• Netapp, Inc. v. Realtime Data LLCInstitution denied
  PTAB · Nov 14, 2017 · IPR2017-01354 · APJ Kamran Jivani · IPR · Institution

  The Board denied institution of NetApp’s petition challenging claims 1, 2, 9, 10, 15, 17, 20, and 24, exercising discretion under § 314(a) based on the General Plastic factors.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied

    “IPR2016-01357 Paper 19, 16 (citations omitted). We recognize that these General Plastic factors typically have been used to analyze situations in which the same party files multiple petitions challenging the same patent. However, our discretion under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a) is not limited to situations where the same party files multiple petitions, and we find that the General Plastic factors provide a useful framework for analyzing the facts and circumstances present in this case, in which a different petitioner filed a petition challenging a patent that had been challenged already by previous petitions. Applying the General Plastic factors to the present Petition, we conclude that the circumstances present here warrant discretionary denial of institution.” slip op. at 10

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

    “provides that the “Director[3] may not authorize an inter partes review to be instituted unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” “Congress did not mandate that an inter partes review must be instituted under certain” slip op. at 8

  Discretionary denial
  Patents in suitUS 9,054,728
• Guardant Health, Inc. v. Foundation Medicine, Inc.Rehearing denied
  PTAB · Nov 8, 2017 · IPR2017-01170 · APJ Richard J Smith · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving instituted review of claims 65, 66, 72, 73, 75–77, and 80–85 based on its reasonable-likelihood determination.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “DISCUSSION When rehearing a decision on petition, 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 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.” 37 C.F.R. § 42.71(d).” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

    “According to the ’830 patent, the term “bait” is defined as including “a nucleic acid molecule . . . which can hybridize to (e.g., be complementary to), and thereby allow capture of a target nucleic acid.” Ex. 1001, 28:47–50. Patent Owner acknowledges that “both primers and baits hybridize to a complementary portion of the target nucleic acid.” Req. Reh’g. 3 (citing Prelim. Resp. 30). However, Patent Owner does not explain or otherwise persuasively address why the subject nucleic acids in Shah are not included within that definition of “bait.” We did not overlook Patent Owner’s explanation of why, in its view, “primers” are not “baits.” Rather, at this stage of the proceeding, we found such explanation unpersuasive as we stated in the Decision. Dec. 13. (stating “we are not persuaded that the definition of the term ‘bait,’ as set forth in the ’830 patent, does not include primers”). Moreover, because we did not overlook Patent Owner’s explanation, we find no basis to reconsider the disclosures of Shah.” slip op. at 4

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successDecided for petitioner

    “We did not overlook and/or misapprehend Patent Owner’s argument. We expressly addressed that argument with respect to bait sets (i) and (ii) by stating that “we find that choosing bait sets that select somatic mutations that appear at a frequency of about 5% or less and at a frequency of about 10% or higher is taught or suggested by the combined teachings of Levin and Shah.” Dec. 17 (emphasis added); see also Dec. 20 (“Having considered the arguments and evidence, we are persuaded at this stage of the proceeding that Petitioner has sufficiently shown that the limitations of claim 65 are taught or suggested by, or would have been obvious in view of, the combined teachings of Levin and Shah.”). Moreover, contrary to Patent Owner’s argument, the fact that the Decision may not recite the words “used together” does not indicate that we overlooked and/or misapprehended Patent Owner’s argument. See Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017) (stating “this court has said on multiple occasions that failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it”) (citing cases).” slip op. at 5

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

    “We did not overlook and/or misapprehend Patent Owner’s argument; rather, we considered it and found it unpersuasive. See Dec. 13 (stating “on this record, we find that Levin’s disclosure of multiple baits would include multiple bait sets”). In particular, we found that Levin teaches the use of multiple bait sets, not one bait set as argued by Patent Owner. See id. Furthermore, Patent Owner’s argument that all of the baits in Levin were “designed in precisely the same way” was based on Levin’s statement that “[b]aits were designed in a tiling fashion with minimal overlap to span the entire protein-coding region of each transcript.” See Prelim. Resp. 28 (citing Ex. 1010, 2). However, that statement suggests the design of multiple different baits that would include multiple different bait sets.” slip op. at 6

  Claim construction§ 103 obviousness
  Patents in suitUS 9,340,830
• Parrot S.A. / Parrot Drones, S.A.S. et al. v. Qfo Labs, Inc.Institution denied
  PTAB · Sep 28, 2017 · IPR2017-01089 · APJ Hyun J Jung · IPR · Institution

  The Board denied institution on claims 1–9 under § 314(a), finding the General Plastic follow-on petition factors strongly favored non-institution.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied

    “institute an inter partes review. Prelim. Resp. 25; 35 U.S.C. § 314(a) (stating “[t]he Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition” (emphasis added)); 37 C.F.R. § 42.108(a) (stating “the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim” (emphasis added)). There is no per se rule precluding the filing of follow-on petitions after the Board’s denial of one or more first-filed petitions on the same patent. The Board consistently has considered a number of factors in determining whether to exercise that discretion. See NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 6–8 (PTAB May 4, 2016) (Paper 9) (“NVIDIA”); LG Elecs. Inc. v. Core Wireless Licensing S.A.R.L., Case IPR2016-00986, slip op. at 6–7 (PTAB Aug. 22, 2016) (Paper 12); see also Xactware Sols., Inc. v. Eagle View Techs., Inc., Case IPR2017- 00034, slip op. at 7–8 (PTAB Apr. 13, 2017) (Paper 9); Gen. Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, Case IPR2016-01357, slip op. at 15– 16 (PTAB Sept. 6, 2017) (Paper 19) (designated informative) (“Gen. Plastic”). Those factors are: 1. whether the same petitioner previously filed a petition directed to the same claims of the same patent; 2. whether at the time of filing of the first petition the petitioner knew of the prior art asserted in the second petition or should have known of it; 3. whether at the time of filing of the second petition the petitioner already received the patent owner’s preliminary response to the first petition or received the Board’s decision on whether to institute review in the first petition; 4. the length of time that elapsed between the time the petitioner learned of the prior art asserted in the second petition and the filing of the second petition; 5. whether the petitioner provides adequate explanation for the time elapsed between the filings of multiple petitions directed to the same claims of the same patent; 6. the finite resources of the Board; and 7. the requirement under 35 U.S.C. § 316(a)(11) to issue a final determination not later than 1 year after the date on which the Director notices institution of review.” slip op. at 7

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

    “CONCLUSION For the foregoing reasons, based on the circumstances of this case and our assessment that the NVIDIA factors strongly favor non-institution, we exercise our discretion under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a) to deny the Petition in this proceeding. Petitioners’ Motion for Joinder is also dismissed as moot. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied as to claims 1–9 of the ’239 patent, and” slip op. at 11

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

    “our assessment that the NVIDIA factors strongly favor non-institution, we exercise our discretion under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a) to deny the Petition in this proceeding. Petitioners’ Motion for Joinder is also dismissed as moot. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied as to claims 1–9 of the ’239 patent, and FURTHER ORDERED that the Motion for Joinder is dismissed as moot.” slip op. at 11

  Discretionary denial
  Patents in suitUS 7,931,239
• Parrot S.A. / Parrot Drones, S.A.S. et al. v. Qfo Labs, Inc.Institution denied
  PTAB · Sep 28, 2017 · IPR2017-01090 · APJ Hyun J Jung · IPR · Institution

  The Board denied institution on claims 1–7 and 15–24 under § 314(a), finding the follow-on petition factors strongly favored non-institution, and dismissed the joinder motion as moot.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied

    “The factors are intended to take into account undue inequities and prejudices to Patent Owner. Gen. Plastic, slip op. at 17. Multiple, staggered petitions challenging the same patent and same claims raise the potential for abuse, such as petitioners strategically staging their prior art and arguments in multiple petitions, “using our decisions as a roadmap, until a ground is found that results in the grant of review.” Id. Consideration of these factors allows for assessing whether a petitioner should have or could have raised the new challenges earlier. Id. at 18. “[T]here may be circumstances where multiple petitions by the same petitioner against the same claims of a patent should be permitted, and that such a determination is dependent on the facts at issue in the case.” Id. We agree with Patent Owner that applying the factors from NVIDIA strongly favors exercising our discretion under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a). We address each of the factors in the order presented above.” slip op. at 8

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

    “We agree with Patent Owner that the Director has discretion to institute an inter partes review. Prelim. Resp. 23; 35 U.S.C. § 314(a) (stating “[t]he Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition” (emphasis added)); 37 C.F.R. § 42.108(a) (stating “the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim” (emphasis added)). There is no per se rule precluding the filing of follow-on petitions after the Board’s denial of one or more first-filed petitions on the same patent. The Board consistently has considered a number of factors in determining whether to exercise that discretion. See NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 6–8 (PTAB May 4, 2016) (Paper 9) (“NVIDIA”); LG Elecs. Inc. v. Core Wireless Licensing S.A.R.L., Case IPR2016-00986, slip op. at 6–7 (PTAB Aug. 22, 2016) (Paper 12); see also Xactware Sols., Inc. v. Eagle View Techs., Inc., Case IPR2017-” slip op. at 7

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

    “CONCLUSION For the foregoing reasons, based on the circumstances of this case and our assessment that the NVIDIA factors strongly favor non-institution, we exercise our discretion under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a) to deny the Petition in this proceeding. Petitioners’ Motion for Joinder is also dismissed as moot. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied as to claims 1–7 and 15–24 of the ’532 patent, and FURTHER ORDERED that the Motion for Joinder is dismissed as moot.” slip op. at 11

  Discretionary denial
  Patents in suitUS 9,073,532
• Coherus Biosciences, Inc. v. Abbvie Biotechnology Ltd.Institution denied
  PTAB · Sep 7, 2017 · IPR2017-01009 · APJ Michelle N Ankenbrand · IPR · Institution

  The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show a reasonable likelihood of proving obviousness over the cited combination.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we deny the Petition and do not institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedOther

    “that, as of November 30, 2007, a person of ordinary skill in the art “would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline)” and “at least two years of experience preparing formulations of proteins suitable for therapeutic use.” Pet. 22–23 (citing Ex. 1302 ¶¶ 62–63). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill, which we adopt for purposes of this decision. See Prelim. Resp. 13 (“For the limited purpose of this Preliminary Response, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art.”). We also find, for purposes of this decision, that the prior art itself is sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the appropriate level of ordinary skill in art).” slip op. at 7

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

    “Petitioner proposes that we construe the phrase “does not comprise a buffering system.” Pet. 23–24. Although Patent Owner does not dispute Petitioner’s proposed construction at this stage of the proceeding (see Prelim. Resp. 13), neither party identifies a dispute that turns on the meaning of the phrase “does not comprise a buffering system.” See generally Pet.; Prelim. Resp. Thus, we determine that no claim term requires construction for purposes of this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 7

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

    “buffer system of the 2003 HUMIRA formulation based on Fransson’s teachings, we find that Fransson neither discloses nor suggests removing the buffer system from a formulation. To the contrary, as Patent Owner points out, Fransson describes all of its formulations as including a buffer. Prelim. Resp. 33–34. Specifically, Fransson states that the tested formulations “were prepared by mixing disodium phosphate, monosodium phosphate, and sodium chloride in water for injection to give isotonic solutions of different pH and buffer concentration. hIGF-I was added to some of the solutions by ultrafiltration.” Ex. 1304, 1012–13. Petitioner does not explain adequately how that express teaching of buffered formulations, with no disclosure of any tested formulations without a buffer, would have prompted the ordinary artisan to eliminate buffer from the 2003 HUMIRA formulation. Moreover, in summarizing the results of its study, Fransson explains that although an intermediate phosphate buffer concentration of 10 mM resulted in less injection pain than a higher buffer concentration of 50 mM, further reducing the phosphate buffer concentration to 5 mM “did not reduce pain further.” Id. at 1014. In other words, Fransson teaches that reducing the buffer concentration below a particular threshold concentration provides no additional pain reducing benefit. That disclosure fails to support Petitioner’s assertion, and Dr. Radtke’s testimony (Ex. 1302 ¶ 86), that Fransson would have prompted the skilled artisan to eliminate Humira’s buffer system to reduce injection site pain.” slip op. at 14

  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,085,619
• Coherus Biosciences, Inc. v. Abbvie Biotechnology Ltd.Institution denied
  PTAB · Sep 7, 2017 · IPR2017-01008 · APJ Michelle N Ankenbrand · IPR · Institution

  The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show a reasonable likelihood that either asserted §103 combination would succeed.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we deny the Petition and do not institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art. Petitioner contends that, as of November 30, 2007, a person of ordinary skill in the art “would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline)” and “at least two years of experience preparing formulations of proteins suitable for therapeutic use.” Pet. 22 (citing Ex. 1202 ¶ 64). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill, which we adopt for purposes of this decision. See Prelim. Resp. 15 (“For the limited purpose of this Preliminary Response, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art.”). We also find, for purposes of this decision, that the prior art itself is sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the appropriate level of ordinary skill in art).” slip op. at 7

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

    “Petitioner proposes that we construe the phrase “does not comprise a buffering system.” Pet. 22–23. Although Patent Owner does not dispute Petitioner’s proposed construction at this stage of the proceeding (see Prelim. Resp. 15), neither party identifies a dispute that turns on the meaning of the phrase “does not comprise a buffering system.” See generally Pet.; Prelim. Resp. Thus, we determine that no claim term requires construction for purposes of this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 8

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

    “buffer system of the 2003 HUMIRA formulation based on Fransson’s teachings, we find that Fransson neither discloses nor suggests removing the buffer system from a formulation. To the contrary, as Patent Owner points out, Fransson describes all of its formulations as including a buffer. Prelim. Resp. 33–34. Specifically, Fransson states that the tested formulations “were prepared by mixing disodium phosphate, monosodium phosphate, and sodium chloride in water for injection to give isotonic solutions of different pH and buffer concentration. hIGF-I was added to some of the solutions by ultrafiltration.” Ex. 1219, 1012–13. Petitioner does not explain adequately how that express teaching of buffered formulations, with no disclosure of any tested formulations without a buffer, would have led the ordinary artisan to eliminate buffer from the 2003 HUMIRA formulation.” slip op. at 16

  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,085,619
• Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.Institution denied
  PTAB · Sep 7, 2017 · IPR2017-00823 · APJ Tina E Hulse · IPR · Institution

  The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show Gokarn ’011 anticipated them.

  RulingsInstitution decision

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

    “2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear” slip op. at 9

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

    “2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear” slip op. at 9

  • Skill levelSkill level petitioner adoptedOther

    “skill in the art of pharmaceutical antibody formulation would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline) with at least two years of experience preparing formulations of proteins suitable for therapeutic use. Pet. 20 (citing Ex. 1102 ¶¶ 61–62). At this stage of the proceeding, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. Prelim. Resp. 10. On this record, we adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6

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

    “unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to inter partes review proceedings). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 7

  Claim construction§ 102 anticipation
  Patents in suitUS 9,085,619
• Coherus Biosciences, Inc. v. Abbvie Biotechnology Ltd.Institution denied
  PTAB · Sep 7, 2017 · IPR2017-00822 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution because Coherus did not show a reasonable likelihood that claims 16–19 and 24–30 were anticipated by Gokarn PCT or obvious over Gokarn PCT and the Humira Label.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we deny the Petition and do not institute an inter partes review.” slip op. at 2

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

    “Petitioner proposes that we construe the phrase “does not comprise a buffering system,” which appears in independent claim 16, to encompass formulations that have a de minimis amount of buffer components. Pet. 19– 20. Although Patent Owner does not dispute Petitioner’s proposed construction at this stage of the proceeding, it suggests that construction of this term is unnecessary at this stage. See Prelim. Resp. 11. Because Petitioner does not identify a dispute we need to resolve that turns on the meaning of the phrase “does not comprise a buffering system,” see generally Pet., we determine that no claim term requires construction for purposes of this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 8

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art. Petitioner contends that a person of ordinary skill in the art “would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline)” and “at least two years of experience preparing formulations of proteins suitable for therapeutic use.” Pet. 18–19 (citing Ex. 1002 ¶ 61–62). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill, which we adopt for purposes of this decision. See Prelim. Resp. 11 (“For the limited purpose of this Preliminary Response, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art.”). We also find, for purposes of this decision, that the prior art itself is sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the appropriate level of ordinary skill in art).” slip op. at 7

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

    “self-buffering proteins, especially in regard to adalimumab. Although Gokarn PCT describes self-buffering protein formulations, it repeatedly emphasizes that empirical data is needed to determine the buffering capacity of any particular protein. See Ex. 1003, 31:14–28 (stating “the buffer capacity of self-buffering protein formulations in accordance with the invention preferably is determined empirically by both acid titration and base titration over a given range of pH change from the desired pH of the composition”); id. at 36:10–14 (stating empirical measurements of protein buffer capacities are preferred); see also id. at 36:29–38:9 (describing determining protein buffer capacity from pH titration curves). Gokarn PCT does describe methods of predicting protein buffer capacity, but cautions that “[s]uch calculations generally will be of less utility and less accurate than empirical determinations of protein buffer capacity, in accordance with the methods described elsewhere herein. But they can be useful to provide rough maximum estimates of the buffer capacity of proteins in solution.” Id. at 40:15–18; see also id. at 38:10–14 (stating while “empirical determinations as described herein are generally a crucial aspect of formulating self-buffering compositions in accordance with various aspects and preferred embodiments of the invention, theoretical and computations methods also can be productively employed to guide the design, manufacture, and use of such compositions (in conjunction with empirical determinations)”). Gokarn PCT explains why empirical data is so crucial in determining protein buffer capacity: Conformational folding typically partitions large polypeptides and proteins in polar solvents into exposed solvent-accessible regions and more or less non-polar core regions that have little or no contact with the ambient environment. Folding produces many environments between these two extremes. Furthermore, the micro environment around a given amino acid side chain in a protein typically is affected by one or more of: solvent effects; binding of ions, chelation; complexation; association with co-factors; and post-translational modifications; to name just a few possibilities. Each of these can influence the pKa of a given amino acid ionization in a protein. The pKas for specific residues in a given protein, thus, can vary dramatically from that of a free amino acid. Id. at 38:26–39:2. No such empirical data is provided for adalimumab. See generally Ex. 1003; Prelim. Resp. 16. Rather, Gokarn PCT only provides examples of four different self-buffering proteins: Ab-hOPGL, Ab-hB7RP1, Ab-hCD22, and Ab-hIL4R. Prelim. Resp. 5 (citing Ex. 1003, 74:19–80:24).” slip op. at 16

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,085,619
• 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
• RPX Corporation v. Rothschild Connected Devices Innovations, LLCAll claims unpatentable
  PTAB · Jul 6, 2017 · IPR2016-00443 · APJ Scott C Moore · IPR · Final written decision

  Claims 1–8 are unpatentable under § 103: claims 1–7 over the Zimmerman-based combinations, and claims 1 and 8 over the Omnisphere- and Zimmerman-based grounds, respectively.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “would have had an undergraduate degree in computer science, electrical engineering, or computer engineering, or an equivalent degree, and at least two years of experience with network control systems, or have an equivalent amount of relevant work or research experience. Pet. 10. In our Decision on Institution, we declined to adopt the specific formulation set forth by Petitioner, and instead treated the cited references as being representative of the level of ordinary skill in the art. Dec. on Inst. 12 n.5 (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001)). In its Response, Patent Owner does not propose a specific formulation regarding the level of skill in the art, and does not object to treating the cited references as being representative of the level of ordinary skill in the art. Petitioner also does not object in its Reply to treating the cited references as being representative of the level of skill in the art. On this record, we decline to adopt a specific formulation regarding the level of ordinary skill in the art, and instead find that the cited references are representative of the level of ordinary skill in the art. See Okajima, 261 F.3d at 1355 (the level of ordinary skill in the art may be evidenced by the cited references themselves). However, our analysis of the issues below would have been the same had we adopted Petitioner’s proposed formulation.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “In general, preambles are not construed as claim limitations. Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). “[W]here a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). We find, on this record, that the body of claim 1 defines a structurally complete invention. In particular, the body of claim 1 defines a system that includes a remote server, and a predetermined product that includes a first communication module, wherein the remote server is configured to perform certain recited actions and to interact with the first communication module in the recited manner. Furthermore, the preamble of claim 1 recites “[a] system for customizing a product according to a user’s preferences.” That is, claim 1 recites a system with the intended purpose of customizing a product. We determine on this record that the preamble of claim 1 is a non-limiting statement of intended use.” slip op. at 10

  • Prior constructionPrior construction adoptedDecided for petitioner

    “Confirmation of Undisputed Claim Construction In our Decision on Institution, we expressly construed the claim term “predetermined product” by determining that this claim term “encompasses a type or class of product,” and rejecting “Patent Owner’s contention that this claim term is limited to a specific, unique product in customized form.” Dec. on Inst. 9. The parties do not dispute our prior construction of this claim term. Thus, on this record and to the extent necessary for our Final Written Decision, we see no reason to disturb our prior construction of “predetermined product,” and adopt the supporting reasoning from our Decision on Institution. See Dec. on Inst. 7–9. Accordingly, the claim term “predetermined product” encompasses a type or class of product, and is not limited to a specific, unique product in customized form. 3.” slip op. at 9

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

    “We determine that Patent Owner has not identified objective indicia of nonobviousness. For example, Patent Owner does not allege, much less persuasively show, that the cited mass customization literature demonstrates a long-felt but unresolved need that is satisfied by the claimed invention, or the failure of others to solve a problem addressed by the claimed invention. See PO Resp. 5–7. Patent Owner uses the cited mass customization literature to bolster its claim construction arguments, but does not offer any coherent or persuasive explanation of how this literature would constitute objective evidence that the claims of the ’090 patent are nonobvious. See id. at 4–7, 11–21. Patent Owner also has failed to establish any nexus between this alleged objective evidence of nonobviousness and the claims of the ’090 patent. Our reviewing court has held that objective evidence of nonobviousness must be “reasonably commensurate with the scope of the claims.” In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011). Patent Owner does not sufficiently explain how the mass customization literature relates to the claimed invention, or to any problem addressed by the claimed invention. For example, Patent Owner does not persuasively explain how the challenged claims relate to the specific need that is allegedly identified in the mass customization literature, i.e., to “kee[p] the products affordable.” PO Resp. 4. Patent Owner does not cite sufficient persuasive evidence that the inventor of the ’090 patent was attempting to address the issue of cost, or that the claimed invention would result in less-costly product as compared to the prior art. See id. at 4–7. Accordingly, even if Patent Owner had identified a specific secondary consideration that is evidenced by the cited mass customization literature, this evidence would not be entitled to substantial weight in the obviousness analysis. Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010) (“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.”); In re Kao, 639 F.3d at 1068 (same). 3.” slip op. at 13

  Patent outcomesUS 8,788,090 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,788,090

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.