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  • PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

    Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “We find that a rigid requirement as to the subject of a POSITA’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 that “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 POSITA 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 POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a 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 POSITA 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 9

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

      “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

    • BurdenNot shown unpatentable

      “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

      “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

    Patent outcomesUS 11,959,109 unpatentable
    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,959,109
  • PTAB · Sep 1, 2026 · IPR2025-00914 · APJ Brian P Murphy · IPR · Final written decision

    Claims 1–19 are unpatentable as obvious over Menon, Trefethen, RS6000, and POEref.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and We adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the ’679 patent, the prior art of record, and the testimony of both experts.” slip op. at 10

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

      “The Petition relies on the ordinary and customary meaning of the claim terms consistent with the Phillips standard. Pet. 12–13 (citing 37 C.F.R. § 42.100(b)). The Petition also addresses the construction of “peer-to-peer architecture” recited in independent claim 1 of the ’679 patent, a limitation we need not construe to resolve the parties’ dispute in this proceeding. Id. at 13; see, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Owner relies on the ordinary and customary meaning of the claim terms consistent with the Phillips standard without further analysis. Resp. 7.” slip op. at 11

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

      “RS6000 with Menon, namely because RS6000 provides an overview of the IBM SP2 multiprocessor and Menon teaches the use of “IBM SP2, a modern high performance distributed memory multiprocessor” used in the MultiMATLAB system. Id. at 24–25 (citing Ex. 1003 ¶¶ 142–145; Ex. 1005, 5–6, 14; Ex. 1007, 1, 11). The Petition also explains why POEref pertains to the field of cluster computing in a parallel operating environment. Id. at 26 (citing Ex.1008, 11 (“PE Software is designed to run on an … RS/6000 network cluster”)); (further citing Ex. 1001, 1:14–15; Ex. 1003 ¶¶ 146–149). The Petition contends that a POSITA would have been motivated to combine the teachings of POEref with Menon “because Menon suggests the combination by teaching that MultiMATLAB uses ‘POE, IBM's Parallel Operating Environment.’” Id. at 26–27 (citing Ex. 1005, 6); (further citing Ex. 1003 ¶¶ 150–153; Ex. 1005, 14; Ex. 1008, 11, 46). We agree with Petitioner’s analysis. We find the Petition’s argument and evidence of a motivation to combine the asserted prior art references in the manner claimed to be compelling, persuasive, consistent with the disclosures in the references, which include internal cross-references to each other, and supported by the expert testimony of Dr. Bajaj.” slip op. at 19

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Patent Owner argues that Menon teaches away from a combination with Trefethen because “Menon expressly states that Trefethen’s first-generation architecture is inadequate for the objectives that motivated the newer design.” Resp. 35–37. The evidence does not support Patent Owner’s position. First, Patent Owner’s teaching away argument is inconsistent with the strong evidence of a motivation to combine Menon and Trefethen discussed above. Second, Patent Owner’s teaching away argument is contrary to the evidence of record for the reasons given in Petitioner’s Reply. Reply 13–15 (e.g., “Menon explicitly cites Trefethen and explains that Menon builds on the teachings of Trefethen.”) (citing Pet. 22; Ex. 1003 ¶ 70; Ex. 1005, 1–3; Ex. 1163 ¶¶ 47–53). We are further persuaded by Dr. Bajaj’s reply testimony: the “MultiMATLAB teachings in Trefethen. In fact, Menon describes enhancing the system of Trefethen. For example, Menon describes a list of “goals” already achieved by MultiMATLAB and then states that the architecture has been “redesigned to achieve two further goals.” One of these two “further goals” is “extensibility,” which Menon achieves by its description of adding “MEX routines” to the system of Trefethen. Far from showing an “incompatibility” between Menon and Trefethen as the POR argues, Menon’s addition of the “MEX routines” to MultiMATLAB shows that such a modification was within the capabilities of a POSITA, because the authors of the Menon paper actually implemented the modification. Ex. 1163 ¶ 49 (citing Ex. 1005, 1–3). Dr. Bajaj’s testimony is unrebutted, credible, and supported by the record. We agree with Dr. Bajaj’s reasoning, which is based on direct quotes in Menon. We further agree with Dr. Bajaj’s conclusion that Menon does not teach away from the combination with Trefethen. Id. ¶¶ 50–52. Menon’s description of building on and enhancing the teachings of Trefethen—the earlier work of the same research group at Cornell—by adding MEX routines to achieve high-performance parallel computing and extensibility for MATLAB, demonstrates a classic motivation for a POSITA to combine the teachings of Menon and Trefethen. RS6000 and POEref are specifically referenced in Menon-Trefethen and add operational details of the parallel operating platform that teach a POSITA how to implement the MultiMATLAB system with a reasonable expectation of success. Such facts are inconsistent with Patent Owner’s teaching away and lack of motivation arguments.” slip op. at 24

    Patent outcomesUS 12,021,679 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 12,021,679
  • PTAB · Aug 26, 2026 · IPR2025-00913 · APJ Brian P Murphy · IPR · Final written decision

    Claims 1–30 are unpatentable: claims 1–25, 27–28, and 30 as obvious over Menon, Trefethen, RS6000, and POEref; claims 26 and 29 over those references plus MPIref.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. We adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the ’034 patent, the prior art of record, and the testimony of both experts.” slip op. at 11

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

      “processor,” “multi-core” processor, or “singular ‘hardware processor’ that ‘comprises’ (or ‘with’) multiple ‘processing cores’” as Patent Owner contends. Resp. 11–12, 21; see also Ex. 1163 ¶ 22 (“The claim does not recite ‘single chip,’ ‘single package,’ ‘single die,’ or ‘single multi-core microprocessor.’”). Nor do the claims recite a plurality of processing cores “within” a single-chip package or read as “multi-core within a processor” as argued by Patent Owner. Resp. 12–14; Sur-Reply 2; see Reply 6 (citing Ex. 1163 ¶ 23 (“Thus, the phrase ‘with a plurality of processing cores’ identifies the required processing resources associated with the hardware processor; it does not import a packaging limitation.”)). The claims do recite a hardware processor “with” a plurality of processing cores; a critical distinction even Patent Owner reads as open-ended, i.e., as a hardware processor that “comprises” a plurality of processing cores. See Resp. 11 (“the claims require a singular ‘hardware processor’ that ‘comprises’ (or ‘with’) multiple ‘processing cores’”). Consequently, the claim language does not support Patent Owner’s proposed construction of “a . . . hardware processor with a plurality of processing cores” as a single multi-core processor. cores it contains” in reliance on a parsed description in the ’034 patent specification: The specification explains: “Each processor can contain one or more processor cores that are capable of single-threaded execution. Processor cores are generally independent microprocessors, but more than one can be included in a single-chip package.” Id. at 1212 (partially quoting Ex. 1001, 5:11–16); Sur-Reply 2. The quoted description does not support Patent Owner’s contention that the claimed “a . . . hardware processor with a plurality of processing cores” must be limited to a “single multi-core processor” that “locates multiple cores within a ‘single-chip package,’” i.e. limited to a single multi-core microprocessor such as “a Core 2 Duo is one processor package with two cores.” Resp. 12– 13, 21 (citing Ex. 1001, 7:15–25). The description quoted above from column 5, moreover, describes a “processor” that “can contain one or more processor cores” each of which can be an independent microprocessor. Reply 2–3 (citing Ex. 1001, 5:11–16; Ex. 1163 ¶¶ 10–14). As Petitioner emphasizes, the specification distinguishes a “processor” from a “microprocessor” and describes a “processor” that “can be one or more general purpose single-core or multi-core microprocessors,” rather than limiting a “processor” to a single multi-core microprocessor. Reply 3–5 (citing Ex. 1001, 7:14–36, Fig. 1; Ex. 1163 ¶¶ 15–18).” slip op. at 13

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

      “art because they pertain to the same “field of cluster computing” as the ’034 patent and “are reasonably pertinent to the problem of the ’034 patent, namely, executing a single program on multiple nodes.” Pet. 22 (citing Ex. 1001, 1:14–15; Ex. 1003, ¶¶ 65–69; Ex. 1005, 2; Ex. 1006, Abstract). The Petition emphasizes that Menon expressly cites and builds on the MultiMATLAB system taught by Trefethen. Id. (citing Ex. 1003 ¶ 71; Ex. 1005, 1–2). The Petition contends that: combination of prior art elements according to known methods (executing MATLAB code on a multiprocessor system) to yield the predictable result discussed in both papers: the MultiMATLAB system executing MATLAB in parallel to perform mathematical calculations. Id. at 22–23 (citing Ex. 1003 ¶ 70; Ex. 1005, Abstract; Ex. 1006, 2–7). The Petition further contends that a POSITA would have found it predictable to combine Trefethen with Menon with a reasonable expectation of success “because researchers had a strong desire to parallelize MATLAB.” Id. at 23–24 (citing Ex. 1003 ¶ 73; Ex. 1005, 2; Ex. 1006, 11–12.)” slip op. at 27

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

      “A POSITA would have had an especially strong reason to read these references together because they address the same project, the same MATLAB-based parallel-computing problem, and the same MultiMATLAB command environment. Menon expressly identifies Trefethen’s MultiMATLAB work and then describes a redesigned architecture that preserves the same user-level objective––parallel MATLAB computations—while improving implementation details and extensibility. A POSITA therefore would not view the references as mutually exclusive alternatives. Rather, a POSITA would understand Trefethen as teaching specific MultiMATLAB commands and examples, including Eval, Send, Recv, and the architecture was implemented and improved in a later version. Ex. 1163 ¶¶ 71–72 (emphases added). We find the above reasoning persuasive and adopt it as our own. Petitioner and Dr. Bajaj demonstrate a sound technical motivation for a POSITA—someone having a bachelor’s degree in computer science, computer engineering, or electrical engineering and two years of experience working in the field of cluster computing or parallel processing—to combine Menon and Trefethen: to improve MATLAB’s operational performance and extensibility in a parallel operating environment. Menon builds on Trefethen to improve and extend the parallel processing capabilities of MultiMATLAB: “This system will enable users to access high-performance parallel routines from within the MATLAB environment, to extend the environment with new parallel routines, and to use these routines to develop parallel applications with the MATLAB language.” Ex. 1005 Abstract. Menon is intended to be read in conjunction with Trefethen, as would be expected from two references generated by the same research group at the same university addressed to the same technical subject matter about a year apart. Ex. 1005, 1; Ex. 1006, Ex. 1086 ¶¶ 65, 101, 102. The very first citation in Menon is to Trefethen. Ex. 1005, 2, 16.” slip op. at 30

    Patent outcomesUS 11,570,034 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,570,034
  • 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
  • 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
  • PTAB · Aug 3, 2026 · IPR2025-00430 · APJ Bach V Hoang · IPR · Final written decision

    Claims 1–3, 5–9, 13–15, 18, 19, and 22 are unpatentable as obvious over Dumais, Rose, and Rose with Bieganski.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Our Institution Decision adopted Petitioner’s definition of a person of ordinary skill in the art. Inst. Dec. 7–8. In its Response, Patent Owner adopts Petitioner’s proposed level of ordinary skill. See PO Resp. 13–14 (“Patent Owner and its expert adopt the Board’s definition for purposes of this Response”). Having considered the record, we continue to adopt Petitioner’s proposed level of skill, as articulated above. We are satisfied that Petitioner’s proposal comports with the level of skill necessary to understand and implement the teachings of the ’217 Patent. Accord Inst. Dec. 7–8.” slip op. at 8

    • ExcludeMotion to exclude, deniedOther

      “We have not considered any of the evidence Patent Owner moves to exclude in reaching our findings and conclusions set for in this Decision. As a result, Patent Owner’s Motion to Exclude this evidence is dismissed as moot.” slip op. at 55

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artPriority date, deniedDecided for petitioner

      “We determine that Patent Owner has not carried its temporary burden of production to support its contention that the inventors were reasonably diligent throughout the critical period. See Parus Holdings, 70 F.4th at specifically cite the relevant record evidence combined with an explanation of the significance of the produced material in briefs. See id. at 1372 (explaining that “[t]he burden of production cannot be met without some combination of citing the relevant record evidence with specificity and explaining the significance of the produced material in briefs”). Patent Owner states that it “submitted extensive evidence.” PO Sur-reply 14. But simply submitting dozens of exhibits is not enough. As our reviewing court has admonished, the “burden of production cannot be met simply by throwing mountains of evidence at the Board without explanation or identification of the relevant portions of that evidence.” See Parus Holdings, 70 F.4th at 1371. Instead of citing what specific portions of those exhibits are relevant and why, Patent Owner cites entire exhibits and asserts, without analysis or explanation, that they show diligence. See PO Resp. 49– 50 (citing numerous exhibits without pinpoint citations). Patent Owner’s Sur-reply asserts that Patent Owner’s Response was adequate (PO Sur-reply 17), but an examination of the Response shows that it was not. For example, in its Response, Patent Owner states “numerous documents corroborating [the inventors’] testimony that, during the critical period, they were refining the formulas to implement the BlueSpace relevance model” by citing the entirety of so-called “corroborating documentation” spanning Exhibits 2032 through 2074 as well as the entirety of Justin Marston’s Second Supplemental Declaration (Ex. 2030) and Paul Marston’s Declaration (Ex. 2031). See PO Resp. 49. However, there is not a single pinpoint citation to any particular paragraph, page, or entry for any of those exhibits (a number of which approach 100 pages in length) in Patent Owner’s discussion. See id. Even less helpful, the Response does not inventors actually worked on the claimed invention. See id. That is, the Response does not state exactly what in the “corroborating documentation” actually corroborates the inventors’ testimony or itself shows diligence. If anything, the Response points out that the inventors were engaged in other activities: “Justin Marston had numerous other obligations running the company BlueSpace, and Paul Marston was working a full-time position as a lecturer on statistics.” PO Resp. 49; PO Sur-reply 15–16. We do not fault the Marstons for engaging in other activities, but Patent Owner’s discussion of the Marstons’ other activities and mere conclusory assertions of diligence, without more, do not show that the Marstons were reasonably diligent as to the relevant activities during the critical time period. Simply put, Patent Owner’s Response does not adequately explain exactly how or why the evidence supports its argument that the inventors were reasonably diligent throughout the critical period. We decline the invitation to sift through the hundreds of pages spanning dozens of exhibits in search of evidence and reasons supporting Patent Owner’s assertion of diligence.” slip op. at 12

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

      “combined Rose and Bieganski. Rose and Bieganski are both concerned with recommending content to a user based on other users’ content preferences. Ex. 1006, code (57); Ex. 1007, code (57). Petitioner, supported by Dr. Fox, adequately shows that Bieganski discloses an improved technique for selecting which other users’ preferences are considered in a recommendation. Pet. 71 (citing Ex. 1003 ¶¶ 235–236), 75 (citing Ex. 1003 ¶¶ 247–248). We agree that improving Rose’s content ranking system using Bieganski’s content recommendation technique sufficiently motivates the combination. See KSR Int’l, 550 U.S. 417 (noting that where “a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”). Patent Owner’s argument that Bieganski’s approach is not an improvement over Rose because Rose “teach[es] that feedback from all users is valuable” (PO Sur-reply 9–10 (citing Ex. 2029 ¶ 199)) has two faults. First, that argument mischaracterizes Rose. We find no description in Rose which states that feedback from all users is “valuable” such that selecting certain users is not an improvement. Rather, Rose aligns with Bieganski’s selection of relevant users because Rose emphasizes feedback from similar users by adjusting the weight given to feedback from users who are more or less correlated. Ex. 1006, 6:64–7:1, 7:10–34 (“Rjk is the correlation of users i and k, the Vkj is the weight indicating the feedback of user k on document j.”). Second, even if Rose describes an embodiment where feedback from all users is considered, that does not preclude motivating improvement. See PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1197–98 (Fed. Cir. 2014) (noting it is not necessary to show that a combination is “the best option, only that it be a suitable option”).” slip op. at 47

    Patent outcomesUS 7,716,217 unpatentable
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 7,716,217
  • PTAB · Jan 22, 2026 · IPR2024-01158 · APJ Ken B Barrett · IPR · Final written decision

    Claims 1–5, 7–15, 17, and 18 are unpatentable: claims 1–4, 9–14, 17, and 18 as anticipated by Tateishi, and claims 5, 7, 8, and 15 as obvious over Tateishi.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We discern no material difference between the parties’ definitions. 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. We note, however, that were we to adopt Patent Owner’s assessment, the outcome of this Decision would be the same.” slip op. at 13

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

      “After considering the parties’ arguments and evidence, we determine that Patent Owner has not offered persuasive evidence that a person of ordinary skill in the art reading the claims in light of the Specification would understand the plain and ordinary meaning of “control signal” to be as narrow as Patent Owner proposes. We do not construe the claims such that the “control signal” must be the exclusively controlling factor of a component, as Patent Owner urges. Petitioner’s position, on the other hand, is consistent with the evidence of record. We construe “control signal” as having its plain and ordinary meaning, namely a signal configured to control a circuit component. D. The Asserted Anticipation of Claims 1–4, 9–14, 17, and 18 by Tateishi” slip op. at 24

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “We determine that Petitioner has demonstrated by a preponderance of the evidence that Tateishi discloses the “control signal” recited in limitations 1B2 and 1D of independent claim 1.” slip op. at 37

    • BurdenNot shown unpatentable

      “based on the Tateishi application publication (Ex. 1007), that the Tateishi Patent (Ex. 1005) also anticipates claims 1–4, 9–14, 17, and 18. See Pet. 23–24 (“The Tateishi Patent is also prior art under (pre-AIA) §102(e)”; identifying Ground 1 as anticipation “under §102 by Tateishi and/or the Tateishi Patent”). However, we are unable to locate in the Petition or Petitioner’s Reply a discussion of or citation to the Tateishi Patent other than under the Petitioner’s heading “Identification of Challenge and Relief Requested” on pages 23 and 24 of the Petition. Cf. id. at i–x (Table of Contents identifying a section of the Petition discussing the Tateishi (Application) anticipation ground but not a section discussing a Tateishi Patent anticipation ground). Although the issued patent may be substantively identical to the published application, Petitioner does not assert that, and we decline to compare the documents to determine whether that is the case. In light of Petitioner’s silence on the alternative ground, Petitioner has not demonstrated by a preponderance of the evidence that the Tateishi Patent anticipates 1–4, 9–14, 17, and 18.” slip op. at 47

    Patent outcomesUS 9,041,377 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,041,377
  • PTAB · Nov 21, 2025 · IPR2025-00956 · APJ Ryan H Flax · IPR · Institution

    The Board instituted IPR on claims 1–12 under all asserted grounds, finding a reasonable likelihood that at least one claim is unpatentable.

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

      “institute trial in an inter partes review. We institute an inter partes review only if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’992 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “These two proposed definitions of the ordinarily skilled artisan share many consistencies, for example, the types of degrees and experience such a person would have had, but differ in the number of years of experience. Petitioner proposes the ordinarily skilled artisan would have had at least five years of experience and Patent Owner proposes at least three years (which would necessarily include five years, too). Patent Owner also proposes that the ordinarily skilled artisan would have consulted a dentist, oral surgeon, prosthodontist, or periodontist with experience in dental implants and prosthetics. At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 40. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’992 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” 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)). This parties may further developed this issue at trial, if desired. C.” slip op. at 13

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

      “The Board interprets claim terms in an inter partes review using the same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.100(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc).” slip op. at 14

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

      “Here, the first claim limitation at issue is broad, i.e., different thread pattern/profile between a definite and a temporary screw, and the Specification’s and priority applications’ disclosure is narrow and specific, asymmetric buttress style threads in a temporary screw and symmetrical threads in a definite screw (are different). Any apparent predictability in or maturity of the relevant field here must be contrasted with the fact that the Specification, considering the ’992 patent itself or any of the identified priority applications, never once even discusses the (claimed) concept of specifically differing the thread style between a temporary and a definitive screw. Any differences in thread style are not called out by the disclosure, but are described and can be discerned only in relation to the respective threads’ functionality, i.e., Fig. 75’s temporary screw 190 has buttress-style threading so it can be pulled out rather than unscrewed from the abutment; Fig. 9’s definitive screw 75 has male threads that fill the female threads of the abutment 8 for a secure permanent engagement. Ex. 1001, 15:23–30, 21:25–44, 23:3–36; Ex. 1012, 97–98, Figs. 9, 75. And, although it is possible for a single disclosed species to provide written description support for a claimed genus, “a sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350; see also Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). That does not appear to be the case here—the present record does not support that the described asymmetrical buttress, serrated style of different temporary screw threading (relative to that of the definitive screw and regardless of the direction of the threads for rotation) is sufficiently representative of the genus’s “different” thread patterns/profiles. See, e.g., Ex. 1006 (a buttress style thread does not function the same as a buttress reverse or 75º joint profile or rounded, or trapezoidal thread).” slip op. at 30

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham
    Patents in suitUS 11,937,992
  • PTAB · Nov 19, 2025 · IPR2025-00915 · APJ Arthur M Peslak · IPR · Institution

    The Board instituted IPR on claims 1–30 on both asserted § 103 grounds, finding a reasonable likelihood that Petitioner would prevail.

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

      “to determine whether or not to institute an inter partes review. Paper 12, 2–3. We, thus, have authority, acting on the designation of the Director, to determine whether to institute an inter partes review under 35 U.S.C. § 314(a). See 37 C.F.R § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition, the Preliminary Response, and all supporting evidence, we conclude that the information presented in the Petition establishes a reasonable likelihood that Petitioner would prevail in its challenge of at least one claim of the ’621 patent as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby institute an inter partes review of all challenged claims of the ’621 patent on the grounds stated in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner, supported by Dr. Bajaj’s testimony (Ex. 1003 ¶¶ 24–27) submits that a person of ordinary skill in the art “would have been someone knowledgeable of and familiar with computer cluster systems and cluster computing techniques” in June 2006. Pet. 12. According to Petitioner, a person of ordinary skill in the art would have had a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent training, and approximately two years of experience working in the field of cluster computing or parallel processing and would be knowledgeable regarding high-level scientific computing languages. Additional work experience can substitute for specific educational background, and vice versa. Id. (citing Ex. 1003 ¶¶ 24–27). Patent Owner does not address Petitioner’s proposed level of ordinary skill in the art. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed level of ordinary skill in the art because it appears consistent with the problems address in the ’621 patent and the cited prior art. C. Claim Construction” slip op. at 10

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

      “Petitioner “submit[s] that no claim term requires express construction.” Pet. 12–13. Patent Owner does not address claim construction in the Preliminary Response. We determine, at this stage of the proceeding, that we need not construe any claim terms to resolve the controversy before us. 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 11

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

      “6. Printed Publication Status of Petitioner’s Asserted Prior Art The Federal Circuit instructs that “[t]o qualify as a printed publication, a reference ‘must have been sufficiently accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Cronyn, 890 F. 3d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was ‘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.” Id. (citing Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F. 3d 1340, 1350 (Fed. Cir. 2008)). Further, the question of whether a document qualifies as a “printed publication” for the purposes of 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to a member of the public.” Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018) (citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). At this stage of the proceeding, Petitioner “must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential). The reasonable likelihood standard “is lower than the ‘preponderance’ standard to prevail in in a final written decision.” Id.” slip op. at 16

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,563,621
  • PTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision

    Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner

      “For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

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

      “would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9

    Patent outcomesUS 8,901,378 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 8,901,378
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