- Intuitive Surgical, Inc. v. Ethicon LLCSome claims unpatentablePTAB · Jan 13, 2020 · IPR2018-01254 · APJ Matthew S Meyers · IPR · Final written decision
Claims 1–10 are unpatentable under § 103; claims 11 and 24 were not shown unpatentable because the proposed combinations did not adequately establish the articulation limitations.
RulingsFinal written decision- BurdenOther
“of proving unpatentability of the challenged claims, and the burden of persuasion never shifts to Patent Owner. To prevail, Petitioner must prove 1 Our decision does not rely on any information deemed confidential by the parties. unpatentability by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d) (2017). This decision is a Final Written Decision under 35 U.S.C. § 318(a) as to the patentability of claims 1–11 and 24 of the ’969 patent. For the reasons discussed below, we hold that Petitioner has demonstrated by a preponderance of the evidence that claims 1–10 of the ’969 patent are unpatentable under § 103(a). We also hold that Petitioner has not demonstrated by a preponderance of the evidence that claims 11 and 24 of the ’969 patent are unpatentable under § 103(a).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not appear to dispute Petitioner’s definition of one of ordinary skill in the art. See generally PO Resp. Neither party argues that the outcome of this case would differ based on our adoption of any particular definition of one of ordinary skill in the art. In light of the record now before us, we adopt Petitioner’s definition of one of ordinary skill in the art. The level of ordinary skill in the art is also reflected by the references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.’”); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (finding that the Board of Patent Appeals and Interferences did not err in concluding that the level of ordinary skill in the art was best determined by the references of record).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“(Fed. Cir. 1993). Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes review). Here, neither Petitioner nor Patent Owner identifies terms for construction or provides any proposed constructions. Pet. 12; PO Resp. 10; see generally Pet. Reply; Prelim. Resp. 11. Instead, the parties agree that claims of the ’969 patent should be construed according to their broadest reasonable interpretation. Pet. 12; PO Resp. 10. We determine that no claim term needs express interpretation. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Patent Owner asserts that Petitioner’s expert, Dr. Knodel, “admitted that the tool base shown in Wallace’s figures is not designed to drive an endocutter that clamps and fires.” PO Resp. 36–37 (citing Ex. 2011, 24:20– 23). This admission deserves little weight, however, given that Wallace expressly discloses that “any suitable end effector 66 may be used” in its robotic surgery system depending on the surgical need, including clamps and staplers. Ex. 1008, 7:50–56; see also id. at 2:18–21 (“As used herein, the term ‘end effector’ means the actual working part of the surgical instrument and can include clamps, graspers, scissors, staplers, and needle holders, for example.”); Pet. Reply 18–20; see Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (Obviousness “cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.”).” slip op. at 33
Patent outcomesUS 8,479,969 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,479,969 - Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,271,731 - Dexcom, Inc. v. Waveform Technologies, Inc.Some claims unpatentablePTAB · Sep 12, 2018 · IPR2017-01051 · APJ Elizabeth M Roesel · IPR · Final written decision
Claims 1, 4–12, and 15–19 were held unpatentable as obvious over Hagiwara; claims 2, 3, 13, and 14 were not shown unpatentable. The motion to amend was granted in part.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“j. Conclusion Regarding Obviousness Based on Hagiwara (Proposed Substitute Claims) We conclude that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 20, 22, 23, and 26–29 are unpatentable as obvious in view of Hagiwara. We conclude that Petitioner has not shown by a preponderance of the evidence that proposed substitute claims 21, 24 and 25 are unpatentable as obvious in view of Hagiwara. 2. Remaining Grounds of Unpatentability Asserted by Petitioner (Proposed Substitute Claims) In view of our determination that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 20, 22, 23, and 26–29 are unpatentable as obvious in view of Hagiwara, we do not reach Petitioner’s remaining grounds of unpatentability as to these claims. Regarding proposed substitute claims 24 and 25, Petitioner’s contentions regarding the Handbook, Wilson, and Say do not remedy the deficiencies in Petitioner’s contentions regarding Hagiwara, as discussed above. Accordingly, we conclude that a preponderance of the evidence does not show that proposed substitute claims 24 and 25 are unpatentable as obvious based on Hagiwara in view of the Handbook, Wilson, or Say. H.” slip op. at 71
- ExcludeOther
“As discussed above, we do not reach the Wilson-Based Grounds with respect to claims 1, 4–12, and 15–19 of the ’574 patent. As for claims 2, 3, 13, and 14, we determine that Petitioner has not shown unpatentability based on the Wilson-Based Grounds, even if Exhibit 1037 and the corresponding portions of Petitioner’s Reply (Paper 37) are not excluded, because Petitioner does not offer Exhibit 1037 to cure the deficiency we noted in Wilson. See Section II.F, supra. For this reason, we dismiss as moot Patent Owner’s motion.” slip op. at 72
- Expert testimonyPetitioner expert discountedPatent owner expert discountedDecided for patent owner
“sensor would not have been a motivation to combine Hagiwara’s embodiments” because Hagiwara’s catheter prevents damage to the sensor during insertion and because a sensor with a side sensor window creates a greater risk of damage and vascular injury and reduces exposure to blood, as compared with a sensor with an end sensor window. PO Resp. 20–25. We have considered Patent Owner’s arguments, but, for the reasons discussed above, we are persuaded that Petitioner has established a motivation to combine, notwithstanding the conflicting expert testimony regarding the disadvantages of a side sensor window versus an end sensor window. Neither of the expert opinions on this topic is supported by objective facts or data. Ex. 1006 ¶ 155;13 Ex. 2008 ¶¶ 54–57, 87–95; Ex. 2009, 92:8–97:12. For this reason, we give little or no weight to either side’s expert testimony 13 Dr. Vachon cites “WO 01/13102, Vadgama” (Ex. 1006 ¶ 155), however, this reference was not submitted as an exhibit in this proceeding. on this topic. 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (nothing in the Federal Rules of Evidence or Federal Circuit jurisprudence requires the fact finder to credit unsupported assertions of an expert witness). As discussed above, however, there is no disagreement that a side sensor window was a known alternative to an end sensor window. Ex. 1006 ¶¶ 73, 155; Tr. 43:22–44:3. That undisputed fact, together with Petitioner’s other evidence, is sufficient to establish a motivation to combine.” slip op. at 42
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art For purposes of our Institution Decision, we accepted the definition of a person of ordinary skill in the art (“POSITA”) provided by Petitioner’s declarant, Dr. Vachon. Dec. 11 (citing Ex. 1006 ¶ 28). That definition is: a person having a bachelor’s degree or the equivalent training or experience in mechanical engineering, bioengineering, or related field and at least three years of experience relating to biosensor research and development, or a master’s degree or the equivalent training or experience in mechanical engineering, bioengineering, or related field, and at least one year of experience relating to biosensor research and development. Id. Patent (https://www.uspto.gov/sites/default/files/documents/guidance_on_motions_ to_amend_11_2017.pdf); Bosch Automotive Service Solutions, LLC v. Matal, 878 F.3d 1027 (Fed. Cir. 2017); Bosch Automotive Service Solutions, LLC v. Iancu, Order on Petition for Panel Rehearing, No. 2015-1928 (Fed. Cir. Mar. 15, 2018). Owner’s declarant accepts and applies this definition of a POSITA for purposes of his opinions. Ex. 2008 ¶ 30. Neither party’s declarant indicates that any proffered opinion would change depending on the level of ordinary skill in the art. Therefore, consistent with our Institution Decision, we adopt Dr. Vachon’s definition of a POSITA. Ex. 1006 ¶ 28. We also rely on the cited prior art references as reflecting the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 20
Patent outcomesUS 7,529,574 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,529,574 - 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 · GrahamPatents in suitUS 8,649,538 - Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,073,987 - Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,017,680 - Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,889,135 - Boston Scientific Corporation v. Uab Research FoundationRehearing grantedPTAB · Mar 7, 2016 · IPR2015-00918 · APJ James A Worth · IPR · Rehearing
Rehearing was granted, and IPR was instituted on anticipation of claims 1–20 by KenKnight ’967; no other grounds were instituted.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“II. STANDARD OF REVIEW Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). The request must identify, specifically, all matters the party believes the Board misapprehended or overlooked. 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“background art in which two other patents described “pacing or pretreatment pulses” delivered through the same electrodes as defibrillation. Id. (citing Ex. 1002, 7). We recognize that Patent Owner has not yet had an opportunity to introduce testimonial evidence as to whether a person of ordinary skill would understand the ’261 Application to disclose the use of pacing (in addition to pretreatment pulses) through an electrode with the claimed positioning. At this stage of the proceeding, we determine that Petitioner has shown a reasonable likelihood of prevailing on its assertion that the patentee was not in possession of the claimed configuration of electrodes at the time of the filing of the ’261 Application. As such, Petitioner has demonstrated a reasonable likelihood of prevailing on its related assertion that the claims of the ’563 patent cannot benefit from the priority from the ’261 Application. Thus, Petitioner has demonstrated a reasonable likelihood of prevailing on its assertion that KenKnight ’967 is prior art to the ’563 patent.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“Application (from .01 or .05 to 1 or 2 Joules) is greater than the value of a typical pacing pulse (0.000025 Joules). See Pet. 12; Ex. 1006 ¶¶ 132–133; compare Ex. 1002, 12:29–31, with Ex. 1006 ¶ 66). We credit Dr. Benditt’s testimony that the smallest disclosed energy for the auxiliary pulse in the ’261 Application is about ten thousand times stronger than a pacing pulse, and a person of ordinary skill in the art would understand that such a pulse does not correspond to a pacing pulse. Id. Based on this difference, and based on our claim construction, we conclude that Petitioner has established a reasonable likelihood that the “auxiliary” pulses disclosed in the ’261 Application are not antitachycardia pacing energies, and do not otherwise qualify as antitachycardia pacing. Patent Owner, nevertheless, asserts that the ’261 Application states the intent to treat ventricular tachycardia (see supra), i.e., “[t]he present invention may be used to treat all forms of cardiac tachyarrythmias, including ventricular fibrillation, with defibrillation (including cardioversion) shocks or pulses.” See Opposition 3 (quoting Ex. 1002, 7:4– 9). However, the intent to treat ventricular tachycardia by itself is not enough because the claims require antitachycardia pacing as the treatment for tachycardia. In this regard, Petitioner correctly observes that the disclosure of the ’261 Application describes in large part defibrillation in combination with cardioversion shocks, including in the above passage relied on by Patent Owner. In other words, the above passage discloses defibrillation and cardioversion but does not necessarily include pacing.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“D. Anticipation by KenKnight ’967 1. Claims 1, 3–7, 9–14, and 16–20 Relying on the Declaration of Dr. Benditt, Petitioner sets forth argument and evidence as to how KenKnight ’967 would anticipate each element of claims 1, 3–7, 9–14, and 16–20. Pet. 25–48. Patent Owner does not appear to dispute in its Preliminary Response that KenKnight ’967, if prior art, would anticipate claims 1, 3–7, 9–14, and 16–20. As above, we determine that there is a reasonable likelihood that KenKnight ’967 is prior art to the ’563 patent. Further, based on our own independent review of KenKnight ’967, we determine that Petitioner has shown a reasonable likelihood of prevailing on its assertion that KenKnight ’967 would anticipate claims 1, 3–7, 9–14, and 16–20.4” slip op. at 11
Claim construction§ 102 anticipationcites PhillipsPatents in suitUS 6,266,563 - Tietex International, Ltd. v. Precision Fabrics Group, Inc.No claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 8,501,639 - Volkswagen Group Of America, Inc. v. Emerachem Holdings, LLCAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 5,451,558
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.