• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-00440 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–4, 6–7, 10–16, 18, and 20 are unpatentable; claims 5 and 8 are not shown unpatentable. Substitute claims 21, 30, and 38 are unpatentable as obvious over Sackier and Kirsch.

  RulingsFinal written decision

  • Expert testimonyOther

    “3. Dr. Nicosia’s Declaration in support of its Opposition to Patent” slip op. at 7

  • Skill levelOther

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the” slip op. at 16

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

    “B. “clip” The Parties now agree that “clip,” as the term is generally understood,” slip op. at 14

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

    “as recited in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). We conclude that Petitioner has not met its burden of showing this element to be present in Sackier because Petitioner combines features from distinct embodiments in Sackier without establishing persuasively that those embodiments are so directly related to each other such that one of ordinary skill in the art, looking at the reference as a whole, would recognize a disclosure of the invention as claimed. Accordingly, although a very close call, we conclude that Petitioner has failed to demonstrate anticipation of claims 1, 12, and 20 by Sackier for this reason.” slip op. at 21

  Patent outcomesUS 9,271,731 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,271,731
• K/S Himpp v. III Holdings 4, LLCNo claims unpatentable
  PTAB · Jun 28, 2018 · IPR2017-00496 · APJ James T Moore · IPR · Final written decision

  Claims 1–17 were not shown unpatentable under § 103 over Topholm and Michael because the cited art did not teach adjusting a hearing aid profile.

  RulingsFinal written decision

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

    “The problem we find with this position is that the Petitioner is reading claim elements into the description of these references. Patent Owner points out that the profiles are not being adjusted, but rather being selected from twenty-four previously stored profiles. Resp. 30–31. While the ear module operational profile changes, we observe that this is because it is using a different profile, which was just uploaded from the control unit. The act of moving the finger around on the screen to us perhaps appears to change the profile, when it is in fact moving through a set of preexisting profiles and uploading them to the hearing aid instead, changing operation of the hearing aid itself but not adjusting the profile itself. Michael states: This permits the user to select a hearing profile by simply moving visual indicator 924 over main region 922 while listening to a sound stream broadcast by ear 35 module 10; the sound stream being heard by the user reflects the hearing profile corresponding to the current position of the visual indicator 924 in real-time. Ex. 1005, 8:32–37.” slip op. at 21

  • Expert testimonyPetitioner expert creditedOther

    “4 Petitioner also relies upon the declaration testimony of Dr. Robert E. Morley, Jr. (Ex. 1002). Both references appear to be prior art under 35 U.S.C. § 102(b). We find Dr. Morley, by virtue of his education and experience, qualified to testify to the subject matter of this proceeding. Ex. 1002 ¶¶ 2–14 and Exhibit A thereto. We are cognizant of Patent Owner’s suggestion that we give his testimony “little, if any, weight” because of the similarity of the testimony with Petitioner’s arguments and discrepancies between it and his deposition testimony. PO Resp. 34–36. We give Dr. Morley’s testimony appropriate contextual weight herein based upon the content of the testimony itself, and any contrary testimony in Exhibit 2006. We decline to assign generally no weight to his testimony, however.” slip op. at 3

  • Skill levelSkill level petitioner adoptedOther

    “These underlying factual considerations consist of: (1) the “level of ordinary skill in the pertinent art,”5 (2) the “scope and content of the prior art,” (3) the “differences between the prior art and the claims at issue,” and (4) “secondary considerations” of non-obviousness such as “commercial success, long felt but unsolved needs, failure of others, etc.”6 KSR, 550 U.S. at 406 (quoting Graham, 383 U.S. at 17–18). 5 Petitioner defines the level of ordinary skill in the art as someone with a B.S. degree in electrical or computer engineering, or the equivalent, and at least two years of experience in the design of audiological products. Pet. 7-8 (citing Ex. 1002, ¶ 32). Patent Owner does not challenge this level. PO Resp., passim. The references in the record tend to support a finding that this is the appropriate level.” slip op. at 12

  Patent outcomesUS 8,761,421 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,761,421
• K/S Himpp v. III Holdings 4, LLCOther
  PTAB · Jun 28, 2018 · IPR2017-00414 · APJ James T Moore · IPR · Final written decision

  Claims 1–7 were not shown unpatentable under § 103 over either Cohen and Martin or Holmes and Martin because the combinations did not establish the claimed separate shaping before mixing.

  RulingsFinal written decision

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

    “As used herein, the term “hearing aid profile” refers to a collection of acoustic configuration settings for hearing aid 102, which are used by a processor 110 to shape electrical signals related to sounds to compensate for the user's hearing loss. Ex. 1001, 3:11–15. Petitioner states that Patent Owner defined this term in the ’538 patent as “a collection of acoustic configuration settings for hearing aid 102, which are used by processor 110 to shape electrical signals related to sounds to compensate for the user’s hearing loss.” Pet. 15. According to Petitioner, this construction is consistent with the plain and ordinary meaning of the term, relying upon the testimony of its witness Dr. Les Atlas. Pet. 15 (citing Ex. 1003 ¶ 38).10 Patent Owner does not dispute Petitioner’s proposed construction. Resp. 10–11. 10 Dr. Les Atlas is the Petitioner’s witness in this matter. We find him qualified to testify as to the subject matter of this proceeding, by virtue of his education and experience. See Ex. 1003 ¶ 4, and Appendix A thereto. We are cognizant of Patent Owner’s suggestion that we give his testimony “little, if any, weight” because of the similarity of the testimony with Petitioner’s arguments and discrepancies between it and his deposition testimony. Resp. 31–34. We give Dr. Atlas’ testimony appropriate contextual weight herein based upon the content of the testimony itself, and any contrary testimony in Exhibit 2005. We decline to assign generally no weight to his testimony, however. supports, and is consistent with, Petitioner’s proposal. Ex. 1001, 3:12–16. Accordingly, we determine that the broadest reasonable construction, in light of the specification of the ’538 patent, of the term “hearing aid profile” is a “collection of acoustic configuration settings for hearing aid, which are used by a processor to shape electrical signals related to sounds to compensate for a user’s hearing loss.”” slip op. at 8

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

    “For the purposes of our decision, we determine that no other claim terms need explicit construction. See, e.g., 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.’”) (citation omitted).” slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “11 Petitioner defines the level of ordinary skill in the art as someone with a Bachelor’s degree in electrical engineering and at least two years of experience in the field of audio engineering. Pet. 14 (citing Ex. 1003 ¶ 25). Patent Owner does not challenge Petitioner’s definition. Resp. passim. The references in the record support a finding that this is the appropriate level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of skill in the art). 12 The record contains no allegations or evidence of secondary considerations.” slip op. at 10

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “We find the testimony of Dr. Atlas on the key point of obviousness of pre-mixing processing to be less persuasive than that of Mr. Brown. We also find Dr. Atlas’ testimony falls short of adequately explaining how the combination of Cohen and Martin teaches a nexus (i.e., the “based on both the first [shaped] output signal and the second [shaped] output signal” (emphasis added) (hereinafter, “based on both limitation”) limitation recited in claim 1) between the claim 1 requirements of: (1) a condition precedent of shaping both a first output signal and a second output signal; and (2) a subsequent result of using both the first shaped output signal and the second shaped output signal if the hearing aid is in a third mode. Dr. Atlas assumes that one of ordinary skill in the art would process separately each signal and then mix them. Ex. 1003 ¶ 66. We find Dr. Atlas’ assumption is flawed. Specifically, in making this assumption, Dr. Atlas does not address adequately how the combination of Cohen and Martin opines “it would have been obvious to a person of ordinary skill in the art” (emphasis added), his later sentences appears to base his opinion principally on the reason one of ordinary skill in the art could do it. Id. In particular, he testifies: Because Cohen’s hearing aid applies different hearing aid profiles to different input sources, it would have been obvious to a person of ordinary skill in the relevant art to add the functionality of the combination mode as taught by Martin to Cohen’s hearing aid such that the speaker would produce an audible sound based on the output signals of the processor. Combining two signals such that both signals are sent to a speaker to an audible combination of sounds, that is where each signal is sufficiently perceived, was well within the technical ability of a person of ordinary skill in the art. To accomplish this would require that each one of the two signals is passed through an appropriate hearing aid profile. For example, it would have been obvious to a person of ordinary skill in the art that a different hearing aid profiles could be used for an audio coil inputs and that of a neighboring conversation and environmental sounds through a microphone. Namely, it is commonly known that the different frequency sensitivity of an audio telecoil versus a microphone can be beneficially compensated for. (Rodriquez, Ex. 1011, Abstract)” slip op. at 24

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,649,538
• Argentum Pharmaceuticals LLC v. Cipla Ltd.Rehearing denied
  PTAB · Oct 31, 2017 · IPR2017-00807 · APJ Kristi L R Sawert · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in declining to construe the terms or in reserving disputed motivation and reasonable-expectation issues for trial.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “We are not persuaded that the Board abused its discretion by declining to expressly interpret “nasal spray” and “suitable for nasal administration” in the Institution Decision. As the Board explained in the Institution Decision, Petitioner showed sufficiently for the purpose of institution that the prior art teaches pharmaceutical compositions in the form of nasal sprays. Instit. Dec. 14. Specifically, the Board found that the prior-art references explicitly teach nasal sprays that are administered nasally. See id. (citing Ex. 1007 (Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57– 60, 33:12–14). Patent Owner does not allege its proposed construction of “nasal spray” and “suitable for nasal administration” is different from the plain and ordinary meaning of those terms to an ordinarily skilled artisan. Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not persuaded that the Board overlooked or misapprehended this matter or that the Board would have declined institution on the obviousness grounds had it explicitly adopted Patent Owner’s proposed interpretation.” slip op. at 4

  • Expert testimonyOther

    “osmolality, poor spray quality, and unacceptable settling and caking” resulting from the attempted formulation of Cramer’s Example III. Id. at 8– 10; see also Prelim. Resp. 25. The Board, however, addressed those issues in the Institution Decision and determined that “Patent Owner’s arguments and expert testimony highlight disputed issues of fact about whether the skilled artisan would have been motivated to combine the teachings of Hettche, Phillipps, and Segal to arrive at the claimed subject matter, and would have had a reasonable expectation of success.” Instit. Dec. at 20 (citing Ex. 1002, 268–87; Ex. 2007 ¶¶ 40–47; Ex. 2111, 1; Ex. 2044, 1–2). The Board concluded that those “issues are best resolved following trial with the benefit of a full record.” Id. We are still of that view. Accordingly, we are not persuaded that the Board misapprehended or overlooked the issue of reasonable expectation of success.” slip op. at 5

  • BurdenOther

    “II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes the Board misapprehended or overlooked and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review 1 Helmut Hettche, U.S. Patent No. 5,164,194 (Nov. 17, 1992) (“Hettche”). Ex. 1007. 2 Gordon H. Phillipps, et al., U.S. Patent No. 4,335,121 (Jun. 15, 1982) (“Phillipps”). Ex. 1009. 3 Catherine A. Segal, Int’l Publication No. WO 98/48839 (Nov. 5, 1998) (“Segal”). Ex. 1012. 4 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product Information (Dec. 1998) (“Flonase Label”). Ex. 1010. the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “In the Institution Decision, the Board determined that “no claim term requires express interpretation for purposes of this Decision.” Instit. Dec. 7. In its Rehearing Request, Patent Owner argues that the Board “misapprehended or overlooked the importance of construing the terms ‘nasal spray’ and ‘suitable for nasal administration’” found in all the challenged claims. Reh’g Req. 2. In particular, Patent Owner asserts that those terms mean “pharmaceutical formulations that are tolerable to patients, homogeneous, and can be suitably deposited onto the nasal mucosa.” Id. (citing Paper 7, Preliminary Response (“Prelim. Resp.”), 9). Patent Owner alleges that, had the Board construed “nasal spray” and “suitable for nasal administration,” then the Board would have denied the obviousness grounds because “none of the combinations of cited art teach a person of ordinary skill in the art how to make the claimed fixed-dose combination ‘nasal spray’ or formulation ‘suitable for nasal administration’ with a reasonable expectation of success.” Id. at 2–3 (citing Prelim. Resp. 9). We are not persuaded that the Board abused its discretion by declining to expressly interpret “nasal spray” and “suitable for nasal administration” in the Institution Decision. As the Board explained in the Institution Decision, Petitioner showed sufficiently for the purpose of institution that the prior art teaches pharmaceutical compositions in the form of nasal sprays. Instit. Dec. 14. Specifically, the Board found that the prior-art references explicitly teach nasal sprays that are administered nasally. See id. (citing Ex. 1007 (Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57– 60, 33:12–14). Patent Owner does not allege its proposed construction of “nasal spray” and “suitable for nasal administration” is different from the plain and ordinary meaning of those terms to an ordinarily skilled artisan. Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not persuaded that the Board overlooked or misapprehended this matter or that the Board would have declined institution on the obviousness grounds had it explicitly adopted Patent Owner’s proposed interpretation.” slip op. at 3

  Claim construction§ 103 obviousness
  Patents in suitUS 8,168,620
• 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
• Tietex International, Ltd. v. Precision Fabrics Group, Inc.No claims unpatentable
  PTAB · Jan 27, 2016 · IPR2014-01248 · APJ Jo-Anne M Kokoski · IPR · Final written decision

  Claims 1–22 were not shown unpatentable under § 103 over Radwanski, Rowan, and Murch because the petitioner did not establish the claimed thermal protective performance value.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Thus, in order to prevail, Petitioner must provide evidence establishing that the claimed TPP values are inherent in the prior art. Petitioner cannot, as an examiner can, establish unpatentability of the challenged claims based on the presumption that the structure of fabric that results from the combination of Radwanski, Rowan, and Murch would necessarily possess the claimed properties. Allowing Petitioner to rely solely on a presumption of inherency would improperly shift the burden to Patent Owner to establish that the claimed properties are not necessarily present in the prior art. Therefore, we are not persuaded that the Appeal Decision establishes “that one of ordinary skill in the art would have found it obvious to construct a flame retardant, intumescent fabric in accordance with the teachings of the prior art” with the claimed TPP value of at least 4.5 as Petitioner contends. Pet. 16.” slip op. at 11

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

    “After considering Petitioner’s and Patent Owner’s positions, as well as their supporting evidence, we determine that Petitioner has not shown, by a preponderance of the evidence, that claim 1 of the ’639 patent, and claims 2– 10, 13–16, and 19–22 that depend, directly or indirectly, therefrom, would have been obvious over the combined teachings of Radwanski, Rowan, and Murch. Independent claims 11, 12, and 17 also require a TPP value of at least 4.5. Ex. 1001, 12:47–13:20, 14:1–18. Therefore, for the reasons set forth above, we also determine that Petitioner has not shown, by a preponderance of the evidence, that claims 11, 12, and 17, and dependent claim 18, would have been obvious over the combination of Radwanski, Rowan, and Murch. D. Secondary Considerations of Non-obviousness Patent Owner contends that secondary considerations of non- obviousness, including unexpected results, long-felt but unsolved need, and commercial success of the patented product “compel a determination of nonobviousness.” PO Resp. 49; see id. at 49–59. As discussed above, we find that Petitioner has not established that claims 1–22 of the ’639 patent would have been obvious over the combination of Radwanski, Rowan, and Murch. Thus, we need not address Patent Owner’s evidence regarding secondary considerations of non-obviousness.” slip op. at 17

  • Strike new argumentNew argument disregardedDecided for patent owner

    “In our judgment, Petitioner’s arguments and evidence in the Reply are outside the scope of a proper reply because they do more than merely address Patent Owner’s argument that Petitioner did not establish that fabrics made by the combination inherently would have the claimed TPP value; rather, they attempt to provide new evidence that was not set forth clearly in the Petition as to why the fabric resulting from the combination of Radwanski, Rowan, and Murch necessarily would have the claimed TPP values. Because Petitioner waited until the Reply to serve this evidence on Patent Owner, Patent Owner was denied the opportunity to file responsive evidence. Consideration by the Board of the arguments in the Reply and evidence presented in the Horrocks Declaration in support thereof would be unfair to Patent Owner. Petitioner could have presented this argument and evidence with the Petition, and has not contended or offered any evidence to show otherwise. Because Petitioner belatedly presented these new arguments and evidence to make its case that the TPP value is dictated by the structure of the fabric, we decline to consider the portions of the Reply and the Horrocks Declaration on this issue. See Office Trial Practice Guide, 77 Fed. Reg. at 48,767. Patent Owner had a chance to, and in fact did, cross-examine Dr. Horrocks, but had no further briefing opportunity to challenge Petitioner’s evidence. Although Patent Owner did file observations regarding the cross-examination of Dr. Horrocks, such observations are not designed for submitting substantive arguments. See id. at 48,768 (“An observation (or response) is not an opportunity to raise new issues, re-argue issues, or pursue objections.”). Considering the new arguments and evidence at this late stage would not serve the interests of justice. We have, however, reviewed and considered the arguments in the Petition and evidence therein, and are in agreement with Patent Owner that Petitioner has not provided adequate explanation or evidence to support its contention that the claimed TPP values are inherent in the prior art.” slip op. at 14

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “Secondary Considerations of Non-obviousness Patent Owner contends that secondary considerations of non- obviousness, including unexpected results, long-felt but unsolved need, and commercial success of the patented product “compel a determination of nonobviousness.” PO Resp. 49; see id. at 49–59. As discussed above, we find that Petitioner has not established that claims 1–22 of the ’639 patent would have been obvious over the combination of Radwanski, Rowan, and Murch. Thus, we need not address Patent Owner’s evidence regarding secondary considerations of non-obviousness.” slip op. at 18

  Patent outcomesUS 8,501,639 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,501,639
• Volkswagen Group Of America, Inc. v. Emerachem Holdings, LLCAll claims unpatentable
  PTAB · Jan 22, 2016 · IPR2014-01555 · APJ Fred E Mckelvey · IPR · Final written decision

  Claims 1–2, 7–12, 14–17, 19, 21–24, and 31–42 are unpatentable based on the grounds sustained in the final written decision.

  RulingsFinal written decision

  • Strike new argumentNew argument consideredDecided for petitioner

    “Unlike Corning, the inherency theory matured during cross- examination of Patent Owner’s witness, Dr. Crocker. Ultimately, in our view, Dr. Crocker agreed that no platinum migrated to the alkali metal layer—based on an analysis with a correct “0.018” number. The Reply evidence, consistent with Dr. Crocker’s testimony, agreed that a correct number is “0.018” and on that basis, Petitioner’s witness agreed with Dr. Crocker. Further, unlike Corning, a whole new theory of anticipation did not arise in the first instance with the Reply; rather, it was essentially developed during cross-examination of Patent Owner’s witness.” slip op. at 74

  • ExcludeMotion to exclude, deniedMixed

    “The fact that evidence is filed with a reply does not mean the evidence is per se inadmissible. The exhibits relate to the issue of whether there is a typographical error in Example 1 of Hoekstra, i.e., is “2.018” a typographical error which should be “0.018.” In presenting the Petition, Petitioner’s witness Dr. Farrauto explained why he felt Hoekstra’s Example 1 anticipates claim 1 of the ʼ558 patent. Dr. Crocker, Patent Owner’s witness, disagreed with Dr. Farrauto’s explanation.” slip op. at 73

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

    “While the matter of assigning the weight to be given to the testimony of the two witnesses in this case is a close call, based on the direct and crossexamination testimony with respect to Kinoshita and its Example 3, and to the extent that there is a conflict between Dr. Crocker’s testimony and that of Dr. Farrauto, we credit the testimony of Dr. Crocker over that of Dr. Farrauto. However, even if one were to find the testimony of Dr. Crocker and Dr. Farrauto evenly balanced, then a preponderance of the evidence on inherency does not emerge. Under those circumstances, the party with the burden of proof cannot be said to have proved its case. See Yamaha Int’l Corp. v. Hoshino Gakki Co., 840 F.2d 1572, 1580 n.11 (Fed. Cir. 1988) (where a party is under a burden to establish a fact by a preponderance of the evidence and where the evidence is so evenly balanced that no preponderance emerges, the party having the burden of persuasion necessarily loses). We are also concerned that Example 3 does not describe enough detail to indicate clearly whether there is enough potassium to cover the platinumimpregnated alumina. Ex. 2002 ¶ 32.” slip op. at 51

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

    “We hold that “intimately and entirely coated” mean exactly what it says. In other words, it means the embodiment shown in Figs. 1a through 1c of the ʼ558 patent drawings and associated discussion in the written description portion of the specification. We appreciate why both parties would prefer a broader construction, i.e., “intimately and entirely coated” means (1) coated with a monolayer where catalytic action would occur through diffusion (our construction) as well as (2) direct contact with the combustion gas without diffusion. Petitioner would favor a broader construction because Takeshima anticipates a direct contact embodiment. Patent Owner would favor a broader construction because more “material” might infringe claim 1. Takeshima Figs. 5(A) and 5(B) describe an embodiment where the exhaust gas directly contacts the catalyst. A direct contact embodiment does not fall within the scope of claim 1 of the ʼ558 patent. Accordingly, Takeshima does not describe the “intimately and entirely coated” limitation of claim 1.” slip op. at 23

  Patent outcomesUS 5,451,558 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 5,451,558
• Volkswagen Group Of America, Inc. v. Emerachem Holdings, LLCAll claims unpatentable
  PTAB · Jan 22, 2016 · IPR2014-01558 · APJ Fred E Mckelvey · IPR · Final written decision

  Claims 1–14 and 16–20 are unpatentable as obvious over Campbell, Saito, and Stiles; the Board found the Hirota, Takeshima, and Saito anticipation grounds insufficient.

  RulingsFinal written decision

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

    “We see no need to repeat that discussion here, and adopt it as written therein. Petitioner has failed to establish that Hirota describes a regeneration gas falling within the scope of the regeneration gas of claim 1 of the ʼ758 patent. Accordingly, Petitioner has failed to satisfy its burden of proving by a preponderance of the evidence that the subject matter of claim 1 of the ʼ758 patent is anticipated by Hirota.” slip op. at 9

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

    “Whenever a ground based on obviousness is involved, the preferred manner of setting out differences is to state “the subject matter of claim x differs from the reference in that (1) …, (2) …., and (n) ….” Vague statements or hints of differences not only burdens the Board, but puts a patent owner at somewhat of a disadvantage with having to guess what any differences a petitioner believes may exit. Reluctance on the part of counsel to “admit” to and identify a difference is hard to understand, given the fact that a difference does not mean the subject matter claimed is non-obvious. Dann v. Johnston, 425 U.S. 219, 230 (1976) (mere existence of differences between the prior art and an invention does not establish the invention’s non-obviousness).4 Campbell appears to differ from the subject matter of claim 1 of the ʼ758 patent in that Campbell does not describe an in situ regeneration.” slip op. at 40

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

    “4. Discussion While Campbell does not describe in situ regeneration, and assuming arguendo that claim 1 of the ʼ758 patent requires in situ regeneration, in situ regeneration is a well-known technique described by Saito and Stiles. An in situ regeneration in Campbell makes sense because it eliminates a need to discard spent catalyst and permits one skilled in the art to reuse catalytic material. The reuse of catalytic material would have been recognized as significant due to the expense of platinum. Ex. 1056, page 13:20–23. Patent Owner maintains that the catalytic material of Saito and Stiles “is very different from that of the ʼ758 patent.” Paper 29, 4 Petitioner’s failure to clearly identify differences is not consistent with 37 C.F.R. § 42.104(b)(4) and 42.104(b)(5), as well as 35 U.S.C. § 312(a)(3), which require identifying the grounds “with particularity.” The Petition must specify where each element of a challenged claim is found in the prior art patents or printed publications. 37 C.F.R. § 42.104(b)(2). page 29. “There is nothing in either Saito or Stiles to suggest . . . that the regeneration methods of these two references might be succesfully used for regenerating the catalyst/absorber of Campbell.” Id. at page 30.” slip op. at 41

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

    “balance in favor of non-obviousness, both in the courts and the PTO. Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923); Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403 (1902); The Barbed Wire Patent, 143 U.S. 275 (1892); Webster Loom v. Higgins, 105 U.S. 580 (1881); Ex parte Artsana USA, Inc., Appeal 2014-004116, 2014 WL 4090808 (PTAB Aug. 18, 2014); Murata Mfg. Co. v. Synqor, Inc., Appeal 2014-001167, 2014 WL 1397381 (PTAB Apr. 10, 2014); Ex parte Whirlpool Corp., Appeal 2013-008232, 2013 WL 5866602 (PTAB Oct. 30, 2013). However, in this case, we are unable to credit much, if any, weight, to Patent Owner’s evidence of long-felt need and commercial success. For long-felt need and commercial success to be convincing, there must be a “nexus” between (1) the long-felt need/commercial success and (2) the claimed subject matter. In re Fielder, 471 F.2d 640, 646 (CCPA 1973). Patent Owner’s evidence is bottomed on Patent Owner’s experience with what is referred to as a “SCONOx catalytic absorption system.” Ex. 2006A ¶ 4 (direct Declaration testimony of Thomas Girdlestone). Patent Owner characterizes the claimed method as embodying a SCONOx system. Paper 29, page 37:3–4. According to Mr. Girdlestone, the effectiveness of reducing NOx in a SCONOx system was tested at a turbine facility run at EmeraChem’s then-affiliate Sunlaw Energy in California. Ex. 2006A, ¶ 5. Further according to Mr. Girdlestone, both the EPA and the Cal EPA” slip op. at 46

  Patent outcomesUS 5,599,758 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 5,599,758

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.