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  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • PTAB · Sep 23, 2015 · IPR2014-00587 · APJ Meredith C Petravick · IPR · Final written decision

    Claim 1 was not shown unpatentable because Petitioner did not establish that Hughes and Abraham qualify as prior art.

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

      “construction, in light of the Specification, of “contents of the packet” in step c is the header and/or payload of the packet. Petitioner’s construction is supported, sufficiently, by the ’694 patent, itself, which discloses embodiments of selecting access rules based upon the header and/or payload of the packet. The ’694 patent discloses a first embodiment in which the firewall selects a rule based on header parameters only, and discloses that, based on the header parameters, the packet may be passed or dropped. See Ex. 1004, col. 2, ll. 35–37, 40–43, col. 3, ll. 10–12, Fig 1 (path formed by steps 101, 102, 103, and 104). The ’694 patent also discloses that an access control proxy selects a rule based on an analysis of the payload of a single or multiple packets. Id. at col. 3, ll. 4–8, 18–22, 30–32, col. 4, ll. 28–34, 38–40, Fig. 1 (path formed by steps 106 and 107). The ’694 patent further discloses alternate embodiments in which the “access control proxy selects an access rule that pertains to the packet based both on an analysis of the payload and the header parameters of the packet” (Ex. 1004, col. 3, ll. 38–41) and the “access rule is retrieved based upon a combination of the contents and header parameters of the packet” (id. at col. 4, ll. 36–38).” slip op. at 9

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

      “To establish an actual reduction to practice, the patentee must prove that he (1) constructed an embodiment or performed a process that meets all the claimed limitations of the invention, and (2) determined that the invention worked for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998). “The essential inquiry here is whether the advance in the art represented by the invention . . . was embodied in a workable device that demonstrated that it could do what it was claimed to be capable of doing.” Scott v. Finney, 34 F. 3d 1058, 1063 (Fed. Cir. 1994) (emphasis omitted) (quoting Farrand Optical Co. v. United States, 325 F.2d 3278, 333 (2d Cir. 1963)). “In order to establish an actual reduction to practice, an inventor’s testimony must be corroborated by independent evidence. . . . [A] ‘rule of reason’ analysis is applied to determine whether an inventor’s testimony regarding reduction to practice has been sufficiently corroborated.” Cooper, 154 f.3d at 1330 (citation omitted); see also Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996) (corroboration requirement “arose out of a concern that inventors testifying in patent infringement cases would be tempted to remember facts favorable to their case by the lure of protecting their patent or defeating another’s patent”). The sufficiency of corroboration is determined according to a “rule of reason.” Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir. 1993). This, however, does not dispense with the requirement that some independent evidence provide corroboration. Coleman v. Dines, 754 F.2d 353, 360 (Fed. Cir. 1985). The requirement of “independent” corroboration requires evidence other than the inventor’s testimony. In re NTP, Inc., 654 F.3d 1279, 1291–92 (Fed. Cir. 2011).” slip op. at 12

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

      “of the evidence, that the challenged claim is unpatentable. 35 U.S.C. § 316(e). This burden includes, inter alia, showing that any reference on which it relies is prior art under 35 U.S.C. § 102. See Mahurkar, 79 F.3d at 1576 (holding that accused infringer “bore the burden of persuasion . . . on all issues relating to the status of [the asserted reference] as prior art”). Hughes and Abraham presumptively constitute prior art under 35 U.S.C. §§ 102(a) or 102(e) because their filing dates are prior to the ‘694 patent’s earliest effective filing date, giving rise to Patent Owner’s burden of coming forward with evidence supporting a date of invention before September 9, 1998. Mahurkar, 79 F.3d at 1576–77; see Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir. 2008) (finding that when party challenging validity came forward with art that is prior to the challenged patent’s application date, the patentee has the burden of going forward with evidence that “the asserted claim is entitled to the benefit of a filing date prior to the alleged prior art”). Upon consideration of the all the evidence, we are persuaded that Patent Owner has met its burden of coming forward with sufficient evidence to corroborate independently inventor Mr. Dutta’s testimony that the inventors of the ’694 patent reduced to practice the claimed invention “at least as early as early 1996 but no later than June 11, 1996” (PO Resp. 36). Thus, we are not persuaded that Hughes and Abraham are prior art under 35 U.S.C. §§ 102(a) or 102(e). C. Obviousness over Hughes and Abraham Petitioner fails to demonstrate that claim 1 is unpatentable under 35 U.S.C. § 103 because Petitioner has not demonstrated that Hughes and Abraham are prior art.” slip op. at 18

    • ExcludeMotion to exclude, deniedMixed

      “under Federal Rule of Evidence (“FRE”) 602. Pet. Mot. 4–5; Pet. Mot. Reply 1–3. FRE 602 states that “[a] witness may testify to a matter only if evidence is introduced sufficient to support a finding that the witness has personal knowledge of the matter. Evidence to prove personal knowledge may consist of the witness’s own testimony.” Fed. R. Evid. 602. Exhibit 2006 is the Declaration of Partha Dutta. According to Petitioner, in paragraphs 22, 23, and 26, Mr. Dutta testimony contains statements that require an understanding of the proper legal scope of the ’694 patent, but there is insufficient evidence to support a finding Mr. Dutta has personal knowledge of that proper legal scope of the ’694 patent. Id. at 4. We dismiss Petitioner’s motion to exclude paragraphs 22, 23, and 26 paragraphs of Exhibit 2006 as moot because we do not rely upon the statements made in these paragraphs that Petitioner alleges to require an understanding of the proper legal scope of the ’694 patent in reaching our decision. Although we cite to paragraphs 22, 23, and 26 of Ex. 2006 above, we only rely upon other statements in those paragraphs, which do not address the legal scope of the ’694 patent, such as “the prototype code is no longer available.” Ex. 2006 ¶ 26.” slip op. at 20

    Patent outcomesUS 6,826,694 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 6,826,694
  • PTAB · Jul 10, 2015 · IPR2014-00438 · APJ James T Moore · IPR · Final written decision

    Claims 1–3 are unpatentable as obvious over Palmer and Vanden Heuvel; claims 4, 5, 13, and 17 are unpatentable over Palmer, Vanden Heuvel, and Osamu.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “We have determined that Mr. Ball’s testimony as to the level of ordinary skill in the art is most credible and accurate – while the level of skill in the pertinent time period was somewhat low, that “an ordinary artisan would have at least some experience working in the field” either “designing or building” portable computing devices. Ex. 2014 ¶ 18. In other words, the skilled artisan would have a grasp as to what was practicable to do back in the time the invention was made.” slip op. at 7

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

      “We find that the preamble is non-limiting. A claim preamble has the import that the claim as a whole suggests for it. When the claim preamble recites structural limitations of the claimed invention, the PTO and courts give limiting effect to that usage. Conversely, when the claim body defines a structurally complete invention and the preamble only states a purpose or intended use for the invention, the preamble is not claim limiting. Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). While the preambles in the challenged claims may give some overall context for the claim limitations, we find that they are not necessary to give life to the claim terms or breathe meaning into the claims. The claims and the Specification indicate that the challenged claims may be used in the field of golf or similar sporting events, without necessarily limiting their application only to golf.4 We observe that claims 1–5 and 17 each contain specific references to golf in the preamble of the claim. Ex. 1001, 16:65– 17:41, 20:50–21:9. Claim 13 does not discuss golf in either the body or the preamble. Id. at 19:3–33. In any event, as Palmer describes a handheld golf device, for the purposes of this decision, we see no practical difference in whether the “golf” portion of the preamble applies to the challenged claims, as handheld golf devices were well-known.” slip op. at 8

    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyMixed

      “To invoke § 112, paragraph six, the alleged means-plus-function claim element must not recite a definite structure that performs the described function. Cole v. Kimberly-Clark Corp., 102 F.3d 524, 531 (Fed. Cir. 1996). As in Cole, the drafter of the instant claims was “enamored of the word ‘means,’” id., utilizing it seven times in the final paragraph of claim 1 to include a piece of structure which essentially was completely recited within the claim. Stripped of the excessive “means” verbiage, claim 1 recites: key entry . . . wherein the key entry . . . includes first key . . . comprising one entry key for selectively displaying information screens, second screen-dependent field select key . . . the second screen-dependent field select key . . . comprising two bi-directional tab keys for scrolling in opposite directions through the data input fields on a displayed information screen, and third screen-dependent value select key . . . the third screen-dependent value select key . . . comprising two bi-directional scroll keys for scrolling in opposite directions through the predefined data associated with the data input field on the displayed information screen. Ex. 1001, 17:7–26 (“means” language deleted). We are persuaded that such detailed recitation of structure (including three particular types of keys with particular functions) removes these limitations of claim 1 from the ambit of § 112, sixth paragraph. As a consequence, we conclude the final paragraph of claim 1 describes a user 5 Because the ’566 patent has an effective filing date before September 16, 2012, we refer to the pre–AIA version of 35 U.S.C. § 112. key interface which requires three types of keys, each having the particular function recited — an entry key for selecting a display screen, two bi-directional tab keys for scrolling through entry fields in a display screen, and two bi-directional scroll keys for scrolling through data to input in a display screen.” slip op. at 10

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

      “We believe the Patent Owner is misinterpreting the guidance of the Supreme Court in its argument. As the Supreme Court noted: A person of ordinary skill is also a person of ordinary creativity, not an automaton. . . . When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. . . . [We] must ask whether the improvement is more than the predictable use of prior art elements according to their established functions. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417–21 (2007). While the Petitioner’s proposed screen size motivation is no longer persuasive (or necessary) to this panel and this decision, we conclude that a preponderance of evidence in this trial supports a conclusion that replacing an alphanumeric keyboard with a set of tab and scroll keys was a substitution of one known data entry method with an equivalent data entry mechanism. We expressly reject the screen washout argument made, and the underlying testimony in Mr. Ball’s Declaration.” slip op. at 19

    Patent outcomesUS 5,779,566 unpatentable
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 5,779,566

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.