• Shenzhen Apaltek Co., Ltd. v. Asetek Danmark A/SAll claims unpatentable
  PTAB · Jan 22, 2024 · IPR2022-01318 · APJ Jason W Melvin · IPR · Final written decision

  Claims 1, 2, 6 are unpatentable as obvious over Duan; claims 5, 8 are unpatentable as obvious over Duan and Wu.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. LEVEL OF ORDINARY SKILL IN THE ART Petitioner proposes that a person of ordinary skill would have been knowledgeable regarding liquid cooling systems for computer systems, would have had a Bachelor of Science (B.S.) in electrical or mechanical engineering, or similar advanced post-graduate education in this area, or would have possessed at least 2–3 years of experience in liquid cooling systems for computer systems or similar systems. A POSITA would be knowledgeable of the concepts, components, and their functions described as “prior art” in the ’355 patent such as, e.g., pumps, radiators, fans, reservoirs, and other techniques of heat dissipation and liquid cooling. (Ex- 1001,1:11–47.) In addition, a POSITA would be knowledgeable about electric motors and their components (e.g., electromagnetic coils, rotors, stators, AC/DC motors, etc.) Pet. 6–7 (citing Ex. 1003 ¶¶ 13–18). Patent Owner has not proposed a level of ordinary skill in the art. We adopt Petitioner’s proposed level of ordinary skill as it appears to be consistent with the level of skill reflected by the specification and in the asserted prior art references.” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Based on our analysis of the proceeding, we conclude that no claim term requires express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).” slip op. at 9

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “disclosures. Pet. 17–45. Petitioner maps the claimed reservoir to Duan’s “structure formed by an accommodation chamber 21, lower cover 225, cap 3, and cooling plate 1.” Id. at 18. Petitioner maps the claimed double-sided chassis to Duan’s accommodation chamber 21 and the claimed impeller cover to Duan’s lower cover 225. Id. at 22–27. Petitioner maps the claimed thermal-exchange chamber to Duan’s cap 3 and cooling plate 1, with heat-absorbing face 11 and cooling plate 1 corresponding to the claimed heat exchanging interface. Id. at 27–36. Petitioner maps the claimed radiator to Duan’s cooling stage 53. Id. at 36–39. Petitioner asserts that Duan’s inlet is “below a center of the impeller” because it is along the axis about which the impeller rotates. Id. at 39–41. Petitioner asserts that Duan’s lower cover 225 defines an outlet tangential to the impeller’s circumference. Id. at 41–45. In summary, Petitioner asserts that Duan, without modification, discloses all of claim 1’s limitations. Patent Owner does not challenge Petitioner’s contentions, as it has filed no Patent Owner Response. We have reviewed Petitioner’s contentions and conclude that they show by a preponderance of the evidence that claim 1’s subject matter would have been obvious over Duan. See Pet. 17– 45. We adopt Petition’s unchallenged contentions as our analysis.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “As to claim 5, Petitioner asserts that it would have been obvious to use Wu’s approach to securing chassis and heat-exchanging interface to the heat generating component, because Duan discusses the need to assemble its components but does not provide detailed instruction. Id. Thus, the modification would provide the benefit of securing Duan’s cooling plate module and cooling plate to the CPU. Id. at 72. For claim 8, Petitioner asserts that it would have been obvious to use Wu’s approach to blowing air through the radiator using a fan driven by a motor separate from the pump’s motor. Id. at 72–73. Petitioner reasons that doing so would improve Duan’s performance by increasing heat dissipation. Id. at 74. We agree that Petitioner’s contentions support the modification with rational underpinning.” slip op. at 12

  Patent outcomesUS 10,078,355 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 10,078,355
• Apotex Inc. / Apotex Corp. v. Celgene CorporationRehearing denied
  PTAB · Apr 30, 2020 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Rehearing

  The Board denied rehearing, leaving in place its denial of institution on all challenged claims under § 325(d) for grounds I and II and for failure to establish printed-publication status for ground III.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.”” slip op. at 3

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

    “presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 10 (Feb. 13, 4 2020) (precedential). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments. Id. If the same or substantially the same art or arguments were previously presented to the Office, we then consider whether petitioner has demonstrated the Office erred. Id. In evaluating the Petition and accompanying evidence in light of the Becton, Dickinson factors, we determined that grounds I and II were “based on substantially the same prior art and arguments previously presented to the office,” and that Petitioner had “neither sufficiently pointed out how the Examiner erred, nor provided additional evidence or facts that warrant reconsideration of the Examiner’s decision.” Inst. Dec. 26. Accordingly, we exercised our discretion under 35 U.S.C. §325(d) and denied institution of grounds I and II on that basis.” slip op. at 4

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

    “we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3

  § 102 anticipation§ 103 obviousnessDiscretionary denial
  Patents in suitUS 8,741,929
• L’Oréal USA, Inc. v. Liqwd, Inc.Some claims unpatentable
  PTAB · Jul 30, 2019 · PGR2018-00025 · APJ Timothy G Majors · PGR · Final written decision

  Claims 1–13, 19–23, 29, and 30 are unpatentable as obvious; claims 14–16, 18, and 24–28 were not shown unpatentable.

  RulingsFinal written decision

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner

    “combination of Pratt and Tanabe teaches or suggests all of claim 1’s limitations, and that the skilled artisan had a sufficient reason to combine the art as proposed with a reasonable expectation of success in arriving at the bleaching method that is claimed. Before reaching a conclusion of obviousness, however, we consider the parties’ argument and evidence related to alleged objective indicia of nonobviousness. WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir. 2016).” slip op. at 35

  • ExcludeMotion to exclude, deniedMixed

    “those exhibits) as discussed above in the context for which they were offered (objective indicia of nonobviousness as to alleged unexpected results and industry skepticism). We gave the exhibits little weight on those issues for the reasons explained, and ultimately found in Petitioner’s favor—that objective indicia of nonobviousness did not outweigh the evidence of obviousness on this record. Thus, excluding this evidence would not change the result. Accordingly, we dismiss Petitioner’s motion to exclude Exhibits 2038 and 2041 as moot.” slip op. at 85

  Patent outcomesUS 9,668,954 mixed
  § 103 obviousnesscites KSR
  Patents in suitUS 9,668,954
• Apple Inc. v. Voip-Pal.Com, Inc.Rehearing denied
  PTAB · May 24, 2019 · IPR2016-01201 · APJ Scott R Boalick · IPR · Rehearing

  The Board denied Apple’s rehearing request, leaving intact the finding that the challenged claims were not shown obvious over the asserted Chu and Chen combinations.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “At the outset, we note that in a request for rehearing we do not review the merits of the Final Written Decision de novo. Instead, we consider whether Petitioner has met its burden of showing that a matter has been misapprehended or overlooked in the Final Written Decision. 37 C.F.R. § 42.71(d) (“The burden of showing a decision should be modified lies with the party challenging the decision. The request 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.”). We conclude that Petitioner has not met this burden in its Request for Rehearing.” slip op. at 2

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

    “view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “evidence that, in Chu ’684, users would dial according to the dialing conventions of their geographic area. Reh’g Opp’n 8 (citing Ex. 2016 ¶ 66). Patent Owner’s expert witness, Dr. Mangione-Smith, testified that “in Chu ’684, the users would dial PSTN ‘public numbers’ based on the location of the customer premises.” Ex. 2016 ¶ 66 (citing Ex. 1006, Fig. 2). Figure 2 of Chu ’684 supports Dr. Mangione-Smith’s testimony, in that Figure 2 of Chu ’684 illustrates customer premises 105 (which includes IP phones) as connected to a service provider central office 205. See Ex. 1006, Fig. 2; Reh’g Opp’n 9 (contrasting Petitioner’s assertion” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,542,815
• Apple Inc. v. Voip-Pal.Com, Inc.Rehearing denied
  PTAB · May 24, 2019 · IPR2016-01198 · APJ Scott R Boalick · IPR · Rehearing

  The Board denied Apple’s rehearing request, leaving intact the finding that challenged claims of the ’005 and ’815 patents were not shown obvious over the asserted combinations.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “At the outset, we note that in a request for rehearing we do not review the merits of the Final Written Decision de novo. Instead, we consider whether Petitioner has met its burden of showing that a matter has been misapprehended or overlooked in the Final Written Decision. 37 C.F.R. § 42.71(d) (“The burden of showing a decision should be modified lies with the party challenging the decision. The request 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.”). We conclude that Petitioner has not met this burden in its Request for Rehearing.” slip op. at 2

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9

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

    “view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “testimony by Dr. Mangione-Smith—when rejecting Petitioner’s view of the prior art and reason for the combination. See FWD 19 (citing Ex. 2016 ¶¶ 65–67); Reh’g Opp’n 6. Thus, when the panel concluded that Petitioner had not shown that Chu ’684’s method would apply to a number reformatted by the secondary references (see FWD 22–23), it relied on record evidence supporting its conclusion. We determine that the panel did not misapprehend the nature of the proposed combination; rather, based on the record, it resolved a factual dispute and concluded that Petitioner failed to show the proposed combination would operate as asserted.” slip op. at 5

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 9,179,005
• Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution denied
  PTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution

  The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.

  RulingsInstitution decision

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

    “As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24

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

    “As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached

    “support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
  Patents in suitUS 8,741,929
• Lupin Ltd. / Lupin Pharmaceuticals, Inc. v. Horizon Therapeutics, Inc.All claims unpatentable
  PTAB · Sep 26, 2017 · IPR2016-00829 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–15 are unpatentable under § 103 over the ’859 publication, Blau, and Simell; claims 3, 6, 11, 14, and 15 also rely on Brusilow ’84.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We are not persuaded by Patent Owner’s argument that the lack of specific residency/fellowship training or certification, disqualifies Dr. Vaux from providing opinion testimony on the motivations, understandings, and actions of those of ordinary skill in the art. Dr. Vaux testifies that he is “a medical doctor with specialty training in Pediatrics and Clinical Genetics” and is currently Professor and Clinical Chief of the Division of Medical Genetics in the Department of Medicine at UC San Diego. Ex. 1002 ¶ 1. He also testifies: Since 1994, I have regularly diagnosed and treated patients with urea cycle disorders (“UCD”), and continue to do so today. In treating UCD patients, I regularly prescribe nitrogen scavenging drugs and treat patients who are maintained on therapy with nitrogen scavenging drugs. Ex. 1002 ¶ 1. Thus, Dr. Vaux has actually treated UCD patients for at least five years (a requirement recited by Patent Owner, see PO Resp. 16), including prescribing drugs. Patent Owner does not direct us to evidence that Dr. Vaux’s testimony is untruthful or that his treatment of UCD patients is ineffective, indicating that he does not understand how to treat them. Accordingly, even if Dr. Vaux does not have the specialized certificates or particular training that Patent Owner argues are necessary, he has done the job for over twenty years of one who would carry out the claimed methods. We consider this experience more relevant than certificates or training. Thus, we determine that Dr. Vaux is qualified to provide opinions about the motivations, understandings, and actions of one of ordinary skill in the art.” slip op. at 15

  • Skill levelSkill level board ownOther

    “Patent Owner and Petitioner define a person of ordinary skill in the art as having similar qualifications (compare Pet. 8–9, citing Ex. 1002 ¶ 19 with PO Resp. 15–16, citing Ex. 2006 ¶ 26), but Patent Owner argues that the ordinarily skilled artisan must additionally have “at least three years of residency/fellowship training in Medical Genetics, including Biochemical Genetics, followed by certification in Clinical Genetics and Clinical Biochemical Genetics by the American Board of Medical Genetics and Genomics.” PO Resp. 15–16, citing Ex. 2006 ¶ 26. We agree with the qualifications on which the parties agree and find that one of ordinary skill in the art would have an M.D. or equivalent degree, with a residency and specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCDs and other nitrogen retention disorders. See Pet. 8– 9; PO Resp. 15–16. We also agree with Patent Owner that one of ordinary skill in the art would have experience treating patients with nitrogen retention disorders, including UCDs. See PO Resp. 16.” slip op. at 15

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “Nevertheless, we agree with the parties8 that the claim term “upper limit of normal” (“ULN”) means the highest value in a range of normal values. See Pet. 10; PO Resp. 21. We determine that the plain meaning and the broadest reasonable interpretation of the claim term “less than the upper limit of normal” is any value less than the highest value in the range of normal values. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); see 37 C.F.R. § 42.100(b).” slip op. at 11

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “In summary, the ’859 publication teaches that those of skill in the art would have known to use HPN-100 to treat subjects with UCDs. It also teaches that measuring plasma or blood level of ammonia was known to be useful in determining the effectiveness of a drug regimen for a particular patient and that measuring blood ammonia was a known step in adjusting drug dosages. The ’859 publication teaches that maintaining normal plasma ammonia levels was desirable in the art. Although specific measurements of 8 Patent Owner notes that the parties do not dispute the meaning of any of the claim terms. PO Resp. 2. Because the meaning of the terms in the challenged claims are evident from their ordinary meaning and not controversial, we need not provide a separate analysis of them. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“claim terms need only be construed ‘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).”). plasma ammonia do not necessarily indicate the upper limit of normal consistently across different ways of measuring it, the ’859 publication teaches that treatment would have been considered to be effective when plasma ammonia levels were less than what is determined to be the upper limit of normal in a given case. In addition to the ’859 publication, Petitioner relies on Blau and Simell for the teaching to collect blood from UCD patients after a fast in order to measure plasma ammonia levels. Ex. 1006 at 273 (Table 11.9); Ex. 1005 at 1118; see Pet. 25–26 (citing Ex. 1002 ¶¶ 58, 59); see also id. 1002 ¶ 46, n.2 (citing Ex. 1015 at S11). Anticipating Patent Owner’s argument that Blau relates to diagnosis not treatment of UCDs, Petitioner also cites to Exhibits 1010 and 1015 as evidence that it was generally recommended to measure plasma ammonia after a fast. See Pet. 16, n.2. Exhibit 1010 is a “Lab Update” about measurement in ammonia in blood, and Exhibit 1015 is a publication entitled “Measurement of ammonia in blood.” Both state that most methods recommend collecting a sample from patients who have fasted for at least 6 hours. See Ex. 1010, 4; Ex. 1015, 1. From this evidence, we agree with Petitioner that those of skill in the art would have known that measuring fasting serum ammonia levels, as taught in at least Simell and Blau, was known to be useful with the methods taught in the ’859 publication. In regard to Ground 2, which challenges claim 3 and the claims that depend on it, Petitioner cites Brusilow ’84 for its teaching of measuring a patient’s fasting plasma ammonia level when he or she is admitted, presumably to a hospital, and, in response to elevated levels, treating with the nitrogen scavenging drugs sodium benzoate and phenylacetate. See Pet.” slip op. at 11

  Patent outcomesUS 9,095,559 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,095,559
• Mylan Pharmaceuticals Inc. / Wockhardt Bio AG et al. v. Astrazeneca ABNo claims unpatentable
  PTAB · Aug 18, 2017 · IPR2015-01340 · APJ Rama G Elluru · IPR · Final written decision

  Petitioners failed to prove claims 1, 2, 4, 6–22, 25–30, 32–37, and 39–42 unpatentable under the instituted §103 grounds, chiefly because the proposed modifications lacked a reasonable expectation of success.

  RulingsFinal written decision

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “C. Credibility of the Experts We give more weight to the testimony of Patent Owner’s expert, Dr. Weber, over that of Petitioners’ expert, Dr. Rotella, with respect to testimony that is in direct conflict. We favor Dr. Weber’s testimony because of her extensive experience in the design and development of DP 4 inhibitors for type-2 diabetes treatment. See Ex. 2056 ¶¶ 9–12; Ex. 2210, 1– 2. Moreover, Dr. Weber entered the DP 4 field at the relevant time, i.e., the time of invention, around 2000. Ex. 1073, 108:16–21; Tr. 35:16–22. We find that her testimony has been consistent, not just throughout this proceeding, but also with evidence predating this proceeding. See, e.g., Ex. 2056 ¶¶ 88, 115–118; 154–162; Ex. 1073, 51:2–54:14, 113:6–16, 119:19– 121:9; Ex. 2161, 558.” slip op. at 9

  • Skill levelSkill level board ownOther

    “The parties’ formulations as to the level of ordinary skill in the art are similar, and neither side identifies with specificity an error in the opposing side’s formulation. See PO Resp. 21; Pet. Reply 10. On the record presented, we hold that the cited prior art is representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evidenced by the cited references themselves). Specifically, the references are consistent with the parties’ formulations and demonstrate the level of skill in the art. Our determinations regarding the patentability of the challenged claims would remain the same under either side’s proposed formulation.” slip op. at 8

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “On the full record before us, we determine that Petitioners have not demonstrated by a preponderance of the evidence that a skilled artisan would have chosen Ashworth I’s compound 25 as a “lead compound.” Although Ashworth I indicates that compounds 24–29 were non-toxic in T cell assays up to 72 hours, and further indicates compound 25 was one among four compounds that were comparable to boroprolines, no further data is provided to guide the skilled artisan to select compound 25 among the other 2-cyanopyrrolidides as a lead compound for further modification to develop a DP 4 inhibitor. Ex. 1007, 1165–66. More importantly, the data reported in Ashworth I was based on in vitro data at room temperature, not in vivo data. PO Resp. 25 (citing Ex. 2174, 82:23–83:11). Indeed, Dr. Rotella states, “those studies were carried out at room temperature, which is roughly 20 degrees [Celsius]. I’ll point out that body temperature is higher than that, and that temperature has a direct effect on half-life. As you elevate temperature, you can expect half-life to decrease.” Ex. 2174, 82:23-83:11. Dr. Rotella further admits that he is not aware of any disclosure describing testing of Ashworth compounds in humans. Ex. 2174, 60:23-61:9. In addition, Ashworth I acknowledged that these compounds exhibited an intramolecular cyclization problem and that further work on optimization of the pyrrolidine ring was necessary and would be reported shortly. Ex. 1007, 1163–65. Others in the prior art also continued to seek solutions to the problem of intramolecular cyclization, such as those posed by Ashworth I compounds. See PO Resp. 27–28.” slip op. at 16

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

    “(4) No Reasonable Expectation of Increasing Stability We are not persuaded that the skilled artisan would have had a reasonable expectation of success in achieving increased stability of Ashworth I’s compound 25 based on Hanessian I’s teachings concerning the cyclopropanation of proline. See Pet. 29. There was no disclosure in the prior art of cylopropanating the pyrrolidine ring of compound 25, or any similar compound. Indeed, Dr. Rotella admitted “that there wasn’t anything in the literature prior to the invention of saxagliptin that actually suggested that cyclopropanation of an Ashworth-One type DPP4 inhibitor would improve its stability.” Ex. 2174, 142:3-9. In addition, there is not sufficient evidence as to how the modified cyano-moiety would have been understood to affect compound 25’s stability. Given the structural differences, we find there is insufficient evidence suggesting that the skilled artisan could have reasonably predicted how cyclopropanating compound 25’s P1 group (as opposed to the proline compound discussed in Hanessian I) would have affected the cyano moiety’s (as opposed to the substituent in Hanessian I) orientation in space. Furthermore, there is insufficient evidence as to whether that modified orientation would have sufficiently decreased intramolecular cyclization. Indeed, Dr. Rotella testified that: [I]n the process of that modification of orientation in space [when you fuse two rings together], you may observe effects on potency, you may observe effects on solution stability, you may observe other effects on other properties that one might measure in connection with a drug discovery project. Ex. 2174, 119:10–120:2. When asked, “[a]nd those effects might be either positive or negative; correct?” Dr. Rotella replied, “[t]hey might be, yes.” Ex. 2174, 120:3–5. Dr. Rotella also testified that at the time of the invention, the objective of adding a cyclopropyl substituent to the pyrrolidine ring of compound 25 would have been exploratory. He testified: Q. Well, what is the objective of putting the cyclopropane on the molecule, in your opinion? A. There are two possible objectives based on the data -- there are at least two possible objectives based on the data available surrounding compound 25. Q. And what are they? A. One would be to explore whether or not you could improve potency. A second would be whether or not you could improve solution stability. One might also explore how that -- those changes, either by themselves or in combination with two changes, might also improve or change -- sorry -- to improve solid-state stability. Furthermore, since nothing is known, at least at this point in time, about other properties associated with compound 25, you’d want to understand what those properties were and adjust them as need be. Generally speaking, those properties are things that we call, collectively, pharmaceutical properties. Ex. 2174, 115:11–116:13 (emphasis added). This testimony does not sufficiently support Petitioners’ contention that a skilled artisan would have reasonably expected cyclopropanating the pyrrolidine ring of compound 25 to increase its stability.” slip op. at 26

  Patent outcomesUS RE44,186 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
• Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Rehearing denied
  PTAB · Aug 3, 2017 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Rehearing

  The Board denied Merial’s rehearing request, leaving institution denied for claims 1–22 because the evidence did not show that the prior art suggested the claimed cyphenothrin concentration.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Id. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

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

    “teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3 For the foregoing reasons, Petitioner has not demonstrated that we abused our discretion in denying institution of an inter partes proceeding in this case. Consequently, Petitioner’s Request for Rehearing is denied.” slip op. at 5

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

    “teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We considered this evidence of Dr. Clark’s testimony concerning the teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5

  § 103 obviousness
  Patents in suitUS 8,614,244
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Indivior UK LimitedRehearing denied
  PTAB · Jun 23, 2017 · IPR2016-01113 · APJ Jacqueline Wright Bonilla · IPR · Rehearing

  The Board denied rehearing of its decision denying institution because the petition did not show the claimed local pH range was known or obvious.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). 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.” 37 C.F.R. § 42.71(d). A party who requests rehearing bears the burden of showing that a decision should be modified. Id. II.” slip op. at 2

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

    “obviousness analysis. In stating that Petitioner did “not point to where the SBOA, the Suboxone® 2002 Label, and/or LabTec suggest that anyone actually measured a local pH for the Suboxone tablets in an oral cavity, much less determined that local pH should be from about 3 to about 3.5, as recited in the challenged claims,” we addressed Petitioner’s reliance on those three references as collectively teaching or suggesting the claim limitations “[a] buffer in an amount to provide a local pH” of “about 3 to about 3.5.” Dec. 13 (citing Pet. 27–32). We concluded that those three references did not provide sufficient evidence to establish those claim limitations as known prior art elements. See id. at 13–14. Petitioner is incorrect that we ignored teachings in those three references concerning pH. Rather, we considered the Suboxone® Label’s disclosure of a buffering system consisting of citric acid and sodium citrate and Petitioner’s contention, relying on Dr. Çelik’s testimony, that a citric acid and sodium citrate buffer operates within the range of 3.0 to 6.2. Id. at 12–13 (citing Pet. 31–32). We also considered the SBOA’s disclosure of in vitro dissolution studies identifying redacted pH values, and Petitioner’s conclusion based on the SBOA, “that in order for buprenorphine to dissolve, the local pH of the saliva had to be below a certain value, and for naloxone to dissolve, the pH had to be above a certain value because the solubility profiles of these drugs are dependent on pH.” Id. at 11 (quoting Pet. 29); id. at 13 (citing Pet. 29–32). And we further considered LabTec’s disclosure of the relationship between pH and absorption. Id. at 11 (citing Pet. 27–28); id. at 17. We found, however, insufficient evidence to support a conclusion that a local pH value for Suboxone® in the oral cavity or a local pH range of about 3 to about 3.5 were known or obvious. Id. at 11–14.” slip op. at 5

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

    “We considered Petitioner’s argument that “‘it would have been nothing more than routine experimentation’ to identify ‘the claimed pH range of 3 to 3.5 as optimal.’” Id. at 16 (quoting Pet. 33). As we discussed in our Decision, however, the relationship between pH and absorption that LabTec discloses is that “[f]or a basic active ingredient, one would adjust the pH of the solution to below the pKa of the conjugate acid” as a “means for retarding absorption of the active ingredient through the oral mucosa.” Id. at 17 (alteration in original) (emphasis omitted) (quoting Ex. 1007, at 15). In other words, for a basic active ingredient like buprenorphine, this teaching suggests to lower the pH where the goal is to retard oral absorption. See id.; see also Ex. 1009, at 28 (describing buprenorphine as a “weak base” and stating that “[a]bsorption of lipophilic weak bases should increase with salivary pH increases”). As such, as noted in our Decision, LabTec does not suggest preparing a film that lowers a local pH to 3–3.5 in the saliva for the purpose of increasing absorption of an active ingredient such as buprenorphine. Dec. 17. In contrast, the claims of the ’832 patent require adjusting the local pH to “optimize absorption of said buprenorphine,” and the specification further explains that “[i]n a dosage form that is to be placed in the oral cavity, it is desired to absorb the agonist [buprenorphine] buccally, so as to provide rapid integration of the agonist into the body of the user.” Ex. 1001, 11:10–13, 23:65–67, 24:33–35.” slip op. at 6

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We disagree with Petitioner that we erred in finding Dr. Çelik’s statement that the “anatomy of the oral and nasal mucosa is quite similar, thus, one of ordinary skill would expect that the same principle of drug delivery will apply to both tissues” (Ex. 1003 ¶ 105) is merely conclusory. In the Request for Rehearing, Petitioner argues that Dr. Çelik’s testimony in the same paragraph as this statement provides support. Req. Reh’g 12 (citing Ex. 1003 ¶ 105). We have reviewed this paragraph of Dr. Çelik’s declaration, however, and we find that with the exception of the paragraph’s final sentence (which is the statement at issue), the entirety of the paragraph is a summary of Birch’s disclosures and concerns delivery to the nasal mucosa. See Ex. 1003 ¶ 105. Before the final sentence of the paragraph, the testimony in this paragraph fails to mention oral mucosa, let alone provide reasoning or support for why Dr. Çelik concludes that “[t]he anatomy of the oral and nasal mucosa is quite similar” or why it would have been expected “that the same principle of drug delivery will apply to both tissues.” See id.” slip op. at 8

  § 103 obviousness
  Patents in suitUS 8,475,832

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.