• Pfizer, Inc. v. Biogen, Inc.Institution denied
  PTAB · Nov 13, 2017 · IPR2017-01166 · APJ Jacqueline T Harlow · IPR · Institution

  The Board denied institution on the sole claim, claim 1, because Pfizer did not show a reasonable likelihood of proving obviousness without the Rituxan Label as prior art.

  RulingsInstitution decision

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

    “Petitioner bears the ultimate burden of persuasion to prove unpatentability by a preponderance of the evidence, as well as the initial burden of production to establish the existence of prior art that renders the claims unpatentable. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–79 (Fed. Cir. 2015). In this regard, we have often required a petitioner to make a threshold showing that the reference relied upon was publicly accessible as a printed publication prior to the effective filing date of a challenged patent. See, e.g., Mylan Pharms. v. Boehringer Ingelheim Int’l GmbH, Case IPR2016-01566, slip op. at 10–12 (PTAB Feb. 3, 2017) (Paper 15) (finding that purported “printed package insert” was not a printed publication); Frontier Therapeutics, LLC v. Medac Gesellschaft Fur Klinische Spezialpraparate MBH, Case IPR2016-00649, slip op. at 22 (PTAB Sept. 1, 2016) (Paper 10) (same).” slip op. at 11

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

    “The Federal Circuit has held that “public accessibility” is “the touchstone” in determining whether a reference is a printed publication. In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc.,” slip op. at 10

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

    “Accordingly, in view of the above, we determine that Petitioner has failed to establish sufficiently in the Petition that the Rituxan Label was publically accessible as of the critical date of August 11, 1998. Thus, on this record, the Rituxan Label fails to qualify as prior art under 35 U.S.C. § 102, and Petitioner has not established a reasonable likelihood of prevailing in demonstrating the obviousness of claim 1 without the Rituxan Label.” slip op. at 17

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the art at the time of the invention would have been “a practicing oncologist with at least an M.D. degree and several years of experience treating patients with NHL and/or researching treatments for NHL, including with chemotherapeutic drugs.” Pet. 10 (citing Ex. 1002 ¶ 15). Patent Owner does not address Petitioner’s position on this matter and does not propose its own description for a person of ordinary skill in the art at the time of the invention. At this stage in the proceeding, we determine that Petitioner’s description of the level of ordinary skill in the art is supported by the current record. Moreover, we have reviewed the credentials of Dr. Ozer (Ex. 1002, Attachment A), and, at this stage in the proceeding, we consider him to be qualified to opine on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

  § 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 8,329,172
• Celltrion, Inc. v. Biogen, Inc.Institution denied
  PTAB · Oct 6, 2017 · IPR2017-01093 · APJ Jacqueline T Harlow · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving claim 1 unpatentable under either anticipation ground or either obviousness ground.

  RulingsInstitution decision

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

    “Accordingly, for the foregoing reasons, we conclude that Petitioner has not shown a reasonable likelihood of prevailing on its assertion that claim 1 is obvious in view of Grossbard and the Rituxan Label.” slip op. at 22

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

    “terms. Pet. 25–26; Prelim. Resp. 12–14. In view of our analysis, we 6 determine that construction of claim terms is not necessary for purpose of this Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (Only terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy).” slip op. at 6

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the art at the time of the invention would have been “a practicing physician specializing in hematology or oncology, with at least three years of experience in treating patients with NHL.” Pet. 27 (citing Ex. 1003 ¶ 22); see also Ex. 1002 ¶ 18. 7 Patent Owner does not address Petitioner’s position on this matter and does not propose its own description for a person of ordinary skill in the art at the time of the invention. At this stage in the proceeding, we determine that Petitioner’s description of the level of ordinary skill in the art is supported by the current record. Moreover, we have reviewed the credentials of Dr. Lossos (Ex. 1003, Exhibit A) and Dr. Longo (Ex. 1002, Exhibit A), and, at this stage in the proceeding, we consider each of them to be qualified to opine on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “The Federal Circuit has held that “public accessibility” is “the touchstone” in determining whether a reference is a printed publication. In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons 9 interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 9

  Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 8,329,172
• BASF Corporation v. Enthone, Inc.No claims unpatentable
  PTAB · Sep 11, 2017 · IPR2016-00696 · APJ Kevin F Turner · IPR · Final written decision

  BASF did not prove claims 1–15, 17–22, and 26–28 unpatentable because it failed to show a motivation and reasonable expectation of success for the proposed combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Based on the arguments of the parties, we agree that one of ordinary skill in the art would have had at least a bachelor’s degree in materials science, chemistry, or a related discipline, and would have had approximately two or more years of experience as a process engineer. We are further persuaded that such skilled artisans would have had to understood the differences between conformal and superfilling electrolytic plating, and that they would have appreciated that it was unpredictable whether a given molecule would have served as a suppressor effective for superfilling. This 12 was conformed at Oral Hearing, where counsel for BASF acknowledged that it was not uncommon to try a plating bath component, even if the mechanisms of how it may work are not fully understood. See Tr. 25.” slip op. at 12

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

    “or reason to use a specific compound or series of compounds, with a reasonable expectation that the plating bath components would allow for superfilling. Independent claims 1 and 17 make clear that the methods must provide for superfilling: claim 1 provides that it must “superfill the submicron-sized features by rapid bottom-up deposition at a rate of growth in the vertical direction which is greater than a rate of growth in the horizontal direction,” and claim 17 provides that it must “superfill the submicron-sized features by rapid bottom-up deposition at a vertical Cu deposition growth rate in features from the bottoms of the features to the top 19 openings of the features which is greater than 15 times faster than a field deposition growth rate on substrate surfaces outside the features.” Thus, any combination must have a reasonable expectation of success in achieving the results required by the claims. Although Barstad and Morrissey both disclose superfilling, as discussed above, a person of ordinary skill in the art must have a reasonable expectation that any changes to the plating bath components, as contemplated by the instant grounds of unpatentability, will leave the ability to provide superfilling undisturbed.” slip op. at 19

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “In addition, we find the testimony of Dr. Pound to be less persuasive than the testimony of Dr. Barkey, with respect to how one of ordinary skill in the art would have viewed Alling. Dr. Pound testifies that in view of Alling, “a person of ordinary skill in the art would likely have used Tetronic® polymers as suppressors in copper electroplating compositions” (Ex. 1002 ¶ 31), but that testimony omits considerations of superfilling. Dr. Pound also testifies that In view of the knowledge provided by IBM’s achievements and the teachings by Alling, Barstad, and Morrissey, a person of skill in the art would have used Tetronic polymers as suppressor agents in copper electroplating solutions and would have optimized the concentration of the suppressors and other agents to maximize the rate of superfilling and ensure that void formation is avoided. Id. at ¶ 29. This testimony does not indicate what in Alling would have suggested the use of Tetronic polymers as suppressor agents in the context of superfilling. Dr. Pound also contends that “[t]he broader disclosure in Alling can be shown to relate to superfilling” (Ex. 1029 ¶ 21), but Alling does not tie that broad applicability to the specific use of Tetronic polymers as suppressor agents. Dr. Pound also testifies as to the similarities between” slip op. at 24

  Patent outcomesUS 7,303,992 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,303,992
• Celltrion, Inc. v. Genentech, Inc.Rehearing denied
  PTAB · Aug 18, 2017 · IPR2016-01667 · APJ Erica A Franklin · IPR · Rehearing

  The Board denied Celltrion’s rehearing request, leaving institution denied for claims 1–14 because the petition did not show a reasonable likelihood of prevailing.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. § 42.71(d). Because Petitioner has not met its burden, as discussed below, the Rehearing Request is denied.” slip op. at 3

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

    “evidence of record, we determined that Petitioner failed to demonstrate a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Dec. 1. In the Rehearing Request, Petitioner seeks reconsideration of that determination. Reh’g Req. 1.” slip op. at 3

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

    “Although the Specification explains that the invention, as a whole, is not limited to treating patients who have had a prior treatment with a TNFα- inhibitor, the challenged claims are directed to such a population. Petitioner relies on a broader disclosure of the invention when referring to the Specification’s description of patients who “may be considered to be prone to experience a toxicity . . . with a TNFα-inhibitor before therapy therewith has begun, or the patient may be determined to be one who is unlikely to respond to therapy with a TNFα-inhibitor.” Ex. 1001, 28:55–61. The challenged claims are directed to methods of treating rheumatoid arthritis in a patient “who experiences an inadequate response to a TNFα-inhibitor,” and as we explained in the Decision, the Specification expressly defines the term “inadequate response to a TNFα-inhibitor” as “an inadequate response to previous or current treatment with a TNFα-inhibitor because of toxicity and/or inadequate efficacy.” Dec. 7 (quoting Ex. 1001, 5:25−28).” slip op. at 4

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentableNot shown unpatentable

    “of the patients in the study had already failed treatment with TNFα- inhibitor,” Petitioner asserts that, based upon its proposed construction, the claims do not require a prior therapy step. Id. at 2–3, 8–9. Petitioner asserts also that “statistics establish that Edwards necessarily and inevitably practiced the claimed method” on at least one patient, based upon the testimony of Drs. Boers and Marais that many RA patients are inadequate responders. Id. at 3, 10–11. In the Decision, we squarely address this argument explaining that inherency may not be established by probabilities or possibilities. Dec. 7–9. Thus, Petitioner has not established that we overlooked or misapprehended its argument as to this issue. Petitioner’s assertions in the Rehearing Request concerning Patent Owner’s alleged admissions regarding the patient population in Edwards does not overcome the deficiency in the Petition insofar as it relies upon probabilities to establish inherency. See Reh’g Req. 3, 11 (citing Preliminary Resp. 24–25).” slip op. at 4

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 7,976,838
• 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
• Lupin Limited v. Vertex Pharmaceuticals IncorporatedNo claims unpatentable
  PTAB · Jul 28, 2017 · IPR2016-00558 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 2, 3, and 10–12 were not shown unpatentable because the evidence did not establish a reasonable expectation of success, and unexpected results supported patentability.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Petitioner bears the burden of proving unpatentability of the challenged claims, and the burden of persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish the facts supporting its challenge by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Below, we explain why Petitioner has failed to meet its burden with respect to the challenged claims.” slip op. at 6

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

    “As discussed above, Grobelny teaches that the inclusion of a solubilizing group to a protease inhibitor compound having low water solubility for the purposes of improving water solubility and bioavailability of those compounds. Ex. 1022, 74:1116. In this regard, Grobelny provides general guidance for using a solubilizing agent phosphate ester salt to solve the solubility problem of amprenavir. However, the success of discovering fosamprenavir was not discovering a compound with improved solubility. Rather, the success was finding a compound that had the requisite bioavailability to treat HIV and minimize the development of drug-resistance mutations in patients.6 The evidence of record does not support a finding that a person of ordinary skill in the art would have had a reasonable expectation of success in developing fosamprenavir, a protease inhibitor prodrug having the same or improved bioavailability as its parent drug.” slip op. at 16

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia with nexusDecided for patent owner

    “b. Unexpected Results We further conclude that Patent Owner has demonstrated evidence of unexpected results regarding fosamprenavir’s improved resistance profile, pharmacokinetics, and side effect profile, which weighs in favor of patentability.” slip op. at 22

  • ExcludeMotion to exclude, deniedNot reached

    “PATENT OWNER’S MOTION TO EXCLUDE Patent Owner seeks to exclude Ex. 1093. Paper 27, 1–6. Because we do not rely on Ex. 1093 to reach the final decision, we dismiss the Patent Owner’s motion to exclude as moot. IV.” slip op. at 26

  Patent outcomesUS 6,436,989 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,436,989
• Neste Oil Oyj v. Reg Synthetic Fuels, LLCSome claims unpatentable
  PTAB · Jul 26, 2017 · IPR2013-00578 · APJ Christopher L Crumbley · IPR · Remand

  Claims 1, 3, 4, and 8 are unpatentable as anticipated by Craig; claims 2 and 5 are not proven unpatentable because Dindi is not prior art.

  RulingsRemand decision

  • RemandDecided for patent owner

    “To remove Dindi as a prior art reference, the record must establish either: (1) a conception and reduction to practice before the filing date of Dindi; or (2) a conception before the filing date of the Dindi patent combined with diligence and reduction to practice after that date. See Taurus IP, LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed. Cir. 2013). The Federal Circuit held that the record before us establishes, with sufficient corroboration, that Mr. Abhari conceived of the invention of claims 2 and 5 of the ’804 patent on April 29, 2008. REG Synthetic Fuels, 841 F.3d at 963. It is undisputed that Dindi was filed on June 13, 2008, and that Mr. Abhari filed on December 4, 2008 the application that issued as the ’804 patent. Dindi is not prior art—and, therefore, Neste’s ground of unpatentability fails—if either: (1) Mr. Abhari actually reduced to practice the invention of claims 2 and 5 between April 29 and June 13, 2008, or (2) Mr. Abhari exercised reasonably continuous diligence between June 13 and December 4, 2008, when the invention was constructively reduced to practice by filing of a patent application. Because, as set forth below, we find sufficient evidence of actual reduction to practice, we do not address Mr. Abhari’s alleged diligence.” slip op. at 5

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentableNot shown unpatentable

    “To remove Dindi as a prior art reference, the record must establish either: (1) a conception and reduction to practice before the filing date of Dindi; or (2) a conception before the filing date of the Dindi patent combined with diligence and reduction to practice after that date. See Taurus IP, LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed. Cir. 2013). The Federal Circuit held that the record before us establishes, with sufficient corroboration, that Mr. Abhari conceived of the invention of claims 2 and 5 of the ’804 patent on April 29, 2008. REG Synthetic Fuels, 841 F.3d at 963. It is undisputed that Dindi was filed on June 13, 2008, and that Mr. Abhari filed on December 4, 2008 the application that issued as the ’804 patent. Dindi is not prior art—and, therefore, Neste’s ground of unpatentability fails—if either: (1) Mr. Abhari actually reduced to practice the invention of claims 2 and 5 between April 29 and June 13, 2008, or (2) Mr. Abhari exercised reasonably continuous diligence between June 13 and December 4, 2008, when the invention was constructively reduced to practice by filing of a patent application. Because, as set forth below, we find sufficient evidence of actual reduction to practice, we do not address Mr. Abhari’s alleged diligence.” slip op. at 5

  • ExcludeNot reached

    “As noted above, the Federal Circuit vacated our decision on Neste’s Motion to Exclude as to Exhibits 2012, 2013, 2057, and 2062, for further consideration of the hearsay objections in light of the decision on appeal, “because [they] may be relevant for diligence and reduction to practice.” REG Synthetic Fuels, 841 F.3d at 965. Upon review, however, we have determined that we need not rely on any of the exhibits in question to reach our decision in REG’s favor. For this reason, Neste’s objections to the exhibits are moot, as we would have found against Neste on the merits regardless of the outcome of the Motion.” slip op. at 19

  Patent outcomesUS 8,231,804 mixed
  § 102 anticipation
  Patents in suitUS 8,231,804
• 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
• Celanese International Corporation v. Daicel CorporationRehearing denied
  PTAB · Jun 19, 2017 · IPR2017-00166 · APJ Sheridan K Snedden · IPR · Rehearing

  The Board denied Daicel’s rehearing request, leaving institution on Miura anticipation of claims 1–3, 5, 6, 10, 11, and 13 in place.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “We are not persuaded. Miura discloses as follows: The concentration of the carboxylic acid ester may be about 0.1 to 20% by weight, preferably 0.5 to 15% by weight, and more preferably about 0.5 to 6% by weight (e.g., about 2 to 6% by weight). Ex. 1006, 5:50–55. Methyl acetate is a carboxylic acid ester disclosed in Miura. Ex. 1002 ¶¶ 79–80. The disclosed claimed range of, for example, 2 to 6% by weight falls within the range of 0.5 to 9% by weight recited in the challenged claims. Patent Owner fails to address the above-noted teaching of Miura in its Request, but rather focuses on the use of 9.8% methyl acetate in a specific embodiment disclosed in Miura. Request 4–5. However, the disclosure in Miura of a range narrower than what is claimed is pertinent to the anticipation analysis, and is distinct from a factual situation requiring analysis of “the criticality of a claimed range to the claimed invention in order to avoid anticipation by a prior art reference disclosing a broader, overlapping range.” Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 870 (Fed. Cir. 2015). Patent Owner directs us to no persuasive authority suggesting that “an erroneous interpretation of law of anticipation has been applied to institute on Ground 3.” Request 5.” slip op. at 3

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “We are not persuaded. Miura discloses as follows: The concentration of the carboxylic acid ester may be about 0.1 to 20% by weight, preferably 0.5 to 15% by weight, and more preferably about 0.5 to 6% by weight (e.g., about 2 to 6% by weight). Ex. 1006, 5:50–55. Methyl acetate is a carboxylic acid ester disclosed in Miura. Ex. 1002 ¶¶ 79–80. The disclosed claimed range of, for example, 2 to 6% by weight falls within the range of 0.5 to 9% by weight recited in the challenged claims. Patent Owner fails to address the above-noted teaching of Miura in its Request, but rather focuses on the use of 9.8% methyl acetate in a specific embodiment disclosed in Miura. Request 4–5. However, the disclosure in Miura of a range narrower than what is claimed is pertinent to the anticipation analysis, and is distinct from a factual situation requiring analysis of “the criticality of a claimed range to the claimed invention in order to avoid anticipation by a prior art reference disclosing a broader, overlapping range.” Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 870 (Fed. Cir. 2015). Patent Owner directs us to no persuasive authority suggesting that “an erroneous interpretation of law of anticipation has been applied to institute on Ground 3.” Request 5.” slip op. at 3

  § 102 anticipation
  Patents in suitUS 9,006,483

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.