• 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
• 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
• Unified Patents Inc. v. Digital Stream IP, LLCSome claims unpatentable
  PTAB · Mar 9, 2018 · IPR2016-01749 · APJ Michelle N Wormmeester · IPR · Final written decision

  Claims 1, 4, 6–13, 20, and 22 are unpatentable as obvious; claims 2 and 3 were not shown unpatentable because the cited art did not establish portability or handheld use.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “We agree with Petitioner. Although Petitioner bears the burden of correctly identifying the real parties-in-interest, “[w]e generally accept the petitioner’s identification of real parties-in-interest at the time of filing the petition.” See Zerto, Inc. v. EMC Corp., Case IPR2014-01254, at 6 (PTAB Mar. 3, 2015) (Paper 35) (citing Office Patent Trial Practice Guide, 77 Fed. Reg. 48,680, 48,695 (Aug. 14, 2012)). Here, Petitioner identifies in its Petition the real party-in-interest: “Pursuant to 37 C.F.R. § 42.8(b)(1), Unified Patents Inc. (‘Unified’ or ‘Petitioner’) certifies that Unified is the real party-in-interest.” Pet. 1. Such identification gives rise to a rebuttable presumption that Petitioner has complied with its obligation to identify all real parties-in-interest. See Zerto at 6–7. Patent Owner recognizes that “it [is] incumbent on the patent owner to come forward with some rebuttal evidence.” PO Resp. 52. In response to Petitioner’s identification of the real party-in-interest, Patent Owner contends that “this is not an instance where a petitioner’s certification in a petition can be taken at face value” because “evidence proffered by [Petitioner] in support of its position was withdrawn deliberately.” Id. at 53. We do not, however, require evidence beyond a petitioner’s identification of real parties-in-interest in the absence of rebuttal evidence that such identification is erroneous or incomplete. Petitioner’s withdrawal of Exhibit 1012 from the record does not constitute such rebuttal evidence. In view of the foregoing, we find that the circumstances here do not raise sufficient doubt about whether Petitioner has satisfied its obligation to name all real parties-in-interest. Therefore, we determine that the Petition should not be dismissed on this basis.” slip op. at 7

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

    “by applying the broadest reasonable interpretation in light of the specification of the patent in which they appear. See 37 C.F.R. § 42.100(b); Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard). Under that standard, claim terms generally are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). A “claim term will not receive its ordinary meaning if the patentee acted as his own lexicographer,” however, and clearly set forth a definition of the claim term in the specification. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). Petitioner proposes an express construction for the claim term “transceiver.” Pet. 10. Patent Owner does not propose an express construction for any claim term. See generally PO Resp. In light of the parties’ arguments, we determine that no term requires express interpretation to resolve any controversy in this proceeding.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “Rovira teaches each of the recited claim limitations, Petitioner must provide “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). In that regard, Petitioner directs us to Rovira’s teaching that “it is highly desirable to communicate program content information” because “having such information as music title, composer, artist and record label is vital” to music lovers. Pet. 16 (citing Ex. 1003, 1:30–32, 2:5–10); see also Ex. 1003, 1:32–35 (“Frustration of customers, and possible loss of revenue due to subscription cancellation can occur if a subscriber has no method of knowing the title, composer or artist of the particular selection of music.”). Petitioner argues it, thus, would have been obvious to modify Schotz’s system to incorporate a signal that includes both audio data and program data, as taught by Rovira. Pet. 17; see also, e.g., id. at 21 (“[O]ne would have been motivated to (1) modify Schotz’s transmitter 4 to transmit the digital audio signal of Rovira . . . and (2) modify Schotz’s receiver 6 to receive this digital audio signal.”); id. at 23 (“[T]his modification would result in Schotz’s user interface switch 18 selecting the digital audio data . . . within the digital audio signal [of Rovira].”); id. at 25 (“It would have been obvious to utilize the tuner 110 of Rovira in Schotz for [tuning] to frequencies that Schotz is receiving based on its use of Rovira’s digital audio signal. . . . Schotz is essentially doing this already, i.e., tuning to a frequency associated with audio data.”); id. at 27 (“[I]t would have been obvious to modify Schotz to utilize Rovira’s disclosed demodulator 125 to extract the selected digital audio data and the audio program information from the carrier wave, as taught by Rovira.”); id. at 28–29 (“It would have been obvious to modify Schotz to include the digital to analog converter 160 disclosed in Rovira. . . . The receiver 6 of Schotz would necessarily need a digital to analog converter when using the digital signals disclosed in Rovira so that the user can hear the selected music.”). We are persuaded by Petitioner’s reasoning, including specifically the quoted material in the preceding string citation to the Petition, for modifying Schotz’s system to include Rovira’s signal as well as various components for processing such a signal. See Kahn, 441 F.3d at 988. We note that “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton,” and, in modifying Schotz’s system to include Rovira’s signal, would have made any necessary additional modifications such that Schotz’s system could process appropriately Rovira’s signal. See KSR, 550 U.S. at 421.” slip op. at 13

  Patent outcomesUS 6,757,913 mixed
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 6,757,913
• Adidas AG v. Nike, Inc.No claims unpatentable
  PTAB · Oct 19, 2017 · IPR2016-00921 · APJ James B Arpin · IPR · Final written decision

  Petitioner failed to prove claims 1–13 unpatentable as obvious over Reed and Nishida because it did not show a reason to combine their teachings.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Initially, Patent Owner contends that Petitioner has failed to consider appropriate factors identified by our reviewing court and utilized by other panels to assess the level of ordinary skill in the art. Id. at 12–13. We agree with Petitioner that it is not necessary to consider every factor or to weigh the factors equally in order to assess the level of ordinary skill in the art. Reply 2 (quoting In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)). Here, we may rely on Petitioner’s declarant’s testimony (Ex. 1003 ¶ 34) and the teachings of the prior art to evaluate Petitioner’s assessment of the level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). In particular, Reed and Nishida identify the types of problems encountered in the art prior art solutions to these problems, and the sophistication of the technology. E.g., Ex. 1006, 1:13–55; Ex. 1009, 1:10– 36; see, e.g., Ex. 1007, 1:8–32, 2:12–64; Ex. 1008, 1:11–54; Ex. 1010, 145– 160; see also Ex. 1010, Preface (“The aim of this book is to combine in a single volume the fundamental principles of weft and warp knitting in such a manner that its contents are useful to readers in education, industry or commerce. It thus [fulfills] the long felt need for a comprehensive up-to-date textbook explaining this important sector of textile technology.”). Patent Owner contends that the level of ordinary skill in the art is “low” (PO Resp. 13), but it is not clear whether Patent Owner further contends that Petitioner’s assessment is deficient because Petitioner fails to argue that a person possessing such a “low” level of ordinary skill in the art also would have “experience using knitting technologies to create knitted footwear uppers” (id. at 13–14) or whether the inclusion of such skill would raise the “low” level of skill in the art (id. at 14). Alternatively, Patent Owner may merely be contending that Petitioner’s declarant fails to qualify as a person of ordinary skill in the art. Id. at 14 (“If it was too ‘dangerous’ for Mr. Holden with his nearly forty years of experience, a person with just a “few years of experience” would not have had any knitting experience, let alone experience using knitting technologies to create uppers.”); see Tr. 62:17–22. Patent Owner is not required to help us assess the level of ordinary skill in the art and does not do so here. See PO Resp. 18 (“Petitioner may criticize NIKE for not submitting an expert declaration. But it is Petitioner’s burden to prove unpatentability; it is not NIKE’s burden to prove patentability.”). In response to Patent Owner’s contentions, Petitioner argues that the level of ordinary skill in the art is not low and that hands-on knitting experience is not required. Reply 2–3. Petitioner further argues Patent Owner has not required knitting experience in its previous assessment with respect to a related patent of the level of ordinary skill in the art. Id. (citing IPR2013-00067, Ex. 2010 ¶ 52). Based on the record before us and to the extent necessary, we again adopt Petitioner’s assessment of a person of ordinary skill in the relevant art. Inst. Dec. 8 n.3.” slip op. at 10

  • Expert testimonyPetitioner expert creditedMixed

    “document.” Reply 3 (quoting Ex. 2004, 12:7–11); see Ex. 2004, 12:12– 13:16. Declarants often have assistance in authoring their declarations. See Square, Inc. v. Think Computer Corp., Case CBM2014-00159, slip op. at 26–27 (PTAB Nov. 27, 2015) (Paper 47) (“the mechanics of declaration preparation is ‘a waste of time, both for the witness and the Board’”). Mr. Holden was not required to be the sole author of his declaration. Rather, the relevant issue regarding the preparation of Mr. Holden’s declaration is whether Mr. Holden adopted the content of his declaration as his own. Here, he has. See Ex. 1003 ¶¶ 3, 4, 209. As Patent Owner suggests, we weigh Mr. Holden’s declaration testimony in light of his testimony on cross-examination. Although Mr. Holden indicated that he was unable to define or was unfamiliar with certain terms during cross-examination, he did name references, including Spencer (Ex. 1010), that he could and would consult to obtain the answers to specific questions. Tr. 63:20–64:13. Moreover, Patent Owner’s counsel acknowledged that persons of ordinary skill in the art (or declarants) do not have to have all of the knowledge relevant to their testimony in their heads and that they are allowed to consult references, as appropriate. Id. at 63:20– 64:2. Although Patent Owner notes that Mr. Holden apparently was not aware of Spencer until this inter partes review (see Ex. 2004, 77:1–3; Tr. 64:1–6), his learning of and relying on a new reference alone is not sufficient reason to disregard, i.e., give no weight to, Mr. Holden’s testimony. Further, the issue here is not whether Mr. Holden is a person of ordinary skill in the art, but rather whether his testimony is of value to the panel. See Tr. 64:15– 18. Thus, as indicated in the discussion below, we determine the appropriate weight to give to Mr. Holden’s testimony.” slip op. at 31

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “8 Patent Owner contends that Reed is not analogous art. PO Resp. 29–31. In particular, Patent Owner contends that Reed is not from the same field of endeavor as the challenged claims and that Reed’s teachings are not reasonably pertinent to the particular problem with which the recited methods are involved. Id. at 29–30. Because Reed is directed to the manufacture of all types of garments, including footwear (Reply 12–14; see Ex. 1006, 1:33–44), and Reed is related directly to preparation of garments layouts from a knitted textile structure (Reply 14–15; see Ex. 1006, 2:29– 35), we are persuaded that Reed is analogous art to the challenged claims.” slip op. at 17

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

    “i. Failure of Proof Petitioner bears the burden of proving by a preponderance of the evidence that the challenged claims are unpatentable. This includes demonstrating by a preponderance of the evidence that a person of ordinary skill in the art would have had reason to combine the teachings of Reed and Nishida to achieve the methods recited in the challenged claims. As noted above, Petitioner argues that a person of ordinary skill in the art would have had at least three reasons to combine the teachings of Reed and Nishida to achieve the methods recited in the challenged claims. Pet. 12–14; see Tr. 10:12–11:12. First, Petitioner argues that, because Reed teaches that its methods are applicable to “all types of garments” (Ex. 1006, 5:56–57 (emphasis added); see Ex. 1003 ¶ 131), a person of ordinary skill in the art would have had reason to apply the teachings of Reed to the processes and shoe parts of Nishida. Pet. 13 (citing Ex. 1003 ¶ 133). Second, Petitioner argues that, because both Reed and Nishida teach the advantages of reducing cost through the use of computer-controlled knitting machines, a person of ordinary skill in the art would have had reason to combine their teachings. Pet. 13 (citing Ex. 1003 ¶¶ 134–135). Third, Petitioner argues that a person of ordinary skill in the art would have had reason to apply Reed’s methods for producing textile elements, from which to produce garments, to produce Nishida’s shoe upper patterns. Id. at 13–14; see KSR, 550 U.S. at 417. However, none of these reasons or any other reason identified by Petitioner addresses the differences between Reed and Nishida, specifically pre-seaming.” slip op. at 34

  Patent outcomesUS 7,814,598 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,814,598
• Apple Inc. v. Virnetx Inc.All claims unpatentable
  PTAB · Jun 22, 2017 · IPR2016-00332 · APJ Karl D Easthom · IPR · Final written decision

  Claims 1–11, 14–25, 28, and 30 are unpatentable based on the instituted grounds.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedMixed

    “Petitioner’s argument is persuasive. Patent Owner has not met its burden of explaining why Exhibits 1064 and 1065 must be excluded as hearsay. The statements are offered to show that skilled artisans believed the RFC 2401 document and other RFC documents were available at the time of publication. Patent Owner does not challenge the publication dates of the magazines as hearsay. As noted above, Patent Owner does not state what aspects of the documents are hearsay. See Paper 20, 7–10; Paper 24, 4 n.1 (Patent Owner “disagrees” with Petitioner about the documents status as hearsay). In any event, Petitioner shows that the documents also satisfy the residual hearsay exception. They have circumstantial guarantees of trustworthiness as written prior to litigation by disinterested parties in periodical trade magazines that almost qualify as ancient documents. Both magazine articles bear specific volumes and issue numbers along with the publication dates. See Ex. 1064 (Aug. 16, 1999, vol. 21, iss. 33); Ex. 1065 (March 15, 1999, vol. 16, no. 11); Paper 23, 3–8; Fed. Rule Evid. 803 (16) (ancient authentic documents of 20 years old are not hearsay). In addition,” slip op. at 84

  Patent outcomesUS 8,504,696 unpatentable
  Nonecites Phillips · KSR
  Patents in suitUS 8,504,696
• Apple Inc. v. Virnetx Inc.All claims unpatentable
  PTAB · Jun 22, 2017 · IPR2016-00331 · APJ Karl D Easthom · IPR · Final written decision

  Claims 1–11, 14–25, and 28–30 are unpatentable as obvious over Beser and RFC 2401.

  RulingsFinal written decision

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

    “Patent Owner’s contentions are not persuasive. Patent Owner fails to explain sufficiently why the notion of “performing an additional evaluation” constitutes an implicit part of the claimed intercept clause. Addressing similar arguments by Patent Owner, a Board panel made a similar determination in the ’237 FWD relied upon by Petitioner. ’237 FWD 11 (“the record show[s] that the additional functionality urged by Patent Owner should not be imported into the intercepting phrase”).” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “broadest reasonable interpretation in light of the specification. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard under 37 C.F.R. § 42.100(b)). Under this standard, absent any special definitions, claim terms or phrases are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art, in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). For the purposes of this Decision, only the claim terms or clauses below need express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only those terms in controversy need to be construed and only to the extent necessary to resolve the controversy).” slip op. at 7

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “We find Dr. Tamassia’s testimony as to public accessibility of RFCs in general to be credible, especially given the independent support of RFC 2026 (Ex. 1036), the contents of which Patent Owner does not challenge.7 As part of routine discovery, see 37 C.F.R. § 42.51(b)(1)(ii), Patent Owner had the opportunity to cross-examine Dr. Tamassia, but does not point us to any discussion of this issue. Moreover, RFC 2401’s contents are consistent with the publication process described by RFC 2026 and Dr. Tamassia, including the inclusion of a date “November 1998” on the top right corner of the first page of the document. Ex. 1008, 1. In addition, this document—a request for suggestions and improvements for an Internet standards protocol, 7 As addressed below, Patent Owner objects and moves to dismiss a number of Exhibits based on hearsay and relevancy. See Paper 20 (Motion to Exclude). having no indication of being a mere draft or internal paper—is precisely the type of document whose very purpose is public disclosure, including on the Internet. Both of the magazine articles, Exhibits 1064 and 1065, further corroborate the indicia of availability on the face of RFC 2401, although they are not necessary to our finding of public accessibility. We do not rely on the testimony of Sandy Ginoza, Exhibits 1060 and 1063, which Patent Owner seeks to exclude as discussed further below.” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Patent Owner does not articulate a persuasive reason for giving Dr. Tamassia’s declaration, as a whole, little or no weight in our analysis. We agree with Petitioner that experts are not required to opine on every relevant factual and legal issue in order to be accorded substantial weight. The cases upon which Patent Owner relies do not show otherwise. For example, Patent Owner cites Schumer v. Laboratory Computer Systems, Inc., 308 F.3d 1304, 1315 (Fed. Cir. 2002), for the proposition that “[expert] testimony . . . ‘must identify each claim element, state the witnesses’ interpretation of the claim element, and explain in detail how each claim element is disclosed in the prior art reference.’” PO Resp. 52–53. Patent Owner’s quotation, however, mischaracterizes Schumer by omitting introductory words necessary to the meaning of the quoted sentence. In its entirety, the quoted portion of Schumer states the following: Typically, testimony concerning anticipation must be testimony from one skilled in the art and must identify each claim element, state the witnesses’ interpretation of the claim element, and explain in detail how each claim element is disclosed in the prior art reference. The testimony is insufficient if it is merely conclusory. Schumer, 308 F.3d at 1315–16. The Federal Circuit then adds that it is not the task of the courts to “attempt to interpret confusing or general testimony to determine whether a case of invalidity has been made out” and “if the testimony relates to prior invention and is from an interested party, as here, it must be corroborated.” Id. at 1316. So, instead of laying out a specific, required format for the content of all testimony regarding invalidity, as asserted by Patent Owner, this portion of Schumer confirms the unremarkable proposition that conclusory, overly general, confusing, and self-interested testimony should not be relied upon. Id.; see also Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1152 (Fed. Cir. 2004) (“General and conclusory testimony, such as that provided by Dr. Kazmer in this case, does not suffice as substantial evidence of invalidity.”). Patent Owner does not show that the whole of Dr. Tamassia’s testimony suffers from any of these failings. Under 35 U.S.C. § 316(e), the preponderance of the evidence standard governs in determining whether Petitioner establishes unpatentability. We exercise discretion to determine the appropriate weight to accord the evidence presented, including expert opinions, based on the underlying facts supporting the opinion. We accord relevant portions of Dr. Tamassia’s testimony the appropriate weight based on that particular testimony and supporting evidence.” slip op. at 14

  Patent outcomesUS 8,504,696 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,504,696
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

  Claims 1–8 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success using lomitapide in the claimed dosing regimen.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). As to reasonable expectation of success, we agree with Patent Owner that the ordinary artisan would not have had a reasonable expectation of success of combining Pink Sheet with Chang to arrive at the claimed invention. To the extent that Petitioner relies on our Institution Decision, we note that decision was based on the evidence of record at that time. The evidence advanced by Patent Owner during trial, discussed herein, however, tips the scale in favor of a finding different from that set forth in our Institution Decision. slip op. at 36

  • ExcludeMotion to exclude, deniedMixed

    “As to Exhibit 1052, which is the Deposition Transcript of S. David Kimball, and which Patent Owner acknowledges that Petitioner cites in its Reply, Patent Owner argues that it timely objected to the exhibit as an improper duplicate of Exhibit 2304. Mot. Exclude 7. Petitioner responds that Exhibits 2304 and 1052 are the transcripts of Petitioner’s expert. Opp. Mot. Exclude 4. Although acknowledging that the party taking the deposition normally files the transcript, Petitioner asserts that its Reply cites to Ex. 1056, and Patent Owner does not cite to either exhibit. Id. Patent Owner replies that Exhibit 2304 also contains Dr. Kimball’s signed errata sheet and is, thus, the more complete of the two documents. Reply Mot. Exclude. 3. Patent Owner asserts that the citations in Petitioner’s Reply can be updated to reflect the correct exhibit number, if necessary. Id. Given the posture of this proceeding, that is, it is at final written decision, and as Patent Owner notes, the two documents are not exact duplicates, we decline to exclude Ex. 1056, but will allow both Exhibit 1056 and 2034 to remain in the record.” slip op. at 44

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “the unrebutted evidence of commercial success further supports the patentability of the challenged claims. Looking at the entire record before us, we conclude that Petitioner has not meet its burden to establish unpatentability of challenged claims 1‒8 by a preponderance of the evidence over the combination of Pink Sheet and Chang. E. Motion to Amend As discussed above, because we conclude that Petitioner has not demonstrated the obviousness of the claims by a preponderance of the evidence, we need not reach the merits of Patent Owner’s contingent Motion to Amend (Paper 24). We, thus, dismiss the motion a moot.” slip op. at 44

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “biotechnology and medical device companies.” Id. The press release does not even mention Dr. Stein. Thus, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. We, therefore, decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter” (Ex. 1003 ¶ 25 (citing the PPD Press Release)), as there was nothing in the press release discussing MTP inhibitors. That finding informs our analysis of the factors set forth in Klopfenstein. Thus, although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” slip op. at 19

  Patent outcomesUS 7,932,268 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,932,268
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01835 · APJ Lora M Green · IPR · Final written decision

  Claims 1–10 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success substituting lomitapide into Pink Sheet’s dosing protocol.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish facts supporting its challenge by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Based on the record before us, we conclude that Petitioner has failed” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “under 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 14

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

    “Although we find this issue to be very close, we find that the Petitioner has established by a preponderance of the evidence that the ordinary artisan would have looked at other MTP inhibitors, such as lomitapide as taught by Chang, that could be used in the dosing protocol taught by Pink Sheet. Specifically, Pink Sheet teaches a dosing method with the MTP inhibitor, implitamide, wherein, as discussed above, the dosing schedule meets the dosing schedule required by claim 1. Ex. 1013. In addition, Pink Sheet discusses MTP inhibitors generally, and notes that they may have efficacy in situations where high-dose statins are ineffective or inadequate, such as homozygous and severe heterozygous familial hypercholesterolemia. Id. Pink Sheet also acknowledges that the toxicity seen with MTP inhibitors may have been due to the high doses used during the clinical trials. Id. Chang discusses the clinical efficacy of MTP inhibitors, including implitapide (BAY-13-9952) and lomitapide (BMS-201038). Ex. 1015, 566. Specifically, Chang discusses the clinical efficacy of CP-346086, and then notes that similar efficacy was reported for implitapide and lomitapide. Id. Given that implitapide and lomitapide are from the same class of therapeutics, that is, MTP inhibitors, and that they are known to have similar clinical efficacy, based on the record before us, we determine that Petitioner has demonstrated a reasonable basis as to why the ordinary artisan would have substituted lomitapide as taught by Chang for implitapide in the method of Pink Sheet.” slip op. at 32

  • Obviousness (§103) › Objective indicia / secondary considerations › Commercial successObjective indicia with nexusDecided for patent owner

    “Initially, we note that Petitioner does not contest that Juxtapid is a commercial success, and, thus, in view of the unrebutted evidence provided by Patent Owner, we find that Patent Owner has established that Juxtapid is a commercial success. As to Petitioner’s argument that the Juxtapid website does not suggest a forced titration, as set forth in our section on claim construction above, we decline to construe independent challenged claim 1 as requiring a forced titration. Moreover, as shown in the table below, the dosing schedule of independent claim 1 encompasses the dosing method that is given to doctors on the Juxtapid website (Ex. 2301, 1):” slip op. at 43

  Patent outcomesUS 8,618,135 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,618,135

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.