- Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.No claims unpatentablePTAB · Jul 10, 2026 · IPR2025-00147 · APJ Linda E Horner · IPR · Final written decision
The Board found claims 1–6 and 8–20 not shown unpatentable under three obviousness grounds, principally because the proposed combinations did not establish a feasible curved battery or transparent potting encapsulating the components.
RulingsFinal written decision- Skill levelSkill level board ownOther
“at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. Pet. 8 (citing Ex. 1002 ¶ 29). Petitioner also contends that a person of ordinary skill would have been “familiar with, e.g., sensor system design, including inertial and other motion sensor system design, and signal processing” and that “[a] higher level of education or skill might make up for less experience, and vice versa.” Id. Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. Resp. 25. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’124 patent and the references cited in the Petition.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not reach the issue of whether the preamble is limiting for purposes of determining patentability of the challenged claims. Even were we to agree with Patent Owner that the preamble is limiting and the claims are limited to a finger-worn ring wearable computer device, Petitioner has relied on Schröder in each ground to disclose a “wearable computing device configured to be worn around a finger of a wearer.” Pet. 22 (Ground 1), 45 (Ground 2, relying on Yuen for adding the functionality of light sources with a photodetector, temperature sensors, and varying the sampling frequency of sensor data acquisition), 56 (Ground 3). We agree with Petitioner that Schröder discloses such a device. Thus, no explicit claim construction is necessary for this decision.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successReasonable expectation not foundNot shown unpatentableNot shown unpatentable
“We are not persuaded by Petitioner’s arguments and find that Patent Owner has the better position for several reasons. First, the record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor, and “would have to be reduced in size on the 6 There is no Exhibit 2022 in the record of this case. magnitude of 5-10x from its current size to fit in a ring of Schröder.” Resp. 38 (citing Dr. Anthony’s cross-examination testimony at Ex. 2021, 313:12). Second, Petitioner relies on evidence in the Reply that Petitioner failed to specifically identify in the Petition. Compare Reply 3–5 (citing Ex. 1369 ¶¶ 7–14; Ex. 1079 ¶¶ 47, 71; Ex. 2022, 138:7–143:1; Ex. 1002 ¶¶ 96, 337; Ex. 2021, 12–13, 307:7–17; Ex. 2020, 212:6–214:13; Ex. 1081, 130:18–131:14; Ex. 1010 ¶ 168), 9 (referring back to Section § II.B.2) with Pet. 25–26 (citing Ex. 1002 ¶¶ 193–99; Ex. 1010 ¶¶ 157, 163, 168, 201, Fig. 6). More specifically, while the portion of Dr. Anthony’s Declaration cited in the Petition (see Pet. 25–26 (citing Ex. 1002 ¶¶ 193–99)) mentions the Technology Background Section V of his Declaration (Ex. 1002 ¶¶ 42–147), neither Petitioner nor Dr. Anthony sufficiently explains what evidence supports his opinion that it was feasible to incorporate batteries or battery-like devices into finger-rings, or how a person of ordinary skill in the art would have miniaturized a curved battery for incorporation into Schröder’s ring. Ex. 1002 ¶ 196 (describing that rechargeable batteries powering wearable electronic devices were “well-known by 2013” and “had also undergone significant advances in terms of miniaturization and energy density [that] made it feasible to incorporate batteries or battery-like devices such as supercapacitors into smaller form factors, such as finger rings, without sacrificing functionality” such as “lithium-polymer (Li-Po) batteries and solid-state batteries.”). Moreover, some of Petitioner’s citations in the Reply appear to be incorrect as there is no Exhibit 2022 of record in this case, as noted above. These issues undermine the strength of Petitioner’s showing by making it difficult to follow its reasoning, much less identify where in the record that reasoning finds support. See DeSilva v. DiLeonardi, 181 F.3d 865, 866–67 (7th Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archaeologist with the record.”); United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) (“Judges are not like pigs, hunting for truffles buried in briefs.”). Third, even considering Petitioner’s new Reply arguments and” slip op. at 27
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“We credit Dr. Mercier’s testimony over Dr. Anthony’s and agree that Dr. Anthony’s testimony fails to account for the constraints of a substantially smaller form factor in Schröder’s finger-ring as compared to Mestas’s wrist device. Ex. 2018 ¶ 140. Although large curved batteries suitable for use in a wrist band or other larger wearable device, such as shown in Mestas, were known at the time of the ’124 patent, we also have evidence that prior art “finger ring wearables up to the ’124 patent had used ‘coin’ type batteries.” Resp. 40 (citing Ex. 2018 ¶ 140). We credit Dr. Mercier’s testimony that a person having ordinary skill in the art would have looked to a coin type battery for the necessary power requirements of Schröder’s device. Ex. 2018 ¶ 141. Indeed, this testimony is consistent with the other art of record that consistently shows the use of flat batteries in finger-ring devices, often stacked above and protruding from the general ring shape of the device. See, e.g., Ex. 1005 (Niwa), Figs. 22, 28; Ex. 2025 (Asada ’701 patent), Fig. 4; Ex. 1035 (Rhee), Figs. 7-1, 8-1, 8-2; Ex. 1037 (Asada article), Fig. 9; Ex. 1034 (Asada ’199 patent), Fig. 2; Ex. 1028 (Kimura patent), Fig. 24; Ex. 2018 ¶¶ 74–84. In fact, Oura’s first-generation ring design, released in 2015, used a Superbowl ring type design, with the battery and other components mounted on top of the ring. Ex. 2034; Ex. 2018 ¶ 85. We also agree with Dr. Mercier that Dr. Anthony’s testimony lacks evidence or a technical analysis of the power requirements for the various sensors he suggests including in a wearable device and the capacity of the proposed GMBPow battery. See, e.g., Ex. 1002 ¶¶ 94, 210, 214–17; Ex. 2018 ¶ 97. Moreover, Dr. Anthony does not address the issues with the batteries that are identified in the references he discusses. For example, Dr. Anthony does not address Lee’s disclosure that “direct coating of electrode slurry onto plain paper led to the occasional internal-shorting of the device due to the leakage of the electrode material through a large-sized hole in the paper.” Ex. 1019, 2415. In contrast, Dr. Mercier discusses the pitfalls the skilled artisan faced in developing finger-ring devices. See, e.g., Ex. 2018 ¶¶ 77–79 (discussing the issues Rhee’s and Asada’s large rings), 83 (identifying power requirements as a design constraint). For example, Dr. Mercier explains that “flexible or curved batteries include flexible packaging materials such as aluminum laminated films that house the electrodes and electrolyte” such that “once the battery packaging is added to a battery such as GMBPow and then placed within a housing (e.g., external housing shell and internal potting), the resulting device would have dimensions that are not suitable for a finger-worn ring.” Id. ¶ 96 (citing Ex. 2026).” slip op. at 34
Patent outcomesUS 11,188,124 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,188,124 - PTAB · Apr 15, 2026 · IPR2025-00103 · APJ Gregg I Anderson · IPR · Institution
The Board instituted IPR of claims 1–15 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on each obviousness challenge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Based on the current record and for the reasons explained below, we institute an inter partes review of claims 1–15 of the ’766 patent on all challenges in the Petition. Upon consideration of the Petition and the evidence of record, for the reasons given below we determine there is a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’766 patent. Accordingly, we institute an inter partes review of claims 1–15 of the ’766 patent based upon the asserted grounds of unpatentability set forth in the Petition. Pet. 1.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“If Petitioner succeeds in establishing these limitations lack written description support in the priority applications, then the challenged claims will not receive the benefit of the priority applications’ earlier filing dates and Singh129 will qualify as prior art. On the present record, we are not directed to adequate written description support for the limitations reciting receiving data from a “shortrange wireless enabled data capture device” or “use[s] HTTP” to upload/transfer “new-data along with user information” to a user data publishing website, and wherein “the user information corresponds to a user identifier.” See Pet. 12. Even if support for these limitations is found in Singh906, beyond the initial incorporation by reference, “Singh906 is not mentioned or otherwise referenced in the specification” of the ’766 patent, and on the current record, we are not otherwise apprised of disclosure within the four corners of the specification that demonstrates possession of the system or mobile application as claimed. For the above reasons, we determine that Petitioner has demonstrated a reasonable likelihood that the challenged claims lack adequate written description support, and thus that Singh129 qualifies as prior art to the challenged claims.” slip op. at 23
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artOther
“If Petitioner succeeds in establishing these limitations lack written description support in the priority applications, then the challenged claims will not receive the benefit of the priority applications’ earlier filing dates and Singh129 will qualify as prior art. On the present record, we are not directed to adequate written description support for the limitations reciting receiving data from a “shortrange wireless enabled data capture device” or “use[s] HTTP” to upload/transfer “new-data along with user information” to a user data publishing website, and wherein “the user information corresponds to a user identifier.” See Pet. 12. Even if support for these limitations is found in Singh906, beyond the initial incorporation by reference, “Singh906 is not mentioned or otherwise referenced in the specification” of the ’766 patent, and on the current record, we are not otherwise apprised of disclosure within the four corners of the specification that demonstrates possession of the system or mobile application as claimed. For the above reasons, we determine that Petitioner has demonstrated a reasonable likelihood that the challenged claims lack adequate written description support, and thus that Singh129 qualifies as prior art to the challenged claims.” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner argues that a person of ordinary skill in the art would have been motivated to look to the features of both Singh129 and Singh906 when considering an improved publishing system. Pet. 16. Further, Petitioner points out that Singh129 incorporates by reference the ’802 application, published as Singh906. Id. According to Petitioner, a person of ordinary skill in the art would have been motivated to modify Singh129’s system to add Singh906’s user authentication credentials to Singh129’s user preferences to give the “user more control over the publishing of their multimedia content.” Id. at 17 (citing Ex. 1030 ¶ 456). Petitioner cites four additional reasons for a person of ordinary skill in the art to modify Singh129 with Singh906 including solving a known problem, avoiding sending authentication credentials to publish content, virtual spaces provided for clients in Singh906, and that authentication credentials would have been an obvious design choice. Id. at 17–18 (citing Ex. 1009 ¶ 47, Figs. 2, 5; Ex. 1010 ¶¶ 17, 18, 27; Ex. 1030 ¶¶ 457–461). Petitioner also asserts a person of ordinary skill in the art would have had a reasonable expectation of success for the modification of Singh129 with Singh906. Pet. 18. Petitioner argues “the proposed combination would have required no more than the application of known techniques (using authentication credentials and HTTP in accordance with Singh906) to a known system (Singh129’s system) in the same field of endeavor (media publishing) and from the same assignee (CellSpinSoft) to obtain the benefits described above.” Id. (citing Ex. 1030 ¶ 461). Based on the record before us, we find sufficient the argument and evidence that the combination of Singh129 and Singh906 teaches or suggests all of the limitations of claim 1, and that a person of ordinary skill in the art would have had reason to combine features from Singh906 into Singh129 with a reasonable expectation of success, for the reasons discussed in the Petition. See Pet. 16–19. We have also reviewed Petitioner’s contentions with respect to dependent claims 2–15, and find the same for these claims. See id. at 28–38.” slip op. at 25
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,900,766 - PTAB · Apr 15, 2026 · IPR2025-00102 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted review of claims 1–10 on both obviousness grounds, finding a reasonable likelihood that Petitioners would prevail.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons explained below, we institute an inter partes review of claims 1–10 of the ’121 patent on all challenges in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time the invention was made. See Graham, 383 U.S. at 17–18. Petitioners contend that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”) would have had: at least a bachelor’s degree in electrical engineering, computer engineering, or computer science, and two years of experience in the field consumer electronics, with exposure to digital camera technology and wireless communications. Superior education could compensate for a deficiency in work experience, and vice-versa. Pet. 6 (citations omitted) (citing Ex. 1030 (Lett Decl.) ¶¶ 94–95). Because Petitioners’ proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioners assert that no express constructions are required to institute review and find the challenged claims unpatentable. See Pet. 7. We find it unnecessary to construe any claim term to decide whether Petitioners satisfy the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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))). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis in this Decision. Any final claim constructions will be based on the full trial record.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“E. Ground 1 – Alleged Obviousness Over Hiroishi, Kahn, Endsley, and Bluetooth Petitioners assert that claims 1–10 are unpatentable as obvious over the combination of Hiroishi, Kahn, Endsley, and Bluetooth. Pet. 16–65. After considering Petitioners’ arguments and cited evidence, we find that for purposes of institution, Petitioners have shown a reasonable likelihood of establishing that claims 1–10 are unpatentable as obvious over the combination of Hiroishi, Kahn, Endsley, and Bluetooth.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,234,121 - PTAB · Apr 15, 2026 · IPR2025-00104 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1, 2, 4–7, and 9–18 based on all presented grounds, finding a reasonable likelihood of success on obviousness grounds 1A and 1B.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). The petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition shows a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSITA”) would have “had at least a bachelor’s degree in electrical engineering, computer engineering, or computer science, and two years of experience in the field [of] consumer electronics, with exposure to digital camera technology and wireless communications.” Pet. 5 (citing Ex. 1030 ¶¶ 94–95).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We find it unnecessary to construe any claim term to decide whether Petitioners satisfy the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. 35 U.S.C. § 103; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) when in evidence, objective evidence of nonobviousness.10 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). An obviousness determination requires finding a reason to combine accompanied by a reasonable expectation of achieving what is claimed in the challenged patent. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 419–20.” slip op. at 10
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 8,904,030 - Axion Biosystems, Inc. v. Agilent Technologies, Inc.No claims unpatentablePTAB · Feb 2, 2026 · IPR2024-01467 · APJ David Cotta · IPR · Final written decision
Claims 1–8 and 11–15 were not shown unpatentable over Xu-752 and Jones because the proposed combination did not establish obvious millisecond time resolution.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends a person of ordinary skill in the art (“POSA”) as of May 2009 “would have had a B.S. in electrical/mechanical/biomedical engineering or biological science, or a related field, and approximately 2 years of relevant experience or equivalent study in systems and methods for bioanalysis of cells.” Pet. 14 (citing Ex. 1003 ¶¶ 23–25). Patent Owner adopts this definition for purposes of this proceeding. PO Resp. 9 (citing Ex. 2009 ¶ 19). We find Petitioner’s description of the level of ordinary skill in the art to be consistent with the level of skill reflected in the ’508 patent and in the prior art of record. Accordingly, we apply Petitioner’s definition in this decision.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“As used herein, “impedance measurement at millisecond time resolution” refers to the ability to perform a series of at least two consecutive impedance measurements within milliseconds of one another for each and every well of the system where each well is associated with an electrode array for impedance measurement. In each instance the time between two consecutive impedance measurements are less than 300 milliseconds from one another. Id. at 10:8–15. There does not appear to be any dispute as to the definitional nature of the first sentence in the passage above. That is, the parties agree that millisecond time resolution should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15 (proposing construction); Pet. Reply. 23 (“Axion also agrees that the term ‘millisecond time resolution’ is ‘the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.’”). The parties also agree that we do not need to determine whether the time interval between two consecutive impedance measurements is less than 300 milliseconds, as set forth in the definition portion of the specification, or whether it can be met by some other time interval, as suggested by other portions of the specification. See e.g., Ex. 1001, 23:49–55 (explaining that “[i]n some embodiments 500 millisecond time resolution is sufficient”), 24:37–39 (similar); PO Resp. 15 (arguing that “the distinction between 300 milliseconds and 500 milliseconds is immaterial to the dispute in this IPR because Jones teaches a 1.5 second update period, thus at least three times longer than the 500 milliseconds formulation”); Pet. Reply 23–24 (section headed “[Petitioner] Agrees That, In This IPR, The 300 Versus 500 Milliseconds Distinction is Immaterial To Addressing the Unpatentability of the Challenged Claims”), see also, Pet. Reply 24–26 (asserting that the claims are indefinite because it is not clear whether they require a 300 or a 500 millisecond time interval, but arguing that “the claims’ unpatentability can be determined without resolving the 300 versus 500 milliseconds indefiniteness issue”). We agree with the parties that “millisecond time resolution” should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15; Pet. Reply. 23. We further agree that resolution of this case does not require that we determine whether the period between two consecutive impedance measurements is less than 300 or less than 500 milliseconds because Petitioner has not carried its burden under either time interval.” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1003 ¶ 179. But Dr. Kim does not cite to any additional supporting evidence or provide any technical reasoning to support his statements. The notion that one can reduce the time between measurements by, e.g., reducing the number of frequencies measured, has intuitive appeal and appears mathematically correct. However, the absence of technical reasoning and supporting evidence diminishes the persuasiveness of Dr. Kim’s testimony that the POSA would made such modifications to reduce the time between measurements. Dr. Kim does provide some technical reasoning in connection with his discussion of eliminating all reference channels as a way to get the time resolution down to the levels required by, e.g., claim 14, which recites a millisecond time resolution of “less than 5 milliseconds.” See e.g., Ex. 1003 ¶ 172 (“A POSA seeking to study biological cell phenomena occurring on the order of a few milliseconds would have recognized that after measuring the reference network channels at the start, the reference network channels would not need measured again for some time, e.g., because temperature and other drift factors do not change appreciably on a millisecond time scale.”). However, even if we were to credit this testimony, Dr. Kim still lacks support and reasoning for the selection of the other parameters in his noreference-channel calculations. See, e.g., id. ¶ 173 (positing, but not providing technical reasoning for using, a no-reference-channel impedance system with 16 wells, a single 10kHz measurement frequency, and 16 daughter boards that measure simultaneously rather than sequentially).” slip op. at 29
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentableNot shown unpatentable
“Given that Jones’s only exemplified embodiment targets a 1.5 second update period, that Jones does not suggest reducing the update period, and that much of Jones’s focus is on benefits other than speed of measurement, Jones’s impedance analyzer seems an unlikely choice for a POSA seeking to take measurements having millisecond time resolution. Put another way, we find no persuasive non-hindsight reason that supports Petitioner’s assertion that the POSA would have sought to apply Jones’s impedance analyzer to Xu-752’s system in order to take measurements in millisecond time resolution.” slip op. at 22
Patent outcomesUS 11,906,508 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,906,508 - MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentablePTAB · Jan 27, 2026 · IPR2023-00016 · APJ Michael A Valek · IPR · Remand
On remand, the Board held claims 1–6 not shown unpatentable because unexpected results outweighed the prima facie obviousness case, and granted Patent Owner’s motion to exclude.
RulingsRemand decision- RemandOther
“the Court of Appeals for the Federal Circuit (“Federal Circuit”)See Paper 83 (“CAFC Decision”). The Federal Circuit did not disturb our determination that Petitioner “established a prima facie case of obviousness.” See CAFC Dec. 6–8. However, it took issue with the unexpected results analysis in the Decision, explaining that “without more explanation from the Board as to its determination that the experiments [offered by Patent Owner to show unexpected results] compared the challenged claims to the closest prior art, we cannot reach a judgment on MSN’s challenges to the Board’s holding of non-obviousness.” Id. at 14. Accordingly, the Federal Circuit vacated the Decision and remanded the case for further consideration of the unexpected results evidence. Id.” slip op. at 2
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 35
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia with nexusObjective indicia outweighedDecided for patent owner
“We find Patent Owner’s evidence persuasive to show that the Glu3 substitution results in an unexpected improvement in interconversion stability. As explained above, RP-HPLC was a known technique for separating the topoisomers of human uroguanylin. Ex. 2010, 230–231; Ex. 2011, 27–28; Ex. 2020, 223; Ex. 2028, TRUL00018269; see also Ex. 1063 ¶¶ 37, 40 (Petitioner’s expert confirming same). It was also known that one of human uroguanylin’s topoisomers was biologically active, whereas the other, i.e., what we and the parties refer to as the “inactive” topoisomer, had significantly less or no activity at the same concentration. Ex. 2011, 31 (“compound I shows significant activity in the cGMP producing assay, whereas compound II is practically inactive”); see also Ex. 2010, 238–239 (Fig. 8) (showing the “A isomer” had a potency “with a minimal concentration between 10-7and 10-8 M,” but that the B isomer “had virtually no effect on cGMP level at 10-6 M”); Ex. 2074, 48 (compound II “showed maximal 10% of the activity of compound I at 10-6 M”). The chromatograph for uroguanylin in Patent Owner’s data is consistent with these teachings, showing two peaks representing the active and inactive topoisomers. Compare Ex. 2028, TRUL00018269 (Fig. 1) with Ex. 2011, 28 (Fig. 2). The chromatograph for SP-304 shows a markedly different result, i.e., a “single peak,” which was confirmed “using the cGMP T84 cell assay” to represent “the fully active conformer of SP-304.” Ex. 2028, TRUL00018269; Ex. 2024 ¶¶ 208–209. We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 34
- ExcludeMotion to exclude, grantedGranted
“motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding.” slip op. at 58
Patent outcomesUS 7,041,786 not shown unpatentable§ 103 obviousnessPatents in suitUS 7,041,786 - MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentablePTAB · Jan 27, 2026 · IPR2022-00722 · APJ Michael A Valek · IPR · Remand
Claims 1–6 were not shown unpatentable because the unexpected results from the Glu3 substitution outweighed the prima facie obviousness showing; Patent Owner’s motion to exclude was granted.
RulingsRemand decision- RemandOther
“More specifically, the Federal Circuit identified “three reasons” why “the Board’s determination that the[se] experiments compared the claimed invention with the closest prior art lack[ed] adequate explanation” and instructed us to address these issues on remand. See CAFC Dec. 11–13. First, the Court stated we “should determine, based on the evidence put forward by the parties, whether plecanatide exhibits topoisomerism and whether the testing of the challenged claims should encompass both the active and inactive forms.” Id. at 12.3 Second, the Court instructed us to reconsider what the closest prior art compound is in view of Patent Owner’s “contention that highly pure A-form uroguanylin could be maintained as a lyophilized powder,” noting that “[i]f it is true . . . that uroguanylin can be maintained and therefore tested in its active A form as a lyophilized powder, that would support that the experiments [which were conducted in solution] did not use the closest prior art.” Id. Third, the Court observed that the Decision did not sufficiently address “whether the experiments submitted by [Patent Owner] actually used” the closest prior art and instructed the Board “to reevaluate the experimental evidence consistent” with the determinations noted above. Id. at 12–13.” slip op. at 3
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner
“In sum, we find that there is a sufficient nexus between Patent Owner’s results and the challenged claims and that those results are reasonably commensurate with the same. Accordingly, for all of reasons explained above, the unexpected results Patent Owner relies upon are probative of non-obviousness. E. Conclusion for Ground 1 Weighing the record as a whole in view of the findings and analysis above as well as our findings and analysis relating to Petitioner’s prima facie showing in the Decision, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution (see Dec. 20–38 (§ III.E.ii)) is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Indeed, the interconversion and potency categories of Patent Owner’s unexpected results showing are particularly strong such that even without the additional results in Liu, we would still reach the same ultimate conclusion on obviousness. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 56
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for patent owner
“same combination of Currie and Li for the limitations of claim 1 and the similar limitations recited in the other independent claims. In the Decision, we found that, based on the teachings in those references, an ordinarily-skilled artisan would have been motivated both to select human uroguanylin as a lead compound and modify its sequence by making a conservative Glu3 substitution for uroguanylin’s Asp3. Dec. 15–37. We did not, however, credit Petitioner’s other purported rationales for that modification. Id. at 34–37. Those findings were not disturbed on appeal. See CAFC Dec. 6–8 (rejecting 9 The Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became effective after the filing of the application that led to the ’786 patent. Therefore, we apply the pre-AIA version of 35 U.S.C. § 103. 10 U.S. Pat. 5,489,670, issued Feb. 6, 1996 (Ex. 1005) (“Currie”). 11 Z. Li et al., Purification, cDNA Sequence, and Tissue Distribution of Rat Uroguanylin, 68 Regulatory Peptides 45–56 (1997) (Ex. 1006) (“Li”). 12 R. Narayani et al., Polymer-coated Gelatin Capsules as Oral Delivery Devices and their Gastrointestinal Tract Behavior in Humans, 7 J. Biomater. Sci. Polymer Edn. 39–48 (1995) (Ex. 1007) (“Narayani”). 13 M. Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone in Active Crohn’s Disease, 41 Gut 209–214 (1997) (Ex. 1008) (“Campieri”). 14 U.S. Pat. 5,359,030, issued Oct. 25, 1994 (Ex. 1009) (“Ekwuribe”). Patent Owner’s alternative arguments for affirmance). We incorporate by reference the portions of the Decision addressing Petitioner’s prima facie showing herein. See Dec. 8–37 (§§ III.A–D and E.i–ii). We consider the findings and explanation therein to the extent it bears on our analysis below.” slip op. at 10
- ExcludeMotion to exclude, grantedGranted
“motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding. For these reasons, we grant Patent Owner’s motion to exclude page 86 of Exhibit 1067.” slip op. at 58
Patent outcomesUS 7,041,786 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,041,786 - PTAB · Dec 10, 2025 · PGR2025-00054 · APJ Ryan H Flax · PGR · Institution
The Board instituted PGR on claims 1–16 on all four grounds, finding at least one claim more likely than not unpatentable based on obviousness, indefiniteness, or lack of written description.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in a post-grant review. We institute a post-grant review only if the information presented in the petition filed under 35 U.S.C. § 321, if unrebutted, shows that it is more likely than not that at least one claim challenged in the petition is unpatentable. 35 U.S.C. § 324. On the existing record, we conclude that Petitioner demonstrates it is more likely than not that Petitioner would prevail in showing that at least one challenged claim of the ’781 patent is unpatentable under a presented ground. See generally Pet. Therefore, we grant institution of post-grant review. Our reasoning is discussed below.” slip op. at 2
- PTAB / AIA Trials › Real party in interest / privityDecided for petitioner
“STANDING Petitioner states that it certifies that: (1) the ’781 patent is available for post grant review because its earliest claimed effective filing date is October 9, 2018, and the patent issued less than nine months ago, on December 3, 2024; and (2) Petitioner is not barred or estopped from requesting a post grant review on the grounds in this petition. Pet. 5. This is sufficient. See 35 U.S.C. § 100(note)(A)–(B), § 321; 37 C.F.R. § 42.204(a). Patent Owner does not contest standing. See generally Prelim. Resp. B. REAL PARTIES-IN-INTEREST Petitioner states that “[t]he real parties-in-interest are Petitioner Straumann USA, LLC and its affiliates Institut Straumann AG and JJGC Indústria e Comércio de Materiais Dentários S.A.” Pet. 3. Patent Owner raises no objection and itself identifies “Smart Denture Conversions, LLC is the real party-in-interest.” Paper 4, 2; see generally Prelim. Resp. C.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 42. And, as set forth above, Patent Owner asserts that, for the sake of its present arguments, it matters not which of the two proposed definitions we use for this proceeding. Prelim. Resp. 21. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This issue may be further developed at trial by the parties, if desired. C.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“same claim construction standard that is used to construe patent claims in a civil action in federal district court thus, by default, we give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” 37 C.F.R. § 42.200(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner indicates that None of the claim terms of claims 1–16 need to be construed to determine the patentability issues presented in this petition. The petition applies the ordinary meaning of the claim language as it would be understood by a POSA after reading the ’781 patent. Ex. 1002, ¶130. Petitioner will propose a construction if Patent Owner argues or the Board determines that one is required for any term. Pet. 31 (citing Ex. 1002). And, Patent Owner presents no express position on claim construction at this point. See generally Prelim. Resp. At this stage of the proceeding, we do not expressly construe any claim terms; however, this position is preliminary and we may change it based on the fully developed record at trial.8 D.” slip op. at 19
Claim construction§ 103 obviousness§ 112 disclosurecites GrahamPatents in suitUS 12,156,781 - PTAB · Nov 21, 2025 · IPR2025-00956 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–12 under all asserted grounds, finding a reasonable likelihood that at least one claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in an inter partes review. We institute an inter partes review only if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’992 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“These two proposed definitions of the ordinarily skilled artisan share many consistencies, for example, the types of degrees and experience such a person would have had, but differ in the number of years of experience. Petitioner proposes the ordinarily skilled artisan would have had at least five years of experience and Patent Owner proposes at least three years (which would necessarily include five years, too). Patent Owner also proposes that the ordinarily skilled artisan would have consulted a dentist, oral surgeon, prosthodontist, or periodontist with experience in dental implants and prosthetics. At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 40. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’992 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” 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)). This parties may further developed this issue at trial, if desired. C.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Board interprets claim terms in an inter partes review using the same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.100(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc).” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Here, the first claim limitation at issue is broad, i.e., different thread pattern/profile between a definite and a temporary screw, and the Specification’s and priority applications’ disclosure is narrow and specific, asymmetric buttress style threads in a temporary screw and symmetrical threads in a definite screw (are different). Any apparent predictability in or maturity of the relevant field here must be contrasted with the fact that the Specification, considering the ’992 patent itself or any of the identified priority applications, never once even discusses the (claimed) concept of specifically differing the thread style between a temporary and a definitive screw. Any differences in thread style are not called out by the disclosure, but are described and can be discerned only in relation to the respective threads’ functionality, i.e., Fig. 75’s temporary screw 190 has buttress-style threading so it can be pulled out rather than unscrewed from the abutment; Fig. 9’s definitive screw 75 has male threads that fill the female threads of the abutment 8 for a secure permanent engagement. Ex. 1001, 15:23–30, 21:25–44, 23:3–36; Ex. 1012, 97–98, Figs. 9, 75. And, although it is possible for a single disclosed species to provide written description support for a claimed genus, “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350; see also Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). That does not appear to be the case here—the present record does not support that the described asymmetrical buttress, serrated style of different temporary screw threading (relative to that of the definitive screw and regardless of the direction of the threads for rotation) is sufficiently representative of the genus’s “different” thread patterns/profiles. See, e.g., Ex. 1006 (a buttress style thread does not function the same as a buttress reverse or 75º joint profile or rounded, or trapezoidal thread).” slip op. at 30
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 11,937,992 - PTAB · Nov 19, 2025 · IPR2025-00949 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted inter partes review of all 23 claims after finding a reasonable likelihood that Azurity would show claim 1 obvious over Herrstedt and Bös.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“legal requirement for a reasonable expectation of success. Petitioner must show that a POSA would have had a reasonable expectation of success in combining the prior art teachings in the manner claimed. See Life Techs. Inc. v. Clontech Labs. Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000) (“Reasonable expectation of success is assessed from the perspective of the person of ordinary skill in the art. That the inventors were ultimately successful is irrelevant to whether one of ordinary skill in the art, at the time the invention was made, would have reasonably expected success.”). Thus, Petitioner must show that a POSA would have had a reasonable expectation of success in modifying Herrstedt’s combination therapy for treating CINV by substituting netupitant for aprepitant and “inducing in [the patient] therapeutically effective blood levels of palonosetron and netupitant in a combination regimen with dexamethasone,” as recited in claim 1. Framed properly, the record evidence shows adequate support for a reasonable expectation of success. The POSA would need only substitute one known NK1 antagonist for another, and the record supports that she would know how to dose it. See Ex. 1014, 42:5–11 (Bös teaching a dosing range for netupitant); see also Ex. 1009 ¶¶736–737 (opining as to dosing and reasonable expectation of success). In fact, Patent Owner does not identify any obstacle a POSA might encounter in carrying out the proposed modification. Prelim. Resp. 26–28. Rather, Patent Owner disputes that a POSA would attempt to carry out the proposed modification because she would not have expected the netupitant to prevent CIN. However, as discussed above, the prior art taught treating CINV with aprepitant, a known NK1 antagonist. Netupitant was another known NK1 antagonist. The Petition demonstrates sufficiently, at least for institution purposes, both a reason to combine the prior art and a reasonable expectation of success.” slip op. at 21
- Skill levelOther
“At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts” slip op. at 9
- Expert testimonyPetitioner expert creditedOther
“We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2070 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment of CINV is required, Dr. Peroutka appears to have published in that field. See, e.g., Ex. 1020 at 10 (publication 16: article on “Combination antiemetics” in Cancer Treatment Reports), 11 (publication 37: article on “Neurotransmitter receptor binding studies predict antiemetic efficacy and side effects” in Cancer Treatment Reports), 13 (publication 51: article on “Chemotherapeutic agents do not interact with neurotransmitter receptors” in Cancer Chemotherapy and Pharmacology).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionTerm construed board ownOther
“First, Petitioner proposes that “complete response” (recited in the preamble of independent claim 2 and the bodies of dependent claims 8 and 18) means: no emetic episodes, no rescue medication.” Pet. 10 (citing Ex. 1004, 18:9–12). The cited portion of the Specification supports such a construction. Ex. 1004, 18:9–12 (“The primary efficacy endpoint was the complete response rate (defined as no emetic episodes, no rescue medication) within 120 hours after the start of the highly emetogenic chemotherapy administration.”). On the instant record, with no argument to the contrary by Patent Owner, we adopt it. Second, Petitioner proposes that “independently effective” (recited in dependent claims 12, 18, and 23) means “protection against nausea and vomiting for five consecutive days, regardless of whether other drugs are administered.” Pet. 10 (citing Ex. 1007, 329; Ex. 1009 ¶785). Dr. Peroutka states that “that the ’297 patent specification does not define or otherwise disclose what is meant by ‘independently effective.’” Ex. 1009 ¶785. However, according to Dr. Peroutka, its meaning is evident from the prosecution history. Id. (citing Ex. 1007, 329). On the instant record, with no argument to the contrary by Patent Owner, we agree that “independently effective” means protection against something regardless of whether other drugs are administered. However, we do not agree that the protection is limited to being “against nausea and vomiting for five consecutive days.” Rather, other claim terms provide context for “independently effective.” See Ex. 1004, 22:22–25 (“12. The method of claim 1, wherein said blood levels of netupitant are independently effective to prevent acute and delayed nausea and vomiting in a subject receiving highly emetogenic cancer chemotherapy. (Emphasis added)), 23:1–3 (“23. The method of claim 3, wherein said blood levels of netupitant are independently effective to prevent nausea in a subject receiving highly emetogenic cancer chemotherapy. (Emphasis added)). Third, Petitioner proposes that “inducing in said subject therapeutically effective blood levels” (recited in all three independent claims) means “administering therapeutically-effective amounts that reach the target receptors in the central nervous system (CNS) via the circulatory system—as would be necessary for orally- or intravenously-administered drugs.” Pet. 10. As support, Petitioner relies on testimony from Dr. Peroutka, interpretation of the prosecution history, and the ’297 patent. Id. (citing Ex. 1009 ¶¶729–732; Ex. 1008, 120, 165–167; Ex. 1004, 7:54–60). The text of the ’297 patent is the best source as to the meaning of its claims. See Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (“The specification is . . . the primary basis for construing the claims.”); Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1360 (Fed. Cir. 2004) (“In most cases, the best source for discerning the proper context of claim terms is the patent specification wherein the patent applicant describes the invention.”). And, the most relevant portion of what Petitioner cites from the ’297 patent states: “As used herein, ‘therapeutically effective amount’ refers to an amount sufficient to elicit the desired biological response.” Ex. 1004, 7:54–56.8 On the instant record, with no input from Patent Owner, we construe “inducing in said subject therapeutically effective blood levels” to mean “inducing in said subject blood levels sufficient to elicit the desired biological response.”” slip op. at 10
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,297
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.