• Lupin Ltd. / Lupin Pharmaceuticals, Inc. v. Horizon Therapeutics, Inc.All claims unpatentable
  PTAB · Sep 26, 2017 · IPR2016-00829 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–15 are unpatentable under § 103 over the ’859 publication, Blau, and Simell; claims 3, 6, 11, 14, and 15 also rely on Brusilow ’84.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We are not persuaded by Patent Owner’s argument that the lack of specific residency/fellowship training or certification, disqualifies Dr. Vaux from providing opinion testimony on the motivations, understandings, and actions of those of ordinary skill in the art. Dr. Vaux testifies that he is “a medical doctor with specialty training in Pediatrics and Clinical Genetics” and is currently Professor and Clinical Chief of the Division of Medical Genetics in the Department of Medicine at UC San Diego. Ex. 1002 ¶ 1. He also testifies: Since 1994, I have regularly diagnosed and treated patients with urea cycle disorders (“UCD”), and continue to do so today. In treating UCD patients, I regularly prescribe nitrogen scavenging drugs and treat patients who are maintained on therapy with nitrogen scavenging drugs. Ex. 1002 ¶ 1. Thus, Dr. Vaux has actually treated UCD patients for at least five years (a requirement recited by Patent Owner, see PO Resp. 16), including prescribing drugs. Patent Owner does not direct us to evidence that Dr. Vaux’s testimony is untruthful or that his treatment of UCD patients is ineffective, indicating that he does not understand how to treat them. Accordingly, even if Dr. Vaux does not have the specialized certificates or particular training that Patent Owner argues are necessary, he has done the job for over twenty years of one who would carry out the claimed methods. We consider this experience more relevant than certificates or training. Thus, we determine that Dr. Vaux is qualified to provide opinions about the motivations, understandings, and actions of one of ordinary skill in the art.” slip op. at 15

  • Skill levelSkill level board ownOther

    “Patent Owner and Petitioner define a person of ordinary skill in the art as having similar qualifications (compare Pet. 8–9, citing Ex. 1002 ¶ 19 with PO Resp. 15–16, citing Ex. 2006 ¶ 26), but Patent Owner argues that the ordinarily skilled artisan must additionally have “at least three years of residency/fellowship training in Medical Genetics, including Biochemical Genetics, followed by certification in Clinical Genetics and Clinical Biochemical Genetics by the American Board of Medical Genetics and Genomics.” PO Resp. 15–16, citing Ex. 2006 ¶ 26. We agree with the qualifications on which the parties agree and find that one of ordinary skill in the art would have an M.D. or equivalent degree, with a residency and specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCDs and other nitrogen retention disorders. See Pet. 8– 9; PO Resp. 15–16. We also agree with Patent Owner that one of ordinary skill in the art would have experience treating patients with nitrogen retention disorders, including UCDs. See PO Resp. 16.” slip op. at 15

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “Nevertheless, we agree with the parties8 that the claim term “upper limit of normal” (“ULN”) means the highest value in a range of normal values. See Pet. 10; PO Resp. 21. We determine that the plain meaning and the broadest reasonable interpretation of the claim term “less than the upper limit of normal” is any value less than the highest value in the range of normal values. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); see 37 C.F.R. § 42.100(b).” slip op. at 11

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

    “In summary, the ’859 publication teaches that those of skill in the art would have known to use HPN-100 to treat subjects with UCDs. It also teaches that measuring plasma or blood level of ammonia was known to be useful in determining the effectiveness of a drug regimen for a particular patient and that measuring blood ammonia was a known step in adjusting drug dosages. The ’859 publication teaches that maintaining normal plasma ammonia levels was desirable in the art. Although specific measurements of 8 Patent Owner notes that the parties do not dispute the meaning of any of the claim terms. PO Resp. 2. Because the meaning of the terms in the challenged claims are evident from their ordinary meaning and not controversial, we need not provide a separate analysis of them. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“claim terms need only be construed ‘to the extent necessary to resolve the controversy.’ Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).”). plasma ammonia do not necessarily indicate the upper limit of normal consistently across different ways of measuring it, the ’859 publication teaches that treatment would have been considered to be effective when plasma ammonia levels were less than what is determined to be the upper limit of normal in a given case. In addition to the ’859 publication, Petitioner relies on Blau and Simell for the teaching to collect blood from UCD patients after a fast in order to measure plasma ammonia levels. Ex. 1006 at 273 (Table 11.9); Ex. 1005 at 1118; see Pet. 25–26 (citing Ex. 1002 ¶¶ 58, 59); see also id. 1002 ¶ 46, n.2 (citing Ex. 1015 at S11). Anticipating Patent Owner’s argument that Blau relates to diagnosis not treatment of UCDs, Petitioner also cites to Exhibits 1010 and 1015 as evidence that it was generally recommended to measure plasma ammonia after a fast. See Pet. 16, n.2. Exhibit 1010 is a “Lab Update” about measurement in ammonia in blood, and Exhibit 1015 is a publication entitled “Measurement of ammonia in blood.” Both state that most methods recommend collecting a sample from patients who have fasted for at least 6 hours. See Ex. 1010, 4; Ex. 1015, 1. From this evidence, we agree with Petitioner that those of skill in the art would have known that measuring fasting serum ammonia levels, as taught in at least Simell and Blau, was known to be useful with the methods taught in the ’859 publication. In regard to Ground 2, which challenges claim 3 and the claims that depend on it, Petitioner cites Brusilow ’84 for its teaching of measuring a patient’s fasting plasma ammonia level when he or she is admitted, presumably to a hospital, and, in response to elevated levels, treating with the nitrogen scavenging drugs sodium benzoate and phenylacetate. See Pet.” slip op. at 11

  Patent outcomesUS 9,095,559 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,095,559
• Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentable
  PTAB · Jun 9, 2017 · IPR2016-00189 · APJ James T Moore · IPR · Final written decision

  Claims 1 and 2 are unpatentable as obvious over Kempeni and van de Putte because the combined teachings would have motivated the claimed biweekly 40 mg subcutaneous regimen with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Dr. Baughman describes the ordinarily skilled artisan physician as an M.D. with at least three years of experience treating RA patients, including with one or more anti-TNFα biologic agents. Ex. 1006 ¶ 15; see Pet. 26; Ex. 1007 ¶ 12 (Dr. O’Dell agreeing with Dr. Baughman’s definition of the skilled physician). Dr. Baughman describes the ordinarily skilled artisan pharmacokineticist as having a Ph.D. in pharmacokinetics or a related field, and at least three years of experience with the pharmacokinetics and pharmacodynamics of biologic agents, either in industry or academia. Ex. 1006 ¶ 15; see Pet. 26–27. Patent Owner’s experts Dr. Gibofsky and Dr. Vinks apply Petitioner’s and Dr. Baughman’s description of the ordinary artisan. Ex. 2065 ¶¶ 53–54; Ex. 2069 ¶¶ 101–103. We adopt that description of the level of ordinary skill in the art, because it is the description that both parties have applied in this proceeding without challenge, and it is consistent with the level of ordinary skill in the art as reflected by the prior art of record.” slip op. at 5

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

    “Owner asserts that “[a]s of June 2001, a treating physician who satisfied the definition of a POSA[4] would have understood the claims to require meaningful therapeutic efficacy.” Resp. at 61 (citing Ex. 2065 ¶¶ 20, 92– 93). As support, Patent Owner points to the ’987 patent specification’s disclosure that “administration of D2E7 produces a meaningful improvement in a variety of clinical outcome measures” such as ACR20, ACR50, and SJC.5 Id. at 62. Patent Owner also contends that the specification of the ’987 patent provides “clinically meaningful outcome parameters” for the treatment of RA. Id. (citing Ex. 2065, ¶¶ 92–93). Patent Owner, therefore, again asserts that we should construe the phrase to mean that the treatment has “meaningful therapeutic efficiency.” We again decline to interpret the claim in this manner. Such a construction would add much uncertainty to the 4 We understand POSA to be used as shorthand for a Person of Ordinary Skill in the Art. 5 ACR is shorthand for the American College of Rheumatology improvement criteria. SJC stands for swollen joint count. Ex. 1001, 28:23;30:22. claim. Meaningful is a highly subjective term, depending on the outcome sought by a treating physician and what he or she might regard as meaningful as regards that outcome.” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMotivation foundMixed

    “Petitioner does not carry its burden to show that a person of ordinary skill in the art would have been so motivated. As explained above, in the Petition Petitioner asserts that the ordinary artisan would have doubled van de Putte’s 20 mg dose to 40 mg and weekly dosing interval to biweekly based on the single PK parameter of half-life. In support of that assertion, Dr. Baughman testifies that “half-lives are routinely used to develop the appropriate dosing frequency.” Ex. 1006 ¶ 66. Dr. Baughman’s testimony in that regard may be valid, but the record in this case does not include sufficient persuasive evidence from which we can make that determination. That is, neither Petitioner nor Dr. Baughman directs us to a monoclonal antibody drug with a dosing interval that corresponds to its particular half-life, or to other evidence supporting the assertion that skilled artisans routinely use half-lives to develop a dosing schedule. Accordingly, Dr. Baughman’s testimony on those issues is entitled to little or no weight. 37 C.F.R. § 42.65(a).” slip op. at 20

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

    “We see the evidence somewhat differently. A reference teaches away from the claimed invention if it criticizes, discredits, or would have RA, the 40 mg subcutaneous dose also is insufficient, given the lower bioavailability of a drug after subcutaneous administration. Tr. 46:16–21. We address that contention below in discussing Patent Owner’s argument that Kempeni, and the prior art as a whole, teach away from the 0.5 mg/kg dose. See infra §§ II.C.3.b.(2)(ii)–(2)(iii). 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). Kempeni 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. 1003, 2 (emphasis added). Thus, far from criticizing, discrediting, or discouraging the person of ordinary skill from pursuing a biweekly regimen, as explained above, Kempeni expressly discloses such dosing frequency.11 We agree with Patent Owner that, for some portion of the treatment period, patients were treated only on flare up. Resp. 49; Ex. 1003, 2. That disclosure, however, does not negate Kempeni’s teaching of biweekly dosing. Nor does it fairly teach away from biweekly dosing. We also agree that some patients were “updosed” for “inadequate clinical response.” Resp. 50; Ex. 1003, 2–3. 11 Additional prior art references support the finding regarding Kempeni’s disclosure. For example, one reference describes the DE003 study as a clinical trial in which “D2E7 was given in doses of 0.5–10 mg/kg [intravenously] over 3–5 minutes every two weeks over a time period of now 1½ years.” Ex. 2114, 4. We find that such disclosure represents, at most, an alternative dosing schedule to the biweekly dosing Kempeni discloses, with patient variability accommodated. In any event, we find that persons of ordinary skill were not led in a direction divergent from that taken by Patent Owner. To the contrary, evidence in the record demonstrates that skilled artisans conducted studies dosing D2E7 subcutaneously in fixed doses, and on a biweekly schedule. Ex. 1004, 1 (disclosing that D2E7 was administered subcutaneously in fixed doses of 20, 40, and 80 mg); Ex. 1005, 3 (describing the DE010 study, in which patients initially were treated with 1 mg/kg D2E7 intravenously, 1 mg/kg D2E7 subcutaneously, or placebo, but thereafter received subcutaneous injections of 1 mg/kg D2E7 biweekly in the open label portion of the study).” slip op. at 24

  Patent outcomesUS 9,073,987 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,073,987
• Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentable
  PTAB · Jun 9, 2017 · IPR2016-00188 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–4 are unpatentable as obvious over van de Putte and Kempeni because the prior art supplied motivation and a reasonable expectation of success for the claimed dosing regimen.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “art as of June 8, 2001—the priority date of the ’135 patent, of which the ’680 patent is a continuation. Petitioner and Dr. Baughman explain that a skilled artisan would possess the skill sets of both a physician treating RA patients and a pharmacokineticist with experience in monoclonal antibodies. Pet. 28; Ex. 1006 ¶ 15; Ex. 1007 ¶ 12, 13. Dr. Baughman describes the ordinarily skilled physician as an M.D. with at least three years of experience treating RA patients, including with one or more anti-TNFα biologic agents. Ex. 1006 ¶ 15; see Pet. 28; Ex. 1007 ¶ 12 (Dr. O’Dell agreeing with Dr. Baughman’s definition of the skilled physician). Dr. Baughman describes the ordinarily skilled pharmacokineticist as having a Ph.D. in pharmacokinetics or a related field, and at least three years of experience with the pharmacokinetics and pharmacodynamics of biologic agents, either in industry or academia. Ex. 1006 ¶ 15; see Pet. 27. Patent Owner’s experts Dr. Gibofsky and Dr. Vinks apply Petitioner’s and Dr. Baughman’s description of the ordinary artisan. Ex. 2065 ¶¶ 53–54; Ex. 2069 ¶¶ 101– 103. We adopt that description of the level of ordinary skill in the art, because it is the description that both parties have applied in this proceeding and it is reflected by the prior art of record.” slip op. at 5

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

    “invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). On the other hand, “a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). Here, the steps of the method, dosage amount, timing, route of administration, and active component are all specified in the body of the claim. The phrase “reducing the signs and symptoms of rheumatoid arthritis,” therefore, merely recites an intended use. See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (statements of intended use typically do not limit the scope of a claim because they “usually do no more than define a context in which the invention operates”). Stated another way, the claims do not expressly recite any particular level of efficacy, meaningful or otherwise. Rather, the claims require administering the antibody in a particular dosage amount, by a particular route, at a particular interval—to a patient with moderately to severely active rheumatoid arthritis.” slip op. at 8

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

    “2. “40 mg dosage unit form” According to the ’680 patent, “dosage unit form” “refers to physically discrete units suited as unitary dosages for the mammalian subjects to be treated; each unit containing a predetermined quantity of active compound[.]” Ex. 1001, 23:9–12. Petitioner contends, “[b]ased upon this definition, a ‘40 mg dosage unit’ form would encompass a syringe filled with 40 mg of D2E7.” Pet. 17.” slip op. at 9

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

    “Patent Owner does not challenge Petitioner’s showing that the prior art discloses each element of claims 1–4. See generally PO Resp. Based on the full trial record, we determine that van de Putte and Kempeni collectively disclose each limitation of the challenged claims. That is, we agree with Petitioner that van de Putte discloses all of the elements of claims 1–4, with the exceptions of biweekly dosing, and administering the antibody in combination with methotrexate. As explained above, van de Putte discloses a study in which RA patients received weekly doses of 20, 40, or 80 mg of D2E7, or placebo, via subcutaneous self-administration over the course of three months. Ex. 1004, 1. D2E7, therefore, was administered in a pharmaceutically acceptable composition, in unit dosage form. Id. Further, D2E7 is a known recombinant human anti-TNFα antibody having the six CDRs and heavy chain constant region required by claims 1–4, and the amino acid sequences for the variable light and variable heavy chain regions required by claims 2 and 4. Ex. 1001, 3:40–42 (explaining that D2E7 is “described in U.S. Pat. No. 6,090,382, incorporated in its entirety herein by reference”); see Ex. 1008, 2:59–67. Petitioner also shows, by a preponderance of the evidence, that Kempeni accounts for the differences between van de Putte and the recited biweekly dosing frequency required by all of the challenged claims, as well as administering the antibody with methotrexate. Specifically, Kempeni describes a study in which patients received D2E7 via intravenous injection every two weeks for at least 6 months (i.e., 24 weeks), and also teaches that “D2E7 is safe and effective . . . in combination with methotrexate when administered by single and multiple intravenous and subcutaneous injections.” Ex. 1003, 2, 3.” slip op. at 15

  Patent outcomesUS 9,017,680 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,017,680
• Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentable
  PTAB · May 16, 2017 · IPR2016-00172 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–5 are unpatentable as obvious over Kempeni and van de Putte because their combined teachings would have motivated the claimed dosing regimen with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “art as of June 8, 2001—the priority date of the ’135 patent. Petitioner and Dr. Baughman explain that a skilled artisan would possess the skill sets of both a physician treating RA patients and a pharmacokineticist with experience in monoclonal antibodies. Pet. 27; Ex. 1006 ¶ 15. Dr. Baughman describes the ordinarily skilled physician as an M.D. with at least three years of experience treating RA patients, including with one or more anti-TNFα biologic agents. Ex. 1006 ¶ 15; see Pet. 27; Ex. 1007 ¶ 12 (Dr. O’Dell agreeing with Dr. Baughman’s definition of the skilled physician). Dr. Baughman describes the ordinarily skilled pharmacokineticist as having a Ph.D. in pharmacokinetics or a related field, and at least three years of experience with the pharmacokinetics and pharmacodynamics of biologic agents, either in industry or academia. Ex. 1006 ¶ 15; see Pet. 27. Patent Owner’s experts Dr. Gibofsky and Dr. Vinks apply Petitioner’s and Dr. Baughman’s description of the ordinary artisan. Ex. 2065 ¶¶ 53–54; Ex. 2069 ¶¶ 101–103. We adopt that description of the level of ordinary skill in the art, because it is the description that both parties have applied in this proceeding and it is reflected by the prior art of record.” slip op. at 5

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

    “The parties do not dispute our preliminary determination that the preamble phrase “[a] method for treating rheumatoid arthritis” is not limiting. We have reassessed that determination in light of the arguments and evidence adduced at trial, and maintain that determination based on the full record.” slip op. at 7

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

    “As we explained in the Institution Decision, claims 1 and 5 do not recite any particular level of efficacy. Rather, they require administering the antibody for a time sufficient to treat RA. Inst. Dec. 9. Consistent with the claims, the specification uses the word “treat” in its customary and ordinary way. For example, the specification describes administering the antibody for therapeutic purposes to alleviate the symptoms and/or progression of the disorder. Ex. 1001, 24:25–60. The portions of the specification on which Patent Owner relies do not persuade us otherwise. The specification explains that the data in Figures 1B and 2–4 “indicate that subcutaneous, biweekly D2E7 treatment combined with methotrexate was significantly better than placebo in reducing the signs and symptoms of RA,” and that all of the doses “were statistically significantly more effective than placebo.” Ex. 1001, 30:25–30. A statement that the treatment is significantly better than placebo, however, does not mean that the treatment significantly reduced the signs and symptoms of RA, as Patent Owner argues.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMotivation foundMixed

    “After reviewing the entire record developed during trial, we find that Petitioner does not carry its burden to show that a person of ordinary skill in the art would have been so motivated. As explained above, Petitioner asserts in the Petition that the ordinary artisan would have doubled van de Putte’s 20 mg dose to 40 mg and weekly dosing interval to biweekly based on the single PK parameter of half-life. In support of that assertion, Dr. Baughman testifies that “half-lives are routinely used to develop the appropriate dosing frequency.” Ex. 1006 ¶ 66. Dr. Baughman’s testimony in that regard may be valid, but the record in this case does not include sufficient evidence from which we can make that determination. That is, 8 Cmax is the highest blood level observed between doses and AUC is the total area under the concentration time curve that reflects the total amount of drug observed in the blood. Ex. 1006 ¶ 62; Ex. 2069 ¶ 35. neither Petitioner nor Dr. Baughman direct us to a drug with a dosing interval that corresponds to its half-life, or to other evidence supporting the assertion that skilled artisans routinely use half-lives to develop a dosing schedule. Accordingly, Dr. Baughman’s testimony on those issues is entitled to little or no weight. 37 C.F.R. § 42.65(a).” slip op. at 21

  Patent outcomesUS 8,889,135 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,889,135
• Bioeq IP AG v. Genentech, Inc.Institution denied
  PTAB · Feb 22, 2017 · IPR2016-01608 · APJ Erica A Franklin · IPR · Institution

  The Board denied institution because Petitioner failed to show a reasonable likelihood that any challenged claim was unpatentable over Seeger alone or with the additional references.

  RulingsInstitution decision

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

    “Therefore, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing that Seeger anticipates claims 1, 3–4, 6, 9, 15–16, 20–22, 24–25, 27–28, 30, 33, and 39. Consequently, we decline to institute an inter partes review of claims 1, 3–4, 6, 9, 15–16, 20–22, 24–25, 27–28, 30, 33, and 39 based on this ground. C.” slip op. at 13

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

    “We agree with Patent Owner that the Specification provides an explicit definition for the claim phrase “reducing the metabolic rate.” The Specification states, “[a]s used herein, ‘reducing metabolic rate’ or ‘shifting down metabolic rate’ means altering the host cell culture such that the host” slip op. at 5

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

    “persuaded that Petitioner has not established that Seeger discloses reducing the metabolic rate of the cultured recombinant host cells at the time of induction of polypeptide expression, as required by the challenged claims, for the reasons discussed by Patent Owner. In particular, Petitioner relies upon the disclosure of the ’602 patent describing reducing metabolic rate in cells already in a reduced growth state by reducing the rates of oxygen uptake and the corresponding rates of uptake of a carbon/energy source. Pet. 32–36 (citing Ex. 1001, 4:15–18). However, Petitioner has not addressed adequately how Seeger’s method of inducing expression by increasing temperature from 30 to 42○C may have affected the metabolic rate. Id. at 32–36.” slip op. at 12

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “dependent claims. Pet. 27. Petitioner relies upon Seeger alone as disclosing the elements of the independent claims from which those challenged claims depend. Id. at 43–57. Indeed, Petitioner does not address the elements recited in the independent claims in any of the obviousness grounds. Id. To relied upon only to address additional elements of dependent claims, and are not asserted to cure any deficiencies of Seeger with respect to elements of the independent claims. Id. at 46–58. Therefore we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing in showing the unpatentability of dependent claims 7–8 and 31–32 over Seeger, dependent claims 10, 12, 23, 34, and 36 over Seeger and Makrides, or dependent claims 11, 13–14, 18, 35, and 37–38 over Seeger and Cabilly, under 35 U.S.C. § 103(a), for the same reasons discussed regarding the independent claims from which they depend. Consequently, we decline to institute an inter partes review of claims 7–8, 10–14, 18, 23, 31–32, and 34–38 based on the respective ground challenging those claims.” slip op. at 13

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 6,716,602
• Orstar Industrial Co., Ltd. v. Cosmo Lighting Inc.All claims unpatentable
  PTAB · Jan 13, 2017 · IPR2015-01787 · APJ Jennifer S Bisk · IPR · Final written decision

  Claims 1–3 are unpatentable as obvious over Popovich and Lin-US, and over Popovich, Lin-US, and Lin-CN.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For the foregoing reasons, we are not persuaded that the level of ordinary skill in the art requires specific experience in the packaging of optoelectronic devices as is argued by Patent Owner. We also are not persuaded that the level of ordinary skill in the art requires education in the form of a Master Degree in Material Sciences, Electrical Engineering, or Mechanical Engineering, as is argued by Patent Owner. Instead, we are persuaded by Petitioner’s statement of the level of ordinary skill in the art, and our finding of the level of ordinary skill is similar to that proposed by Petitioner, but with a slight modification, i.e., that a basic level of technical education is required, at the level of an Associate Degree (two year college program) in Physics, Electrical Engineering, Mechanical Engineering, or Industrial Engineering. We find that the level of ordinary skill in the art is that of one having at least an Associate Degree or Bachelor’s Degree in Physics, Mechanical Engineering, Electrical Engineering, or Industrial Engineering, plus 1–4 years of working experience with semiconductor electronic device packaging or printed wiring board assembly. A more advanced degree would be paired with a shorter period of working experience.” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Patent Owner has not articulated a persuasive reason for giving Dr. Pugliandla’s testimony little or no weight. Petitioner submits other evidence contrary to Dr. Denbaars unsupported assertion that LED’s are never encapsulated in glass. Reply 8 (citing Ex. 1022). For example, Exhibit 1022 is a journal article, dated 2006 and titled “Optical characteristics of spherical glass encapsulated LEDs.” Ex. 1022, Title. Moreover, as discussed above, we are not persuaded that a person of ordinary skill in the art of the ’978 patent would be required to have specific experience in the packaging of optoelectronic devices as opposed to electronic packaging in general. We are, thus, not persuaded that Dr. Pugliandla’s answers, during deposition, to two questions about the material used for transparent encapsulation is wrong or that the entirety of his testimony should be given little or no weight based on this disagreement. In fact, Dr. Pugliandla is highly qualified in the area of electronic packaging. Dr. Pugliandla has several degrees, including a Ph.D. in chemistry. Reply 8–9; Ex. 1002 ¶ 9. He spent many years working in the areas of electronic packaging and surface mount technology, has taught courses in electronic packaging, and has served as a member of the Board of Directors for the National Surface Mount Technology Association. Id. at ¶¶ 12–18. We are persuaded that Dr. Pugliandla’s education and experience is relevant to the issues discussed in the ’978 patent. Moreover, given the subject matter of the ’978 patent and Dr. Pugliandla’s experience in electronic packaging, we do not find his admitted lack of direct experience in optoelectronic device packaging (see Ex. 2002, 38:15–22) as basis to accord his testimony little or no weight. On this record, we still credit the testimony of Dr. Pugliandla over the contrary testimony of Dr. Stephen P. Denbaars (Dr. Denbaars)6 about whether glass is commonly used as transparent material to encapsulate LEDs or never used to encapsulate LED. An expert does not have to have direct hands-on design experience on a subject to know what existed as a common technique on that subject.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “C. Claim Construction We construe all terms, whether or not expressly discussed here, using the broadest reasonable construction in light of the ’978 patent specification. 37 C.F.R. § 42.100(b). For purposes of the Institution Decision, we expressly construed the following terms: (1) “contact-pad area” as “an opening in an insulating layer of a conducting wire where electrical contact can be made”; and (2) “encapsulating” as “enclosing.” Decision 8–15. In the post-institution briefs, Patent Owner disputes only the construction of “encapsulating.” For purposes of this decision, therefore, we continue to apply the construction of “contact-pad area” as set forth above and we address the construction of the term “encapsulating” below. We construe all other terms using the broadest reasonable construction in light of the ’978 patent specification.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “Thus, the only relevant question is whether we should append the phrase “on all sides” to our construction. We are not persuaded that encapsulating components requires that each and every side of the components be surrounded by encapsulating material. In other words, when only a subset of surfaces of a device is exposed to the environment, the plain and ordinary meaning of encapsulate would include covering only those exposed surfaces with encapsulating material. The ’978 patent supports this understanding by describing the process of encapsulating the components in Figure 6 as “a layer of transparent package 5 is further applied to an outer side of every paired first and second contact-pad areas 13, 23 on the first and second conducting wire 1, 2 and the surface mounted light emitting component 3 bonded thereto . . . .” Ex. 1001, 4:63–5:15 (emphasis added). This understanding is also consistent with the ’978 patent’s stated goal of encapsulation, preventing the components “from electrically contacting with an external environment,” “protect[ing] the surface mounted light emitting components 3 against failure due to contacting with external dust and particles,” and strengthening the connections by “protecting . . . against damage and separation . . due to external impact.” Id. Ex. 1002 ¶ 46 (“The use of encapsulating materials to [improve the ruggedness and reliability] is a common practice in the electronic assembly industry, and was commonly practiced for decades prior to the critical date of the ’978 patent.”); see also, Ex. 2001 ¶¶ 65–67 (Dr. Denbaars testifying that without full enclosure, a device would not be protected from the environment); Ex. 2002, 46:4–19 (Dr. Puligandla testifying similarly). The relevant components are fully protected from the external environment when the surfaces exposed to such environment are covered by encapsulating material. We, therefore, continue to give the term “encapsulating” its plain and ordinary meaning: enclosing the exposed surfaces of the recited components. We do not construe the term encapsulating, however, to require covering all component surfaces by encapsulating material.” slip op. at 15

  Patent outcomesUS 7,926,978 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,926,978
• Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc.Some claims unpatentable
  PTAB · Jan 4, 2017 · IPR2015-01490 · APJ Lora M Green · IPR · Final written decision

  Claims 1–3, 10–15, 23, 25, 27, 30, and 41–43 are unpatentable; claims 17 and 47 were not shown unpatentable; claims 28 and 29 were cancelled.

  RulingsFinal written decision

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

    “based on the complex as a whole, rather than just the carbohydrate component, as Fishbane related to iron dextran complexes. Reply 10. We agree with Petitioner that the language of the term “substantially non-immunogenic carbohydrate component” itself only requires an assessment of the immunogenicity of the carbohydrate component, and disagree with Patent Owner that the claims require an assessment of the immunogenicity of the iron carbohydrate complex as a whole. In that regard, we note that the Specification of the ’702 patent supports our construction that the “substantially non-immunogenic carbohydrate component” is limited to the carbohydrate component as opposed to the iron carbohydrate complex as a whole. Specifically, the Specification teaches in the background section that previously available iron dextran products suffered from a “high incidence of anaphylactoid reactions . . . believed to be caused by the formation of antibodies to the dextran moiety,” while “[o]ther parenteral iron products (e.g., iron sucrose and iron gluconate) do not contain the dextran moiety, and the incidence of anaphylaxis with these products is markedly lower.” Ex. 1001, 1:53–57; see also id. at 11:3‒4 (“non-immunogenic carbohydrate component; no cross reactivity with anti-dextran antibodies”). Moreover, the language of independent claim 1 itself does not require a non-immunogenic complex, but only specifies that the “iron carbohydrate complex has a substantially non-immunogenic carbohydrate component.” Moreover, we decline to limit the term “substantially non- immunogenic carbohydrate complex” to require an incidence level of lower than 0.6%. Rather, what is supported by the claim language and the Specification is a low risk such that the incidence of adverse events of the carbohydrate complex is lower than dextran. See, e.g., Tr. 53‒54 (counsel for Patent Owner acknowledging that Fishbane was not incorporated by reference, and that it was only cited as a “see generally”).” slip op. at 10

  • Skill levelOther

    “We do not find a significant different between the requirements for the ordinary artisan proposed by Petitioner and Patent Owner. We agree with Petitioner (Pet. 14) that the best evidence of the level of skill in the art are the references themselves, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and, thus, we need not explicitly adopt either Petitioner’s or Patent Owner’s characterization of the level of skill in the art. Moreover, we note that the result of the analysis regarding the patentability of the claims would be the same under the requirements for the ordinary artisan proposed by either Petitioner or Patent Owner.” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable

    “Petition (Pet. 22–27), we find that Petitioner has demonstrated by a preponderance of the evidence that Geisser teaches all the limitations of claim 1, either inherently or explicitly. That is, we agree with Petitioner that Geisser teaches a method of treating a disease characterized by an iron deficiency, specifically iron deficiency anemia (Pet. 23; Ex. 1003, Abstract, 1:4‒7, 2:4‒7, 9:30‒31). We further agree that Geisser teaches a method of administering an iron carbohydrate complex, that is, iron carboxymaltose, in a single dosage form of at least 0.6 grams of elemental iron, as Geisser teaches administering iron carbohydrate complexes as a single dose of 500‒ 1000 mg of iron. Pet. 23 (citing Ex. 1003, 1:26‒4:1, 8:7-10, 10:14‒17). In that regard, we credit the testimony of Dr. Linhardt that Geiser discloses iron carboxymaltose, and that Geisser describes a general synthetic method that is nearly identical to the method described in the ʼ702 patent. Ex. 1005 ¶¶ 8‒10, 13. In addition, as Geisser teaches one of the iron carbohydrate complexes explicitly recited by claim 1, that is, iron carboxymaltose, it would inherently meet the limitation that the carbohydrate component is substantially non-immunogenic and would have substantially no cross-reactivity with anti-dextran antibodies. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition can not have mutually exclusive properties.”). The teachings of Geisser support that finding, as Geisser specifically teaches that the complexes have low toxicity and a reduced danger of anaphylactic shock. Pet. 23 (citing Ex. 1003, 1:26‒ 2:1, 8:7‒10); see also Ex. 1001, 12:12‒14 (noting that as “[t]he iron carboxymaltose complex (e.g., VIT-45) generally does not contain dextran and [it] does not react with dextran antibodies.”).” slip op. at 18

  Patent outcomesUS 7,754,702 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,754,702
• TC Heartland LLC v. Kraft Foods Group Brands LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2015-01131 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–29 were not shown unpatentable under § 103 over Lohrman and Ackilli because the petitioner did not explain why a skilled artisan would modify Ackilli’s ranges to reach the claimed pH range.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “having a pH of about 1.9 to about 2.4,” “flavoring,” and “drip index value.” Pet. 21–23. Patent Owner asserts that we need construe no claim term. PO Resp. 19–20. We agree with Patent Owner that no claim term requires 9 express construction for purposes of rendering a final written decision in this trial.” slip op. at 9

  • Skill levelSkill level board ownOther

    “Ms. Ferruzzi states that one of skill in the art included at least the ability to make the subject matter disclosed in Ackilli. Ex. 1010 ¶¶ 12–13; Pet. 24–25. Ms. Ferruzzi also states that one of skill in the art at the time of the invention also would have the ability “to make predictable use of the compositions and materials described” in Ackilli, and also have the education and experience in food chemistry to have knowledge of the information in Ackilli. Ex. 1010 ¶¶ 12–13; Pet. 25 (adding the ability to make predictable use of the containers described in the art such as Lohrman). Dr. Marvin J. Rudolph, Patent Owner’s declarant, disagrees with Ms. Ferruzzi’s assessment of the level of skill. Ex. 2012 ¶¶ 20–22. Dr. Rudolph asserts that one of skill in the art at the time of the invention would have “at least a Bachelor of Science in Food Science, Chemistry, or Chemical Engineering and at least five years of experience in the design and formulation of consumer beverage products” and “a Bachelor of Science in a packaging science or Mechanical Engineering or at least five years of experience in the design and manufacture of consumer product packaging.” Ex. 2012 ¶ 21. It is not apparent that Ms. Ferruzzi’s and Dr. Rudolph’s definitions relating to flavored beverage liquid concentrates are necessarily disparate. In reviewing the ’557 patent and Ackilli and applying the factors set forth above from Custom Accessories, we find that one of skill in the art who has the education and experience in food chemistry to understand Ackilli and the ’557 patent and can make predictable use of such 16 information, would have at least a Bachelor of Science in Food Science, Chemistry, or Chemical Engineering and at least five years of experience in the design and formulation of consumer beverage products.” slip op. at 16

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

    “overlap or are encompassed by disclosed ranges in the prior art. See Peterson, 315 F.2d at 1329–30 (“Selecting a narrow range from within a somewhat broader range disclosed in a prior art reference is no less obvious than identifying a range that simply overlaps a disclosed range.”). The overlap itself of the disclosed ranges and the claimed ranges provides sufficient motivation to optimize the ranges because of the “normal desire of scientists or artisans to improve upon what is already generally known.” See Peterson, 315 F.3d at 1330. Here, Ackilli, which addresses optimizing dispersion of its flavoring composition concentrates in water, does not mention pH, much less disclose a pH range for the flavoring compositions. See Ex. 1003, 1:10–13. Also, it is clear that Ackilli did not recognize pH as a result-effective variable for compositions as it did not discuss pH. Only if a variable is known to be result-effective is the optimization of the variable within the grasp of one of ordinary skill in the art. Applied Materials, Inc., 692 F.3d at 1295 (citing Antonie, 559 F.2d at 620); In re Boesch, 617 F.2d 272, 276 (CCPA 1980)). Because the Peterson presumption does not apply here, we need to identify where Petitioner offered some articulated reasoning with some rational underpinning to support a conclusion of obviousness. See KSR, 550 U.S. at 418.” slip op. at 30

  • Strike new argumentNew argument disregardedOther

    “We rejected this inherency theory in our Decision on Institution. We recognized that Ackilli does not disclose the pH of any of its disclosed concentrations, and Petitioner had not established that the pH of any of Ackilli’s working samples met the requirements of the challenged claims. Dec. Instit. 18–19. Therefore, we agreed with Patent Owner that Ackilli does not expressly or inherently disclose concentrations meeting the pH range of the challenged claims. Id. In the Declaration submitted with Petitioner’s Reply, Mr. Ackilli offers a new theory for how Ackilli teaches the claimed pH range. Mr. Ackilli testifies that the pH of a beverage is driven by the desired taste profile of the finished beverage and relies on alleged commercial embodiments of the Ackilli reference to prove that the beverage concentrates described in Ackilli included beverage concentrates with a pH in the claimed range. Ex. 1202 ¶¶ 55–61. Including such a new theory and new evidence concerning what a reference teaches is inappropriate at the reply stage. See 35 U.S.C. 312(a)(3); 37 C.F.R. § 41.104. Also, the evidence of the pH of alleged embodiments of the Ackilli reference on sale before the critical date, such as the peach and orange-flavored Water Sensations, is beyond the scope of this inter partes 28 proceeding because such evidence is not a patent or printed publication. See 35 U.S.C. § 311(b) (stating the scope of an inter partes review is limited to challenges under §§ 102 or 103 and “only on the basis of prior art consisting of patents or printed publications”); Tr. 32:24–33:14 (asserting that Water Sensations evidence is beyond scope of Petition).” slip op. at 28

  Patent outcomesUS 8,603,557 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,603,557
• TC Heartland LLC v. Kraft Foods Group Brands LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2015-01128 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–22 were not shown unpatentable under § 103 over Ackilli because the petitioner did not explain why a skilled artisan would modify Ackilli’s compositions to reach the claimed pH range.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “improved taste (including a lasting taste impression and desirable body), improved palatability, improved keeping qualities, and stabilized flavor and color may be achieved by modifying the compositions of Ackilli to include higher amounts of citric acid and lower amounts of sodium citrate or potassium citrate buffers that result in compositions falling within the scope of the claim. 23 Ex. 1010 ¶ 24. Ms. Ferruzzi, however, cites only two references in support, references that we found a person of ordinary skill would not look to when seeking to modify Ackilli’s beverage concentration. Dec. Instit. 19; see PO Resp. 36 n.8. Without further support as to what one of skill in the art would have known, we do not credit this testimony.” slip op. at 23

  • Strike new argumentNew argument disregardedDecided for patent owner

    “recognize in Ackilli should have been in the Petition.” Tr. 34:23–25. We agree; Petitioner’s assertion of and reliance on Mr. Ackilli’s testimony to establish what one or ordinary skill in the art would have gleaned from Ackilli should have been in the Petition. See 35 U.S.C. § 312(a)(3) (stating that the petition must identify in writing and with particularity the evidence that supports the grounds for the challenge to each claim including affidavits or declarations of supporting evidence and opinions that petitioner relies upon). The fact that an argument may be responsive to Patent Owner’s arguments set forth in its Response does not relieve the Petitioner of its initial burden to identify “with particularity” the “evidence that supports the grounds for the challenge to each claim.” Maxlinear, Inc. v. Cresta Tech. Corp., Case IPR2015-00594, slip op. at 29 (PTAB Aug. 15, 2016) (quoting Intelligent Bio-Systems, 821 F.3d 1359, 1367–68 (Fed. Cir. 2016)); see also 37 C.F.R. § 42.104 (describing required content of the Petition).” slip op. at 19

  • ExcludeMotion to exclude, deniedDenied

    “As Patent Owner notes, we are “well positioned to determine and assign appropriate weight to evidence presented” to us. We agree that the arguments presented in Petitioner’s Motion to Exclude go to the weight that we give the evidence, and therefore, are an improper basis for excluding evidence. For this reason, we dismiss Petitioner’s Motion to Exclude.” slip op. at 25

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Dr. Marvin J. Rudolph, Patent Owner’s declarant, disagrees with Ms. Ferruzzi’s assessment of the level of skill. Ex. 2012 ¶¶ 20–22. Dr. Rudolph asserts that one of skill in the art at the time of the invention would have “at least a Bachelor of Science in Food Science, Chemistry, or Chemical Engineering and at least five years of experience in the design and formulation of consumer beverage products.” Ex. 2012 ¶ 21. It is not apparent that Ms. Ferruzzi’s and Dr. Rudolph’s definitions are necessarily disparate. In reviewing the ’299 patent and Ackilli and applying the factors set forth above from Custom Accessories, we find that one of skill in the art who has the education and experience in food chemistry to understand Ackilli and the ’299 patent and can make predictable use of such information, would have at least a Bachelor of Science in Food Science, Chemistry, or Chemical Engineering and at least five years of experience in the design and formulation of consumer beverage products.” slip op. at 10

  Patent outcomesUS 8,293,299 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,293,299
• Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2016-00283 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–12 were not shown unpatentable because Par failed to establish that the prior art would have motivated a skilled artisan to dose based on about 60% conversion.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Horizon, on the other hand, contends that a person of ordinary skill in the art would have the following qualifications: (a) An M.D. or equivalent degree; (b) At least three years of residency/fellowship training in Medical Genetics, including Biochemical Genetics, followed by certification in Clinical Genetics and Clinical Biochemical Genetics by the American Board of Medical Genetics and Genomics; and (c) At least five years of experience treating patients with nitrogen retention disorders, including UCDs. Corr. PO Resp. 26. Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “First, regardless of whether one of ordinary skill in the art would have understood Brusilow ’91 to teach 80% to 90% conversion, or something closer to 100% conversion, we credit Dr. Sondheimer’s testimony that one of ordinary skill in the art would have sought out prior art references “discuss[ing] the conversion of PAA to PAGN” (Ex. 1002 ¶ 42) if only “[b]ecause Brusilow ’91 involved a single subject and observed a range of conversion rates” (id. at 43). As for the parties’ diametrically opposed views on whether Dr. Brusilow preselected all three doses administered to the patient, or adjusted the dose in Period III to account for the 90% conversion observed in Period II (see Ex. 1012, Table 1), we find we need not resolve the controversy, because, even if we accept that the dose in Period III was adjusted based on the results in Period II, it would not change our ultimate disposition of the case.” slip op. at 27

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

    “encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. 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)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11

  Patent outcomesUS 8,642,012 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,642,012

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.