- Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Mar 25, 2026 · IPR2024-01498 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over the Lesniak- and Native-based grounds; the Squatch and Sturgis ground fails because Squatch was not shown to be a printed publication.
RulingsFinal written decision- BurdenDecided for patent owner
“We agree with Patent Owner that Petitioner has not shown sufficiently that Squatch is a printed publication. As described above, Petitioner relies on Squatch as a “website excerpt” placed on its site at the relevant time, but has not produced a screen shot of the website to show that it ever existed. See Ex. 1059. Petitioner provides internal documents that purport to describe what would have been on Dr. Squatch’s website at the relevant time, but falls short of establishing what was on the website for the interested consumer to view. Thus, we determine that this ground fails.” slip op. at 55
- Skill levelSkill level petitioner adoptedDecided for petitioner
“or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 17 (citing Ex. 1002 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. We adopt and apply Petitioner’s proposed definition of a POSA, which is consistent with the level of skill reflected in the asserted prior art. See e.g., Exs. 1003, 1004.” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a secondary wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Pet. Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claims 1, 16, and 19 reciting “a deodorant stick” is limiting as it provides antecedent basis for the recitation of “said deodorant stick being free of an aluminum salt” for each independent claim. PO Resp. 7–10. Patent Owner also points to dependent claims 6–9 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 9. We agree. Petitioner does not argue to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick).” slip op. at 8
Patent outcomesUS 11,844,752 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,752 - 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 - Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentablePTAB · Mar 10, 2026 · IPR2024-01209 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–27 are unpatentable as obvious over the asserted combinations, principally Racz, Fitz, and Lee; both parties’ motions to exclude are dismissed as moot.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“PO Resp. 30 (citing Ex. 2006 ¶ 58). Patent Owner’s proposal is too narrow in two respects. First, it mandates certain education and experience in RF neurotomy specifically. This is too narrow as the description of the scope of the invention set forth in the ’782 patent as described above is not limited to RF neurotomy. Second, it requires the POSA to be both a physician who performs thermal ablation (RF neurotomy specifically) and an engineer with training and experience “in the design and development of devices and methods” for performing the same. Id. This is too narrow because it excludes physicians and other advanced degree holders who research and design devices and methods for performing thermal ablation but do not actually operate on patients. We adopt the Petitioner’s definition of a POSA, quoted above, as it is reflective of the level of skill in the art when viewed in light of the disclosure of the ’782 patent. Supra (quoting Pet. 11).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 12 (citing Ex. 1031 ¶106 (Dr. Robert D. Tucker’s11 testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 12. We likewise find no need to do so now, as neither party has proposed a construction for any claim term and none of the parties’ arguments turns on a disputed meaning of any claim language.” slip op. at 11
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“(Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Clay, 966 F.2d at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 34. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 18.” slip op. at 24
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 148 of his declaration. Ex. 1031 ¶148. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶110–117 (Racz), ¶¶118–123 (Fitz), ¶¶124–131 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶132–147). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he has “been a Professor at the University of Iowa where [he] direct[s] an active research program in radiofrequency electrosurgical procedures and instrumentation.” Ex. 1031 ¶3. He has a Ph.D. in biophysics, and he is also a medical doctor (albeit he is not Board certified as pointed out by Patent Owner19). Id. ¶2. He also has additional training and experience that is relevant, but which is not necessary, but further establishes that he is well qualified to offer the opinions set forth in his declaration. Id. ¶¶2–11. Patent Owner argues that Dr. Tucker is not qualified to testify here because “he is not Board certified” and he is “not a pain-specialist physician and has never performed a neurotomy.” PO Resp. 30. Dr. Tucker explained, however, that he is not Board certified nor does he operate on 19 See PO Resp. 30 (citing Ex. 2020, 10:19–12:20). patients because his work focuses on the development of instrumentation, not the use of it, explaining on cross-examination:” slip op. at 39
Patent outcomesUS 10,966,782 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,966,782 - Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentablePTAB · Mar 6, 2026 · IPR2024-01211 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 18–47 and 53–74 are unpatentable as obvious over the asserted combinations of Racz, Fitz, Lee, and the additional references in Grounds 2–8.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In sum, the field of the invention is thermal ablation. It encompasses RF neurotomy, but it is not limited to RF neurotomy. With that settled, we turn now to the person of ordinary in the field/art (POSITA or POSA).” slip op. at 17
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 162 of his declaration. Ex. 1033 ¶162. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶124–131 (Racz), ¶¶132–137 (Fitz), ¶¶138–145 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶146–161). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he” slip op. at 39
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“35. “Although § 103 does not, by its terms, define the ‘art to which [the] subject matter [sought to be patented] pertains,’ this determination is frequently couched in terms of whether the art is analogous or not, i.e., whether the art is ‘too remote to be treated as prior art.’” In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992) (quoting In re Sovish, 769 F.2d 738, 741 (Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Id. at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 33. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 17.” slip op. at 25
- BurdenDecided for petitioner
“Patent Owner does not identify any legal requirement for petitions to illustrate proposed combinations of prior art features. Indeed, the very statute identified by Patent Owner as “requiring petitions to set forth challenge grounds ‘with particularity’” (see PO Resp. 36) calls for the requisite particularity to be “in writing,” not by illustration. See 35 U.S.C. § 312(a)(3) (“A petition filed under section 311 may be considered only if . . . (3) the petition identifies, in writing and with particularity . . . the grounds on which the challenge to each claim is based.”). Simply put, there is no legal requirement to provide multiple illustrations of a proposed combination of prior art features (as Patent Owner implies), let alone a single illustration (as Petitioner has done).” slip op. at 28
Patent outcomesUS 10,736,688 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,736,688 - Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentablePTAB · Mar 6, 2026 · IPR2024-01210 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–17 and 48–52 are unpatentable as obvious over the asserted combinations of prior art, principally Racz, Fitz, and Lee.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In sum, the field of the invention is thermal ablation. It encompasses RF neurotomy, but it is not limited to RF neurotomy. With that settled, we turn now to the person of ordinary in the field/art (POSITA or POSA).” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“F.2d 656, 658 (Fed. Cir. 1992) (quoting In re Sovish, 769 F.2d 738, 741 (Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Id. at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59.” slip op. at 24
- BurdenDecided for petitioner
“illustrate proposed combinations of prior art features. Indeed, the very statute identified by Patent Owner as “requiring petitions to set forth challenge grounds ‘with particularity’” (see PO Resp. 36) calls for the requisite particularity to be “in writing,” not by illustration. See 35 U.S.C. § 312(a)(3) (“A petition filed under section 311 may be considered only if . . . (3) the petition identifies, in writing and with particularity . . . the grounds on which the challenge to each claim is based.”). Simply put, there is no legal requirement to provide multiple illustrations of a proposed combination of prior art features (as Patent Owner implies), let alone a single illustration (as Petitioner has done).” slip op. at 26
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“a POSA would have had an apparent reason to make Racz’s modified device. Pet. 22–27. We need not address these additional arguments and evidentiary citations, however, as Petitioner has demonstrated by a preponderance of the evidence that implementing deployable filaments on the distal tip of an RF ablation device was a known technique for expanding and controlling the ablation volume. Thus, so long as there would have been a reasonable expectation of success in making Racz’s modified device (addressed infra), the combination would have been obvious. See Intel Corp., 61 F.4th at 1380 (“[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”); Medichem, 437 F.3d at 1165 (“[A]n obviousness determination requires not only the existence of a motivation to combine elements from different prior art references, but also that a skilled artisan would have perceived a reasonable expectation of success in making the invention via that combination.”).” slip op. at 31
Patent outcomesUS 10,736,688 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,736,688 - Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentablePTAB · Mar 5, 2026 · IPR2024-01212 · APJ Arthur M Peslak · IPR · Final written decision
Claims 1–29 are unpatentable because Petitioner showed by a preponderance of the evidence that the asserted prior-art combinations rendered them obvious under §103.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. In this case, we must determine whether one of ordinary skill in the art would recognize that applying the teachings of Fitz and Lee of deploying multiple filaments to increase and control the ablation volume to Racz’s distal tip would improve Racz’s device in the same way. For us to resolve this question in Petitioner’s favor, Petitioner must provide “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. at 418 (citing In re Kahn, 441 F.3d at 988). However, bodily incorporation, i.e., “an actual physical substitution of” Lee’s filaments into Racz is not required. See In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.”); In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”).” slip op. at 30
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“11. Balancing the Graham Factors After weighing all the evidence submitted by the parties in light of the Graham factors, we determine Petitioner has demonstrated by a preponderance of the evidence that the claims 1, 3–10, 18–26, 28, and 29 would have been obvious over Racz, Fitz, and Lee. As discussed above, Petitioner’s evidence establishes that the combination of Racz, Fitz, and Lee teaches every limitation of claims 1, 3–10, 18–26, 28, and 29 and that an ordinarily skilled artisan would have been motivated to combine Racz, Fitz, and Lee with a reasonable expectation of success. Further, as discussed above, Patent Owner’s evidence of secondary considerations is entitled to little, if any, weight because Patent Owner fails to establish nexus. Consequently, after considering all the evidence in the record both for and against patentability, we determine that Petitioner has shown by a preponderance of the evidence that claims 1, 3–10, 18–26, 28, and 29 would have been obvious over Racz, Fitz, and Lee. E. Ground B: Obviousness in view of Racz, Fitz, Lee and Young ’965 Petitioner contends that claims 1–10, 18–26, and 28–29 are also obvious over Racz, Fitz, Lee, and Young ’965. Pet. 62–67. Patent Owner argues that Young ’965 does not cure the alleged deficiencies in Ground 1, is directed to tumor ablation not neurotomy, would require a substantial redesign of Racz’s modified device, and there is no motivation to combine. PO Resp. 59–60. We start with a brief overview of Young ’965 and address the parties’” slip op. at 78
- ExcludeMotion to exclude, deniedDenied
“Accordingly, both Motions are dismissed as moot.” slip op. at 94
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of” slip op. at 12
Patent outcomesUS 10,925,664 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,925,664 - Alamar Biosciences, Inc. v. Olink Proteomics ABNo claims unpatentablePTAB · Mar 4, 2026 · IPR2024-01353 · APJ Tawen Chang · IPR · Final written decision
Claims 1–20 were not shown unpatentable: the asserted obviousness grounds failed, including because Kanan and Neri did not teach selecting the claimed cis-reactive cells.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Accordingly, for purposes of this decision we adopt Petitioner’s proposal of a person of ordinary skill in the art, with the following changes noted in italics below: A person with “an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to small molecules and proteins and would have been familiar with nucleic acid chemistry and conventional hybridization techniques; and (b) access to one or more team members having an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to high throughput screening techniques such as nucleic acid sequencing. A person could also have qualified as a POSA with less formal education and more technical or professional experience.11 We emphasize, however, that our decision would not change if we instead used Patent Owner’s proposed definition of a POSA.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Because the parties have placed the limitation “selecting all cis- reactive cells exhibiting the detectable trace” into controversy, we construe the term below, but only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)). For the reasons discussed below, we agree with Patent Owner that the plain and ordinary meaning of this phrase, in light of the language of the claims, the Specification, and the prosecution history of record, requires “selecting all of the [molecular complexes or structures] meeting the defined criteria for [cis-reactive cells (CRCs)] and exhibiting the detectable trace.” Sur-reply 8 (citing Ex. 2008 ¶¶ 94, 98–119). We further agree that cis-reactive cells should be construed to mean “an association of at least two interactor moieties, joined by an associated oligonucleotide.” (PO Resp. 9 (quoting Ex. 1001, 9:35-37)). Accordingly, we determine that, properly construed, the claims require that what is “selected” at step 1(d) — what is differentiated or set apart from other molecular complexes or structures in the reaction mixture at the conclusion of step 1(d) — to be “an association of at least two interactor moieties joined by an associated oligonucleotide” that exhibits the detectable trace.” slip op. at 16
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We agree that Petitioner has not shown that the combination of Kanan and Neri teaches “selecting all cis-reactive cells exhibiting the detectable trace,” as we have construed that phrase above. In particular, we determine that, properly construed, the limitation requires the selection of “all associations of at least two interactor moieties joined by an associated oligonucleotide and exhibiting the detectable trace.” Instead, as described in Kanan, what is “selected” is the molecules of interest joined by bond formation, with only one of the molecules of interest coupled to a nucleic acid moiety. Thus, the selected molecular complex or structure does not comprise two interactors (i.e., two molecules of interest coupled to NAMs). Moreover, to the extent there are two interactors, they are joined by the bond between the molecules of interest rather than an associated oligonucleotide.” slip op. at 35
- ExcludeMotion to exclude, deniedDenied
“III. PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE Patent Owner moved to exclude Exhibit 1008, on the ground that it contains settlement statements and that Rule 408 of the Federal Rule of Evidence prohibits Petitioner from using the statements to impeach or contradict Patent Owner. Mot. 5. Because we do not rely in our analysis on this exhibit, we dismiss the Motion to Exclude as moot.” slip op. at 43
Patent outcomesUS 7,883,848 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,883,848 - Penumbra, Inc. v. Rapidpulse, Inc.No claims unpatentablePTAB · Feb 17, 2026 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–20 were not shown unpatentable because the asserted combinations did not teach the claimed predetermined cycle for controlling distal fluid flow.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its PO Response, it “accepts ¶ 44). We adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“specification explicitly includes sensors similar to those in the prior art in support of their argument that the claimed “predetermined cycle” must not exclude the use of such sensors. Pet. Reply 15 (citing Ex. 1001, 32:55–33:7, 40:66–41:5, 44:9–29). We reviewed the portions of the specification cited by Petitioner. We agree with Patent Owner that one excerpt discussing sensor use appears to be directed to triggering the predetermined cycle rather than causing timing changes during the cycle itself (Ex. 1001, 32:55–66) (describing use of a pressure sensor to “determine when the vacuum channel 3 is clogged by a thrombus and automatically perform the unclogging procedures described herein”), while another excerpt discusses a sensor that Petitioner that the ’402 patent discusses the use of sensors to “tune” the system and that such “tuning” can be done statically (setting the cycle timing in advance) or dynamically (adjusting the timing during the cycle itself). See Ex. 1001, 48:19–49:50. Overall, we find that these disclosures involving sensors demonstrate that sensors may be used in various ways in different embodiments. However, none of these disclosures explicitly discuss the use of sensors in conjunction with a “pre-determined cycle.” Therefore, we find that the ’402 patent specification’s discussion of “sensors” are not particularly informative as to the appropriate construction of a “predetermined cycle” and do not outweigh the other explicit disclosures of “predetermined cycle” in the patent. We next turn to the other intrinsic evidence discussed by the parties — the prosecution history. As discussed by Patent Owner, in the Notice of Allowance, the Examiner found that Garrison did not teach or suggest a “predetermined cycle” because Garrison’s controller “changed the cycle of opening and closing the valves based on feedback from sensors.” Ex. 1004, 86. We acknowledge that the patent applicant filed subsequent comments during prosecution in which they stated that they “do[] not concede that the Examiner’s characterizations of the terms of the claims and the prior art are correct.” Id. at 29. However, we agree with Patent Owner that the importance of the Examiner’s statement in the Notice of Allowance does not rely on it being an express disclaimer (a standard which it does not meet). PO Sur-reply 8. We also considered Petitioner’s contention that the Examiner’s interpretation of Garrison may have been in error (PO Resp. 16); however, even if this were true, the Examiner’s statement still provides helpful insight into how the Examiner was interpreting the term sensors to change the opening and closing of valves during a cycle was not a “predetermined cycle.” Id. at 86. In sum, we find that Patent Owner’s proposed construction is consistent with the usage of the term “predetermined cycle” in the ’402 patent specification and prosecution history. Thus, after considering all of the cited evidence, we construe “predetermined cycle” to mean that “the timing of the sequence of valve operations in the cycle is determined beforehand, i.e., fixed, rather than varying based on feedback after operation begins.”” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“2. Other Terms The parties also provided proposed constructions for the limitations of “[limited/limiting] to a positive amount of exit flow” and “control[ling] fluid flow in and out from the distal end of the catheter.” See Pet. 15–16; Pet. Reply 1–8; PO Resp. 22–24; PO Sur-Reply 2–6. However, having evaluated the arguments and evidence before us, we determine that construction of these terms is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“We agree with Patent Owner that neither Petitioner nor Mr. Brown propose any combination of Yang and Mullins that does not include Mullins’s pressure sensor in order “to control fluid flow in and out from the distal end of the catheter.” Indeed, in addressing the “predetermined cycle” limitation, Mr. Brown contends that Mullins discloses a “cycling controller that ‘varies aspiration pressure according to sensed pressure within the catheter lumen.’” Ex.1005 ¶¶ 131–32 (citing, e.g., Ex.1008, 27:40–28:20 (“[a] novel aspect of this pump system is the incorporation of feedback into the pump algorithm in order to produce more effective pressure cycling”)). This use of a sensor to change pressure during a cycle, is not a “predetermined cycle” under our construction. combinations is its discussion of distal end flow control, not for its sensors.” Pet. Reply 17 (citing Ex. 1035 ¶ 83). However, Petitioner’s obviousness grounds rely on the combination of Yang and Mullins, especially with regard to Mullins’s disclosure of “a controller” in order “to control fluid flow in and out.” As discussed above, Mullins relies on the sensor-feedback approach in order to control flow and we find that Petitioner has not presented persuasive evidence of how the combined disclosures of Yang and Mullins would control flow without using Mullins’s sensor feedback approach. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (error to “consider[] … references in less than their entireties, i.e., in disregarding disclosures in [them] … that diverge from and teach away from the invention”). Therefore, we determine that Petitioner has not sufficiently shown that the combination of Yang and Mullins discloses or renders obvious “a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle to change a level of vacuum at the distal end of the catheter and to control fluid flow in and out from the distal end of the catheter.” Accordingly, having considered the parties’ respective evidence and arguments, we find that Petitioner has not shown by a preponderance of the evidence that claim 1 of the ’402 patent would have been unpatentable as obvious over the combination of Yang and Mullins.” slip op. at 27
Patent outcomesUS 11,406,402 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,406,402 - Alpinestars S.P.A. / Alipinestars USA Inc. v. Dainese S.P.A.Rehearing deniedPTAB · Feb 9, 2026 · IPR2025-00750 · APJ Benjamin D M Wood · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show a reasonable likelihood of prevailing on claims 1–22 under the challenged obviousness grounds.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Petitioner misstates the Decision’s reasoning. As is clear from the previous discussion, we determined that Petitioner’s articulated reasons for combining EP’536 with CN’180 lacked a rational underpinning, not because “EP’536 does not relate to ‘air bags,’” but because the means by which EP’536’s device inflates differs fundamentally from that of CN’180’s device. Dec. 17–18. Petitioner did not acknowledge this critical difference in the Petition, and continues not to do so in its Rehearing Request.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“EP’536 with CN’180 lacked a rational underpinning because EP’536’s inflation mechanism differs fundamentally from CN’180’s inflation mechanism. Dec. 17–18. As we stated, whereas CN’180’s fall-protection belt uses an airbag that requires an external source of pressurized air to inflate, EP’536’s garment does not need an external inflation device because “the gas generating agent 18 in each envelope automatically generates gas and inflates the envelopes in response to rising temperatures.” Id. at 18 (citing Ex. 1004 ¶ 15; Ex. 1005 ¶¶ 5, 19). This difference reflects the fundamentally different purposes of the two devices: CN’180’s device is designed to provide “fall protection” to, e.g., “elderly people,” (Ex. 1005 ¶ 1, 3), whereas EP’536’s device provides “adaptive thermal insulation” for, e.g., garments worn by fire fighters. Ex. 1004 ¶¶ 1–3, 250. Because of the different means by which EP’536’s and CN’180’s devices inflate and the different purposes for doing so, we were not persuaded that one of ordinary skill in the art would have combined the references as Petitioner proposed. Dec. 18. We further noted that the modification would not have improved the reusability of EP’536’s device “by having only one mechanism to recharge,” because EP’536’s “gas generating agent does not need any ‘mechanism to recharge.’” Dec. 18. Instead, we noted EP’536’s teaching that its gas generating agent “automatically recombines or condenses in response to a temperature decrease to return the envelopes, and therefore the garment, to its original thickness, at which point the gas generating agent is ready for subsequent reactivation.” Id. (citing Ex. 1004 ¶¶ 139–141). Finally, we determined that replacing EP’536’s envelopes with CN’180’s airbag “would have made EP’536’s invention unsuitable for its intended purpose: providing a protective garment with ‘adaptive thermal insulation.’” Dec. 19. We stated that “Petitioner does not suggest, and we have found nothing in the record to establish, that CN’180’s airbag would provide this feature.” Id. at 20.” slip op. at 3
- Obviousness (§103) › KSR rationalesMotivation not foundNot shown unpatentable
“rationales for combining EP’536 and CN’180. Reh’g Req. 6–7. First, Petitioner asserts that we “improperly rejected Petitioner’s ‘simple substitution’ evidence in view of [the Board’s] incorrect conclusion that EP’536 does not disclose an ‘external source of inflation [EP’536’s dosing aids].’” Id. at 6 (citing Dec. 18–19). This argument is unpersuasive at least because, as we discussed above, EP’536’s dosing aids do not constitute an external source of inflation. Petitioner further argues that we incorrectly evaluated its “obvious to try” rationale because, contrary to our analysis, Petitioner did in fact identify a problem to be solved by its “finite number of solutions”: “simplify[ing] the design and reduc[ing] the number of required inflation mechanisms.” Id. at 6–7. The Petition’s entire “obvious to try” discussion is as follows: [A] POSITA would have found it obvious to try a one-piece airbag 10 with strip-shaped inflation units 12 in the EP’536- CN’180 airbag system because it would have been a selection from a finite number of identified predictable solutions (i.e., using one chamber with connected individual inflation units 12 versus multiple individual envelopes 20). 5 Petitioner also argues that dosing aids are “needed in order to make the disclosed device reusable.” Reh’g Req. 5–6. This is incorrect, as EP’536 conveys that the reusability of the device is a result of the gas generating agent condensing or recombining when temperatures fall. Ex. 1004 ¶¶ 139– 141. Even if it were true, however, it is unclear how it would support Petitioner’s argument. Pet. 16. As is evident, Petitioner did not identify a design need, market pressure, or other problem that would have been addressed by its identified “solutions,” and therefore we were not persuaded by this rationale. Dec. 19. Petitioner’s attempt to cure this deficiency in its Rehearing Request is tardy. We cannot misapprehend or overlook an assertion that Petitioner fails to make in the Petition. It is also insufficient. Petitioner does not provide any evidence of a known design need or market pressure to “simplify [EP’536’s] design” or reduce the number of “required inflation mechanism” it uses.” slip op. at 7
§ 103 obviousnessPatents in suitUS 12,012,065 - 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
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.