- Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Mar 24, 2025 · IPR2024-01235 · APJ Hubert C Lorin · IPR · Institution
The Board instituted IPR of claims 1–3, 6–11, and 14–16 on all proposed grounds after finding a reasonable likelihood of prevailing on the §103 ground over Mañosa and Patel.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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), 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) (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). slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedPrinted publication not establishedMixed
“[T]here is no presumption in favor of institution or in favor of finding a reference to be a printed publication under § 42.108(c) or any other authority. . . . [T]he burden is on the petitioner to identify with particularity evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent, and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner
“May” expresses a possibility. The Specification reflects this interpretation of “may” when it states that “[i]n one embodiment, the organic material is not lyotropic. Thus, the organic material may not be a phospholipid.” Ex. 1001, 8:27–28 (emphasis added). One of ordinary skill would understand from this that the organic material “may not be” a phospholipid if the organic material is not lyotropic. It follows that if the organic material is lyotropic, then the organic material may be a phospholipid. Reading the statement “[t]he organic material may not be . . . a phospholipid” (id. at 8:59–63) in light of the earlier stated possibility that the organic material may be a phospholipid if the organic material is lyotropic, one of ordinary skill in the art would interpret “may not be” as excluding phospholipids under some conditions, not under all conditions. Taking the Specification’s discussion about phospholipids as exemplifying the permissive nature of the word “may,” we are unpersuaded that in stating that “[t]he organic material may not be [PMMA], a polyvinylidene difluoride-containing polymer, such as [PVDF] or PVDF- TrFE-CTFE, or a phospholipid, such as [DHPE]’” (Ex. 1001, 8:59–63), the specification “contains a clear and unmistakable disavowal of the compounds PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE” and “disclaims the listed compounds” from the “organic material” of the claims under all conditions, as Patent Owner argues. Prelim. Resp. 6–7. Moreover, the claims themselves limit the “organic material” only to the extent that it is “barocaloric cooling or heating agent” and can perform in the manner claimed. See Ex. 1001, claim 1, supra. As broadly worded, the claims do not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE per se from the group of organic materials employed by the claimed method. Adopting Patent Owner’s construction would impermissibly import a limitation (i.e., not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE) into the claims. For the reasons stated, at this stage of the proceeding, we agree with Petitioner’s broad construction of “organic material.” We do not adopt Patent Owner’s proposed construction whereby PMMA, PVDF, PVDF- TrFE-CTFE, and DHPE are excluded from the scope of the claim term “organic material.” The parties are invited to address this issue further during trial, if desired. slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner shows that (a) Mañosa (i.e., inorganic compounds such as Ni-Mn-In, Gd5Si2Ge2, and La-Fe-Co-Si) and (b) Patel (i.e., PVDF-TrFE- CTFE) teach materials exhibiting inverse BCEs. Pet. 59 (citing, inter alia, Ex. 1007, pages 4–8; Ex. 1009, 1, 4–5; Ex. 1004 ¶ 108). In our view, at this stage, Petitioner sufficiently shows (via the five reasons listed supra) why it would have been obvious to one of ordinary skill in the art to substitute the barocaloric cooling or heating agent of Patel for that taught in Mañosa, thereby reaching the claimed method with a reasonable expectation of success. Cf. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (U.S., 2007) (“The Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”)” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,230,656 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 13, 2024 · IPR2022-01600 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–20 are unpatentable as obvious: claims 1–7 and 9–20 over Olmos and Varela ’774, and claim 8 over Olmos, Varela ’774, and Oglaza.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention. Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”): would have had a bachelor’s degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields, and would have had further appreciation of various technical concepts in this field. Pet. 18 (citing Ex. 1002 ¶¶ 32–35). Patent Owner does not dispute Petitioner’s proposal. See Response 8. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 13
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“We credit Mr. Drewry’s testimony that it would have been well within the ordinary skill of a POSITA to make the proposed modifications. See Ex. 1002 (Drewry Decl.) ¶¶ 34, 56–71 (discussing the qualifications of a POSITA and the types of engineering concepts the POSITA would have understood); Ex. 1030 (Drewry Reply Decl.) ¶¶ 37, 48–56, 59–66. To the extent Mr. Culbert testifies otherwise, we do not find such testimony persuasive. Indeed, Olmos itself further supports Mr. Drewry’s testimony that a POSITA would have known how to modify dimensions to fit specific needs and make changes necessary to adapt features from one embodiment to fit another. See Ex. 1006 (Olmos) ¶¶ 153, 188 (providing a range of implant sizes and noting that “specific dimensions” of any disclosed 9 Patent Owner’s citation to Mr. Drewry’s deposition transcript at 87:13– 88:9 appears to be incorrect. We understand that the intended citation is 69:34–70:7. embodiment can be varied as is apparent to a POSITA and “all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein to form various combinations and sub-combinations”). Given the POSITA’s ability to make the proposed modifications, we do not find that Patent Owner’s evidence regarding the number of modifications required undermines Petitioner’s articulated reasoning for the combination.” slip op. at 35
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that “no terms require constructions differing from their plain and ordinary meaning.” Pet. 19. Patent Owner states that it “takes no position on Petitioner’s assertion because the Board need not construe any claim term to find that the Challenged Claims are not unpatentable.” Response 8. We find that for purposes of this Decision, we need not construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
Patent outcomesUS 10,973,649 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,973,649 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Apr 18, 2024 · IPR2022-01435 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–11 are unpatentable: Chung anticipates claim 10, and the Olmos-based obviousness grounds establish unpatentability of claims 1–11.
RulingsFinal written decision- Skill levelOther
“B. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 11
- Strike new argumentNew argument consideredDenied
“9 Patent Owner asserts that Petitioner’s Reply brief “presents copious new evidence and theories that exceed the scope of proper reply” and “[t]he Board should refuse to consider” it. Sur-reply 7–9. This generic objection to the entire Reply fails to provide adequate notice regarding which of Petitioner’s theories and arguments Patent Owner contends are allegedly new and improper. See, e.g., Rembrandt Diagnostics, LP v. Alere, Inc., 76 F.4th 1376, 1383 (Fed. Cir. 2023) (rejecting generic objection to alleged new theories in reply as failing to provide adequate notice of which theories are allegedly new). Accordingly, we reject Patent Owner’s request that we “refuse to consider” the entirety of the Reply. Where Patent Owner’s Sur-reply raises more particularized complaints regarding Petitioner’s allegedly improper new arguments, we address those complaints as appropriate below.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningOther
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, we find Petitioner has not shown that claim 1 is unpatentable as anticipated by Chung.” slip op. at 65
Patent outcomesUS 10,137,001 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,137,001 - Life Spine, Inc. v. Globus Medical, Inc.Some claims unpatentablePTAB · Mar 20, 2024 · IPR2022-01434 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1–9 and 15 are unpatentable over Chung and Olmos-based obviousness grounds; claims 10–14 were not shown unpatentable because the asserted references did not teach the claimed complementary relationship.
RulingsFinal written decision- Expert testimonyOther
“improperly incorporates-by-reference 12 pages of expert testimony via a single sentence.” PO Sur-reply 16 n.2 (citing Pet. Reply 17, which in turn cites Ex. 1026 (Hatch Decl.) ¶¶ 49–66). We find that many of the paragraphs within the cited range (i.e., Hatch Declaration paragraphs 49–66) appear to have a tenuous connection to the proposition for which Petitioner cites these paragraphs. See Pet. Reply 17. That said, we find that paragraphs 53–55 directly relate to Petitioner’s proposition in the Reply, i.e., that “Petitioner’s experts explain why a [person of ordinary skill in the art] would rely on a cross-sectional view over a perspective view for making the determination in question, because only the cross-sections provide the needed side view directly orthogonal to the positions of the yellow expansion portion and the end of the dovetail.” Id. Accordingly, we find that paragraphs 53–55—the only paragraphs we cite from Petitioner’s range in reaching our conclusion—are not improperly incorporated by reference into Petitioner’s Reply.” slip op. at 66
- Strike new argumentNew argument consideredDenied
“provide Petitioner an opportunity to respond under the new construction, and decline to strike Petitioner’s relevant argument and evidence. Cf. Axonics, 75 F.4th at 1383 (“[W]hen the Board adopts a new claim construction following institution, an IPR petitioner must have adequate notice and an opportunity to respond under the new construction.”). Like in Axonics, in its new arguments on Reply, Petitioner here relies on the same embodiment from the same prior art reference that it relies on in the Petition to support the same legal argument, i.e., that Olmos’s Figure 16 embodiment discloses the “complementary with one another” limitation of challenged claims 10– 14. See Axonics, 75 F.4th at 1384; see also Apple Inc. v. Andrea Elecs. Corp., 949 F.3d 697, 706 (Fed. Cir. 2020) (permitting petitioner to elaborate in reply on an unpatentability theory presented in the petition). Moreover, we permitted Patent Owner to file (and it indeed did file) a sur-reply brief and expert declaration that addressed Petitioner’s new obviousness theories. Accordingly, both parties had adequate notice of our preliminary construction and an opportunity to respond under that new construction. For these reasons, we deny Patent Owner’s motion to strike.” slip op. at 124
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“from the expansion portion. We agree with Patent Owner that the wording of this limitation as a whole requires that the “extension necessarily must protrude beyond a longitudinal end of the expansion portion.” Id. at 11. We also agree with Patent Owner that “[u]nder Petitioner’s tenuous theory, an extension in any direction except 90 or 180 degrees would satisfy the claim language since any such direction has a so-called ‘longitudinal component.’” Id. at 13. For these reasons, we disagree with Petitioner’s argument that the purported “longitudinal component” of Chung’s extension satisfies limitation 1[h].” slip op. at 55
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“would have been motivated to add an extension to the Figure 16 embodiment because “an integrally-formed extension advantageously requires fewer parts, which facilitates both manufacturing and use.” Pet. 118. We agree with Patent Owner that this argument is unavailing. PO Resp. 50. Petitioner’s combination entails adding an extension (from Figure 8) to an embodiment lacking one (Figure 16). We agree with Patent Owner that adding a new component (whether separately or integrally) can in some instances complicate manufacturing/assembly and increase costs. See id. (citing Ex. 2013 (Culbert Decl.) ¶ 115). Petitioner has not sufficiently demonstrated that the proposed combination in this instance would reduce complexity or facilitate the manufacturing process. Accordingly, we do not rely on this argument offered by Petitioner.” slip op. at 106
Patent outcomesUS 8,845,731 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,845,731 - Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentablePTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision
The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedOther
“It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. 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 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction We construe claims 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. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner
“Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16
Patent outcomesUS 10,561,659 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,561,659 - Intuitive Surgical, Inc. v. Ethicon LLCSome claims unpatentablePTAB · Jan 13, 2020 · IPR2018-01254 · APJ Matthew S Meyers · IPR · Final written decision
Claims 1–10 are unpatentable under § 103; claims 11 and 24 were not shown unpatentable because the proposed combinations did not adequately establish the articulation limitations.
RulingsFinal written decision- BurdenOther
“of proving unpatentability of the challenged claims, and the burden of persuasion never shifts to Patent Owner. To prevail, Petitioner must prove 1 Our decision does not rely on any information deemed confidential by the parties. unpatentability by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d) (2017). This decision is a Final Written Decision under 35 U.S.C. § 318(a) as to the patentability of claims 1–11 and 24 of the ’969 patent. For the reasons discussed below, we hold that Petitioner has demonstrated by a preponderance of the evidence that claims 1–10 of the ’969 patent are unpatentable under § 103(a). We also hold that Petitioner has not demonstrated by a preponderance of the evidence that claims 11 and 24 of the ’969 patent are unpatentable under § 103(a).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not appear to dispute Petitioner’s definition of one of ordinary skill in the art. See generally PO Resp. Neither party argues that the outcome of this case would differ based on our adoption of any particular definition of one of ordinary skill in the art. In light of the record now before us, we adopt Petitioner’s definition of one of ordinary skill in the art. The level of ordinary skill in the art is also reflected by the references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.’”); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (finding that the Board of Patent Appeals and Interferences did not err in concluding that the level of ordinary skill in the art was best determined by the references of record).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“(Fed. Cir. 1993). Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes review). Here, neither Petitioner nor Patent Owner identifies terms for construction or provides any proposed constructions. Pet. 12; PO Resp. 10; see generally Pet. Reply; Prelim. Resp. 11. Instead, the parties agree that claims of the ’969 patent should be construed according to their broadest reasonable interpretation. Pet. 12; PO Resp. 10. We determine that no claim term needs express interpretation. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Patent Owner asserts that Petitioner’s expert, Dr. Knodel, “admitted that the tool base shown in Wallace’s figures is not designed to drive an endocutter that clamps and fires.” PO Resp. 36–37 (citing Ex. 2011, 24:20– 23). This admission deserves little weight, however, given that Wallace expressly discloses that “any suitable end effector 66 may be used” in its robotic surgery system depending on the surgical need, including clamps and staplers. Ex. 1008, 7:50–56; see also id. at 2:18–21 (“As used herein, the term ‘end effector’ means the actual working part of the surgical instrument and can include clamps, graspers, scissors, staplers, and needle holders, for example.”); Pet. Reply 18–20; see Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (Obviousness “cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.”).” slip op. at 33
Patent outcomesUS 8,479,969 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,479,969 - Dexcom, Inc. v. Waveform Technologies, Inc.Some claims unpatentablePTAB · Sep 12, 2018 · IPR2017-01051 · APJ Elizabeth M Roesel · IPR · Final written decision
Claims 1, 4–12, and 15–19 were held unpatentable as obvious over Hagiwara; claims 2, 3, 13, and 14 were not shown unpatentable. The motion to amend was granted in part.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“j. Conclusion Regarding Obviousness Based on Hagiwara (Proposed Substitute Claims) We conclude that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 20, 22, 23, and 26–29 are unpatentable as obvious in view of Hagiwara. We conclude that Petitioner has not shown by a preponderance of the evidence that proposed substitute claims 21, 24 and 25 are unpatentable as obvious in view of Hagiwara. 2. Remaining Grounds of Unpatentability Asserted by Petitioner (Proposed Substitute Claims) In view of our determination that Petitioner has shown by a preponderance of the evidence that proposed substitute claims 20, 22, 23, and 26–29 are unpatentable as obvious in view of Hagiwara, we do not reach Petitioner’s remaining grounds of unpatentability as to these claims. Regarding proposed substitute claims 24 and 25, Petitioner’s contentions regarding the Handbook, Wilson, and Say do not remedy the deficiencies in Petitioner’s contentions regarding Hagiwara, as discussed above. Accordingly, we conclude that a preponderance of the evidence does not show that proposed substitute claims 24 and 25 are unpatentable as obvious based on Hagiwara in view of the Handbook, Wilson, or Say. H.” slip op. at 71
- ExcludeOther
“As discussed above, we do not reach the Wilson-Based Grounds with respect to claims 1, 4–12, and 15–19 of the ’574 patent. As for claims 2, 3, 13, and 14, we determine that Petitioner has not shown unpatentability based on the Wilson-Based Grounds, even if Exhibit 1037 and the corresponding portions of Petitioner’s Reply (Paper 37) are not excluded, because Petitioner does not offer Exhibit 1037 to cure the deficiency we noted in Wilson. See Section II.F, supra. For this reason, we dismiss as moot Patent Owner’s motion.” slip op. at 72
- Expert testimonyPetitioner expert discountedPatent owner expert discountedDecided for patent owner
“sensor would not have been a motivation to combine Hagiwara’s embodiments” because Hagiwara’s catheter prevents damage to the sensor during insertion and because a sensor with a side sensor window creates a greater risk of damage and vascular injury and reduces exposure to blood, as compared with a sensor with an end sensor window. PO Resp. 20–25. We have considered Patent Owner’s arguments, but, for the reasons discussed above, we are persuaded that Petitioner has established a motivation to combine, notwithstanding the conflicting expert testimony regarding the disadvantages of a side sensor window versus an end sensor window. Neither of the expert opinions on this topic is supported by objective facts or data. Ex. 1006 ¶ 155;13 Ex. 2008 ¶¶ 54–57, 87–95; Ex. 2009, 92:8–97:12. For this reason, we give little or no weight to either side’s expert testimony 13 Dr. Vachon cites “WO 01/13102, Vadgama” (Ex. 1006 ¶ 155), however, this reference was not submitted as an exhibit in this proceeding. on this topic. 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (nothing in the Federal Rules of Evidence or Federal Circuit jurisprudence requires the fact finder to credit unsupported assertions of an expert witness). As discussed above, however, there is no disagreement that a side sensor window was a known alternative to an end sensor window. Ex. 1006 ¶¶ 73, 155; Tr. 43:22–44:3. That undisputed fact, together with Petitioner’s other evidence, is sufficient to establish a motivation to combine.” slip op. at 42
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art For purposes of our Institution Decision, we accepted the definition of a person of ordinary skill in the art (“POSITA”) provided by Petitioner’s declarant, Dr. Vachon. Dec. 11 (citing Ex. 1006 ¶ 28). That definition is: a person having a bachelor’s degree or the equivalent training or experience in mechanical engineering, bioengineering, or related field and at least three years of experience relating to biosensor research and development, or a master’s degree or the equivalent training or experience in mechanical engineering, bioengineering, or related field, and at least one year of experience relating to biosensor research and development. Id. Patent (https://www.uspto.gov/sites/default/files/documents/guidance_on_motions_ to_amend_11_2017.pdf); Bosch Automotive Service Solutions, LLC v. Matal, 878 F.3d 1027 (Fed. Cir. 2017); Bosch Automotive Service Solutions, LLC v. Iancu, Order on Petition for Panel Rehearing, No. 2015-1928 (Fed. Cir. Mar. 15, 2018). Owner’s declarant accepts and applies this definition of a POSITA for purposes of his opinions. Ex. 2008 ¶ 30. Neither party’s declarant indicates that any proffered opinion would change depending on the level of ordinary skill in the art. Therefore, consistent with our Institution Decision, we adopt Dr. Vachon’s definition of a POSITA. Ex. 1006 ¶ 28. We also rely on the cited prior art references as reflecting the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 20
Patent outcomesUS 7,529,574 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,529,574 - Zhongshan Broad-Ocean Motor Co. Ltd. v. Nidec Motor CorporationSome claims unpatentablePTAB · Jun 22, 2016 · IPR2015-00465 · APJ James A Tartal · IPR · Final written decision
Claims 1, 3, 7, and 18 are unpatentable as anticipated by Mullin and Pant; claim 2 was not shown unpatentable, and the motion to amend was denied.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“the ‘first sensing circuit’ and the ‘second sensing circuit’ sense power simultaneously,” and further argues “[n]or does Patent Owner present any argument with reference to, e.g., the 459 Patent specification or prosecution history as to why this additional limitation should be read into this claim.” Pet. Reply 23. Petitioner’s reply, however, fails to recognize that Petitioner bears the burden of demonstrating that Mullin anticipates the claim, including providing sufficient evidence and argument in support of its proposed claim interpretation. The Petition fails to provide a sufficient explanation to support that “when both” should be construed in the manner asserted by Petitioner, particularly when the more natural reading of the claim language conveys that two sensing circuits sense power at the same time. Although Petitioner provided a second declaration from Mr. McAlexander in reply to Patent Owner’s response, neither that declaration nor Mr. McAlexander’s first declaration provides sufficient support for how claim 2 would have been understood by a person of ordinary skill to show that it is anticipated by Mullin. See Exs. 1007 and 1011. Because Petitioner failed to persuasively prove that claim 2 requires only that one of two sensors senses power for the motor controller to determine that power is applied to the second input, Petitioner has not shown by a preponderance of the evidence that claim 2 of the ’459 patent is anticipated by Mullin.” slip op. at 14
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“Mot. 15. Patent Owner’s attorney argument, which cites no evidence, does not support the contention that the proposed amended claim would not have been obvious to a person of ordinary skill in the art. Nonobviousness cannot be established by attacking the references individually when unpatentability is predicated upon a combination of prior art disclosures. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Even if each prior art reference is “missing at least two of the required limitations,” that has limited bearing on whether a combination of those references renders the claim obvious. Similarly, Patent Owner provides insufficient support for its implicit argument that one would not combine the references because, individually, they provide a “complete solution” to the problem they intend to address. Where “a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Thus, Patent Owner’s suggestion that there “is no reason one of skill would engage in mixing and matching,” fails to adequately address whether the combination would have been obvious. See Mot. 15.” slip op. at 28
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“We agree with Petitioner that, for Mullin to anticipate claim 1, Mullin need not disclose power sensed at COM. See Pet. Reply 19–22. The claim language does not require power to be sensed at any specific location, only that one sensing circuit senses “power applied to” the first and second inputs, and the other senses “power applied to” the second and third inputs. Patent Owner does not direct us to any persuasive disclosure in the ’459 patent to support its contention that claim 1 requires that power be sensed at the second input. See PO Resp. 21–26. Similarly, although Dr. Horenstein states that “the Mullin circuit is incapable of providing unique information that power has been connected to COM,” a point not in dispute, Dr. Horenstein provides only conclusory assertions and no persuasive explanation for why claim 1 would be understood to require such “unique information” for the second input. See Ex. 2001 ¶¶ 56, 63. Moreover, in Mullin, when a sensor detects power at either P2 or P3, power is necessarily applied to COM (neutral) to complete the circuit, even if the sensor does not directly detect power at COM. As Dr. Horenstein explained, “at least two inputs from the source of AC power – generally line and neutral – would have to be connected in order to complete the circuit and enable the flow of power to the motor.” Ex. 2001 ¶ 53. Mr. McAlexander similarly explained that by the very nature of alternating current, “the flow of electric charge periodically reverses direction.” Ex. 1011 ¶ 12. Thus, when alternating current is applied to Mullin’s input P2 and COM it will “be input from the input P2 and return by way of the COM, and at other times it will be input from the COM and return by way of the input P2.” Id. ¶ 13. The same is true of P3 and COM. See id. As shown by Petitioner, Dr. Horenstein confirmed during cross-examination that, when AC power, as referred to in Mullin, is applied to the power input P2 and common input COM as shown above, the opto-isolator ISO1 senses this power and outputs a corresponding signal, [and] when Mullin’s AC power is applied to the power input P3 and common input COM as shown above, the opto-isolator ISO2 senses this power and outputs a corresponding signal. Pet. Reply 22; see also Ex. 1010, 68:24–69:19. Accordingly, the testimony of Mr. McAlexander and Dr. Horenstein supports our determination that Mullin discloses a first sensing circuits that “senses power applied to the first and second inputs” and a second sensing circuit that “senses power applied to the second and third inputs,” as well as a motor controller that is “operable for determining that power is applied to the first input when the first sensing circuit senses power,” as required by claim 1.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Ex. 2001 ¶¶ 104–105. Thus, Dr. Horenstein contends there is a lack of a motivation to combine the references because opto-couplers are simpler and require fewer parts than the current based sensor of Nordby. In KSR, the Supreme Court rejected the Federal Circuit’s rigid application of its “teaching, suggestion, motivation” test in favor of an expansive and flexible approach. 550 U.S. at 415. The Supreme Court noted that often, it will be necessary: to look to interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue. Id. at 418. Moreover, the Federal Circuit has explained that: an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the “improvement” is technology-independent and the combination of references results in a product or process that is more desirable for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal – and even common-sensical – we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references. Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006). In this case, Patent Owner’s contention that there is no motivation to substitute one sensor for another is not supported by anything beyond conclusory statements. Moreover, contrary to the assertion that voltage and current sensors are “not substitutable,” Nordby expressly states that “[v]oltage (potential) sensing may be used, or alternately, current (flow) sensing may be used. Since the sensing scheme is used only to detect the presence or absence of voltage or current on the sensed line and does not require any significant accuracy, the cost of either type of sense circuitry can be made very low.” Ex. 1004, 4:43–48. In light of the evidence that current and voltage sensors were known to be interchangeable, Patent Owner’s contention that there was “no reason one of skill would have sought to replace those voltage based opto-isolator systems with the bulky current transformer and attendant circuitry of Nordby,” is insufficient to demonstrate the combination of references was not obvious. See Mot. 16.” slip op. at 30
Patent outcomesUS 8,049,459 mixed§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,049,459 - Boston Scientific Corporation v. Uab Research FoundationRehearing grantedPTAB · Mar 7, 2016 · IPR2015-00918 · APJ James A Worth · IPR · Rehearing
Rehearing was granted, and IPR was instituted on anticipation of claims 1–20 by KenKnight ’967; no other grounds were instituted.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“II. STANDARD OF REVIEW Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). The request must identify, specifically, all matters the party believes the Board misapprehended or overlooked. 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“background art in which two other patents described “pacing or pretreatment pulses” delivered through the same electrodes as defibrillation. Id. (citing Ex. 1002, 7). We recognize that Patent Owner has not yet had an opportunity to introduce testimonial evidence as to whether a person of ordinary skill would understand the ’261 Application to disclose the use of pacing (in addition to pretreatment pulses) through an electrode with the claimed positioning. At this stage of the proceeding, we determine that Petitioner has shown a reasonable likelihood of prevailing on its assertion that the patentee was not in possession of the claimed configuration of electrodes at the time of the filing of the ’261 Application. As such, Petitioner has demonstrated a reasonable likelihood of prevailing on its related assertion that the claims of the ’563 patent cannot benefit from the priority from the ’261 Application. Thus, Petitioner has demonstrated a reasonable likelihood of prevailing on its assertion that KenKnight ’967 is prior art to the ’563 patent.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“Application (from .01 or .05 to 1 or 2 Joules) is greater than the value of a typical pacing pulse (0.000025 Joules). See Pet. 12; Ex. 1006 ¶¶ 132–133; compare Ex. 1002, 12:29–31, with Ex. 1006 ¶ 66). We credit Dr. Benditt’s testimony that the smallest disclosed energy for the auxiliary pulse in the ’261 Application is about ten thousand times stronger than a pacing pulse, and a person of ordinary skill in the art would understand that such a pulse does not correspond to a pacing pulse. Id. Based on this difference, and based on our claim construction, we conclude that Petitioner has established a reasonable likelihood that the “auxiliary” pulses disclosed in the ’261 Application are not antitachycardia pacing energies, and do not otherwise qualify as antitachycardia pacing. Patent Owner, nevertheless, asserts that the ’261 Application states the intent to treat ventricular tachycardia (see supra), i.e., “[t]he present invention may be used to treat all forms of cardiac tachyarrythmias, including ventricular fibrillation, with defibrillation (including cardioversion) shocks or pulses.” See Opposition 3 (quoting Ex. 1002, 7:4– 9). However, the intent to treat ventricular tachycardia by itself is not enough because the claims require antitachycardia pacing as the treatment for tachycardia. In this regard, Petitioner correctly observes that the disclosure of the ’261 Application describes in large part defibrillation in combination with cardioversion shocks, including in the above passage relied on by Patent Owner. In other words, the above passage discloses defibrillation and cardioversion but does not necessarily include pacing.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“D. Anticipation by KenKnight ’967 1. Claims 1, 3–7, 9–14, and 16–20 Relying on the Declaration of Dr. Benditt, Petitioner sets forth argument and evidence as to how KenKnight ’967 would anticipate each element of claims 1, 3–7, 9–14, and 16–20. Pet. 25–48. Patent Owner does not appear to dispute in its Preliminary Response that KenKnight ’967, if prior art, would anticipate claims 1, 3–7, 9–14, and 16–20. As above, we determine that there is a reasonable likelihood that KenKnight ’967 is prior art to the ’563 patent. Further, based on our own independent review of KenKnight ’967, we determine that Petitioner has shown a reasonable likelihood of prevailing on its assertion that KenKnight ’967 would anticipate claims 1, 3–7, 9–14, and 16–20.4” slip op. at 11
Claim construction§ 102 anticipationcites PhillipsPatents in suitUS 6,266,563
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.