• 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
• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.No claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-00435 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–4, 6–18, and 20 were not shown unpatentable over Malecki; the contingent motion to amend was denied as moot.

  RulingsFinal written decision

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

    “construction more persuasive because it is grounded in, and most consistent with, the specification of the ’731 patent. Contrastingly, Petitioner does not offer a specific interpretation of “inner walls” and its arguments are generally based on extrinsic evidence, including claim charts from the related district court litigation (Pet. 15), arguments from related proceedings (Pet. Reply 3), and the prior art reference (Malecki) relied on to challenge the claims (id. at 3–4). Petitioner criticizes the Patent Owner’s position but provides no express interpretation of “inner walls of the first and second clip arms;” instead, Petitioner argues why Patent Owner’s proposed construction is wrong. Pet. Reply 4–5. Dr. Nicosia does not expressly define or otherwise persuasively explain the definition of “inner walls” in his declarations either. See generally Exs. 1037, 1095, and 1109.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’731 patent would have possessed the knowledge and skill of an engineer or similar professional 5 The parties have not introduced evidence of secondary considerations in this proceeding. with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 10 (citing Ex. 1037 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it based on the final record before us. It is also consistent with the level of skill evidenced by the references.” slip op. at 15

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id.” slip op. at 25

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

    “Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id. Finally, Petitioner seems to recognize that a modification would be” slip op. at 25

  Patent outcomesUS 9,271,731 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,271,731
• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentable
  PTAB · Nov 15, 2018 · IPR2017-00135 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1, 3–5, and 10 are unpatentable as obvious over Kimura (claims 1, 3–5) and Kimura with Sackier (claim 10); claims 7, 11–15, and 17 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’371 patent would have possessed the knowledge and skill of an engineer or similar professional with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 8 (citing Ex. 1029 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it for purposes of this Decision.” slip op. at 15

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

    “The issue we have with Patent Owner’s contentions, as pointed out by Petitioner, is that Patent Owner does not establish persuasively how its claims require the “reversible open/close” feature and the “tactile feel features.” See Pet. Reply 27–29. Even presuming that these features did indeed drive tremendous commercial success and industry praise for the commercial products, Patent Owner does not adequately explain in its analysis how the claims of the challenged patent require these particular features that drive commercial success. Patent Owner seems to suggest that a break section in the control wire will fracture and that this feature in the commercial product relates to the tactile feel. PO Resp. 57 (citing Ex. 2029 ¶¶ 91–93) (“After the yoke has disengaged, if the handle spool is moved further proximally, a break section in the control wire will fracture, leaving the ball within the yoke and uncoupling the control wire from the distal components of the device.”). This “break section in the control wire” is not, however, claimed or covered in claim 1, the claim that purportedly embodies the commercial product. The claims alleged to cover the product do not specifically require any “tactile feel feature.”3 Likewise, while the claims may allow for an opening and closing of the clip assembly, there is no requirement in these claims that the clip assembly, as “demanded” by physicians, repeatedly open and close. Thus, both of the drivers of commercial success and industry praise are not commensurate in scope with the claims of the patented invention. See Ex. 1046 ¶¶ 23–29 (explaining how features are not claimed).” slip op. at 16

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

    “district court proceeding, Petitioner contends that “coupled to the sheath” means “slideable inside the sheath” and “the sheath confines the bushing.” Pet. 9. Petitioner provides no additional support. The district court tentatively rejected this broad interpretation. See Ex. 2003, 27–28 (“[T]he Court recommends that ‘coupled to the sheath’ be construed as ‘linked together, connected, or joined, but not slidable inside the sheath.’”). Patent Owner contends that Petitioner’s proposed construction of “coupled to the sheath” is “unreasonably broad,” but provides little citation to the intrinsic record before us. Prelim. Resp. 13–14. Instead, Patent Owner notes that the plain and ordinary meaning of coupled is “linked together, connected, or joined,” citing to an unrelated Federal Circuit decision as well as the related district court determination. Id. at 14; Ex. 2003, 28. In our proceeding, Petitioner has not provided persuasive evidence or argument to support its claim interpretation by merely pointing to what Patent Owner purportedly argued in district court. Based on the final record before us, “coupled to the sheath” means “linked together, connected, or joined” to the sheath. Our construction is consistent with the district court’s analysis and reflects the common understanding of the term “coupled” in the mechanical arts to require more than simply abutting or contacting. See generally Ex Parte Paul Robert Homrich, Appeal 2014-005786, 2016 WL 3541285, at *3 (PTAB, June 27, 2016) (“When used in mechanical systems, the plain and ordinary meaning of ‘coupled’ means to link together or connect,” and coupled requires more than contact or abut.).” slip op. at 10

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

    “We are not persuaded that Petitioner has demonstrated sufficiently that Adams discloses “a bushing extending between a proximal end coupled to the sheath,” (Ex. 1027, 17:4–5) as required by claim 1 of the ’371 patent. Based on the final record, Petitioner’s contention that retainer 110 [bushing] is slidable inside the sheath, or confined by the sheath, does not establish persuasively that the proximal end of the bushing is coupled to the sheath as required by claim 1. The claimed coupling must be “proximal coupling” and Petitioner can only point to distal coupling via distal tabs 118, 119 (Pet. Supp. Reply 6) – this is not “proximal” coupling. Further, for the bushing and the sheath to be coupled requires them to be “linked together, connected, or joined” in some manner and Petitioner has not established any such connection for proximal coupling. Petitioner also has failed to establish a persuasive reason for linking or connecting retainer 110 and sheath 112 – indeed, doing so would negatively impact the ability of retainer 110 to freely slide out of sheath 112. See Prelim. Resp. 27. Adams suggest that when control wire 108 is actuated and the clip is locked into the lock sleeve, retainer release 109 pulls retainer 110 back, disengaging retainer tabs 118, 119 from the two retainer holes as depicted in Figure 4.” Ex. 1023, 7:26–44 Finally, we note that our decision would not change if we adopted the district court’s claim interpretation. The district court adopted a claim construction of “a bushing extending between a proximal end coupled to the sheath” as “linked together, connected, or joined, but not slidable inside the sheath.” Ex. 2003, 28 (emphasis added). Should the district court’s interpretation be the correct one, Patent Owner’s position is much stronger whereas Petitioner’s theory is based on slidable movement. See Pet. 9 (arguing for “slideable inside the sheath” and “the sheath confines the bushing”); Pet. Supp. Reply 6. Having now considered the evidence in the complete record established during trial, we are not persuaded that Petitioner has demonstrated by a preponderance of the evidence that claim 1 would have been anticipated by Adams. Petitioner has not established persuasively that Adams discloses “a bushing extending between a proximal end coupled to the sheath.” For this reason, Petitioner has failed to prove by a preponderance of the evidence that Adams anticipates claim 1.” slip op. at 22

  Patent outcomesUS 8,974,371 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,974,371
• 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
• 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
• Geosys-Intl, Inc. v. Farmers Edge Precision Consulting, Inc.All claims unpatentable
  PTAB · Aug 17, 2016 · IPR2015-00708 · APJ Josiah C Cocks · IPR · Final written decision

  Claims 1–29 are unpatentable as obvious under § 103 over the three instituted combinations of Hauwiller, the patent Background, and, for specified claims, Dickson or Shibusawa.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The differences between Dr. Johannsen’s and Dr. Heiniger’s articulations of the level of ordinary skill in the art are fairly minor. Our analysis below, including the conclusions we reach, would be substantially the same under either proposal. Nevertheless, after considering the evidence of record, we adopt Dr. Heiniger’s definition of the level of ordinary skill in the art.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownPlain and ordinary meaningOther

    “their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard). Under the broadest reasonable construction standard, claim terms are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). In the Decision to Institute, we construed the phrase “calculating a map”4 in claims 1–3, 12, 14, 20–22, and 28 to mean “performing calculations to produce a map.” Dec. to Inst. 6–7. With respect to the phrase “maximum possible crop yield” in claims 1, 14, and 20, we declined to adopt Petitioner’s proposed meaning of that term as “yield goal” and instead applied the ordinary and customary meaning of the claim language. Id. at 7–8. We further determined that no other claim term required express construction. Id. at 8. Following institution, neither party challenged those constructions or proposed other terms for construction. On the record now before us, we do not discern reason to deviate from the constructions set forth in the Decision to Institute.” slip op. at 5

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

    “a “conventional method” that is used for calculating nitrogen needs for a field. Ex. 1001, 1:39–40. Hauwiller’s system is open to a variety of recommendation equations, as Patent Owner’s declarant agrees. See Ex. 1005, 8:36–48, 9:18–21, 9:34–38, 13:30–35, 13:39–45; Ex. 1020, 8:11–16. This openness supports the obviousness of employing within Hauwiller’s system a conventional equation (or certain aspects of a conventional equation) such as the one set forth in the Background of the ’620 patent. Furthermore, while the conventional equation includes several variables, a basic teaching of the equation is that in calculating the fertilizer recommendation, the amount of nitrogen already present should be subtracted from the nitrogen needed to realize the yield goal. See Ex. 1001, 1:39–50. Dr. Johannsen’s testimony that “subtraction of existing nutrients from the nutrient amount was a conventional thing to do particularly because it helps reduce leaching due to over fertilization” is consistent with this understanding of the conventional equation. See Ex. 1008 ¶ 71. We also recognize that the ’620 patent describes the equation as being a conventional approach for calculating nitrogen needs “for a field” rather than for a specific site within the field. Ex. 1001, 1:39–40. But Hauwiller recognizes that “[d]esired yield potential varies depending upon the soil characteristics by location” and, for that reason, describes the desirability of constructing “a yield goal map for creating an application map based upon site specific yield goals.” Ex. 1005, 9:32–41 (emphasis added). Thus, Hauwiller teaches the advantages and desirability of a site-specific approach. We agree with Petitioner that the “subtracting” step would have been accomplished by applying the teachings of the equation in the Background of the ’620 patent to the site-specific approach of Hauwiller. The evidence supports Petitioner’s contentions summarized above, and we agree with Petitioner that all of the features of claims 1 and 20 are disclosed in Hauwiller and the prior art described in the Background of the ’620 patent, and that there is adequate reason to combine the teachings of the prior art. We have considered Patent Owner’s arguments to the contrary, but we do not find them persuasive for the reasons discussed below.” slip op. at 14

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We have considered Patent Owner’s and Dr. Heiniger’s opposing views. We observe that Dr. Heiniger does not explain adequately the basis of his opinion that, despite the teachings of the prior art, a person of ordinary skill in the art would have “thought that yield data from previous years would not work for that purpose” because a skilled artisan would have viewed yield data as “fundamentally different” from a measure of biomass. See Ex. 2033 ¶ 167. We also do not discern that either Patent Owner or Dr. Heiniger adequately considers that, in view of the teachings of the prior art, one of ordinary skill in the art would have known that “leaf area index” is a known measure of biomass. See Ex. 1001, 1:63–65. In that regard, they do not explain why a skilled artisan would not understand readily that leaf area index constitutes the type of field history data and previous crop information that Hauwiller contemplates as useful in developing a map for a given field. Accordingly, on the record before us, we conclude that Petition has shown where all the features of claims 2 and 21 are found in the prior art, and that there is articulated reasoning why a person of ordinary skill in the art would have combined the teachings of Hauwiller and the Background of the ’620 patent. Patent Owner’s and Dr. Heiniger’s general views to the contrary, in our view, do not account appropriately for how a skilled artisan would have understood the teachings of the prior art.” slip op. at 23

  Patent outcomesUS 6,889,620 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,889,620
• Tietex International, Ltd. v. Precision Fabrics Group, Inc.Institution denied
  PTAB · Feb 11, 2016 · IPR2015-01671 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution on both asserted § 103 grounds, finding no reasonable likelihood of success and exercising § 314(a) discretion for the Radwanski, Rowan, and Murch ground.

  RulingsInstitution decision

  • Other 314aInstitution denied discretionary otherInstitution denied

    “We approach our discretion to deny a petition on a case-by-case basis. There are sufficient reasons under the specific facts of this case to exercise our discretion to deny institution on Petitioner’s asserted ground that claims 1–30 of the ’162 patent would have been obvious over the combination of Radwanski, Rowan, and Murch. Notably, in this proceeding, the claims of the ’162 patent are so similar in scope and content to those in the ’639 patent that Petitioner is relying on the same arguments that we found to be unpersuasive in the 1248 Final Decision. See Pet. 29; 1248 Final Dec. 22. We do not see how the efficient administration of the Office, or the just, speedy, and inexpensive resolution of every proceeding, would be secured by instituting an inter partes review in this proceeding when the same prior art references and arguments are asserted against substantially the same claim limitations as in the 1248 IPR.” slip op. at 8

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

    “A showing of obviousness must be supported by an articulated reasoning with rational underpinning to support a motivation to combine the prior art teachings. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 414 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). An analysis regarding an apparent reason to combine known elements “should be made explicit.” Id.” slip op. at 12

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

    “A showing of obviousness must be supported by an articulated reasoning with rational underpinning to support a motivation to combine the prior art teachings. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 414 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). An analysis regarding an apparent reason to combine known elements “should be made explicit.” Id.” slip op. at 12

  • Prior constructionPrior construction adoptedDecided for petitioner

    “terminology as the claims in related US patent 8,501,639, which is the subject of [the] previously instituted [1248 IPR]” and argues “that for purposes of this proceeding, the same definitions should apply.” Pet. 7. In the 1248 IPR, we determined that the broadest reasonable interpretation of the term “intumescent” in light of the specification is “a substance that swells and chars upon exposure to heat or flame.” Tietex Int’l, Ltd. v. Precision Fabrics Group, Inc., Case IPR2014-01248, slip op. at 5–6 (PTAB Jan. 30, 2015) (Paper 14); see id., slip. op. at 4–5 (PTAB Jan. 27, 2016) (Paper 39). Petitioner and Patent Owner agree that “intumescent” as used in claim 1 of the ’162 patent should be interpreted the same way in this proceeding. Pet. 7; Prelim. Resp. 17. Therefore, for purposes of this Decision, we interpret “intumescent” to mean “a substance that swells and chars upon exposure to heat or flame.” B.” slip op. at 5

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,796,162
• 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

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.