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  • Court Report

            By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al.
    1:15-cv-00679; filed August 3, 2015 in the District Court of Delaware

    • Plaintiffs:  Janssen Biotech Inc.; Janssen Oncology Inc.; Janssen Research & Development LLC
    • Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Par Pharmaceutical Inc.; Par Pharmaceutical Companies Inc.

    Infringement of U.S. Patent No. 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer).  View the complaint here.  [NB: The complaint was voluntarily dismissed.]


    BTG International Ltd. et al. v. Actavis Laboratories FL, Inc. et al.
    9:15-cv-81076; filed August 3, 2015 in the Southern District of Florida

    • Plaintiffs:  BTG International Ltd.; Janssen Biotech Inc.; Janssen Oncology Inc.; Janssen Research & Development LLC
    • Defendants:  Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.; Actavis, Inc.

    Infringement of U.S. Patent Nos. 5,604,213 ("17-Substituted Steroids Useful in Cancer Treatment," issued February 18, 1997) and 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer).  View the complaint here.  [NB: The complaint was voluntarily dismissed.]


    Sanofi-Aventis US LLC et al. v. AstraZeneca Pharmaceuticals LP et al.
    1:15-cv-00662; filed July 31, 2015 in the District Court of Delaware

    • Plaintiffs:  Sanofi-Aventis US LLC; Sanofi-Aventis Deutschland GmbH
    • Defendants:  AstraZeneca Pharmaceuticals LP; Amylin Pharmaceuticals LLC

    Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 6,902,744 ("Exendin Agonist Formulations and Methods of Administration Thereof," issued June 7, 2005), 7,399,489 ("Exendin Analog Formulations," issued July 15, 2008), and 7,521,423 ("Exendin Pharmaceutical Compositions," issued April 21, 2009) based on Sanofi's filing of an NDA seeking approval to market in the U.S. its Lyxumia® product (lixisenatide, a GLP-1 agonist used for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control).  View the complaint here.


    IDEXX Laboratories Inc. et al. v. Charles River Laboratories Inc. et al.
    1:15-cv-00668; filed July 31, 2015 in the District Court of Delaware

    • Plaintiffs:  IDEXX Laboratories Inc.; IDEXX Distribution Inc.
    • Defendants:  Charles River Laboratories Inc.; Charles River Laboratories International Inc.

    Infringement of U.S. Patent Nos. 8,927,298 ("Sample Collection and Analysis," issued January 6, 2015), 8,945,945 (same title, issued February 3, 2015), and 9,040,308 (same title, issued May 26, 2015) based on Charles' River's marketing of its EZ-Spot® product, a dry whole blood spot sample collection method, using Multiplexed Fluorometric Immunoassay technology to detect virus, bacterial, and other contaminants, similar to IDEXX's Opti-Spot® product.  View the complaint here.


    Galderma Laboratories L.P. et al. v. Dr. Reddy's Laboratories Ltd. et al.
    1:15-cv-00670; filed July 31, 2015 in the District Court of Delaware

    • Plaintiffs:  Galderma Laboratories L.P.; Nestle Skin Health S.A.; TCD Royalty Sub LLC
    • Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.; Promius Pharma LLC

    Infringement of U.S. Patent Nos. 7,211,267 ("Methods of Treating Acne" issued May 1, 2007), 7,232,572 ("Methods of Treating Rosacea," issued June 19, 2007), 8,603,506 ("Once Daily Formulations of Tetracyclines" issued July 6, 2010), 7,749,532 ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), 8,206,740 ("Once Daily Formulations of Tetracyclines," issued June 26, 2012); 8,394,405 (same title, issued March 12, 2013); 8,394,406 (same title, issued March 12, 2013); 8,470,364 (same title, issued same title, issued March 12, 2013); and 8,709,478 (same title, issued April 29, 2014) following a Paragraph IV certification as part of Dr. Reddy's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Galderma's Oracea® (doxycyline delayed release capsules, used to treat inflammatory lesions of rosacea).  View the complaint here.


    Validus Pharmaceuticals LLC v. Aurobindo Pharma Ltd. et al.
    3:15-cv-05912; filed July 31, 2015 in the District Court of New Jersey

    • Plaintiff:  Validus Pharmaceuticals LLC
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Aurolife Pharma LLC

    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 Aurobindo's 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.

  • Conference & CLE Calendar

    CalendarNovember 4, 2015 - Patent Quality Roadshow (U.S. Patent and Trademark Office) – Western Michigan University Thomas M. Cooley Law School, Auburn Hills, MI

    November 4, 2015 - European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (ET)

    November 5, 2015 – "Objective Evidence in IPRs: Demonstrating Sufficient Nexus — Linking Evidence and Merits of Claimed Invention, Leveraging Prosecution Declarations" (Strafford) – 1:00 to 2:30 pm (EST)

    November 10, 2015 - Patent Quality Chat webinar series (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

    November 12, 2015 - Patent Quality Roadshow (U.S. Patent and Trademark Office) – North Carolina Central University School of Law, Durham, NC

    November 12, 2015 – "Leveraging Experts for USPTO Prosecution and PTAB — Developing Strong Patentability Records to Strengthen Claims Against IPR and PGR Challenges" (Strafford) – 1:00 to 2:30 pm (EST)

    November 12, 2015 – "Protecting Privilege: Patent Agents within the Bar and Attorneys Beyond the Border" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    November 16-17, 2015 – Patent Litigation 2015 (Practising Law Institute) – New York, NY

    ***Patent Docs is a media partner of this conference or CLE

  • AIPLA Webinar on Protecting Privilege

    AIPLA #1The American Intellectual Property Law Association (AIPLA) will be offering a webinar entitled "Protecting Privilege: Patent Agents within the Bar and Attorneys Beyond the Border" on November 12, 2015 from 12:30 – 2:00 pm (Eastern).  Jeffrey I. D. Lewis of Fried Frank Harris Shriver & Jacobson, LLP; Angela Sebor of GlobeImmune, Inc.; and Anthony C. Tridico of Finnegan Henderson Farabow Garrett & Dunner, LLP will discuss attorney-client privilege as applied to domestic patent agents and non-lawyer patent attorneys outside the United States.  The webinar will explore unsettled and often complex issues surrounding privilege and communications between U.S. patent agents or foreign patent practitioners and their clients, and address recent efforts by the USPTO and intellectual property organizations to engage stakeholders in a discussion of privilege for patent practitioners, as well as possible solutions for resolving current inconsistent treatment of privilege rules in the U.S. and abroad.

    The registration fee for the program is $95 (AIPLA member rate) or $150 (non-member rate).  Those interested in registering for the program, can do so here.

  • USPTO Enhanced Patent Quality Initiative Roadshows and Patent Quality Chat Webinar Series

    USPTO SealThe U.S. Patent and Trademark Office will be hosting patent quality roadshows on November 4, 2015 at the Western Michigan University Thomas M. Cooley Law School in Auburn Hills, MI and on November 6, 2015 at the North Carolina Central University School of Law in Durham, NC.  During the full-day roadshows, patent quality experts and executives will be on-hand and via remote presentation to lead discussions on clarity of the record, improving global patent prosecution, measuring patent quality, enhancing examiner interviews, and patent automation initiatives.  An agenda for the November 4 roadshow can be found here and an agenda for the November 6 roadshow can be found here.

    The USPTO will also be offering the next webinar in its Patent Quality Chat webinar series on November 10, 2015 from 12:00 to 1:00 pm (ET).  The latest webinar, which will be hosted by Deputy Commissioner for Patent Quality Valencia Martin Wallace and Senior Advisor Sandie Spyrou, will provide an update on the Enhanced Patent Quality Initiative (EPQI).  Ms. Spyrou will share a summary of the EPQI comments collected by the USPTO to date, and Ms. Wallace will discuss next steps that the USPTO is considering to be responsive to these comments as the Initiative moves forward.  Ms. Wallace and Ms. Spyrou will be encouraging feedback on how to improve these programs.

    Additional information regarding the Patent Quality Chat webinar series, including how to view the webinar online can be found here.

  • European Biotech Patent Law Webinar

    D Young & CoD Young & Co will be offering its next European biotech patent law update on November 4, 2015.  The 45-minute webinar will be offered at three times: 4:00 am, 7:00 am, and 12:00 pm (ET).  D Young & Co European Patent Attorneys Simon O'Brien and Catherine Mallalieu will provide an essential update and live Q&A on EPO biotechnology case law.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • USPTO Revises Rules to Facilitate Access to Applications and File Contents by Foreign IP Offices

    By Donald Zuhn —

    USPTO SealIn a notice published earlier this week in the Federal Register (80 Fed. Reg. 65649), the U.S. Patent and Trademark Office issued a final rule revising the rules of practice to permit applicants to authorize the USPTO to give certain foreign IP offices access to all or part of the file contents of an unpublished U.S. patent application in order to satisfy a requirement for information imposed on a counterpart application filed with the foreign IP office.  The final rule also revises the rules of practice so that applicants will  not be charged a fee when the USPTO provides a foreign IP office with an electronic copy of an application-as-filed or an electronic  copy of file contents.

    In addition to the rules changes, the notice indicates that the application data sheet (ADS) form (PTO/AIA/14) will be revised to include separate access authorizations for the priority document exchange (PDX) program and for the program by which U.S. search results are delivered to the European Patent Office (EPO).  The most noticeable difference between the prior ADS form and the revised ADS form will be that in the revised ADS form an "opt-out" check box rather than an "opt-in" check box will be included for each access authorization.  The notice notes that the revised ADS form will make it easier for applicants to give the necessary authorization for access to an application.

    The notice contains a specific discussion of the rules changes at pages 65651-52 and comments (and the USPTO's responses to those comments) that were received by the USPTO in response to a notice of proposed rulemaking that was published in July of 2014 at pages 65652-53.

    The changes in the final rule will take effect on November 30, 2015 and apply to all applications filed before, on, or after the effective date.

  • Pigs Fly, Hell Has Frozen Over, and the New York Times Supports Small Inventor and University Patenting

    By Kevin E. Noonan —

    New York TimesAdmittedly, only on its Op-Ed page.  But last Saturday Joe Nocera wrote a remarkably sane and reasoned column, entitled "The Patent Troll Smokescreen," pointing out that "big companies with large lobbying budgets" are using the patent troll meme to change patent law in their favor (but in ways that will not increase innovation, benefit the country or "promote progress" for anything other than their bottom lines).

    The column was prompted by the paradox that for some, like the Electronic Frontier Foundation, anyone who is a non-practicing entity (or NPE) and asserts a patent is a patent troll.  Mr. Nocera clearly understands the received wisdom about patent trolls:  they are NPEs that "use [their patents] not to further innovation or manufacture a product but to conduct a kind of legal extortion racket," based on patents that are "sometimes absurdly vague."  He cites as an example the Lemelson bar code patents (which of course were never accused of being vague but this is journalism so, close enough).  Patent trolls, Mr. Nocera writes, are "sand in the engine of commerce."

    But it is clear that Mr. Nocera has been taken aback by the rhetoric that patent trolls should include universities because "[w]henever the university's scientists come up with innovations — which they rarely intend to use to manufacture a product — WARF [who licenses patents from the University of Wisconsin] applies for a patent and then seeks to license it, just as trolls do."  Naively, he then states that "of course, nobody thinks a university is a patent troll" based on his (correct) understanding that "[u]niversities are supposed to come up with new ideas, not manufacture new products.  That's what companies do."  And he further understands that even anti-troll champions like Hastings College of Law Professor Robin Feldman recognizes the social utility of encouraging universities to license their patented technology, because it will "encourage the commercialization of new products."

    The social utility could be hampered, Mr. Nocera realizes, if the bills in Congress aimed at curtailing the type of "trolling" he disparages ends up "having huge negative consequences for legitimate inventors."  Or if "a series of Supreme Court rulings make matters worse, putting onerous burdens on inventors while making it easier for big companies to steal unlicensed innovations."  (The latter has, of course, already happened; see "The ACLU, Working for the Man").

    According to Mr. Nocera, those decisions and the AIA have created a situation where "big companies can now largely ignore legitimate patent holders."  And the companies doing it "don't call it stealing"; instead, they call it "efficient infringing" according to Robert Taylor, a patent lawyer for the National Venture Capital Association.  The result:  the big company expropriates patented technology and then has "top-notch" patent lawyers working for it to invalidate any patent asserted against it.  And "[b]ecause the courts have largely robbed small inventors of their ability to seek an injunction [] the worst that can happen is that the infringer will have to pay some money.  Which, for a rich company like, say, Apple, [is] no big deal," according to Mr. Nocera.  In Apple's case, the piece states that Apple has a policy, expressly stated on its website, that "the company can lay claim to any unsolicited [note, not unpatented] idea."  He then describes the lawsuit between Wisconsin and Apple and the $234 million judgment the WARF obtained against Apple for patent infringement.  But he mentions that this doesn't make Wisconsin whole, due to lost opportunity costs, stating that WARF didn't have the chance to license the technology exclusively to an Apple competitor, and in addition had to risk infringement litigation to obtain any recovery at all.

    The piece ends with a reminder that bills remain pending in both the House and Senate that "will [] effectively tilt the playing field even further toward big companies with large lobbying budgets" and states:

    For the sake of real innovation, and in the name of the small inventor, who holds a special place in America's mythology, the pendulum needs to start swinging in the other direction.

    Perhaps a measure of sanity will return to the patent law debate, if the Times Op-Ed editors saw fit to publish Mr. Nocera's column.  Patentees would do well to send a copy to their Senators and Representatives in Congress, and perhaps take the opportunity to engage legislators in a discussion of these issues.

    Because we can be sure that those "large lobbying budgets" are not going unspent by companies engaging in "efficient infringement."

  • Dynamic Drinkware, LLC v. National Graphics, Inc. (Fed. Cir. 2015)

    By Andrew Williams —

    Federal Circuit SealIt is well accepted that in order to establish that a patent is entitled to claim priority to a previously filed provisional application, it must be shown that the claims of the patent have written description support in the provisional.  Indeed, this is what 35 U.S.C. § 119(e)(1) requires:

    An application for patent filed under section 111 (a) or section 363 for an invention disclosed in the manner provided by section 112 (a) (other than the requirement to disclose the best mode) in a provisional application filed under section 111 (b), by an inventor or inventors named in the provisional application, shall have the same effect, as to such invention, as though filed on the date of the provisional application filed under section 111 (b) . . . .

    It has also been a commonly held belief that for a potentially invalidating prior art reference to be entitled to the filing date of a provisional application, the provisional application itself must contain the same invalidating disclosure.  In other words, it has been believed that if a provisional application contains an invalidating disclosure, any patent claiming priority and containing the same (although not necessarily verbatim) disclosure as that provisional would be prior art as of the provisional filing date.  However, last month, in Dynamic Drinkware, LLC v. National Graphics, Inc., the Federal Circuit explained that we were all doing it wrong.  Instead, just as with any other analysis ascertaining valid priority claims to provisional applications, it is the claims of the relevant patent that are important.  Or, as the Federal Circuit put it "[a] provisional application's effectiveness as prior art depends on its written description support for the claims of the issued patent of which it was a provisional."  Of course, this can create the odd situation (as explained below) where a provisional application contains no disclosure whatsoever related to the patent whose validity is being challenged, but it nevertheless can be used to establish an earlier priority date — provided the disclosure does support the claims of the invalidating patent reference.

    This case arose in the context of an IPR appeal from the Patent Trial and Appeal Board ("Board").  The technology was not particularly important for the issues addressed, but National Graphics' patent (U.S. Patent No. 6,635,196) was directed to making molded plastic articles bearing "lenticular" images.  Lenticular imaging is described on National Graphics website.  Dynamic Drinkware filed an IPR petition asserting that U.S. Patent No. 7,153,555 ("the Raymond patent") anticipated this patent.  The Board ultimately concluded that Dynamic had not meet its burden of establishing by a preponderance of the evidence that two of the claims of the '196 patent were anticipated under § 102(e)(2) because, in part, it did not prove that the Raymond patent was entitled to the provisional application filing date to which it claimed priority ("the Raymond provisional").  Importantly, the Board found it significant that Dynamic only compared a claim of the '196 patent to the Raymond provisional rather than comparing the portions of the Raymond patent relied upon to invalidate the '196 patent to the Raymond provisional.  Then, because the '196 patent claims were found to be reduced to practice between the filing dates of the Raymond provisional and the Raymond patent, the Board concluded that it was not invalidating prior art.

    The Federal Circuit first dealt with the issue of who had the burden of establishing either that the Raymond patent was entitled to the prior date of the Raymond provisional, or that the Raymond patent was not entitled to the earlier priority date.  Unsurprisingly, the burden of persuasion in establishing the invalidity of the '196 patent never shifted from the petitioner, Dynamic.  Instead, the relevant issue was the burden of production.  In this case, Dynamic initially asserted that the Raymond patent anticipated certain claims of the '196 patent.  This shifted the burden of production to the patent owner.  National had two options for meeting this burden; either argue that the Raymond patent did not anticipate, or, what National did, that it reduced to practice before the Raymond patent.  Once again, the production burden shifted, this time to Dynamic to prove that the potentially invalidating Raymond patent was entitled to the Raymond provisional filing date.  It did not meet this burden, and therefore did not meet the ultimate burden of proof.

    The Federal Circuit pointed out that Dynamic was basically arguing that a patent is presumptively entitled to the priority date of its provisional application.  This cannot be the case because the Patent Office does not routinely examine priority claims made in a patent application.  Only when it is necessary to make such a determination will the patent office do so, such as when an applicant attempts to overcome a prior art reference or in an interference setting.  See M.P.E.P. § 211.05(I)(A).  Therefore, the Federal Circuit concluded, such a presumption is incorrect.

    For its part, in arguing this appeal, National argued that Dynamic had waived the argument of the provisional filing date because it was not made in the original petition.  However, the Court pointed out that Dynamic did not need to raise such an argument in the first place, because the Raymond patent was considered to be prior art to the '196 patent until Dynamic established an earlier reduction to practice date.  It was only when the burden of production shifted that Dynamic was required to come forward with the provisional priority date argument.

    Finally, as referenced above, Dynamic's argument failed because it improperly made its priority claim to the Raymond patent.  The Court emphasized that "the relevance of the Raymond provisional application date here is not to give the Raymond patent any earlier priority over a competing application or patent, but to serve third party Dynamic's goal of creating earlier prior art against the '196 patent."  Therefore, because Dynamic did not compare the claims of the Raymond patent to the Raymond provisional, it could not prove that the patent was entitled to priority date.

    It goes without saying that as a practical consideration, any claim of priority to a provisional should focus of the claims of the patent for which priority is sought.  Of course, it might also be advisable to show where in the provisional the disclosure can be found that is relevant to the patent for which invalidation is sought.  The problem is that a scenario can be envisioned in which a provisional application contains disclosure "A," but a subsequent non-provisional application is filed adding disclosure "B."  This "B" disclosure could be identical to the claims of another patent with an earlier filing date than the non-provisional application.  The prior conventional wisdom was that this non-provisional application (or subsequent patent) could not invalidate this other patent, even if the provisional filing date was earlier, because the provisional did not contain the invalidating "B" disclosure.  According to Dynamic Drinkware, however, if this non-provisional application (or any resulting patent) only contained claims that were supported by disclosure "A," it would nevertheless be anticipatory with regard to the "B" disclosure.  While the potential for mischief on the part of patent applicants is probably minimal, because there is still a one-year deadline for claiming priority to the provisional, it will be interesting to see how this new way of analyzing priority claims will play out.

    Dynamic Drinkware, LLC v. National Graphics, Inc. (Fed. Cir. 2015)
    Panel: Circuit Judges Lourie, Bryson, and O'Malley
    Opinion by Circuit Judge Lourie

  • PTAB Issues Questionable 101 Decision

    Ex parte Nathan Victor Bak, Elizabeth Baruka Silberg, Yelena Bayeva, Sukadev Bhattiprolu, And Alexis Hope Bruemmer

    By Joseph Herndon —

    The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has likely seen an increase in the number of appealed rejections under 35 U.S.C. § 101 due to the Supreme Court's decision in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S.Ct. 2347 (2014).  A review of a recent decision shows some inconsistencies in the application of the framework set forth in Alice.

    On October 19, 2015, the PTAB issued a Decision on Appeal for U.S. Application No. 12/822,772 (Appeal 2013-009289) in Ex parte Nathan Victor Bak, Elizabeth Baruka Silberg, Yelena Bayeva, Sukadev Bhattiprolu, and Alexis Hope Bruemmer.  The Appeal Brief identified the Real Party in Interest as International Business Machines Corporation, the assignee of the patent application.

    The invention described in the patent application "relates to the automated scheduling of meetings on calendars and the organization of such calendars of invitees based upon the importance of a set of predetermined attributes of such meetings."  Independent claim 1 is reproduced below.

    1.    In a network of computer controlled user interactive display stations, a method for the scheduling of meetings on the calendars of invitee users comprising:
        prompting an inviter, at a sending display station, to enter into an invitation a predetermined set of general attributes for the scheduled meeting;
        enabling each invitee to predetermine a set of invitee-specific attributes applicable to each invitation; and
        enabling each invitee to prioritize each predetermined general attribute and each invitee-specific attribute to a numerical priority level to determine the priority of said meeting on the invitee's calendar.

    The Examiner rejected claim 1 (and claims 2-8 dependent upon claim 1) under 35 U.S.C. § 101 as being directed to non-statutory subject matter.  Additionally, the Examiner rejected all pending claims 1-20 under 35 U.S.C. § 103(a).

    With respect to the § 101 rejection, the Examiner stated that "none of the recited steps in claim 1 are explicitly or inherently performed using a particular machine; thus, no particular machine imposes a meaningful limit on the scope of the claims."  The Examiner also determined that in claim 1 "no subject matter transforms into a different state or thing."  The Examiner determined that Appellants' method of scheduling meetings on calendars of invitee users is an abstract idea that is not eligible for patenting.

    After the mailing of the Examiner's Answer, the Supreme Court issued its decision in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S.Ct. 2347 (2014), and thus, the Board applied the framework set forth in Alice for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.

    Step 1: Are the claims at issue directed to a patent-ineligible concept?

    For the analysis of Step 1, the Board simply paraphrased claim 1, and then stated "[w]e determine that, when read as a whole, independent claim 1 constitutes a patent-ineligible abstract idea — i.e., the claim is directed to the abstract idea of scheduling a meeting."

    Such analysis is troubling since there is no reasoning given for why this concept of "scheduling a meeting" is an abstract idea.  Presumably, following such absence of reasoning, any idea whatsoever can be considered to fall within the "abstract idea" prong of patent-ineligible concepts, and it is only whether the claim is found to satisfy step 2 that section 101 will be satisfied.  The Board must give some rationally based reasoning for why this claim's features for scheduling a meeting are directed to an abstract idea, or why even the act of scheduling a meeting itself is directed to an abstract idea.  Not much is required, but some reasoning is needed to hold the Board accountable.

    For example, even if the claims can be considered to be directed to an abstract idea as asserted by Board, the Board has not shown that the claims would preempt all applications of the alleged abstract idea, and failed to provide any reasoning to show that the specific combination of features recited by the claims will "disproportionately [tie] up the use of the underlying idea," thereby pre-empting all applications of the abstract idea, which the Supreme Court stated is the "concern that undergirds our § 101 jurisprudence" (Alice Corporation Pty. Ltd. v. CLS Bank Int'l, slip op. at 13).  In particular, the Board did not identify a single previously known application that would be preempted by the presently claimed combination of features.  Rather, the Board offered mere conclusory statements without identifying any particular facts in the record of this application that support the stated conclusion.

    Step 2: Is there something else in the claim which ensures that the claim is directed to "significantly more" than a patent-ineligible concept?

    The analysis of Step 2 should have been more cursory than the analysis of Step 1, since here, the recitation of a network of computer controlled user interactive display stations and a sending display station in claim 1 amounts to nothing more than generic components insufficient to transform the claim into a patent-eligible application.

    However, the Board provided further reasoning here and stated that "[t]aking the elements of claim 1 separately, for example, the function performed by the computer display at the claimed step of the process is purely conventional."  This reasoning, of course, contradicts the requirements of considering the claim as a whole, and so, such reasoning is further flawed.

    Perhaps equally troubling is that of the pending claims 1-20, only claims 1-8 stand rejected under 35 U.S.C. § 101.  However, assuming the § 101 analysis by the Board is correct (despite flawed or non-existent reasoning), then the other two independent claims 9 and 13 must fall as well with claim 1.  Independent claims 9 and 13 are reproduced below.

    9.    A computer controlled system, for the scheduling of meetings on the calendars of invitee users in a network of computer controlled user interactive display stations, comprising:
        a processor; and
        a computer memory holding computer program instructions which when executed by the processor perform the method comprising:
        prompting an inviter, at a sending display station, to enter into an invitation an predetermined general set of attributes for the scheduled meeting;
        enabling each invitee to predetermine a set of invitee-specific attributes applicable to each invitation; and
        enabling each invitee to prioritize each predetermined general attribute and each invitee-specific attribute to a numerical priority level to determine the priority of said meeting on the invitee's calendar.

    13.    A computer usable storage medium having stored thereon a non-transitory computer readable program for the scheduling of meetings on the calendars of invitee users in a network of computer controlled user interactive display stations, wherein the computer readable program when executed on a computer causes the computer to:
        prompt an inviter, at a sending display station, to enter into an invitation a predetermined set of general attributes for the scheduled meeting;
        enable each invitee to predetermine a set of invitee-specific attributes applicable to each invitation; and
        enable each invitee to prioritize each inviter-predetermined general attribute and each invitee-specific attribute to a numerical priority level to determine the priority of said meeting on the invitee's calendar.

    Independent claim 9 recites a traditional "computer" claim with functions that mirror the functions of the method claim 1, and independent claim 13 recites a traditional computer-readable medium (CRM) claim with functions that also mirror claim 1.  Alice was clear that a statutory category of a claim does not impact the analysis of patent-eligibility of the claim.  Thus, it would appear that all claims should be rejected under section 101.

    Since the rejection of claims 1-8 under 35 U.S.C. § 101 was affirmed, the Board designated the rejection as a new ground of rejection, to the extent the rationale differed from that set forth by the Examiner, and Section 41.50(b) provides that "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review."  Thus, the Applicant has two months from the date of the decision to (1) Reopen prosecution and submit an appropriate response, or (2) Request rehearing.

    As a note, with respect to the § 103 rejections, the Board reversed the Examiner's rejections since the cited art failed to describe all features of the independent claims.

    As a take-away from this Decision, with the increase of § 101 rejections being levied upon Applicants by Examiners and the Board at the USPTO, Applicants must be diligent in forcing strict application of the framework set forth by Alice to avoid rejections unsupported by rationale reasoning.  Otherwise, literally any claim can be called into question as directed to some kind of "abstract idea".

  • Natera Responds to Sequenom’s Petition for Rehearing En Banc

    By Donald Zuhn –-

    NateraLast week, Appellee Natera, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En Banc") (a summary of the response filed by Appellee Ariosa Diagnostics, Inc. can be found here).  In its response, Natera argues that in affirming a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"), the Ariosa panel "faithfully applied Mayo, Myriad, and Alice to conclude that the asserted claims are ineligible for patenting."  Natera suggests that "[a]t bottom, Sequenom and its amici disagree with the Supreme Court's jurisprudence on patent-eligibility," but contends that the Federal Circuit is "constrained to follow precedent" and therefore asserts that Sequenom's petition should be denied.

    Arguing that the Federal Circuit panel correctly found the asserted claims to be patent ineligible, Natera explains that:

    The asserted claims are drawn to the discovery that cell-free fetal DNA (cffDNA) circulates organically in maternal plasma, which is an ineligible natural phenomenon under Myriad, 133 S. Ct. at 2111.  The claims apply only routine analytical methods (such as amplification and detection) to that natural phenomenon, which is insufficient to confer patent-eligibility under Mayo, 132 S. Ct. at 1297–98.

    As for the doctrinal and policy objections raised by Sequenom and its amici, Natera contends that:

    The very same arguments were presented, often by the same amici, to the Supreme Court in the Mayo–Myriad–Alice trilogy.  The Supreme Court rejected those arguments, expressly or implicitly, in adopting its eligibility framework.  Since this Court does not sit to check the Supreme Court's work, the recycled objections to that framework now presented by Sequenom and its amici cannot support review or revision, much less reversal, of the panel decision.

    Natera points out that "[n]ovelty and non-obviousness are necessary, but not sufficient, preconditions to patentability," adding that these requirements "do not substitute for the independent (and antecedent) requirement of patent-eligibility."  According to Natera, "[i]f novelty and non-obviousness were all that is required, patentees would be able to monopolize natural phenomena where, as here, the existence or utility of the phenomenon was not known or obvious before the discovery."  Natera argues, however, that "[t]he proper Section 101 eligibility inquiry, by contrast, assumes that knowledge of the phenomenon is in the public domain, where it rightfully belongs," and suggests that the instant case "illustrate[s] the wisdom of this dichotomy," because "[o]nce it was discovered that maternal plasma contains cffDNA, the application of routine analytical methods to that plasma and its contents was a simple step."

    As for the argument made by Sequenom and its amici that the asserted claims recite an eligible application of the natural phenomenon that fetal DNA exists in maternal plasma, Natera counters that the asserted claims "amount to prototypical 'apply it' instructions, which Mayo squarely forecloses."

    With respect to the issue of complete preemption, Natera states that:

    Contrary to amici's suggestion, . . . complete preemption has never been required to hold claims ineligible.  See Flook, 437 U.S. at 597; Diehr, 450 U.S. at 204; Mayo, 132 S. Ct. at 1303.  Rather, "the underlying functional concern here is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor."  Mayo, 132 S. Ct. at 1303.  In this case, the patent contributes no invention: the newly discovered natural phenomenon is in the public domain, and the asserted methods were well-known in the prior art.  Thus, any preemption would be too much preemption. [emphasis in response]

    Natera also argues that the instant case "would be a particularly bad vehicle for rethinking preemption analysis, even if that path were not foreclosed by Mayo and Alice, because the claims asserted here, in fact, broadly preempt all known methods for detecting cffDNA in maternal plasma and making diagnoses therefrom."

    In response to the concerns expressed by Sequenom and its amici that the panel decision will deter investment and innovation in the biotechnology industry, Natera counters that "they do not address the deleterious effects of over-expansive patent monopolies covering natural phenomena, including the economic and social costs to the health care system in general, and pregnant women and their families in particular."

    In concluding that Sequenom's petition for rehearing en banc should be denied, Natera suggests that:

    Congress struck a delicate balance in Section 101, and the Supreme Court has maintained that balance in its recent trilogy of eligibility decisions.  As with their doctrinal arguments, the policy arguments advanced by Sequenom and its amici reflect no more than their disagreement with the Supreme Court's precedents in this area.  They are free to take up their differences (once again) with the Supreme Court, or they may use these arguments to urge legislative change, but under the extant statute as authoritatively construed by the Supreme Court, the panel could not — and this Court cannot — adopt their policy agenda.