- Zhuhai Cosmx Battery Co., Ltd. v. Ninge Amperex Technology LimitedInstitution deniedPTAB · Aug 20, 2025 · IPR2025-00385 · APJ Debra L Dennett · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–10 were anticipated by Nishikawa or obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review under 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.” For the reasons set forth below, upon considering the Petition and Preliminary Response, we determine that Petitioner has not established a reasonable likelihood of prevailing with respect to at least one challenged claim. Accordingly, we deny the Petition and decline to institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“Petitioner contends that A person of ordinary skill in the relevant art would typically hold an advanced degree in chemistry, material science, and/or a related discipline, and have at least two years of experience with designing and/or fabricating battery separators or have an equivalent level of education, training, and experience. Pet. 5. Patent Owner “adopts the definition proposed by Petitioner” for the purposes of the Preliminary Response. Prelim. Resp. 22. In light of the record before us, and for purposes of this Decision, we adopt Petitioner’s unopposed definition because it is consistent with the specification. We note that neither party indicated that the result would change under any different definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Absolute plastic deformation rate” and “relative plastic deformation rate” are the only claim terms disputed in this proceeding, and are clearly defined in the Specification and in claim 1. See Spec. 4:22–27, 4:47–54; 25:31–37. Because we determine that claim construction is not necessary to decide whether to institute, we do not expressly construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review). slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Petitioner’s arguments are unconvincing. Petitioner points to nothing in Nishikawa that allows a POSITA to determine L2 (defined as “a length of 4 Tensile strength is measured as force per units area, such as MPa or psi. One MPa equals one N/mm2. Nishikawa Table 1 discloses tensile strength in N/cm. Ex. 1004 Table 1. Petitioner makes calculations to convert the reported N/cm into N/m2 and then to GPa, but provides no explanation for why tensile strength is reported in N/cm or how it was measured. See Pet. 31. the porous substrate after the porous substrate is stretched to breakage and docked along the fracture caused by the breakage and flattened”) or L2 – L0. See generally Pet., Ex. 1004. Petitioner and its expert, Dr. Pecht, fail to adequately explain why tensile strength divided by Young’s modulus is “a proxy for L1 – L2” or why such a proxy is sufficient to disclose the limitation as stated. Instead, we are required to rely on “approximations” and “estimates” with insufficient explanation of why such they are appropriate or adequate. See Pet. 26, 30, 32; see also Ex. 1003 ¶¶ 97, 105–108, 111.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,964,927 - Solus Advanced Materials Co., Ltd. v. SK Nexilis Co., Ltd.Institution deniedPTAB · Apr 25, 2025 · IPR2024-01462 · APJ Jo-Anne M Kokoski · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–8 were unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“experience working on the development of materials or components for electronic devices such as batteries.” Pet. 2. Petitioner further contends that “[a]dditional education, such as a graduate degree, could compensate for less work experience, and additional work experience could compensate for less formal education.” Id. Patent Owner states that, “[f]or purposes of this Preliminary Response, Patent Owner applies Petitioner’s level of skill for a person of ordinary skill in the art.” Prelim. Resp. 4. For purposes of this Decision, we adopt Petitioner’s undisputed proposed definition because it appears to be consistent with the cited prior art and the disclosure of the ’014 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). in this proceeding.” Pet. 3. Patent Owner contends that “[t]he Board need not construe any term in order to determine that institution should be denied.” Prelim. Resp. 4. Based on the record before us, we determine that no claim term requires express construction for purposes of this Decision. See Realtime Data, 912 F.3d at 1375.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For these reasons, we are not persuaded that Petitioner sufficiently establishes that a POSITA would have been motivated to modify Hanafusa in light of Dobashi with a reasonable expectation of success as Petitioner contends. Accordingly, we determine that Petitioner fails to demonstrate a reasonable likelihood of prevailing in its assertion that the subject matter of claim 1, and claims 4 and 8 that depend therefrom, would have been obvious over the combined teachings of Hanafusa and Dobashi.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“Petitioner also focuses on Hanafusa’s teaching that all known methods can be used to make a rough surface low-profile, and Dobashi’s teaching that RSm can be used as an indicator for judgment of the surface, to support its contention that a POSITA would have been motivated to apply Dobashi’s RSm to further achieve Hanafusa’s purpose, without explaining how and why that would be the case. In particular, neither Petitioner nor Dr. Josefowicz adequately explain why a POSITA looking for ways to make Hanafusa’s surface roughness low-profile would look to methods to achieve as the period of waviness, RSm can also be used as an indicator for judgment of the surface.” Ex. 1005, 2:66–3:1, 6:23–26. Dobashi explains that waviness is “an indicator for determining whether the fine pattern forming performance is good or bad,” and “[t]he surface has small waviness and is smooth when RSm is large, and the surface has large waviness and is rough when RSm is small.” Id. at 3:1–3, 6:27–29. Dobashi also teaches that surface roughness Rzjis is used as a low-profile indicator. Ex. 1005, 2:66– 3:1. Dobashi, therefore, teaches that RSm is an indicator of surface waviness, which Dobashi explains is different than surface roughness. Id. at 2:66–3:3, 6:23–29. Given these teachings in Dobashi, neither Petitioner nor Dr. Josefowicz sufficiently explains how or why a POSITA would have been motivated to implement Dobashi’s RSm values to make Hanafusa’s surface roughness low-profile. See Pet. 10–12; Ex. 1003 ¶¶ 46–52.” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 11,346,014 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution deniedPTAB · Feb 22, 2024 · IPR2023-01325 · APJ Timothy G Majors · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 2, and 4–6 were unpatentable under any asserted obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For reasons discussed below, we do not institute review of claims 1, 4, and 4–6 of the ’033 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“concerning the ’834 patent, the intrinsic evidence is minimally helpful in revealing an affirmative meaning for the claims’ “spacing(s)” terms. IPR2023-01151, Paper 12, 39–41. The Specification does not use the term “spacings” in relation to the positioning of adjacent fibers; the drawings might be helpful, but neither party proposes a specific construction that is reliant on them. And, portions of the prosecution record are arguably confounding. For example, the applicant distinguished claimed “spacings” from “tightly knitted fibers.” Ex. 2140, 1001 (suggesting a more “loosely defined fiber structure” may be covered); see also Ex. 1002, 29–30 (asserting the claimed design has “a lesser [fiber] density construction” compared to Walther). This begs the question, at what point does a cloth of “tightly knitted fibers” convert to a cloth having a “loosely defined” fiber structure that would come within the scope of the claimed “spacings?” The record does not answer. Applicant’s suggestion during prosecution that the claimed spacings between fibers are “intentionally placed” about the frame and not simply “the spacing that may be inherent” in fibrous cloths is also unavailing on this record in clearly defining the metes and bounds of the term. Ex. 1002, 28–29. Whether the alleged absence of “objective boundaries” for the term “spacings” supports a conclusion that the claims are invalid as indefinite would be a question for the court. Paper 11, 5 (arguing There is insufficient technical detail available to determine whether the SAPIEN 3 Ultra does or does not include “spacings” as claimed and we take no position on whether such device infringes any claim of the ’033 patent. that a conclusion that the claims are indefinite is “outside the Board’s [IPR] jurisdiction”).12 Notwithstanding the lack of any express claim construction for the “spacings” term from either party, claim 1 of the ’033 patent requires something more than just “spacings.” Claim 1 requires “spacings extending through a thickness of the sealing assembly that allow fluid to pass therethrough when the prosthetic heart valve assembly is in an undeployed state.” Ex. 1001, 22:11–15 (emphasis added). In other words, the spacings must allow fluid to pass through the sealing assembly’s thickness when the valve is undeployed. For reasons discussed below, we are not persuaded on this record that Petitioner is reasonably likely to prevail in showing that this limitation is met—particularly the fluid-passing element—in the proposed combinations of Spenser or Levi with Spenser II.” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We, thus, find Dr. Brecker’s testimony more credible that “[i]t would, accordingly, be counterintuitive for a [POSA] to look to a device designed to occlude a blood vessel when designing a TAVR.” Id. ¶¶ 119–120 (testifying “[n]o [POSA] would look to this [occluder] design when considering a TAVR valve and . . . would further have concerns about the pro-thrombotic potential of the arrangement of fibers in Chuter”). Where a proposed combination would run counter to the primary reference’s stated purpose, the POSA would not generally be motivated to make that combination. Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1069–70 (Fed. Cir. 2018).” slip op. at 43
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for patent owner
“Grounds 1 and 2 is based on the combination of either Levi and Spenser II, or Spenser and Spenser II. Yet Petitioner purports to modify Spenser II’s compressible material, or supplant it with something else, based on “porous” fabrics allegedly known elsewhere in the art, which art is not identified in the Petition itself as part of any asserted combination. Pet. 49. To see what specific modifications or combinations Petitioner might be suggesting, requires we look to three paragraphs of Dr. Buller’s Declaration, cited but not discussed by Petitioner, where eight additional references are mentioned. Ex. 1003 ¶¶ 157–159 (identifying Exs. 1106–1112, and 1129). This format is an improper incorporation-by-reference of argument and evidence that, had Petitioner wanted to pursue some other combination of asserted art beyond Levi, Spenser, and Spenser II, needed to be set forth explicitly in the Petition. 37 C.F.R. § 42.6(a)(3). Moreover, it leaves the record unclear and forces Patent Owner, the Board, and the public to guess at what combination(s) are, in fact, being urged. We also find that Petitioner’s position reveals a hindsight bias insofar as it suggests, with the aim of arriving at the claimed subject matter, removing Spenser II’s “sufficiently dense” and fluid impermeable compressible material (Ex. 2128 ¶ 222) in favor of some other sufficiently “porous” and fluid permeable material. Hindsight is further evidenced because Spenser II’s cited material is already described as being compressible and adapted to allow coagulation and tissue ingrowth—factors cited by Patent Owner as allegedly motivating a change to some other material. Ex. 1011 ¶ 145. Altogether, we find unpersuasive Petitioner’s position based on unspecified combinations of unasserted prior art to achieve benefits that Spenser II’s existing compressible material already provides.” slip op. at 36
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,491,033 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122 - Guardant Health, Inc. v. University Of WashingtonInstitution deniedPTAB · Jan 13, 2023 · IPR2022-01159 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 6, 7, and 9–26 were obvious over Kinde and Craig.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In sum, Petitioner has not met its burden to sufficiently explain the reason to combine the teachings of Kinde and Craig. Thus, Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claim 1, as well as claims 6, 7, and 9–26, which depend from claim 1, would have been obvious over the combination of Kinde and Craig.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“adapter-DNA molecules.” Id. at 19. But, the Y-shaped adapters in Kinde are different from those in Craig: the former do not contain barcodes, whereas the latter do. Compare Ex. 1006, S9 (showing the adapters used in the endogenous method do not contain barcodes), with Ex. 1007, Supplementary Table 3 (showing adapters with barcodes). To the extent Petitioner argues that an ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig’s, that is insufficient for our analysis. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”). To answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe-SeqS approach, Petitioner contends that “Kinde cites Craig in discussing exogenous barcodes with DNA molecules.” Pet. 19; see also id. at 22–23 (“[C]iting to Craig, Kinde discusses methods including assigning exogenous barcodes to nucleic acid fragments.”). But, as Patent Owner points out, Kinde does not use Craig’s approach. Prelim. Resp. 1. Instead, immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Ex. 1006, 9531. Thus, Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 15; 2 Kinde et al., Detection and quantification of rare mutations with massively parallel sequencing, 108 PNAS 9530–35 (2011) (Ex. 1006, “Kinde”). Petitioner also submits, as part of Exhibit 1006, Supporting Information for Kinde. See Ex. 1006, S1–S10. 3 Craig et al., Identification of genetic variants using bar-coded multiplexed sequencing, 5 NATURE METHODS 887–93 (2008) (Ex. 1007, “Craig”). Petitioner also submits, as part of Exhibit 1007, supplementary figures and text associated with Craig. See Ex. 1007, 10–19. Prelim. Resp. 7. The parties nevertheless seek to provide context, or reiterate the plain meaning, of certain claim terms. Pet. 15–17; Prelim. Resp. 7–8. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term.” slip op. at 6
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,752,951 - Guardant Health, Inc. v. University Of Washington Through Its Center For CommercializationInstitution deniedPTAB · Nov 17, 2022 · IPR2022-00935 · APJ John G New · IPR · Institution
The Board denied institution on all grounds because the petition did not show a reasonable likelihood that claims 1–23 were unpatentable over the asserted obviousness combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response, and the evidence of record, we determine that the evidence presented does not demonstrate a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of the challenged claims of the ’631 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 17–18; Prelim. Resp. 5. Nor do we perceive, at this stage of the proceeding, a need to construe any claim term of the ’631 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); 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).” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“filing would typically have had an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field. Pet. 15 (citing Ex. 1002, ¶¶ 53–54). Alternatively, Petitioner proposes, a skilled artisan could have less education but significant professional experience in one or more of these fields. Id. Patent Owner does not contest Petitioner’s proposed definition of a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding and for purposes of our analysis in this Decision, we therefore adopt Petitioner’s proposed definition. We find that this definition is consistent with the level of skill in the art as reflected by the prior art. See, e.g., Exs. 1003, 1006, 1007, 1010, 1021; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig was insufficient for our analysis. IPR2022-00816, Paper 16 at 14 (citing Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (holding that “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”)). In the ’816 IPR, we further observed that, to answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe- SeqS approach, Petitioner contends that “Kinde identifies Craig in expressly discussing exogenous barcodes with DNA molecules.” IPR2022-00816, Paper 16 at 14 (citing Paper 3 at 22, 30). Again, Petitioner repeats the same argument in the present Petition. See Pet. 44; see also Ex. 1002 ¶ 42. But, as we observed in the ’816 proceeding, Kinde does not use Craig’s approach. IPR2022-00816, Paper 16 at 14. Instead, we found that immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Id. (quoting Ex. 1006, 9531). We therefore found that Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs. Id. The same reasoning applies equally here.” slip op. at 33
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,287,631 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCInstitution deniedPTAB · Sep 6, 2022 · IPR2022-00549 · APJ John G New · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–9, 11, and 12 were obvious over the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Having considered the Petition, the Preliminary Response, the Supplemental and Reply Briefs, and the evidence of record, we determine that the evidence presented fails to demonstrate a reasonable likelihood that” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. Pet. 30. Petitioner contends that such a skilled artisan would, when necessary, work as a member of a team in combination with a medical device engineer to experiment with, or manufacture, a prosthetic heart valve. Id. (citing Ex. 1003 ¶ 45). Patent Owner does not argue otherwise. See generally Prelim. Resp. Decision, we adopt Petitioner’s definition because we find that that definition is consistent with the level of skill reflected by the prior art. See generally, e.g., Exs. 1007, 1010, 1011, 1012; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). See 37 C.F.R. § 100(b) (2020). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). “In determining the evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). Extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)). Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 30; see generally Prelim. Resp. Nor do we perceive a need to construe any claim terms of the ’735 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); 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).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“Petitioner argues additionally that “POSITAs were motivated to routinely adjust the size and shape of outer cloths to maximize sealing while minimizing the profile of the valve.” Pet. 52. Even accepting that, however, does not provide an adequate motivation to modify Walther’s valve in a way that would result in the claimed valve. Petitioner has not shown, for example, that the small reduction possible in the outer cloth (which protruded below the native valve no more than 2 mm) would have meaningfully minimized the Walther’s valve profile. Accordingly, we determine that Petitioner has not adequately justified modifying Walther’s valve such that the apices extend proximally beyond the outer cloth. Having found that Walther, upon which Petitioner relies, neither teaches nor suggests the limitations at issue, we are consequently not persuaded that Petitioner has established a reasonable likelihood of success in prevailing at trial on Grounds 1 and 2.” slip op. at 19
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 11,129,735 - Neurocrine Biosciences, Inc. v. Spruce Bosciences, Inc.Institution deniedPTAB · Dec 10, 2021 · PGR2021-00088 · APJ John G New · PGR · Institution
The Board denied institution on all five grounds, finding the petition did not show any challenged claim was likely unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon consideration of the Petition, the Preliminary Response, and the evidence presently before us, we determine that Petitioner has failed to demonstrate that it is more likely than not that it would prevail in establishing the unpatentability of at least one challenged claim of the ’908 patent. We consequently deny institution of post-grant review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001 col. 42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“likely than not that independent claims 1 and 11 are anticipated by Grigoriadis. “For a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Therasense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010). The single clinical trial taught by Example 6 of Grigoriadis does not establish a baseline value for patients against which to compare the data obtained from patients receiving 300 mg or 600 mg of the test drug, NBI- 77860 (verucerfont). See Ex. 1006 ¶¶ 90–94. Specifically, Example 6 does not establish a baseline “which include[s] an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose,” as disclosed by the ’908 patent. See Ex. 1001, col. 42, ll. 12–16. We therefore conclude that Grigoriadis fails to disclose expressly the limitations of claims 1 and 11 severally reciting “wherein [the] … hormone … level in the human is reduced by at least 10 % from baseline.”” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“A reference may anticipate if a claim limitation that is not expressly disclosed is inherently disclosed because it “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908 - Medivators Inc. v. Arc Medical Design LimitedInstitution deniedPTAB · Sep 17, 2021 · IPR2021-00706 · APJ John G New · IPR · Institution
The Board denied institution on all grounds because Hitoshi teaches away from the claimed distal projection position, and Axon and Reydel do not overcome that teaching.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response, Petitioner’s Reply, and Patent Owner’s Sur-Reply, and the evidence of record, we determine that the evidence presented fails to demonstrate a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’103 patent.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away found
“In sum, Hitoshi teaches that the situation depicted in Figure 21, in which the fin-shaped projections are deflected so as to “point towards a distal end of the cover,” as recited in claim 1, is one to be avoided because “during a pulling operation the effect of the aforementioned endoscope insertion assistance tool 3 in pressing on the intestinal wall would be lost and, furthermore, even in the case of insertion by a pressing-in operation, ease of insertion would deteriorate, due to increase in diameter of the insertion portion.” Hitoshi ¶ 78. We conclude that a person of ordinary skill in the art would consequently be “discouraged from following the path set out in the reference.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). As such, we conclude that Hitoshi teaches away from the third position in which: [O]ne or more of the tips of the projecting elements of the distal ring point towards a distal end of the cover, and wherein, when coupled to the medical device shaft and in the third position, the one or more of the tips of the projecting element are sized and configured to extend distally further than the distal end of the cover and the distal end of the medical scoping device shaft, as recited in claim 1.” slip op. at 23
- Expert testimonyPetitioner expert discountedOther
“The testimony of Petitioner’s Declarant, Dr. East, fails to squarely address this teaching away by Hitoshi. Dr. East attests merely that “Hitoshi discloses an embodiment where the tips of the projecting elements extend distally further than the distal end of the endoscope cover in Figure 21, extending past projection 26” and that: A POSA would immediately envisage that the hood of Hitoshi is adapted for one or more of the tips of the projecting elements to be sized and configured to extend distally further than the distal end of the cover and endoscope given the Figures and disclosure. … A POSA viewing Figures 7 and 8 would understand that given the disclosed length and flexibility of the projecting elements 32 of the hood, as well as the teaching of positioning the projecting elements in any position along the endoscope cover, the device of Hitoshi could readily be adapted such that at least some of the projecting elements 32 of the distal ring extend further distally than the end of hood 31 and the distal end of the medical scoping device 21. East Decl. ¶¶ 182–183. Dr. East does not mention that Hitoshi teaches that the situation depicted in Figure 21, in which the fin-like projections are deflected to point distally, is a situation that Hitoshi expressly warns is to be avoided, and to which Hitoshi teaches preventative structural elements. See Hitoshi ¶ 80. Nor does Petitioner, or Dr. East, point to any teaching in Axon that would negate this teaching away in Hitoshi.” slip op. at 24
§ 103 obviousnesscites PhillipsPatents in suitUS 10,722,103
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.