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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 · Aug 19, 2026 · PGR2025-00027 · APJ George R Hoskins · PGR · Final written decision

    Claims 1–6 and 8–20 are unpatentable under § 101; claim 7 was not shown unpatentable.

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

      “Pet.”) pursuant to 35 U.S.C. §§ 321–329 to institute a post-grant review of U.S. Patent No. 11,966,920 B2 (Ex. 1001, “the ’920 patent”), claims 1–20. We issued an Institution Decision (Paper 12) granting the petitioned review. slip op. at 2

    • Skill levelOther

      “B. Level of Ordinary Skill in the Art Petitioner contends a person having ordinary skill in the art pertaining” slip op. at 11

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

      “thereby supporting our conclusion that the plain and ordinary meaning of “affordance” in claim 1 refers to an interactive user interface element.” slip op. at 30

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “For the foregoing reasons, we conclude Petitioner’s reliance on Low’s” slip op. at 21

    Patent outcomesUS 11,966,920 mixed
    Claim construction§ 101 eligibility§ 103 obviousnesscites Alice · Mayo · Bilski · Berkheimer · Enfish · Electric Power · KSR
    Patents in suitUS 11,966,920
  • PTAB · Aug 19, 2026 · PGR2025-00028 · APJ George R Hoskins · PGR · Final written decision

    Claims 1–6 and 8–20 are unpatentable under § 102, § 103, or § 101; claim 7 was not shown unpatentable because the asserted grounds did not establish its limitations.

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

      “1. Legal Standards “Anticipation requires that every limitation of the claim in issue be” slip op. at 10

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

      “2016) (alteration in original) (quoting Kinetic Concepts, 688 F.3d at 1368). Further, an assertion of obviousness “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); accord In re NuVasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (stating that “conclusory statements” amount to an “insufficient articulation[] of motivation to combine”; “instead, the finding must be supported by a ‘reasoned explanation’” (quoting In re Lee, 277 F.3d 1338, 1342 (Fed. Cir. 2002))); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.”).” slip op. at 36

    • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionMixed

      “because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108

    • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptMixed

      “because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108

    Patent outcomesUS 11,972,423 mixed
    § 101 eligibility§ 102 anticipation§ 103 obviousnesscites Alice · Mayo · Bilski · Enfish · Electric Power · KSR · Graham
    Patents in suitUS 11,972,423
  • 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 · Jun 30, 2026 · IPR2025-00381 · APJ Eric C Jeschke · IPR · Final written decision

    Claims 1–10 are unpatentable: claims 1–8 and 10 are anticipated by KR996, and claim 9 is obvious over KR996 and Bares.

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

      “2. Independent Claim 1 Petitioner contends that KR996 both anticipates and renders obvious independent claim 1. Pet. 23–46. To support its arguments, Petitioner identifies certain passages in the cited references and explains the significance of each passage with respect to the corresponding claim limitation. Id. Patent Owner argues that KR996 does not disclose a “loader support” and thus fails to disclose limitations requiring “linkage[s]” and an “actuator” attached to the “loader support.” See PO Resp. 37–40; PO Sur-reply 20. In addition, Patent Owner presents evidence of objective indicia of nonobviousness. See PO Resp. 51–68; PO Sur-reply 23–27. We address each issue in turn. a. The Loader Support Limitations Claim 1 recites, in relevant part, “[1.3] a loader support having a first side and a second side . . . ; [1.5] a first linkage connected to the first side of the loader support . . . ; [1.6] a second linkage connected to the first side of the loader support . . . ; [1.7] a second actuator for raising the loader, the second actuator being connected to the loader support.” Ex. 1001, 6:56, 6:60–7:1 (collectively, the “loader support limitations”). As to the recitation of “a loader support having a first side and a second side,” Petitioner provides the following annotated version of Figure 9 of KR996: Pet. 30. In the annotated version of Figure 9 of KR996 above, Petitioner added (1) red text and arrows identifying a “loader support,” a “first side of loader support,” and a “second side of loader support” and (2) blue text identifying a “loader.” Id. Petitioner adds that “the loader support includes the portions of the frame of the KR996 vehicle that when in operation, support the attached loader unit 40 having loader arms of the booms 44.” Pet. 29. Petitioner also states that “KR996’s loader support includes the bracket to which the link 45 and boom cylinder 46 attach, as well as the frame protrusion, connected to the bracket, to which the forward link attaches.” Id. (citing Velinsky Pet. Decl. ¶ 72).” slip op. at 32

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

      “2. Dependent Claim 9 Petitioner contends that KR996, modified based on Bares, satisfies the additional limitations of claim 9. Pet. 60–69. To support its arguments, Petitioner identifies certain passages in the cited references and explains the significance of each passage with respect to the corresponding claim limitation. Id. Petitioner also articulates reasons to combine the relied-upon aspects of KR996 and Bares and explains why there would have been a reasonable expectation of success. Pet. 62–65. Patent Owner argues that one of ordinary skill in the art would not have had reason to combine KR996 and Bares. See PO Resp. 41–50; PO Sur-reply 22–23. Patent Owner also relies on its prior arguments that KR996 does not disclose the “loader support” limitations in independent claim 1. See PO Resp. 50. In addition, Patent Owner relies on the same evidence of objective indicia of nonobviousness discussed above. See PO Resp. 51–68; PO Sur-reply 21–27. We address each issue in turn. a. The Reasons to Combine KR996 and Bares Petitioner presents reasons why one of ordinary skill in the art would have combined KR996 and Bares and why the proposed combination would have had a reasonable expectation of success. See Pet. 62–65; Velinsky Pet. Decl. ¶¶ 157–162. After discussing why KR996 and Bares are analogous art to the claimed invention, Petitioner states that one of ordinary skill in the art “would have been motivated to combine the teachings of Bares with KR996 to produce a predictable and beneficial configuration of a tracked vehicle” in that “[t]he simple substitution of Bares’ track assembly for the wheels in the KR996 vehicle would have been predictable with a reasonable expectation of success that both KR996 and Bares relate to similar vehicle types with a similar mainframe having a drive mechanism attached thereto.” Pet. 63 (citing Velinsky Pet. Decl. ¶¶ 158–162). Petitioner asserts that “designing this vehicle type with a drive” slip op. at 64

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

      “probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Thus, notwithstanding what the teachings of the prior art would have suggested to one skilled in the art, secondary considerations (objective evidence of non-obviousness) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Our obviousness analysis includes consideration and weighing of Patent Owner’s objective indicia of non-obviousness. In order to accord substantial weight to secondary considerations in an obviousness analysis, “the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)); Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417 (Fed. Cir. 2022). Although the patent owner bears the initial burden of proving a nexus (WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)), a presumption of nexus may be appropriate if the patent owner shows “the asserted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coextensive with them.’” Polaris Indus, Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018) (quoting Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000) (emphasis added)); Quanergy, 24 F.4th at 1417. On the other hand, “[w]hen the [product] is not coextensive with the patented invention—for example, if the patented invention is only a component of a commercially successful machine or process,” the patent owner is not entitled to a presumption of nexus. Demaco, 851 F.2d at 1392. A patent owner may establish nexus, either through (1) the use of a rebuttable presumption that arises when certain conditions are met or (2) a direct showing of nexus. In the first, a patent owner may rely on a rebuttable presumption of nexus as follows:” slip op. at 43

    • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

      “2. Analysis “The moving party has the burden of proof to establish that it is entitled to the requested relief.” 37 C.F.R. § 42.20. Exhibit 1005 is an English language translation of Korean Patent No. 10-1041996. Exhibit 1006 is an English language translation of Japanese document JP2004-17705A. Exhibit 1014 is an English language translation of Korean Patent No. 10-1023528. A Certification of Translation signed by Takashi Maeshiro of HC Language Solutions, Inc., accompanies each of Exhibits 1005, 1006, and 1014. Ex. 1005 at 28; Ex. 1006 at 16; Ex. 1014 at 16. Each Certification of Translation is worded substantially the same except for the references to the document at issue and the source language being either Korean or Japanese. Exhibit 1005’s Certification of Translation, for example, states: I, Takashi Maeshiro, on behalf of HC Language Solutions, Inc., do solemnly and sincerely declare, to the best of my knowledge and belief, that the attached text represents a translation of Korean Patent No. 10-1041996, that the translation was performed by HC Language Solutions, Inc., and that the translation represents a true, correct, and faithful translation from Korean to English in a form that reflects the intention and meaning of the original text. I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code. Ex. 1005 at 28 (emphasis added).” slip op. at 17

    Patent outcomesUS 11,465,891 unpatentable
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 11,465,891
  • Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentable
    PTAB · Mar 5, 2026 · IPR2024-00634 · APJ Meredith C Petravick · IPR · Final written decision

    Claims 1, 3, 8–13, 15, 16, and 19–24 are unpatentable over Brown and Ho, with claims 16 and 19 also relying on the Quick Connection Art; the remaining challenged claims were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “Patent Owner proposes that: A [person of ordinary skill in the art (“POSITA”)] in the field to which the ’105 Patent is directed would have had at least a Bachelor of Science degree in mechanical engineering or a related field or, as a substitute, at least two years of work or” slip op. at 9

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

      “of “integrally molded with” as “molded together as a single structure.” Paper 21, 15.” slip op. at 11

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

      “Patent Owner responds that: a POSITA would not have been motivated to make the proposed modification, nor does the Petition include any analysis regarding why a POSITA would be motivated to move from a vertical extended portion to a radial extended portion. Indeed, a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar as it introduces another sudden directional change into the fluid flow system. PO Resp. 58–59 (citing Ex. 2013 ¶ 242).” slip op. at 32

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “Patent Owner argues that the ’105 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 63–65; PO Sur-reply 26–29. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 of the bowl fill valve 109, the flow of water through the bowl fill valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288. Further, the ’606 Application states: The bowl fill valve 109 may be, for example, a ball valve, a gate valve, a globe valve, a plug valve, a diaphragm valve, a butterfly valve, a needle valve, a sliding gate, a quick turn valve, a knife valve or any other appropriate type of valve as can be appreciated by those with ordinary skill in the art.” slip op. at 42

    Patent outcomesUS 9,103,105 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 9,103,105
  • Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentable
    PTAB · Dec 15, 2025 · IPR2024-00633 · APJ Meredith C Petravick · IPR · Final written decision

    Claims 1, 7–15, 19, and 20 are unpatentable over Brown and Ho; claims 2–6 and 16–18 were not shown unpatentable on the asserted grounds.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

      “Brown’s adapter tube 23 (i.e., the extended portion) does not extend radially from a longitudinal axis of valve assembly 13 (i.e., the toilet fill valve). Ex. 1021, Fig. 1. Mr. Jobin testifies that a POSITA would not be motivated to move adapter tube 23 from a vertical position to a radial position because “a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar system.” Ex. 2013 ¶ 251; see Ex. 1021, 1:9–62. Patent Owner’s argument is persuasive. Petitioner’s analysis and Dr. Cameron’s testimony is conclusory and does not sufficiently explain why a POSITA would be motivated to make the proposed modification to Brown. For example, Petitioner does not sufficiently explain how such a modification would result in a more compact toilet fill valve system that could be adapted to fit in more toilet tank designs. Further, neither Petitioner nor Dr. Cameron sufficiently address Mr. Jobin’s testimony regarding Brown’s desire for a quieter toilet. See Pet. Reply 23; Ex. 1036 ¶ 84. Petitioner fails to meet its burden to show by a preponderance of the evidence that claim 2 is unpatentable over Brown and Ho.” slip op. at 35

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “description is an objective inquiry into the four corners of the specification from the perspective of a POSA. Using this test, the invention must be described in a manner sufficient to demonstrate that the inventor actually invented the claimed invention. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Written description is a question of fact judged as of the relevant filing date. Falko–Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). An ipsis verbis disclosure, however, is not necessary to satisfy the written description requirement. Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The disclosure need only reasonably convey to a POSA that the inventor had possession of the subject matter in question, even if every nuance of the claims is not explicitly described in the specification. Id.; see Ariad, 598 F.3d at 1351. Patent Owner argues that the ’993 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 68; PO Sur-reply 28–30. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. Ex. 1012, 47, ¶ 8 (emphasis added); see also Ex. 1001, 2:28–39. As can be seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288.” slip op. at 48

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

      “1. Analysis of Claims 1–18 Schuster is available as prior art if the ’993 patent is only entitled to its January 27, 2014, filing date and not entitled to claim priority to earlier filing dates of the parent applications. On its face, the ’993 patent claims priority to a number of earlier parent applications, including Application No. 12/786,904 (the ’904 Application) filed May 25, 2010, and the Application code 63. Petitioner contends that the ’993 patent is not entitled to claim priority to the filing date of the earlier parent applications, and, thus, Schuster, a parent application of the ’993 patent, is available as prior art.15 Pet. 91–92. Petitioner alleges that the earlier parent applications, specifically Application No. 12/786,904 (the ’904 Application), do not provide written description support for the ’993 patent’s claim term “water flow regulator.” According to Petitioner, “water flow regulator” encompasses both adjustable devices for restricting the flow of water (i.e., valves) and fixed devices for restricting the flow of water (i.e., restrictors). Pet. 15. Petitioner contends that the ’904 Application does not provide support for water flow restrictors and, thus, does not provide support for the broader claim term water flow regulators. Id. at 14–15, 91–92. Petitioner argues that only adjustable water flow devices (i.e., valves) are supported by the ’904 Application. Id. Petitioner, thus, asserts that earliest effective filing date of the ’993 patent’s claims is the filing date of its application, January 27, 2014. Id. at 92. To be entitled to claim the benefit of an earlier filing date under 35 U.S.C. § 120 each application in the priority chain must comply with the written description requirement of 35 U.S.C. § 112(a). See Hollmer v. 14 The parties do not dispute that the ’993 patent and the earlier parent applications, including the ’904 Application and the ’606 Application, have the same pertinent portions of their specifications. See PO Resp. 71, n.16; Ex. 1004 ¶ 324. 15 Schuster issued on January 31, 2012, from Application No. 12/786,904, filed on May 25, 2010. Ex. 1029, code (21), (22), (45). Schuster, thus, issued more than one year prior to January 27, 2014.” slip op. at 46

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable

      “2. Analysis of Claims 19 and 20 Claim 19 depends from claim 14 and additionally recites, “wherein the waterflow regulator comprises an adjustable water flow regulator that is configured to adjust the flow rate of the second portion of the water based at least in part on a setting of the adjustable water flow regulator.” Ex. 1001, 12:16–20. Claim 20 depends from claim 14 and recites the same additional limitation. Id. at 12:21–24. Claims 19 and 20, thus, require the water flow regulator to be an adjustable water flow regulator. Petitioner indicates that the earlier parent applications provide written description support for an adjustable water flow regulator. Pet. 91 (“[T]he ’904 application specification makes it clear that the adjustability of the bowl fill valve is a desirable and essential feature of the invention”); PO Surreply 28. Accordingly, Petitioner fails to meet its burden to show, by a preponderance of the evidence, that claims 19 and 20 are unpatentable over Schuster.” slip op. at 50

    Patent outcomesUS 9,139,993 mixed
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 9,139,993
  • 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 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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