• Gilead Sciences, Inc. v. Regents Of The University Of MinnesotaRehearing denied
  PTAB · Dec 21, 2020 · IPR2017-01753 · APJ Zhenyu Yang · IPR · Rehearing

  The Board denied Gilead’s rehearing request, leaving institution denied because Petitioner did not show the Board abused its discretion or misapprehended the obviousness record.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A 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.” Id. When rehearing a decision on institution, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). It is not an abuse of discretion to have made an analysis or conclusion with which a party disagrees. Instead, an abuse of discretion occurs 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. Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004).” slip op. at 2

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

    “before us did not support Petitioner’s alleged reasons to modify the references (Dec. 16–22), nor establish a reasonable expectation of success of doing so (id. at 22–23). In reaching this conclusion, we did not rely solely on references presented by Patent Owner. Instead, we mainly relied on the express teachings of the art cited by Petitioner, including Marquez I and Marquez II. Id. at 17–20. Our plain reading of the prior art persuades us that Petitioner has not demonstrated a reasonable likelihood of prevailing in its patentability challenge. See Rovalma, S.A. v. Bohler-Edelstahl GmbH & Co. KG, 856 F.3d 1019, 1027 (Fed. Cir. 2017) (noting that the Board is not precluded “from relying on arguments made by a party and doing its job, as adjudicator, of drawing its own inferences and conclusions from those arguments, even when the result is use of the party’s submissions against it”).” slip op. at 5

  • BurdenDecided for patent owner

    “Under Rule 42.108(c), The Board’s decision will take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence, but a genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review. Thus, under the Rule, it is only genuine issues of material fact created by testimonial evidence provided by a patent owner with its preliminary response that we view “in the light most favorable to the petitioner.” 37 C.F.R. § 42.108(c) (2017).2 Because Patent Owner did not provide testimonial evidence in this proceeding, there is no “genuine issue of material fact created by such testimonial evidence.” Accepting Petitioner’s argument that we must always resolve any genuine dispute of material fact in the light most favorable to the petitioner would compel institution in every case where a petitioner presents unrebutted expert testimony. But a patent owner has no obligation to rebut the petitioner’s contentions or to submit an expert declaration rebutting the petitioner’s expert testimony. See 37 C.F.R. §§ 42.107(a) (“The patent owner may file a preliminary response to the petition.” (emphasis added)); 42.108(c) (“The Board’s decision will take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence.” (emphasis added)). And the Board is not required to accept every statement made by a petitioner’s expert as established fact simply because the patent owner does not submit contradictory expert testimony. Fanduel, Inc. v. Interactive Games LLC, 966 F.3d 1334, 1344 (Fed. Cir. 2020). Instead, “it is the Board’s duty to independently assess the strength of a petitioner’s argument and evidence.” Id., see also id. (“[I]n every case, it remains the Board’s essential function to make factual findings based on its view of the record.”).” slip op. at 3

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

    “In the Decision denying institution, we concluded that the evidence before us did not support Petitioner’s alleged reasons to modify the references (Dec. 16–22), nor establish a reasonable expectation of success of doing so (id. at 22–23). In reaching this conclusion, we did not rely solely on references presented by Patent Owner. Instead, we mainly relied on the express teachings of the art cited by Petitioner, including Marquez I and Marquez II. Id. at 17–20. Our plain reading of the prior art persuades us that Petitioner has not demonstrated a reasonable likelihood of prevailing in its patentability challenge. See Rovalma, S.A. v. Bohler-Edelstahl GmbH & Co. KG, 856 F.3d 1019, 1027 (Fed. Cir. 2017) (noting that the Board is not precluded “from relying on arguments made by a party and doing its job, as adjudicator, of drawing its own inferences and conclusions from those arguments, even when the result is use of the party’s submissions against it”).” slip op. at 5

  § 103 obviousness
  Patents in suitUS 8,815,830
• Nof Corporation v. Nektar TherapeuticsRehearing denied
  PTAB · Jun 10, 2020 · IPR2019-01396 · APJ Zhenyu Yang · IPR · Rehearing

  The Board denied NOF Corporation’s rehearing request, leaving institution denied on all challenged claims because the petition did not show Bentley taught or suggested using its star molecules for biological applications.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When rehearing a decision on institution, the Board reviews 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.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A rehearing request “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “How much we credit an expert’s testimony, however, depends on whether the opinion adequately addresses the disclosures of a reference as a whole and adequately provides the justification for its conclusions. See TQ Delta, LLC v. Cisco Sys., Inc., 942 F.3d 1352, 1359–60 (Fed. Cir. 2019). Here, Dr. Yamamoto did not adequately explain why Bentley’s disclosure of being able to conjugate nearly any polymer to nearly any amine-containing material teaches or suggests the specific polymer identified at column 7, lines 14–20 of Bentley, would be useful when conjugated to biologically active molecules. Moreover, Bentley generally teaches that activated PEG polymers can be conjugated to molecules or surfaces and specifically incorporates by reference Merrill, which discloses conjugating “star” molecules to the support surface of an affinity column. Ex. 1015, 6:12–13; Ex. 2020, 2:5–8. Dr. Yamamoto did not address these disclosures or explain adequately why one of ordinary skill in the art would have sought to conjugate the specific activated PEG molecule disclosed in Bentley (Ex. 1015, 7:14–20) to a biologically active molecule, as opposed to the support surface of an affinity column (Ex. 2020, 2:5–8). Indeed, Dr. Yamamoto did not persuasively identify any actual properties of the specific activated PEG molecule of Bentley relied upon in the Petition. As a result, although we considered Dr. Yamamoto’s testimony, we accorded it proper weight. Petitioner has not established that we erred in doing so.” slip op. at 6

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “The level of ordinary skill in the art asserted by Petitioner is high. A high level of skill in the art tends to favor an obviousness conclusion. See Innovention Toys, LLC v. MGA Entm’t, Inc., 637 F.3d 1314, 1323 (Fed. Cir. 2011) (“A less sophisticated level of skill generally favors a determination of nonobviousness, and thus the patentee, while a higher level of skill favors the reverse.”). Despite so, to meet its burden for institution, Petitioner still must adequately explain why the art and such a high skill level would have led to the claimed invention. As noted above, we do not find that Petitioner and Dr. Yamamoto did so. Thus, Petitioner has not established that we overlooked its argument as to this issue.” slip op. at 8

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

    “In other words, Bentley does not teach that all of the PEG conjugates would be useful for all possible purposes. Nor does it describe how to determine which conjugates will be useful for any particular desired application. Instead, Bentley discloses a tool that can be used to conjugate a broad variety of polymers to nearly any amine-containing substance or surface. Petitioner does not persuasively explain why such a general disclosure teaches or suggests a conjugate of any particular PEG polymer to any particular type of amine-containing substance.” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,809,453
• Nof Corporation v. Nektar TherapeuticsRehearing denied
  PTAB · Apr 21, 2020 · IPR2019-01395 · APJ Jon B Tornquist · IPR · Rehearing

  The Board denied NOF’s rehearing request, leaving institution denied for claims 1–6 because Bentley did not sufficiently teach or suggest the claimed conjugations.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. STANDARD FOR REHEARING Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. 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. 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 exists where a “decision [i]s 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).” slip op. at 2

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

    “these conjugates would be useful for all possible purposes. Dec. 11–12. Nor does it describe how to determine which conjugates will be useful for any particular desired application. At most, Bentley discloses a tool that can be used to conjugate a broad variety of polymers to nearly any amine-containing substance or surface. Petitioner does not persuasively explain why a disclosure that a particular tool may be used to conjugate polymers to amine-containing materials is a teaching or suggestion to conjugate any particular PEG polymer to any particular type of amine-containing substance.” slip op. at 4

  • Expert testimonyDecided for patent owner

    “We need not credit expert testimony that does not adequately address the disclosures of a reference as a whole or adequately provide the justification for certain conclusions. See TQ Delta, LLC v. Cisco Sys., Inc., 942 F.3d 1352, 1359–60 (Fed. Cir. 2019); Ashland Oil, Inc. v. Delta Resins & Refractories, 776 F.2d 281, 294–95 (Fed. Cir. 1985). As discussed above, Petitioner and Dr. Yamamoto did not adequately explain why Bentley’s disclosure of being able to conjugate nearly any polymer to nearly any amine-containing material is a teaching or suggestion that nearly any polymer, or the specific polymer identified at column 7, lines 14–20, would be useful when conjugated to any amine-containing substance identified in Bentley, including biologically active molecules. Moreover, Bentley generally discloses that activated PEG polymers can be conjugated to molecules or surfaces and specifically incorporates by reference Merrill, which discloses conjugating “star” molecules to the support surface of an affinity column. Ex. 1015, 6:12–13; Ex. 2020, 2:5–8. Dr. Yamamoto does not address these disclosures or explain adequately why one of ordinary skill in the art would have sought to conjugate the specific activated PEG molecule disclosed in Bentley (Ex. 1015, 7:14–20) to a biologically active molecule, as opposed to the support surface of an affinity column. Ex. 2020, 2:5–8. Indeed, Dr. Yamamoto does not persuasively identify any actual properties of the specific activated PEG molecule of Bentley relied upon in the Petition.” slip op. at 6

  • Skill levelDecided for patent owner

    “A high level of skill in the art tends to favor an obviousness conclusion. See Innovention Toys, LLC v. MGA Entm’t, Inc., 637 F.3d 1314, 1323 (Fed. Cir. 2011) (“A less sophisticated level of skill generally favors a determination of nonobviousness, and thus the patentee, while a higher level of skill favors the reverse.”). Even when the level of skill is high, to meet its burden for institution, Petitioner must still adequately explain why the art and such high skill would have led to the claimed invention. As noted above, we do not find that Petitioner and Dr. Yamamoto did so. Thus, Petitioner has not established that we overlooked its argument as to this issue.” slip op. at 7

  § 103 obviousness
  Patents in suitUS 7,872,072
• Agilent Technologies, Inc. v. Bio-Rad Laboratories, Inc.Rehearing denied
  PTAB · Oct 23, 2019 · IPR2019-00268 · APJ Zhenyu Yang · IPR · Rehearing

  The Board denied Agilent’s rehearing request, leaving in place the denial of institution because it had not shown Kordunsky was prior art or provided a specific motivation to combine.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When rehearing a decision on institution, the Board reviews 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.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A rehearing request “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

    “Kordunsky. Pet. 39–49. According to Petitioner, Kordunsky qualifies as prior art because the priority application fails to provide written-description support for the limitations “heater” and “a plurality of openings,” recited in claim 1. Id. at 20–24. In our Decision denying the Petition, we determined Petitioner has not met its burden in showing that Kordunsky qualifies as prior art. Dec. 7–14.” slip op. at 2

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

    “Kordunsky. Pet. 39–49. According to Petitioner, Kordunsky qualifies as prior art because the priority application fails to provide written-description support for the limitations “heater” and “a plurality of openings,” recited in claim 1. Id. at 20–24. In our Decision denying the Petition, we determined Petitioner has not met its burden in showing that Kordunsky qualifies as prior art. Dec. 7–14.” slip op. at 2

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

    “obvious over various combinations of prior art teachings. Pet. 49–72. In our Decision denying the Petition, we found “Petitioner merely offer[ed] general statements regarding the reason to combine the teachings of the prior art,” and those “‘generic motivations with no specificity’ fall short of the articulated rationale required.” Dec. 19 (quoting Prelim. Resp. 41). In its rehearing request, Petitioner argues that we overlooked and misapprehended the strong evidence of motivation to combine presented in the Petition. Reh’g Req. 2–3. We are not persuaded.” slip op. at 7

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,835,118
• Agilent Technologies, Inc. v. Bio-Rad Laboratories, Inc.Rehearing denied
  PTAB · Oct 23, 2019 · IPR2019-00266 · APJ Michelle N Ankenbrand · IPR · Rehearing

  The Board denied rehearing, finding no abuse of discretion in denying institution because Petitioner failed to show a reasonable likelihood of prevailing on its anticipation and obviousness challenges to claims 1–22.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When rehearing a decision on institution, the Board reviews 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.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A rehearing request “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

    “CONCLUSION In sum, we determine that, in its Petition, Petitioner did not establish a reasonable likelihood that it would prevail in showing the unpatentability of the challenged claims. On rehearing, Petitioner does not persuade us that our decision was based on an erroneous conclusion of law or clearly erroneous factual findings. Accordingly, we conclude that Petitioner has not demonstrated that we abused our discretion in denying institution of the challenged claims.” slip op. at 8

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner

    “In our Decision, we agreed with Patent Owner that “a patent applicant need not describe information that is ‘well-known in the art’ in order to satisfy the written description requirement.” Dec. 14 (citing Prelim. Resp. 31 (quoting Boston Sci., 647 F.3d at 1366)). We further explained that the Federal Circuit had set forth a number of factors for evaluating the adequacy of the disclosure for generic claims, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 14 (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). And we noted that Petitioner did not address the factors, whereas Patent Owner directed us to evidence in the record “indicating that the broader category of heaters was well-known before 2003, given the existing knowledge in the field, the extent and content of the prior art, and the maturity of the technology.” Id. at 15. Based on that evidence, we concluded, “the disclosure in the priority applications of a lid heater reasonably conveys to those of ordinary skill in the art that the inventor was in possession of the broader genus of a ‘heating element’/‘heater.’” Id. at 16.” slip op. at 4

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

    “to improve similar and related devices.” Id. at 4 (quoting Pet. 57). But a generalized desire to improve existing devices is different from a specific reasoning to combine the prior art asserted in this proceeding. See Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 381 F.3d 1371, 1377 (Fed. Cir. 2004) (“Recognition of a need does not render obvious the achievement that meets that need.”).” slip op. at 7

  § 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 8,236,504
• Aquestive Therapeutics, Inc. v. Neurelis, Inc.Rehearing denied
  PTAB · Sep 27, 2019 · IPR2019-00449 · APJ Jon B Tornquist · IPR · Rehearing

  The Board denied rehearing and denied institution on the § 103 Cartt ’865 and Ueda ground for claim 8, finding insufficient reason to use Ueda’s alcohol levels in Cartt’s nasal spray.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. STANDARD FOR REHEARING Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. 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. 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 exists where a “decision [i]s 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).” slip op. at 2

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

    “We are not persuaded by Petitioner’s arguments. Ueda’s example formulations utilize other compounds that serve to increase the solubility of compound [I], including 0.8% or 0.6% carboxyvinyl polymer (Carbopol 940) and 15% or 20% polyethlyene glycol (PEG-600) (formulations 1 and 2, respectively). See Ex. 1019, Table (disclosing the use of both carboxyvinyl polymer and polyethylene glycol in Formulations 1 and 2), 3:29–30 (noting that a gelling agent and an alcohol improve poor solubility of Compound [I]), 3:33–41 (identifying Carbopol 940 as a gelling agent), 3:55–4:11 (identifying monohydric alcohols and polyhydric alcohols, such as polyethylene glycol, as “alcohols”). Petitioner does not explain sufficiently why one of ordinary skill in the art would have continued to use the same amounts of ethanol and benzyl alcohol in Cartt ’865 in the absence of the 15% or 20% polyethylene glycol and the 0.8% or 0.6% carboxyvinyl polymer used in formulations 1 and 2 of Ueda. Nor does Petitioner’s obviousness analysis direct us to disclosure in Ueda of applying its topical compositions to nasal mucosa, or provide persuasive reasoning or evidence to suggest that the combination of 20% ethanol and 5% benzyl alcohol or 25% ethanol and 10% benzyl alcohol used in Ueda would provide the same successful results for a benzodiazepine drug (as opposed to compound [I]). Thus, although it was known in the art that 20% ethanol and 5% benzyl alcohol and 25% ethanol and 10% benzyl alcohol had previously been used in combination to improve the solubility of compound [I] in a topical formulation for the treatment of acne, it is not evident from Petitioner’s arguments set forth on pages 61–63 of the Petition1 why one of 1 Petitioner’s Request for Rehearing includes additional citations to Dr. Peppas’ declaration that were not provided in the section addressing Petitioner’s obviousness ground based on Cartt ’865 and Ueda. Compare Pet. 61–63 (citing various portions of Exhibit 1019 and Ex. 1041 ¶ 322) with Req. Reh’g 6 n.3 (citing Ex. 1041 ¶¶ 127, 127, 140, 142). The Petition also provides a string cite to paragraphs 375–387 of Dr. Peppas’ declaration, but provides no analysis as to why these paragraphs support its conclusions with respect to claim 8. Pet. 63; 37 C.F.R. § 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”). A request for rehearing is not an opportunity to assert arguments that were not made, or not sufficiently explained, in the Petition for a particular ground of unpatentability. ordinary skill in the art would have sought to use the same levels of ethanol and benzyl alcohol in Cartt ’865’s benzodiazepine-based nasal spray, especially in the absence of the additional 15% or 20% polyethylene glycol and 0.8% or 0.6% gelling agent used in formulations 1 and 2 of Ueda.” slip op. at 5

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

    “We are not persuaded by Petitioner’s arguments. Ueda’s example formulations utilize other compounds that serve to increase the solubility of compound [I], including 0.8% or 0.6% carboxyvinyl polymer (Carbopol 940) and 15% or 20% polyethlyene glycol (PEG-600) (formulations 1 and 2, respectively). See Ex. 1019, Table (disclosing the use of both carboxyvinyl polymer and polyethylene glycol in Formulations 1 and 2), 3:29–30 (noting that a gelling agent and an alcohol improve poor solubility of Compound [I]), 3:33–41 (identifying Carbopol 940 as a gelling agent), 3:55–4:11 (identifying monohydric alcohols and polyhydric alcohols, such as polyethylene glycol, as “alcohols”). Petitioner does not explain sufficiently why one of ordinary skill in the art would have continued to use the same amounts of ethanol and benzyl alcohol in Cartt ’865 in the absence of the 15% or 20% polyethylene glycol and the 0.8% or 0.6% carboxyvinyl polymer used in formulations 1 and 2 of Ueda. Nor does Petitioner’s obviousness analysis direct us to disclosure in Ueda of applying its topical compositions to nasal mucosa, or provide persuasive reasoning or evidence to suggest that the combination of 20% ethanol and 5% benzyl alcohol or 25% ethanol and 10% benzyl alcohol used in Ueda would provide the same successful results for a benzodiazepine drug (as opposed to compound [I]). Thus, although it was known in the art that 20% ethanol and 5% benzyl alcohol and 25% ethanol and 10% benzyl alcohol had previously been used in combination to improve the solubility of compound [I] in a topical formulation for the treatment of acne, it is not evident from Petitioner’s arguments set forth on pages 61–63 of the Petition1 why one of 1 Petitioner’s Request for Rehearing includes additional citations to Dr. Peppas’ declaration that were not provided in the section addressing Petitioner’s obviousness ground based on Cartt ’865 and Ueda. Compare Pet. 61–63 (citing various portions of Exhibit 1019 and Ex. 1041 ¶ 322) with Req. Reh’g 6 n.3 (citing Ex. 1041 ¶¶ 127, 127, 140, 142). The Petition also provides a string cite to paragraphs 375–387 of Dr. Peppas’ declaration, but provides no analysis as to why these paragraphs support its conclusions with respect to claim 8. Pet. 63; 37 C.F.R. § 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”). A request for rehearing is not an opportunity to assert arguments that were not made, or not sufficiently explained, in the Petition for a particular ground of unpatentability. ordinary skill in the art would have sought to use the same levels of ethanol and benzyl alcohol in Cartt ’865’s benzodiazepine-based nasal spray, especially in the absence of the additional 15% or 20% polyethylene glycol and 0.8% or 0.6% gelling agent used in formulations 1 and 2 of Ueda.” slip op. at 5

  § 103 obviousness
  Patents in suitUS 9,763,876
• Aquestive Therapeutics, Inc. v. Neurelis, Inc.Rehearing denied
  PTAB · Sep 27, 2019 · IPR2019-00451 · APJ Jamie T Wisz · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting review of claims 1–36 because Patent Owner did not show entitlement to the provisional priority date.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. ANALYSIS Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. 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. 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 exists where a “decision [i]s 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).” slip op. at 2

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner

    “burden of going forward to show that there is invalidating prior art. Dynamic Drinkware, 800 F.3d at 1379. As discussed in our Decision, Petitioner satisfied its initial burden of production on the issue of whether Gwozdz is prior art by establishing that Gwozdz is entitled to the effective filing date of the Gwozdz provisional. Decision 7. Therefore, Gwozdz is prior art to the ’876 patent under 35 U.S.C. § 102(e)(1) unless Patent Owner can show that the ’876 patent is entitled to the effective filing date of its provisional application (“the ’558 provisional”). Id. Thus, the burden of production shifts to Patent Owner, who must show not only the existence of earlier applications, but also how the written description in the earlier applications supports the challenged claims. Dynamic Drinkware, 800 F.3d at 1379–80. “[T]o gain the benefit of the filing date of an earlier application 4 under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112.” Zenon Envtl., Inc. v. U.S. Filter Corp., 506 F.3d 1370, 1378 (Fed. Cir. 2007) (quoting Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997)); see also In re Hogan, 559 F.2d 595, 609 (CCPA 1977) (“[T]here has to be a continuous chain of copending applications each of which satisfies the requirements of § 112 with respect to the subject matter presently claimed.” (alteration in original) (quoting In re Schneider, 481 F.2d 1350, 1356 (CCPA 1973))). Thus, as discussed in our Decision, Patent Owner must show that each application in the priority chain1 makes the requisite disclosure of subject matter; otherwise, the ’876 patent is not entitled to the benefit of the filing date of the ’558 provisional. Decision 7 n.6. On this record, Patent Owner fails to satisfy its burden of production to show entitlement to an earlier filing date. All of Patent Owner’s arguments are focused on the alleged deficiencies with Petitioner’s contentions regarding the disclosure of alkyl glycosides in the ’558 provisional. Prelim. Resp. 24–27. Patent Owner offers no analysis demonstrating that every patent application along the priority chain conveys with reasonable clarity to those skilled in the art that the inventors were in possession of each limitation of each of the challenged claims, as well as the 1 In this case, the priority chain for the ’876 patent includes a provisional application and a continuation-in-part application. Decision 6. 5 claimed invention as a whole. See Lockwood, 107 F.3d at 1572. Therefore, on this record, Patent Owner has not demonstrated that the claims of the ’876 patent are entitled to the priority date of the ’558 provisional.” slip op. at 4

  § 102 anticipation
  Patents in suitUS 9,763,876
• Eset, LLC / Eset Spol S.R.O. v. Finjan, Inc.Rehearing denied
  PTAB · Aug 10, 2018 · IPR2017-01738 · APJ Patrick M Boucher · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving review instituted on all challenged claims and all grounds presented in the Petition.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “Nevertheless, like Petitioner, the panel “is not aware of a single case where a partially-instituted IPR was de-instituted post-SAS, as requested by Patent Owner.” Opp. 5. The panel is sympathetic to the position in which institution of the Freund-based grounds places Patent Owner. If now faced with the Petition in the first instance, and understanding that we have only a “binary choice,” it may well be appropriate to deny the Petition in its entirety. But we have been instructed that the Office SAS Guidance is to be interpreted with the weight of Office policy as precluding termination of a partially instituted proceeding in response to SAS Institute. Given that constraint, we are not persuaded that we abused our discretion in our modification Order to include review of all challenged claims and all grounds presented in the Petition. See 37 C.F.R. § 42.71(c). Thus, notwithstanding the panel’s significant reservations, we continue to give effect to the Director’s policy guidance, and deny Patent Owner’s Rehearing Request.” slip op. at 10

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “SAS procedure outlined herein and determines that the trial must be instituted on all grounds or none, Patent Owner requests that the proceedings be terminated pursuant to 35 U.S.C. § 325(d).” Req. Reh’g 10. In making this request, Patent Owner raises important issues regarding the interplay of SAS Institute and 35 U.S.C. § 325(d). The panel is sensitive to Patent Owner’s concern that Under the full-institution full-review paradigm laid out in the Board’s Modified Institution Order and envisioned by the Guidelines, Patent Owners will be forced to defend against the very types of harassing challenges that these sections of the America Invents Act [35 U.S.C. §§ 314(a) and 325(d)] were designed to prevent, namely to “prevent parties from mounting attacks on patents that raise issues that are substantially the same as issues that were already before the Office with respect to the patent.” Id. at 6 (quoting 157 Cong. Rec. S1360 at S1376 (Mar. 8, 2011) (remarks of Senator Kyl); citing H.R. Rep. No. 112-98, pt. 1, at 48 (2011) (warning the AIA’s procedures should not be used as tools for harassment)).5 Nevertheless, like Petitioner, the panel “is not aware of a single case where a partially-instituted IPR was de-instituted post-SAS, as requested by Patent Owner.” Opp. 5. The panel is sympathetic to the position in which institution of the Freund-based grounds places Patent Owner. If now faced with the Petition in the first instance, and understanding that we have only a “binary choice,” it may well be appropriate to deny the Petition in its entirety. But we have been instructed that the Office SAS Guidance is to be interpreted with the weight of Office policy as precluding termination of a partially instituted proceeding in response to SAS Institute. Given that constraint, we are not persuaded that we abused our discretion in our modification Order to include review of all challenged claims and all grounds presented in the Petition. See 37 C.F.R. § 42.71(c).” slip op. at 9

  Discretionary denial
  Patents in suitUS 7,975,305
• Complete Genomics, Inc. v. Illumina Cambridge Ltd.Rehearing denied
  PTAB · Aug 2, 2018 · IPR2017-02172 · APJ Timothy G Majors · IPR · Rehearing

  The Board denied rehearing, leaving institution denied under § 325(d) because the same claims and prior art had already received full consideration.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “In response to a request for rehearing, the panel reviews a decision whether to institute trial for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). Moreover, the request “must specifically identify all matters the [challenging] 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. As discussed below, we deny the Request because Petitioner does not establish an abuse of discretion.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner

    “The exercise of discretion under § 325(d) involves a balance of interests. For example, as the Board has previously noted, “on the one hand, there are interests in conserving the resources of the Office and granting patent owners repose on issues and prior art that have been considered previously.” Fox Factory, Inc. v. SRAM, LLC, IPR2016-01876, slip op. at 7 (PTAB Oct. 4, 2017). But “there are the interests of giving petitioners the opportunity to be heard and correcting any errors by the Office in allowing a patent.” Id.” slip op. at 4

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

    “Petitioner argues the ordinarily skilled person “would have been motivated to combine Tsien’s method with the azidomethyl group for applications that did not require more than a few sequential nucleotide additions” (Pet. 46), but Petitioner’s expert does not go that far. Rather, Dr. Sutherland opines that “[o]ne of ordinary skill would have appreciated that the method of Tsien could be used to detect or characterize these polymorphisms, even without a high deblocking yield.” Ex. 1101, ¶ 88;6 see also id. ¶ 89 (“Tsien’s method could have been used to modify the Arrayed Primer Extension (APEX) technique, which was used for the detection of SNPs.”). The standard for obviousness, however, is not whether something could have been done, but whether the ordinarily skilled person, at the time of the invention, predictably would have done so. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Petitioner also cites no support in Tsien for using its methods in this way. Pet. 46; Ex. 1101, ¶¶ 88–89. To the contrary, Tsien’s SBS methods involve long sequences, and Petitioner’s argument appears to us as little more than after-the-fact rationalization to circumvent high efficiency, quantitative deblocking — Tsien’s required criteria. Dec. 11–13; Ex. 1094, 11–12; Ex. 1003, 20:24–31:3; Intelligent Bio-Systems, 821 F.3d at 1364. With no clear support in Tsien, Petitioner cites the ’537 patent itself as describing use of the claimed sequencing methods for detection of polymorphisms/SNP studies. See, e.g., 24 (citing Ex. 1001, 2:7–9). But” slip op. at 9

  • BurdenDecided for patent owner

    “whether to institute trial for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). Moreover, the request “must specifically identify all matters the [challenging] 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. As discussed below, we deny the Request because Petitioner does not establish an abuse of discretion.” slip op. at 2

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 7,566,537
• Complete Genomics, Inc. v. Illumina Cambridge Ltd.Rehearing denied
  PTAB · Aug 2, 2018 · IPR2017-02174 · APJ Timothy G Majors · IPR · Rehearing

  The Board denied Complete Genomics’ rehearing request, leaving in place the denial of institution because the petition did not show a reasonable likelihood of prevailing on the challenged obviousness grounds.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “In response to a request for rehearing, the panel reviews a decision whether to institute trial for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). Moreover, the request “must specifically identify all matters the [challenging] 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. As discussed below, we deny the Request because Petitioner does not establish an abuse of discretion.” slip op. at 2

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

    “35 U.S.C. § 103 over the combined teachings of Dower, Church, and Zavgorodny. Pet. 8–9; Dec. 7–8. Claim 3 was challenged for obviousness based on the above prior art combination, in further view of Prober. Pet. 8– 9; Dec. 7–8. Based on the information presented in the Petition and the Preliminary Response, we determined that Petitioner had not established a reasonable likelihood of prevailing with respect to at least one of the challenged claims on the grounds advanced and, accordingly, we denied the Petitioner has made this necessary threshold showing). Among other things, we determined Petitioner had not made a sufficiently persuasive showing that the ordinarily skilled person would have combined Dower, Church, and Zavgorodny based on a “simple substitution” theory or the alleged “advantageous properties” of an azidomethyl protecting group as argued in the Petition. Dec. 25–38; Pet. 32–52.” slip op. at 2

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

    “Petitioner’s argument fails to meet the burden in showing the Board overlooked or misunderstood relevant matters, and abused our discretion in denying institution based, in part, on the Board’s determination that an ordinarily skilled person would have been discouraged from using an azidomethyl protecting group and Zavgorodny’s deprotecting conditions in Dower’s DNA sequencing methods. Dec. 30–33. As explained in the Decision, Zavgorodny does not disclose any specific use for its protected molecules, much less disclose or suggest a use in DNA sequencing methods like disclosed in Dower. Dec. 18; Dec. 27–28. Petitioner admitted (and the art reflected) that potential harm to the DNA was a key consideration in selecting suitable protecting groups. Dec. 23. And, as discussed in the Decision, the evidence of record persuaded us that the skilled person would not have been motivated to use Zavgorodny’s deprotection conditions 1 Petitioner also contends the Board appears to have misunderstood the word “very specific” in relation to Zavgorodny’s reaction conditions. Req. Reh’g 8 n.1 (citing Dec. 30 n.22). According to Petitioner, Zavgorodny used the term to describe the specificity of the reaction, not to suggest that the reaction must use the specific conditions recited. Id. Assuming, for argument’s sake, Petitioner is correct, we are unpersuaded the Decision should be modified. The fact remains that even nearly 10 years after the initial Zavgorodny publication, Zavgorodny ’00 does not disclose any other suitable removal conditions. Dec. 30 n.22. We were unpersuaded those conditions would be considered suitable for Dower’s DNA sequencing methods as discussed in the Decision. Dec. 30–33. reactions because pyridine is a well-known DNA denaturant. Dec. 28 (discussing references describing pyridine as one of the “most effective” DNA denaturants); see also id. at 31 (discussing the Board’s determination that conditions disclosed as mild in some contexts does not demonstrate those conditions are mild and suitable in other contexts). That the Board found persuasive the evidence clearly and explicitly disclosing that pyridine is an especially effective DNA denaturant, over the opinion of Petitioner’s expert that such solvents would not be a concern does not constitute an abuse of discretion. Req. Reh’g 6–7.” slip op. at 4

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for patent owner

    “Second, Petitioner’s argument about optimizing the conditions for an azidomethyl protecting group presumes there was sufficient motivation for the ordinary artisan to use that group in DNA sequencing methods to begin with. As we explained throughout the Decision, we were unpersuaded for many reasons that the evidence of record provided an adequate motivation to do so. See, e.g., 21–38. There may well be conditions under which a 3'-O-azido protecting group is usable in DNA-sequencing methods. Indeed, that is the invention claimed. But it is impermissible hindsight to start with the end result and work backwards, asserting that whatever roadblocks are reflected in the art or that might arise in relation to the use of that protecting group, the skilled person would just work around them by changing the conditions to yield the claimed invention. As we explained in the Decision, in the years before the invention there were numerous known protecting groups described in the art for DNA sequencing methods like Dower (e.g., 3'-O-allyl, tBOC, 3'-O-acetyl). Dec. 26. Why choose an azido or azidomethyl group for this purpose when there is no indication in the art to have done so, and ample evidence suggests selection of such a group would be accompanied by a host of discouraging factors (e.g., DNA-denaturing conditions, low yields, steric bulk)? See Dec. 26–37. For reasons discussed in the Decision, the Petition failed to provide a sufficiently persuasive answer to this question.” slip op. at 6

  § 103 obviousness
  Patents in suitUS 7,566,537

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.