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  • PTAB · Mar 4, 2026 · IPR2024-01353 · APJ Tawen Chang · IPR · Final written decision

    Claims 1–20 were not shown unpatentable: the asserted obviousness grounds failed, including because Kanan and Neri did not teach selecting the claimed cis-reactive cells.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Accordingly, for purposes of this decision we adopt Petitioner’s proposal of a person of ordinary skill in the art, with the following changes noted in italics below: A person with “an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to small molecules and proteins and would have been familiar with nucleic acid chemistry and conventional hybridization techniques; and (b) access to one or more team members having an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to high throughput screening techniques such as nucleic acid sequencing. A person could also have qualified as a POSA with less formal education and more technical or professional experience.11 We emphasize, however, that our decision would not change if we instead used Patent Owner’s proposed definition of a POSA.” slip op. at 13

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

      “Because the parties have placed the limitation “selecting all cis- reactive cells exhibiting the detectable trace” into controversy, we construe the term below, but only to the extent necessary to resolve the controversy. 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)). For the reasons discussed below, we agree with Patent Owner that the plain and ordinary meaning of this phrase, in light of the language of the claims, the Specification, and the prosecution history of record, requires “selecting all of the [molecular complexes or structures] meeting the defined criteria for [cis-reactive cells (CRCs)] and exhibiting the detectable trace.” Sur-reply 8 (citing Ex. 2008 ¶¶ 94, 98–119). We further agree that cis-reactive cells should be construed to mean “an association of at least two interactor moieties, joined by an associated oligonucleotide.” (PO Resp. 9 (quoting Ex. 1001, 9:35-37)). Accordingly, we determine that, properly construed, the claims require that what is “selected” at step 1(d) — what is differentiated or set apart from other molecular complexes or structures in the reaction mixture at the conclusion of step 1(d) — to be “an association of at least two interactor moieties joined by an associated oligonucleotide” that exhibits the detectable trace.” slip op. at 16

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

      “We agree that Petitioner has not shown that the combination of Kanan and Neri teaches “selecting all cis-reactive cells exhibiting the detectable trace,” as we have construed that phrase above. In particular, we determine that, properly construed, the limitation requires the selection of “all associations of at least two interactor moieties joined by an associated oligonucleotide and exhibiting the detectable trace.” Instead, as described in Kanan, what is “selected” is the molecules of interest joined by bond formation, with only one of the molecules of interest coupled to a nucleic acid moiety. Thus, the selected molecular complex or structure does not comprise two interactors (i.e., two molecules of interest coupled to NAMs). Moreover, to the extent there are two interactors, they are joined by the bond between the molecules of interest rather than an associated oligonucleotide.” slip op. at 35

    • ExcludeMotion to exclude, deniedDenied

      “III. PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE Patent Owner moved to exclude Exhibit 1008, on the ground that it contains settlement statements and that Rule 408 of the Federal Rule of Evidence prohibits Petitioner from using the statements to impeach or contradict Patent Owner. Mot. 5. Because we do not rely in our analysis on this exhibit, we dismiss the Motion to Exclude as moot.” slip op. at 43

    Patent outcomesUS 7,883,848 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,883,848
  • PTAB · Jan 13, 2026 · IPR2024-00964 · APJ Annette R Reimers · IPR · Final written decision

    Claims 1–8 were not shown unpatentable over either asserted §103 combination because the prior art did not teach the discarding step or establish a reasonable expectation of success.

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

      “specification to interpret the meaning of a claim and importing limitations from the specification into the claim can be a difficult one to apply in practice.” Phillips, 415 F.3d at 1323. “[T]he line between construing terms and importing limitations”, however, “can be discerned with reasonable certainty and predictability if [our] focus remains on understanding how a person of ordinary skill in the art would understand the claim terms.” Id. Ultimately, we construe claim terms to “capture the scope of the actual invention more accurately than either strictly limiting the scope of the claims to the embodiments disclosed in the specification or divorcing the claim language from the specification.” Id. at 1324. Here, we are tasked with resolving the dispute between the parties as to the scope of the source of the claimed cross-over error. See Sur-reply 2. Although claim 1 does not explicitly recite cross-over error is created during cluster amplification, the specification shows otherwise. It repeatedly, consistently, and exclusively describes cross-over errors as arising from the formation of chimeric molecules during the amplification step of the sequencing workflow. See Ex. 1001, Fig. 1, Fig. 2, 4:29–52 (describing “improper molecular overlap via formation of a heteroduplex between patient A’s nucleic acid template and patient B’s nucleic acid template” “[w]hen the amplification process begins”), 5:29–58 (the same), 6:25–44 (the same), 6:64–7:23 (the same).” slip op. at 15

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 17 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 19–22). We adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 8

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

      “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 9 Because, as explained below, we find Petitioner has not met its burden to show reasonable expectation of success, we do not need to address whether Petitioner has shown sufficient reason to combine the asserted references. 821 F.3d 1359, 1367 (Fed. Cir. 2016); see also Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (stating that “failure to consider the appropriate scope of the . . . patent’s claimed invention in evaluating the reasonable expectation of success . . . constitutes a legal error”). Here, the claimed invention is a method for reducing template cross-over error. Thus, we must determine whether, in December 2010, an ordinarily skilled artisan would have reasonably expected that the combination of Parameswaran and Gloor would reduce template cross-over error. slip op. at 26

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

      “Thus, on this record, we are persuaded by Patent Owner’s argument that Parameswaran’s “unexpected perfect pairings of unmatched forward and reverse barcodes” are not cross-over error. PO Resp. 31 (citing Ex. 2001 ¶¶ 116–123). In addition, as Petitioner acknowledges, Parameswaran merely “distinguished,” but did not “discard” sequences with mismatches. Pet. 34. Parameswaran states that “[t]he low false-discovery rate for perfect matches strengthens the argument that any sequence with both 5’ and 3’ barcode motifs will be placed with reasonable accuracy into the correct bin.” Ex. 1004, 8. But, because Parameswaran achieved a “remarkably low misassignment rate,” it did not discard, but included any sequence with a matched barcode. Id. Indeed, Parameswaran explains that “[f]or our purposes, all sequences with a match to one of the two expected sequence motifs were considered as true members of the corresponding dataset.” Id. In its Reply, Petitioner emphasizes Parameswaran’s language “[f]or our purposes.” Reply 14 (citing Ex. 1004, 8). According to Petitioner, “[a] POSA would have understood from Parameswaran that chimeric sequences could be kept or discarded, depending on the sequencing ‘purpose.’” Id. (citing Ex. 1054 ¶¶ 79–82). Petitioner is asking us to deem unpatentable a claim based on its reading of “for our purposes,” a broad, undefined statement, to mean something specific—a suggestion to discard perfect unexpected pairings, which Parameswaran explicitly did not do. See Ex. 1004, 8. Petitioner has not presented sufficient evidence and persuasive argument for us to do so.” slip op. at 24

    Patent outcomesUS 11,041,852 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,041,852
  • PTAB · Dec 10, 2025 · IPR2024-01186 · APJ Brian D Range · IPR · Final written decision

    Claims 1–20 were not shown unpatentable because Kwatra does not teach or suggest minimizing rotational velocity and acceleration as required by the claims.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art (POSITA) would have the following characteristics: “a bachelor’s degree in engineering or computer science, or equivalent field, and two years of experience working on image or video processing or digital cameras.” Pet. 6 (citing Ex. 1002 ¶¶ 36–37). Petitioner states that, “[a]lternatively, a POSITA would have four years of experience working on image or video processing 6 Patent Owner asserts objective evidence of nonobviousness. Prelim. Resp. 19–27. or digital cameras.” Id. Petitioner further contends “[a]n advanced graduate degree in the disciplines cited above may make up for the work experience indicated above.” Id. Patent Owner does not dispute the level of ordinary skill in the art. Prelim Resp. 14–15. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’894 patent specification and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 10

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

      “Petitioner “does not believe any terms require a formal construction.” Pet. 6. Patent Owner agrees “no claim terms presently require construction to resolve any current dispute between the parties.” PO Resp. 15. We do not discern a need to construe explicitly any claim language at this juncture because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. 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

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

      “Kwatra teaches, at Equation 7, minimizing velocity and acceleration of a function representing camera path (P). FF ¶¶ 6, 8–9. Kwatra does not state that this camera path function considers rotation. Rather, the words “camera path” suggest x, y, z movement of the camera rather than rotation of the camera. Dr. Foroosh’s testimony that Kwatra’s minimization of a smoothed camera path does not result in minimizing rotational velocity and acceleration is credible because this testimony is consistent with Kwatra as a whole and consistent with the other evidence of record. Id. ¶ 10. Kwatra recognizes that image rotation angle (“θ”) may not remain smooth. Id. ¶ 12. But rather than attempting to minimize velocity and acceleration of rotation of the camera housing, Kwatra states that applying a smoothness constraint on rotation angle “may be non-linear.” Id. ¶ 13. Consistent with Kwatra, Dr. Foroosh credibly explains the difficulty of applying linear techniques to rotation. Id. Thus, Kwatra proposes instead constraining the sine and cosine of theta. Id. ¶ 14. The Kwatra provisional application is part of the Kwatra reference (id. ¶ 15), and it similarly opts for simpler schemes rather than estimating all parameters for all frames jointly. Id. ¶ 16. The provisional explains that the rotational component is relatively small such that non-linear computations minimizing velocity and rotation can be avoided. Id. ¶¶ 17–18. The testimony of Patent Owner’s witness, Dr. Foroosh, explaining the provisional is credible (Ex. 2018 ¶ 72) because it is consistent with Kwatra’s complete disclosure. Dr. Foroosh’s testimony is more credible than the testimony of Petitioner’s witness, Dr. Katsaggelos, because Dr. Katsaggelos did not review the Kwatra provisional application and, thus, did not review the entire disclosure of Kwatra. Id. ¶ 19; see also In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc) (obviousness analysis considers whether “the claimed inventions are rendered obvious by the teachings of the prior art as a whole” (emphasis added)).” slip op. at 28

    • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

      “(id. ¶ 15), and it similarly opts for simpler schemes rather than estimating all parameters for all frames jointly. Id. ¶ 16. The provisional explains that the rotational component is relatively small such that non-linear computations minimizing velocity and rotation can be avoided. Id. ¶¶ 17–18. The testimony of Patent Owner’s witness, Dr. Foroosh, explaining the provisional is credible (Ex. 2018 ¶ 72) because it is consistent with Kwatra’s complete disclosure. Dr. Foroosh’s testimony is more credible than the testimony of Petitioner’s witness, Dr. Katsaggelos, because Dr. Katsaggelos did not review the Kwatra provisional application and, thus, did not review the entire disclosure of Kwatra. Id. ¶ 19; see also In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc) (obviousness analysis considers whether “the claimed inventions are rendered obvious by the teachings of the prior art as a whole” (emphasis added)).” slip op. at 28

    Patent outcomesUS 10,574,894 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,574,894
  • PTAB · Nov 25, 2025 · IPR2024-01165 · APJ William V Saindon · IPR · Final written decision

    Claims 1–21 were not shown unpatentable because Zhou does not teach the claimed low-light high-pass or stickiness parameter limitations.

    RulingsFinal written decision
    • BurdenFwd all claims patentableNot shown unpatentable

      “4. Conclusion for the Prior Art Analysis In sum, we find that Zhou does not disclose the low-light high-pass parameter or the stickiness parameter. Petitioner’s grounds for both independent claims 1 and 16 rely on Zhou for teaching a low-light high-pass parameter or a stickiness parameter. Pet. 23–28, 64. Because we find Zhou does not teach these limitations, all of Petitioner’s grounds fall for this reason. III. CONCLUSION For the reasons given above, we determine that Petitioner has not established by a preponderance of the evidence that any claim of the ’840 patent would have been obvious in view of the prior art cited.” slip op. at 18

    • Skill levelSkill level petitioner adoptedOther

      “A person of ordinary skill in the art (POSITA) in the field of the ’840 patent would have a bachelor’s degree in engineering or computer science, or equivalent field, and two years of experience working on image or video processing, or digital cameras. Alternatively, a POSITA would have four years of experience working on image or video processing, or digital cameras. An advanced graduate degree in the disciplines cited above may make up for the work experience indicated above. Pet. 6 (citing Ex. 1002 ¶ 32). Patent Owner applies the same standard. PO Resp. 26–27. We use this agreed-upon standard for purposes of this Decision.” slip op. at 7

    • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

      “We review this testimony based on the strength of the underlying factual basis. 37 C.F.R. § 42.65(a); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value . . ..”). Here, the underlying factual basis is not very strong for either witness. That said, we find that Dr. Foroosh’s testimony is more logically sound and consistent with the ’840 patent disclosure. Based on our reading of the specification, we find a clear indication that “stickiness” has to do with the past. In order to control “the extent by which preceding portion(s) . . . impacts determination of the smoothed trajectory” (emphasis added), one must control the degree by which the past frames impact determination. And to control the degree of the past’s influence, one must, as a consequence, favor the past over the future. That is, the frame of reference of the stickiness parameter is the past. The specification could have used a time-agnostic term, like a “nearness” or “adjacency” parameter, but it did not. Thus, the fact that “stickiness” is used in conjunction with “preceding” indicates that it deals with a preference for preceding frames. On this basis, we find Dr. Katsaggelos’s testimony less persuasive than Dr. Foroosh’s.” slip op. at 10

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

      “That said, we do not construe a stickiness parameter as prohibiting consideration of future frames. Instead, we determine that the stickiness parameter’s value determines the impact of the preceding portions, versus the following portions. The ’840 patent recognizes this, when it says that a stickiness parameter value of “1,” representing a “lazy” stabilizer that maximally favors the past, would not override a violation of the margin constraint based on the look-ahead (i.e., would not allow the viewing window to fall out of bounds in the event of large future motion). See Ex. 1001, 22:26–30; see also id. at 12:61–13:29 (acknowledging that favoring the past may lead to a conflict with the viewing window determination), 15:39–60 (adjusting the viewing window to ensure it does not violate a margin constraint). Thus, while a past-favoring parameter by necessity favors the past over the future, it does not prohibit consideration of the future. In view of the above, we construe the claimed “stickiness parameter” as a parameter that controls the extent by which preceding portions of the trajectory impacts determination of the smoothed trajectory, with an understanding that in order to favor preceding portions, to some extent, the parameter must relatively disfavor following portions.” slip op. at 10

    Patent outcomesUS 10,958,840 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,958,840
  • PTAB · Aug 20, 2025 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Final written decision

    The Board held claim 8 not shown unpatentable under each of three §103 grounds because Petitioner failed to establish motivation to combine the references with a reasonable expectation of success.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In addressing the level of ordinary skill in the art, Petitioner contends that a person of ordinary skill in the art (“POSA” or “POSITA”) would have had at least a Ph.D. in biochemistry, molecular biology, or a related field and between one and four years of post-doctoral experience in the field of gene therapy. Alternatively, a POSA would have had at least a Master’s or Bachelor’s Degree in biochemistry, molecular biology, or a related field, with a corresponding number of additional years of experience in the field of gene therapy. Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not challenge Petitioner’s definition. PO Resp. 10. On this complete record, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’274 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11

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

      “Petitioner asserts that the ’274 patent “does not specify a particular program or set of program parameters that should be used to align sequences and calculate percent identity for purposes of determining whether a particular test sequence falls within the scope of the claims.” Pet. 21. Petitioner asserts that it analyzed the percent identity claim elements, as Patent Owner did in the parallel District Court litigation, Penn-II, “using the Clustal program at default settings to generate amino acid sequence alignments and calculate percent identity values.” Id. at 21–22. Petitioner, however, does not ask for any particular construction of any claim term. See id. Patent Owner states that it “does not challenge Petitioner’s articulation of the lack of a need for claim construction.” PO Resp. 10. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., 200 F.3d at 803)).” slip op. at 12

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “According to the import of the complete recitation of paragraph 250 of the ’772 Publication set forth above that Petitioner relies upon for the motivation to improve efficient gene transfer in liver, AAV8 already fulfills this need. See Tr. 28:15–18. We do not read the ’772 Publication as calling for a search for a more efficient variant to improve efficient gene transfer in liver. We credit Dr. Samulski’s testimony that supports this view of the teachings of the ’772 Publication. Dr. Samulski testifies: Additionally, when the inventors compared AAV8’s expression in the liver against new serotypes AAVrh2, AAVrh10, AAVrh13, and AAVrh21, they found that AAV8 remained superior: EX1007, ¶ 253. Notably, AAV8 was shown to have over fifty percent (50%) greater expression in liver than AAVrh10. As I discuss more below, a skilled artisan in 2005 would not have expected a single amino acid substitution to significantly alter tropism in order to target to a different tissue. Thus, in my opinion, in 2005, a skilled artisan with the goal of targeting the liver would have selected the best known vector for delivery to liver at that time—AAV8. Ex. 2027 ¶ 42. We also agree with Dr. Samulski’s opinion that a POSA would have selected the best vector for liver, AAV8, instead of modifying another vector to increase tropism to liver. Dr. Samulski testifies: In my opinion, a skilled artisan in 2005 would not have looked solely to modify a vector to try to improve tropism to a particular tissue. As discussed throughout this declaration, changing tropism is difficult to predict, and a skilled artisan would not have had a reasonable expectation that changes could be made to improve or alter tropism. A skilled artisan would also have been concerned that changes, even small ones, could negatively impact other properties of the capsid protein. Therefore, rather than seek to modify a vector, a skilled artisan” slip op. at 29

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

      “The ’772 Publication, however, does not indicate as Petitioner asserts that a new variant is necessary to improve the efficiency of gene transfer to liver; the ’772 Publication indicates that AAV8 fulfills that need. See Ex. 1007 ¶ 250. In the paragraph that Petitioner relies upon for the alleged need to improve the efficiency of gene transfer to the liver, the ’772 Publication states in full: The tropism of each new vector is favorable for in vivo applications. AAV2/7 vectors appear to transduce skeletal muscle as efficiently as AAV2/1, which is the serotype that confers the highest level of transduction in skeletal muscle of the primate AAVs tested to date. Importantly, AAV2/8 provides a substantial advantage over the other serotypes in terms of efficiency of gene transfer to liver that until now has been relatively disappointing in terms of the numbers of hapatocytes stably transduced. AAV2/8 consistently achieved a 10 to 100-fold improvement in gene transfer efficiency as compared to the other vectors. The basis for the improved efficiency of AAV2/8 is unclear, although it presumably is due to uptake via a different receptor that is more active on the basolateral surface of hepatocytes. This improved efficiency will be quite useful in the development of liver-directed gene transfer where the number of transduced cells is critical, such as in urea cycle disorders and familial hypercholesterolemia. Id. (citations omitted) (emphasis added). According to the import of the complete recitation of paragraph 250 of the ’772 Publication set forth above that Petitioner relies upon for the motivation to improve efficient gene transfer in liver, AAV8 already fulfills this need. See Tr. 28:15–18. We do not read the ’772 Publication as calling for a search for a more efficient variant to improve efficient gene transfer in liver. We credit Dr. Samulski’s testimony that supports this view of the teachings of the ’772 Publication. Dr. Samulski testifies: Additionally, when the inventors compared AAV8’s expression in the liver against new serotypes AAVrh2, AAVrh10, AAVrh13, and AAVrh21, they found that AAV8 remained superior:” slip op. at 28

    Patent outcomesUS 11,680,274 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,680,274
  • PTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision

    Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.

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

      “As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18

    • Expert testimonyPetitioner expert creditedMixed

      “person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

      “In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. 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 26

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

      “415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25

    Patent outcomesUS RE47,045 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  • PTAB · Aug 30, 2024 · IPR2023-00529 · APJ Brian D Range · IPR · Final written decision

    Claims 1–8, 11–16, and 21 were not proven unpatentable over Mauer and Waylett because the asserted combinations did not teach key claim limitations.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “II. ANALYSIS A. LEVEL OF ORDINARY SKILL Petitioner defines the person of ordinary skill in the art as follows: As of February 2006, a person of ordinary skill in the art (“POSITA”) would have been a person with a degree in 1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. § 103. Because the challenged claims of the ’414 patent have an effective filing date before the effective date of the applicable AIA amendments, we refer to the pre-AIA version of 35 U.S.C. § 103 throughout this Decision. 2 Mauer et al., U.S. Patent No. 7,395,085 B1, issued July 1, 2008 (Ex. 1005, “Mauer”). 3 Waylett et al., U.S. Patent No. 8,184,603 B2, issued May 22, 2012 (Ex. 1006, “Waylett”). computer science, electrical or computer engineering, physics, or a similar discipline . . . [and] would also have at least two years of relevant experience including, for example, work related to telecommunications networks. Pet. 3 (citing Ex. 1003 ¶ 54). The institution decision adopted Petitioner’s definition of a person having ordinary skill in the art. Dec. on Inst. 11–12. Patent Owner applied this definition for its response. Resp. 19. Petitioner’s undisputed definition of a person of ordinary skill in the art is reasonable and consistent with the prior art and ’414 patent specification. Based on the record before us, we adopt Petitioner’s undisputed proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 12

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

      “Petitioner does not submit constructions for any claim terms. According to Petitioner, “[t]he Board construes claims under the same standard used in civil actions in federal district court. The district court for the related litigation has not yet construed the claim terms.” Pet. 7. The parties provided briefing regarding construction of “distributed mobile architecture (DMA).” Resp. 19–34; Pet. Reply 1–3; PO Sur-reply 11–14. But we do not need to construe “distributed mobile architecture (DMA)” to resolve this inter partes review. We thus do not construe this claim term. We also do not discern a need to construe explicitly any other claim language because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. 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)). We discuss the meaning of ’414 patent claims to the extent necessary to resolve the issues we address below. Id.” slip op. at 14

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

      “a) Combination of Mauer and Waylett In support of both Ground 1 and Ground 2, Petitioner argues that a person of ordinary skill in the art would have been motivated to combine Mauer’s and Waylett’s disclosures, “using Waylett’s Network-in-a-box 224 in each of Mauer’s WWAN 14 and WLAN 12, resulting in at least two DMA systems.” Pet. 11–13. Asserting that “Mauer teaches providing sufficient network coverage by use of different kinds of networks, network interfaces, and protocols,” Petitioner contends that a person of ordinary skill in the art would have recognized that “Waylett discloses an inexpensive way to implement the same networks used in Mauer’s WWAN 14 and WLAN 12.” Id. Citing similarities in Mauer’s and Waylett’s systems, Petitioner argues that “a POSITA would have been able to modify Mauer’s WWAN 14 and WLAN 12 networks so that each network uses Waylett’s NIB 224.” Id. at 14. According to Petitioner, the combination would have included a number of beneficial features from Mauer. Id. at 14–15. Petitioner further advances three reasons that a person of ordinary skill would have had to combine the references’ teaching. Id. at 15–16. First, asserting that Waylett discloses cost benefits and Mauer discloses “an improved method and system for notifying mobile stations,” Petitioner contends the “references each provide reasoning” to combine their disclosures. Id. at 15. Second, Petitioner argues that a person of ordinary skill in the art would have been motivated to “improve Mauer’s distributed wireless network system by consolidating it into a single box, making it compact in design allowing for faster deployment.” Id. at 16. “Third, Waylett’s NIB would help mitigate the shared concern of Mauer—that is, reaching a mobile station as it roams or moves outside of the service or coverage area.” Id.” slip op. at 24

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

      “Petitioner does not establish that Mauer sends calls to voicemail based on the two determinations claim 1 recites. Resp. 55–56. In particular, as we explain above, claim 1 requires making use of the DPR after first determining the second mobile subscriber is not located within a first wireless coverage area based on HLR and VLR information and also determining that the second mobile subscriber is not located within a second wireless coverage area based on certain CLR information. The Petition, at best, attempts to establish that Mauer directs to voicemail when a “communication session cannot be established over the first or second wireless network.” Pet. 37. But a general determination that a “communication session cannot be established” does not teach or suggest claim 1’s specific requirements that first, the DPR is utilized in the specific circumstance that the second mobile subscriber is not located within the first wireless coverage area (with this determination being made based on HLR and VLR information), and second, that the DPR is also not located within the second wireless coverage area (with this determination being made based on CLR information). See PO Sur-Reply 8–9; Ex. 2001 ¶¶ 111–113. For the reasons above, Petitioner does not establish by a preponderance of the evidence that the combined art teaches or suggests the final “when” recitation of claim 1.” slip op. at 29

    Patent outcomesUS 7,653,414 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,653,414
  • PTAB · Jan 26, 2024 · IPR2022-01400 · APJ Michael A Valek · IPR · Final written decision

    Claims 1–29 were not shown unpatentable over the asserted obviousness grounds because the prior-art combinations did not teach key limitations of claims 1, 17, and 29.

    RulingsFinal written decision
    • BurdenNot shown unpatentable

      “Having considered these arguments on the full trial record, we find Patent Owner has the better position because Petitioner’s showing that element 1(b) is taught by Schmitt is unpersuasive. We begin with Patent Owner’s argument concerning the distinction between the cfDNA molecules and the duplex tag comprising the molecular barcode found in the text of claim 1. Element 1(a) recites “a population of cell-free deoxyribonucleic acid (cfDNA) molecules.” Ex. 1001, 61:7–9. Element 1(b) recites “tagging a plurality of the cfDNA molecules in the population” of element 1(a) “with duplex tags comprising molecular barcodes to produce tagged parent polynucleotides . . . wherein the duplex tags are attached to both ends of a added). We agree with Patent Owner and credit the testimony of its declarant that this claim language distinguishes the duplex tags from the ends of the cfDNA molecule to which they are attached. Resp. 8; Ex. 2015 ¶¶ 38–39, 60, 61. That is, the duplex tag is not part of the cfDNA molecule itself, but rather is “attached to both the ends” of that molecule by “tagging” it as recited in element 1(b). We also agree with Patent Owner that given this distinction, claim 1 does not encompass Schmitt’s hybrid embodiment. Resp. 18–20. As Petitioner notes, “[i]n Schmitt’s hybrid-tag embodiment, the strands are grouped based on the combination of the short n-mer barcode and the end of the target DNA.” Pet. 11; see Resp. 17 (“[T]he combination of the endogenous shear sequence and exogenous 3-mer sequence together provide the SMI used for grouping and matching in Schmitt’s DCS process.”). Petitioner and its declarant illustrate the grouping in Schmitt’s hybrid embodiment with the following diagram. Pet. 12; Ex. 1002 ¶¶ 96–98. Petitioner’s diagram shows the PCR products produced from sequencing a “Target DNA” molecule that has been tagged with 3-mers X and Y according to Schmitt’s hybrid embodiment. See Ex. 1002 ¶ 98 (describing diagram). A portion of the endogenous sequence of the DNA molecule labeled L and R is used in combination with the 3-mer sequence to group the resulting strands into two families labeled the “X+L→R+Y Family” and the “R+Y→X+L Family.” Ex. 1002 ¶ 98; Ex. 2015 ¶ 62 (explaining that Petitioner’s diagram shows that “the relied upon hybrid SMI sequences of Schmitt include sequence from the sample DNA molecule not contained in the adapter or the duplex tags”). SMIs, differently label the strands and therefore are the recited “duplex tags.” See Pet. 27–28 (“duplex tags comprise both the fragment DNA end sequences and a shorter n-mer tag”) (emphasis added) (internal quotations omitted). However, we credit Dr. Quackenbush’s testimony that end sequences L and R are not “attached to both ends” of the cfDNA molecule by “tagging” it as recited in element 1(b). See Ex. 2015 ¶ 59–62 (explaining that Schmitt’s hybrid SMI sequences include a portion of the sample DNA molecule, which is “not contained in adapter molecules or duplex tags that are attached to the DNA molecules”). Rather, end sequences L and R are the pre-existing, endogenous ends of that molecule. Id. Thus, Petitioner’s theory of unpatentability does not account for the distinction the claim language draws between the cfDNA molecule and the duplex tags. Petitioner’s argument that the ’306 patent defines “duplex tag” as a” slip op. at 20

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

      “That is, although Meyer teaches that its particular protocol results in 40–60% tagging efficiency, Petitioner has not sufficiently explained why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, the Petition does not address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer tag (such as 1 or 2 or 3 or 4 or more degenerate or semi degenerate bases) in the adaptor.” Ex. 1083 ¶ 30. sticky-end adapter-DNA litigation to be even more efficient than Meyer’s blunt-end adapter-DNA ligation” is also unpersuasive. See Pet. 60–61. The KAPA data sheet discloses sticky-end adapter DNA ligation, but KAPA teaches that only 0.5 to 15% tagging efficiency is expected when the starting sample is 100 pg–100 ng of “high quality DNA.” Ex. 1015, 4. Thus, the KAPA data suggests that the use of sticky-end adapters, such as what Schmitt discloses, does not in and of itself teach or suggest the tagging efficiency limitations. Moreover, the record shows that tagging efficiency depends on a variety of other factors, including the quality of the input DNA. The KAPA data sheet states that tagging efficiency “can be significantly lower for DNA of lower quality.” Ex. 1015, 4. Fisher also explains that “the efficiency of adaptor ligation varies between samples, probably because of variation in input DNA quality.” Ex. 1031, 5–6. Petitioner’s argument that the DNA the KAPA data sheet refers to as “lower quality” is “from formalin-fixed, paraffin-embedded (‘FFPE’) samples (well known for having chemically damaged DNA)” is unavailing. See Reply 25–26 (citing Ex. 1098 ¶¶ 96–98). First, neither Petitioner, nor its declarant, address the similar teaching in Fisher. Second, even if the specific type of lower quality DNA in the KAPA data sheet is different, the salient point, i.e., that tagging efficiency depends on DNA quality, remains unrebutted. This is significant because Petitioner does not sufficiently address how the quality of the cfDNA of Narayan compares to the quality of the genomic DNA samples of Meyer and Schmitt or how that would affect the expected tagging efficiency. Petitioner’s assertion that “significant quantities of cfDNA could be isolated from blood samples” (see Reply 26), fact that a significant quantity of cfDNA could be obtained does not show that the quality of that DNA is similar such that a POSA using such would have expected to achieve a tagging efficiency similar to that in Meyer.” slip op. at 40

    • Strike new argumentNew argument disregardedDenied

      “We are not persuaded. First, this is an inappropriate new argument. The Petition presents a different mapping, alleging that the “duplex tag” comprises both the endogenous end sequence of the cfDNA molecule and the 3-mer barcode of Schmitt’s hybrid tag embodiment. Pet. 27 (“the duplex tags comprise both the fragment DNA end sequences and ‘a shorter n-mer tag’ to serve as ‘unique molecular identifiers’”) (quoting Ex. 1083 ¶ 30, Ex. 1002 ¶¶ 162–163); see also Tr. 62:13–63:19 (Petitioner’s counsel noting he was unaware of any explicit statement in the Petition that Schmitt’s duplex tag comprised just the 3-mer without the end sequence). Nor did Petitioner regarding element 1(b). See Reply 8–10. Rather, consistent with the mapping in the Petition, the Reply identifies “Schmitt’s hybrid tags,” i.e., the combination of the endogenous end sequence and the n-mer, as the duplex tags in element 1(b). See Reply 8 (urging that “duplex tags” are “tags that differently label the complementary strands,” which “is precisely what Schmitt’s hybrid tags do”). Because this argument was not previously presented, Patent Owner has not been afforded a sufficient opportunity to address it. Thus, Petitioner’s new argument excluding the end sequences in Schmitt’s hybrid tag embodiment from the alleged “duplex tags comprising molecular barcodes” has been waived. Second, even if we were to consider it on the merits, Petitioner’s new mapping for element 1(b) is inconsistent with Petitioner’s allegations for element 1(e). Element 1(e) recites “reducing or tracking redundancy” in sequence reads “using at least sequencing information from the molecular barcodes of the duplex tags to determine distinct cfDNA molecules.” Ex. 1001, 61:26–30. For these limitations, the Petition points to Schmitt’s grouping of reads into families based on their SMI and asserts that Schmitt determines distinct cfDNA molecules based on “the complementary nature of the SMI on the two strands of the duplex.” See Pet. 30–32 (internal quotations omitted). Thus, like Petition’s mapping for element 1(b), Petitioner’s allegations for element 1(e) rely on a duplex tag that includes both the 3-mer and the end sequence of the cfDNA molecule. Petitioner has not sufficiently explained, much less shown by a preponderance of the evidence, that Schmitt teaches or suggests the limitations in element 1(e) based on its new mapping of the 3-mer alone as duplex tags.” slip op. at 25

    • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Motion to exclude, deniedDenied

      “We do not rely on any of these exhibits in rendering our decision on Petitioner’s grounds. Therefore, we dismiss as moot Petitioner’s motion to exclude Exhibits 1069, 1074, 1078, 1079, and 1085–1088.” slip op. at 46

    Patent outcomesUS 11,149,306 not shown unpatentable
    § 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,149,306
  • PTAB · Dec 9, 2022 · IPR2021-00989 · APJ Brian D Range · IPR · Final written decision

    Claims 1–6, 11, and 13 were not shown unpatentable under either obviousness ground because Petitioner did not establish a motivation to combine Yagiura and Shimasaki.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDenied

      “Petitioner’s position is persuasive. We agree that documents from the Japanese Patent Office are self-authenticating official government documents. The technical issues regarding missing pages in the originally filed version of the document do not cause us to question authenticity. We also agree that Petitioner uses the documents to establish what the documents teach rather than establishing the truth of what the documents teach. In Reply, Patent Owner argues that Petitioner relies on the date printed on the document to prove up the truth of when the document was published. Mot. Excl. Reply 1–2. To the extent this is the case, an exception to hearsay applies because the document is a record of a public office. Fed. R. Evid. 803(8)(B) (a record of public office is an exception to the hearsay rule if the opponent does not show that the source of information or other circumstances “indicate a lack of trustworthiness”). Here, Patent Owner does not persuasively demonstrate a lack of trustworthiness; Patent Owner does not identify any substantively meaningful distinction in the missing pages of the originally filed document and does not identify any evidence to suggest that the missing pages were anything more than a harmless clerical error. For the reasons above, Patent Owner’s motion to exclude is denied with respect to these documents. B.” slip op. at 8

    • Skill levelSkill level board ownOther

      “Petitioner’s proposal is too broad. PO Resp. 8. For example, a person who merely installs solar panels for three years (satisfying “professional experience in solar energy”) while having some familiarity with module manufacturing would not be of ordinary skill in the design aspects of the ’060 patent as, for example, reflected by the claims at issue and the ’060 patent’s text and figures. See, e.g., Ex. 1101, Figs. 2a, 2b, 3a, 3b, 4a, 4b, 3:22–7:44. On the other hand, we also determine that Patent Owner’s proposal is too narrow. A person could, for example, have ordinary skill in the art of the ’060 patent by virtue of non-professional experience (for example, academic experience). When assessing relevant experience, research work done for a university (beyond mere classroom study) would have been just as valuable as research work done for a corporation. Also, ordinary skill in the art could be demonstrated by work that requires understanding of the ’060 patent’s field even if not “designing, developing, and/or researching” in the field itself We, thus, determine that a person of ordinary skill in the art of the ’060 patent would have been someone with a bachelor’s degree in electrical engineering, applied physics, or the like, and at least two years of (a) experience designing, developing, and/or researching in the field or (b) experience in solar energy that required an understanding of the ’060 patent’s field. Alternatively, that person would have had an advanced degree in electrical engineering, applied physics, or the like and at least one year of” slip op. at 11

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “qualifies as evidence in this matter. The Federal Circuit has held that expert testimony about the perspective of person of ordinary skill in the art (as Dr. Kimball provides here) must come from a person having at least ordinary skill in the art. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–78 (Fed. Cir. 2022) (quoting Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362, 1364–65 (Fed. Cir. 2008)) (holding that ITC Administrative Law Judge abused discretion by admitting expert testimony of witness who lacked the experience of a person having ordinary skill in the art); see Mot. Excl. 6–7 (arguing this point). Patent Owner, however, cites no authority that expert testimony on such matters come from a person having ordinary skill in the art at the time of the invention. Cf. Scentair Tech., LLC v. Prolitiec Inc., IPR2021-00012, Paper 22 at 61 (PTAB Apr. 22, 2022) (similarly noting a party’s lack of authority on this point). Beyond needing to come from a person of ordinary skill in the art, expert testimony is admissible if the expert has the “scientific, technical, or other specialized knowledge [that] will help the trier of fact to understand the evidence or to determine a fact in issue.” Fed. R. Evid. 702. Furthermore, “[t]here is … no requirement of a perfect match between the expert’s experience and the relevant field.” USPTO, Patent Trial and Appeal Board Consolidated Trial Practice Guide, 34 (Nov. 2019). Here, Petitioner adequately establishes that Dr. Kimball qualifies as a” slip op. at 12

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

      “The Petition argues that all claim terms should be given their plain and ordinary meaning. Pet. 18. Patent Owner does not dispute this. PO Resp. 13. We determine that no claim term requires express construction for purposes of this Final Written Decision. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms that are in controversy, and only to the” slip op. at 15

    Patent outcomesUS 10,749,060 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 10,749,060
  • PTAB · Aug 10, 2022 · IPR2021-00491 · APJ John E Schneider · IPR · Final written decision

    Claims 1–3 were not shown unpatentable because the relied-upon portions of the Cell Article and PCT Publication were not shown to be the work of another and thus were not prior art.

    RulingsFinal written decision
    • BurdenDecided for patent owner

      “Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19

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

      “Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 (2018). As discussed above, the ’807 patent meets all four criteria set forth above for each application in the priority chain of the PCT application listed on the face of the ’807 patent. Since the claim of priority arises under Section 120, the provisions of the Paris Convention and PCT do not apply.” slip op. at 12

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artNot shown unpatentable

      “Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19

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

      “We are not persuaded by Petitioner’s arguments. Although the laboratory techniques and starting materials used by Drs. Brenner and Bieganowski may have been known in the art, that is not the claimed invention. The invention as recited in claim 1 is directed a composition comprising isolated NR combined with one or more of tryptophan, nicotinic acid, or nicotinamide and one of the recited carriers, wherein the composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration. See Ex. 1001, col. 53. That the certain individual elements of the claimed composition may have been known elsewhere in the prior art does not lead to a conclusion that the relied-upon portions of the Cell Article are “by another.”” slip op. at 30

    Patent outcomesUS 8,197,807 not shown unpatentable
    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,197,807
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