent application within 26 months of its filing date (scenario #1 above) or on a Japanese national stage application within 26 months of the international filing date (scenario #2).

    Upon entry into national stage in the U.S., applicants interested in participating in the New Route program and having applications meeting the above criteria must fax the following documents to the Office of the Commissioner for Patents, directed to the attention of Magdalen Greenlief (571-273-0125):

    (i) request for participation in the New Route pilot program,
    (ii) petition to make the U.S. national stage application special under 37 C.F.R. § 1.102(d),
    (iii) copy of the first office action by the JPO and an English translation thereof,
    (iv) copy of the claims searched and examined by the JPO and an English translation thereof,
    (v) statement that the translations are accurate, and
    (vi) information disclosure statement listing any documents cited in the JPO office action together with copies of all cited documents except U.S. patents or U.S. patent application publications.

  • Draft Report on Senate Patent Reform Bill: Applicant Quality Submissions & Micro-Entities

        By Kevin E. Noonan —

    Senate_seal
    As we reported last week, a draft of the Senate Judiciary Committee’s report on the Patent Reform Act of 2007 (S. 1145) has been circulated on the internet.  The 106-page draft report
    contains sections on the background and purpose of the bill, the
    legislative history of the bill, a section-by-section summary of the
    bill, a placeholder for a cost estimate, a regulatory impact
    evaluation, and a list of the changes to Titles 15, 28, and 35 that
    would result if the Senate bill were passed into law.  The circulation
    of the draft report suggests that Senator Patrick Leahy,
    Chairman of the Senate Judiciary Committee, intends to keep his
    mid-December patent reform bill pledge to seek "favorable Senate action
    as early as the floor schedule permits" (see "Patent Reform Discussed on Senate Floor").  In view of the length of the draft report, Patent Docs
    has been
    providing a discussion of selected sections of the bill since the draft
    report began to circulate.  Today, we address section 11 of the bill.

    Section 11 of S. 1145 amends Title 35 to add the following new section:

    § 123. Additional information; micro-entity exception

    (a) IN GENERAL.–The Director shall, by regulation, require that an applicant for a patent under this title submit to the Director–

    (1) a search report and analysis relevant to patentability; and
    (2) any other information relevant to patentability that the Director, in his
    discretion, determines necessary.

    (b) FAILURE TO COMPLY.–If an applicant fails to submit the search report, analysis, or information required under subsection (a) in the manner and within the time period prescribed by the Director, such application shall be regarded as abandoned.
    (c) EXCEPTION.–Any application for a patent submitted by a micro-entity shall not be subject to the requirements of this section.
    (d) MICRO-ENTITY DEFINED.–

    (1) IN GENERAL.–For purposes of this section, the term "micro-entity" means an applicant who makes a certification under either paragraph (2) or (3).
    (2) UNASSIGNED APPLICATION.–For an unassigned application, each applicant shall certify that the applicant–

    (A) qualifies as a small entity, as defined in regulations issued by the Director;
    (B) has not been named on 5 or more previously filed patent applications;
    (C) has not assigned, granted, or conveyed, and is not under an obligation by contract or law to assign, grant, or convey, a license or any other ownership interest in the particular application; and
    (D) does not have a gross income, as defined in section 61(a) of the Internal Revenue Code (26 U.S.C. 61(a)), exceeding 2.5 times the average gross income, as reported by the Department of Labor, in the calendar year immediately preceding the calendar year in which the examination fee is being paid.

    (3) ASSIGNED APPLICATION.–For an assigned application, each applicant shall certify that the applicant–

    (A) qualifies as a small entity, as defined in regulations issued by the Director, and meets the requirements of paragraph (2)(D);
    (B) has not been named on 5 or more previously filed patent applications; and
    (C) has assigned, granted, conveyed, or is under an obligation by contract or law to assign, grant, or convey, a license or other ownership interest in the particular application to an entity that has 5 or fewer employees and that such entity has a gross income, as defined in section 61(a) of the Internal Revenue Code (26 U.S.C. 61(a)), that does not exceed 2.5 times the average gross income, as reported by the Department of Labor, in the calendar year immediately preceding the calendar year in which the examination fee is being paid.

    (4) INCOME LEVEL ADJUSTMENT.–The gross income levels established under paragraphs (2) and (3) shall be adjusted by the Director on October 1, 2009, and every year thereafter, to reflect any fluctuations occurring during the previous 12 months in the Consumer Price Index, as determined by the Secretary of Labor.

    Dudas_jon
    According to the draft report, this new section is almost completely the
    result of testimony by Jon Dudas (at left), Director of the U.S. Patent and
    Trademark Office.  Anyone familiar with Patent Office efforts over the
    past few years to cast the various proposed "new rules" as being
    directed to improving patent quality will recognize the "through the
    looking-glass" nature of the proposals.  The draft report accurately states
    that the number of patent applications filed each year has been rising,
    and that 440,000 applications were filed in Fiscal Year 2006.  The draft report also states, based on Mr. Dudas’s testimony, that 25% of these
    applications cite no prior art, and another 25% cite twenty or more
    references.  Each circumstance is viewed as problematic, since the
    absence of a requirement to provide any explanation of the relevance of
    submitted prior art references means that even cited references are of
    limited use in helping patent examiners do their duties, in view of the
    limited amount of time they are given to perform examinations.  The draft report also accepts the PTO’s contention that it is the applicant who
    is "often in the best position to know the invention and the relevant
    art that may apply."  This statement, part of the PTO’s recent mantra,
    of course flies in the face of the long-standing representations by the
    Office that patent examiners have special expertise in their art units,
    and thus would be expected to know the prior art as well or better than
    most applicants, especially after the examiner performs a search (not
    required of applicants under current law).  (Indeed, the PTO’s position would appear
    to provide evidence to any applicant who receives an Office Action
    having rejections that depend on an examiner’s purported expertise in
    his or her art unit.)

    The draft report states "[t]he USPTO strongly advocated for inclusion of
    ‘applicant quality submissions’ [AQS] provision in the bill, stating
    it was one of its highest priorities in order to improve the patent
    examination process and the quality of issued patents."  The PTO’s
    fingerprints can be discerned in the draft report’s statements that:

    [a]lthough patent examiners have excellent electronic search tools,
    and are well trained in the art of searching, added assistance from
    applicants citing relevant prior art and explaining how it applies to
    their applications will improve the quality of issued patents.  In
    addition, requiring applicants to do their own initial research and
    disclosure will improve the quality of the application.

    Once again,
    the fig leaf of quality used to mask the transfer of the burden of
    patent examination from the Office to the applicant.

    Steve_jobs_apple
    The proposed new Section purports to exempt certain applicants from
    the burden of compliance with the new search and analysis
    requirements.  However, unlike the current "small entity status," the
    "microentity" exemption has significant limitations.  The exemption
    includes, on its face, independent inventors, small business concerns,
    and non-profit organizations (collectively referred to as "small
    business entities").  However, belonging to these classes of applicants
    is not enough:  the proposed new statute is intended to benefit "a
    group of inventors who are even smaller, in order to be sure that the
    USPTO can tailor its requirements, and its assistance, to the people
    with very little capital, and just a few inventions, as they are
    starting out."  To this end, certain members of the "small entity"
    class are denied admittance to this "even smaller group – the
    micro-entity – which comprises only true, independent inventors."  To
    achieve (but certainly not justify) these ends, the exemption is lost,
    most significantly, for any small entity named on five or more patent
    applications.  This provision would eliminate from the exemption almost
    all universities, for example, and an undefined number of prolific
    inventors of humble means — just the kind of inventors the current
    small entity exemption helps defray the cost of patent application
    filings.

    As discussed on Patent Docs before, submitting an AQS is foolhardy
    at best so long as the current standards for alleging and proving
    inequitable conduct are in force.  (And the proposed changes do
    little to improve the situation.)  We have seen how the PTO intends to
    exercise any power granted to it under these provisions, with regard to
    its accelerated examination provisions and the new Information
    Disclosure Statement rules.  The issue, of course, is the
    liability that will predictably attach by filing an AQS (alternatively
    termed an examination support document (ESD)).  It would be nothing
    but folly for an applicant to comply with this rule except in cases
    where there is objectively no prior art to be cited.  Although such
    instances may exist (for example, where an International Search Report
    provides only "A" references), they can be expected to be both unlikely
    and rare.  The potential for a later determination that a patent is
    unenforceable for inequitable conduct in any other circumstance places
    applicants between the Scylla and Charybdis of the provisions of new
    Sections 123 and  298.

    Should S. 1145 contain provisions requiring
    evidence of recklessness (as in the willfulness standard recently
    announced by the Federal Circuit in In re Seagate) or actual
    intent to deceive (something like mens rea) to prove inequitable
    conduct, an applicant could comply with the proposed provisions and
    perhaps help the PTO achieve its goal of having applicants shoulder at
    least a part of the burden of identifying relevant prior art.  Of
    course, these provisions are not part of any pending proposal.  In
    addition, the PTO has issued a series of not so subtle threats that the
    Office of Enrollment and Discipline intends to monitor practitioner
    activity with regard to IDS submissions, including requiring that every
    reference submitted by a practitioner be personally reviewed by that practitioner (see "New Rules, New Threats: More on the Office of Enrollment and Discipline").  The Senate’s failure to address the changes to the inequitable
    conduct standard needed to enable applicants to comply with proposed
    new Section 123 puts applicants and their representatives in an
    impossible position, further suggesting that the intent of the backers
    of these changes is not to reform or improve U.S. patent law but to hamper it.  This will make it easier for them to use the exercise of
    their economic power to maintain their market dominance.  This is not
    only shortsighted but a national disaster in a world where global
    forces put the U.S. economy in the most precarious position it has been
    in since the early 1980’s.  For those with sufficient memories, that
    was before the existence of a robust patent system offered real
    protection for nascent American industries like biotechnology, and
    helped rescue this country from a fate of rust-bucket decline.  We may
    not be so lucky this time.

    For additional information on the draft report, please see:

    For additional information regarding this topic, please see:

  • Patent Profile: Senomyx Announces Issuance of “Sweet and Savory” Patents

        By Donald Zuhn —

    363846_senomyxlogo
    Senomyx, Inc. announced last week that it has been granted five U.S. patents directed to human umami and sweet taste receptors.  The patents are U.S. Patent Nos. 7,294,474; 7,297,543; 7,297,772; 7,301,009; and 7,309,577.  With the addition of the five new patents, the San Diego-based company, which uses proprietary taste receptor technologies to discover and develop novel flavor ingredients for the food, beverage, and ingredient supply industries, now has sixteen U.S. patents in its portfolio.

    Exec_zoller
    According Dr. Mark Zoller (at left), Senomyx Chief Scientific Officer and Executive Vice President of Discovery and Development, the five patents "add to Senomyx’s already extensive taste receptor patent franchise and expand upon [the company’s] earlier patents relating to the human sweet and umami (savory) taste receptors" (the five basic tastes include sweetness, sourness, bitterness, saltiness, and umami — or savoriness).  Dr. Zoller explained that the new patents would strengthen Senomyx’s position regarding the use of the claimed taste receptors in screening assays designed to identify new flavor ingredients that induce or modulate sweet and savory tastes.  For example, Senomyx has used taste receptor assays similar to those claimed in the new patents to discover S2383, an enhancer of the artificial sweetener sucralose, and S5742, an enhancer of sucrose (table sugar).  Senomyx is currently involved in product discovery and development collaborations with Ajinomoto Co., Inc., Cadbury Schweppes, Campbell Soup Company, The Coca-Cola Company, Firmenich SA, Nestlé SA, and Solae, LLC.

    Representative independent claims 1 and 40 of the ‘474 patent, which issued from U.S. Application No. 10/725,475, recites:

    1.  A method for identifying a compound that potentially modulates a T1R2/T1R3 receptor comprising:
        (i) screening one or more compounds in a functional assay that detects compounds which modulate (enhance or inhibit) the activity of the T1R2/T1R3 receptor by another compound; and
        (ii) identifying compounds that potentially modulate the T1R2/T1R3 receptor-based on their modulation (enhancement or inhibition) of the activity of the T1R2/T1R3 receptor by another compound, wherein said T1R2 is a T1R2 polypeptide and is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 10, (ii) encoded by a nucleic acid sequence comprising a nucleic acid that hybridizes to SEQ. ID. NO: 10 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, and 1% SDS and washing at 65o C. in a solution comprising 0.2xSSC and 0.1% SDS, or (iii) a T1R2 polypeptide possessing at least 90% sequence identity to the T1R2 polypeptide of SEQ. ID. NO: 6;
        wherein said T1R3 is a T1R3 polypeptide and is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 9; (ii) encoded by a nucleic acid sequence that hybridizes to SEQ. ID. NO: 9 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, 10% SDS; and washing at 65o C. in a solution comprising 0.2xSCC and 0.1% SDS, or (iii) a T1R3 polypeptide possessing at least 90% sequence identity to the T1R3 polypeptide of SEQ. ID. NO: 7;
        and wherein said T1R2/T1R3 receptor specifically binds to a ligand that specifically binds to an endogenous (wild-type) human T1R2/T1R3 receptor comprised of at least one endogenous T1R2 polypeptide and at least one endogenous T1R3 polypeptide.

    Representative independent claims 1 and 40 of the ‘543 patent, which issued from U.S. Application No. 10/725,103, recite:

    1.  An isolated recombinant cell that expresses a heteromeric taste receptor, wherein said receptor is comprised of at least one T1R2 polypeptide and at least one T1R3 polypeptide, wherein said T1R2 polypeptide is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 10, (ii) encoded by a nucleic acid sequence comprising a nucleic acid that hybridizes to SEQ. ID. NO: 10 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, and 1% SDS and washing at 65o C. in a solution comprising 0.2xSSC and 0.1% SDS, or (iii) a T1R2 polypeptide possessing at least 90% sequence identity to the T1R2 polypeptide of SEQ. ID. NO: 6;
        wherein said T1R3 polypeptide is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 9; (ii) encoded by a nucleic acid sequence that hybridizes to SEQ. ID. NO: 9 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formaniide [sic], 5xSSC, 10% SDS; and washing at 65o C. in a solution comprising 0.2xSCC and 0.1% SDS, or (iii) a T1R3 polypeptide possessing at least 90% sequence identity to the T1R3 polypeptide of SEQ. ID. NO: 7;
        and wherein said isolated cell expresses a heteromeric taste receptor that specifically binds to a ligand that specifically binds to an endogenous (wild-type) human heteromeric T1R2/T1R3 receptor comprised of at least one endogenous T1R2 polypeptide and at least one endogenous T1R3 polypeptide.

    40.  An isolated eukaryotic recombinant cell that expresses a heteromeric taste receptor, wherein said receptor is comprised of at least one T1R2 polypeptide and at least one T1R3 polypeptide, wherein said T1R2 polypeptide is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 10, (ii) encoded by a nucleic acid sequence comprising a nucleic acid that hybridizes to SEQ. ID. NO: 10 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, and 1% SDS and washing at 65o C. in a solution comprising 0.2xSSC and 0.1% SDS, or (iii) a T1R2 polypeptide possessing at least 90% sequence identity to the T1R2 polypeptide of SEQ. ID. NO: 6;
        wherein said T1R3 polypeptide is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 9; (ii) encoded by a nucleic acid sequence that hybridizes to SEQ. ID. NO: 9 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, 10% SDS; and washing at 65o C. in a solution comprising 0.2xSCC and 0.1% SDS, or (iii) a T1R3 polypeptide possessing at least 90% sequence identity to the T1R3 polypeptide of SEQ. ID. NO: 7;
        and wherein said isolated cell expresses a heteromeric taste receptor that specifically binds to a ligand that specifically binds to an endogenous (wild-type) human heteromeric T1R2/T1R3 receptor comprised of at least one endogenous T1R2 polypeptide and at least one endogenous T1R3 polypeptide.

    Representative independent claim 1 of the ‘772 patent, which issued from U.S. Application No. 10/725,037, recites:

    1.  An isolated heteromeric receptor comprising at least one T1R2 polypeptide and at least one T1R3 polypeptide, wherein said T1R2 polypeptide is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 10, (ii) encoded by a nucleic acid sequence comprising a nucleic acid that hybridizes to SEQ. ID. NO: 10 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, and 1% SDS and washing at 65o C. in a solution comprising 0.2xSSC and 0.1% SDS, or (iii) a T1R2 polypeptide possessing at least 90% sequence identity to the T1R2 polypeptide of SEQ. ID. NO: 6;
        wherein said T1R3 polypeptide is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 9; (ii) encoded by a nucleic acid sequence that hybridizes to SEQ. ID. NO: 9 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, 10% SDS; and washing at 65o C. in a solution comprising 0.2xSCC and 0.1% SDS, or (iii) a T1R3 polypeptide possessing at least 90% sequence identity to the T1R3 polypeptide of SEQ. ID. NO: 7;
        and wherein said heteromeric receptor comprised of at least on [sic] T1R2 polypeptide and at least one T1R3 polypeptide specifically binds to a ligand that specifically binds to an endoenous (wild-type) human heteromeric T1R2/T1R3 receptor.

    Representative independent claim 1 of the ‘009 patent, which issued from U.S. Application No. 10/725,080, recites:

    1. An isolated heteromeric receptor comprising at least one T1R1 polypeptide and at least one T1R3 polypeptide, wherein said T1R1 polypeptide is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 8, (ii) encoded by a nucleic acid sequence comprising a nucleic acid that hybridizes to SEQ. ID. NO: 8 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, and 1% SDS and washing at 65o C. in a solution comprising 0.2xSSC and 0.1% SDS, or (iii) a T1R1 polypeptide possessing at least 95% sequence identity to the T1R1 polypeptide of SEQ. ID. NO: 5;
        wherein said T1R3 polypeptide is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 9; (ii) encoded by a nucleic acid sequence that hybridizes to SEQ. ID. NO: 9 or under stringent hybridization conditions which are conducting the hybridization reaction at 42 [sic] C. in a solution comprising 50% formamide, 5xSSC, 10% SDS; and washing at 65o C. in a solution comprising 0.2xSCC and 0.1% SDS, or (iii) a T1R3 polypeptide possessing at least 95% sequence identity to the T1R3 polypeptide of SEQ. ID. NO: 7;
        and wherein said heteromeric receptor comprised of at least one T1R1 polypeptide and at least one T1R3 polypeptide specifically binds to a ligand that specifically binds to an endogenous (wild-type) human heteromeric T1R1/T1R3 receptor.

    Representative independent claim 1 of the ‘577 patent, which issued from U.S. Application No. 10/725,418, recites:

    1.  A method for identifying a compound that potentially modulates a T1R1/T1R3 receptor comprising:
        (i) screening one or more compounds in a binding assay which identifies compounds that specifically bind to a T1R1/T1R3 receptor or which specifically modulate (enhance or inhibit) the specific binding of another compound to a T1R1/T1R3 receptor; and
    (ii) identifying compounds that potentially modulate T1R1/T1R3 based on their (a) specific binding to a T1R1/T1R3 receptor or (b) modulation of the specific binding of another compound to a T1R1/T1R3 receptor, wherein said T1R1 is a T1R1 polypeptide and is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 8, (ii) encoded by a nucleic acid sequence comprising a nucleic acid that hybridizes to SEQ. ID. NO: 8 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, and 1% SDS and washing at 65o C. in a solution comprising 0.2xSSC and 0.1% SDS, or (iii) a T1R1 polypeptide possessing at least 95% sequence identity to the T1R1 polypeptide of SEQ. ID. NO: 5;
        wherein said T1R3 is a T1R3 polypeptide and is (i) encoded by a nucleic acid sequence comprising SEQ. ID. NO: 9; (ii) encoded by a nucleic acid sequence that hybridizes to SEQ. ID. NO: 9 under stringent hybridization conditions which are conducting the hybridization reaction at 42o C. in a solution comprising 50% formamide, 5xSSC, 10% SDS; and washing at 65o C. in a solution comprising 0.2xSCC and 0.1% SDS, or (iii) a T1R3 polypeptide possessing at least 95% sequence identity to the T1R3 polypeptide of SEQ. ID. NO: 7;
        and wherein said T1R1/T1R3 receptor specifically binds to a ligand that specifically binds to an endogenous (wild-type) human T1R1/T1R3 receptor comprised of at least one endogenous T1R1 polypeptide and at least one endogenous T1R3 polypeptide.

  • USPTO News: USPTO Announces Change to Acceptable Language in Oaths or Declarations

        By Christopher P. Singer —

    Uspto_seal_no_background
    In a Notice signed January 22, 2008, the U.S. Patent and Trademark Office announced that the language of oaths and declarations filed on or after June 1, 2008 will have to comply with the express language of 37 C.F.R. § 1.63.  That is, oaths and declarations will need to recite the language found in § 1.63(b)(3), which requires a person making the oath or declaration to acknowledge his or her duty to disclose all information known to that person to be "material to patentability as defined in § 1.56."  This language was entered in a 1992 amendment to that rule which read, "material to the examination of the application in accordance with § 1.56(a)."  In its Notice, the PTO indicated that applicants are still filing oaths and declarations containing the outdated language.  Failure to include the express language of § 1.63(b)(3) in an oath or declaration filed on or after June 1, 2008 will result in an objection from the Office that the document fails to comply with the requirements of the rule, and a supplemental oath or declaration filed under 37 C.F.R. § 1.67 will be required to remedy the problem.

    The Office is waiving this requirement in a number of situations including:  where an oath or declaration is filed prior to June 1, 2008 (with the understanding that use of the old language is effectively an acknowledgement of the duty to disclose information "material to patentability"); in continuation or divisional applications (not continuation-in-part applications) filed after June 1, 2008 and having a benefit claim under 35 U.S.C. § 120, where the oath or declaration is a copy of the previously accepted oath or declaration; and for issued patents in which the oath or declaration was filed prior to June 1, 2008.