• Coalition For Affordable Drugs Vii LLC v. Pozen Inc.Institution denied
  PTAB · Dec 17, 2015 · IPR2015-01344 · APJ Jacqueline Wright Bonilla · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–19 unpatentable over the asserted obviousness combinations or by anticipation.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “Petition (Paper 1, “Pet.”) requesting an inter partes review of claims 1–19 of U.S. Patent No. 8,858,996 B2 (Ex. 1001, “the ’996 patent”). Pozen Inc. (“Patent Owner”) filed a Preliminary Response. Paper 14 (“Prelim. Resp.”).1 Under 35 U.S.C. § 314, we may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “The specification of the ’996 patent does not define expressly the term “inhibit.” Considering the ordinary and customary meaning of the term in view of the specification and the claims themeselves, however, we construe “inhibit” to mean prevent (stop), hinder, or restrain. Ex. 1035, 2; Ex. 1036, 49; Ex. 2006, 3; Ex. 2007, 3. For example, claim 1 of the ’996 patent recites that “release of at least a portion” of napoxin “is inhibited unless the pH” is 3.5 or higher (emphasis added). Claim 12 recites a “coating that inhibits release of said naproxen from said core layer unless said dosage form is in a medium with a pH of 3.5 or higher” (emphasis added). Thus, “inhibits” refers to preventing, hindering, or restraining the release of naproxen “unless” the dosage form is exposed to a pH of 3.5 or higher. The use of “unless” in claim 1 and 12 and “at least a portion” in claim 1 indicates that the terms “inhibited” and 7 “inhibits” in the claims do not encompass a “slowing down” of a release when the pH is below 3.5 (which would make “at least a portion” superfluous in claim 1), but rather refers to no release of “at least a portion” (claim 1) or all (claim 12) of the drug “unless” the dosage form is at a pH of 3.5 or higher.” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “We agree that Petitioner has not established that the teachings of Goldman, Remington, and Lindberg would have given an ordinary artisan a reason to formulate a tablet with the structural and functional features required by the challenged claims. Although Goldman discloses a combination dosage form comprising a PPI and NSAID (discussed above), Petitioner does not point to anything in Goldman that describes or suggests adequately why one would have prepared, for any reason, a composition as claimed, where at least some PPI (i.e., esomeprazole) is released regardless of pH and the release of at least some NSAID (i.e., naproxen) is inhibited unless the pH is 3.5 or higher (e.g., via a coating). Moreover, although Goldman incorporates Remington’s discussion of oral solid dosage forms by reference (Ex. 1004, 6:26–33), Petitioner does not identify anything in Goldman that points to any particular dosage form 14 among the many disclosed by Remington. Goldman’s citation to Remington generally in relation to “[v]arious conventional techniques for preparing medicament tablets or caplets” does not persuade us that an ordinary artisan would have made the connection that Petitioner contends. Id.; Pet 11, 14– 16, 22–25. Nor does Petitioner explain adequately how Lindberg remedies the deficiencies discussed above in relation to Goldman and Remington.” slip op. at 14

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “In an inter partes review, the burden is on the petitioner to show a reasonable likelihood that it would prevail on a ground of unpatentability. 35 U.S.C. § 314(a). With respect to entitlement to any earlier effective filing date, however, a patent owner is not presumed to be entitled to the earlier filing dates of ancestral applications that do not share the same disclosure, such as in a continuation-in-part situation. Focal Therapeutics, Inc. v. SenoRx, Inc., Case IPR2014-00116, slip op. at 9 (Paper 8) (PTAB Apr. 22. 2014); see also PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305–06 (Fed. Cir. 2008) (stating that once a defendant establishes that a reference is § 102(b) prior art, burden is on patent owner to come forward with evidence proving priority to an earlier filing date). Nonetheless, a petitioner first must raise the issue by identifying, specifically, the features, claims, and ancestral applications allegedly lacking written description support for the claims based on the identified features. Focal Therapeutics, 24 Case IPR2014-00116, slip op. at 10 (Paper 8). Then, the patent owner must make a sufficient showing of entitlement to earlier filing date(s), in a manner that is commensurate in scope with the specific points and contentions raised by the petitioner. Id. Here, Petitioner cites nothing in the record to support its assertions regarding a lack of written description in the pre-2003 applications, other than to refer to those pre-2003 applications generally. Pet. 47–51. When asserting a “break in priority,” Petitioner does not identify, specifically, the features or claims that allegedly lack written description support. Instead, Petitioner discusses in very general terms what “the ’996 Patent claims are broad enough to encompass” and what the “pre-2003 applications disclose” (id. at 50–51) without referring to any specific challenged claim or providing specific citations to any specification at issue. Even if we assume Petitioner adequately raises the issue, however, we are persuaded that Patent Owner provides a sufficient showing of entitlement to the filing date of at least the ’216 application (the ’255 Publication), in a manner that is commensurate in scope with the points and contentions raised by Petitioner. For example, Patent Owner points to paragraphs 10, 13, and 82 in the ’255 Publication. Prelim. Resp. 35–38 (citing Ex. 1008 ¶¶ 10, 13, 82). Paragraph 10 describes a release of NSAID that “minimizes the adverse effects of the NSAID on the gastroduodenal mucosa.” Ex. 1008 ¶ 10 (emphasis added). Similarly, paragraph 13 describes “preferably provid[ing] for coordinated drug release” that 25 “reduces the deleterious effects of the NSAID on the gastroduodenal mucosa.” Id. ¶ 13 (emphasis added). Paragraph 13 also describes a “most preferred form” where an inner core is “surrounded by a polymeric barrier coating that does not dissolve unless the surrounding medium is at a pH of at least 3.5.” Id. (emphasis added). Paragraph 82 in Example 7 also refers to a coordinated delivery dosage that provides “the delayed release” of naproxen. Id. ¶ 82 (emphasis added). Although we recognize that the ’255 Publication (and indeed the ’996 patent specification itself) does not use the exact words “at least a portion” in relation to a release of naproxen, the ’255 Publication “does not have to describe exactly the subject matter claimed.” Vas–Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (citing In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989). Rather, the description must “‘reasonably convey[] to the artisan that the inventor had possession at that time of the later claimed subject matter.’” Id. at 1563 (quoting Ralston Purina Co. v. Far– Mar–Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985)). Thus, we consider whether the ’255 Publication as a whole conveys to one of ordinary skill in the art, either explicitly or inherently, that the inventors of the ’996 patent invented the subject matter claimed in the challenged claims. Reiffin v. Microsoft, 214 F.3d 1342, 1346 (Fed. Cir. 2000) (citing Vas–Cath, 935 F.2d at 1563). Here, words such as “minimizes,” “reduces,” and “delayed” in paragraphs 10, 13, and 82 in the ’255 Publication, as well as disclosure of 26 different preferred forms in paragraph 13, indicate that the inventors possessed a dosage form and/or coordinated drug release where a portion (e.g., a small portion) of the NSAID (e.g., “most preferred NSAID” naproxen (Ex. 1008 ¶ 12)) was released when the pH of the medium was below 3.5, even if most or nearly all of the drug was not released until the pH was 3.5 or higher. See, e.g., id. ¶ 13 (also stating in one sentence that in “a preferred embodiment, the unit dosage form is a multilayer tablet, having an outer layer comprising the acid inhibitor and an inner core which comprises the NSAID” without referring to when or under what conditions NSAID is released). Moreover, every species in a genus need not be described in order for the genus to meet the written description requirement. Regents of U. California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) (citing Utter v. Hiraga, 845 F.2d 993, 998–99 (Fed. Cir. 1988)). In this case, the genus at issue has two easily identified species, i.e., inhibiting the release of all or a portion of a drug unless a pH is reached, as opposed to a complex chemical genus, for example, encompassing a large number of possible species. Id.; see also Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1352 (Fed. Cir. 2011) (stating that whether disclosure of a species supports a genus “depends upon the state of the art and the nature and breadth of the genus,” finding sufficient support where the genus consisted of only two species). We are persuaded that the ’255 Publication as a whole conveys to one of ordinary skill in the that the inventors of the ’996 patent” slip op. at 24

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,858,996
• Bioactive Laboratories v. BTG International Inc.Institution denied
  PTAB · Dec 10, 2015 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim under the asserted anticipation and obviousness grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

    “on May 29, 2015, requesting an inter partes review of claims 1–22 of U.S. Patent No. 8,048,414 B1 (Ex. 1001, “the ’414 patent”). BTG International Inc. (“Patent Owner”) filed a Preliminary Response (Paper 12, “Prelim. Resp.”) on September 11, 2015.1 We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable

    “As discussed above, however, in an inter partes review, claim terms in an unexpired patent are interpreted according to their broadest reasonable construction in light of the specification of the patent in which they appear. The specification of the ’352 patent (which matured from the ’629 application), like the specification of the ’414 patent, discloses that “lethality-neutralizing . . . tests clearly established that the F(ab) fragment antibodies and IgG produced by the processes of this invention afford . . . protection against venom-induced pathophysiology” (Ex. 1004, 4:53–57), and that “F(ab)2 fragments [produced according to the invention] should also afford . . . protection against venom-induced pathophysiology” (id. at 4:66– 67). In addition, the specification of the ’352 patent, like the specification of the ’414 patent, discloses that “IgG, F(ab) fragments and F(ab)2 fragments often have separate utilities” and “F(ab) and F(ab)2 fragments may sometimes be used together.” Id. at 1:61–63. We are not persuaded that Petitioner has shown that the ’629 priority application (or the ’352 patent) fails to provide proper written descriptive support or enablement for claim 1. In a nutshell, we agree with Patent Owner that “construing the limitation to include compositions in which the Fab or Fab/F(ab)2 fragments do not neutralize the lethality of Crotalus venom is not reasonable in light of the specification.” Prelim. Resp. 25. That is, we agree that “[p]roperly construed, the claims cover a composition” slip op. at 10

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “As discussed above, however, in an inter partes review, claim terms in an unexpired patent are interpreted according to their broadest reasonable construction in light of the specification of the patent in which they appear. The specification of the ’352 patent (which matured from the ’629 application), like the specification of the ’414 patent, discloses that “lethality-neutralizing . . . tests clearly established that the F(ab) fragment antibodies and IgG produced by the processes of this invention afford . . . protection against venom-induced pathophysiology” (Ex. 1004, 4:53–57), and that “F(ab)2 fragments [produced according to the invention] should also afford . . . protection against venom-induced pathophysiology” (id. at 4:66– 67). In addition, the specification of the ’352 patent, like the specification of the ’414 patent, discloses that “IgG, F(ab) fragments and F(ab)2 fragments often have separate utilities” and “F(ab) and F(ab)2 fragments may sometimes be used together.” Id. at 1:61–63. We are not persuaded that Petitioner has shown that the ’629 priority application (or the ’352 patent) fails to provide proper written descriptive support or enablement for claim 1. In a nutshell, we agree with Patent Owner that “construing the limitation to include compositions in which the Fab or Fab/F(ab)2 fragments do not neutralize the lethality of Crotalus venom is not reasonable in light of the specification.” Prelim. Resp. 25. That is, we agree that “[p]roperly construed, the claims cover a composition” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “We agree with Patent Owner on this point—Chang explicitly characterizes both the Fab fragments and the purified antibody as “valuable tools for an immunochemical approach to the elucidation of the toxic nature 16 of snake venom” (Ex. 1005, 7), but only the purified antibody is mentioned in connection with “the therapy of snake bites” (id.), despite Chang’s observation that “[t]he specific neutralizing capacity of F I [the fraction containing Fab fragments] was even higher than that of the purified antibody” (id. at 4, Table II).” slip op. at 16

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,048,414
• Neptune Generics, LLC. v. Auspex Pharmaceuticals, Inc.Institution denied
  PTAB · Dec 9, 2015 · IPR2015-01313 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–10 were unpatentable under § 103(a).

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “An inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of claims 1–10. Accordingly, we decline to institute an inter partes review of the challenged claims.” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “We recognize that an obvious analysis requires us to consider whether an ordinary artisan would have had a reasonable expectation of success, not absolute predictability of success. In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988). We agree with Patent Owner, however, that Petitioner has not demonstrated that the ordinary artisan would have combined Fogelman with Miwa with a reasonable expectation of arriving at the invention claimed by the ’317 patent. Although Fogelman teaches that ODV may account for 90% of the pathway for intrinsic clearance of VF (Ex. 1003, 483), Fogelman 9 Amanda Yarnell, Heavy Hydrogen Drugs Turn Heads, Again, 87(25) Chem, Eng. News 36–39 (2009). teaches also that ODV has a receptor affinity profile similar to its parent compound VF (id. at 481). As noted by Patent Owner (Prelim. Resp. 32), Petitioner has not explained, through evidence or adequate scientific reasoning, why the ordinary artisan would have wanted to prevent the metabolism of VF to its pharmaceutically active metabolite, ODV. Stated differently, because ODV is a desired metabolite, as it has the same pharmacological activity as its parent compound, VF, Petitioner has not explained why the ordinary artisan would have had a reason to prevent VF from being metabolized to ODV, rather than only preventing metabolism to a non-active metabolite, or make a substitution that would prevent the further metabolism of ODV.” slip op. at 13

  • Obviousness (§103) › KSR rationalesNot shown unpatentable

    “We agree. In In re O’Farrell, the Federal Circuit set forth two situations in which an “obvious to try” rationale was usually applied improperly. In re O’Farrell, 853 F.2d at 903. The first improper situation was to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters are critical or no direction as to which of many possible choices is likely to be successful.” Id. The second improper situation was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.” Id.; see also In re Kubin, 561 F.3d 1351, 1358–1360 (Fed. Cir. 2009) (noting that the rationale in O’Farrell was “affirmed in the logical inverse” in KSR, 550 U.S. at 417, in a statement that “§103 bars patentability unless ‘the improvement is more than the predictable use of prior art elements according to their established functions.’”). Based on the above framework, we conclude that it would not have been obvious to try to achieve the invention of claim 1 of the ’317 patent. As noted by Patent Owner (Prelim. Resp. 35), and not disputed by Petitioner (see Pet. 10–11), there are approximately 227-1, or 124,217,727 deuterated forms of VF, minus some number of forms which are equivalent due to symmetry or rotatable bonds. Although Petitioner contends that as P-450 enzymes act on two main sites of VF—that is, -OCH3 and –N(CH3)2, arguing that it would have been obvious to deuterate only those sites (Pet. 10–11)—as discussed above, the ordinary artisan would not have had a reasonable expectation that deuteration of those sites would result in enhanced bioavailability and maintaining the activity of VF for a longer period of time. Thus, the ordinary artisan would be left with trying the over 100,000,000 possible deuterated forms of VF until possibly arriving at a successful result.” slip op. at 20

  • Additional discoveryAdditional discovery, deniedDenied

    “III. PENDING MOTIONS Patent Owner filed a Motion for Additional Discovery (Paper 9). In addition, Petitioner filed a Motion to Seal (Paper 18), as well as a Motion to Expunge Paper 17 (Paper 19). We grant Petitioner’s Motion to Expunge. We deny Patent Owner’s Motion for Additional Discovery as moot in view of our denial of the Petition. Finally, as we did not rely on the material Petitioner sought to seal, we decline to address the merits of the Motion to Seal. Petitioner is authorized to file a motion to expunge any material that it seeks to keep confidential within thirty (30) days of the date of this decision, or within thirty (30) days of a decision on rehearing, if rehearing is requested.” slip op. at 22

  § 103 obviousness
  Patents in suitUS 7,456,317
• Zhejiang Yankon Group, Ltd. v. Cordelia Lighting, Inc.Institution denied
  PTAB · Nov 25, 2015 · IPR2015-01420 · APJ Jacqueline T Harlow · IPR · Institution

  The Board denied institution because Zhejiang Yankon Group failed to identify Yankon-US as a real party-in-interest, and a corrected petition would be time-barred.

  RulingsInstitution decision

  • PTAB / AIA Trials › Real party in interest / privityInstitution denied rpiDenied

    “Because Cordelia provides sufficient rebuttal evidence that reasonably brings into question the accuracy of Yankon-China’s identification of real” slip op. at 17

  • PTAB / AIA Trials › §315(b) time barInstitution denied time barDenied

    “E. Corrected Petition Would Be Time-Barred The Petition was accorded a filing date of June 16, 2015. Paper 3, 1. At this stage of the proceeding, correction of the Petition to include Yankon- US as a real party-in-interest would require assignment of a new filing date. See 37 C.F.R. § 42.106(b). Granting Yankon-US a new filing date would be futile in this instance because, even if corrected, the earliest filing date that could be accorded to the Petition would fall outside the one-year time bar for pursuing inter partes review set forth in 35 U.S.C. § 315(b). III. ORDER In consideration of the foregoing, it is ORDERED that the Petition is DENIED and no trial is instituted.” slip op. at 19

  Discretionary denial
  Patents in suitUS 8,454,204
• United States Department Of Homeland Security v. Larry GoldenRehearing denied
  PTAB · Nov 17, 2015 · IPR2014-00714 · APJ Kevin W Cherry · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving in place denial of substitute claims 154–156 because they were broader, lacked written description support, and were not shown patentable over the prior art.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “without prior authorization from the Board.” 37 C.F.R. § 42.71(d). “The burden of showing [the] decision should be modified lies with the party challenging the decision.” Id. The request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

    “three independent reasons: (1) substitute claims 154–156 are impermissibly broader than the claims they replaced; (2) Patent Owner failed to show written description support for substitute claims 154–156 as a whole; and (3) Patent Owner failed to show that claims 154–156 were patentable over the prior art of record. Final Dec. 15–21 (improper broadening), 21–22, (written description), 22–31 (prior art of record). Therefore, to succeed on this Rehearing Request, Patent Owner must show that we misapprehended or overlooked matters in reaching each of these determinations. Patent Owner has not done so. We address Patent Owner’s arguments in detail below.” slip op. at 3

  • ScopeDenied

    “In any event, this priority date argument does not contain any reason why our determination that substitute claims 154–156 are broader in scope than cancelled claims 11, 74, and 81 that they seek to replace was in error. Reh’g Req. 4–5. To the extent that Patent Owner does contest our finding that the claims are broader in scope, we do not find it persuasive because Patent Owner does not show amending a claim to replace a particular species with an entire genus would not be broadening. Thus, this argument regarding priority date does not persuade us that we erred in denying Patent Owner’s motion to amend.” slip op. at 4

  • 112 supportDenied

    “B. Lack of Written Description Support Patent Owner argues that we should also excuse Patent Owner’s failure to identify written description support for the entire claim because of the “special circumstances” discussed above. Reh’g Req. 2–3. Without determining whether such an exception exists for the requirement of providing written description support for the entire claim, Patent Owner fails to identify anywhere in the Patent Owner Response or Motion to Amend where this argument was raised. Because the argument was not raised, we could not have misapprehended or overlooked it. Thus, we determine that Patent Owner has failed to show that we erred in our determination that the Motion to Amend failed to show written description support for the claim as a whole.” slip op. at 5

  § 102 anticipation
• Lupin Limited v. Vertex Pharmaceuticals IncorporatedRehearing denied
  PTAB · Nov 2, 2015 · IPR2015-00405 · APJ Sheridan K Snedden · IPR · Rehearing

  The Board denied Lupin’s rehearing request, leaving institution on claims 1 and 4–9 in place because Lupin showed no overlooked or misapprehended matter.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “In view of the above, we conclude that the evidence of record submitted by Petitioner and Patent Owner was considered in our Decision to Institute and, when considered in light of the Petition and Dr. Fisher’s declaration, found to be insufficient to establish a reasonable likelihood of unpatentability. We did not misapprehend or overlook the evidence or arguments now raised by Petitioner.” slip op. at 8

  • BurdenDecided for patent owner

    “In view of the above, we conclude that the evidence of record submitted by Petitioner and Patent Owner was considered in our Decision to Institute and, when considered in light of the Petition and Dr. Fisher’s declaration, found to be insufficient to establish a reasonable likelihood of unpatentability. We did not misapprehend or overlook the evidence or arguments now raised by Petitioner.” slip op. at 8

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Request 811. In our Decision, we relied, in part, on the teachings set forth in Ex. 2014 and Ex. 2017 disclosing that the I50V mutation is associated with the highest levels of amprenavir resistance, and on the teachings of Ex. 2030 and Ex. 2031 suggesting that the I50V is absent in certain fosamprenavir therapy. Dec. 19 (citing Ex. 2014, 112; Ex. 2017, 84; Ex. 2030 (Abstract No. 598); Ex. 2031, 652). Petitioner argues that Exs. 2030 and 2031 relate to resistance profiles for fosamprenavir administered with another active agent, ritonavir, and not fosamprenavir administered alone. Request 910. Petitioner supports this new argument with reference to Ex. 1047, which discloses that the I50V mutation is observed with unboosted fosamprenavir. Id. We are not persuaded by Petitioner’s argument that a clear error was made based on the record at the time of our Decision. First, we note that these arguments are being made for the first time in the Request, and as such, cannot be the basis for rehearing. The Board cannot have misapprehended or overlooked an argument that was not presented earlier. Second, Lupin arguments are supported by new evidence and fail to comply with 37 C.F.R. § 42.71(d). It would be inappropriate for us to consider Ex. 1047 in a request for rehearing.” slip op. at 6

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “B. Grounds 3 and 4 Patent Owner confirms that it will not rely on 35 U.S.C. § 103(c) to remove Roy I as prior art, thus mooting those grounds in Petitioner’s rehearing request. Response 15. IV. ORDER” slip op. at 8

  § 103 obviousness
  Patents in suitUS 6,436,989
• Roche Molecular Systems Inc. v. Illumina, Inc.Institution denied
  PTAB · Oct 30, 2015 · IPR2015-01091 · APJ Lora M Green · IPR · Institution

  The Board denied joinder and denied institution on claims 1–22, citing substantially the same arguments previously presented and the petition’s belated, duplicative filing.

  RulingsInstitution decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied

    “circumstances of each proceeding. See Unified Patents, Inc. v. Personalweb Techs., LLC and Level 3 Commc’ns, LLC, Case IPR2014-00702, slip. op. at 4 (PTAB Jan. 13, 2015) (Paper 12). In the instant proceeding, we agree with Patent Owner that joinder with IPR2014-01093 would not promote the efficient resolution of those proceedings. After carefully considering both Petitioner’s and Patent Owner’s evidence and argument, we deny Petitioner’s Motion for Joinder. As noted by Patent Owner, Roche announced the acquisition of Ariosa at least as early as December 2, 2014. Ex. 2017. And as also noted by Patent Owner, at that time, Roche was aware that “Ariosa . . . [was] embroiled in a number of patent infringement lawsuits, including with . . . Illumina[ ] and Illumina’s Verinata Health business, and Roche will continue to defend the company in court, Zambrowski said, adding that Roche ‘went into this agreement with our eyes wide open.’” Id. Given that Petitioner had announced the acquisition of Ariosa as early as December 2, 2014, noting that it went into the agreement to acquire Ariosa with its eyes wide open, Petitioner has not provided a persuasive reason as to why it waited until April 24, 2015, to file the instant Petition.” slip op. at 10

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “We approach our discretion to deny a petition on a case-by-case basis. As explained above, one factor that favors denial of the instant Petition is that it raises “substantially the same” arguments as the Petition in IPR2014- 01093. 35 U.S.C. § 325(d). We have compared the prior art and arguments raised in the instant Petition to those raised in the Petition filed in IPR2014- 01093. Based on the information presented, we are persuaded that the instant Petition raises, at minimum, “substantially the same . . . arguments” that “previously were presented to the Office” in the Petition filed in IPR2014-01093. 35 U.S.C. § 325(d). That is one factor, contributing to the totality of circumstances in this case, that informs our decision to exercise our discretion to deny the Petition.” slip op. at 14

  • Other 314aInstitution denied discretionary otherInstitution denied

    “Another factor that tips the balance in favor of denying institution of inter partes review is the timing of the filing of the instant Petition. As noted by Patent Owner, Petitioner had the advantage of the Patent Owner’s response in IPR2014-01093 (Prelim. Resp. 20), as well the depositions of Patent Owner’s expert in that proceeding, which were conducted by counsel for Roche (id. at 8). Essentially, the only reason that Petitioner has provided for waiting until April of 2015 to file the instant Petition is that it did not complete its acquisition of Ariosa until January 12, 2015. However, as discussed above, Petitioner was aware of the possibility of acquiring Ariosa as early as June of 2014, and announced its acquisition as early as December of 2014. Petitioner has not provided any persuasive reason as to why it could not have filed the Petition earlier, much less why the Petition could not have been filed within one month of institution of IPR2014-01093. On this record, we are persuaded that our resources are better spent addressing matters other than Petitioner’s belated, and essentially, second attempt to raise a plurality of duplicative grounds against the same patent claims. See Heckler v. Chaney, 470 U.S. 821, 831 (1985) (when deciding whether to take action in a particular matter, an agency must determine whether its resources are best spent on one matter or another). Petitioner provides no persuasive reason why we should institute inter partes review in light of the above facts. Based on the totality of circumstances before us, we exercise our discretion and deny institution of inter partes review. 35 U.S.C. §§ 314(a), 316(b), 325(d); 37 C.F.R. § 42.108(b).” slip op. at 15

  Discretionary denial
  Patents in suitUS 7,955,794
• Eli Lilly And Company v. Los Angeles Biomedical Research Institute At Harbor-Ucla Medical CenterNo claims unpatentable
  PTAB · Oct 22, 2015 · IPR2014-00693 · APJ Lora M Green · IPR · Final written decision

  Claims 1–5 were not shown unpatentable because Whitaker did not anticipate the required continuous administration for at least 45 days.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “Whitaker anticipates claim 1 by a preponderance of the evidence. To anticipate, a prior art reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)).” slip op. at 8

  • ExcludeOther

    “1115–1116, 1118–1121, 1124, 1127, 1128–1130, 1131, 1135–1137, 1139– 1140, 1142, 1144, and portions of Dr. Bivalacqua’s deposition testimony (Ex. 1122). As we did not rely on any of those exhibits in this Decision, Patent Owner’s Motion to Exclude is dismissed as moot.” slip op. at 10

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted

    “E. Objections to Demonstratives Each of Petitioner (Paper 42) and Patent Owner (Paper 43) objected to the other’s demonstratives. In view of those objections, we expunge the demonstratives from the record. Thus, Petitioner’s demonstratives (Paper 41) and Patent Owner’s demonstratives (Paper 40), are expunged.” slip op. at 10

  Patent outcomesUS 8,133,903 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 8,133,903
• Eli Lilly And Company. v. Los Angeles Biomedical Research Institute At Harbor-Ucla Medical CenterAll claims unpatentable
  PTAB · Oct 22, 2015 · IPR2014-00752 · APJ Lora M Green · IPR · Final written decision

  Claims 1–5 are unpatentable under § 103 over Montorsi, Whitaker, and Porst because their combination renders the claimed method obvious.

  RulingsFinal written decision

  • Skill levelOther
  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “Lederman, 355 F.3d 1343, 1348 (Fed. Cir. 2004); see 35 U.S.C. § 120. “In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. Id. “Put another way, one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims.” Id. However, “the question [of adequate written description] is not whether a claimed invention is an obvious variant of that which is disclosed in the specification.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); see also Tronzo v. Biomet Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998) (“A disclosure in a parent application that merely renders the later-claimed invention obvious is not sufficient to meet the written description requirement; the disclosure must describe the claimed invention with all its limitations.”).” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

    “1257 (Fed. Cir. 2007). “[A] claim construction analysis must begin and remain centered on the claim language itself, for that is the language the patentee has chosen to ‘particularly point[ ] out and distinctly claim[ ] the subject matter which the patentee regards as his invention.’” Innova/Pure Water, Inc. v. Safari Water Filtration Sys,, Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004); see also Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (“The starting point for any claim construction must be the claims themselves.”). Only terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). 1. “continuous long-term regimen” In the Decision on Institution, we interpreted this claim phrase as: the administration of drug over a certain period of time without intermission such that the treatment is therapeutically effective. With regard to claims of the ’903 patent, the time period is not less than 45 days, as recited in claim 1.” slip op. at 6

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “2. “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis” Patent Owner contends that the term “should be construed to mean ‘an individual with fibrosis of either the tunica albuginea or corpora cavernosa of the penis, in which the fibrosis is clinically significant.’” PO Resp. 22 (emphasis removed). In particular, Patent Owner contends that “a person of ordinary skill in the art would understand the claims of the ’903 patent to concern treatment of penile fibrosis, a disease.” Id. According to Patent Owner, Petitioner’s proposed interpretation of a patient having any degree of fibrosis “risks encompassing not only men with subclinical penile fibrosis, but men with no penile fibrosis at all.” Id. at 22–23. Petitioner responds that the term “clinically significant” “is largely subjective—what is clinically significant to one patient or doctor may not be clinically significant to another.” Reply 11. The ’903 patent teaches that there is a need “to treat and/or ameliorate the symptoms of a variety of fibrotic disease, such as PD, ED and arteriosclerosis.” Ex. 1001, 2:42–46. Thus, although the claim requires the patient to have penile tunical fibrosis or corporal tissue fibrosis, we conclude that the broadest reasonable interpretation of “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis,” in view of the Specification of the ’903 patent, requires that the individual have symptoms that may be associated with penile fibrosis, such as ED, but not that the patient be specifically diagnosed as having penile tunical fibrosis or corporal tissue fibrosis.” slip op. at 7

  Patent outcomesUS 8,133,903 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosure
  Patents in suitUS 8,133,903
• United States Department Of Homeland Security v. Larry GoldenOther
  PTAB · Oct 1, 2015 · IPR2014-00714 · APJ Kevin W Cherry · IPR · Final written decision

  The Board canceled claims 11, 74, and 81 and denied substitute claims 154–156 because they broadened claim scope, lacked written-description support, and were not shown patentable over Mostov.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “A petition for inter partes review must identify “all real parties in interest.” 35 U.S.C. § 312(a)(2). The Office Patent Trial Practice Guide provides guidance regarding factors to consider in determining whether a party is a real party in interest. 77 Fed. Reg. 48,756, 48,759–60 (Aug. 14, 2012). Considerations may include whether a non-party “funds and directs and controls” an IPR petition or proceeding. Id. at 48,760. Additional relevant factors include: the non-party’s relationship with the petitioner; the non-party’s relationship to the petition itself, including the nature or degree of involvement in the filing; and the nature of the entity filing the petition. Id. Generally, a party does not become a “real party-in-interest” merely through association with another party in an unrelated endeavor. Id. A party also is not considered a real party in interest in an inter partes review solely because it is a joint defendant with a petitioner in a patent infringement suit or is part of a joint defense group with a petitioner in the suit. Id. Whether a party who is not a named participant in a given proceeding is a “real party-in-interest” to that proceeding “is a highly fact-dependent question.” Id. at 48,759. There is no “bright line test.” Id. Courts invoke the term “real party-in-interest” to describe relationships and considerations sufficient to justify applying conventional principles of estoppel and preclusion. Id. Here, even assuming this contention is timely, Patent Owner has failed to provide any evidence, besides the mere fact that the other parties are co-defendants in a lawsuit or alleged infringers, to support the contention that Petitioner has failed to name all of the real parties in interest. That one fact, without any further proof of control or involvement by these parties in this proceeding, is insufficient to establish that Petitioner has failed to name” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “ii. Petitioner’s Expert Patent Owner asks that we “dismiss [Petitioner’s] Expert Declaration and disqualify [Petitioner’s Declarant] for making and using a false writing.” PO Resp. 9. Patent Owner contends that Petitioner’s Declarant falsely claimed that certain patent applications were patents by listing them under the heading “Patents” in his Resume. Id. at 8–9. A Patent Owner Response is not the proper vehicle to seek to exclude testimony. See 37 C.F.R. § 42.64(c). Moreover, even if it were the proper vehicle, we are not persuaded that the alleged “falsehood” that Patent Owner identified—listing patent applications, which are clearly identified as such, under a heading titled “Patents”—is, in any way, misleading. Thus, we decline Patent Owner’s request that we dismiss Dr. Vishwanath’s testimony.3 C. Motion to Amend As discussed above, in the Motion to Amend, Patent Owner requests” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “i. Level of Ordinary Skill in the Art Neither party puts forward a succinct definition of the level of ordinary skill in the art. Petitioner’s declarant, however, has put forward a detailed discussion of various references dated before April 20064 (the date Patent Owner now alleges is the priority date) related to subject matter of the ’990 patent. See Ex. 1005 ¶¶ 20–74, 94–99. We have reviewed that discussion and the references cited in those paragraphs. We have found it accurately reflects the teachings of the references. Moreover, we agree with Petitioner’s declarant that the references are analogous to the claimed invention, and, as such, represent the level of skill in the relevant art at the time of the invention. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (finding that the Board did not err in concluding that the level of ordinary skill was best determined by the references of record); In re Oelrich, 579 F.2d 86, 91(CCPA 1978) (“[T]he PTO usually must evaluate . . . the level of ordinary skill solely on the cold words of the literature.”); see 4 We accept this date as the priority date only for the sake of argument. also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.”’).” slip op. at 13

  • ScopeMotion to amend, deniedDenied

    “We agree with Petitioner and find, based on the Patent Owner’s own arguments, that these terms improperly broaden the scope of the claims. As Patent Owner explains, the added language is broad enough to include the removed items, and is intended to reflect the entire genus of “monitoring equipment” and “communications devices” that “are capable of communication and capable of receiving signals.” Mot. to Amend 4, 5. Thus, the claim has been broadened to not only include the listed species that have been removed, but anything falling within the claimed genus. Accordingly, we find that this amendment impermissibly broadens the claim. As for the second change in the claim language, we find that Patent Owner has failed to show why removal of the entire passage “wherein, the communication device receives a signal via any of one or more products listed in any of the plurality of product grouping categories,” would not impermissibly broaden the scope of claim 154. The deletion of this limitation necessarily broadens the claim in that limitation’s aspect. See In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997) (“For example, a reissue claim that deletes a limitation or element from the patent claims is broader in that limitation’s aspect.”). Given that Patent Owner has entirely deleted this limitation and Patent Owner bears the burden of showing entitlement to the amendment, it was incumbent on Patent Owner to explain why removing this entire passage from claim 154 would not broaden the scope of the claim. See In re Bennett, 766 F.2d 524, 526 (Fed. Cir. 1985) (en banc) (“[A] claim is broadened if it is broader in any respect than the original claim, even though it may be narrowed in other respects.”).” slip op. at 17

  § 102 anticipation

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.