- 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 - 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 - Hyperbranch Medical Technology, Inc. v. Incept LLCAll claims unpatentablePTAB · Apr 9, 2018 · IPR2016-01836 · APJ Kristi L R Sawert · IPR · Final written decision
Claims 1–6 and 8–12 are unpatentable as obvious under § 103 over Rhee ’500 or Rhee ’587, each combined with Bass or Tse.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Upon review of the parties’ respective definitions of a person of ordinary skill in the art, we adopt Petitioner’s definition as a person with either: (1) a Ph.D. in the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and having at least one year of educational or work experience in the synthesis and development of biocompatible polymer materials; (2) a bachelor’s degree in in [sic] the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and at least two years of work experience in the synthesis and development of biocompatible polymer materials; or (3) any education and experience equivalent to (1) or (2). Pet. 22 (citing Ex. 1003 ¶ 49). We find that Patent Owner’s definition of the ordinarily skilled artisan, i.e., a person having “a Ph.D. degree, or equivalent education, in polymer chemistry, or a bachelor of science degree in chemistry or a closely related field and several years of experience in the development and manufacture of polymer materials for use as tissue sealants,” PO Resp. 15–16 (citing Ex. 2006 ¶ 27), does not differ materially from Petitioner’s definition. Furthermore, our analysis would be the same under either parties’ definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“1. “visualization agent” In its Petition, Petitioner proposed interpretations of certain claim terms. Pet. 18–22. The Board determined in its Institution Decision, however, that only the term “visualization agent” required express interpretation. Inst. Dec. 8 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). The Board set forth the broadest reasonable interpretation of “visualization agent” as “an agent that reflects or emits light at a wavelength detectable to a human eye so that a human eye may visualize the hydrogel coating.” Id. at 9. Neither party challenges that interpretation. See, e.g., Third Tr. 6:15–17. 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 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the 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) (quotation omitted). “Conversely, 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. Here, we determine that the preamble phrase “suitable to coat a tissue of a patient” is not merely a statement of purpose, but instead represents the “essence or a fundamental characteristic of the claimed invention.” Vizio, Inc. v. Int’l Trade Com’n, 605 F.3d 1330, 1340 (Fed. Cir. 2010). In Vizio, the Federal Circuit held that a preamble reciting “for decoding” certain data “is properly construed as a claim limitation” because the apparatus and method claims reciting that preamble “would have little meaning without the intended objective of decoding.” Id. at 1341. Similarly here, we determine that the method step of claim 1—namely, mixing reactive nucleophilic precursor species, electrophilic precursor species, and a visualization agent—would have little meaning without the intended objective of forming a hydrogel coating on the tissue of a patient. Put differently, there would be no reason to perform the method step of claim 1 but for forming a hydrogel coating on the patient’s tissue. See Ex. 1001, 39:56–40:2 (claim 1) (providing that the reactive precursors crosslink after contact with the tissue to form a hydrogel in the form of a coating). Thus, we determine that “suitable to coat a tissue of a patient” is limiting in this case because it gives “life and meaning” to method claim 1. We further find that the arguments and evidence in this case show that skilled artisans would reasonably interpret “suitable to coat a tissue of a patient” as encompassing a biocompatibility requirement. Although Petitioner correctly notes that “[n]one of challenged claims recite the term ‘biocompatible,” Petitioner acknowledges that skilled artisans understand “that hydrogels are, by their nature as water-swelled materials, known to be biocompatible.” Pet. Suppl. Br. 4–5. Petitioner’s expert, Dr. Lowman, declared that “biocompatibility is presumed as a fundamental aspect of the claimed and disclosed inventions.” Ex. 2018 ¶ 40. And in his deposition, Dr. Lowman testified that skilled artisans would understand “biocompatible” to mean that the hydrogel composition is “suitable for use and tolerated by a patient.” Ex. 2019, 13:2–11 (emphasis added). Thus, we agree with Patent Owner that “suitable to coat a tissue of a patient” reasonably encompasses a biocompatibility requirement for the hydrogel composition. slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“3. Motivation to combine the prior art references and reasonable expectation of success Even “[i]f all elements of the claims are found in a combination of prior art references,” “the factfinder should further consider whether a person of ordinary skill in the art would [have been] motivated to combine those references, and whether in making that combination, a person of ordinary skill would have [had] a reasonable expectation of success.” Merck & Cie v. Gnosis S.P.A., 808 F.3d 829, 833 (Fed. Cir. 2015). The “motivation to combine” and “reasonable expectation of success” factors are subsidiary requirements for obviousness subsumed within the Graham factors. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007).” slip op. at 28
Patent outcomesUS 7,009,034 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,009,034 - 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 - Orstar Industrial Co., Ltd. v. Cosmo Lighting Inc.All claims unpatentablePTAB · Jan 13, 2017 · IPR2015-01787 · APJ Jennifer S Bisk · IPR · Final written decision
Claims 1–3 are unpatentable as obvious over Popovich and Lin-US, and over Popovich, Lin-US, and Lin-CN.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“For the foregoing reasons, we are not persuaded that the level of ordinary skill in the art requires specific experience in the packaging of optoelectronic devices as is argued by Patent Owner. We also are not persuaded that the level of ordinary skill in the art requires education in the form of a Master Degree in Material Sciences, Electrical Engineering, or Mechanical Engineering, as is argued by Patent Owner. Instead, we are persuaded by Petitioner’s statement of the level of ordinary skill in the art, and our finding of the level of ordinary skill is similar to that proposed by Petitioner, but with a slight modification, i.e., that a basic level of technical education is required, at the level of an Associate Degree (two year college program) in Physics, Electrical Engineering, Mechanical Engineering, or Industrial Engineering. We find that the level of ordinary skill in the art is that of one having at least an Associate Degree or Bachelor’s Degree in Physics, Mechanical Engineering, Electrical Engineering, or Industrial Engineering, plus 1–4 years of working experience with semiconductor electronic device packaging or printed wiring board assembly. A more advanced degree would be paired with a shorter period of working experience.” slip op. at 11
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Patent Owner has not articulated a persuasive reason for giving Dr. Pugliandla’s testimony little or no weight. Petitioner submits other evidence contrary to Dr. Denbaars unsupported assertion that LED’s are never encapsulated in glass. Reply 8 (citing Ex. 1022). For example, Exhibit 1022 is a journal article, dated 2006 and titled “Optical characteristics of spherical glass encapsulated LEDs.” Ex. 1022, Title. Moreover, as discussed above, we are not persuaded that a person of ordinary skill in the art of the ’978 patent would be required to have specific experience in the packaging of optoelectronic devices as opposed to electronic packaging in general. We are, thus, not persuaded that Dr. Pugliandla’s answers, during deposition, to two questions about the material used for transparent encapsulation is wrong or that the entirety of his testimony should be given little or no weight based on this disagreement. In fact, Dr. Pugliandla is highly qualified in the area of electronic packaging. Dr. Pugliandla has several degrees, including a Ph.D. in chemistry. Reply 8–9; Ex. 1002 ¶ 9. He spent many years working in the areas of electronic packaging and surface mount technology, has taught courses in electronic packaging, and has served as a member of the Board of Directors for the National Surface Mount Technology Association. Id. at ¶¶ 12–18. We are persuaded that Dr. Pugliandla’s education and experience is relevant to the issues discussed in the ’978 patent. Moreover, given the subject matter of the ’978 patent and Dr. Pugliandla’s experience in electronic packaging, we do not find his admitted lack of direct experience in optoelectronic device packaging (see Ex. 2002, 38:15–22) as basis to accord his testimony little or no weight. On this record, we still credit the testimony of Dr. Pugliandla over the contrary testimony of Dr. Stephen P. Denbaars (Dr. Denbaars)6 about whether glass is commonly used as transparent material to encapsulate LEDs or never used to encapsulate LED. An expert does not have to have direct hands-on design experience on a subject to know what existed as a common technique on that subject.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“C. Claim Construction We construe all terms, whether or not expressly discussed here, using the broadest reasonable construction in light of the ’978 patent specification. 37 C.F.R. § 42.100(b). For purposes of the Institution Decision, we expressly construed the following terms: (1) “contact-pad area” as “an opening in an insulating layer of a conducting wire where electrical contact can be made”; and (2) “encapsulating” as “enclosing.” Decision 8–15. In the post-institution briefs, Patent Owner disputes only the construction of “encapsulating.” For purposes of this decision, therefore, we continue to apply the construction of “contact-pad area” as set forth above and we address the construction of the term “encapsulating” below. We construe all other terms using the broadest reasonable construction in light of the ’978 patent specification.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“Thus, the only relevant question is whether we should append the phrase “on all sides” to our construction. We are not persuaded that encapsulating components requires that each and every side of the components be surrounded by encapsulating material. In other words, when only a subset of surfaces of a device is exposed to the environment, the plain and ordinary meaning of encapsulate would include covering only those exposed surfaces with encapsulating material. The ’978 patent supports this understanding by describing the process of encapsulating the components in Figure 6 as “a layer of transparent package 5 is further applied to an outer side of every paired first and second contact-pad areas 13, 23 on the first and second conducting wire 1, 2 and the surface mounted light emitting component 3 bonded thereto . . . .” Ex. 1001, 4:63–5:15 (emphasis added). This understanding is also consistent with the ’978 patent’s stated goal of encapsulation, preventing the components “from electrically contacting with an external environment,” “protect[ing] the surface mounted light emitting components 3 against failure due to contacting with external dust and particles,” and strengthening the connections by “protecting . . . against damage and separation . . due to external impact.” Id. Ex. 1002 ¶ 46 (“The use of encapsulating materials to [improve the ruggedness and reliability] is a common practice in the electronic assembly industry, and was commonly practiced for decades prior to the critical date of the ’978 patent.”); see also, Ex. 2001 ¶¶ 65–67 (Dr. Denbaars testifying that without full enclosure, a device would not be protected from the environment); Ex. 2002, 46:4–19 (Dr. Puligandla testifying similarly). The relevant components are fully protected from the external environment when the surfaces exposed to such environment are covered by encapsulating material. We, therefore, continue to give the term “encapsulating” its plain and ordinary meaning: enclosing the exposed surfaces of the recited components. We do not construe the term encapsulating, however, to require covering all component surfaces by encapsulating material.” slip op. at 15
Patent outcomesUS 7,926,978 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,926,978 - Geosys-Intl, Inc. v. Farmers Edge Precision Consulting Inc.Rehearing grantedPTAB · Nov 22, 2016 · IPR2015-00711 · APJ James T Moore · IPR · Rehearing
Rehearing was granted, and claim 25 was held unpatentable as obvious over Hauwiller, the Background of the ’867 patent, and Shibusawa.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“After considering the arguments in the Request for Rehearing and reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also now agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’867 patent, and Shibusawa.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentableUnpatentable
“Applying this corrected understanding of claim 25, we also now agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’867 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 45–46; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5; Dec. 39–40.” slip op. at 5
§ 103 obviousnessPatents in suitUS 7,343,867 - Geosys-Intl, Inc. v. Farmers Edge Precision Consulting Inc.Rehearing grantedPTAB · Nov 22, 2016 · IPR2015-00709 · APJ Timothy J Goodson · IPR · Rehearing
Rehearing granted; claim 25 held unpatentable as obvious over Hauwiller, the Background of the ’912 patent, and Shibusawa.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“was based on a misapprehension of what is required by claim 25. Req. Reh’g 6. Specifically, Petitioner argues that claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Id. at 1. Petitioner points out that claim 25 requires that the soil electrical conductivity map is used for the calculation of the “site-specific measures of the soil nutrient existing in the field.” Id. at 2. Claim 15 requires that the map of site-specific field characteristic data generated using a satellite image of the agricultural field is used in the calculation of the map of “site-specific soil nutrient amount needed to produce at each site a maximum possible crop yield.” Ex. 1001, 12:7–12. In other words, the map of soil electrical conductivity recited in claim 25 is used in the first calculating step of claim 15, not the second calculating step that uses a map generated through satellite imaging. After considering the arguments in the Request for Rehearing and reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’912 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 47; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5–6; Dec. 34.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“reconsidering the evidence of record, we agree with Petitioner that the reasoning in our Final Decision misapprehended what is required by claim 25. Claim 25 does not require satellite imaging to create a map of soil electrical conductivity. Applying this corrected understanding of claim 25, we also agree that Petitioner established by a preponderance of the evidence that claim 25 would have been obvious in view of Hauwiller, the Background of the ’912 patent, and Shibusawa. As summarized above, Petitioner presented evidence that Shibusawa discloses a map of measurements of soil electrical conductivity, and that combining Shibusawa’s teachings with Hauwiller’s system would have been obvious because electrical conductivity testing is a relatively efficient method for determining soil properties. Pet. 47; Ex. 1004, 20:11–16, 23:14–17; Ex. 1009 ¶ 80. As Petitioner points out, the subject matter recited in claim 25 is similar to that of claims 7 and 14, and we determined in our Final Decision that Petitioner’s contentions regarding the obviousness of those claims were persuasive. See Req. Reh’g 5–6; Dec. 34.” slip op. at 4
§ 103 obviousnessPatents in suitUS 7,171,912 - Geosys-Intl, Inc. v. Farmers Edge Precision Consulting Inc.Some claims unpatentablePTAB · Aug 17, 2016 · IPR2015-00709 · APJ Timothy J Goodson · IPR · Final written decision
Claims 1–24 are unpatentable as obvious; Petitioner did not show claim 25 would have been obvious.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Petitioner’s declarant, Dr. Johannsen, testifies that a person of ordinary skill in the field of this invention “would have had at least a Bachelor of Science degree in Agricultural Systems Management, Agriculture, Agronomy, or a related degree and would have had several years of experience with precision farming.” Ex. 1009 ¶ 16. Patent Owner’s declarant, Dr. Heiniger, testifies that a person of ordinary skill in this field would have “at least a Bachelor of Science degree in agronomy or a related field, and at least a Masters Degree in a discipline that involves engineering systems using remote sensing data or comparable work experience. Such a person would have had some practical experience integrating these remote sensing systems.” Ex. 2033 ¶ 18; see also PO Resp. 26 (same). Although Dr. Heiniger’s position is not exactly the same as Dr. Johannsen’s, Dr. Heiniger adds that the “[d]ifferences between who Dr. Johannsen and I view as a person of ordinary skill in the art are not material to my opinions . . . .” Ex. 2033 ¶ 19. 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 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“In the Decision to Institute, we construed the phrase “calculating a map”5 in claims 1, 6, 8, 13, 15, 17–19, and 24 to mean “performing calculations to produce a map.” Dec. to Inst. 7. With respect to the phrase “maximum possible crop yield” in claims 1, 8, and 15, we declined to adopt Petitioner’s proposed construction of “yield goal” and instead applied the ordinary and customary meaning of the claim language. Id. at 8–9. We further determined that no other claim term required express construction. Id. at 9. Following institution, neither party challenged those constructions or proposed other terms for construction. Therefore, for the reasons explained in the Decision to Institute, we maintain the constructions set forth therein. 5 We understand the phrase “calculating a map” to have the same construction, regardless of whether it appears as “calculating . . . a map,” “calculate . . . a map,” or “calculating a map.”” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“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. 1006, 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 ’912 patent. Further, 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. 1009 ¶ 71. We also recognize that the ’912 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. 1006, 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 obvious by applying the teachings of the equation in the Background of the ’912 patent to the site-specific approach of Hauwiller. The evidence supports Petitioner’s contentions summarized above, and we agree with Petitioner that claim 15 would have been obvious based on Hauwiller and the prior art described in the Background of the ’912 patent, even taking into account the secondary considerations discussed in Section II.E. below. 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 12
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“We agree with Petitioner that Patent Owner has not shown the required nexus between the alleged objective indicia of nonobviousness and the merits of the claimed invention. Although the agreements between Petitioner and the former owner of the ’912 patent convey rights under the ’912 patent, they involve significantly more than the pertinent licenses. The 2008 and 2011 agreements convey licenses to a broader portfolio of U.S. and Canadian patents as well as copyrights, trademarks, and a domain name. Ex. 2022, 4–6; Ex. 2023, 4–6. Moreover, the licenses to intellectual property are just one facet of these agreements, the primary purpose of which is “to set forth the terms upon which Geosys shall provide sales, marketing and support for Field InSite as part of the Geosys FarmSat Platform.” Ex. 2022, 2; Ex. 2023, 2. Similarly, the 2012 agreement conveys rights beyond the ’912 patent. Ex. 2024, 2–3. Patent Owner does not point to, and we do not find, any portion of these agreements assigning a particular royalty rate or value for the ’912 patent. Given the breadth of the agreements and the absence of evidence or explanation from Patent Owner concerning nexus, any determination of how much of the value of the agreements is attributable to the ’912 patent would be speculative. See In re Cree, 818 F.3d 694, 703 (Fed. Cir. 2016). Further, the 2012 agreement calls for a lump sum payment for all of the rights conveyed, the amount of which is less than a reasonable estimate of potential litigation costs. Ex. 2024, 2–3. This detracts further from Patent Owner’s argument that the agreements support the nonobviousness of the ’912 patent. See EWP Corp. v. Reliance Universal Inc., 755 F.2d 898, 907– 08 (Fed. Cir. 1985) (noting that licensing programs “are not infallible guides to patentability. They sometimes succeed because they are mutually beneficial to the licensed group or because of business judgments that it is cheaper to take licenses than to defend infringement suits, or for other reasons unrelated to the unobviousness of the licensed subject matter.”). Patent Owner’s argument based on its acquisition of the ’912 patent is also unpersuasive. The evidence that Patent Owner cites in support of that argument shows only that The Mosaic Company filed and subsequently dismissed a Canadian patent infringement suit against Patent Owner. See Exs. 2025, 2026.8 Patent Owner does not cite to the agreement by which ownership of the ’912 patent was transferred, nor does Patent Owner provide the details of that agreement. The evidence Patent Owner relies on does not support Patent Owner’s argument that its decision to acquire the ’912 patent constitutes objective evidence of nonobviousness of the ’912 patent. Finally, the commercial success argument Patent Owner presents in a” slip op. at 36
Patent outcomesUS 7,171,912 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,171,912
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.