- Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentablePTAB · Feb 5, 2026 · IPR2024-01330 · APJ Ryan H Flax · IPR · Final written decision
Claims 3, 4, and 12–19 are unpatentable as obvious under each asserted ground.
RulingsFinal written decision- Skill levelOther
- Expert testimonyOther
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“embody claims of the ’746 patent, the product has features not covered by the ’746 patent’s claims, some of which are critical unclaimed elements according to Patent Owner. Accordingly, Cologuard is not coextensive with the challenged claims, and no nexus between the product and the challenged claims is shown on this record.” slip op. at 35
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“developed where the patient need not manipulate their fecal sample to portion it, but the law of obviousness does not require an option to be the best option to be obvious. For these reasons, bearing in mind that the ultimate burden here is always on Petitioner, we are not persuaded by Patent Owner’s argument. We also reject Patent Owner’s argument that only impermissible” slip op. at 60
Patent outcomesUS 11,970,746 unpatentable§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,970,746 - Petitioner v. Intent Iq, LLCAll claims unpatentablePTAB · Oct 14, 2025 · IPR2025-00129 · APJ Scott B Howard · IPR · Final written decision
Claims 1–152 are unpatentable over the asserted prior-art grounds; the Board also struck Section II of Petitioner’s reply claim-construction brief.
Nonecites Phillips · KSR · GrahamPatents in suitUS 7,861,260 - Viant Techology LLC v. Intent Iq, LLCAll claims unpatentablePTAB · Oct 14, 2025 · IPR2024-00422 · APJ Scott B Howard · IPR · Final written decision
The Board held claims 1–152 unpatentable based on the asserted obviousness grounds and struck Section II of Petitioner’s reply claim-construction brief.
RulingsFinal written decision- BurdenFwd all claims unpatentableUnpatentable
“Decision issues pursuant to 35 U.S.C. § 318(a). For the reasons that follow, we determine that Petitioner has shown by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14
- Strike new argumentGranted
“FURTHER ORDERED that Section II of Petitioner’s Reply Claim Construction Brief is stricken from the record; and” slip op. at 80
Patent outcomesUS 7,861,260 unpatentableClaim constructioncites Phillips · KSR · GrahamPatents in suitUS 7,861,260 - Viant Technology, Inc. v. Intent Iq, LLCAll claims unpatentablePTAB · Oct 14, 2025 · IPR2025-00128 · APJ Scott B Howard · IPR · Final written decision
The Board held claims 1–152 unpatentable based on obviousness grounds and struck Section II of Petitioner’s Reply Claim Construction Brief.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a preponderance of the evidence that the subject matter of claim 1 would have been obvious over Baig, Costa, and Zwicky. 5. Analysis of Claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137– 145, 147, 148, 151, and 152 Petitioner argues that the combination of Baig, Costa, and Zwicky teaches the limitations recited in claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137–145, 147, 148, 151, and 152 and that a person having ordinary skill in the art would have combined the teachings with a reasonable expectation of success. Pet. 28–60; 422Pet. 29–51. Petitioner’s arguments are supported by citations to the prior art and the testimony of Mr. Lett. See Pet. 28–60; 422Pet. 29–51. We have reviewed Petitioner’s arguments and evidence, agree with them, and, therefore, adopt Petitioner’s arguments and evidence as our own. Patent Owner does not separately address those claims. See PO Resp.; 422PO Resp. Instead, Patent Owner only relies on the arguments discussed above for claim 1. See PO Resp. 13–16; 422PO Resp. 13–16. For the same reason as discussed above in Section II.D.4(b), we do not agree with Patent Owner’s arguments regarding the reason to combine the references. Accordingly, Petitioner has shown by a preponderance of the evidence” slip op. at 50
- Strike new argumentNew argument disregardedGranted
“F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74
Patent outcomesUS 7,861,260 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,861,260 - Viant Techology LLC v. Intent Iq, LLCAll claims unpatentablePTAB · Oct 14, 2025 · IPR2024-00421 · APJ Scott B Howard · IPR · Final written decision
The Board held claims 1–152 unpatentable over the asserted prior art and struck Section II of Petitioner’s reply claim construction brief.
RulingsFinal written decision- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a” slip op. at 50
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14
- Strike new argumentGranted
“F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74
Patent outcomesUS 7,861,260 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,861,260 - Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentablePTAB · Jul 9, 2025 · IPR2024-00459 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–20 are unpatentable as obvious under § 103 over each of the six asserted grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Here, as in our Institution Decision, we do not discern a significant difference between the parties’ respective proposed definitions beyond the number of years of experience after obtaining a doctoral degree. Compare Pet. 12, with Prelim. Resp. 47, and Resp. 19–20; see also DI 7–8. Under either proposed definition, the ordinarily skilled artisan would have been very highly skilled and educated. For purposes of this Final Decision, we maintain that Patent Owner’s definition appears to be reasonable (and it falls between Petitioner’s two definitions asserted in the reexamination request and in the Petition). Further, Patent Owner’s proposed definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent itself, for example, Vilkin’s authors are a group of medical doctors and an editor of the journal is a PhD, Joost Louwagie, the named inventor of the ’781 patent, holds a PhD in Biochemistry, and the authors of Itzkowitz are medical doctors and PhDs. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)); see Ex. 1005, 3 (list of authors); Ex. 1016 (Dr. Louwagie profile); Ex. 1055; see also generally Reply (Petitioner did not contest our similar determination at Institution). Therefore, we adopt and use Patent Owner’s definition of the ordinarily skilled artisan, set forth above. C.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no claim construction is necessary in this proceeding. See generally Pet. Similarly, Patent Owner states that it “does not believe that claim construction is necessary to resolve patentability” in this proceeding. Resp. 21. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We agree with the parties that no construction of any claim term is necessary for purposes of our Final Decision. D.” slip op. at 14
- Expert testimonyOther
“Pet. 12. In support of these grounds for unpatentability, Petitioner relies on, inter alia, the 1st and 2nd Declarations of Duncan Whitney, PhD. Ex. 1002; Ex. 1080. In support of its positions, Patent Owner relies on, inter alia, the 1st and 2nd Declarations of Vadim Backman, PhD, and the Declaration of Peter Wood. Ex. 2001; Ex. 2022; Ex. 2023.” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“We have no reasonable doubt that aspects of the Cologuard product practice the invention of the ’781 patent’s claims 1 and 3, which are most generally directed to steps of collecting two portions of a fecal sample at home, and combining a respective buffer stabilizer/preservative with each of the two portions for claim 1, and then processing those fecal samples by testing for blood and nucleic acids (e.g., DNA) for claim 3. These appear to be nearly the most basic steps for using the Cologuard kit. See generally Ex. 2032. And, these steps do illustrate a certain ease of use and consumerfriendliness that may be a contributing factor in Cologuard’s success. See, e.g., Ex. 2022 ¶¶ 140–142, 155, 158–159, 170–171.” slip op. at 25
Patent outcomesUS 11,634,781 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,634,781 - Apple Inc. v. Willow Laboratories, Inc.All claims unpatentablePTAB · Jun 26, 2025 · IPR2024-00296 · APJ Alyssa A Finamore · IPR · Final written decision
Claims 1–4, 6, 8, 10–13, 15, 17, 19–21, 23–26, and 28 are unpatentable as obvious over Abdul-Hafiz and Raley, or over Abdul-Hafiz, Raley, and Secker.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“appear to be that Patent Owner specifies that the POSITA’s knowledge and experience may include optical sensors and that the POSITA may have a degree emphasizing software. We do not deem these differences material, particularly because the optical sensors and technologies at issue are those used in physiological monitoring technologies. Moreover, both parties agree that the POSITA would have a working knowledge of physiological monitoring technologies. Ex. 1003 ¶ 22; Ex. 2079 ¶ 37. Nonetheless, we find the additional specificity of Patent Owner’s definition to be helpful. Also, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’911 patent. Accordingly, for purposes of this Decision, we adopt Patent Owner’s proposed definition of the POSITA. We note, however, that we would reach the same outcome under either definition of the POSITA. See also PO Resp. 12 (Patent Owner asserting “under any proposed level of skill, the claims’ patentability is confirmed for at least the reasons set forth below.”).” slip op. at 13
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Dr. Kenny’s explanation finds support in Raley, and we find his explanation credible. Ex. 1079 ¶¶ 9–11. We agree that Raley’s opening 26 has a vertical depth. In order for emitters 21, 22, 23, 24 to be flush with opening 26 as depicted in Raley’s Figure 3 (see PO Resp. 17–18 (arguing that LEDs are flush with opening 26)), the opening must have a depth to accommodate the thickness of the emitters. We further agree that opening 26 is within a solid body, namely interconnect cable 20. We also agree that, in view of the structure and function of Raley’s probe 40 and interconnect cable segment 20, a POSITA would have understood opening 26 is designed to receive the emitters therein. Given that Raley’s interconnect cable segment 20 includes opening 26 that is designed to receive emitters 21, 22, 23, 24 therein, Petitioner has persuaded us that Raley’s LEDs are recessed into a cavity under both the plain and ordinary meaning of “cavity” and Petitioner’s construction from the Delaware Litigation.” slip op. at 27
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“testimony regarding a POSITA’s understanding of Figure 11B of Abdul-Hafiz. Ex. 2079 ¶¶ 87–88. More pertinent to claim construction, however, is a POSITA’s understanding of the claim term in view of the Specification. See, e.g., Phillips, 415 F.3d at 1315 (“As we stated in Vitronics, the specification ‘is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.’” (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Circ. 1996))). In this regard, Petitioner points to Dr. Madisetti’s Rebuttal Expert Report, which was submitted on behalf of Patent Owner in the Delaware Litigation, where, upon reviewing the Specification of the ’911 patent for written description support for the claims, Dr. Madisetti testifies that “[a] POSITA would have known that the detection surface area of a given detector is essentially the entire surface area of the detector.” Ex. 1082 ¶ 912. During oral argument, Patent Owner attempts to reconcile the apparent inconsistency between this testimony and Patent Owner’s proposed construction. Tr. 34:20–36:12. In particular, Patent Owner asserts that, according to the ’911 patent Specification, the entire surface of the light-detecting side of the detector is the area that light reaches because there is “nothing blocking the entire area of the of the light-detecting side of the detector from receiving light.” Id. at 35:12–13. Patent Owner’s assertion, however, ignores EMI shield grid 2444 and foil 2450 that are placed on and at least partly cover the light-detecting side of the detector. Ex. 1001, 13:38–53, Fig. 24. Accordingly, we find Dr. Madisetti’s testimony regarding a POSITA’s understanding of the Petitioner’s construction, and we adopt Petitioner’s construction of “a detection surface area of the at least one detector” as the surface area of the light-detecting side of the detector.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“reasons against it in the Sur-reply, we are persuaded that a POSITA would have found it obvious to modify Abdul-Hafiz’s aperture to have an area smaller than the detection surface area to prevent optical noise sources such as ambient light and piped light reaching the detector. We disagree with Patent Owner that Petitioner does not explain why a POSITA would have made Abdul-Hafiz’s aperture smaller than the detection surface area. Preventing optical noise sources explains why a POSITA would have made Abdul-Hafiz’s aperture smaller than the detection surface area because making the area of the aperture smaller than the detection surface area helps prevent optical noise sources from reaching the detector. Even if Abdul-Hafiz’s low noise housing 400 and fixed shield 1005 mitigate optical motivation to make something better. See Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006) (“[W]e have repeatedly held that an implicit motivation to combine exists . . . 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.”). Adding an additional protection against optical noise by limiting the diameter of Abdul-Hafiz’s aperture would have enhanced the optical noise mitigation of the low noise housing and fixed shield. Moreover, apart from Abdul-Hafiz, Petitioner does not identify in the prior art an opening having a smaller area than a detection surface area. Petitioner, however, identifies a known relationship between the size of the opening relative to the detection surface area and preventing optical noise from ambient light and piped light. Pet. 50 (citing Ex. 1004 ¶¶ 3, 33); Reply 11–12 (citing Ex. 1011, 96–97, Fig. 6.6; Ex. 1079 ¶¶ 30–32; Ex. 1080 ¶ 73; Ex. 1081, 12:51–63, 14:19–47, 14:28–47). When one parameter is known to influence a specific result, such as the size of the opening relative to the detection surface area preventing optical noise, discovering the optimum value of the parameter is generally obvious. See In re Boesch, 617 F.2d 272, 276 (Fed. Cir. 1980) (“Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citing In re Antoine, 559 F.2d 618 (CCPA 1977); In re Aller, 220 F.2d 454 (CCPA 1955))). Furthermore, we agree with Petitioner that the proposed modification to Abdul-Hafiz, namely reducing the area of the aperture to be smaller than the detection surface area, is simple and that a” slip op. at 43
Patent outcomesUS 10,984,911 unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,984,911 - Apple Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Oct 26, 2023 · IPR2022-01186 · APJ Jeffrey N Fredman · IPR · Final written decision
Claims 1–14 are unpatentable as obvious, including under the Albert–Vyshedskiy–Platt and Batkin–Vyshedskiy grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had either (1) at least a bachelor of science in electrical engineering, mechanical engineering, or biomedical engineering, or a related discipline, with at least two years of relevant multidisciplinary work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals, or (2) a medical degree and at least five years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals. Pet. 5; Ex. 1003 ¶ 15. Patent Owner “applies the level of skill provided in the petition.” PO Resp. 9; Ex. 2003 ¶ 25. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). For this decision, we apply Petitioner’s stated level of ordinary skill in the art, which is consistent with the level of skill reflected in the ’042 patent and the prior art of record.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Here, we construe only those claim terms that require analysis to determine the patentability of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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))); Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”). Petitioner asserts “no formal claim constructions are necessary in this proceeding.” Pet. 5–6. Patent Owner asserts “no claim term needs to be expressly construed to find that Petitioner has not met its burden in establishing the unpatentability of the claims by a preponderance of the evidence. EX2003, ¶¶26-27.” PO Resp. 9. We agree that no terms require claim construction.” slip op. at 7
- Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for petitioner
“Ph.D., in support of the asserted grounds. Ex. 1003. Patent Owner relies upon the declaration of Dr. Roozbeh Jafari, Ph.D. Ex. 2003. Based on the statements of qualifications and curricula vitae, we find Petitioner’s declarant Dr. Sarrafzadeh qualified to provide technical opinions from the perspective of a person of ordinary skill in the art in this proceeding. See 1 Because the patent was filed before March 16, 2003, pre-AIA § 103(a) is applicable. 2 Albert et al., US 5,735,285, issued Apr. 7, 1998. Ex. 1022. 3 Vyshedskiy et al., US 2004/0220488 A1, published Nov. 4, 2004. Ex. 1005. 4 Platt et al., US 6,485,416, issued Nov. 26, 2002. Ex. 1006. 5 Annavaram et al., Multimodal Sensing for Pediatric Obesity Applications, Proceedings of the International Workshop on Urban, Community, and Social Applications of Networked Sensing Systems (UrbanSense) 1–5 (Nov. 2008). Ex. 1007. 6 Batkin et al., US 2005/0239493 A1, published Oct. 27, 2005. Ex. 1008. 7 Sacco Boschetti, US 7,394,899 B2, issued July 1, 2008. Ex. 1021. curricula vitae, we find Patent Owner’s declarant Dr. Jafari qualified to provide technical opinions from the perspective of a person of ordinary skill in the art in this proceeding. See Ex. 2003 ¶¶ 1–9.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundDecided for patent owner
“Patent Owner asserts that Petitioner’s reliance on avoidance of voice interference as a rationale is based on hindsight. See PO Resp. 17–19. Petitioner does not point to any specific disclosure in either Albert, Vyshedskiy, or Platt that suggests voice interference would have been an issue in the transmission of the ECG acoustic signals, instead relying on statements of Dr. Sarrafzadeh such as to choose a carrier frequency from about 6 kHz to about 20 kHz (e.g., 42 f3=7,500 Hz, f4=10,000 Hz, f5=12,500 Hz, f6=15,000 Hz, f7=17,500 Hz, f8=20,000 Hz) to avoid interference from human voice, which can reach the frequency of about 5 kHz. Ex. 1003 ¶ 53 (cited in Pet. 12). Dr. Jafari acknowledges in deposition testimony that “the interference was a known fact. But in the context of how this invention is expected to operate, was novel at the time in my opinion.” Ex. 1027, 65:23–65:1. We agree with Dr. Jafari and Patent Owner that simply because interference of sound waves was a known phenomenon at the time of the invention does not demonstrate that the ordinary artisan would have had reason to select particular carrier frequencies for the ECG acoustic signals that avoided human voice frequencies in the absence of any disclosure that such frequencies were known to interfere. Rather, we agree with Patent Owner that this is hindsight reasoning because until the ’042 patent pointed out this concern in the context of claim 1, there is no indication the prior art recognized that human voice interference was an issue.” slip op. at 29
Patent outcomesUS 9,649,042 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,649,042 - Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentablePTAB · Oct 11, 2023 · IPR2022-00796 · APJ David Cotta · IPR · Final written decision
Claims 1–13 are unpatentable as obvious over Sun and the Teva Press Release; the Board did not reach the Bigal ground.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“POSA helpful. Moreover, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’434 patent. We do not see a need to specify that the POSA would have experience studying the role of CGRP in migraine. Accordingly, for purposes of this Decision, we accept Patent Owner’s proposed definition of the person of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). The differences between Petitioner’s and Patent Owner’s identification of the POSA do not materially affect our decision. Put another way, we would reach the same decision under either definition.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“adverse event” beyond the portion of the Specification defining “inadequate response” to include when “treatment has to be interrupted because of adverse events that made it intolerable.” Ex. 1045, 6:45–52; PO Resp. 13– 14 (acknowledging that “[t]he ’434 patent does not provide an express definition of an ‘adverse event’” and citing only extrinsic evidence); Pet. Reply 22–25 (citing only extrinsic evidence); PO Sur-Reply 18–19 (citing only extrinsic evidence). Like the parties, we do not find any other intrinsic evidence bearing on the construction of “adverse event.” Accordingly, we turn to the extrinsic evidence provided by the parties. slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“d) Conclusion regarding motivation to combine We find that Petitioner has established, by a preponderance of the” slip op. at 64
- ExcludeMotion to exclude, deniedMixed
“A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 102
Patent outcomesUS 10,392,434 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,392,434 - Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentablePTAB · Sep 25, 2023 · IPR2022-00739 · APJ David Cotta · IPR · Final written decision
Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the separate Dodick and Sharma ground.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“(iii) Conclusion with respect to Group I patients In sum, we find that the only difference between Sun’s patients who” slip op. at 33
- Expert testimonyPetitioner expert creditedOther
“be advantageous as compared to galcanezumab on the basis that galcanezumab is a “less selective agent” than erenumab. Patent Owner and Dr. Grosberg cite Shi 2016 (Ex. 2049) as teaching the “high selectivity” of erenumab for blocking the CGRP complex as compared to “less selective agents,” and use this teaching to imply that galcanezumab is less selective than erenumab. PO Resp. 22; Ex. 2037 ¶ 218. But, as Dr. Hay explains, “[t]he ‘less selective agents’ that Shi 2016 refers to are the small-molecule CGRP receptor antagonists, Gepants, not galcanezumab.” Ex. 1239 ¶ 29. We find Dr. Hay’s testimony on this point persuasive, as it is consistent with Shi 2016. See Ex. 2049, 2 (discussing concerns regarding small molecule CGRP antagonists that have prevented their approval and opining that “[a] monoclonal antibody may be a preferred modality to target the CGRP receptor”). Moreover, Shi 2016 concludes with a discussion of the advantages of the superior selectivity of mAbs as a class. Id. at 8 (discussing advantages of mAbs over small molecule CGRP-receptor antagonists, noting “[i]n addition to high potency and superior selectivity, which may provide the benefit of fewer off-target side effects, monoclonal antibodies provide advantages that make them better suited for preventive treatment compared with small molecules”); Ex. 1239 ¶ 32 (interpreting Shi as teaching that “antibodies as a class have limited off-target effects as compared to small molecules because they bind to fewer biological targets and are therefore considered more specific.”). Accordingly, the evidence of” slip op. at 50
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1002, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’161 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’161 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1002, 18:61–19:7. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8
- ExcludeMotion to exclude, deniedMixed
“A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 107
Patent outcomesUS 11,028,161 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,028,161
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.