- 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 - 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 · Aug 5, 2025 · IPR2025-00249 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted inter partes review of claims 1–8 on all grounds in the Petition, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. §42.4(a). We may not institute an inter partes review “unless . . . there is 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). In this decision, we address the merits of the issues raised by the parties regarding claims 1–8 of the ’227 patent. For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one challenged claim of the ’227 patent is unpatentable, we institute an inter partes review of all challenged claims based on the grounds set forth in the Petition.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“II. ANALYSIS A. Discretionary Denial under 35 U.S.C. § 325(d) Patent Owner filed a request for discretionary denial under 35 U.S.C. § 325(d). Paper 9. Petitioner opposed. Paper 9. The Acting Director denied the discretionary denial request. Paper 12 (June 26, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s patentability challenges and do not address the discretionary denial arguments presented by the parties.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSITA”) relevant to the ’227 patent “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.C). Patent Owner does not dispute this skill level. Prelim. Resp. 10. At this stage of the proceeding and for purposes of our analysis in this Decision, we adopt Petitioner’s definition as that definition is consistent with the level of skill in the art reflected by the 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 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner nor Patent Owner proposes a construction for any claim terms. Pet. 19; Prelim. Resp. 10. We also do not perceive a need to construe any claim terms of the ’227 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes review).” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 11,318,227 - PTAB · Aug 5, 2025 · IPR2025-00248 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted IPR on claims 1–12 and all petition grounds, finding a reasonable likelihood that at least one claim is unpatentable, including based on Huang2’s inherent FFT symmetry.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. §42.4(a). We may not institute an inter partes review “unless . . . there is 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).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“II. ANALYSIS F. Discretionary Denial under 35 U.S.C. § 325(d) Patent Owner filed a request for discretionary denial under 35 U.S.C. § 325(d). Paper 8. Petitioner opposed. Paper 10. The Acting Director denied the discretionary denial request. Paper 13 (June 26, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s 2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the’223 patent claims priority to a provisional application filed before the effective date of the applicable AIA amendments (March 16, 2013), we refer to the pre-AIA versions of the statutes throughout this Decision. 3 Huang et al., The involvement of integrin β1 signaling in the migration and myofibroblastic differentiation of skin fibroblasts on anisotropic collagen-containing nanofibers, 33 Biomaterials 1791-1800 (Feb. 2012) (“Huang2”) (Ex. 1005). A different reference by Huang, identified as “Huang1” in the Petition, was considered by the Examiner during prosecution. Pet. 15–17; Ex. 1008. 4 Kumbar et al., Electrospun nanofiber scaffolds: engineering soft tissues, Biomed. Mater. 3 (2008) (“Kumbar”) (Ex. 1006). 5 Lee et al., U.S. Patent Application No. US 2010/0331980 A1, Pub. Date December 1, 2011 (“Lee”) (Ex. 1011). patentability challenges and do not address the discretionary denial arguments presented by the parties.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSITA”) relevant to the ’223 patent “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. 18–19 (citing Ex. 1003 §II.C). Patent Owner does not dispute this skill level. Prelim. Resp. 10. At this stage of the proceeding and for purposes of our analysis in this Decision, we adopt Petitioner’s definition as that definition is consistent with the level of skill in the art reflected by the 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 7
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Simpson’s testimony at this preliminary stage. Dr. Simpson extensively discusses the FFT methodology used in the Ayres papers (for which he is the senior author), and we find these papers provide sufficient underlying facts, data, and technical reasoning to support his opinion regarding the inherent symmetry of the FFT output image. Ex. 1003 ¶¶ 38–51. Contrary to Patent Owner’s argument, the fact that the Ayres 2008 paper uses the term “typically” does not undermine Dr. Simpson’s conclusion. Ex. 1010, 609. In context, it is clear that the refenced statement only speaks to how the data is typically reported rather than whether the result itself would only be typical. Indeed, the same sentence goes on to explain that the reason why the data is typically reported only for 0–180° is because “the frequency plot is symmetric.” Id. We are also not persuaded by Patent Owner’s argument that Ayres 2008 undermines Dr. Simpson’s testimony regarding “typical[] practice” because it presents FFT analysis results plotted to 360°. Rather than undermining his testimony, the plot shown in Figure 1F of Ayres 2008 further confirms the symmetrical nature of the FFT results for aligned fibers. Moreover, the fact that there are minor variations at the tips of the two peaks shown in Figure 1F does not undermine or contradict the conclusion that the major peaks for aligned fibers will necessarily be about 180° apart. The challenged claims do not require a perfect repetition or identity of the major peaks in the FFT output plot. Additionally, Dr. Simpson’s own reproduced FFT analysis of the SEM image in Huang2’s Figure 1B using the methodologies described in the Ayres 2006 and Ayres 2008 papers, which shows major peaks at 90° and 270°, further confirms that the claimed FFT analysis result is an inherent feature of Huang2’s anisotropic fibers. Ex. 1003 ¶¶ 110–111. We do not find that Dr. Simpson’s testing violates 37 C.F.R. § 42.65(b), insofar as Dr. Simpson’s declaration sufficiently explains: (1) “why the test or data is being used”; (2) “how the test was performed and the data was generated”; (3) “how the data is used to determine a value”; (4) “how the test is regarded in the relevant art”; and (5) “any other information necessary for the Board to evaluate the test and data.” See Ex. 1003 ¶¶ 38–51 (explaining FFT methodology used by Dr. Simpson). Although Dr. Simpson’s declaration does not appear to spell out all the details of the particular protocol or the version of the ImageJ software he used, we find his explanation that he used the methodology described in Huang2 (which references the Ayres 2006 paper) and the ’223 patent (which references the Ayres 2008 paper) sufficient for purposes of institution. Even assuming there may be some differences in the specific FFT methodology used in the two Ayres papers, we do not find anything at this stage to indicate that any such differences would matter with regard to the claim requirement that the major peaks are about 180° apart, especially given that both papers confirm the symmetrical nature of the FFT output plot. Furthermore, while Patent Owner argues that Dr. Simpson does not account for certain aspects of the FFT analysis discussed in the Ayres 2006 and Ayres 2008 papers, there is no evidence at this stage that Dr. Simpson did not follow the protocol described in his own papers, or that he failed to account for any specific aspects that could make a meaningful difference with regard to the FFT analysis result.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 10,137,223 - Azurity Pharmaceuticals, Inc. v. Exelixis Inc.Institution deniedPTAB · Jun 4, 2025 · IPR2025-00210 · APJ Jeffrey N Fredman · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving claims 1–3 unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that the combination of Brown, Kubo, and Remington would inherently result in less than 200 ppm impurity and Petitioner has not shown that it has a reasonable likelihood that it would prevail on the obviousness ground.” slip op. at 29
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“Here, there is no dispute that the ’349 patent and Wilson, which issued from a patent application from which priority was claimed for the ’349 patent, share the identical disclosure of a pharmaceutical composition comprising Compound IA or IB; one or more fillers; one or more disintegrants; one or more glidants; and one or more lubricants. In this embodiment, the filler comprises microcrystalline cellulose. In this embodiment, the disintegrant comprises croscarmellose sodium. In this embodiment, the disintegrant comprises croscarmellose sodium and sodium starch glycolate. In this embodiment, the glidant comprises fumed silica. In this embodiment, the lubricant comprises stearic acid. Ex. 1001, 21:1–12; Ex. 1002, 20:51–62. There is express ipsis verbis disclosure of the elements recited in claim 1 of the ’349 patent.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“1. Reason to reduce contaminant levels We agree with Patent Owner that Petitioner identifies no teaching in the prior art providing any reason to reduce levels of 6,7-dimethoxy-quinoline-4-ol specifically. And while Brown does teach a desire to form “substantially pure” compounds, Brown focuses on “at least about 90 wt.%” of the compound, then lists specifically “about 90, about 91, about 92, about 93, about 94, about 95, about 96, about 97, about 98, about 99 and about 100% wt. %.” Ex. 1003 ¶ 97. This permits a range of concentration for contaminants from about 0 to 10%.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“to modify Brown’s process with Kubo to eliminate the added step. See, e.g., Id. ¶ 73. But even with that combination, Dr. Dichtel states only that a “POSA would have expected there to be a decrease in the amount of 6,7- dimethoxy-quinoline-4-ol at the end of cabozantinib (L)-malate’s synthesis that was attributable to hydrolytic degradation of the 4- (nitrophenoxy)quinoline intermediate by avoiding its use in the synthesis.” Id. ¶ 78. That is not, however, the standard for inherency. It must be the necessary result, not a possible expected result. The Federal Circuit in Par explained that: Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” slip op. at 28
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,349 - Mediatek, Inc. / Mediatek USA, Inc. v. Redstone Logics LLCInstitution deniedPTAB · Apr 22, 2025 · IPR2025-00085 · APJ Andrew L Nalven · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable, principally failing to show independent input clock signals.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Pursuant to 35 U.S.C. § 314(a), an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons that follow, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing in demonstrating the unpatentability of any of the challenged claims. Accordingly, we do not institute an inter partes review.” slip op. at 2
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Petitioner’s position further relies on the declaration testimony of Dr. Baker who states a POSITA “would read Knoth to include independent first and second PLLs within clock ratio controllers 106a and 106n, respectively, receiving the first and second clock signals (the timing pulses generated by oscillators 219a and 219n) that are independent from each other.” Pet. 28– 29 (quoting Ex. 1003 ¶ 132, citing id. ¶¶ 111, 131). We do not credit Dr. Baker’s testimony on this point because it lacks sufficient explanation and is inconsistent with the disclosure of Knoth as detailed above. 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight”); Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). Dr. Baker’s testimony appears premised on the assertion that each clock ratio controller 106a-n operate independently from each other. Ex. 1003 ¶ 130. However, Dr. Baker does not explain why independently operating clock ratio controllers teach or suggest that each clock ratio controller would receive an independent input clock signal.” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“determine that Petitioner has not sufficiently shown that Knoth or Allarey disclose two independent clock signals. First, we are not persuaded that Petitioner has shown sufficiently that Knoth includes a PLL in each clock ratio controller. Instead, we agree with Patent Owner that Knoth discloses clock ratio controllers 106a-n coupled to a single PLL 202 where PLL 202 receives a single clock input from oscillator 119. Prelim. Resp. 6–8 (citing Ex. 1005 ¶¶ 22, 41, Fig. 2A). Figure 2A, reproduced above, clearly delineates clock ratio controller 106 within a dotted line separate from PLL 202 and oscillator 119. Further, as noted by Patent Owner, Knoth explicitly describes a plurality of clock ratio controllers and processor cores designated as a-n, but only describes a single PLL 202 and oscillator 119. Id. at 8, 11 (citing Ex. 1005 ¶¶ 22, 41–42). Because Petitioner has not shown that Knoth discloses two PLLs, Petitioner fails to show a first and second PLL with respective first and second clock signals as inputs where the first clock signal is independent from the second clock signal.” slip op. at 19
§ 103 obviousnesscites GrahamPatents in suitUS 8,549,339 - Sterlite Technologies Inc. v. Afl Telecommunications, LLC.Institution deniedPTAB · Apr 9, 2025 · IPR2025-00127 · APJ Josiah C Cocks · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–4, 8, or 13 were unpatentable over either proposed obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“At this preliminary stage, we determine whether the information presented shows a reasonable likelihood that Petitioner would prevail in establishing that at least one of the challenged claims would have been unpatentable over the proposed prior art. We analyze the asserted grounds with the above-noted principles in mind.” slip op. at 10
- Skill levelOther
“B. Level of Ordinary Skill in the Art As noted above, resolving the question of obviousness requires determination of the level of ordinary skill in the art. Graham, 383 U.S. at 17–18. Here, however, as Patent Owner observes (Prelim. Resp. 10), 8 Patent Owner does not present arguments or evidence of secondary considerations in its Preliminary Response. Therefore, secondary considerations do not constitute part of our analysis herein. Petitioner has provided no assessment as to the level of ordinary skill to be considered in evaluating the grounds of obviousness that are advanced by Petitioner. The absence of such assessment calls into question the fundamental adequacy of Petitioner in carrying its burden to show a reasonable likelihood of success of unpatentability of the challenged claims that necessarily must take into account the level of ordinary skill in the art.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In any event, we do not discern that there is any apparent dispute between the parties as to the meaning of any claim term. In considering the record at hand, we determine that it is unnecessary to make explicit, or further address, any claim term in deciding whether or not to institute trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the 9 Throughout their briefings, the parties refer to the limitations designated [1.1] through [1.7] using the term “element,” e.g., “element [1.7]” (see, e.g., Pet. 23; Prelim. Resp. 23). For consistency with the parties’ chosen nomenclature, we do the same in this Decision. controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“A POSITA would have been motivated to modify Summers’ fiber optic cable 50 to include Kaji’s intermittently-fixed optical fiber tape 2A to obtain the predictable result of enabling a higher density of optical fibers to be packed in Summers’ fiber optic cable 50, as contemplated by Kaji. *** a POSITA would have had a reasonable expectation of success because such modification would amount to nothing more than a simple substitution of Summers’ four-fiber ribbons 52 with Kaji’s intermittently-fixed optical fiber tape 2A by known methods of cable manufacturing. ***” slip op. at 20
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,287,591 - Innoscience (Zhuhai) Technology Company, Ltd. / Innoscience America, Inc. v. Efficient Power Conversion CorporationNo claims unpatentablePTAB · Mar 25, 2025 · IPR2023-01382 · APJ Kimberly Mcgraw · IPR · Final written decision
Claims 1–3 were not shown unpatentable under any of five § 103 grounds because Petitioner failed to establish sufficient motivation to modify or combine the prior art.
RulingsFinal written decision- BurdenNot shown unpatentable
“A petition must identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim.” 35 U.S.C. § 312(a)(3) Here, Petitioner merely provides general assertions about multiple references, without clearly identifying how, or why a POSITA would have been motivated, to modify the processes disclosed in those references to arrive at the claimed invention. Thus, the Petition does not state with particularity that Saxler’s particular technique for etching is to be used instead of Beach’s etching step when substituting Beach’s self-aligned process for Saxler’s two mask process. Nor does the Petitioner provide a sufficient reason, absent hindsight, why a POSITA would have been motivated to combine the references to result in a process that forms Saxler’s Modified Figure 1A. Thus, for these additional reasons, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over Saxler, Beach, and Shenoy.” slip op. at 34
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Both parties agree that the differences between the definitions do not impact the analysis. Resp. 11; Reply 2. In light of the record before us, and for purposes of this Decision, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’347 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’347 patent and the prior art. We also note that our Decision would be the same under either parties’ definition.” slip op. at 13
- Expert testimonyOther
“Petitioner’s expert, Dr. Shealy states that he understands paragraph 52 to mean that it is “fair game to pull the recess out of any of those figures [Figures 1A through 6].” Ex. 2004, 39:12–21. Dr. Shealy, however, also clarifies that “[a]s I said before, I think you could take all the embodiments and bring in which ones you want, depending on what you’re trying to accomplish.” Ex. 2004, 40:24–41:1. During the hearing, Petitioner admitted that Dr. Shealy’s “statement to modify the reference depending on what you're trying to accomplish” means that “a POSITA may modify with reason to do so. A POSITA would have removed Saxler’s recess to obtain the benefits of enhancement-mode.” Tr. 19:19–25. Again, the Petition does not provide a reason why a POSITA would have removed Saxler’s gate recess.” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“remove the recess in Saxler Figure 1A to arrive at the allegedly enhancement mode transistor of Modified Figure 1A. Contrary to Petitioner’s assertions in its Reply and at the hearing, the Petition makes no argument that a POSITA would have removed the recess from Saxler Figure 1A to realize the benefits of an enhancement mode transistor. See Reply 4–5; Pet. 24–68. Rather, the Petition merely asserts that a POSITA would have understood that the gate recess of Figure 1A is optional without providing any persuasive reason why a POSITA would have removed the gate recess but retained the sloped sidewalls of Figure 1A. Pet. 25, 40, 45. For example, Petitioner asserts that Saxler’s gate contact may be “recessed or non-recessed” and that when the gate recess shown in Figure 1A is not utilized, Saxler would have the structure of Saxler Modified Figure 1A. Pet. 25 (citing Ex. 1003 ¶ 81; Ex. 1007 ¶ 52, 66); see also Pet. 40, 45 (citing Ex. 1007 ¶ 52). Neither of these paragraphs provide sufficient motivation to a POSITA to remove the gate recess from Saxler Figure 1A. Saxler paragraph 52 states: Exemplary devices according to some embodiments of the present invention are schematically illustrated in FIGS. 1A through 6. Thus, while embodiments of the present invention are described herein with reference to a recessed gate structure or a non-recessed gate structure, other embodiments of the present invention may include or not include a gate recess. Accordingly, embodiments of the present invention should not be construed as limited to the particular exemplary embodiments described herein but may include any suitable structure having a cap layer and/or passivation layer as described herein. Ex. 1007 ¶ 52. Petitioner’s expert, Dr. Shealy states that he understands paragraph 52 to mean that it is “fair game to pull the recess out of any of those figures [Figures 1A through 6].” Ex. 2004, 39:12–21. Dr. Shealy, however, also clarifies that “[a]s I said before, I think you could take all the embodiments and bring in which ones you want, depending on what you’re trying to accomplish.” Ex. 2004, 40:24–41:1. During the hearing, Petitioner admitted that Dr. Shealy’s “statement to modify the reference depending on what you're trying to accomplish” means that “a POSITA may modify with reason to do so. A POSITA would have removed Saxler’s recess to obtain the benefits of enhancement-mode.” Tr. 19:19–25. Again, the Petition does not provide a reason why a POSITA would have removed Saxler’s gate recess.” slip op. at 28
Patent outcomesUS 9,748,347 not shown unpatentable§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,748,347
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.