All Challenged Claims Found To Be Drawn To Unpatentable Subject Matter CBM2014-00079

Takeaway: An improved calculation, even when tied to a specific use, is unpatentable subject matter under § 101. In its Final Written Decision, the Board held that claims 1-17 of the ’196 patent are unpatentable under §101. The Board also … Continue reading

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  • Denying Institution Where Prior Art Merely Hopes a Certain Result Will be Useful IPR2015-01136

    Takeaway: A reference that supports a finding that one skilled in the art “hopes” a certain result will be useful in treating a disorder does not constitute applicable prior art because a “hope” may or may not come to pass. … Continue reading

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  • Politico says Goodlatte’s Innovation Act is dead in the water

    From Politico:

    The House’s patent reform bill appears dead in the water for now, partly due to biopharma’s demand for a carveout from the inter partes review process that Judiciary Chairman Bob Goodlatte rejected. Meanwhile, efforts to address the biotech industry’s concerns in the Senate’s companion PATENT Act drew the spotlight last week, when the Congressional Budget Office estimated an IPR exemption would cost $1.3 billion over a decade because of delayed competition from generic drugs. Pharma hopes to push a bill through the Senate and that the House will eventually come around. However, that’s unlikely to happen this fall, with a jam-packed congressional calendar and so many other players with their own sets of concerns on these bills.


    Recall back in June 2015 the Washington Post ran a story which included:

    “Chairman Goodlatte is continuing to work with all stakeholders and Members of the Committee to address concerns,” a committee aide said in a statement. “Chairman Goodlatte has tasked specific Members of the Judiciary Committee to work directly with stakeholders on ways to make improvements.”

    Update: A bipartisan group of lawmakers have pulled together a late amendment to the venue revisions that aims to address the biggest immediate concern of the bill’s proponents. Led by Republicans Blake Farenthold (Texas) and Darrell Issa (Calif.), and Democrat Zoe Lofgren (Calif.), the amendment could be the fix that holds the bill’s coalition together.

    “Let’s just say this whole process could’ve unraveled” without it, said a House aide. “It was closer than I think most people realize.”


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  • CAFC explicates evidentiary burdens when patent challenger relies on the disclosure of a provisional patent application

    From Dynamic Drinkware v. National Graphics, 2015-1214

    Dynamic argues that the Board erred in shifting the
    burden to Dynamic to prove that the Raymond patent was
    entitled to the filing date of its provisional application.
    According to Dynamic, as a presumptively valid prior art
    patent, Raymond’s presumed effective date is its February
    15, 2000 provisional application filing date. Dynamic
    contends that it made a prima facie showing that Raymond
    was thus prior art to the ’196 patent under § 102(e)
    as of its provisional date, and, under Giacomini, the
    burden should have shifted to National Graphics to prove
    that Raymond was not entitled to the filing date of its
    provisional application.
    In response, National Graphics argues that the Board
    properly placed the burden of proof on Dynamic to support
    its contention that the Raymond provisional application
    provided written description support for the claims of
    the Raymond patent. According to National Graphics,
    priority claims are not examined by the PTO as a matter
    of course, and consequently are not entitled to a presumption
    of adequate written description support in the provisional

    We agree with National Graphics that the Board did
    not err in placing the burden on Dynamic, the petitioner
    in the inter partes review, to prove that the prior art
    Raymond patent was entitled to the filing date of its
    provisional application. As an initial matter, and to
    clarify the relative burdens, we begin with the established
    concept that there are two distinct burdens of proof: a
    burden of persuasion and a burden of production. See
    Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316,
    1326–27 (Fed. Cir. 2008). The burden of persuasion “is
    the ultimate burden assigned to a party who must prove
    something to a specified degree of certainty,” such as by a
    preponderance of the evidence or by clear and convincing
    evidence. Id. (citations omitted). In an inter partes
    review, the burden of persuasion is on the petitioner to
    prove “unpatentability by a preponderance of the evidence,”
    35 U.S.C. § 316(e), and that burden never shifts to
    the patentee. “Failure to prove the matter as required by
    the applicable standard means that the party with the
    burden of persuasion loses on that point—thus, if the fact
    trier of the issue is left uncertain, the party with the
    burden loses.” Tech. Licensing, 545 F.3d at 1327.
    A second and distinct burden, the burden of production,
    or the burden of going forward with evidence, is a
    shifting burden, “the allocation of which depends on
    where in the process of trial the issue arises.” Id. (citations
    omitted). The burden of production may entail
    “producing additional evidence and presenting persuasive
    argument based on new evidence or evidence already of
    record.” Id.

    These burdens are illustrated in Technology Licensing,
    where the patentee, TLC, sued Gennum for infringement,
    and Gennum argued that TLC’s patent was
    anticipated by certain prior art. Id. At issue was whether
    the asserted patent was entitled to the benefit of the
    priority date of a related nonprovisional application. Id.
    TLC argued that the asserted claim was entitled under 35
    U.S.C. § 120 to the benefit of the earlier filing date of its
    parent nonprovisional application. Id. Section 120, which
    has language similar to that found in § 119(e)(1), provides
    that a patent application for an “invention disclosed in the
    manner provided by the first paragraph of section 112 of
    this title in an application previously filed in the United
    States . . . shall have the same effect, as to such invention,
    as though filed on the date of the prior application . . . .”
    (emphasis added).
    Gennum, having the ultimate burden of proving its
    defense of invalidity based on anticipating prior art, also
    had the initial “burden of going forward with evidence
    that there is such anticipating prior art.” Tech. Licensing,
    545 F.3d at 1327. In response, TLC then had “the burden
    of going forward with evidence either that the prior art
    does not actually anticipate, or, as [TLC] attempted in
    this case, that it is not prior art because the asserted
    claim is entitled to the benefit of a filing date prior to the
    alleged prior art.” Id. We noted that “[t]his requires TLC
    to show not only the existence of the earlier application,
    but why the written description in the earlier application
    supports the claim.” Id. We concluded that once “TLC’s
    evidence and argument in support of the earlier filing
    date is . . . before the court, the burden of going forward
    again shifts to the proponent of the invalidity defense,
    Gennum, to convince the court that TLC is not entitled to
    the benefit of the earlier filing date.” Id. at 1328.
    The aforementioned shifting burdens and related priority
    claims under § 120 in district court litigation parallel
    the shifting burdens and related priority claims under
    § 119(e)(1) in inter partes reviews. Although, as Dynamic
    notes, the patent in Technology Licensing was entitled to
    the presumption of validity under 35 U.S.C. § 282, the
    different evidentiary standard in an inter partes review
    does not alter the shifting burdens between the parties
    because § 316(e) also places the burden of persuasion on
    the petitioner to prove unpatentability. Compare § 282
    (“The burden of establishing invalidity of a patent or any
    claim thereof shall rest on the party asserting such invalidity.”),
    with § 316(e) (“In an inter partes review . . . , the
    petitioner shall have the burden of proving a proposition
    of unpatentability by a preponderance of the evidence.”)

    In the present case

    In this case, Dynamic, as the petitioner, had the burden
    of persuasion to prove unpatentability by a preponderance
    of the evidence, and this burden never shifted.
    Dynamic also had the initial burden of production, and it
    satisfied that burden by arguing that Raymond anticipated
    the asserted claims of the ’196 patent under
    § 102(e)(2).

    The burden of production then shifted to National
    Graphics to argue or produce evidence that either Raymond
    does not actually anticipate, or, as was argued in
    this case, that Raymond is not prior art because the
    asserted claims in the ’196 patent are entitled to the
    benefit of a filing date (constructive or otherwise) prior to
    the filing date of Raymond. National Graphics produced
    evidence that the invention claimed in the ’196 patent
    was reduced to practice prior to the filing date of Raymond,
    and thus contended that the asserted claims were
    entitled to a date of invention prior to that of the Raymond
    As a result, the burden of production returned to Dynamic
    to prove that either the invention was not actually
    reduced to practice as argued, or that the Raymond prior
    art was entitled to the benefit of a filing date prior to the
    date of National Graphics’ reduction to practice. As the
    Board found, however, Dynamic failed to carry its burden
    of proving that Raymond’s effective date was earlier than
    the date that the invention claimed in the ’196 patent was
    reduced to practice. The burden of production was on
    Dynamic to prove that, under § 119(e)(1), Raymond was
    entitled to the benefit of the filing date of its provisional
    application, and it failed to do that.

    The reasoning of the CAFC:

    In contrast, Dynamic’s proffered approach would create
    a presumption that a patent is entitled to the benefit
    of the filing date of its provisional precursor, but that
    would be unsound because the PTO does not examine
    provisional applications as a matter of course; such a
    presumption is therefore not justified. The PTO’s Manual
    of Patent Examining Procedure (“MPEP”), which is
    “commonly relied upon as a guide to patent attorneys and
    patent examiners on procedural matters,” Litton Sys., Inc.
    v. Whirlpool Corp., 728 F.2d 1423, 1439 (Fed. Cir. 1984),
    explains this:

    If the filing date of the earlier provisional application
    is necessary, for example, in the case of an interference
    or to overcome a reference, care must be
    taken to ensure that the disclosure filed as the
    provisional application adequately provides (1) a
    written description of the subject matter of the
    claim(s) at issue in the later filed nonprovisional
    application, and (2) an enabling disclosure to
    permit one of ordinary skill in the art to make and
    use the claimed invention in the later filed
    nonprovisional application without undue experimentation.
    MPEP § 211.05(I)(A) (2014) (emphasis added). Thus,
    because the PTO does not examine priority claims unless
    necessary, the Board has no basis to presume that a
    reference patent is necessarily entitled to the filing date of
    its provisional application. See, e.g., PowerOasis, Inc. v.
    T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008)
    (“When neither the PTO nor the Board has previously
    considered priority, there is simply no reason to presume
    that claims in a [continuation-in-part] application are
    entitled to the effective filing date of an earlier filed
    application. Since the PTO did not make a determination
    regarding priority, there is no finding for the district court
    to defer to.”).
    Indeed, Dynamic’s reliance on Giacomini to argue for
    a presumption is misplaced.


    An issue here is “what” must be compared for the prior art patent to have the
    priority date of the provisional. The CAFC seemed to indicate the disclosure of the
    provisional must support the later claims of the related patent:

    We ultimately agree with National Graphics, however,
    that the Board’s decision was supported by substantial
    evidence because Dynamic failed to compare the claims of
    the Raymond patent to the disclosure in the Raymond
    provisional application
    . A reference patent is only entitled
    to claim the benefit of the filing date of its provisional
    application if the disclosure of the provisional application
    provides support for the claims in the reference patent in
    compliance with § 112, ¶ 1.
    In re Wertheim, 646 F.2d 527,
    537 (CCPA 1981).2 As Dynamic acknowledges, it provided
    charts to the Board comparing the claims of the ’196
    patent to the disclosure of the Raymond patent and claim
    1 of the ’196 patent to the disclosure of the Raymond
    provisional application.
    See, e.g., Appellant’s Br. at 22.
    Nowhere, however, does Dynamic demonstrate support in
    the Raymond provisional application for the claims of the
    Raymond patent. That was Dynamic’s burden. 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. Dynamic did not
    make that showing.

    Is the priority issue “all or none” or “claim by claim”?

    Wertheim notes:

    We emphasize that the above noted statutes, §§ 102(e), 120, and 112, speak with reference to some specific claimed subject matter by use of the terms emphasized. It is axiomatic in patent law that questions of description, disclosure, enablement, anticipation, and obviousness can only be discussed with reference to a specific claim which identifies “the invention” referred to in the statutes.

    Thus, the determinative question here is whether the invention claimed in the Pfluger patent finds a supporting disclosure in compliance with § 112, as required by § 120, in the 1961 Pfluger I application so as to entitle that invention in the Pfluger patent, as “prior art,” to the filing date of Pfluger I. Without such support, the invention, and its accompanying disclosure, cannot be regarded as prior art as of that filing date.


    To look at it another way, without the benefit of the Pfluger I filing date, that part of the reference patent disclosure relied upon cannot be said to have been incipient public knowledge as of that date “but for” the delays of the Patent and Trademark Office, under the Milburn rationale. Here, it cannot be said to have been “carried over” into the reference patent for purposes of defeating another’s application for patent under §§ 102(e)/103.

    The dictum in Lund,[4] supra, that

    * * * the continuation-in-part application is entitled to the filing date of the parent application as to all subject matter carried over into it from the parent application * * * for purposes of * * * utilizing the patent disclosure as evidence to defeat another’s right to a patent * * * [emphasis in original]

    is hereby modified to further include the requirement that the application, the filing date of which is needed to make a rejection, must disclose, pursuant to §§ 120/112, the invention claimed in the reference patent. Where continuation-in-part applications are involved, the logic of the Milburn holding as to secret prior art would otherwise be inapplicable. Without the presence of a patentable invention, no patent could issue “but for the delays of” the PTO.

    Cross-reference to two posts on PatentlyO

    Ex parte Yamaguchi (BPAI 2008)(Precedential Opinion)

    In prosecution, the Examiner cited the Narayanan reference against a Texas Instruments patent application filed by Yamaguchi. The rejection identified Narayanan as prior art under 35 U.S.C. § 102(e). The issue on appeal to the BPAI was whether the Narayanan reference can be considered 102(e) prior art as of the filing date of its provisional application.

    Section 102(e) allows for submarine prior art – these are typically pending US patent applications that, when published or patented, suddenly become prior art as of their filing date. The statute allows that “[a] person shall be entitled to a patent unless . . .the invention was described in . . .a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent.. . .” 35 U.S.C. § 102(e).

    102(e) Provisional: The issue here is whether Narayanan’s provisional application can be used in 102(e) analysis. The expanded BPAI panel agreed with the examiner that the 102(e) prior art date does reach-back to the date of provisional filing. This result is based on their analysis of 35 U.S.C. § 111(b). Section 111(b) requires that “provisions of this title relating to applications for patent shall apply to provisional applications for patent.”



    Federal Circuit Backtracks (A bit) on Prior Art Status of Provisional Applications and Gives us a Disturbing Result

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  • Lex Machina’s Copyright Litigation Report

    Following up on its Trademark Litigation Report, IP data analytics firm Lex Machina has recently released its Copyright Litigation Report (“Report”).  The Report reviews and gleans insight from copyright litigations filed in the U.S. Federal District Courts in the last five years.  The Report divides its analysis between “ordinary copyright” litigation as distinguished from “file sharing” litigation.  Notably, in 2014, there were 2138 “ordinary copyright” litigation cases filed and 2127 “file sharing” litigation cases.  Interestingly, the file sharing cases have spiked in the first half of 2015 to 1700.  The Report defines “[f]ile sharing cases . . . as copyright cases involving claims of infringement for BitTorrent/P2P file sharing brought against John Doe(s), anonymous defendants, their IP addresses, or Internet Service Providers (ISP).”  The top three federal districts for copyright filings include: the Central District of California, first; the Southern District of New York, second; and the Northern District of California, third.  The two districts in California dominate the filings with almost 2,500 since 2011 in the Central District of California (Los Angeles) and 400 since 2011 in the Northern District of California (San Francisco/San Jose/Palo Alto).  The Southern District of New York had 1,061 cases filed since 2011.  The Report notes that:

    Textile pattern litigation has risen greatly: looking at four leading plaintiffs in the space (Star Fabrics, Unicolors, L.A. Printex, and United Fabrics Int’l.) case filings have increased: from 67 in 2011 and 62 in 2012, to 87 in 2013, and 106 in 2014 (with 95 cases filed through June 30, 2015). Since 2009, these four parties have filed 546 cases. These companies are represented by the Doniger Burroughs law firm, causing that firm to be the top copyright plaintiffs firm as discussed below.

    The Report further notes that:

    Top plaintiffs include companies in the music (Broadcast Music, Sony/ATV Songs, Songs of Universal, UMG Records, EMI, and more), software (Microsoft), fashion (Coach), and textile  patterns (Star Fabrics) industries.

    Top Defendants include retailers (Ross Stores, TJX (TJ Maxx), Amazon, Burlington Coat Factory, Rainbow USA, J.C. Penny, Sears, Forever 21, Wal-mart, and Nordstroms), music labels (Universal Music, Sony Music Entertainment, UMG Recordings), and publishing / education (Pearson Education and John Wiley and Sons).

    The Report also states that fair use is “usually” resolved by summary judgment and includes other interesting findings such as, “About three quarters (72.9%) of those who successfully contest ownership / validity do so at summary judgment.”  In discussing file sharing, the Report states that many file sharing cases are brought by “erotic website owner” Malibu Media—around 4,322 cases.  On a very controversial issue—statutory damages in copyright cases, the Report notes that, “The District of Oregon, despite seeing 8 cases, awarded a median of less than $1,000 in statutory damages for consent/defaults, significantly less than the other busy districts. The Southern District of Indiana has the highest such median award ($51,800, 11 cases).”  The Report contains a wealth of interesting information and is available, here.  Enjoy!

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  • Denying Institution where Claimed Invention Merely Capable of Use with a Financial Service CBM2015-00078

    Takeaway: A covered business method patent is a patent that claims a method or apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, not a method or apparatus … Continue reading

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  • Board Boots Bass Tecfidera IPR On The Merits

    On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the Tecfidera IPR petition, The PTAB sidestepped Biogen’s argument that the institution should be denied because its “primary purpose” was to “depress stock prices … Continue reading this entry

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  • Assignor Estoppel and Contractual Bar Were Not Found As Defenses Against An IPR Challenge IPR2015-00781

    Takeaway: Patent Owner failed to establish that assignor estoppel is a defense under 35 U.S.C. § 314(a) given that 35 U.S.C. § 111(a) provides a broad statutory mandate that any third party requester may file a request for inter partes … Continue reading

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  • Is the label "patent death squad" appropriate for IPRs on pharma patents?

    FiercePharma reports:

    But how much do pharma companies need to worry about these patent reviews affecting their IP protection?

    According to an analysis of past IPR challenges, not a lot, Bernstein analyst Ronny Gal wrote in a Thursday note to clients. In 165 pharma cases so far, only 88 have gone through a decision on whether to institute review proceedings. Of those 88, the U.S. Patent and Trademark Office (PTO) has only chosen to fully institute proceedings 41 times, or in 47% of cases. That rate is “remarkably lower” than the 75%-plus rate across all sectors, which includes tech, he pointed out.

    And so far, only 7 cases have come to a final decision following the 12-month review process. All claims were found valid only 5 times, and all patents were invalidated only twice–for Suboxone and Vyvanse.


    His conclusion? It’s “not much of an ‘IP death squad,'” he wrote. While the comparatively speedy nature of IPR review has some drugmakers–and their investors–worried, the stats so far “suggest 15% of patents challenged via IPR are invalidated,” and that’s “reasonably similar to patent challenges via the court system.”

    “In short, it appears the IPR process is doing exactly what it is supposed to do–providing fast, low cost way to eliminate patents which should have never been granted,” he wrote.

    Of course, the sample size is still small, Gal cautioned; 26 more already-instituted cases are up for final decisions over the course of the next year, and that’ll provide a much larger sample set.

    IPBiz notes IPRs are about claims identified in the IPR, so the text — All claims were found valid only 5 times, and all patents were invalidated only twice–for Suboxone and Vyvanse. –



    As to the claim-centric nature of IPR, note this early discussion from :

    As of April 2, 2014, thirty-nine final decisions1 have issued in IPR proceedings. Challenged claims upon which trial was instituted survived in only five final written decisions.2 The petitioners of these thirty-nine IPRs had petitioned for review of a total of 668 claims. IPR trials were instituted for 80.5% of these claims (538 out of 668 claims). It should also be noted that only 36% of the grounds petitioned were actually instituted (137 out of 384 grounds). The most sobering number for patent owners is the percentage of claims found unpatentable in final written decisions: 95% (510 out of 538 claims).

    Note that the law firm Harness Dickey provides information on IPRs at the website:

    From the link one has the information on patent type challenged in IPR:

    454 Chemical and Biotech
    1826 Electrical and Computer
    696 Mechanical and Transportation
    13 Design

    and one has outcome information:

    4643 claims cancelled
    855 claims confirmed as patentable

    As to the rate of cancellation in the final written
    decision, grouped by subject matter:

    86% Chem/Bio
    86% Electrical/Computer
    77% Mechanical

    This information might seem in conflict with
    that discussed in the FiercePharma post, and might suggest
    Pharma companies do have something to worry about in IPR.

    Note also the paper by Brian Love, 81 U Chi L Rev Dialogue 93 , which includes the text

    Narrowing our focus further to IPRs with a decision on claim validity, we find that petitioners have also been quite successful before the PTAB on the merits of their challenges. As shown in Table 6, among instituted IPRs with a final decision on the merits, the PTAB eliminated all instituted claims almost 78 percent of the time. Among the same group, the PTAB eliminated all claims challenged in the petition 65 percent of the time, giving petitioners a complete victory almost two-thirds of the time that they pursued their IPRs to a final decision.

    Unlike acceptance rates, which are similar for both IPR and inter partes reexamination, the rate at which petitioners have succeeded on the merits of their petitions is markedly different: inter partes reexaminations ended in complete victory for the petitioner just 31 percent of the time, less than half as often as for IPR. In addition, over 60 percent of inter partes reexaminations ended with patentees securing new, amended claims.31 To date, the PTAB has granted just a single motion to amend—one that was both unopposed and filed by the United States itself.

    ****And from AIPLA, one has

    To date, almost every major medical device/technology company has been involved in at least one IPR.[14] In addition, generic pharmaceutical companies have been quick to utilize the IPR process to circumvent the traditional lengthy district court proceedings typical in Hatch-Waxman litigation.[15] However, in light of the potential offensive use of the IPR process by NPEs, life sciences companies would be advised to become expert at the IPR process in order to successfully meet this new challenge.

    Reference 15: Scott McKeown and Richard Kelly, “Generic Pharma Leverages PTAB” March 20, 2014, found at



    ***Elsewhere, on the blog patentlyO, in a post about “conflicts of interest”, one has a comment

    MM, how to you feel about Kyle Bass. He continues his piracy in the name of the public interest according to Greg A.

    “Hedge-fund manager Kyle Bass isn’t taking his early losses to the drug industry lightly. The Hayman Capital Management founder claims the Patent and Trademark Office is purposefully denying his challenges to drug patents because it finds him “too disruptive.”
    His response: File more cases targeting what he contends are patents of questionable validity that he said are protecting overpriced drugs from competition. “It’s clear they want us to go away,” Bass said Thursday in a telephone interview. “We’re not going away.”
    Bass has filed nine petitions challenging patents since Aug. 24, the day the Patent Trial and Appeal Board declined to review two Acorda Therapeutics Inc. cases. Four petitions filed Wednesday again challenge Acorda patents on the multiple sclerosis drug Ampyra.
    In all, Bass’s Coalition for Affordable Drugs has filed almost three dozen petitions since February. The Acorda petitions were rejected after the Patent Trial and Appeal Board said the information he provided wasn’t publicly available. A different three-judge panel on Sept. 1 said information of a clinical trial wasn’t evidence that could be used to challenge Biogen Inc.’s MS drug Tecfidera.
    “They threw Acorda out on a technicality; they threw Biogen out by ignoring the law,” Bass said. “They’re acting like a kangaroo court, and we are not going to stand for it.” Patrick Ross, a spokesman for the patent office, said the Alexandria, Va.-based agency had no comment.”

    “The fact that a hedge fund or others can file endless challenges to the same patents over and over again, forcing small companies like Acorda to divert their time, attention, and limited resources to fighting these improper attacks rather than focusing on bringing new cures to patients, is outrageous and offensive,” the Biotechnology Industry Organization said in a statement. “His abuse of this system highlights the need for reform.”
    Ardsley, N.Y.-based Acorda, in a regulatory filing, said it would oppose any effort to institute the review and defend its patents.
    Bass accused patent office director Michelle Lee of directing the judges to find ways to not institute any reviews. “What Michelle Lee and the PTAB need to do is call balls and strikes and not try to change the rules of the game that were legislated to them by Congress,” Bass said.
    By law, the board’s administrative patent judges are independent of oversight by the director. Their decisions on whether to begin a review or not can’t be appealed.
    Bass can ask the panels to reconsider their decisions, but most of those requests are denied, said Lana Gladstein, a patent attorney with the Boston firm of Nutter McClennen & Fish, who’s been involved in other cases before the board.
    In both the Acorda and Biogen cases, the drug makers argued that Bass is misusing the system to make money by undermining drug patents. Neither panel addressed that issue. A different three-judge panel has asked Bass and Shire PLC’s NPS Pharmaceuticals to provide legal arguments on whether that should be a consideration. NPS is scheduled to file its arguments next week, with Bass given another seven business days to respond.
    The board has allowed third parties to proceed with other petitions. In those instances, it’s been a group like Unified Patents, which collects money from technology companies to challenge patents that are being asserted in specific fields.
    Bass said he is motivated both by the desire to make money and an urge to “go after the worst offenders” when it comes to drug pricing and patent quality.
    “If not me, then who?” Bass said. “I don’t see anyone else hiring legal teams with purely altruistic motives.”

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  • BIO’s Jim Greenwood addresses the challenges of Kyle Bass to patent claims on Acorda’s Ampyra

    A press release from BusinessWire presented the opinion of BIO’s Jim Greenwood
    on the recent activities of Kyle Bass:

    The following statement may be attributed to BIO President and CEO Jim Greenwood:

    “Billionaire hedge fund manager Kyle Bass continues to attack biotechnology companies with endless series of Inter Parte Review (IPR) challenges to legitimate patents. Bass has filed more than a dozen such IPR challenges in August alone. The most recent examples – four new IPR filings yesterday against Acorda Therapeutics – are particularly egregious, coming on the heels of Bass’ prior failed attempt to attack two of those same patents covering Acorda’s innovative multiple sclerosis drug Ampyra.

    “The fact that a hedge fund or others can file endless challenges to the same patents over and over again, forcing small companies like Acorda to divert their time, attention and limited resources to fighting these improper attacks rather than focusing on bringing new cures to patients, is outrageous and offensive. His abuse of this system highlights the need for reform.

    “BIO again calls on the Patent and Trademark Office (PTO) and Congress to quickly take action to stop this abuse, which is threatening to undermine the medical innovation system in this country.”

    IPBiz notes that the AIA, in defining the procedure for IPRs, expressly allowed third-party non-competitors
    to file IPRs. The same was true for the IPR predecessor, inter partes re-examination.

    In the specific case of the Bass challenge to a patent on Acorda’s Ampyra, PTAB denied institution of an IPR
    on the basis that Bass had not presented sufficient evidence that the art in question qualified as
    a printed publication under the guidelines set out in Klopfenstein case, which determined that the poster
    presentation in that case was a “printed publication.” The PTAB ruling did not address whether or not
    the prior art (Goodman) would have rendered the Acorda claims invalid. This decision invited additional
    filings by Bass, which is indeed an unfortunate result for Acorda.

    FiercePharma has a post on the issue including the words “death squads”; upon visiting it one obtains:

    The website that you’re trying to reach is having technical difficulties and is currently unavailable.

    We are aware of the issue and are working hard to fix it. Thank you for your patience.

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  • Denying Institution Where Claim Interpretation Would Render Claim Terms Superfluous IPR2015-00353

    Takeaway: The Board will tend to disfavor a claim interpretation that would render a claim term or phrase superfluous. In its Decision, the Board concluded that a reasonable likelihood had not been shown that Petitioner would prevail as to at … Continue reading

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  • Media Rights loses appeal at CAFC

    Media Rights Technologies is a means-plus-function case:

    Media Rights Technologies, Inc. (“Media Rights”) appeals
    the district court’s decision to grant judgment on the
    pleadings that all claims of U.S. Patent No. 7,316,033 (the
    “’033 Patent”) are invalid for indefiniteness. Because the
    trial court correctly determined that the term “compliance
    mechanism,” which is a limitation in every single claim, is
    a means-plus-function term that lacks sufficient structure,
    we affirm.

    As to 35 USC 112:

    A claim fails to
    satisfy this statutory requirement and is thus invalid for
    indefiniteness if its language, when read in light of the
    specification and the prosecution history, “fail[s] to inform,
    with reasonable certainty, those skilled in the art
    about the scope of the invention.” Nautilus, Inc. v. Biosig
    Instruments, Inc., 134 S. Ct. 2120, 2124 (2014). Notably,
    a claim is indefinite if its language “might mean several
    different things and no informed and confident choice is
    available among the contending definitions.” Id. at 2130
    n.8 (quotation omitted). We review the district court’s
    indefiniteness determination de novo. See Interval Licensing
    LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed Cir.
    2014). Because the indefiniteness issue in this case is
    intertwined with claim construction, we review any
    factual determinations for clear error. See Atmel Corp. v.
    Info. Storage Devices, Inc., 198 F.3d 1374, 1379 (Fed. Cir.
    1999) (“[A] court’s determination of the structure that
    corresponds to a particular means-plus function limitation
    is indeed a matter of claim construction.”); see also Teva
    Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 836

    As to 112 P6:

    But this flexibility in claim drafting
    comes at a price. Such claims are construed to cover only
    “the structure, materials, or acts described in the specification
    as corresponding to the claimed function and
    equivalents thereof.” Williamson v. Citrix Online, LLC, _
    F.3d _, No. 2013-1130, 2015 U.S. App. LEXIS 10082, at
    *15 (Fed. Cir. June 16, 2015).
    “It is well settled that [a] claim limitation that actually
    uses the word ‘means’ invokes a rebuttable presumption
    that § 112, [¶] 6 applies.” Apex Inc. v. Raritan
    Comput., Inc., 325 F.3d 1364, 1371 (Fed. Cir. 2003) (quotation
    omitted). And, it is equally understood that “a
    claim term that does not use ‘means’ will trigger the
    rebuttable presumption that § 112, [¶] 6 does not apply.”
    Id. at 1371 (quotation omitted). But this presumption
    against the application of § 112, ¶ 6 to a claim term
    lacking the word “means” can be overcome if a party can
    “demonstrate[] that the claim term fails to ‘recite sufficiently
    definite structure’ or else recites ‘function without
    reciting sufficient structure for performing that function.’”
    Williamson, 2015 U.S. App. LEXIS 10082, at *19 (quoting
    Watts v. XL Sys., Inc., 232 F.3d 877, 880 (Fed. Cir. 2000)).
    “In undertaking this analysis, we ask if the claim language,
    read in light of the specification, recites sufficiently
    definite structure to avoid § 112, ¶ 6.” Robert Bosch, LLC
    v. Snap-On Inc., 769 F.3d 1094, 1099 (Fed. Cir. 2014)
    (citing Inventio AG v. Thyssenkrupp Elevator Ams. Corp.,
    649 F.3d 1350, 1357 (Fed. Cir. 2011)).


    Here, the district court properly determined that
    “compliance mechanism” is a means-plus-function term,
    and that the specification fails to adequately disclose the
    structure to perform all four of its functions. We agree
    with the district court that this fact renders all claims in
    the ’033 Patent indefinite. Accordingly, we affirm the
    district court’s grant of judgment of invalidity as to claims
    1–27 of ’033 Patent.

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  • Ivera wins reversal in Hospira case at CAFC

    The bottom line in Ivera v. Hospira at the CAFC was a reversal of summary judgment of invalidity:

    For the foregoing reasons, we hold that Ivera established
    a genuine dispute over whether one of ordinary
    skill in the art would have been motivated to add a vent
    to the disinfecting cap described in Hoang. Accordingly,
    we reverse the district court’s entry of summary judgment
    of invalidity.

    Judge Reyna began the decision:

    Ivera Medical Corp. (“Ivera”) sued Hospira, Inc.
    (“Hospira”) in the Southern District of California alleging
    infringement of U.S. Patent Nos. 7,780,794 (the ’794
    patent), 7,985,302 (the ’302 patent), and 8,206,514 (the
    ’514 patent). The district court granted summary judgment
    of invalidity, finding the asserted patent claims
    obvious under 35 U.S.C. § 103. Ivera appeals. For the
    reasons that follow, we reverse and remand.

    As to the prosecution history:

    In February 2007, Bobby Rogers and Paul DiPerna
    filed non-provisional application no. 11/705,805 (the “’805
    application”), which led to the ’794 patent. In response to
    a September 2009 Office Action, which rejected all of the
    claims as either anticipated by Hoang or obvious over
    Hoang and various secondary references, the applicant
    amended the claims to recite, inter alia, vents that allow
    for evaporation or drying of the cleaning agent. J.A.
    5412–18. In response, the examiner allowed the application.
    J.A. 5029–33. In the Notice of Allowance, the examiner
    stated that “the reviewed prior art does not disclose
    or render obvious a medical implement cleaning device
    comprising a cap having holes or openings for venting the
    device while in use,” J.A. 5033, and that Hoang does not
    disclose “vent holes, apertures, or additional openings to
    inhibit vacuum [sic] in the cap cleaning device.” J.A.
    5034. The ’794 patent issued thereafter in August 2010.
    The ’794 and ’302 patents were each subject to ex
    parte reexamination. In each of these proceedings, the
    examiner initially rejected the claims over various references.
    In at least the reexamination of the ’794 patent,
    the examiner considered the Hoang reference. J.A. 5097–
    98. The examiner determined that the challenged claims
    of the ’794 and ’302 patents were patentable over the cited
    prior art based at least partially on the vent limitations.
    J.A. 38; J.A. 54; J.A. 5097–98; J.A. 5161–62.
    Hospira later requested inter partes reexamination of
    the patents-in-suit, which the United States Patent and
    Trademark Office granted. After the examiner rejected
    claims in an Action Closing Prosecution (“ACP”), Ivera
    attempted to enter seven declarations, including one from
    an inventor of the Hoang reference, Minh Hoang, and
    another from Dr. Alan Buchman, the sole inventor of a
    prior art reference relied on during the inter partes reexaminations,
    but not at issue here. J.A. 5473. In the Right
    of Appeal Notice (“RAN”), the examiner determined that
    these declarations would not be considered because Ivera
    had not explained why this evidence was not presented
    earlier in the proceedings. J.A. 5473.

    Assessing the merits, the examiner rejected all of the
    challenged claims as obvious over the combination of
    Hoang and Chin-Loy (among other rejections). J.A. 5467–
    68, 5513–14, 5553–54. The examiner concluded that it
    would have been obvious to one of ordinary skill to include
    “the venting channel of Chin-Loy in the cap housing of
    Hoang because it would allow for venting from the cap
    interior while preventing the infiltration of microorganisms
    to maintain the sterile condition of the catheter
    access site.” J.A. 5468. The examiner also concluded that
    because threaded luer connections are not fluid-tight, a
    threaded opening (such as the ones disclosed in Hoang
    and White) can meet the vent limitations. See J.A. 5521.
    Ivera informs us that it is appealing the rejections to the
    Patent Trial and Appeal Board. Appellant’s Br. 18.

    As to the district court’s finding of obviousness:

    Considering the differences between the prior art and
    the claimed inventions, the court found that the “patentsin-suit
    contain the same elements that perform the same
    functions they had been known to perform in the prior
    art,” J.A. 16, and that the “arrangement of elements in
    the asserted claims do[es] not yield anything other than
    predictable results,” J.A. 18. The court noted, however,
    that Hoang does not disclose the vent limitations. J.A. 19.
    Still, a person of ordinary skill would not “need the benefit
    of hindsight to realize that adding a vent would relieve
    possible pressure on the inside of the cap.” J.A. 19.
    According to the court, a person of ordinary skill would
    recognize the benefits of adding a vent as allegedly taught
    in Chin-Loy, i.e., it would allow venting of the interior of
    the medical device through a blood port during sterilization.
    J.A. 19 (citing Chin-Loy col. 5 ll. 1–20). A person of
    ordinary skill would also recognize that adding a second
    opening would allow the cleaning agent to “vent onto the
    exterior of the medical implement, sterilizing a larger
    portion of it,” as allegedly described in White. J.A. 19
    (citing White col. 7 ll. 23–35). Thus, the district court
    determined that “the record demonstrates no triable issue
    of material fact on obviousness for the asserted claims of
    the patents-in-suit.” J.A. 20.

    The CAFC noted

    Ivera argues that a person of ordinary skill in the art
    would not have been motivated to add a vent to Hoang’s
    cap. Appellant’s Br. 33. Instead, the record shows, according
    to Ivera, that the conventional wisdom among
    those skilled in the art was that disinfecting caps should
    be fluid tight. Id. Hospira responds that Chin-Loy describes
    benefits of venting a cap, which would have motivated
    a person of ordinary skill to add a similar vent to
    Hoang’s cap. Appellee’s Br. 29. Hospira also cites the
    written description of the patents-in-suit as encouraging
    evaporation of cleaning agents. Id. A person of ordinary
    skill in the art would also have, according to Hospira,
    seen the benefit of bathing the exterior of a cap, as allegedly
    described in White. Id. at 31.
    We agree with Ivera that record evidence establishes
    a genuine dispute over whether a person of ordinary skill
    would have been motivated to add a vent to Hoang’s
    disinfecting cap. During the inter partes reexaminations,
    Ivera submitted multiple expert declarations. As noted
    above, the examiner decided not to consider these declara-
    tions because Ivera did not establish why it had not
    submitted them earlier. Hospira does not, however,
    challenge Ivera’s reference to these declarations at the
    summary judgment stage before the district court. The
    declarations indicate that a person of ordinary skill would
    have desired fluid-tight disinfecting caps to retain the
    cleaning agent included within the cap. For example,
    Ivera relies on a declaration from an inventor of the
    Hoang reference, Minh Hoang. In his declaration, Minh
    Hoang states that “[a]t the time of my invention, it was
    the understanding and belief of persons of ordinary skill
    in the art, such as myself, that such a cap should seal over
    the access portion of the access valve and retain the
    cleaning solution contained in the cap.” J.A. 5652.
    to the cap described in the Hoang reference, Minh
    Hoang explains the cap “avoided using any pathways or
    channels out of the housing of the cap during placement
    or use on the access valve, because doing so would allow
    an exit of the cleaning solution from the cap, which I
    believed would reduce the effectiveness of the cap.” J.A.
    5653. Although the statements of an inventor are not
    controlling as to the content of a patent application,
    Hospira does not challenge Minh Hoang’s assertion that
    he is a person of ordinary skill. I


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  • One Year Bar Triggered By Complaint Asserting the Reissue Patent, Not the Surrendered Patent IPR2014-00358

    Takeaway: Section 315(b) does not bar a petition for review of a reissue patent when the petition is filed within one year after the petitioner is served with a complaint alleging infringement of the reissue patent but more than one … Continue reading

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  • Institution Denied Where Articulated Reasoning Was Not Provided For Obviousness Ground IPR2015-00968

    Takeaway: Without articulated reasoning with some rational underpinning to support the legal conclusion of obviousness, a bare recitation of disparate claim elements in multiple prior art references is insufficient to render obvious a claim. In its Decision, the Board denied … Continue reading

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