- Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthSome claims unpatentablePTAB · Aug 4, 2026 · IPR2025-00249 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1 and 4–8 are unpatentable: claims 1 and 4–6 as obvious over Huang2 and Kuo, and claims 7–8 as anticipated by Huang2; claims 2–3 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for patent owner
“(“POSITA”) “would be a Ph.D. student with a minimum of two years of experience in their faculty advisor’s laboratory” and would have an understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 20– 21 (citing Ex. 1003 § II.C7). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:28–29. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”). Importantly, the Specification does not treat the existence of minor peaks as prerequisites for the existence of major peaks. Indeed, the Specification does not discuss “minor peaks” at all. See generally Ex. 1001. Likewise, none of the claims of the ’227 patent, whether challenged or unchallenged, recites “minor peaks” or any additional peaks beyond the disputed “major peaks.” Id. at 23:30–24:42. Nor does the Specification include an example of FFT analysis results in which the average of the peaks therein is calculated and those higher than the average are identified as major peaks.8” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMixed
“Petitioner has the better position. Huang2 teaches crosslinking and provides a reason for doing so (stability). In particular, Huang2 states: “To better mimic skin ECM, electrospun collagen fibers have been fabricated, however, the rapid degradation and poor mechanical properties determine that either crosslinking or combination with other materials is necessary to obtain a stable scaffold.” Ex. 1005, 1791 (emphasis added). It is true that, in describing work actually carried out, Huang2 states that blending with PCL was performed and does not mention crosslinking. See id. at 1792 (“Nanofibrous matrices of PCL and Collagen at a weight ratio of 3:1 were fabricated using electrospinning as previously described.”). However, the prior art – here, Huang2 – is not limited to that which it describes having created. See In re Mills, 470 F.2d 649, 651 (C.C.P.A. 1972) (“a reference is not limited to the disclosure of specific working examples”); see also In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”); In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (“It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art.”). Huang2 teaches two stabilization methods when using collagen in scaffolds. Huang2 states that one or the other “is necessary to obtain a stable scaffold” (when using collagen), but it does not preclude or teach away from using Patent Owner-cited testimony of Dr. Mikos is not as definitive as Patent Owner suggests; Dr. Mikos’s testimony is that a person of ordinary skill in the art “typically would not have done both.” Ex. 2015 ¶64 (emphasis added). The bottom line is that Huang2 teaches the person of ordinary skill in the art two ways to stabilize scaffolds/matrices comprised of collagen, provides a reason for doing so (stability), and does not teach away from using both. We are persuaded that a “scaffold comprising crosslinked fibers comprising collagen” would have been obvious in view of the cited teachings of Huang2.” slip op. at 33
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We are not persuaded by Appellant’s citations to either reference. As discussed above, Petitioner’s Ground 1 is premised on a person of ordinary skill in the art altering the native flat sheet structure of Huang2 by rolling it into a jelly-roll structure as taught by Kuo. See Pet. 41 (Beginning its claim 2 arguments with the following: “Claim 1 is obvious for the reasons expressed above in § X.A., supra, which are incorporated herein.”); see also Pet. Reply 17 (“[B]ased on the explicit teaching of Kuo, a POSA would have been motivated to take the electrospun flat scaffold made by the techniques of Huang2, seed it with the desired cells, and roll it to treat a tendon and ligament.” (emphasis added)). Indeed, the paragraphs of Kuo that Petitioner cites for disclosing “scaffold sheets,” explicitly describe rolling them into jelly-roll like structures. See Ex. 1018 ¶7 (stating that “the sheet is spirally contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct”), ¶22 (describing a method comprising “forming a tissue construct by contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct” and implanting it in a patient). Petitioner fails to argue that that “one or more elongated sheets” recited in claim 2 would encompass the rolled structure of its proposed modification. Nor does Petitioner articulate a claim construction argument that could support such an argument. Petitioner has failed to prove, by a preponderance of the evidence, that claim 2 would have been obvious over Huang2 and Kuo.” slip op. at 42
Patent outcomesUS 11,318,227 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSRPatents in suitUS 11,318,227 - Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthAll claims unpatentablePTAB · Aug 4, 2026 · IPR2025-00248 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–3 and 5–12 are unpatentable as anticipated by Huang2; claim 4 is unpatentable as obvious over Huang2 and Kumbar. Lee grounds failed.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 18– 19 (citing Ex. 1003 § II.C5). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 5–6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“A patentee “may choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (citing Hoechst Celanese Corp. v. BP Chemicals Ltd., 78 F.3d 1575, 1578 (Fed. Cir. 1996)); see Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc) (“[A]ny special definition given to a word must be clearly defined in the specification.”), aff'd, 517 U.S. 370 (1996); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). “[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.” Bell Atlantic Network Services, Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). Among the criteria to consider in whether the patentee acted as a lexicographer to define a claim term include (a) whether the patent specification included the statement in question under a section for marks, (c) whether the sentence uses the term “refer to,” which generally “conveys an intent for [that sentence] to be definitional,” and (d) whether there are other non-limiting terms (e.g., “for example,” or “include”) that contradict a definitional intent. Alnylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (alteration in original). At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:6–7. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at issue sets out “major peaks” in quotation marks, and then uses the term “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“As discussed above, we agree with Patent Owner that the sentence it cites from the Specification of the ’223 patent bears sufficient hallmarks of lexicography. However, the Specification nonetheless lacks any indication that so-called “minor peaks” are a necessary component of the claimed invention. “Although it is firmly settled that an applicant may act as a 9 Figure 8B does not contain “major peaks” despite clearly depicting two “peaks higher than the average of the [three or possibly four] peaks in the result” because none of the peaks is a reflection of fiber alignment. 10 After presenting claim construction arguments based on Ayres 2008, Patent Owner confusingly states: “Finally, whether Ayres-2008 supports [Patent Owner’s] construction is irrelevant.” PO Sur-Reply 5 (emphasis added). definition that is contrary to the ordinary meaning of a claim term unless it communicates a deliberate and clear preference for this alternative definition.” Kumar v. Ovonic Battery Co., 351 F.3d 1364, 1368 (Fed. Cir. 2003). There is no indication that the patentee sought to require “minor peaks” within the scope of the claimed invention. Nor are we persuaded that a person of ordinary skill in the art would readily understand the scope of the term “major peaks” to require non-major peaks. We interpret the Specification’s statement that “‘major peaks’ herein refer to peaks higher than the average of the peaks in the result” (Ex. 1001, 13:6–7) to be teaching a person of ordinary skill in the art how to identify or discern “major peaks,” which indicate a principal axis of alignment, from any non-major peaks, which would be caused by something else. We conclude that a person of ordinary skill in the art would consider “major peaks” as used in the ’223 patent as referring to peaks that reflect the sole axis or primary axis of fiber alignment. See, e.g., id. at code (54) (“ALIGNED FIBER AND METHOD OF USE THEREOF”), code (57) (“A scaffold comprising an aligned fiber.”), 1:6–7 (“The invention relates to an aligned fiber and method of use thereof.”), 1:11–12 (“The invention relates to a scaffold comprising an aligned fiber.”), 13:16–17 (“Alignment of the fibers in the scaffold may be measured by a fast Fourier transform (FFT) analysis.”). This would certainly include peaks materially higher than the average of the peaks in the result, but it would not be limited to situations involving peaks of different heights or require so-called minor peaks. Based on the totality of the evidence before us, we do not construe the claims to require non-major peaks.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Petitioner argues that, for the aligned sample, a major peak occurs at about 90° as identified by Petitioner’s annotation (red arrow). Pet. 30–31. As support, Petitioner directs us to Huang2’s explicit description of what the peak indicates, namely that “[t]he narrow peak of the normalized intensity values in anisotropic [aligned] matrices (Figure 1C) indicated that PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 31 (alterations in original) (quoting Ex. 1005, 1794). Patent Owner disputes that the illustrated peak is a major peak solely based on the lack of any lesser peaks. See PO Resp. 13 (“[T]he height of the sole peak is identical to—not higher than—the average height of the peaks in the result.”). As discussed above, however, we do not construe “major peaks” as requiring the existence of non-major peaks. We find that the illustrated peak in the Aniso plot of the FFT analysis results (Figure 1C) is a major peak within the meaning of the claim. The evidence in support of this finding is overwhelming. First, the term “Aniso” as used in Huang2 refers to fibers “with alignment.” Ex. 1005, 1792. Huang2 describes fabricating such matrices of aligned fibers with electrospinning, the same method used to impart alignment in the ’223 patent. Id. at 1791–92. Huang2 visually confirms that the fibers in fact are aligned via scanning electron microscopy. Id. at Fig. 1B. Further, Huang2 explicitly states that the peak illustrated in the Aniso plot of the FFT analysis results (Figure 1C) is caused by the fact that the “PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 1794. This is precisely what electrospinning may yield aligned fibers and images of aligned fibers will yield FFT results with major peaks. Ex. 1001, 2:18–19, 4:46–60, 13:16–26. Additionally, Huang2 itself considers the peak illustrated in the Aniso plot of the FFT analysis to be significant, stating: “In contrast [to the Aniso plot], the lack of a significant peak for the fibers collected on a stationary surface [(i.e., without electrospinning)] demonstrated no preferred fiber orientation in the isotropic matrices” (i.e., the Iso plot). Ex. 1005, 1794. Indeed, the asserted major peak in the Aniso plot shown in Huang2’s Figure 1C is higher than any other data point on the plot. For these reasons, we find the peak to be a major peak.15 Petitioner acknowledges that Figure 1C only reports its results” slip op. at 32
Patent outcomesUS 10,137,223 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · MarkmanPatents in suitUS 10,137,223 - 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 - Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentablePTAB · Mar 16, 2026 · IPR2024-01378 · APJ John G New · IPR · Final written decision
Claims 1–10 are unpatentable as anticipated by Svihra or obvious over the asserted combinations; the cited non-patent references qualify as printed publications.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Legal Standards Anticipation A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). However, a reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). The “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009).” slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“(citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). Of particular relevance to the case presently before us is the VidStream court’s holding that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” VidStream, 981 F.3d at 1065. Hulu addressed, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. IPR2018-01039, Paper 29 at 8. In Hulu, the Board held that, although testimonial evidence is one way to prove public accessibility, there are also various indicia of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at 18. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established. Id. at 19–20 (see Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)). Here, we find the totality of evidence supports the conclusion that Petitioner has made a sufficient showing that Svihra and Amarenco (as well as the other identified non-patent references) were printed publications, and publicly accessible, prior to the ’477 patent’s priority date. We note at the outset that Patent Owner does not allege that any contested reference is fabricated, or a counterfeit document, but only that Petitioner has not set forth sufficient facts establishing that such references were published and available. Resp. 4. Svihra bears sufficient indicia of publication to conclude it was a printed publication and publicly accessible as of 2002. Ex. 1004. First, it appears on its face to be a legitimate scientific journal article; it indicates it was included at pages 480–83 in volume 103 (No. 12) of Bratisl Lek Listy, the Bratislava Medical Journal, which was established in 1921. The article identifies that it was received for publication on May 30, 2002, and accepted for publication on December 9, 2002; and multiple means of contact for the author and publisher are provided. Id. at 480, 483. Each of these indicia supports the contention that Svihra was published and publicly available in 2002. There is no direct evidence that Svihra was publicly accessed as of this date, but the article is cited as a reference in each of Exhibits 1085–1087, which further supports that Svihra was, generally, publicly available to interested individuals of ordinary skill in the art, which further corroborates that it was a published and publicly accessible publication. Having an established publisher also creates a presumption of publication for Svihra, which has not been rebutted by Patent Owner. VidStream, 981 F.3d at 1065.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Petitioner also explains why a person of ordinary skill would have been motivated to combine the cited references, again citing specific disclosures from the references, and the supporting testimony of Dr. Wingeier. See Pet. at 27–28. Based on our review of Petitioner’s arguments and the evidence of record, we determine that Petitioner has established, by a preponderance of the evidence, that the cited references teach or suggest all of the limitations of challenged claim 1, and that Petitioner has established why a person of ordinary skill would have been motivated to combine the references, as proposed, with a reasonable expectation of success, for the reasons advocated by Petitioner with respect to Ground 2.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 14 (citing Ex. 1003 ¶ 21). Patent Owner does not dispute Petitioner’s proposal. See generally Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and the level of skill in the prior art, we adopt Petitioner’s proposed definition and additionally use the term “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 10
Patent outcomesUS 9,002,477 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,002,477 - Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentablePTAB · Mar 16, 2026 · IPR2024-01375 · APJ John G New · IPR · Final written decision
Claims 1–13 are unpatentable as obvious under § 103 over Svihra, Mann, and Ponsford, and independently over Amarenco, Mann, and Ponsford.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“Ex. 1001, claim 1. In other words, to effectuate “direct” stimulation of the PTN nerve branch, a practitioner of the ’742 patent must: (1) non-invasively position an electrical stimulator relative to a portion of a patient’s body, such that a branch of a posterior tibial nerve within the first portion of the body is directly targeted by the electrical stimulator; (2) passing a current through the electrical stimulator; and (3) delivering an electrical stimulus from the electrical stimulator to the branch of the posterior tibial nerve such that the branch directly receives the electrical stimulation. Merely “placing electrodes over branches of the PTN” cannot be said, in and of itself, to “directly” target and stimulate the branches, as Petitioner argues.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of filing “would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 21 (citing Ex. 1003 ¶¶ 20–21). Patent Owner does not dispute Petitioner’s proposal. See generally Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, we adopt this definition, and also use the term “skilled artisan” to refer to persons with such skill at the time the invention was filed.” slip op. at 13
- Expert testimonyPetitioner expert creditedOther
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“the evidence of record, that a person of ordinary skill in the art would have found it obvious to modify the teachings of Svihra by non-invasively stimulating a nerve branch of the PTN, e.g., the medial or lateral plantar nerves, as taught by Ponsford, to treat OAB/urinary incontinence. A skilled artisan would have understood that the fibers of a given branch of the PTN necessarily constitute a subset of the PTN fibers, stimulation of which is known to be effective in the treatment of OAB/urinary incontinence. See Ex. 1004, 480–481. Just as it was known in the art that stimulation of the much larger sacral nerve, of which the fibers of the PTN form a part, could have beneficial effects in the treatment of incontinence, and that stimulation of the PTN itself could have a similar effect (see Ex. 1084, col. 12, ll. 33–52), so, a skilled artisan could reason, might electrical stimulation of a branch of the PTN exert a similar effect. We also agree that a person of ordinary skill in the art would have been motivated to stimulate a smaller nerve branch of the PTN, rather than the entire PTN itself, so as to minimize undesirable side effects of stimulating the entire PTN, i.e., the recruitment of downstream muscular contraction, as taught by Mann. With respect as to whether a person of ordinary skill in the art would have had a reasonable expectation of success in the treatment of OAB/incontinence via stimulation of a branch of the PTN, rather than the entire PTN itself, we agree with Petitioner that a person of ordinary skill in the art, would understand from Mann that electrical stimulation of the larger, more central sacral nerve could be employed to treat OAB/urinary incontinence, and that a subset of those PTN fibers could be electrically stimulated to achieve a similar effect. See Ex. 1084, col. 12, ll. 33–52. Such a skilled artisan could similarly reason that a subset of those PTN fibers, i.e., a branch of the PTN, particularly major branches such as the plantar nerves, could also be similarly electrically stimulated to treat OAB/urinary incontinence. Although success in such an experiment would not be guaranteed, “only a reasonable expectation of success, not absolute predictability, is necessary for a conclusion of obviousness.” In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985).” slip op. at 46
Patent outcomesUS 11,224,742 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,224,742 - PTAB · Nov 3, 2025 · PGR2025-00043 · APJ Sheridan K Snedden · PGR · Institution
Instituted PGR of claims 1–44 on all asserted grounds after finding it more likely than not that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“post-grant review may not be instituted “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has demonstrated that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. A. Real Parties-in-Interest” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would be “someone with a graduate degree in organic chemistry, medicinal chemistry, pharmaceutical chemistry, or a related field, and four to six years of experience in the synthesis, purification, analysis, design, and/or formulation of pharmaceutical compounds and derivatives.” Pet. 7 (citing Ex. 1034 ¶ 21; Ex. 1033 ¶ 25). Petitioner also asserts that a person of ordinary skill in the art “would have worked with a team of professionals with training in related disciplines, such as pharmacology, pharmacokinetics, formulation, drug discovery and/or drug development as of the date of the claimed inventions.” Id. at 7–8.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Patent Owner attempts to distinguish the scope of the claims between the related ’334 patent and ’391 patent, where the claims of the ’334 patent recite a “an endoxifen composition encapsulated in an enteric capsule.” Prelim. Resp. 11. Patent Owner contrasts this with the scope of the claims of the ’391 patent and contends that the challenged claims are directed to “the underlying composition itself, where the enteric material is an ingredient of the composition combined with the endoxifen.” Id. To support its contentions, Patent Owner attempts to apply the doctrine of claim differentiation across patents, noting that [t]he related ’334 describes a composition where the enteric requirement is not part of the composition, reciting “[a]n oral formulation comprising an endoxifen composition encapsulated in an enteric capsule.” EX2014, cl.1. In other words, the enteric aspect of the ’334 claims is not part of the composition itself. In contrast, the ’391 requires “[a] composition comprising an endoxifen and an enteric material.”” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“distinguish the preamble language reciting “[a] composition comprising an endoxifen and an enteric material” from Ahmad. Prelim. Resp. 13–16. Specifically, Patent Owner contends that Petitioner’s arguments rely on Ahmad’s alleged disclosure of endoxifen encapsulated in enteric-coated capsules. Id. at 14. For example, Patent Owner contends that “every portion of Ahmad relied upon by Petitioner describes a ‘composition containing endoxifen’ that can then be coated with a separate external ‘enteric coating.’” Id. at 15. Patent Owner further contends that these disclosures fail to disclose an enteric material that is a component (with endoxifen) of the composition itself. At most, these disclosures purport to describe (1) a pharmaceutical composition of endoxifen (2) encapsulating the finished composition in a separate external enteric coating. See EX1003, 18:27-29 (“Enteric coating of capsules filled with composition art.”). Prelim. Resp. 15. Patent Owner therefore concludes that “Petitioner identifies no teaching in Ahmad that the enteric material is a component of the endoxifen composition, as claimed.” Id. at 16. Based on our preliminary construction of the term, “[a] composition comprising an endoxifen and an enteric material” discussed above, and, having considered the arguments and evidence presented by the parties at this stage of the proceeding, summarized above, we find that Petitioner has shown it is more likely than not that Ahmad discloses each limitation of claims 1 and 32 for the reasons stated in the Petition, which we adopt for purposes of this Decision. See Pet. 19–25; Ex. 1003, 2:24–40, 3:55–61, 8:47–63, 9:1–20, 11:17–23, 12:14–17, 18:19–29, 19:27–30; Ex. 1033 ¶¶ 54– 64. Accordingly, we find Petitioner has shown that it is more likely than not that claims 1 and 32 are anticipated by Ahmad.” slip op. at 16
Claim construction§ 102 anticipationcites PhillipsPatents in suitUS 12,071,391 - PTAB · Nov 3, 2025 · IPR2025-00799 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–21, finding a reasonable likelihood that claims 1–6, 16, 18, and 21 are anticipated by Liu.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition and Preliminary Response, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least 1 of the challenged claims of the ’151 patent is unpatentable.” slip op. at 2
- PTAB / AIA Trials › §315(e) estoppelNot reached
“On the current record, we tend to agree with Patent Owner that the issues presented in this proceeding concern Liu’s alleged inherency and the Form I or XRPD limitations recited in the challenged claims, which are obviousness grounds asserted in PGR2023-00043. Prelim. Resp. 35. That said, the parties are invited to address the issue of whether collateral estoppel applies in this proceeding based on the Final Written Decision of PGR2023- 00043 during trial. Regardless of whether collateral estoppel applies, however, we determine for the reasons below that Petitioner shows a reasonable likelihood of prevailing in its challenge that at least 1 of the challenged claims of the ’151 patent is unpatentable.” slip op. at 3
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “all terms should be given their plain and ordinary meaning.” Pet. 10. Patent Owner does not propose construction of any terms. See generally Prelim. Resp. Having considered the parties’ positions and evidence of record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. 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))).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“H. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art (“POSA”) would be “someone with a graduate degree in organic chemistry, material science, medicinal chemistry, pharmaceutical chemistry, or a related field, and four to six years of experience in the synthesis, purification, analysis, design, and/or formulation of pharmaceutical compounds and derivatives.” Pet. 9. Petitioner also asserts that a person of ordinary skill in the art “would have worked with a team of professionals with training in related disciplines, such as pharmacology, pharmacokinetics, formulation, drug discovery Patent Owner does not dispute Petitioner’s definition of a person of ordinary skill in the art. See generally Prelim. Resp. We adopt Petitioner’s definition as it is consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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))). To the extent the parties dispute the level of ordinary skill and its impact on the analysis of the challenged claims, we encourage the parties to address this issue further during trial.” slip op. at 8
Claim construction§ 102 anticipationPatents in suitUS 11,261,151 - PTAB · Oct 16, 2025 · IPR2025-00776 · APJ John G New · IPR · Institution
Instituted review of claims 9, 11, 32–58, 60–62, and 64–67 on all remaining petition grounds, after finding a reasonable likelihood that claim 9 is unpatentable over Thomas and Faucette.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of claims 9, 11, 32–58, 60–62, and 64–67 of the ’802 patent is unpatentable, and we on the Grounds set forth in the Petition.” slip op. at 2
- Settled expectationsOther
“Patent Owner also filed a Request with the Acting Director of the USPTO seeking discretionary denial of institution of inter partes review (Paper 6, the “Request”). Petitioner subsequently filed a brief opposing Patent Owner’s Request (Paper 8). On September 3, 2025, the Acting Director denied Patent Owner’s Request for discretionary denial of institution of inter partes review and referred the case to the panel for an institution decision on the merits (Paper 11).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill would have an M.D. or a Ph.D. degree in virology, immunology, and vaccinology, and at least 3 years of experience in one or more of the research, design, development, and testing of antiviral vaccines. Pet. 17. Petitioner asserts that a person of ordinary skill may be part of a multidisciplinary team having such experience. Id. (citing Ex. 1002 ¶ 81). Patent Owner does not dispute the level of skill asserted by Petitioner.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party requests construction of any claim terms. Petitioner asserts that all claim terms should be given their ordinary and customary meaning, and Patent Owner does not disagree. See Pet. 17. Accordingly, we find, for the purposes of this Decision, that no terms of the challenged claims requires construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13; see also Vivid Techs., Inc. v. construes claims only to the extent necessary to resolve a dispute).” slip op. at 10
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,730,802 - PTAB · Oct 14, 2025 · IPR2025-00685 · APJ John G New · IPR · Institution
The Board instituted IPR on claims 1–23 and all petitioned grounds, finding a reasonable likelihood that the claims are obvious over Wei and Liu.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Summary Based upon the record as presently developed, we conclude that Petitioner has met its burden of showing a reasonable likelihood of showing at trial that at least claim 1 of the ’370 patent is obvious over the cited prior art. Because we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in showing that at least one claim is unpatentable on at least one of the stated Grounds, we institute inter partes review of all challenged claims of the ’370 patent, based on all of the remaining grounds identified in the Petition. See 37 C.F.R. § 42.208(a); SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 44
- Skill levelSkill level board ownOther
“appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, at this point we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art. The actual inventor’s skill is not determinative”) (emphasis added, footnotes omitted). Consequently, and for the purposes of this Decision, we adopt Petitioner’s proposed definition as defining a person of ordinary skill in the art as a person who would have had “a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and would further have had at least five years of experience with antibodies and antibody engineering.”” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“Petitioner states that no term of the challenged claims requires construction to resolve the challenges in this Petition. Pet. 32. Patent Owner does not contest Petitioner’s assertion. See generally Prelim. Resp. We find, for the purposes of this Decision, that no terms of the challenged claims require construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“We find, based upon the present record and for the purposes of this Decision, that Petitioner has sufficiently established that a person of ordinary skill in the art would have been motivated to combine the teachings of Wei and Liu to determine the activity and suitability of Liu’s humanized anti- EGFR antibodies in an ADC. We acknowledge that Liu is silent regarding the pH selectivity or tissue preference of its binding affinity, but Patent Owner points to no prior art reference that would have informed a skilled artisan upon this point or that would have discouraged a person of ordinary skill in the art from combining the references. See fn.7, supra. And, even if a skilled artisan might have recognized that Liu’s humanized cetuximab might have been potentially problematic if it failed to show pH-selective activity like Wei’s Y104D, the mere fact that some disadvantage may come with an advantage when combining prior art does not foreclose their combination under § 103. Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). In the instance of Liu’s humanized anti-EGFR antibody, a person of ordinary skill in the art would have recognized that its advantages (enhanced activity against tumor cells compared to chimeric cetuximab, thus requiring smaller dosages) could balance or outweigh its possible disadvantages (e.g., possible activity against non-tumor cells). Furthermore, it is in the nature of scientific research to continue to try new substitutions in drug therapy, even if a promising candidate has been discovered. As the Supreme Court stated in KSR: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. 550 U.S. at 421.” slip op. at 39
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,792,370 - PTAB · Sep 19, 2025 · PGR2025-00025 · APJ Kimberly Mcgraw · PGR · Institution
The Board instituted PGR on claims 1–19 and all asserted grounds, finding it more likely than not that claim 1 is anticipated by the Gatorade Label.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’422 Patent is eligible for post-grant review and has shown it is more likely than not that at least one challenged claim of the ’422 Patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of the challenged claims of the ’422 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would possess at least (1) a Bachelor’s degree in chemistry or a related field, with (2) five years of experience in material identification and characterization using multiple analytical methods and field sampling, or equivalent research or professional experience.” Pet. 12 (citing Ex. 1014 ¶ 24). Patent Owner does not dispute Petitioner’s definition for one of ordinary skill in the art nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposal regarding the level of one of ordinary skill in the art.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“336. The applicant explained that not all combinations of shrink films and light blocking materials are recyclable. Id. at 335. The applicant explained that films can be compatible with PET recycling in two ways, (1) the film can float in water and be separated from PET that sinks in water or (2) the PET films crystallize and “can be recovered with the PET stream.” Id. at 336 (citing “A Resource Document by the Association of Plastic Recyclers (APR)”) (found at Ex. 1002, 323–332) (emphasis omitted). The applicant explained that “removing the label before or during the recycling process is not evidence of the recyclability of the label” and that “[r]emoving the label during the recycling process is not equivalent to actually recycling the label.” Id. at 335. As such, a POSITA reading the prosecution history would understand that a label is not recyclable with a PET container, as recited by the independent claims, by removing the label from the PET recycle stream before or during the recycling process.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“To determine how a person skill in the art would determine if a shrink label is “recyclable” as recited in the independent claims, we look to how the Specification of the ’422 Patent describes or defines recyclable shrink labels. For example, the ’422 Patent states that PET shrink films are generally considered recyclable if no inks are retained on the film after a caustic wash cycle typically used in PET reclaiming processes. Ex. 1001, 6:61–65. The ’422 Patent further states that labels are fully recyclable if the polymers used are clear, preferably clear PET, and the labels include inks that can be washed off in a “typical PET recycling wash (caustic wash).” Id. at 11:44– 49; see also id. at 11:49–54 (describing embodiments in which the labels are free or substantially free of inks that cannot be washed off in a caustic wash or where the labels are free or substantially free of color plastics that cannot be recycled). The ’422 Patent further discusses “industry standards” for determining whether various embodiments of shrink labels are recyclable. See, e.g., id. at 11:29–53. For example, the Specification states that the “Association for Plastic Recyclers (APR) Critical Guidance Protocol for Clear PET Articles with Labels and Closures (PET-CG-02)” (Ex. 1005) can certify that a film is fully recyclable with a container or bottle. Id. at 11:34– 38. Additionally, the Specification states that labels “are recyclable according to the Evaluation of the Near Infrared (NIR) Sorting Potential of a Whole Plastic Article (SORT-B-01)” (Ex. 1010) and/or the “Evaluation of Sorting Potential for Plastic Articles Utilizing Metal, Metalized, or Metallic Printed Components (SORT-B-03)” (Ex. 1011). Ex. 1001, 11:39–44. The ’422 Patent further states that embodiments of the labels “are fully recyclable. For example, the labels may include inks that can be washed off in a typical PET recycling wash (caustic wash) and the polymers” are preferably clear PET. Id. at 11:44–48. The ’422 Patent thus provides various descriptions or standards to determine the recyclability of shrink labels. For the purposes of addressing the anticipation and obviousness grounds, we determine that any of these standards can be used to determine if a shrink label is “recyclable.” We note that our construction is preliminary and is based on the present record. We invite the parties to further the address the construction of “wherein the recyclable shrink label is recyclable with a PET container” during trial.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 11,961,422
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.