- Guardant Health, Inc. v. University Of WashingtonNo claims unpatentablePTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand
On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.
RulingsRemand decision- RemandOther
“B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4
- BurdenNot shown unpatentable
“A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14
- Expert testimonyPatent owner expert creditedDecided for patent owner
“polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26
Patent outcomesUS 10,760,127 not shown unpatentable§ 103 obviousnessPatents in suitUS 10,760,127 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Manufacturing Resources International, Inc.All claims unpatentablePTAB · Sep 1, 2026 · IPR2023-00220 · APJ Jo-Anne M Kokoski · IPR · Final written decision
Claims 1–5, 7–13, and 16 are unpatentable as obvious over the asserted prior art; a separate ground was not reached because those claims were shown obvious on other grounds.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“had a bachelor’s degree in a pertinent discipline, such as mechanical engineering, physics, applied physics, product design, or a related field, and would also have had 2–4 years of experience working with electronic displays, including the thermal management, product design issues, and failure modes associated with such displays, or 5–7 years of experience in the field working with electronic displays and would have developed a similar understanding of thermal management, product design issues, and failure modes associated with electronic displays. Dec. 7–8. The parties’ positions have not changed from those we considered in the Institution Decision, and neither party argues that the outcome of this case would differ based on our adoption of a particular level of ordinary skill in the art. Thus, we apply the same definition in this Decision. Our determination regarding Petitioner’s challenge does not turn on the differences between Petitioner’s and Patent Owner’s proposed definitions, however, and we note that our conclusion would be the same under either definition.” slip op. at 8
- ExcludeMotion to exclude, deniedDenied
“new evidence filed by Patent Owner with its Sur-reply in contravention of 37 C.F.R. § 42.23(b). Paper 47, 1–5. We do not rely on either of these exhibits in rendering this Decision. Accordingly, we dismiss as moot Petitioner’s Motion to Strike.” slip op. at 73
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“that Patent Owner fails to adduce evidence showing how the claimed invention satisfied the alleged need for effective outdoor cooling. See Sjolund v. Musland, 847 F.2d 1573, 1582 (Fed. Cir. 1988) (holding that a proponent of objective evidence of long-felt need must show that “the claimed invention satisfied a long felt need”). Patent Owner states in conclusory fashion that “[d]espite the demand for outdoor displays, no one (including Samsung, despite having attempted to develop outdoor displays at least by 2005) was successful until Mr. Dunn conceived of his invention.” PO Resp. 75. Patent Owner cites no evidence for this proposition, so Patent Owner’s assertions regarding Mr. Dunn’s invention satisfying the alleged need are based on unsupported attorney argument. Accordingly, “we conclude that the nexus between the claimed invention and the purported long-felt, unmet need is too attenuated to provide a persuasive rationale for nonobviousness.” In re Karpf, 758 F. App’x 960, 965 (Fed. Cir. 2019).” slip op. at 64
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner
“objective indicia of nonobviousness (i.e., secondary considerations) may lead to a conclusion that the challenged claims would not have been obvious. See, e.g., Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983) (instructing that evidence of secondary considerations, when present, must always be considered in determining obviousness). Objective evidence of nonobviousness may include evidence of commercial success, licensing, copying, praise by others, long felt but unresolved need, and” slip op. at 58
Patent outcomesUS 9,173,322 unpatentable§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,173,322 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Manufacturing Resources International, Inc.All claims unpatentablePTAB · Aug 31, 2026 · IPR2023-00254 · APJ Jameson Lee · IPR · Final written decision
Claims 1–3, 5–9, 11–13, 15–18, and 20 are unpatentable as obvious over Karppanen and over Yare.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“art. This determination of the level of ordinary skill in the art is consistent with what is reflected by the content of the applied prior art references. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (the applied prior art may reflect an appropriate level of skill). Further, our obviousness conclusions would be no different even if Patent Owner’s articulation of the level of ordinary skill in the art is adopted. B.” slip op. at 15
- Expert testimonyPatent owner expert creditedDecided for patent owner
“Accordingly, we do not discount Mr. Smith-Gillespie’s testimony” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“1. “closed loop” The term “closed loop” is recited in each independent claim. Petitioner asserts that in the Delaware action , the district court construed “closed loop” as “gas pathway within a display housing containing gas that is essentially isolated from external air.” Pet. 11 (citing Ex. 1026, 1). Petitioner asserts that the district court’s construction is the proper construction, in light of the specification and the prosecution history of the ’740 patent. Id. at 11–12. Petitioner explains: The ’740 patent refers to the gas/air, circulating through a closed loop as the circulating gas/air and also as the “isolated gas.” (Ex. 1001, 9:64–10:3, 10:7–9, 10:56–58, 11:30–12:6 (claims reciting circulating gas/air), 3:30–[39], 3:50–52 (specification referring to gas in the closed loop as “circulating gas” and “isolated gas”), FIG. 1.) Moreover, as noted above, the Applicant distinguished the claims from the Thielemans prior art based on the argument that the closed loop must be separate from and in addition to the open loop. (Ex. [1031], pp. 44-45, 160 (Responses filed on 01/07/2019 and 08/15/2019).) The Court’s “closed loop” construction should apply here, though Applicant notes that this claim construction does not affect the applicability of the prior art in this Petition because the art teaches the separate loops. Id. at 12. Petitioner’s characterization of the prosecution history with respect to the Thielemans reference is inaccurate. Our review of the cited portions of the prosecution history reveals that the Applicants did not argue to the Examiner that the closed loop and the open loop must be isolated from each other and cannot mix. Rather, the Applicants argued that Thielemans discloses having an open loop or a closed loop, not both an open loop and a closed loop. Ex. 1031, 44–45, 160. The Applicants also argued that Thielemans’s closed loop is not “about” and is not “encircling” the electronic image assembly. Id. at 160. The cited prosecution history does not support Petitioner’s assertion. Patent Owner explains that the ITC in the related investigation” slip op. at 16
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). “[T]here must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Kahn, 441 F.3d at 988.” slip op. at 34
Patent outcomesUS 10,506,740 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,506,740 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Manufacturing Resources International, Inc.All claims unpatentablePTAB · Aug 31, 2026 · IPR2023-00221 · APJ Jameson Lee · IPR · Final written decision
Claims 1–15 are unpatentable as obvious over Karppanen and Larson; the Board found the evidence of obviousness outweighed the evidence of nonobviousness.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“art. This determination of the level of ordinary skill in the art is consistent with what is reflected by the content of the applied prior art references. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (the applied prior art may reflect an appropriate level of skill). Further, our obviousness conclusions would be no different even if Patent Owner’s articulation of the level of ordinary skill in the art is adopted. B.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“1. “closed loop” The term “closed loop” is recited in each independent claim.” slip op. at 16
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“for outdoor displays, no one (including Samsung, despite having begun attempting to develop outdoor displays at least by 2005) was successful until Mr. Dunn and Mr. Hubbard conceived of their invention.” PO Resp. 65. Patent Owner cites no evidence for this proposition. Thus, Patent Owner’s assertions regarding Mr. Dunn’s and Mr. Hubbard’s invention satisfying the alleged need are based on unsupported attorney argument. Accordingly, “we conclude that the nexus between the claimed invention and the purported long-felt, unmet need is too attenuated to provide a persuasive rationale for nonobviousness.” In re Karpf, 758 F. App’x 960, 965 (Fed. Cir. 2019).” slip op. at 62
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableObjective indicia outweighedUnpatentable
“and against obviousness, and weighed the evidence accordingly. The evidence of obviousness outweighs the evidence of nonobviousness. Petitioner has shown by a preponderance of the evidence that claim 1 would have been obvious over Karppanen and Larson.” slip op. at 74
Patent outcomesUS 11,013,142 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,013,142 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Manufacturing Resources International, Inc.All claims unpatentablePTAB · Aug 31, 2026 · IPR2023-00199 · APJ John A Hudalla · IPR · Final written decision
Claims 1, 4, 7, and 8 are unpatentable as obvious over Na and Kim (claim 1) and Na and Hong (claims 4, 7, and 8); other grounds were not reached.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Manufacturing Resources International, Inc. (“Patent Owner” or “MRI”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). Taking into account the arguments presented by Patent Owner in the preliminary record, we determined that the information presented in the Petition established that there was a reasonable likelihood that Petitioner would prevail with respect to its unpatentability challenges. Pursuant to 35 U.S.C. § 314, we instituted this proceeding on June 20, 2023, as to all challenged claims and all grounds of unpatentability presented in the Petition. Paper 9 (“Dec. on Inst.”).” slip op. at 2
- ExcludeMotion to exclude, deniedDenied
“Petitioner’s Motion to Strike Petitioner moves to strike Exhibits 2055, 2056, and 2058–2061 as being improper new evidence filed by Patent Owner with its Sur-reply in contravention of 37 C.F.R. § 42.23(b). Exclude Mot. 1–5. We have not relied on any of these exhibits in rendering this Decision. Accordingly, we dismiss as moot Petitioner’s Motion to Strike.” slip op. at 73
- Skill levelSkill level board ownDecided for patent owner
“record, we adopted the following definition of the level of ordinary skill in our Decision on Institution: [A] POSITA would have had a bachelor’s degree in a pertinent discipline, such as mechanical engineering, physics, applied physics, product design, or a related field, and would also have had 2–4 years of experience working with electronic displays, including the thermal management, product design issues, and failure modes, associated with such displays, or 5–7 years of experience in the field working with electronic displays and would have developed a similar understanding of thermal management, product design issues, and failure modes, associated with electronic displays. Dec. on Inst. 11. The parties’ positions have not changed since the time of institution, and we discern no reason to change the definition. Thus, we apply the same definition. We are satisfied that this definition comports with the level of skill necessary to understand and implement the teachings of the ’595 patent and the asserted prior art. Notwithstanding, we note that our analysis would not change if we adopted either party’s proposed definition in toto.” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“appear nowhere outside of the claims in the ’595 patent. This fact alone tends to undermine Patent Owner’s suggestion that the “posterior surface” must be distinct from the “rear side.” In addition, Patent Owner’s cited portions of the Specification merely refer to the “posterior surface” as being the surface opposite that on which the LEDs are mounted to which heat from the LEDs is transferred. See Ex. 1001, 4:53–55, 4:57–60. They are inconclusive as to whether the “posterior surface” must be distinct from the “rear side.” Further, Mr. Gershowitz’s testimony in support of a “distinct” construction is based on his interpretation of the words “on the” in claim 4’s recited “posterior surface on the rear side of the PCB.” Ex. 2006 ¶ 128. Specifically, he testifies that “[i]f the posterior surface was the rear side of the PCB, the claim would have said so.” Id. He does not cite any support in the Specification of the ’595 patent for his interpretation. See id. Given that his testimony amounts to speculation divorced from the context of the Specification, Mr. Gershowitz’s testimony is entitled to little weight. We also have considered Mr. Smith-Gillespie’s testimony in support of Petitioner’s contention that an ordinarily skilled artisan “would have understood that the rear outermost surface of the PCB is the recited ‘posterior surface.’” Pet. Reply 20 (citing Pet. 83; Ex. 1002 ¶ 243). He cites a passage in the Specification of the ’595 patent that states: “The PCB may comprise a metal core PCB and the posterior surface of the PCB may be metallic so that air within the constricted convection channel may cool the metallic posterior surface (and subsequently the backlight assembly) more easily and efficiently.” Ex. 1002 ¶ 243 (emphasis omitted) (quoting Ex. 1001, 4:60–65). We accord Mr. Smith-Gillespie’s testimony more weight than Mr. Gershowitz’s testimony given that Mr. Smith-Gillespie’s testimony is rooted in disclosures about metal core PCBs in the ’595 patent. It also gives some credence to the notion that the “posterior surface” and the “rear side” could be one and the same. Based on the record before us, we do not agree with Patent Owner that” slip op. at 19
Patent outcomesUS 8,854,595 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,854,595 - 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 - Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Adverse judgmentPTAB · Jun 3, 2026 · PGR2025-00086 · APJ Tawen Chang · PGR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment and terminated the PGR as to claims 1–34 after Patent Owner disclaimed all challenged claims.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding,” including by “[d]isclaimer of the involved application or patent” or “[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. §§ 42.73(b)(1)–(b)(2). Accordingly, we grant Patent Owner’s Request for Adverse Judgment and terminate the proceeding. slip op. at 2
NonePatents in suitUS 12,290,598 - Apple Inc. v. Smart Mobile Technologies LLCSome claims unpatentablePTAB · Jun 3, 2026 · IPR2022-00981 · APJ Jameson Lee · IPR · Remand
On remand, claims 8–11, 13, 17, and 19 were held unpatentable over Rautiola, Regnier, and Sainton; claim 15 was not shown unpatentable.
RulingsRemand decision- RemandMixed
“8–11, 13, 15, 17, and 19, and remanded “for consideration of the patentability of those claims.” Id. at 14. We understand both the reversal and vacature are with respect to Ground 1 of alleged unpatentability, not Ground 2, because the Federal Circuit’s decision did not discuss anything relating to Ground 2. Paper 43. The parties agreed. Paper 44. In this remand proceeding, neither party requested the filing of additional briefing or evidence. In a telephone conference call, both parties expressed agreement with the Board (1) that “there is no issue regarding collateral estoppel or issue preclusion with respect to dependent claims 8– 11, 13, 15, 17, and 19, and (2) that the remand proceeding would not involve the Board revisiting any matter or issue concerning alleged obviousness of claims 1, 8, 9, 11, 13, 17, and 19 over Ground 2.4 Papers 43, 44. The parties also agreed that the remand proceeding would only involve the Board reviewing the alleged obviousness of dependent claims 8–11, 13, 15, 17, and 19 as obvious over Rautiola, Regnier, and Sainton. Id. We have authority to conduct this inter partes review under 35 U.S.C. § 6. This Final Written Decision on Remand is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. On the record before us, which is the same as the record before us at the time we issued the first final written decision (Paper 34), we determine that Petitioner has proved by a preponderance of the evidence that claims 8– 11, 13, 17, and 19, but not claim 15, of the ’936 patent are unpatentable over Rautiola, Regnier, and Sainton.” slip op. at 3
- Expert testimonyPetitioner expert creditedDecided for patent owner
“5. Petitioner’s Request to Discredit Dr. Cooklev’s Declaration Petitioner makes several arguments discrediting Dr. Cooklev’s declaration (Ex. 2031) and asserts that Dr. Cooklev’s declaration should be accorded little to no weight. Reply 13–14. We have already considered and rejected this request in the Final Written Decision issued on November 7, 2023. Paper 34, 21–23. Our reasoning need not be reiterated here. Petitioner does not persuade us that Dr. Cooklev’s declaration testimony should be accorded little to no weight.” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not dispute Petition’s definition of level of ordinary skill. See generally PO Resp. Patent Owner’s expert, Dr. Cooklev, accepts Dr. Kotzin’s proposed level of ordinary skill in the art. Ex. 2031 ¶ 24. We adopt Petitioner’s proposal regarding the level of ordinary skill in the art. This level of ordinary skill in the art is supported by the testimony of Dr. Kotzin (Ex. 1003 ¶¶ 20–22) and is consistent with the level reflected in the ’936 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“only when it is analogous to the claimed invention.” Airbus S.A.S. v. Firepass Corp., 941 F.3d 1374, 1379 (Fed. Cir. 2019). A prior art reference constitutes analogous art if it is “from the same field of endeavor” or “reasonably pertinent to the particular problem with which the inventor is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). The petitioner bears the burden of establishing that a reference is analogous art. See Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1377 (Fed. Cir. 2023).” slip op. at 16
Patent outcomesUS 8,472,936 mixed§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,472,936 - PTAB · May 26, 2026 · IPR2025-00425 · APJ Kristina M Kalan · IPR · Remand
The Board denied institution of IPR2025-00425 because it instituted the earlier-considered IPR2025-00424 challenging the same patent.
RulingsRemand decision- RemandOther
“Request for Director Review. See Paper 35; IPR2025-00424, Paper 35. The request was denied without prejudice and the cases were remanded to the Board to “allow discovery, narrowly tailored to resolve the RPI and privity issues.” Paper 41, 4. Following such discovery, we were instructed to “then determine on the full record whether Petitioners have met their burden of demonstrating that the Petitions are not time-barred under § 315(b), applying the framework set forth in Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1242– 44 (Fed. Cir. 2018).” Id. A later-issued Order Supplementing Director Review Decision instructed that “if the Board determines that Petitioners met their burden to identify all RPIs in the Petitions, then the Board should maintain at most one IPR challenging” the ’225 patent. Paper 64, 3. Concurrently herewith, we issue a decision in IPR2025-00424 finding that Petitioner has met its burden of demonstrating that the Petition in that case is not time-barred under 35 U.S.C. § 315(b).” slip op. at 3
- Other 314aInstitution denied discretionary otherInstitution denied
“In connection with the ’225 patent, Petitioner filed two petitions requesting inter partes review: the petition in this proceeding (IPR2025- 00425), and the petition in IPR2025-00424. In this proceeding and in IPR2025-00424, Petitioner filed an Explanation regarding the necessity of multiple petitions. Paper 2; IPR2025-00424, Paper 2. Petitioner requested that, “if the Board uses its discretion to institute the Petitions, the Board consider the merits of IPR2025-00424 . . . before IPR2025-00425.” Paper 2,” slip op. at 2
Discretionary denialPatents in suitUS 10,589,225
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.