• 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
• 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
• Boehringer Ingelheim International GmbH / Boehringer Ingelheim Pharmaceuticals, Inc. v. Abbvie Biotechnology Ltd.All claims unpatentable
  PTAB · Jul 6, 2017 · IPR2016-00408 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–5 are unpatentable as obvious over van de Putte 2000 and Rau 2000 because the prior art supported the claimed dosing regimen and the asserted objective indicia did not establish nonobviousness.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “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. See Resp. 15–16; 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. 18–19. 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 board ownDecided for petitioner

    “In the companion inter partes proceeding involving the ’135 patent, 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 is consistent 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. 55–56. 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” slip op. at 10

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

    “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).” slip op. at 30

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

    “Thus, far from criticizing, discrediting, or discouraging the person of ordinary skill from pursuing a biweekly regimen, Rau 2000 expressly discloses such dosing frequency. See also Ex. 1011, 4 (stating in DE003 study, patients received 0.5 to 10 mg/kg of D2E7 intravenously “every two weeks” until DAS responses could be rated as “good”). 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. 1012, 8.” slip op. at 31

  Patent outcomesUS 8,889,135 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,889,135
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Indivior UK LimitedRehearing denied
  PTAB · Jun 23, 2017 · IPR2016-01113 · APJ Jacqueline Wright Bonilla · IPR · Rehearing

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

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). The request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). A party who requests rehearing bears the burden of showing that a decision should be modified. Id. II.” slip op. at 2

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

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

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

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

  • Expert testimonyPetitioner expert discountedDecided for patent owner

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

  § 103 obviousness
  Patents in suitUS 8,475,832
• J Kyle Bass / Erich Spangenberg v. Fresenius Kabi USA, LLCAll claims unpatentable
  PTAB · Jun 7, 2017 · IPR2016-00254 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1, 13–15, 17, 18, 20, and 24–28 are unpatentable as obvious over each of two combinations: Diprivan PDR and Farinotti with van den Heuvel or Lundgren.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “In our Decision to Institute, we adopted Patent Owner’s definition, given the claims recite compositions of propofol in a container. Dec. Inst. 5. 1 Physicians’ Desk Reference, Product Identification Guide and Product Information for Diprivan, 341, 2939–45 (1997) (“Diprivan PDR,” Ex. 1005). 2 R. Farinotti, Interactions physicochimiques et mode de conservation du Diprivan ® [Physio-Chemical Interactions and Storage of Diprivan®], 13 Ann. Fr. Anesth. Reanim. 453–56 (1994) (Ex. 1006). Citations to Farinotti in this Decision are to the certified translation provided as Ex. 1007. 3 J.G. van den Heuvel, US 5,383,864, issued Jan. 24, 1995 (Ex. 1010). 4 Lundren et al., WO 00/12043, published Mar. 9, 2000 (Ex. 1031). addition to the definition was appropriate. PO Resp. 5 (citing Ex. 2035, 203:11–15). Based on the complete trial record, we see no reason to deviate from our prior definition of a person of ordinary skill in the art. That is, we adopt the level of ordinary skill set forth by Patent Owner. Moreover, we note that the prior art itself further demonstrates the level of skill in the art at the time of the invention. Cf. 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 5

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedOther

    “The record shows Dr. Feinberg has some experience with emulsion drug products (Ex. 2035, 16:15–21), with the use of siliconization to improve manufacturing efficiency with drug products (id. at 26:6–27:20), and possibly with propofol, although Dr. Feinberg could not recall (id. at 23:8–24:23). Dr. Davis admits he does not have experience in filling and packaging of pharmaceutical products, but testifies that a person of ordinary skill in the art, as necessary, would consult someone with such experience. Ex. 1043, 37:15–38:12. experience with propofol and drug product emulsions, emulsion systems, and their packaging. Dr. Feinberg has less experience than Dr. Davis with propofol and emulsions, whereas Dr. Davis has less experience than Dr. Feinberg with pharmaceutical packaging. Given their relative experiences, we decline to discount the opinion of either declarant based solely on their differing areas of expertise.” slip op. at 6

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

    “Moreover, having considered the complete trial record, we determine that it is unnecessary to expressly construe any additional 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 8

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

    “We are not persuaded by Patent Owner’s argument. It is well settled that “[a] suggestion, teaching, or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art, as the teaching, motivation, or suggestion may be implicit from the prior art as a whole, rather than expressly stated in the references.” In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006) (emphasis added). That the prior art does not include explicit reports of manufacturing issues with Diprivan rubber stoppers in particular is not fatal to Petitioner’s argument. We are persuaded by the weight of the evidence that it was understood by a person of ordinary skill in the art that rubber stoppers generally have issues with friction during manufacturing, which is commonly cured by adding silicone oil to the stoppers. See, e.g., Ex. 1004, S4 (“Machinability is greatly improved through the use of lubricated packaging components. Siliconization of rubber products reduces the friction present between the rubber closure and with silicone oil, [which] reduces considerably the inherent tackiness in many rubber formulations. The main advantage of a silicone oil coat is that it facilitates the stoppering operation by lubricating the passage of the closures through assembly machines and insertion into the barrel or vial opening.”); Ex. 1002 ¶¶ 20–22.” slip op. at 14

  Patent outcomesUS 8,476,010 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,476,010

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.