- 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 - 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 · Mar 31, 2021 · IPR2019-01662 · APJ Jeffrey W Abraham · IPR · Final written decision
The Board canceled claims 1, 8, 13, and 17; it denied entry of substitute claims 23–26 because claims 23 and 25 lacked written-description support and claims 24 and 26 were indefinite.
RulingsFinal written decision- Skill levelSkill level board ownOther
“C. LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it 1 “One degree Brix is one gram of sucrose in 100 grams of solution . . . . Brewed sweetened tea has a typical Brix level of 10½ to 11.” Ex. 1001, 1:35–43. pertains to brewed beverages, (2) sugar particle size screening, and (3) the storage and use of sugar in commercial settings.” Inst. Dec. 7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019-00045, Paper 9 at 6– 8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. Inst. Dec. 8. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 12–13), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 4
- 112 supportMotion to amend, deniedDenied
“Structurally, Patent Owner has claimed a broad genus of brewing products – any product that includes sugar having particles in the range of U.S. mesh size nos. 3–35. Patent Owner attempts to further distinguish the genus by including the functional limitation of requiring the product to be capable of producing a tea with a Brix level of at least 10.5 degrees. Patent Owner does not dispute that there are products falling within the structural limitations that do not satisfy the functional limitations. Indeed, there is undisputed testing evidence on the record demonstrating that the entire range of recited structures does not perform the recited function. See Ex. 2076 at Exhibit C, 20–29 (Table 3); Revised MTA 8 (Patent Owner arguing the claims only cover products that include particles within the claimed range that perform the recited function). Here, we discern no evidence on this record of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Nor do we discern “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials” in the disclosures, or evidence that “the art has established a correlation between structure and function.” Id. Instead, we view Patent Owner’s proposed substitute claims to involve “merely drawing a fence around the outer limits of a purported genus,” which “is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. We recognize that the subject matter here is different from, and less complex than, the chemical and biochemical subject matter in Ariad. Nevertheless, the written description requirement still requires sufficient description to convey to one of skill in the relevant art that the inventors “had possession of the claimed invention” and “showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1351, 1356. Thus we consider the difference in technology in determining “the level of detail required to satisfy the written description requirement,” but do not consider the difference in technology to eliminate entirely the need for some disclosure in the specification indicating possession of the claimed invention. Id. at 1351. Patent Owner has not directed us to any portion of the ’526 or ’881” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Structurally, Patent Owner has claimed a broad genus of brewing products – any product that includes sugar having particles in the range of U.S. mesh size nos. 3–35. Patent Owner attempts to further distinguish the genus by including the functional limitation of requiring the product to be capable of producing a tea with a Brix level of at least 10.5 degrees. Patent Owner does not dispute that there are products falling within the structural limitations that do not satisfy the functional limitations. Indeed, there is undisputed testing evidence on the record demonstrating that the entire range of recited structures does not perform the recited function. See Ex. 2076 at Exhibit C, 20–29 (Table 3); Revised MTA 8 (Patent Owner arguing the claims only cover products that include particles within the claimed range that perform the recited function). Here, we discern no evidence on this record of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Nor do we discern “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials” in the disclosures, or evidence that “the art has established a correlation between structure and function.” Id. Instead, we view Patent Owner’s proposed substitute claims to involve “merely drawing a fence around the outer limits of a purported genus,” which “is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. We recognize that the subject matter here is different from, and less complex than, the chemical and biochemical subject matter in Ariad. Nevertheless, the written description requirement still requires sufficient description to convey to one of skill in the relevant art that the inventors “had possession of the claimed invention” and “showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1351, 1356. Thus we consider the difference in technology in determining “the level of detail required to satisfy the written description requirement,” but do not consider the difference in technology to eliminate entirely the need for some disclosure in the specification indicating possession of the claimed invention. Id. at 1351. Patent Owner has not directed us to any portion of the ’526 or ’881” slip op. at 20
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable
“which indicates that between 2–25% of the particles in EFG sugar can have a size in the range of U.S mesh sieve nos. 20–30. Ex. 2003, 42 (showing the “Typical Analysis” for “X-fine” granulated sugar). Even if we were to agree with Patent Owner that this shows a typical analysis for EFG sugar, it still presents a variance of up to 20% for particles having a size in the range of U.S. mesh sieve nos. 20 and 30. Ex. 2003, 42. Thus, the evidence of record suggests that the particle size distribution for EFG sugar, including the number of particles falling in the range of U.S. mesh sieve nos. 3–35, can vary among different EFG sugars. Thus, the term “typical grocery store sugar,” “might mean several different things” in terms of the number of its particles having a size in the range of U.S. mesh sieve nos. 3–35, and “no informed and confident choice is available among the contending definitions.” HZNP Meds. LLC v. Actavis Labs UT, 940 F.3d 680, 698 (Fed. Cir. 2019) (quoting Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed. Cir. 2015)); Opp. 7–10; Reply 4. Proposed substitute claims 24 and 26 compare the dissolution of the claimed beverage brewing product against the dissolution of a product using typical grocery store sugar (i.e., EFG). Patent Owner explains that the size of the particles affects dissolution – namely that larger sugar is more advantageous – in the claimed invention. See, e.g., Revised MTA 5; Ex. 1001, 9:23–27, 10:19–22. This suggests that an EFG sugar product having a greater percentage of large particles will be capable of dissolving “more of granulated sugar” as compared to an EFG sugar product having a lower percentage of large particles. As a result, using the dissolution properties of “typical grocery store sugar” as a comparator in the claims is problematic as there is a potential for inconsistent results based on which particular EFG sugar product is used. The potential for inconsistent results undermines Patent Owner’s argument that these claims satisfy the definiteness requirement because a person of ordinary skill in the art “can buy EFG . . . and perform brew tests with it in order to determine the scope of the claims.” Reply 4. Particle size is a critical factor for proposed substitute claims 24 and 26, which require a comparison of dissolution properties of the sugar used in the recited brewing product and typical grocery store sugar. Patent Owner contends “[t]here is an ‘informed and confident’ choice for ‘typical grocery store sugar’ - EFG sugar.” Reply 4. The evidence of record, however, shows the number of large particles (3–35 mesh) varies among EFG sugars. Ex. 2003, 42; Ex. 1004, at pages 51–53. In view of this, we find a person of ordinary skill in the art would not have understood “typical grocery store sugar” identifies sugar having particles of a particular size with sufficient specificity to allow the comparisons that proposed substitute claims 24 and 26 require. Accordingly, proposed substitute claims 24 and 26 are indefinite because they “fail[ ] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014); see USPTO Memorandum on the Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021); MPEP 2173.05(e) (9th ed., Rev. 08.2017, June 2020).” slip op. at 25
§ 112 disclosurecites NautilusPatents in suitUS 9,725,232
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.