- Alliance Laundry Systems, LLC v. Payrange LLCSome claims unpatentablePTAB · Aug 19, 2026 · PGR2025-00028 · APJ George R Hoskins · PGR · Final written decision
Claims 1–6 and 8–20 are unpatentable under § 102, § 103, or § 101; claim 7 was not shown unpatentable because the asserted grounds did not establish its limitations.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“1. Legal Standards “Anticipation requires that every limitation of the claim in issue be” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMixed
“2016) (alteration in original) (quoting Kinetic Concepts, 688 F.3d at 1368). Further, an assertion of obviousness “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); accord In re NuVasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (stating that “conclusory statements” amount to an “insufficient articulation[] of motivation to combine”; “instead, the finding must be supported by a ‘reasoned explanation’” (quoting In re Lee, 277 F.3d 1338, 1342 (Fed. Cir. 2002))); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.”).” slip op. at 36
- Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionMixed
“because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108
- Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptMixed
“because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108
Patent outcomesUS 11,972,423 mixed§ 101 eligibility§ 102 anticipation§ 103 obviousnesscites Alice · Mayo · Bilski · Enfish · Electric Power · KSR · GrahamPatents in suitUS 11,972,423 - Tesla, Inc. v. Intellectual Ventures II LLCSome claims unpatentablePTAB · Aug 18, 2026 · IPR2025-00339 · APJ Kristen L Droesch · IPR · Final written decision
Claims 22, 23, 28, and 30 are unpatentable over Choi, Labaziewicz, and Yu; claims 1–3, 10–12, 24, 25, 32, and 33 were not shown unpatentable.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“We decline Patent Owner’s invitation to construe “during a frame” of “independently controlling simultaneous data acquisition with each of the first and second channels during a frame” by importing the extraneous limitations “at some point between the beginning and the end of the exposure interval during which the image sensors capture a single image.” As pointed out by Petitioner, Patent Owner’s proposed construction is unsupported by the language of claim 22 and the ’180 Specification because Specification does not disclose an exposure interval nor suggest “during a frame” is limited to an exposure interval. Patent Owner and its expert Dr. Saber cite only extrinsic evidence (Exs. 2006, 2009) to support its argument that claim 22 should be limited to an “exposure interval during which the image sensors capture a single image.” See PO Resp. 16–17; Ex. 2020 ¶ 64. Similarly, Patent Owner relies only on extrinsic evidence (e.g., Ex. 2011, 1; Ex. 2022, 1; Ex. 2020 ¶ 66) to limit “during” to “at some point between the beginning and the end.” See id. at 18. When considered in the context of claim 22 and the ’180 Patent Specification which do not limit “during a frame” to an exposure interval, we find that we cannot rely on Patent Owner’s citations to extrinsic evidence to yield a reliable construction for “during a frame.” As demonstrated in the analysis below, we need not provide an explicit construction for “during a frame” to resolve the parties’ disputes regarding the merits of the patentability challenges. See Realtime, 912 F.3d at 1375. We apply the ordinary and customary meaning for “during a frame.” To the extent that an explicit identification of the ordinary and customary meaning may aid the understanding of our analysis, consistent with the language of claim 22 and the ’180 Patent Specification, we find that the ordinary and customary meaning for “during a frame” is “during the period of time that data for an image frame is acquired.” See Ex. 1001, code (57), 20:6–24, 25:23–35.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field and 2-3 years of experience in digital imaging systems,” and that “[l]ess experience may be necessary with additional education, and likewise, less education may be necessary with additional work experience.” Pet. 6 (citing Ex. 1003 ¶¶ 16–19). Patent Owner does not dispute Petitioner’s definition. See generally PO Resp. We adopt Petitioner’s definition of a person of ordinary skill in the art because it is consistent with the level of skill reflected by the ’180 Patent Specification and the prior art of record.” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Owner to show that Labaziewicz is not prior art because the ’180 Patent is entitled to the earliest August 25, 2004, filing date of the ’854 Provisional Application. See Dynamic Drinkware, 800 F.3d at 1379–1380. For a claim in a later-filed application to be entitled to the filing date of an earlier application, the earlier application must provide written description support for the claimed subject matter. Anascape, Ltd. v. Nintendo of Am. Inc., 601 F.3d 1333, 1337 (Fed. Cir. 2010). To satisfy the written description requirement, “a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); see also VasCath v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991) (“[T]he applicant must . . . convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention . . . now claimed.” (emphasis omitted)), Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc) (“[I]t is the specification itself that must demonstrate possession.”). Patent Owner’s arguments fail to meet this burden of production because, aside from addressing deficiencies of written description support the ’854 Provisional Application provides written description support for all of the limitations of the claimed invention. See PO Resp. 60–64; PO Sur-reply 25–28. Specifically, Patent Owner does not address written description support in the ’854 Provisional Application for “independently controlling simultaneous data acquisition with each of the first and second channels during a frame”––limitation [22.3]––the heart of the parties’ claim construction disputes addressed above in Section II.A. See PO Resp. 60–64; PO Sur-reply 25–27. Accordingly, Patent Owner has not met its burden of production in coming forward with evidence or argument to show possession of the claimed invention in the ’854 Provisional Application. As a result, the burden of production does not shift back to Petitioner, and, therefore, the ’180 Patent is not entitled to the benefit of the August 25, 2004, filing date of the ’854 Provisional Application.” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Petitioner does not present arguments that it would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the teachings of Matsushima to acquire data for images 62A and 62B at the argues that Matsushima renders obvious this limitation. See id. at 21, 23, 30; PO Resp. 33–34 (“[T]he Petition provides no further explanation why Matsushima renders this limitation obvious.”). In the Reply for the first time, Petitioner asserts that “a POSITA would understand that Matsushima’s disclosure, including its multi-channel architecture, synchronous control of channels, and capturing two images that are scaled versions of the same scene, renders obvious simultaneous acquisition during a frame. Pet. Reply 13 (citing Ex. 1069 ¶ 49). We do not consider Petitioner’s belated argument because it exceeds the proper scope of a reply. A reply may only respond to arguments raised in the corresponding patent owner response. See 37 C.F.R. § 42.23. As explained in the Trial Practice Guide, “respond” “does not mean proceed in a new direction with a new approach as compared to the positions taken in a prior filing.” Trial Practice Guide at II.I. (December 2025)(citing 37 C.F.R. § 42.23).10 A reply that raises a new issue or belatedly presents evidence may not be considered. See id. For example, a “[p]etitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Id.” slip op. at 32
Patent outcomesUS 7,916,180 mixedClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 7,916,180 - Ipr2026-00338Institution deniedPTAB · Aug 13, 2026 · IPR2026-00338 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00338 after review of discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a), after review of discretionary and non- merits considerations, institution of inter partes review is denied in the following proceedings: IPR2026-00268* IPR2026-00338 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
- Other 314aInstitution denied discretionary otherInstitution denied
“NOTICE Pursuant to 35 U.S.C. § 314(a), after review of discretionary and non- merits considerations, institution of inter partes review is denied in the following proceedings: IPR2026-00268* IPR2026-00338 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
Discretionary denialPatents in suitUS 8,738,103 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - Pgr2026-00039Institution deniedPTAB · Aug 6, 2026 · PGR2026-00039 · APJ John A Squires · PGR · Director review
The Director denied institution of PGR2026-00039 after discretionary review; the opinion explaining the denial is forthcoming.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 12,168,036 - Pgr2026-00023Institution deniedPTAB · Aug 6, 2026 · PGR2026-00023 · APJ John A Squires · PGR · Director review
The Director denied institution of PGR2026-00023 after discretionary review; the accompanying notice states that opinions for the listed discretionary denials are forthcoming.
RulingsDirector review decision- Other 314aInstitution denied discretionary otherDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 12,370,716 - Ipr2026-00297Institution deniedPTAB · Aug 6, 2026 · IPR2026-00297 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00297 after review of discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
- Other 314aInstitution denied discretionary otherInstitution denied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 12,079,667 - Ipr2026-00295Institution deniedPTAB · Aug 6, 2026 · IPR2026-00295 · APJ John A Squires · IPR · Director review
The Director denied institution of IPR2026-00295 after review of discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
- Other 314aInstitution denied discretionary otherInstitution denied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 11,656,915 - Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthSome claims unpatentablePTAB · Aug 4, 2026 · IPR2025-00249 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1 and 4–8 are unpatentable: claims 1 and 4–6 as obvious over Huang2 and Kuo, and claims 7–8 as anticipated by Huang2; claims 2–3 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for patent owner
“(“POSITA”) “would be a Ph.D. student with a minimum of two years of experience in their faculty advisor’s laboratory” and would have an understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 20– 21 (citing Ex. 1003 § II.C7). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:28–29. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”). Importantly, the Specification does not treat the existence of minor peaks as prerequisites for the existence of major peaks. Indeed, the Specification does not discuss “minor peaks” at all. See generally Ex. 1001. Likewise, none of the claims of the ’227 patent, whether challenged or unchallenged, recites “minor peaks” or any additional peaks beyond the disputed “major peaks.” Id. at 23:30–24:42. Nor does the Specification include an example of FFT analysis results in which the average of the peaks therein is calculated and those higher than the average are identified as major peaks.8” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMixed
“Petitioner has the better position. Huang2 teaches crosslinking and provides a reason for doing so (stability). In particular, Huang2 states: “To better mimic skin ECM, electrospun collagen fibers have been fabricated, however, the rapid degradation and poor mechanical properties determine that either crosslinking or combination with other materials is necessary to obtain a stable scaffold.” Ex. 1005, 1791 (emphasis added). It is true that, in describing work actually carried out, Huang2 states that blending with PCL was performed and does not mention crosslinking. See id. at 1792 (“Nanofibrous matrices of PCL and Collagen at a weight ratio of 3:1 were fabricated using electrospinning as previously described.”). However, the prior art – here, Huang2 – is not limited to that which it describes having created. See In re Mills, 470 F.2d 649, 651 (C.C.P.A. 1972) (“a reference is not limited to the disclosure of specific working examples”); see also In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”); In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (“It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art.”). Huang2 teaches two stabilization methods when using collagen in scaffolds. Huang2 states that one or the other “is necessary to obtain a stable scaffold” (when using collagen), but it does not preclude or teach away from using Patent Owner-cited testimony of Dr. Mikos is not as definitive as Patent Owner suggests; Dr. Mikos’s testimony is that a person of ordinary skill in the art “typically would not have done both.” Ex. 2015 ¶64 (emphasis added). The bottom line is that Huang2 teaches the person of ordinary skill in the art two ways to stabilize scaffolds/matrices comprised of collagen, provides a reason for doing so (stability), and does not teach away from using both. We are persuaded that a “scaffold comprising crosslinked fibers comprising collagen” would have been obvious in view of the cited teachings of Huang2.” slip op. at 33
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We are not persuaded by Appellant’s citations to either reference. As discussed above, Petitioner’s Ground 1 is premised on a person of ordinary skill in the art altering the native flat sheet structure of Huang2 by rolling it into a jelly-roll structure as taught by Kuo. See Pet. 41 (Beginning its claim 2 arguments with the following: “Claim 1 is obvious for the reasons expressed above in § X.A., supra, which are incorporated herein.”); see also Pet. Reply 17 (“[B]ased on the explicit teaching of Kuo, a POSA would have been motivated to take the electrospun flat scaffold made by the techniques of Huang2, seed it with the desired cells, and roll it to treat a tendon and ligament.” (emphasis added)). Indeed, the paragraphs of Kuo that Petitioner cites for disclosing “scaffold sheets,” explicitly describe rolling them into jelly-roll like structures. See Ex. 1018 ¶7 (stating that “the sheet is spirally contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct”), ¶22 (describing a method comprising “forming a tissue construct by contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct” and implanting it in a patient). Petitioner fails to argue that that “one or more elongated sheets” recited in claim 2 would encompass the rolled structure of its proposed modification. Nor does Petitioner articulate a claim construction argument that could support such an argument. Petitioner has failed to prove, by a preponderance of the evidence, that claim 2 would have been obvious over Huang2 and Kuo.” slip op. at 42
Patent outcomesUS 11,318,227 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSRPatents in suitUS 11,318,227
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