• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision

  Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38

  Patent outcomesUS 11,236,318 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,236,318
• Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthSome claims unpatentable
  PTAB · 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 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSR
  Patents in suitUS 11,318,227
• Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthAll claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman
  Patents in suitUS 10,137,223
• Skechers U.S.A., Inc. v. Nike, Inc.Other
  PTAB · Sep 10, 2025 · IPR2025-00141 · APJ Ken B Barrett · IPR · Remand

  The Board instituted IPR of claims 1–21 on all asserted grounds after finding a reasonable likelihood of prevailing on the Nishida-based challenges.

  RulingsRemand decision

  • Director reviewDirector review, grantedGranted

    “partes review of U.S. Patent No. 8,266,749 B2 (“the ’749 patent,” Ex. 1001). Paper 1 (“Pet.”). The Petition challenges the patentability of claims 1–21 of the ’749 patent. Nike, Inc. (“Patent Owner”)2 filed a Preliminary Response to the Petition. Paper 6 (“Prelim. Resp.”). With our authorization, Petitioner filed a Reply to Patent Owner’s Preliminary Response (Paper 10) and Patent Owner filed a Sur-reply (Paper 13). We discretionarily denied institution under 35 U.S.C. § 325(d). Paper 20. Petitioner filed a request for Director Review of the Decision denying institution. Paper 21. Director Review was granted, the Decision denying institution of inter partes review was vacated, and the case was remanded to the Board. Id. at 4. Specifically, the case was “remanded to the Board with instructions to consider Petitioner’s Nishida grounds and to determine whether the Petition should be instituted.” Id. at 3–4.” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “presented in the Petition and the Preliminary 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(a). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’749” slip op. at 2

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In support of Petitioner’s position, Dr. Adanur testifies that “Nishida discloses that the unfinished surface area 1.1 is part of the web 1 itself,” that Nishida discloses that the computer-controlled process can (using Nishida’s phrase) “put in” up to seven different textile fibers or yarns into the web of material in one operation, and that, “[t]hus, Nishida discloses simultaneously knitting its layouts 2 and tongue 40 (each a ‘textile element’) with the unfinished surface area 1.1 (a ‘surrounding textile structure’).” Ex. 1002 ¶ 216 (citing Ex. 1022, 2:12–20, 4:47–55, 5:45–49). For purposes of institution, we credit that testimony over the testimony of Dr. Pastore, because, on the current record, we regard Dr. Adanur’s testimony as more consistent with the evidence. This and the other related issues may be explored more fully during the trial.” slip op. at 23

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that: A person of ordinary skill in the art (“POSITA”) in the field of the ’749 patent in March 2004 would have been someone with at least a few years of experience in knit materials and knitting methods and machines that can be used in making footwear, or a bachelor’s degree in textile-related sciences, engineering, or industrial product design, or equivalent academic or work experience, including in the footwear industry. EX1002, ¶68. Such a person of ordinary skill would have at least a general understanding of general construction processes and materials used in the manufacturing process of fabric-based articles. For individuals with a lower educational level, a person could still be of ordinary skill in the art provided that person’s working experience compensates for any such lower educational level, or vice versa. See id. Pet. 23–24. Patent Owner states that, “[f]or purposes of this Preliminary Response, Nike applies Skechers’ definition for a person of ordinary skill in the art.” Prelim. Resp. 14. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 10

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,266,749
• Motorola Solutions, Inc. v. Sta Group LLCSome claims unpatentable
  PTAB · Mar 6, 2025 · IPR2023-01292 · APJ David C Mckone · IPR · Final written decision

  Claims 1–4, 6–10, and 17–21 are unpatentable over Ohel; claims 5 and 11–16 were not shown unpatentable over Ohel or Nigawara.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “III. ANALYSIS A. Level of Skill in the Art Petitioner, relying on the testimony of Mr. Williams, contends that a person of ordinary skill in the art “would have had at least a bachelor’s degree in computer science, electrical engineering, or a similar field, and would have had approximately two years industry experience in networking or communication systems.” Pet. 3 (citing Ex. 1002 ¶¶ 55–58). Patent Owner does not dispute Petitioner’s proposal. PO Resp. 9. Petitioner’s proposal is consistent with the technology described in the Specification and the cited prior art. On the complete record, we adopt this level of skill.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “We have considered the parties’ citations to the specification and find examples that support Petitioner’s view that the term “entity” is broad enough to encompass dispatchers and individual users. See e.g., Ex. 1001, 3:52–4:5, 7:18–20, Fig. 1). However, we find no disclosure that redefines “entity” or excludes dispatchers and individual users from the category of “entity.” Patent Owner’s best examples (e.g., Ex. 1001, 1:15–21, 3:59–62) are no more than non-limiting examples. On the complete record, we conclude that “entity” is broad enough to include dispatchers and individual users.” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “have used a queue with Ohel’s system. This is insufficient because it does not provide evidence of a reason why a skilled artisan would have implemented Ohel’s system with a queue. See Auris Health, Inc. v. Intuitive Surgical Operations, Inc., 32 F.4th 1154, 1158 (Fed. Cir. 2022) (“The motivation-to-combine inquiry asks whether a skilled artisan ‘not only could have made but would have been motivated to make the combinations . . . of prior art to arrive at the claimed invention.’” (quoting Belden Inc. v. Berk- Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (emphasis omitted))).” slip op. at 35

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot reached

    “have used a queue with Ohel’s system. This is insufficient because it does not provide evidence of a reason why a skilled artisan would have implemented Ohel’s system with a queue. See Auris Health, Inc. v. Intuitive Surgical Operations, Inc., 32 F.4th 1154, 1158 (Fed. Cir. 2022) (“The motivation-to-combine inquiry asks whether a skilled artisan ‘not only could have made but would have been motivated to make the combinations . . . of prior art to arrive at the claimed invention.’” (quoting Belden Inc. v. Berk- Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (emphasis omitted))).” slip op. at 35

  Patent outcomesUS 7,324,802 mixed
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 7,324,802
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution denied
  PTAB · Jan 9, 2024 · IPR2023-01151 · APJ Timothy G Majors · IPR · Institution

  The Board denied institution on all asserted grounds because Petitioner did not show a reasonable likelihood that any challenged, undisclaimed claim was unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “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.” For reasons discussed below, we do not institute review of claims 2, 9, 17, and 18 of the ’834 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that the person of ordinary skill in the art (“POSA”) in November 2012 “would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. This [POSA] would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve.” Pet. 21 (citing Ex. 1003 ¶ 49). Patent Owner does not expressly contest Petitioner’s proposed definition. For this Decision, we apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). This POSA level is also consistent with the level the Board applied in earlier decisions involving the same parties and related patents. See, e.g., Ex. 2124, 11; Ex. 1120, 11–12.” slip op. at 16

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “during prosecution. Pet. 18, 99. According to Petitioner, Spenser II never describes its compressible material as including “tightly knitted fibers” and a POSA would, instead, have understood Spenser II’s compressible material as comprising “loose, porous materials.” Pet. 18, 99. We agree with Petitioner that the phrases “tightly knitted” and “tightly knitted fibers” do not appear in Spenser II. At the same time, neither does Spenser II describe its compressible material as being “loose” and “porous.” Notably, in prior proceedings before the Board, Petitioner’s declarant Dr. Buller testified that Spenser II’s compressible material “includes a plurality of PET fibers on the inward-facing surface of the compressible material” (i.e., the “base layer” and alleged “second plurality” of fibers here; Paper 9, 5), that is “sufficiently dense to prevent blood from leaking through the cloth/fabric.” Ex. 2128 ¶ 222; see also Ex. 2122, 20:2–22:18 (testifying that “nonporous” as used in the Specification means “that fluid would not pass through it” and such fluid includes “all components of blood”). We find that Dr. Buller’s description of Spenser II as having a dense, blood impermeable base layer is, on balance, more consistent with applicant’s characterization of Spenser II as having an arrangement of “tightly-knitted fibers”—even if some imagined or microscopic spaces between fibers might still exist in a base layer. Ex. 2128 ¶ 222; see also Ex. 2002 (Brecker testimony) ¶¶ 42–45 (testifying, inter alia, that the description of a “tight fitted outer seal is . . . consistent with Spenser II’s Figure 22” and “knitted” is consistent with Buller’s testimony describing Spenser II’s compressible material as “velour-like woven or knitted” PET (citing Ex. 1003 ¶ 162; Ex. 2134 ¶ 56). We are, thus, unpersuaded on this record that applicant mischaracterized Spenser II.” slip op. at 38

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “Altogether, the parties’ alleged “plain meaning” yet otherwise undefined interpretation of the “spacing” limitations leaves the Board with insufficient clarity about what the claimed “spacing” means in the affirmative. Paper 9, 3 (arguing “plain meaning”); Paper 11, 3 (arguing applicant’s arguments are in “full harmony with the plain meaning”). The intrinsic evidence is minimally helpful: the Specification does not use the term “spacing” in relation to the positioning of adjacent fibers; the drawings might be helpful but neither party proposes a specific construction that is reliant on them.15 The prosecution history provides clues, but portions of the prosecution record are arguably confounding. The applicant distinguished 15 For example, Dr. Brecker, in support of Patent Owner’s argument, identifies several of the patent drawings and testifies that, “as is particularly clear in Figure 13 (but also present elsewhere), there are gaps and spaces between the fibers that extend to the frame” and then proceeds to testify that prior art, like Spenser II’s compressible material, “bears no resemblance” to the “exemplary” spacings identified in prosecution. See, e.g., Ex. 2002 ¶¶ 42–43. Dr. Brecker’s articulation of a “spacing” does not seem to add anything meaningful beyond the language of the claim as written. And, simply comparing the patent drawings to the prior art drawings presumes a sort of “know-it when you see it” interpretation—it is not an affirmative construction for a “spacing” as claimed. the claimed “spacings” from “tightly knitted fibers.” Ex. 1002, 1001. At what point, however, does a cloth of “tightly knitted fibers” qualify as more “loosely defined” and come within the scope of the claimed “spacing?”16 Id. The applicant also described the “spacing” in semi-functional terms based on “advantages” provided by the claim feature. See, e.g., id. (asserting, e.g., that the spacing permits “expansion and contraction” with “lesser rigidity”); see also id. at 1133, 1140 (asserting, e.g., “reduce[d] restrictions” and avoidance of “restrained valve foreshortening” with the then-claimed “openings”). It is not, however, evident where the Specification supports such “advantages”—no citations were given in prosecution. And, in prosecution of related applications, applicant argued, for example, that “[w]hile all fibers have some degree of being spaced-apart, the construction from Applicant’s claimed invention clearly requires some level more spacing.” Ex. 1149, 13–14 (assertion differences over “Dehdashtian” (alias to Spenser II)) (emphasis added). On this record, what would suffice as “some level more spacing” is unclear. Id.” slip op. at 39

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,337,834
• BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentable
  PTAB · Nov 13, 2023 · IPR2022-00998 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 1–13 were not shown unpatentable under the asserted obviousness grounds; Patent Owner’s motion to strike Exhibit 1038 was granted.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We are not persuaded by Petitioner’s contention that we should disregard Dr. Naumovski’s testimony because she may have taken a leave of absence from work for a couple of years. The record supports that Dr. Naumovski not only meets the requirements of the person of ordinary skill in the art, but also appears to have relevant knowledge with respect to Gynostemma pentaphylum (“GP”) saponins. See Ex. 2015 (Appendix A). related field, and at least two years of experience using techniques for extraction and characterization of plant-based materials.” PO Resp. 11 (citing Ex. 2015 ¶ 74). Because there are more than 400 species of plants that contain saponins, Patent Owner disagrees that a person of ordinary skill in the art would be familiar with the structure and utility of saponins. Id. The level of skill in the art is a reference point for gauging what would have been obvious based on the reference disclosures. See Okajima, 261 F.3d at 1355. In other words, the lens of the level of ordinary skill in the art does not change a prior art’s disclosure, though it may change one’s understanding of what is disclosed. Patent Owner, however, does not explain how its definition provides a reference point that would meaningfully alter the Petition’s assertions of obviousness. For purposes of this decision, we analyze the asserted prior art with respect to the level of skill set forth by Petitioner, but there would be no difference in the outcome of this Decision if we were to apply the level of skill in the art set forth by Patent Owner. C.” slip op. at 13

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “during the full trial, we determine that Petitioner has not shown by a preponderance of the evidence that applying the methods of Kim 460 to the G. pentaphyllum starting material of Razmovski necessarily results in the damulin levels as claimed. We agree with Dr. Naumovski’s explanation that the use of an impure damulin B standard containing a double peak renders the results as shown in Exhibit 1013 unreliable. Ex. 2015 ¶¶ 141–143, 162–173; see Ex. 2007. Dr. Naumovski further explains that the use of an impure standard would require the application of a correction factor, but this correction factor would need to be reassessed as the purity of the standard decreases over time. See Ex. 2015 ¶ 166. As Dr. Naumovski explains that applying a correction factor to the linear regression would result in a shallower slope. Ex. 2015 ¶ 165 (citing 2006, 71:12–73:5; 99:2–9). “Reducing the calibration curve slope increases the amount of damulin B calculated from the experimental extracts.” Ex. 2015 ¶ 165. However, in the Experimental Report-1 the same correction factor for the damulin B standard was used to” slip op. at 41

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “Petitioner requests construction of the terms “an effective amount for improving or treating the metabolic syndrome,” which is found in claims 11–13, as meaning “an amount that produces any measurable amount of improvement in the metabolic syndrome” (Pet. 13–15 (citing Ex. 1003 ¶ 91)) and “[a] pharmaceutical composition for improving and treating a metabolic syndrome, comprising at least one of at least 0.7% damulin A and at least 0.5% damulin B . . . and a pharmacologically acceptable carrier or excipient,” which is found in claim 8, as meaning “a pharmaceutical composition that includes an extract with 0.7% and 0.5% of damulin A and damulin B[, respectively,] along with a carrier or excipient” (id. at 15–16 (citing Ex. 1002, 64–65, 251–52, 280; Ex. 1001, 12:15–67, Table 2)). Patent Owner argues that “constructions are not necessary.” PO Resp. 11–12. We agree with Patent Owner and determine that it is not necessary for purposes of this Decision to construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “Obviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903–04 (Fed.Cir.1988)); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (explaining that the expectation of success issue involves a showing of “a reasonable expectation of achieving what is claimed”) (emphasis added). Here, Petitioner relies on Kim 460 to show that heating ginseng, which contains the ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, results in a teaches that ginseng with the higher Rg3 and Rg5 content is 50-fold more potent in their vasodilation studies than the non-treated samples. Razmovski teaches that G. pentaphyllum contains over 100 saponins and eight of those saponins are the same as protoparaxadiol-type ginsenosides Rb1, Rc, Rb3, Rd, F2, Rg3, malonyl-Rb1, and malonyl-Rd that are found in P. ginseng. Ex. 1007, 4. Knowing that G. pentaphyllum also contains ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, we find Petitioner’s conclusion that heating a G. pentaphyllum extract that contains these ginsenosides would similarly increase the ginsenoside levels of Rg3 and Rg5 is a reasonable inference from the cited references. Based on the teachings in Kim 460, we agree with Petitioner that it would have been reasonable to expect that the same source material, although derived from a different plant, would behave similarly to heat treatment. See Pet. 24. Because G. pentaphyllum is a less expensive starting material, we also agree with Petitioner that there is sufficient motivation to substitute G. pentaphyllum for ginseng in the methods of Kim 460. slip op. at 29

  Patent outcomesUS 8,357,786 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,357,786
• Ford Motor Company v. Safe Driving Technologies LLCAll claims unpatentable
  PTAB · Feb 7, 2023 · IPR2021-01341 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–4 and 7–10 are unpatentable as obvious over Tan, Boies, Tan with Shuman and Behr, or Hardouin; Petitioner’s motion to exclude is granted.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “example, the types of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Petitioner asserts: An ordinary artisan would have been a person having, as of October 24, 2001, a Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Computer Engineering, or Computer Science, or an equivalent degree with at least two years of experience in electronic user interface systems and vehicle sensor systems or related technologies. Additional education may substitute for lesser work experience and vice-versa. (Ex.1003, ¶40.) Pet. 3 (citing Andrews Declaration). Patent Owner does not address the definition of the person of ordinary skill in the art, either to contest Petitioner’s proposal or to offer a different definition. See generally Resp. We adopt Petitioner’s unopposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’994 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We find Patent Owner’s reliance on the ’994 patent’s FIELD OF THE INVENTION Section misplaced. To quote it in its entirety, it states: The present invention relates to the field of telematics, namely to the field of integrating information, communication, computing and entertainment technologies into vehicles for civilian or military use. The invention particularly relates to safety control systems for vehicles to reduce driver distraction, avoiding potentially dangerous conditions tending to produce accidents. Ex. 1001, 1:21–27 (emphasis added). Thus, even were we to consider this portion of the Specification informative of the meaning of “telematic device,” it does not limit such to “a central multifunction device,” as argued by Patent Owner, but states that the field of telematics relates to integrating information, communication, computing, and entertainment technologies into vehicles, generally. Id. Nothing about this statement requires all these features to be integrated into a single device, unless the vehicle is considered the single device (which neither party suggests). See Reply 4 (discussing this section of the ’994 patent). Further, we find nothing in the ’994 patent supporting Patent Owner’s contention that the claim term “telematic device” should be restricted to a central multifunction device that integrates together the features of information, communication, computing, and entertainment technologies. The ’994 patent never states this. See Ex. 1001. Moreover, we find the ’994 patent to be much more inclusive than exclusive when describing what a telematic device can be, i.e., the scope of the term. Upon reviewing the written description of the ’994 patent, we find it makes the following statements (all emphasis added):” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “We agree with Petitioner that the disputed claim language is, indeed, somewhat confusing. It appears to us from reading the language of claim 2 as a whole that Patent Owner understood that the phrase “include at least one of” could have been used rather than the language “including at least” because Patent Owner used these different phrases at different portions of claim 2. Compare Ex. 1001, 23:2, with id. at 23:14–15. Had Patent Owner intended that the disputed claim language require only one of the listed devices, it appears that Patent Owner understood how to claim that. Further, the full disputed phrase of claim 2 recites a “communication device including at least a pager, a telephone, a global location sensor, a temporal sensor, an optical sensor, a heading sensor, a bearing sensor, and an altitude sensor.” Id. at 23:14–17. However, adding to the ambiguity of the claim, this list of communication device components is tacked onto the end of a clause listing software applications (e.g., a telephone application and a wireless communication application), not devices. And, moreover, the term “communication device” is not preceded by an associated “a” or “the,” and there is no other “communication device” recited earlier in claim 2 (or claim 1 from which it depends), which further adds to the claim’s ambiguity. Patent Owner asserts that “at least” means “at least one” and Petitioner, at least in an alternative argument, appears to potentially agree and presented a case for unpatentability based on such an interpretation. See Pet. 9 (compare Grounds 1 and 2 with Ground 3). Furthermore, following Patent Owner’s stated position on this claim language in its Response (at page 19), Petitioner does not argue the matter in its Reply, other than stating at one point (not at the claim construction section) that “at least” means “all.” See Reply 1–7; but see id. at 14 (stating that the plain language of claim 2 requires all of the devices). Thus, we could adopt Patent Owner’s interpretation of claim 2’s” slip op. at 24

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

    “Petitioner asserts that it would have been obvious to the ordinarily skilled artisan to combine Shuman with Tan because Shuman’s teachings on its GPS would illuminate the capabilities of and data provided by Tan’s GPS; these are the same or similar devices and may have the same or similar capabilities. Id. at 63 (citing Ex. 1003 ¶ 261). Petitioner asserts that it would have been obvious to the ordinarily skilled artisan to also combine Behr with Tan because Behr’s disclosure of monitoring the time of day to ensure its GPS provides relevant, safe, and legal instructions would also similarly support Tan’s GPS functioning, and also because there would have been a benefit to including Behr’s pager’s functionality in Tan’s system because such was a relevant communication technology. Id. at 64–65 (citing Ex. 1003 ¶¶ 263, 265). We agree with Petitioner’s assertions and reasoning regarding combining these prior art references with a reasonable expectation of success, and Patent Owner does not argue otherwise. See generally Resp.” slip op. at 50

  Patent outcomesUS 9,713,994 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,713,994
• Allstate Insurance Company v. Atos, LLCSome claims unpatentable
  PTAB · Jan 24, 2023 · IPR2021-01209 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–4, 6, and 9–25 are unpatentable; claims 5, 7, and 8 are not shown unpatentable, based on anticipation by Kim and obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art The level of ordinary skill in the art is “a prism or lens” through which” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “C. Claim Construction In inter partes reviews, we interpret claims under the same standard” slip op. at 10

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Accordingly, Petitioner fails to establish that Kim discloses “determining that the individual is a driver of the vehicle based at least in part on acceleration, forces, velocity, the at least one location point, and time.”” slip op. at 46

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “nexus and therefore fails to establish that any alleged evidence of objective indicia supports a finding of non-obviousness. Accordingly, we give Patent Owner’s reliance on objective indicia of non-obviousness no weight in our obviousness analysis.” slip op. at 65

  Patent outcomesUS 9,152,609 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,152,609
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · Dec 12, 2022 · IPR2021-00862 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–24 were not shown unpatentable because Petitioner failed to establish the proposed prior-art combinations and the required motivation to combine with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 25; PO Resp. 9–10. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner does not assert that any claim term requires express construction. See Pet. 6 (stating that it “reserves the right to respond to any constructions that [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCT-guided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “computer system” of the claims and all of its programmed surgical functionality, particularly, using a computer system to construct an anterior capsulotomy cutting region based on the image data. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention.” slip op. at 25

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentableNot shown unpatentable

    “The evidence of record demonstrates, however, that modifying an existing corneal surgery system to image and perform surgery on the lens was not the simple task asserted by Petitioner. For example, in a patent application filed in November 2009, Petitioner asserted that due to the different depth ranges for the laser’s focus, “laser systems designed for corneal procedures do not offer solution[s] for the considerable challenges of performing surgery on the lens of the eye.” Ex. 2007, 4:65–67, 5:30–36, code (22). Similarly, in a different patent filed in December 2008, Petitioner outlined the various challenges in developing laser surgery systems for creating incisions in the lens, including the difficulty in focusing a laser beam that propagates through regions of the eye with different optical properties and different curvatures. Ex. 2014, 15:51–16:18, code (22). This patent then states: Because of all the described hard challenges, corneal surgical laser systems are qualitatively simpler than lens surgical lasers. This is well supported by the fact that even though corneal surgical systems were suggested about 40 years ago, none have been adapted successfully for lens surgery to date. Id. at 16:13–18. During prosecution of another patent filed in 2008, and in responses to office actions filed in 2012 and 2013, Petitioner argued that a corneal OCT system “simply will not work” on the lens and that it would not have been obvious to modify such an OCT system to image the lens. Ex. 2015, 898, 1591, 1788. This was because OCT systems designed to image the lens would be required to deliver and scan an imaging beam “to a depth ten times bigger and a depth range ten times bigger” than an OCT system designed to image the cornea. Id. at 1591. According to Petitioner, “it is not obvious” to modify an OCT imaging system to achieve a depth and scanning range that is ten times larger than that disclosed in the art. Id. at 898 (“Increasing a system’s performance by an order of magnitude cannot be regarded as obvious.”), 1590–1591. Petitioner’s arguments presented in its own patents and during their” slip op. at 39

  Patent outcomesUS 8,709,001 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,709,001

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.