• 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
• Samsung Electronics Co. Ltd. / Samsung Electronics America, Inc. et al. v. Rosetta-Wireless CorporationRehearing denied
  PTAB · Oct 20, 2017 · IPR2016-00622 · APJ John A Hudalla · IPR · Rehearing

  The Board denied Rosetta’s rehearing request, finding it had not shown the Board overlooked or misapprehended its § 318(a) and constitutional arguments.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “should be modified, which includes specifically identifying all matters the party believes we misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. See 37 C.F.R. § 42.71(d).” slip op. at 2

  • PTAB / AIA Trials › Constitutional / APA (Arthrex, Oil States, due process)Not reached

    “property right. Req. Reh’g 4–5. Thus, Rosetta contends “[i]nter partes review is an adjudicatory proceeding which, as in this case, may result in extinguishment of a patentee’s property rights by action of the Board and without the right to trial by jury.” Id. at 3. According to Rosetta, this violates the Seventh Amendment and Article III of the Constitution. Id. Rosetta cites to a pending case before the U.S. Supreme Court that has taken up this issue. Id. (citing Oil States Energy Servs., LLC v. Greene’s Energy Grp., LLC, 137 S. Ct. 2239 (2017)). Accordingly, Rosetta asks us to vacate our Final Written Decision. Id. at 6. Rosetta never made arguments during trial about the purported unconstitutionality of inter partes review. Nor does Rosetta’s request for rehearing attempt to identify such arguments in the trial record. As such, we could not have misapprehended or overlooked this issue.” slip op. at 4

  None
  Patents in suitUS 7,149,511
• Smith & Nephew, Inc. v. Conformis, Inc.Institution denied
  PTAB · Sep 12, 2017 · IPR2017-00984 · APJ James A Worth · IPR · Institution

  The Board denied institution after finding no reasonable likelihood that claims 1–25, 28, 29, 32–46, and 50–64 were unpatentable under the asserted obviousness grounds.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 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.” 35 U.S.C. § 314(a); see also 37 C.F.R. § 42.108. For the reasons set forth below, we determine that Petitioner has not demonstrated a reasonable likelihood that claims 1–25, 28, 29, 32–46, and 50–64 are unpatentable. Accordingly, we do not institute an inter partes review of claims 1–25, 28, 29, 32–46, and 50–64 of the ’827 patent based on the grounds asserted in the petitions.” slip op. at 2

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

    “As to “references the osteophyte,” Petitioner states that the ’827 patent does not define the term “reference,” but argues the broadest reasonable construction of the limitation includes “at least a patient-specific surface that engages or avoids an osteophyte.” Id. Patent Owner does not address this issue directly in this proceeding. For purposes of this Decision, we determine that the broadest reasonable construction of the “references the osteophyte” limitation includes a patient specific surface that “engages or avoids the osteophyte,” consistent with the embodiments of Figures 32 and 33 of the ’827 patent. We note that dependent claims 2 and 3 use the phrase “not engage” with respect to a “second osteophyte.” Ex. 1001, 119:30, 119:36–37 (claims 2, 3). Nevertheless, dependent claims 4 and 5 require that the patient-specific surface “substantially engage[s]” an osteophyte (id. at 119:41–46), and therefore the principle of claim differentiation indicates that independent claim 1 has a broader scope than dependent claims 4 and 5.” slip op. at 8

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

    “The next question is whether referencing osteophytes is the “natural result flowing from” Radermacher’s technique, under the aforementioned Oelrich test, or whether it otherwise would have been obvious to apply Radermacher’s technique to a bone surface with osteophytes. Petitioner argues that it would have been obvious to apply Radermacher’s technique to a bone surface with osteophytes because (1) such a template would be a negative of the “natural (i.e. not pre-treated) surface”; (2) referencing any osteophyte would, in some cases, aid in alignment because the unique structure of the osteophyte would help ensure that the template was placed in the proper position; and (3) it would eliminate the need to pre-treat the joint to remove the osteophyte in a preliminary surgical step, thus reducing surgical time and improving patient safety. Pet. 30 (citing, e.g., Ex. 1003, 10, 12; Ex. 1002 ¶¶ 116–117).” slip op. at 14

  • BurdenNot shown unpatentable

    “Thus, the prior art relied upon in the asserted ground does not disclose referencing an osteophyte, expressly or inherently. Additionally, Petitioner does not provide adequate evidence that it would have been obvious to apply the technique of Radermacher in patients with osteophytes to engage (or avoid or reference) the osteophyte, as opposed to performing an alternate technique, such as first removing the osteophytes. In particular, Petitioner has not provided adequate evidence of a reasonable likelihood of success of applying Radermacher’s technique to a bone surface with osteophytes beyond unsupported and conclusory assertions thereof. For these reasons, we determine that Petitioner has not demonstrated a reasonable likelihood that the combination of Radermacher and Alexander renders obvious independent claim 1. Accordingly, we determine that Petitioner has failed to establish a reasonable likelihood that it would prevail in its assertion that independent claim 1, or dependent claims 2–13, 32, 38, and 44–46, are unpatentable as obvious over Radermacher and Alexander.5” slip op. at 17

  Claim construction§ 103 obviousness
  Patents in suitUS 8,657,827
• Smith & Nephew, Inc. v. Conformis, Inc.Institution denied
  PTAB · Sep 12, 2017 · IPR2017-00983 · APJ James A Worth · IPR · Institution

  The Board denied both petitions and instituted no trial, finding no reasonable likelihood that claims 1–25, 28, 29, 32–46, or 50–64 were unpatentable on the asserted obviousness grounds.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 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.” 35 U.S.C. § 314(a); see also 37 C.F.R. § 42.108. For the reasons set forth below, we determine that Petitioner has not demonstrated a reasonable likelihood that claims 1–25, 28, 29, 32–46, and 50–64 are unpatentable. Accordingly, we do not institute an inter partes review of claims 1–25, 28, 29, 32–46, and 50–64 of the ’827 patent based on the grounds asserted in the petitions.” slip op. at 2

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

    “unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); see Cuozzo Speed Techs. v. Lee, LLC, 136 S. Ct. 2131, 2142–46 (2016). Under that standard, and absent any special definitions, we 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 construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner requests a construction of the term “references the osteophyte.” Pet. 17–18. Patent Owner does not propose construction of any terms. As to “references the osteophyte,” Petitioner states that the ’827 patent does not define the term “reference,” but argues the broadest reasonable construction of the limitation includes “at least a patient-specific surface that engages or avoids an osteophyte.” Id. Patent Owner does not address this issue directly in this proceeding. For purposes of this Decision, we determine that the broadest reasonable construction of the “references the osteophyte” limitation includes a patient specific surface that “engages or avoids the osteophyte,” consistent with the embodiments of Figures 32 and 33 of the ’827 patent. We note that dependent claims 2 and 3 use the phrase “not engage” with respect to a “second osteophyte.” Ex. 1001, 119:30, 119:36–37 (claims 2, 3). Nevertheless, dependent claims 4 and 5 require that the patient-specific surface “substantially engage[s]” an osteophyte (id. at 119:41–46), and therefore the principle of claim differentiation indicates that independent claim 1 has a broader scope than dependent claims 4 and 5.” slip op. at 7

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

    “The next question is whether referencing osteophytes is the “natural result flowing from” Radermacher’s technique, under the aforementioned Oelrich test, or whether it otherwise would have been obvious to apply Radermacher’s technique to a bone surface with osteophytes. Petitioner argues that it would have been obvious to apply Radermacher’s technique to a bone surface with osteophytes because (1) such a template would be a negative of the “natural (i.e. not pre-treated) surface”; (2) referencing any osteophyte would, in some cases, aid in alignment because the unique structure of the osteophyte would help ensure that the template was placed in the proper position; and (3) it would eliminate the need to pre-treat the joint to remove the osteophyte in a preliminary surgical step, thus reducing surgical time and improving patient safety. Pet. 30 (citing, e.g., Ex. 1003, 10, 12; Ex. 1002 ¶¶ 116–117).” slip op. at 14

  Claim construction§ 103 obviousness
  Patents in suitUS 8,657,827
• 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
• Boehringer Ingelheim International GmbH / Boehringer Ingelheim Pharmaceuticals, Inc. v. Abbvie Biotechnology Ltd.All claims unpatentable
  PTAB · Jul 6, 2017 · IPR2016-00409 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–5 are unpatentable under § 103 as obvious over van de Putte 1999 and Kempeni 1999; the Board also found the alternative Rau 1998, Schattenkirchner 1998, and van de Putte 1999 ground established.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Patent Owner asks that we adopt the definition of the level of ordinary skill in the art utilized by both the Petitioner and Patent Owner in the 172 IPR that includes “the skill sets of both a physician treating RA patients and a pharmacokineticist with experience in monoclonal antibodies.” Resp. 17–18; Coherus, Case IPR2016-00172, slip op. at 5–6. Petitioner notes that “[t]o the extent that the level of ordinary skill would have included the skills of a pharmacokineticist, this Petition provides that perspective through the Declaration of Dr. Jusko (Ex. 1004), a world-renowned expert in this field.” Pet. 17–18. As both parties have applied a definition of the level of ordinary skill that includes a pharmacokineticist, and such a level of ordinary skill in the art is reflected in the sophistication of the technology and the educational level of those working in the field of the invention, we adopt the level of ordinary skill in the art for the ’135 patent set forth in the 172 IPR. See In re GPAC, 57 F.2d 1573, 1579 (Fed. Cir. 1995) (setting forth factors to be considered in determining the level of ordinary skill in the art); Coherus, Case IPR2016-00172, slip op. at 5–6.” slip op. at 6

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

    “the 172 IPR, we discussed the meaning of the term “for a time period sufficient to treat the rheumatoid arthritis” citing extensively to the Specification of the ’135 patent. See Coherus, Case IPR2016-00172, slip op. at 6–9 (Paper 60). We adopt here the discussion and the findings set forth in that inter partes proceeding construing the claim term “for a time period sufficient to treat the rheumatoid arthritis.” The construction of this term, as set forth in the companion proceeding, i.e., “for a time period sufficient to reduce the signs, symptoms, and/or progression of RA,” is consistent with our Decision on Institution, where we stated that the claims do not require a particular level of efficacy and with the description in the Specification of the ’135 patent of administering the antibody for therapeutic purposes to alleviate the symptoms and/or progression of RA. See Ex. 1001, 24:25–60. Nothing in Patent Owner’s discussion set forth above concerning its proffered construction alters our view that the claim term does not require a particular level of efficacy. As we found in the 172 IPR, Patent Owner’s proposed construction introduces ambiguity in the claims. Patent Owner discusses “meaningful reduction” in or reducing “significantly” a patient’s signs, symptoms, and disease progression without providing any specific measure for achieving such a goal. See Resp. 64–65. We agree with the 172 IPR finding that such ambiguity arises because “Patent Owner’s construction does not indicate whether reducing ‘significantly’ the signs and symptoms of RA means that patients self-report better overall health status on a health survey, or that patients must achieve an ACR20 response, or even an ACR70 response, or a combination of all of the reported outcome measures.” Coherus, Case IPR2016-00172, slip op. at 9 (Paper 60). Therefore, consistent with our decision in the 172 IPR and with our Decision on Institution, we determine that the phrase “for a time period sufficient to treat the rheumatoid arthritis” does not require any particular level of efficacy and, under the broadest reasonable construction, means “for a time period sufficient to reduce the signs, symptoms, and/or progression of RA.”” slip op. at 10

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

    “One question before us then, is whether a person of ordinary skill in the art would have had a reason to modify van de Putte 1999’s 20 mg weekly dose to a 40 mg biweekly dose based on the express teaching of Kempeni 1999 of a two-week interval for dosing. As with other factual questions, Petitioner bears the burden of proving that the skilled artisan would have been motivated to modify the dosing regimen of van de Putte 1999 to arrive at the claimed invention. In re Magnum Oil Tools Int’l, 829 F.3d 1364, 1375 (Fed. Cir. 2016) (burden-shifting “does not apply in the adjudicatory context of an IPR”). As explained below, we are persuaded by Petitioner’s arguments that it has carried this burden.” slip op. at 25

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “A reference teaches away from the claimed invention if it criticizes, discredits, or would have discouraged a person of ordinary skill in the art from “following the path set out in the reference,” or if a person of ordinary skill “would [have been] led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994); see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). The mere disclosure of alternative designs, however, does not teach away. In re Mouttet, 686 F.3d 1322, 1333–34 (Fed. Cir. 2012). Patent Owner fails to view what the references as a whole teach one of skill in the art. First, van de Putte 1999 teaches subcutaneous administration of fixed doses, 20/40/80 mg doses, of D2E7. Ex. 1008, 7; Ex. 1037, 159:10–160:20. Patent Owner attempts to make efficacy comparisons between these doses as explained above, see Resp. 32–33, but as Dr. Weisman testifies and Dr. Gibofsky and Patent Owner agree, these studies were “not powered to provide statistically meaningful comparisons between doses.” Resp. 11–12; Ex. 2071 ¶ 79 (stating a “POSA would have known that the study was not designed to provide statistically meaningful comparisons between doses, a point Dr. Weisman does not appear to dispute”); Ex. 1037, 155:11–160:20; Ex. 1003 ¶ 35 (stating “the data in van de Putte 1999 suggests that each dose was superior to placebo, but not that any dose was better or worse than another dose”). Kempeni 1999 discloses several clinical studies that utilized different dosing protocols. DE003 was one of those clinical studies. In the DE003 study, patients received 0.5 to 10 mg/kg of D2E7 intravenously “every two weeks” until DAS (Disease Activity Score) responses could be rated as “good.” Ex. 1011, 4 (emphasis added). Thus, far from criticizing, discrediting, or discouraging the person of ordinary skill from pursuing a biweekly regimen, Rau 2000 and Kempeni 1999 expressly disclose such dosing frequency. By the same token, Rau 2000’s conclusion that “D2E7, with a half-life of 12 days, can be administered every two weeks as an intravenous injection over 3-5 minutes or subcutaneously” does not specify any particular dosage level, much less exclude any dosage level described in Rau 2000 to provide a teaching away. See Ex. 2040, 8. Also, Kempeni 1999 does not criticize or disparage the effectiveness of the 0.5 mg/kg biweekly dose. Rather Kempeni 1999 expressly concludes that the biweekly treatment of D2E7 “in the dose range from 0.5 to 10 mg/kg was well tolerated.” Ex. 1011, 4; see Ex. 1037, 167:9–168:2; 170:8–19.” slip op. at 31

  Patent outcomesUS 8,889,135 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,889,135

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.