• Illumina, Inc. v. Molecular Loop Biosciences, Inc.No claims unpatentable
  PTAB · Apr 15, 2026 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–9 were not shown unpatentable because the asserted references failed to disclose the claimed correcting step, and Chee was not prior art to claims 1–3 and 9.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “We have considered both parties’ arguments and evidence and determine that Patent Owner has presented sufficient evidence of reasonable the invention to practice every day during the critical period in order to demonstrate reasonable diligence. See Perfect Surgical Techniques, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1009 (Fed. Cir. 2016). “[D]iligence need not be perfectly continuous—only reasonably continuous.” Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). The key question is whether, “in light of the evidence as a whole, the invention was not abandoned or unreasonably delayed.” Id. (internal quotations omitted). Applying this standard, we determine that Patent Owner sufficiently demonstrates reasonably continuous diligence throughout the critical period.” slip op. at 32

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

    “introduced during said workflow by collapsing target:differentiator tag combinations observed more than once into a single count.” Ex. 1001, 131:46–48 (emphasis added). The “determining step” of claim 2 recites “determining a consensus base call for the target nucleic acid molecule sequences,” but performs “collapsing all sequence reads comprising a same differentiator tag into a single read,” before the “determining step.” Id. at 131:49–53. Patent Owner proposes an interpretation of these “collapsing” and “determining” steps recited in claims 1 and 2 and asserts that they should be construed as distinct steps performed in a particular order in which the “collapsing step” is performed before the “determining step.” PO Resp. 42–45. We agree. First, Patent Owner asserts a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from, and must occur before, the “determining step” of claim 2 based on the plain language of claims 1 and 2. PO Resp. 42–43. Patent Owner argues that the “collapsing step” and the “determining step” are distinct steps because claims 1 and 2 use different terms to describe these distinct steps that are performed sequentially according to the claim language. Id. (citing Ex. 1001, 131:47–54; Ex. 2023 ¶ 133; Ex. 2024, 57:11–58:22). More specifically, Patent Owner explains that claim 1 recites a “collapsing step,” followed by claim 2, which depends from claim 1 and refers to “collapsing” before “determining a consensus base call” such that “claim 2 describes determining a consensus base call from collapsed reads, not performing ‘collapsing’ by determining a consensus base call.” Id. at 42 (citing Ex. 1001, 131:47–54). collapsing corrects for skewing, an issue related to over- or under-amplification, which is a separate and distinct problem from the sequence errors that a consensus base call is designed to address.” Id. at 43 (citing Ex. 1001, 27:47–50, 32:29–34). Patent Owner contends further that “‘[c]ollapsing’ is a different step, performed separately from determining any consensus base call, to provide even greater accuracy when subsequently determining a consensus base call” such that “if one were to collapse by determining the consensus base call, errors from amplification bias could still be represented in the consensus base call generated.” Id. at 43–44 (emphasis omitted, citing Ex. 2023 ¶¶ 134–37). Second, Patent Owner argues a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from the “determining step” based on the specification of the ’730 patent. PO Resp. 43–45. For example, Patent Owner explains that the specification states that “[f]or any target:differentiator tag combination observed more than once, all such reads are ‘collapsed’ into a single read before consensus basecalls are determined. This will cancel the effect of bias on consensus basecall accuracy.” Id. at 43 (emphasis omitted) (quoting Ex. 1001, 72:63– 73:5) (citing Ex. 2023 ¶¶ 133, 138–142).” slip op. at 11

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

    “We have considered both parties’ arguments and evidence and agree with Patent Owner’s position. As discussed above, we agree with Patent Owner that the “collapsing step” recited in claim 1 and the “determining step” recited in claim 2 are two different steps required by the challenged claims such that “collapsing” does not mean determining a consensus base call or sequence, and must occur before any determining step. As a result, we determine Chee’s step of determining a consensus sequence does not disclose the “collapsing step” recited in claim 1 that requires collapsing “target:differentiator tag combinations.” We are also unpersuaded by Petitioner’s reliance on Chee’s process of correcting for amplification bias as disclosing the claimed collapsing step. As recognized by Patent Owner, the claim language of the “collapsing step” requires “collapsing target:differentiator tag combinations,” rather than collapsing only differentiator tags. In view of this requirement, Chee does not disclose the “collapsing step” because Chee teaches quantifying the starting nucleic acid molecules using their unique identifiers, rather than target:differentiator tag combinations. As Petitioner admits, “Chee’s technique for correcting amplification bias corrects quantitative errors without correcting sequencing errors” (Reply 15), whereas claim 1’s “collapsing step” corrects both quantitative errors and sequencing errors by using target:differentiator tag combinations. See Ex. 1001, 131:47–49 target:differentiator tag combinations).” slip op. at 41

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

    “Given this claim interpretation requiring collapsing target:differentiator tag combinations, it is undisputed that McCloskey, who uses unique barcodes alone, does not teach this limitation. Petitioner does not rely on Bignell as teaching this collapsing step. Accordingly, we conclude Petitioner has not shown that the combination of Bignell and McCloskey teaches the “collapsing step” recited in claim 1. Because claims 4 through 6 depend from claim 1, they also require the “collapsing step” of claim 1 that is not taught by the combination of Bignell and McCloskey.” slip op. at 54

  Patent outcomesUS 11,840,730 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 11,840,730
• Alamar Biosciences, Inc. v. Olink Proteomics ABNo claims unpatentable
  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
• Illumina Inc. v. Molecular Loop Innovations LLCNo claims unpatentable
  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
• Sarepta Therapeutics, Inc. v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  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
• Gene Company Pty Ltd v. The Trustees Of Columbia University In The City Of New YorkNo claims unpatentable
  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
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Apr 22, 2024 · IPR2023-00074 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 2, 5–8, 11, and 15 were not shown unpatentable because the cited May references did not sufficiently disclose or guide a skilled artisan to the claimed LCR fragments.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See PO Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 8

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

    “Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See PO Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference not prior artNot shown unpatentable

    “represents the inventors’ own work, and thus the May Thesis is not prior art to the ’061 patent. PO Resp. 14–15. The May Thesis is authored by Chad May, who is a listed inventor of the ’061 patent. Id.; Ex. 1004, 3; Ex. 1001, code (75). Thus, the May Thesis represents the work of one of the ’061 inventors and is therefore ineligible as prior art under 35 U.S.C. § 102(a) based on the July 1, 2002 priority date. See, e.g., In re Katz, 687 F.2d 450, 454–455 (CCPA 1982) (a prior publication by inventors or a subset of the inventors does not qualify as prior art under 102(a)). With respect to 35 U.S.C. § 102(b), we find that the May Thesis is ineligible as prior art, even assuming that the Challenged Claims are not entitled to receive benefit of an earlier filing date. Petitioner provides evidence that the May Thesis was publicly available as of November 26, 2001. Pet. 17 (citing Ex. 1036 ¶¶ 1–26; Ex. 1002 ¶ 60). Patent Owner does not dispute that evidence. Based on the undisputed November 26, 2001 public availability date, the May Thesis represents a disclosure less than one year before the asserted effective filing date, i.e., July 1, 2002. Based on that timing and because the disclosure was made by the inventor, the May Thesis is not available as prior art to the Challenged Claims under 35 U.S.C. §102(b).” slip op. at 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “summarized above, we determine that the May Article fails to disclose the restriction sites surrounding the BstXI and SnaBI HS2-, BamHI and HindIII HS3-, or BamHI and BanII HS4-spanning nucleotide fragments, as required by the challenged claims. According to Petitioner, that limitation is inherently disclosed by the May Article’s description of the lengths of the HS2, HS3, and HS4 fragments in the TNS9 vector and its depiction of those fragments on a map of the LCR. Pet. 28. To support its inherency argument, Petitioner relies on knowledge in the art, i.e., the availability of the entire map of the LCR region, and the availability of restriction enzymes, including BstX1, SnaBI, BamHI, HindIII, and BanII. Id. at 39–40 (citing Kennametal, 780 F.3d at 1381–83). Based on that combined information, Petitioner contends that a POSA would “have been able to map all of the possible restriction sites in the regions flanking the cores of HS2, HS3, and HS4.” Id. Petitioner asserts further that “[g]iven the May Article’s disclosure regarding the size and location of TNS9’s HS2, HS3, and HS4 fragments, a POSA would have placed these fragments onto the restrictionsite map of the LCR” that was available at the time, and would have identified only six possible combinations of restriction enzyme fragments, including the one recited in claim 1. Id. Upon closer inspection, however, we appreciate from the testimony of Petitioner’s declarant, Dr. Bungert, that the process involved in arriving at those six possible combinations is predicated on numerous assumptions guiding a number of exacting steps to be performed in order to achieve the the claimed LCR fragment would have involved the steps of (a) placing fragments that are the disclosed size of the HS2, HS3, and HS4 fragments from the TNS9 vector in the May Article onto the known restriction-site map of the LCR; (b) comparing those fragments to the “‘drawn to scale’ map” in the May Article; and then (c) identifying various fragments and determining which ones are consistent with the May Article’s description and match up with the fragments on the May Article’s drawn to scale map. Ex. 1002 ¶¶ 143–156. To identify the fragments consistent with the May Article’s description, it was necessary for Dr. Bungert to use certain assumptions that exclude unfavorable enzymes, such as using a range of ± 20 bp in order to identify fragments with lengths that are within 20 bp of the fragments reported in the May Article. Id. In view of the number of assumptions and steps required to get from what is disclosed in the May Article to arrive at the alleged “six possible LCRs (i.e., combination of HS2, HS3, and HS4 fragments based on the TNS9 LCR disclosed in the May Article)—including the LCR recited in claim 1,” Ex. 1002 ¶ 156, we do not find that Petitioner has demonstrated that fragments having the restriction sites recited in claim 1 would have been “at once envisaged” by a skilled artisan as argued by Petitioner. Pet. 39–40.” slip op. at 16

  Patent outcomesUS 8,058,061 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,058,061
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Apr 22, 2024 · IPR2023-00070 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 10, 19, and 22 were not shown unpatentable because the May Thesis was not prior art and the May Article and May Abstract did not establish the claimed LCR fragments.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See PO Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’179 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 8

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

    “Based upon our review of the current record, we determine that no claim terms require express construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 8

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

    “the ’179 patent. Id.; Ex. 1004, 3; Ex. 1001, code (75). Thus, the May Thesis represents the work of one of the ’179 inventors and is therefore ineligible as prior art under 35 U.S.C. § 102(a) for challenged claims 1, 19, and 22. See, e.g., In re Katz, 687 F.2d 450, 454–455 (CCPA 1982) (a prior publication by inventors or a subset of the inventors does not qualify as prior art under 102(a)). With respect to 35 U.S.C. § 102(b), we find that the May Thesis is ineligible as prior art, even assuming that claims 1, 19, and 22 are not entitled to receive benefit of an earlier filing date. Petitioner provides evidence that the May Thesis was publicly available as of November 26, 2001. Pet. 17 (citing Ex. 1036 ¶¶ 1–26; Ex. 1002 ¶ 60). Patent Owner does not dispute that evidence. Based on the undisputed November 26, 2001 public availability date, the May Thesis represents a disclosure less than one year before the asserted effective filing date, i.e., the July 1, 2002, for claims 1, 19, and 22 challenged with this reference. Based on that timing and because the disclosure was made by the inventor, the May Thesis is not available as prior art to challenged claims 1, 19, and 22 under 35 U.S.C. §102(b). Petitioner has not established that the May Thesis is prior art to claims” slip op. at 11

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

    “summarized above, we determine that the May Article fails to disclose the restriction sites surrounding the BstXI and SnaBI HS2-, BamHI and HindIII HS3-, or BamHI and BanII HS4-spanning nucleotide fragments, as required by the challenged claims. According to Petitioner, that limitation is inherently disclosed by the May Article’s description of the lengths of the HS2, HS3, and HS4 fragments in the TNS9 vector and its depiction of those fragments on a map of the LCR. Pet. 28. To support its inherency argument, Petitioner relies on knowledge in the art, i.e., the availability of the entire map of the LCR region, and the availability of restriction enzymes, including BstX1, SnaBI, BamHI, HindIII, and BanII. Id. at 30–31 (citing Kennametal, 780 F.3d at 1381–83). Based on that combined information, Petitioner contends that a POSA would “have been able to map all of the possible restriction sites in the regions flanking the cores of HS2, HS3, and HS4.” Id. Petitioner asserts further that “[g]iven the May Article’s disclosure regarding the size and location of [TNS9’s] HS2, HS3, and HS4 fragments, a POSA would have placed these fragments onto the restrictionsite map of the LCR” that was available at the time, and would have identified only six possible combinations of restriction enzyme fragments, including the one recited in claim 1. Id. Upon closer inspection, however, we appreciate from the testimony of Petitioner’s declarant, Dr. Bungert, that the process involved in arriving at those six possible combinations is predicated on numerous assumptions guiding a number of exacting steps to be performed in order to achieve the claimed LCR fragment. According to Dr. Bungert, the process for making the claimed LCR fragment would have involved the steps of (a) placing fragments that are the disclosed size of the HS2, HS3, and HS4 fragments from the TNS9 vector in the May Article onto the known restriction-site map of the LCR; (b) comparing those fragments to the “‘drawn to scale’ map” in the May Article; and then (c) identifying various fragments and determining which ones are consistent with the May Article’s description and match up with the fragments on the May Article’s drawn to scale map. Ex. 1002 ¶¶ 112–117. To identify the fragments consistent with the May Article’s description, it was necessary for Dr. Bungert to use certain assumptions that exclude unfavorable enzymes such as using a range of ± 20 bp in order to identify fragments with lengths that are within 20 bp of the fragments reported in the May Article. Id. In view of the number of assumptions and steps required to get from what is disclosed in the May Article to arrive at the alleged “six possible LCRs (i.e., combination of HS2, HS3, and HS4 fragments based on the TNS9 LCR disclosed in the May Article)—including the LCR recited in claim 1,” Ex. 1002 ¶ 117, we do not find that Petitioner has demonstrated that fragments having the restriction sites recited in claim 1 would have been “at once envisage[d]” by a skilled artisan as argued by Petitioner. Pet. 30–31.” slip op. at 16

  Patent outcomesUS 7,541,179 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,541,179
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.No claims unpatentable
  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
• BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentable
  PTAB · Nov 13, 2023 · IPR2022-00998 · APJ Ulrike W Jenks · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

  • Expert testimonyPatent owner expert creditedDecided for patent owner

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

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

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

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

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

  Patent outcomesUS 8,357,786 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,357,786
• Apple Inc. v. Logantree, LPNo claims unpatentable
  PTAB · Aug 30, 2023 · IPR2022-00037 · APJ Patrick R Scanlon · IPR · Final written decision

  Claims 1–5, 8–11, 20, 25, 30–32, 36, 39–42, 45–51, 61–65, 144, and 147 were not shown unpatentable under the asserted obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In the Decision on Institution, we adopted Petitioner’s proposed level of ordinary skill in the art, stating it was “consistent with the evidence of record, including the asserted prior art.” Dec. Inst. 8. In proposing a different level of ordinary skill in the art, Patent Owner does not explain why its proposed skill level is more appropriate.12 PO Resp. 16. In addition, the parties’ proposed definitions are materially similar. 12 Petitioner does not address the level of ordinary skill in the art in its Reply. definition, although our conclusions with respect to obviousness would be the same if we were to apply Patent Owner’s definition.” slip op. at 10

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

    “We determine that we need not expressly construe “movement sensor” to resolve the parties’ disputes because doing so would have no effect on the analysis below. 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, 200 F.3d at 803 (Fed. Cir. 1999)). To the extent the parties raise claim construction issues in addressing the asserted grounds, we address such issues below.” slip op. at 12

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

    “Also, the Petition merely states that “Ono supports instances where the user stops the step-counting mode operation using switch S2 after the processor detects that” the target distance or the target number of steps has been reached and notifies the user by generating an alarm sound. Pet. 53 (emphasis added). In this case, supporting the notion of the user stopping the step-counting mode operation in response to the alarm is not the same as teaching or suggesting the notion to one of ordinary skill in the art. The possibility that a user could stop the step-counting operation in response the alarm is insufficient to render claims 1 and 20 obvious to one of ordinary skill in the art. See In re Facebook, Inc., 743 F. App’x. 998, 1001–02 (Fed Cir. 2018) (deciding that an example in a prior art reference showing that it is possible for image elements to be contiguous is not sufficient to teach a LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”). Petitioner’s reliance on the Hewlett-Packard and Unwired Planet cases (Pet. 56) is unavailing, as the facts in those cases are distinguishable from the facts of the present proceeding. Namely, both of those cases involved prior art references that disclosed operations that satisfied a claimed feature some, but not all, of the time. Hewlett-Packard, 340 F.3d at 1326; Unwired Planet, 841 F.3d at 1002. Here, Ono does not disclose the user stopping the step-counting mode operation in response to the alarm even some of the time. In view of the above, we determine, based on the full record, that the combination of Ono and Hutchings does not disclose limitations [1f] or [20f]. Accordingly, we are not persuaded that Petitioner has met its burden of showing, by a preponderance of the evidence, that independent claims 1 and 20 are unpatentable over the combination of Ono and Hutchings.” slip op. at 28

  • BurdenNot shown unpatentable

    “We have determined incorporated Grounds 1, 2, 3A, 3B, and 4, as well as Ground 5A, deficient for the reasons discussed above. Furthermore, to the extent Petitioner contends that any of these combinations somehow adds something to supplement or strengthen the patentability analysis of the incorporated grounds, we note that neither the Petition nor Dr. Kenny provides sufficient particularity to support such a position. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” (citing 35 U.S.C. § 312(a)(3)); see 1359, 1369 (Fed. Cir. 2016) (“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” (quoting 35 U.S.C. § 312(a)(3))). Accordingly, we are not persuaded on the complete record before us that Petitioner has demonstrated, by a preponderance of the evidence, that: (1) claims 48, 50, and 51 are unpatentable over the combination of Ono, Hutchings, Amano, Conlan, Kaufman, and Hickman (Ground 5B); (2) claims 1–5, 8–11, 20, 25, 30, 31, 36, 39–42, 45–47, 49, and 61–65 are unpatentable over the combination of Ono, Hutchings, Amano, and Conlan (Ground 6A); (3) claims 48, 50, and 51 are unpatentable over the combination of Ono, Hutchings, Amano, Conlan, and Hickman (Ground 6B); (4) claims 1, 3–5, 8–11, 20, 25, 30, 36, 39–42, 61–65, 144, and 147 are unpatentable over the combination of Ono, Hutchings, Amano, and Kaufman (Ground 7); (5) claims 1–5, 8, 10, 20, 25, 30, 31, 39, 41, 42, 45–47, 49, 61–65, 144, and 147 are unpatentable over the combination of Ono, Hutchings, Conlan, and Kaufman (Ground 8A); and (6) claims 48, 50, and 51 are unpatentable over the combination of Ono, Hutchings, Conlan, Kaufman, and Hickman (Ground 8B).” slip op. at 36

  Patent outcomesUS 6,059,576 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,059,576

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.