- Preomics GmbH / Biognosys AG. v. The Brigham And Women’S Hospital, Inc.Some claims unpatentablePTAB · Mar 23, 2026 · IPR2024-01473 · APJ Michael A Valek · IPR · Final written decision
Claims 1, 4, 6, 17, 22, and 25 are unpatentable as anticipated by and obvious over Cai; claims 2, 3, 7, 23, and 24 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We disagree with Patent Owner and again find Petitioner’s description of the level of ordinary skill in the art sufficient for the reasons explained in the Decision on institution. See Dec. 8–10. As explained before, the formal training required by Petitioner’s description of a POSA includes understanding of both proteins and analytical techniques for studying them. See Dec. 9. Neither Patent Owner, nor its declarant, Dr. Cimas, clearly articulates a competing POSA description at trial, but both suggest more formal training, e.g., a graduate degree, is required. See Resp. 65–66; Ex. 2023 ¶ 8 (agreeing with our observation that the educational backgrounds of the inventors and authors of Cai, Zaccaria, and Hu “suggests that a graduate degree is more typical for a POSA”) (quoting Dec. 9, n. 5). Even if we were to accept that modification, it would not change our findings herein. Nor does it suggest that Dr. Vargas, who holds a Ph.D. in chemistry from Stanford University and has substantial experience with mass spectrometry and other analytical techniques, is unqualified to testify from the perspective of one of ordinary skill in the art. See Ex. 1004 (Vargas CV). Accordingly, our findings and conclusions would be the same, even assuming the perspective of a POSA possessing the higher level of formal training and specific proteomics experience that Patent Owner suggests is appropriate here.5” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Ex. 1001, 20:33–39. As Petitioner points out, the first sentence in this passage does not define the term “biological sample,” but rather the term “sample.” Id. According to that sentence, the term “sample” refers to either “a biological sample or a complex biological sample obtained from a subject.” Id. (emphasis added). Patent Owner’s argument assumes, without explanation, that the phrase “obtained from a subject” modifies both instances of “biological sample” in the first sentence. Id. But it need not be read that way. Indeed, that sentence is more naturally read to define “sample” as one of two things––either a “biological sample” or a “complex biological sample” with only the latter being “obtained from a subject.” Id. In addition, the second sentence in the passage above supports Petitioner’s view that the term “biological sample” is not limited to a sample obtained directly from a subject. It provides a broad, non-exhaustive list of “[s]uitable biological samples” that specifically includes the types of biological samples, i.e., “cell lysates,” “systemic blood,” “plasma,” assayed in Petitioner’s cited references. Ex. 1001, 20:36–39. It also lists as an example “processed tissue samples,” which would include samples that have been modified (i.e., “processed”) from the form in which they were originally obtained. Id.; see also Ex. 1001, 20:52–57 (describing tissue processing). Given this broad description, we agree with Petitioner that there is no basis in the cited intrinsic evidence for reading in the “negative limitations” Patent Owner seeks to try to distinguish the particular biological samples assayed in Cai, Hu, and Zaccaria. See Reply 3–4.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We agree with Petitioner. Step 1(a) recites forming coronas around a plurality of particles of “different particle types.” Ex. 1001, 86:53–60. Step 1(b) recites separating a “subset of the plurality of the particles comprising the coronas.” Id. at 86:61–65. As Petitioner correctly observes, as a matter of ordinary English parlance, “there is no requirement whatsoever that the ‘subset’ have all of the same characteristics as the set from which it is separated.” Reply 10. By way of analogy, consider a jar containing a plurality of coins of different coin types, e.g., nickels and dimes. One can separate out a “subset” of that plurality of coins (plural) by removing any two coins from the jar—this is true even if the two coins are both nickels or both dimes. In the same way, nothing in the ordinary meaning of the claim language requires the subset in step 1(b) to include particles with coronas representative of each of the different particle types in step 1(a). Nor has Patent Owner identified any other evidence that supports its attempt to read such a requirement into the claims. See Resp. 16, 18 (citing expert testimony that is not inconsistent with the broader, ordinary meaning of the claim language and, even if it was, would not be a proper basis for limiting the same). For these reasons, we reject Patent Owner’s interpretation of “a subset of the plurality of particles comprising the coronas” in step 1(b) as limited to a subset of each type of particle comprising the coronas formed in step 1(a).” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We credit Petitioner’s showing above and agree that Cai discloses a method comprising all of the steps in claim 1. Beginning with step 1(a), Cai discloses contacting two different particle types, i.e., MWCNT and CB, with HeLa cell lysate (i.e., a biological sample) to form protein coronas around those particles. Ex. 1003 ¶¶ 199–206; Ex. 1005, Abstr. (describing MWCNT and CB as distinct “forms of carbon nanoparticles” that bind “vastly different sets of proteins”). Cai’s results show the coronas formed around the MWCNT and CB particles comprise overlapping and distinct proteins as recited in step 1(a). Ex. 1003 ¶¶ 216–222; Ex. 1005, 587 (“a small number of CB-binding proteins also bind to MWCNTs”). A subset of the proteins from the coronas on these particles is then prepared by eluting the bound proteins and analyzing them with SDS-PAGE in a MWCNT and CB “pull-down,” which reads on step 1(b). Ex. 1005, 586 (Fig. 1A–B depicting scheme for “pull-down experiment” and describing other “pull-down experiments” used with SILAC media in Fig. 3), 588 (Fig. 3). Regarding step 1(c), Cai discloses assaying the proteins in those subsets using LC-MS/MS with SILAC encoding to characterize and quantify the relative abundance of the proteins that bind to each type of particle.11 Ex. 1003 ¶¶ 225–229; Ex. 1005, 586–587 (describing “systemic characterization of carbon nanoparticle-protein corona”), 588 (Fig. 3). Cai’s results show “the relative abundance of the MWCNT-binding proteins spread over 8 orders of magnitude” and that “some of the proteins with the highest binding efficiencies” are actually “low abundance proteins” in the lysate, meaning that that Cai’s method selectively enriches such proteins for detection. Ex. 1005, 587. We credit Dr. Vargas’s testimony that these results demonstrate that Cai’s method achieves the “dynamic range” recited in step 1(c). Ex. 1003 ¶¶ 225–229.” slip op. at 23
Patent outcomesUS 11,435,360 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,435,360 - 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 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.No claims unpatentablePTAB · Jan 30, 2026 · IPR2024-01078 · APJ Neil T Powell · IPR · Final written decision
Claims 1–6, 11–15, and 38–43 were not shown unpatentable because Petitioner failed to establish obviousness over the asserted combinations, including the feasibility and motivation to use curved batteries in a ring.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. PO Resp. 22; see also Ex. 2018 ¶ 27. 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 ’953 patent and the references cited in the Petition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner expresses that it “does not believe that any term requires express construction.” Pet. 8. “Patent Owner agrees with Petitioner that no terms need to be construed.” PO Resp. 22. We agree with the parties that resolution of their dispute does not require us to construe any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy controversy) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“be improper hindsight in Petitioner’s position. Petitioner and Dr. Anthony assume that a POSITA would position the battery between Schröder’s ring halves and implement Mestas’s curved battery because it “allows a larger battery to conform to a ring’s circular shape without stressing the battery or ring housing.” Pet. 60, 64–65; Ex. 1002 ¶¶ 337, 351–354. That position, however, ignores alternative designs that are at least equally supported by Schröder’s disclosure (see Ex. 1007, Fig. 3), but would not result in a ring configured as recited in the challenged claims. Petitioner attempts to downplay this concern by characterizing the modification of Schröder’s ring to include Mestas’s curved battery as an obvious “matter of choice” in design. See Reply 10–11 (citing Ex. 1079 ¶¶ 71–77). We disagree. As explained above, the record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor because they are “5 to 10 times” the size that would be required for a finger ring. PO Resp. 27 (quoting Ex. 2021, 313:12). Petitioner argues that it “does not propose bodily incorporating Mestas’s battery into Schröder’s ring,” which on the surface is correct. See Reply 10. But this does not help Petitioner meet its burden because its actual obviousness theory that “a POSITA would have found it trivial to implement Mestas’s teachings into a ring like Schröder’s ‘finger-ring’” is not persuasive. See Pet. 60 (citing Ex. 1002 ¶ 338). For the same reasons explained in Section II.D.1 above in our analysis of Ground 1, Dr. Mestas’s teaching of a curved battery (Ex. 1002 ¶ 338) in the much smaller form factor of Schröder’s ring is not credible. See Ex. 2021, 315:9–318:9 (acknowledging that it would have been beyond the level of ordinary skill to miniaturize Mestas’s battery, but that a POSITA could try to procure one); 321:5–10 (conceding that he did not try to ascertain whether such a battery was available in the relevant time frame). Instead, we credit Dr. Mercier’s testimony that Petitioner’s proposed modification would have presented intractable practical challenges. Ex. 2018 ¶¶ 228, 230–240 (describing various aspects of battery design that Dr. Anthony did not consider). As before, Dr. Mercier’s testimony is further supported by evidence showing a consistent pattern of flat battery use in prior art finger-ring devices. See, e.g., Ex. 1005 (Niwa), Figs. 22, 29; 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), Fig. 24; Ex. 2018 ¶¶ 57–67. In sum, Petitioner’s showing for limitation 1[c] is deficient in multiple respects. First, Petitioner assumes that an ordinarily-skilled artisan would have been motivated to implement Mestas’s curved battery in the much smaller interior space occupied by Schröder’s inlay 12 without sufficiently considering the feasibility of that modification or alternative designs suggested by Schröder. Second, even if we accept Petitioner’s purported rationale for the combination (which we do not because we find it that it is predicated on improper hindsight), Petitioner has not shown that an ordinarily-skilled artisan would have had a reasonable expectation of successfully implementing the proposed modification.” slip op. at 46
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia with nexusDecided for patent owner
“We find that the evidence presented by Patent Owner is sufficient to establish that the Oura Ring Gen. 3 Horizon and Gen. 4 products are commercial embodiments of claim 1 of the ’953 patent and that claim 1 is coextensive in that it encompasses the entire structural apparatus of these products. See PO Resp. 82–92; Ex. 2018 ¶¶ 322–346 (comparing these products to claim 1); Ex. 2029; Ex. 2030; Ex. 2118; Ex. 2119.9 Indeed, Petitioner does not challenge any aspect of Dr. Mercier’s limitation-by-limitation analysis showing that these products practice claim 1. But more than just practicing the claimed invention, Patent Owner’s evidence supports that claim 1 recites the overall structure that provides for the particular form factor of the Oura Ring Gen. 3 Horizon and Gen. 4 products, i.e., a fingerring “wedding band” design that allows for the electronic components to be entirely contained within the ring housing with a curved external surface having no protrusions or bulges. Ex. 2018 ¶¶ 359–360; see also id. ¶¶ 322–346 (pictures depicting wedding band design of the Oura Ring Gen. 3 Horizon and Gen. 4 products); Ex. 2019 ¶¶ 47–49 (“[Patent Owner’s] decision to highlight the ring form factor indicates this feature’s importance to the marketplace success of the Oura Ring.”). We disagree with Petitioner’s assertion that the Oura Ring Application and/or Oura Membership are essential, unclaimed features such that a presumption of nexus is not appropriate. The Oura Application functions in conjunction with the Oura Ring to form a “complete solution” 9 Patent Owner and Dr. Mercier only compare these products to claim 1. Patent Owner has not demonstrated a nexus to independent claim 38. ¶¶ 20–21. The Oura Application cannot receive or display any information absent the Oura Ring’s ability to collect the information from the user. Id. Even though the Oura Application may provide additional unclaimed functionality, such as displaying activity, sleep, and readiness scores based on the data collected by the Oura ring that allow “a user to take advantage of the ring’s offerings,” this functionality is secondary to the ring’s ability to collect that data, without which, the Oura Application would serve no purpose. See Ex. 2019 ¶ 21; Ex. 2024, 93:22–95:22. As the Federal Circuit has explained, “there is rarely a perfect correspondence between the claimed invention and the product.” Fox Factory, 944 F.3d at 1374. Here, we find that on the spectrum of “unclaimed features,” the Oura Ring Application is closer to the “insignificant features” end because, while it allows the user to access and interpret data tracked by their Oura Ring, it does not materially impact the functionality of the Oura Ring or its structure.10 See Teva 8 F.4th at 1361 (explaining that “like the coextensiveness requirement itself, the concept of unclaimed features is best viewed as part of a spectrum”).” slip op. at 27
Patent outcomesUS 10,281,953 not shown unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,281,953 - 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 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.No claims unpatentablePTAB · Dec 17, 2025 · IPR2024-01077 · APJ Michael A Valek · IPR · Final written decision
Claims 1, 11, and 13–20 were not shown unpatentable over either Yuen and Mestas or Schröder and Mestas, principally because the curved-battery and waterproof-cavity showings were deficient.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“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.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We agree with Petitioner that the term “ring” is not limited to a finger- worn ring. All of the challenged independent recite a “wearable ring computing device” (claims 1 and 11) or “ring computing device” (claim 14). Nothing in the claim language itself refers to where that device is worn. Moreover, the fact that Patent Owner has in several related patents added claim language to expressly recite a ring that is “finger-worn” or “worn around the finger” evidences that the plain meaning of the term “ring” by itself does not require such. Ex. 1362, 44:45–46:61 (claims 1–18); Ex. 1363, 44:64–46:56 (claims 1–17); Ex. 1364, 48:22–23 (claim 1); see Nystrom v. TREX Co., Inc., 424 F.3d 1135, 1143 (Fed. Cir. 2005) (explaining that the fact that another claim recites a “wood decking board” suggests the term “board” is not itself limited to one made from wood or cut from a log because “[w]hen different words or phrases are used in separate claims, a difference in meaning is presumed”). This understanding is further supported by the Specification of the ’859 patent. It is true, as Patent Owner asserts, that the Specification describes a preferred embodiment that is a finger-worn ring. See, e.g., Ex. 1001, Figs. 22A–B, 23A (depicting a finger-worn ring). But precedent cautions against importing limitations from the preferred embodiment into claims. See, e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2004) (en banc) (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”). Indeed, the Specification here anticipates such arguments and makes clear that the applicants’ wearable computing device (WCD) is not limited to a ring worn on the finger: The WCD can be in the form of a ring that can be worn on the finger of a human (or animal) user. Although the WCD of the present disclosure is depicted as a ring that can be worn on the finger of a user, other shapes, designs, and form factors can be utilized for the WCD. For example, the WCD can be in the form of a wrist band, bracelet, necklace, earring, or any other type of wearable accessory. In this regard, references to the finger of a user in the present application can be considered to apply to other portions of a human body depending on the form of the WCD, such as wrist, neck, ear, etc. Ex. 1001, 8:51–61.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“ordinarily-skilled artisan to modify Yuen’s device to form the waterproof cavity recited in claim 1, much less explain the particular modifications Petitioner contends that artisan would have made to Yuen’s device housing to achieve such. This is particularly problematic given that the figures Petitioner relies upon in Yuen and Mestas uniformly depict larger, wrist/arm-band type devices. See Ex. 1006, Figs. 2–13, 12:52–55 (depicting a “wrist-worn or arm-mounted accessory such as a watch or bracelet”); Ex. 1010, Figs. 1–6, ¶ 151 (same). Thus, Petitioner’s obviousness theory requires multiple modifications to Yuen’s depicted structure: (1) modifying the identified portions of Yuen’s device housing so that they form a waterproof cavity therebetween; and (2) shrinking that device and its components down to a ring designed to fit around a single toe. We credit Dr. Mercier’s testimony that such modifications would require a “complex” re-engineering of Yuen’s existing structure that Petitioner and Dr. Anthony do not sufficiently explain. See Ex. 2018 ¶¶ 108–109, 129–130, 137–138. The testimony in Dr. Anthony’s supplemental declaration does not provide the missing explanation. Dr. Anthony continues to assert that Yuen’s sensor protrusion is sealed in the space between the alleged bounding members, relying on the same annotated versions of Figures 4 and 5, without addressing the fact that according to Petitioner’s own annotations those bounding members only form a shell that is open to the attachment band at either end. See Ex. 1079 ¶¶ 26–28. Indeed, Dr. Anthony appears to acknowledge that Yuen only teaches attaching the sensor module portion of the alleged cavity with watertight glue, but asserts that “it would not make sense to have a device that is waterproof in some areas and not others.” Id. ¶ 29. That assertion, however, is not supported by anything beyond Dr. Anthony’s say-so and ignores that Yuen’s teachings regarding a watertight seal/glue refer only to the sensor package portion of the alleged cavity. See Ex. 1006, 14:66–15:4, 15:10–14. Dr. Anthony’s assertion that Mestas teaches additional “waterproofing techniques” that could be applied to Yuen’s housing is similarly cursory. See Ex. 1079 ¶ 30. He does not identify what those techniques are or how a POSITA would use them to modify Yuen. Id. Accordingly, we do not credit this testimony.” slip op. at 27
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia with nexusDecided for patent owner
“the asserted evidence of secondary considerations and a patent claim if the patentee shows that the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988) (emphasis added)). “That is, presuming nexus is appropriate when the patentee shows that the asserted objective evidence is tied to a specific product and that product embodies the claimed features, and is coextensive with them.” Id. (internal quotation marks omitted). If, on the other hand, “the thing that is commercially successful is not coextensive with the patented invention—for example, if the patented invention is only a component of a commercially successful machine or process, the patentee is not entitled to a presumption of nexus.” Id. (internal quotation marks omitted).” slip op. at 33
Patent outcomesUS 10,139,859 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,139,859 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.All claims unpatentablePTAB · Dec 2, 2025 · IPR2024-00928 · APJ Neil T Powell · IPR · Final written decision
Claims 1–5, 11–13, and 16–18 are unpatentable as obvious over Schröder and Yuen, LeBoeuf, or LeBoeuf and Wissmar; Schröder alone did not render its challenged claims unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. PO Resp. 14. 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 ’034 patent and the references cited in the Petition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Petitioner has the better position, as we agree with Petitioner that the ’034 patent discloses an embodiment that uses transparent potting as a window, rather than to form the overall form factor and encapsulate components: [Figure] 16C is a perspective view of the WCD with potting material 1630. As described above, the PCB, battery, and components can be disposed within the space. Once disposed therein, a potting 1630 can be provided atop the components and within the cutaway portion 1616. The potting 1630 can be transparent to allow for transmission of light through the cutaway portions 1616. Ex. 1001, 20:51–57. This configuration is shown below in Figure 16C. “[Figure] 16C is a perspective view of the WCD with potting material.” Ex. 1001, 6:1–2. As Figure 16C shows, potting material 1616 forms a window in only a portion of the WCD’s exterior. can be used to encapsulate components and form the overall form factor in some embodiments. E.g., Ex. 1001, 17:4–8, 18:61–62. But Patent Owner does not persuade us that claim 12 is limited to those embodiments. PO Resp. 29; SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.”). Accordingly, we do not construe claim 12’s “external transparent potting” as requiring material that “forms the ‘overall form factor of the WCD 120, in addition to providing a housing for one or more electronic components,’” as suggested by Patent Owner. PO Resp. 29. Nor do we construe the claim language as requiring material that “also fills the space and encapsulates the components,” as suggested by Patent Owner. Id.” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We are not persuaded by Petitioner’s arguments and find that Patent Owner has the better position. Although Schröder describes some aspects that are similar to those of a printed circuit board, Petitioner has not sufficiently demonstrated that a person having ordinary skill in the art would understand Schröder’s inlay 12 or carrier foil to be a “printed circuit board,” as recited in independent claims 1, 11, and 16. As an initial matter, while Schröder refers to a “circuit board” in another context, it never refers to the carrier foil or inlay in its finger-ring embodiment as such. See Ex. 1007, 22:48–49; see also Ex. 1079 ¶ 21 (Dr. Anthony acknowledging that Schröder’s only reference to a “circuit board” is “unrelated to Schröder’s finger-ring teachings”). Instead, Schröder describes features of that inlay, explaining that “[t]he carrier foil itself consists of a flexible plastic material, e.g.[,] PET or Kapton” and “antenna coil 8 can for example be printed on the carrier foil by means of a conductive paste” and “a depression is manufactured in the carrier foil, e.g.[,] by milling, lasering, etching, before the chip module 10, the antenna coil 8 and optional further electronic devices are inserted into the depression.” Ex. 1007, 13:26–31, 13:35–37. Schröder further describes that “[a]t least one further foil can be applied to the carrier foil or the ring blank on at least one side” to produce a “multilayer foil composite” that can be “interconnected” by means of “glue” slip op. at 23
- Expert testimonyPetitioner expert discountedOther
“show that Schröder’s inlay 12 is a PCB. Relying on testimony from Dr. Anthony, Petitioner asserts that Schröder’s inlay 12 serves as a flexible carrier made of materials “commonly understood to be printed circuit board materials” such as PET and Kapton. Pet. 23 (citing Ex. 1002 ¶ 172; Ex. 1006, 12:28–29). Dr. Anthony did not provide a clear explanation of a person of ordinary skill in the art’s understanding of a PCB in his direct testimony. article describing a PCB as a “laminated sandwich structure of conductive and insulating layers” was an accurate description of a PCB: Q. So is the first sentence of this Wiki page, in your mind, an accurate description of a printed circuit board? A. So, the first sentence, “A printed circuit board (PCB)[] also called [a] printed wiring board, []is a laminated sandwich structure of conductive and insulating layers, each with a pattern of traces, planes, and other features (similar to wires on a flat surface) etched from one or more sheets of copper laminated onto or between sheet layers of nonconductive substrate.” And so your question again was? Q. Is that a fair definition of printed circuit board in your mind? A. It’s a fair description of the general process for circuit boards, layers of conductive traces.” slip op. at 21
Patent outcomesUS 9,582,034 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 9,582,034 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.Some claims unpatentablePTAB · Nov 25, 2025 · PGR2024-00030 · APJ Linda E Horner · PGR · Final written decision
Claims 17 and 18 are unpatentable under §112(d) for improper dependent form; claims 1–10 and 12–16 were not shown unpatentable on the asserted obviousness grounds.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We do not credit Dr. Anthony’s testimony, which is based on the arbitrary shading in Figure 7 (see Ex. 1002 ¶ 174), that Schröder teaches or suggests limitation 1[d] because it (1) is inconsistent with Petitioner’s reasoning for limitation 1[c], and (2) it is based on an admitted misreading of the embodiment of Schröder’s Figure 5 (see Ex. 1002 ¶ 175). As to the first item, Dr. Anthony states that “a POSITA would have been motivated to place a battery in a part of the cavity that is far from a PCB holding other electrical components because that configuration allows for better thermal management.” Ex. 1002, para. 175. The problem with this statement is that Petitioner relies on Schröder’s teaching that inlay 12, i.e., the alleged PCB, could include “other electrical components,” such as a battery to support its position that Schröder suggests placing a battery between the ring halves. See, e.g., Pet. Reply 2 (pointing to Dr. Mercier’s depo testimony that inlay 12 with “other components” is inserted between ring halves); id. at 3 (relying on Schröder’s teaching about placing components in depressions on inlay 12). So, Petitioner earlier asserts for the battery limitation 1[c] that Schröder teaches or suggests putting a battery on inlay 12 inside the ring halves, but then for limitation 1[d], Dr. Anthony testifies that a POSITA would place the battery “far” away from the inlay 12 (i.e., the alleged PCB). These positions are inconsistent.” slip op. at 25
- 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 ¶¶ 18–22). Petitioner also contends that a person of ordinary skill would have been “familiar with, for example, 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. 26. 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 ’178 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
“Patent Owner indicates that in the related ITC proceeding involving the ’178 patent, the Administrative Law Judge (ALJ) adopted three constructions agreed-upon by the parties in that proceeding8 and also construed two disputed terms.9 Resp. 26–27 (citing Ex. 2016, 5, 6, 14). Patent Owner agrees with Petitioner, however, that no terms need to be construed to decide the issues raised in the Petition. Id. at 27. We reviewed the constructions adopted by the ITC. Ex. 2016, 5, 6, 14. 8 In the ITC proceeding, the ALJ adopted the parties’ agreed-upon constructions that: (1) the preamble of claim 1 [a finger-worn wearable ring device] is limiting; (2) [positioned/configured to fit] within a “cavity” is [positioned/configured to fit] within a “hollow space”; and (3) [the internal housing component] “coupled with” [the external housing component] is [the internal housing component] “connected with” [the external housing component]. Ex. 2016, 5. 9 In the ITC proceeding, the ALJ construed the claims such that: (1) the internal and external housing components of claims 1, 12, and 17 enclose space and do not necessarily exclude potting material; and (2) “circumferential,” as recited in claims 1, 17, and 18, does not require a closed shape. Ex. 2016, 14, 17. These constructions are not germane to the issues we need to decide to resolve this proceeding. Thus, we agree that no explicit claim construction is necessary for this decision. To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context in which they are raised in our analysis below.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“The record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor, and “Mestas’s batteries, layout, and other components . . . would have to be scaled down 5 to 10 times to be appropriately sized for a finger worn ring.” Resp. 64 (internal quotation marks omitted) (citing Dr. Anthony’s cross-examination testimony at Ex. 2021, 313:12). Moreover, we do not credit Dr. Anthony’s testimony that miniaturization of the battery would have been “trivial to implement.” Ex. 1002 ¶ 242. Dr. Anthony admitted on cross-examination that it would not have been within the level of skill of a person having ordinary skill in the art to design a smaller version of Mestas’s battery, and that such a person would need to procure a battery of the appropriate size and specifications for implementation in a finger-ring from a battery manufacturer. Ex. 2021, 315:9–318:9. Yet Dr. Anthony had not ascertained, for purposes of his testimony, whether there was a battery available in 2013 that was appropriate to fit within the inlay space of the modified version of Schröder’s finger-ring that he and Petitioner allege would have been obvious to one of skill in the art at that time. Id. at 321:5–10. Further, we credit Dr. Mercier’s testimony that Dr. Anthony’s testimony fails to consider the differences in power requirements between Mestas and Schröder or to account for the constraints of such a substantially smaller form factor in Schröder’s finger-ring as compared to Mestas’s wrist device. Ex. 2018 ¶¶ 159–160. 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 ’178 patent, we also have evidence that prior art “finger ring wearables up to the ’178 patent had used ‘coin’ type batteries.” Id. at 66 (citing Ex. 2018 ¶ 161). We credit Dr. Mercier’s testimony that a person having ordinary skill in the art would look to a coin type battery for the necessary power requirements of Schröder’s device. Ex. 2018 ¶ 161. 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), Fig. 24; Ex. 2018 ¶¶ 61–70. 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 ¶ 71. Based on these findings, Petitioner has not met its burden to show by a preponderance of the evidence that a person having ordinary skill in the art would have been led to modify Schröder’s finger-ring to place a curved battery between the internal and external housing components in light of the teachings in Mestas. Thus, Petitioner has not met its burden to show by a preponderance of the evidence that dependent claim 3 of the ’178 patent is unpatentable over Schröder and Mestas.” slip op. at 38
Patent outcomesUS 11,868,178 mixedClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,868,178 - PTAB · Nov 13, 2025 · PGR2025-00042 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1, 2, 5, and 7–33, finding likely written-description and enablement failures; it found the obviousness showing insufficient.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XII. CONCLUSION Petitioner has, at this stage of the proceedings, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIII. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1, 2, 5, and 7–33 of the ’618 patent is hereby granted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 46
- Skill levelSkill level petitioner adoptedOther
“Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’618 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 15–16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“On this record, however, we find that the entire text quoted above is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:2–4; see Ex. 2001 ¶¶ 48, 67 (stating a “patent’s definition controls”). Indeed, while some of the language in the definitional paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:1–11. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example as Patent Owner posits, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’618 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Moreover, Dr. Triggs-Raine recognizes the “therapeutic use of hyaluronidases” and notes that “different hyaluronidases were known to have different functions and substrates.” Ex. 2001 ¶¶ 29, 113.6 That is, Dr. Triggs-Raine recognizes hyaluronidase activity as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Instituted
“Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. Ariad explains that for generic claims the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus. Id. at 1349. Ariad explains “that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. at 1350. Ariad also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. . . . But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Id. slip op. at 21
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,037,618 - PTAB · Oct 16, 2025 · PGR2025-00052 · APJ Cynthia M Hardman · PGR · Institution
The Board instituted PGR on claims 1–17 because the written-description and enablement challenges met the more-likely-than-not threshold; it found the indefiniteness and obviousness challenges insufficient.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post grant review. See 35 U.S.C. § 324; 37 C.F.R. § 42.4(a). Considering the arguments and evidence presented, we institute a post grant review because Petitioner demonstrates “that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). The following preliminary findings of fact and conclusions of law are made solely to determine whether to institute review. Any final decision will be based on the full trial record.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to [the] study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16–17 (citing Ex. 1003 ¶¶ 13, 35–36). At this stage of the proceeding and on the record before us, we apply Petitioner’s proposed POSA level, which is presently undisputed and appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownOther
“The definition of “modified PH20 polypeptide” in the ’345 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:8–11. That is, the definition of “modified PH20 polypeptide” in the ’345 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’345 patent to encompass polypeptides with some hyaluronidase activity. The ’345 patent provides a specific definition of the term “hyaluronidase domain,” i.e., a “region of about 340 amino acids in length that corresponds to amino acid residues 38-374 of the precursor human PH20 sequence set forth in SEQ ID NO:6.”6 Ex. 1001, 68:19–24.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Any final written decision entered in this case may include final claim constructions that differ from the preliminary understanding of the claims set forth above. Any final claim constructions will be based on the full trial record.” slip op. at 10
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham · NautilusPatents in suitUS 12,264,345
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.