- 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 - PTAB · Oct 12, 2023 · IPR2023-00614 · APJ Zhenyu Yang · IPR · Institution
The Board instituted review of claims 1–3, 6–18, 21–24, and 27–29 on all asserted grounds, finding a reasonable likelihood of obviousness over Ducharme, Ianiro, Katzir, and Hasnain.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Patent Owner has not persuaded us to exercise our discretion to deny institution. Accordingly, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, 8. We focus our analysis on Ducharme, one of the primary references asserted in the Petition. Although Ducharme was “not before the Office during examination of the [’]895 Patent,” Patent Owner asserts that it is cumulative to a reference that “was presented to the Office during examination by IDS.” Prelim. Resp. 42–43. Patent Owner does not point to, and we have not found, any evidence showing discussion or application of the previously presented reference by the Examiner during prosecution of the ’895 patent or its related patents. In other words, “the record of the Office’s previous consideration of the art is not well developed or silent.” Advanced Bionics, 10. In such situations, “a petitioner may show the Office erred by overlooking something persuasive.” Id.; see also id. at 8 n.9 (“An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.”). On this record, Petitioner has shown sufficiently that the Examiner overlooked Ducharme’s teachings of the limitations that were the basis for allowing the challenged claims. Indeed, the Examiner allowed the challenged claims, stating that the closest prior art references lack the teachings of the emitted light being suitable for the commercial image recording when the emitted light is simultaneously at least 1000 lumens when either the first or the second LEDs are lit, is broad-spectrum white light having a color deviation corresponding to less than 5 points of both green and magenta of color compensation, and has a color rendering index of light emitted from each of the first or the second LEDs (whichever is lit) that is greater than 90. Ex. 1002, 150. Petitioner’s evidence indicates that Ducharme teaches an LED light suitable for commercial image recording that includes a plurality of first white LEDs having a first spectrum and a plurality of second white LEDs having a second spectrum. See, e.g., Ex. 1005, 4:1–7. Petitioner’s evidence also indicates that a person of ordinary skill in the art would have had reason to select first white LEDs with a daylight spectrum and second white LEDs with a tungsten spectrum. See, e.g., Ex. 1003 ¶ 449; Ex. 1006 ¶ 53. Further, Petitioner’s evidence indicates that LEDs satisfying the light quality parameters recited in the challenged claims were known to those of ordinary skill in the art. See, e.g., Ex. 1003 ¶ 480; Ex. 1005, 25:36–43; Ex. 1007, 7:11–15; Ex. 1008, 4:1–3. Thus, the evidence cited in the Petition demonstrates that the Office” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 14; Prelim. Resp. 14. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LEDs.” Pet. 14 (citing Ex. 1003 ¶ 32). Patent Owner does not dispute Petitioner’s definition of the skill level at this stage of the proceeding. Prelim. Resp. 13. For purposes of this Decision, we adopt Petitioner’s definition of the skill level because it is consistent with the prior art’s demonstration of the skill level at the time of the invention.” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,566,895 - PTAB · Oct 10, 2023 · IPR2023-00611 · APJ Christopher L Crumbley · IPR · Institution
The Board instituted IPR on claims 1, 3, 4, 7–13, 23, 25, 26, 28, 29–39, and 41–45 on all asserted grounds, finding a reasonable likelihood of success over Mueller, Ansems, and Simon.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a) (2022). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“whether the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, Paper 6 at 8. Central to this analysis is factor (c) of Becton, Dickinson, which “focuses on the record developed by the Office in previously reviewing the art or arguments.” Id. at 10. In cases where the Office raised a specific teaching of a reference during prosecution, and the petitioner disagrees with that specific finding of record, “then ordinarily the petitioner’s required showing of material error must overcome persuasively that specific finding of record.” Id. On the other hand, we are often presented with circumstances such as those found in the present case, where the prior art that was previously presented to the Office was not substantively remarked upon or applied in a rejection of the claims. This often occurs in the context of art submitted on an IDS, which is the manner in which the majority of the references identified by Colt in this case were incorporated into the file history. Ex. 1002, 216 (Kit, Ducharme ’261, Mueller ’029), 217 (Katzir). Only Simon” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Skill Quasar asserts that a person of ordinary skill in the art at the time of the invention would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LED lights.” Pet. 16 (citing Ex. 1003 ¶¶ 32–33). Colt does not dispute Quasar’s characterization of the level of skill, arguing that “the proposed level of ordinary skill does not affect the ultimate analysis.” Prelim. Resp. 15. At this stage of the proceeding, we adopt Quasar’s definition of the level of skill in the art, which is consistent with the disclosure of the ’224 patent and asserted prior art of record. If the parties disagree with our preliminary finding, they are invited to further brief the issue of level of ordinary skill in the art and, in particular, which disputed issues material to patentability turn on the definition adopted by the Board.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“35 U.S.C. § 282(b), as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and its progeny. See 37 C.F.R. § 42.100(b) (2022). Under this standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. See Phillips, 415 F.3d at 1312–13. Both parties agree that the terms of the claims of the ’224 patent should be given their ordinary and customary meaning, but neither party further elaborates on what those meanings are for any particular claim term. Pet. 16–17; Prelim. Resp. 15. We interpret the parties’ positions to be that no claim term of the ’224 patent requires express construction for purposes of deciding whether to institute trial. Upon review of the record and the parties’ arguments, we agree. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,197,224 - PTAB · Oct 10, 2023 · IPR2023-00613 · APJ Robert J Weinschenk · IPR · Institution
Instituted IPR on claims 1–3, 6–14, 16–19, 21–24, and 26–31 on all petitioned grounds; petitioner showed a reasonable likelihood of prevailing on obviousness over Ducharme, Ianiro, Katzir, and Hasnain.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“would have been obvious over Ducharme, Ianiro, Katzir, and Hasnain. Pet. 47–75. For the reasons discussed below, Petitioner demonstrates a reasonable likelihood of prevailing in showing that claims 1–3, 6–14, 16–19, 21–24, and 26–31 would have been obvious over Ducharme, Ianiro, Katzir, and Hasnain.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LED lights.” Pet. 13 (citing Ex. 1003 ¶ 32). Petitioner’s description of the level of ordinary skill in the art is supported by the testimony of Petitioner’s declarant, Mr. Fred Holmes. Ex. 1003 ¶ 32. Patent Owner does not dispute Petitioner’s description at this stage of the proceeding. Prelim. Resp. 12. We adopt Petitioner’s description for purposes of this Decision.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction In an inter partes review proceeding, a patent claim is construed using the same standard used in a civil action under 35 U.S.C. § 282(b), including construing the claim in accordance with the ordinary and customary meaning of the claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Neither party proposes an express construction for any claim terms at this stage of the proceeding. Pet. 13; Prelim. Resp. 12–14. We determine that no claim terms require express construction for purposes of this Decision.” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialPatents in suitUS 10,411,582 - Hope Medical Enterprises, Inc. v. Fennec Pharmaceuticals, Inc.No claims unpatentablePTAB · Sep 1, 2023 · IPR2022-00125 · APJ Julia Heaney · IPR · Final written decision
The Board granted the revised noncontingent motion to amend, canceled claims 18 and 20, and entered substitute claims 28 and 29, which were not proven obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, relying on the testimony of Dr. Rogers, contends that a person of ordinary skill in the art would have [had] a bachelor’s degree or equivalent in any of the pharmaceutical sciences with at least 5 years of experience in solid state chemistry; a master’s degree in any of the pharmaceutical sciences with at least 3 years of experience in solid state chemistry; or a Ph.D. in any of the pharmaceutical sciences with 1 year of experience in solid state chemistry. Pet. 8 (citing Ex. 1008 ¶¶ 24–28). Petitioner further states that such “[a] person could also have qualified as a [person of ordinary skill in the art] with some combination of (1) more formal education and less technical or professional experience or (2) less formal education and more technical or professional experience.” Id. Patent Owner does not dispute Petitioner’s proposed definition of a person of ordinary skill. See generally MTA, RMTA. Having considered the parties’ arguments and evidence, we adopt the level of ordinary skill in the art proposed by Petitioner, because it is consistent with the disclosures of the ’363 patent and the prior art of record. We note, however, that neither party contends that the outcome of this case would differ based on our adoption of any particular definition of a person of ordinary skill in the art.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“In our Preliminary Guidance, we construed “for a pharmaceutical composition” to mean “in combination with pharmaceutically acceptable excipients,” based on the ’363 patent’s definition providing that “[t]he terms ‘formulation’ or ‘pharmaceutical composition’ as used herein refers to the drug in combination with pharmaceutically acceptable excipients.” Prelim. Guid. 5–6 (citing Ex. 1001, 12:26–28; Ex. 2010, 17:11–12; Ex. 2011, 26:26– 27). We also encouraged the parties to address whether “for a pharmaceutical composition,” which appears in the preamble of substitute claims 28 and 29, is limiting, as opposed to a statement of intended use or purpose. Id. at 6. Following our Preliminary Guidance, the parties submitted further arguments concerning the term “for a pharmaceutical composition.” Patent Owner argues the term requires that the claimed process provide STS that is sufficiently pure for use in a pediatric patient (see RMTA 8–11) and that the word “drug” in the ’363 patent’s definition of “pharmaceutical composition” requires that the anhydrous STS is of sufficient purity for pharmaceutical use. Reply RMTA 3. Petitioner argues that the construction set forth in our Preliminary Guidance was correct. See Sur-reply RMTA 2–3. Having considered the arguments and evidence, we do not further construe the term “for a pharmaceutical composition” in this Decision because, as discussed in our analysis of obviousness below, it is not necessary to construe the term in order to determine whether Petitioner has met its burden of demonstrating by a preponderance of the evidence that proposed substitute claims 28 and 29 are unpatentable. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 13
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“1. Reasonable Number of Substitute Claims A motion to amend must “propose a reasonable number of substitute claims.” 35 U.S.C. § 316(d)(1)(B); see 37 C.F.R. § 42.121(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). Patent Owner proposes the same number of substitute claims as the original challenged claims that are cancelled, i.e., a one-to-one substitution for a total of two substitute claims. MTA 2; RMTA. “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, Paper 15 at 4; see 37 C.F.R. § 42.121(a)(3). Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner proposes a reasonable number of substitute claims. 2. Support in the Original Disclosure Patent Owner has identified written description support in the originally filed disclosure of the ’363 patent for the new limitations added for the proposed substitute claims. See RMTA 5–8. We have reviewed Patent Owner’s assertions of support in the original disclosure for the proposed revised substitute claims and determine that sufficient support exists. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement. 3. Respond to a Ground of Unpatentability “A motion to amend may be denied where . . . [t]he amendment does not respond to a ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i). Patent Owner asserts that the proposed revised substitute claims are patentable over the combination of references that forms the basis of the obviousness ground on which we instituted trial. RMTA 12–13. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement. 4. Scope of the Claims Patent Owner asserts that the proposed revised substitute claims do not enlarge the scope of original claims 18 and 20. RMTA 5. We have reviewed Patent Owner’s assertion that the purity amendments of proposed revised substitute claims 28 and 29 narrow the claims’ scope. Id. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement.” slip op. at 17
- BurdenNot shown unpatentable
“determine the evidence relied on by Petitioner does not support Petitioner’s position that a person of ordinary skill in the art would have been motivated to combine Levenson, Sherman, Edwards, and USP. Petitioner’s contention that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Levenson with Sherman is based on Dr. Rogers’s testimony that “[b]oth references disclose synthesis of sodium thiosulfate pentahydrate.” Ex. 1008 ¶ 151; see Pet. 36, 38. Dr. Rogers further testified it would have been obvious to add Edwards’s dehydrating step to the preparation of STS pentahydrate “which is obtained following the teachings of Levenson and Sherman” because “Edwards itself discloses dehydrating [STS] pentahydrate.” Id. ¶ 154. The Petition included these arguments even though they were inconsistent with Petitioner’s previous statement, during the Sherman prosecution, that Levenson taught STS heptahydrate, and therefore “does not provide any teaching with respect to [STS] pentahydrate.” Ex. 2013, 97. This prior inconsistent statement undercuts Petitioner’s rationale for combining Levenson, Sherman, and Edwards in this proceeding. Moreover, Petitioner’s rationale for combining the references in this proceeding is inconsistent with its statements about Levenson during the Sherman prosecution. Recognizing this inconsistency, Petitioner now takes the position that the Petition and Dr. Rogers’s testimony were incorrect. Paper 32; see Tr. 21:14–22:7, 59:1–2 (reemphasizing that “Petitioner maintains the statements that it made in the Sherman prosecution regarding Levenson”). Petitioner attempts to rationalize the inconsistency between its statements in the Sherman prosecution (including that “Levenson does not provide any teaching with respect to [STS] pentahydrate”) and its position in this proceeding by arguing that Dr. Rogers relies on Levenson as teaching surface activation “regardless of any particular hydrates Levenson discloses.” Tr. 22:8–9. That argument is not persuasive, because Dr. Rogers’s declaration clearly states the primary reason for his opinion that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Levenson with Sherman: “[b]oth references disclose synthesis of sodium thiosulfate pentahydrate.” Ex. 1008 ¶ 151. Contrary to Petitioner’s argument, Dr. Roger’s reliance on the surface activation teachings of Levenson is because he believes that both references pertain to STS pentahydrate; the surface activation teachings are not stated as an independent reason to combine the references. Id. Petitioner provides no further explanation of how a person of ordinary skill in the art would have been motivated to combine Levenson’s teachings regarding manufacture of STS heptahydrate with Sherman’s and Edwards’s teachings regarding STS pentahydrate, or how a person of ordinary skill would have regarded the difference between STS hydrates. Dr. Rogers’s acknowledgement of stability differences among STS hydrates highlights the insufficiency of Petitioner’s showing in this regard. See Ex. 2005, 35, 39. Having changed its position at the close of trial and having effectively withdrawn Dr. Rogers’s testimony as to similarities between Levenson and” slip op. at 24
Patent outcomesUS 10,792,363 not shown unpatentableClaim constructioncites KSR · GrahamPatents in suitUS 10,792,363 - PTAB · May 12, 2023 · IPR2023-00121 · APJ Jo-Anne M Kokoski · IPR · Institution
The Board instituted IPR of claims 1–22 on all asserted grounds, finding a reasonable likelihood that the Higuchi, Kobayashi, and Okochi combination renders at least one claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that 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 (2018); see also 37 C.F.R. § 42.4 (2021). For the reasons discussed below, we determine that Petitioner establishes a reasonable likelihood of prevailing with respect to the unpatentability of at least one claim of the ’092 patent, and we do not exercise discretion to deny the Petition. Accordingly, we institute an inter partes review of claims 1–22 of the ’092 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Prelim. Resp. 11–19. Petitioner asserts (Prelim. Reply 1) that it stipulated that “if the IPRs of [the ’092 patent] are instituted, it will not assert invalidity in the parallel district court proceedings based on grounds that were raised or reasonably could have been raised in the instituted IPRs.” Ex. 1018. We are bound by the guidance in the Memorandum, which states that the Board “will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Memorandum, 7.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). In applying this framework, we consider the Becton, Dickinson9 factors that address discretion to deny when a petition presents the same or substantially the same prior art or arguments previously presented to the Office, including:” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person having ordinary skill in the art (“POSITA”) would have had “a bachelor’s degree in engineering (mechanical, electrical or chemical), general science, materials science or the equivalent and 3-4 years of work experience with electrochemical cell packaging systems.” Pet. 5. Petitioner further contends that “[l]ess work experience may be compensated by a higher level of education, such as a master’s or doctorate degree,” and “less education may be compensated by more work experience.” Id. Patent Owner states that the Preliminary Response “establishes that Petitioner’s arguments fail even under its proffered definition of” a person of ordinary skill in the art. Prelim. Resp. 10. Patent Owner does not propose a different level of skill in the art at this stage of the proceeding. See id. (“Patent Owner reserves the right to dispute Petitioner’s definition of a [person of ordinary skill in the art] if an IPR is instituted.”). the uncontested assessment offered by Petitioner.” slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 11,258,092 - PTAB · May 12, 2023 · IPR2023-00160 · APJ Christopher M Kaiser · IPR · Institution
The Board instituted IPR on claims 1–30 and all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“inter partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” The Board uses a two-part framework for evaluating arguments under § 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSITA”) would have had “a bachelor’s degree in mechanical engineering, electrical engineering, materials or chemical engineering, physics, chemistry, or a related discipline with at least five years of experience in the design of lithium-ion button-cell battery structures.” Pet. 19. Petitioner further contends that “[l]ess work experience may be compensated by more work experience.” Id. Patent Owner states that the Preliminary Response “establishes that Petitioner’s arguments fail under its proffered definition of” a person of ordinary skill in the art. Prelim. Resp. 10. Patent Owner does not propose a different level of skill in the art at this stage of the proceeding. See id. (“Patent Owner reserves the right to dispute Petitioner’s definition of a [person of ordinary skill in the art] if an IPR is instituted.”). To the extent necessary, and for purposes of this Decision, we accept the uncontested assessment offered by Petitioner.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We construe each claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2019). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Petitioner argues that “[t]he claims should be accorded their ordinary and customary meaning and do not require further construction by the Board for determination of this Petition.” Pet. 21. Patent Owner agrees that “no claim construction is necessary to deny institution.” Prelim. Resp. 10. We determine that no claim term requires express construction for purposes of this Decision.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“these drawbacks in a petition directed to a related patent, where Petitioner argued that “a significant portion of the available space within [Kobayashi’s] cell is reduced by the process of crimping the cell closed.” Id. at 46 (quoting Ex. 2008, 2–3). Patent Owner argues that “Petitioner fails to explain why the beaded-over Kobayashi housing Petitioner and its same expert disparaged in another petition would be used in the present combination of references proposed in this Petition.” Id. at 48. Patent Owner’s argument raises an issue about a tradeoff that a person of ordinary skill in the art might or might not have made: under Petitioner’s proposed combination of teachings, it may be that a person of ordinary skill in the art would have had to accept reduced internal volume, and the consequent reduction in energy capacity, as the price of avoiding short circuits. The question of whether this tradeoff existed and, if so, whether a person of ordinary skill in the art would have made the tradeoff is a factual issue best resolved on the full record to be developed at trial. Patent Owner also argues that a person of ordinary skill in the art would not have replaced Higuchi’s housing with Kobayashi’s to reduce the risk of short circuits. Prelim. Resp. 48–49. Patent Owner points to Petitioner’s arguments in a related case regarding claims 27 and 28 of U.S. Patent No. 11,024,905, where Petitioner argues that it would have been obvious to add Kubota’s insulation tape to Higuchi’s leads 11 and 12, and Patent Owner argues that a similar modification here “could reduce such risk Kobayashi’s housing.” Id. at 48–49 (citing Ex. 2042, 2–4). According to Patent Owner, if “Petitioner and its expert are correct that a [POSITA] would have been motivated to adhere an insulation strip to both sides of Higuchi’s lead, it would not be necessary to change Higuchi’s housing for Kobayashi’s beaded-over housing to reduce the risk of short circuits.” Id. at 49. The fact that the prior art may suggest that some combination of techniques is more desirable than, or otherwise preferred over, the combination on which Petitioner relies does not preclude a finding that the challenged claims would have been obvious over Petitioner’s proposed combination. See Bayer Healthcare Pharms., Inc. v. Watson Pharms., Inc., 713 F.3d 1369, 1376 (Fed. Cir. 2013) (quoting In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004)). Thus, we have considered Patent Owner’s arguments, and although they cast doubt on Petitioner’s contentions and create a genuine issue of material fact, we are persuaded, on this record, that Petitioner provides sufficient reasoning with rational underpinning to support a motivation to combine the teachings of Higuchi and Kobayashi as proposed. Pet. 21–33. Specifically, Petitioner sufficiently establishes, for purposes of institution, that a POSITA would have had reason to modify Higuchi’s cell to use Kobayashi’s housing in order to reduce the risk that the cell would short circuit. Id. at 23–27. Whether Petitioner sufficiently establishes this issue to prove unpatentability is an issue we need not, and do not, resolve on this preliminary record. We invite the parties to develop these arguments further at trial, to the extent permitted under our rules.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 11,024,869
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.