• Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.No claims unpatentable
  PTAB · Apr 6, 2026 · IPR2025-00016 · APJ Zhenyu Yang · IPR · Final written decision

  The Board found claims 1–3, 5–12, and 14–19 not shown unpatentable because Meyer did not disclose the claimed enrichment, which the obviousness grounds did not supply.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “for purposes of this Decision, we find a POSA would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had knowledge of how those methods functioned. Id. at 12.” slip op. at 8

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

    “As an initial matter, we acknowledge that the definition “to process so as to add or increase the proportion of a desirable ingredient” has two possible interpretations. In the first interpretation, “add or increase” shares the same object “the proportion of a desirable ingredient.” When the proportion of one ingredient goes higher, the proportion of at least another ingredient would necessarily go lower. Thus, the enrichment process under this interpretation results in a higher proportion of the desirable ingredient relative to other ingredients. Patent Owner adopts this interpretation. See PO Resp. 17 (“In the context of preparing a sequencing library, [Patent Owner] Tecan proposes that a nucleic acid sequence of interest is ‘enriched’ when the proportion of nucleic acid fragments containing the sequence of interest is increased relative to other nucleic acid fragments in the sample.”). According to Patent Owner, “amplifying the one or more oligonucleotide extension products . . . thereby enriching the nucleic acid sequence of interest, by generating amplified products comprising the enriched nucleic acid sequence of interest” in step (c) means “increas[ing] the proportion of the nucleic acid sequence of interest relative to the nucleic acid fragments in the solution not containing the sequence of interest by amplifying the oligonucleotide extension product and its complement.” Id. at 19–20. Under the second interpretation, the object for “add” is “a desirable ingredient,” whereas the object for “increase” is “the proportion of a desirable ingredient.” This interpretation is broader than the first one in that the result of the enrichment process not only encompasses a higher proportion of the desirable ingredient relative to other ingredients, but also more desirable ingredient in raw number.” slip op. at 11

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

    “We agree with Dr. Sims. As explained above, the amplification step must result in at least some enrichment of the sequence of interest, even though it does not have to be the only cause. See supra Section II.C.2.b. Indeed, Petitioner acknowledges that “at least some of the enrichment must result from the recited steps.” Reply 12. Because Meyer’s enrichment for mRNA using the SMART protocol occurred before any recited steps of claim 1, we find it does not meet the claimed “enrichment” under our construction.” slip op. at 22

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

    “shown that Meyer discloses step (c) of claim 1, and Petitioner does not address that limitation in this ground, we find Petitioner has not met its burden to show that claims 8, 17, and 18 would have been obvious over Meyer. F. Alleged Obviousness over Meyer and Siebert Claim 2 depends from claim 1, and further recites “the nucleic acid fragment comprises genomic DNA.” Petitioner asserts that claim 2 would have been obvious over the combination of Meyer and Siebert. Pet. 62–65. Petitioner relies on Siebert for teaching the additional limitation recited in claim 2 only. Id. Because Petitioner has not shown that Meyer discloses step (c) of claim 1, and Petitioner does not rely on Siebert for teaching that limitation, we find Petitioner has not met its burden to show that claim 2 would have been obvious over the combination of Meyer and Siebert.” slip op. at 34

  Patent outcomesUS 10,876,108 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,876,108
• Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.No claims unpatentable
  PTAB · Apr 6, 2026 · IPR2025-00015 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–22 were not shown unpatentable because Meyer does not disclose the claimed enrichment, and the other grounds rely on Meyer for that limitation.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “for purposes of this Decision, we find a POSA would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. Id. at 14. After institution, Patent Owner states that, for purposes of this proceeding, it adopts the Board’s definition of a POSA. PO Resp. 18. After reviewing the record developed during trial, we see no reason to change our finding on this issue. As we stated in the DI, our “definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art.” DI 14.” slip op. at 11

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

    “to “enrich” means to “increase[] relative to the rest of the fragments.” Tr. 12:25–26. The panel asked: “In the starting material, there are three components, A, B, C, that say it’s 30 percent, 50 percent and 20 percent. You do PCR and it -- they all get amplified and the end result is still 30 percent, 50 percent, and 20 percent. Anything got enriched?” Id. at 12:18–21. Petitioner responded that “petitioner’s position is that in that situation, there is no enrichment.” Id. at 12:22–23. In other words, Petitioner does not disagree with Patent Owner that mere increase in the raw number is not enrichment. See also id. at 13:7–9 (“[W]e would agree that if it is truly unbiased amplification, that does not result in an increase in the proportion, and so that does not meet the plain meaning of enrich.”). We find the record, including the testimony from all three declarants, supports Patent Owner’s argument. See Sur-reply 1–5 (citing Ex. 1125, 283:1–6, 286:22–287:14; Ex. 1126, 170:18–171:1; Ex. 2037, 150:18–22, 173:15–17; Ex. 2038 ¶ 95), 8 (citing Ex. 1125, 271:10–15; Ex. 2037, 188:22–189:1). Thus, we adopt Patent Owner’s proposal that “a nucleic acid sequence of interest is ‘enriched’ when the proportion of nucleic acid fragments containing the sequence of interest is increased relative to other nucleic acid fragments in the sample.”9 See PO Resp. 19.” slip op. at 15

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

    “We agree with Dr. Sims. As explained above, the amplification step must result in at least some enrichment of the sequence of interest, even though it does not have to be the only cause. See supra Section II.C.2.b. Indeed, Petitioner acknowledges that “at least some of the enrichment must result from the recited steps.” Reply 12. Because Meyer’s enrichment for mRNA using the SMART protocol occurred before any recited steps of claim 1, we find it does not meet the claimed “enrichment” under our construction.” slip op. at 27

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

    “F. Alleged Obviousness over Meyer and Siebert Claim 2 depends from claim 1, and further recites “the nucleic acid fragment comprises genomic DNA.” Petitioner asserts that claim 2 would have been obvious over the combination of Meyer and Siebert. Pet. 69–72. Petitioner relies on Siebert for teaching the additional limitation recited in claim 2 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Siebert for teaching that limitation, we find Petitioner has not met its burden to show that claim 2 would have been obvious over the combination of Meyer and Siebert. G. Alleged Obviousness over Meyer and Kelley Claim 9 depends from claim 1, and further recites “the barcode sequence is 12 nucleotides in length.” Petitioner asserts that claim 9 would have been obvious over the combination of Meyer and Kelley. Pet. 72–74. Petitioner relies on Kelley for teaching the additional limitation recited in claim 9 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Kelley for teaching that limitation, we find Petitioner has not met its burden to show that claim 9 would have been obvious over the combination of Meyer and Kelley. H. Alleged Obviousness over Meyer, Caruccio, and Bronner Each of claims 15 and 17–19 depends from claim 1. Claim 15 further recites “the second strand of the partial duplex adaptor is ligated to a 3′ end of the nucleic acid fragment.” Claim 17 recites “[t]he method of claim 1, further comprising performing bridge amplification of the annealed strand after step e).” Claim 18 further recites “the sequencing comprises use of four labeled reversible terminators.” And claim 19 further recites “the sequencing comprises semiconductor sequencing.” Petitioner asserts that claims 15 and 17–19 would have been obvious over the combination of Meyer, Caruccio, and Bronner. Pet. 75–80. Petitioner relies on Caruccio and Bronner for teaching the additional limitation recited in claims 15 and 17–19 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Caruccio and Bronner for teaching that limitation, we find Petitioner has not met its burden to show that claims 15 and 17–19 would have been obvious over the combination of Meyer, Caruccio, and Bronner.” slip op. at 38

  Patent outcomesUS 10,036,012 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,036,012
• Salvacion USA, Inc. v. Trutek CorpAll claims unpatentable
  PTAB · Dec 2, 2025 · IPR2024-00711 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–3 and 8 are unpatentable as anticipated by Chen, Baker, Wahi ’005, and, for claims 1, 2, and 8, Rolf; the Board also finds them obvious over the asserted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we adopted Petitioner’s definition of a person of ordinary skill in the art (“POSITA”) as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Based on our consideration of the full record, we maintain our determination that a POSITA at the time the application for the ’802 patent was filed “would have had at least an undergraduate degree in pharmacy, chemistry, biochemistry, biomedical engineering or a closely related field, such that the POSITA generally understand[s] pharmaceutical formulation.” Pet. 12. Additionally, we agree with Petitioner that “[a] POSITA would be familiar with the chemical ingredients in the [’802] Patent, biocidic agents, and cationic agents, have knowledge of airborne particles including viruses and bacteria, and understand electrostatic fields, electrostatic attraction and repulsion, adhesion and cohesion.” Id. (citing Ex. 1002 ¶¶ 38–39).” slip op. at 11

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

    “of independent claims 1, 2, and 8 as limiting. Inst. Dec. 7–8. The parties do not dispute our construction of the preambles of claims 1, 2, and 8 as limiting. See generally PO Resp.; Pet. Reply 2–4. After consideration of the full trial record, we maintain our construction of the preamble of claims 1, 2, and 8 as limiting for the reasons set forth in our Institution Decision. Id. Briefly, the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body are used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.”” slip op. at 8

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

    “After consideration of the full trial record, we maintain our construction. From our perspective, the claims themselves support this construction as the claims expand upon the term “electrostatically inhibiting” with specific means for achieving such inhibition. Specifically, claims 1 and 2 recite electrostatically attracting the particulate matter, holding the matter in place, and inactivating the matter. Additionally, the Specification supports our construction as it describes the use of “an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless.” Ex. 1001, 3:36–40; PO Resp. 10 n.6.” slip op. at 9

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

    “We adopt the parties’ construction of “adequate impermeability” that has been accepted in the related district court litigation: “Adequate impermeability” refers to the “thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual’s nasal passages. This is done by varying the concentration of ingredients . . .[,] thereby adjusting the adhesion and cohesion of the thin film.” Pet. Reply 3 (quoting Ex. 1010, 17). Furthermore, as stated in our Institution Decision, along with that term, the claim language explains that the thin film is meant to stick to the skin or tissue and to hold the particulate matter in place. Inst. Dec. 9–10. The claim language also explains that the cohesion of the formulation is adjusted to provide adequate impermeability to the thin film. Thus, it is reasonable to consider the recited impermeability is a function of the cohesive properties of the thin film, and that such impermeability refers to a property of the thin film, i.e., inhibiting the penetration or passage of matter through it onto the skin or tissue at the application site.” slip op. at 10

  Patent outcomesUS 8,163,802 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,163,802
• Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentable
  PTAB · Jul 18, 2024 · IPR2023-00490 · APJ John G New · IPR · Final written decision

  Claims 1–5 are unpatentable: claim 1 is anticipated by Reddy; claims 2–4 are obvious over the stated combinations; claim 5 is anticipated by Gaur.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “However, we prefer Patent Owner’s definition of the required 2–3 years of experience in “the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis (‘SPOS’)” to Petitioner’s more generalized requirement of having experience in “medicinal chemistry, synthetic organic chemistry, and nucleic acid chemistry, including the development of oligonucleotide therapeutics, diagnostics, or building blocks.” Both parties acknowledge that the level of skill in the art is very high. See, e.g., Resp. 17; Reply 2. We find that, to achieve a level of ordinary skill in the art, a person with the requisite educational background would require 2–3 years of experience for one possessing a doctorate in the relevant field, or 3–5 years for one with a lesser degree (to compensate for the additional educational experience gained by achieving a doctorate) in the specific techniques recited by Patent Owner. We reject the terminal clause “pursuant to P(III) chemistry” proposed by Patent Owner as redundant in that a person engaged for a number of years in “the development and syntheses of nucleosides, nucleotides, and nucleic acids” including SPOS, would likely have an operant knowledge of P(III) chemistry. Consequently we adopt the following definition of a person of ordinary skill in the art: “A person of ordinary skill in the art having a Ph.D. (or equivalent degree) in organic or medicinal chemistry, and 2 to 3 years of post-graduate work experience in the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis (‘SPOS’)” and, alternatively, “a person of ordinary skill in the art would have a Bachelor’s or Master’s degree in organic or medicinal chemistry who had at least 5 years of extensive work experience in these fields.”” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “As for Dr. Baran, we are not persuaded by Patent Owner’s argument that Dr. Baran is not sufficiently experienced or qualified to opine with respect to the claimed subject matter. A review of Dr. Baran’s extensive curriculum vitae (Ex. 1003, 79–137), indicates that he is deeply experienced and extensively published in the field of oligonucleotide synthesis. Patent Owner’s argument that Dr. Baran is principally experienced in P(V) techniques presupposes that experience in that technique indicates an ignorance of P(III) methodologies. We do not find this position consistent with the breadth of Dr. Baran’s C.V. We will weigh Dr. Baran’s testimony, and that of Dr. Hrdlicka, against the cumulative weight of the evidence of record in this inter partes review in assessing the credibility and probative value of their respective testimonies.” slip op. at 13

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

    “Both parties agree that the terms of the challenged claims should be given the ordinary and customary meaning of such terms as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. Pet. 17; PO Resp. 15 (both citing 37 C.F.R. § 42.100). Accordingly we see no need for explicitly construing any of the terms of the challenged claims beyond that standard.” slip op. at 8

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

    “Furthermore, both Petitioner and Patent Owner agree that clear errors exist in the wording of challenged claims 3–5. Both parties agree that a person of ordinary skill in the art would have recognized that the limitation reciting “where M is selected from the group consisting of succinyl, oxalyl, and hydroquinolynyl” should properly read “where M is selected from the group consisting of ethyl, oxalyl, and hydroquinolynyl.” Pet. 18–20; PO Resp. 15. Both parties further agree that the language of claim 5 mistakenly omits the italicized portions of the limitation reciting “NH is capable of being attached to a solid support with a spacer selected from the group consisting of C1–C20 alkyl, ethyloxyglycol, and a combination of alkyl and ethyleneglycoxy,” as is expressly recited in claims 3 and 4. Pet. 21–22 (citing Ex. 1003 ¶ 158); PO Resp. 15. We agree with both parties’ reasoning with respect to these errors, and we construe the claims as reciting the corrected language, such that claims 3–5 read, in relevant part “where M is selected from the group consisting of ethyl, oxalyl, and hydroquinolynyl” and claim 5 additionally reads “NH is capable of being attached to a solid support with a spacer selected from the group consisting of C1–C20 alkyl, ethyloxyglycol, and a combination of alkyl and ethyleneglycoxy.” See Fitbit, Inc. v. Valencell, Inc., 964 F.3d 1112, 1119–20 (Fed. Cir. 2020) (holding that the Board erred in not correcting a “conspicuous” and undisputed error in claim).” slip op. at 8

  Patent outcomesUS 9,884,885 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,884,885
• Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing granted
  PTAB · Dec 20, 2023 · IPR2023-00050 · APJ Ulrike W Jenks · IPR · Rehearing

  The Board granted rehearing and instituted IPR on claims 17, 19, 20, and 22–29 on all petitioned grounds, finding a reasonable likelihood of success and declining § 325(d) denial.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “II. STANDARD OF REVIEW A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was 1 US 7,888,328 B2, issued Feb. 15, 2011 (Ex. 1029, “Bodor”). 2 Rice et al., Cladribine and progressive MS: Clinical and MRI outcomes of a multicenter controlled trial, NEUROLOGY, 54(5):1145–1155 (2000) (Ex. 1008, “Rice”). addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

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

    “Having reconsidered the record before us, we are persuaded that Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis by administering cladribine to a patient in the same claimed total amounts for both induction and the maintenance period to support Petitioner’s challenge to claim 17.” slip op. at 4

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

    “Having considered the record, we agree with Petitioner that the Office erred in its evaluation of the cited art (now asserted) as required by Advanced Bionics. Advanced Bionics cautions that “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Paper 6, 9. Here, both Examiner and Patent Owner interpret Bodor to disclose administering the same dose of cladribine in both the induction and maintenance phase. Claim 17 encompasses administering the same dose of cladribine – 1.7 mg/kg – in both the induction and maintenance phase. By interpreting claim 17 as requiring a maintenance dose that is lower than the induction dose, we agree with Petitioner that Examiner misapprehended the scope of claim 17. We, therefore, decline to exercise our discretion to deny institution under § 325(d).” slip op. at 12

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted

    “the claims. “All that is required is that the total dose reach a stated level in each period, and Bodor discloses a total dose within that range for what a person of ordinary skill in the art would understand to be an average patient.” Req. Reh’g 14 (emphasis omitted) (citing Pet. 42–50). Dr. Greenberg testifies that Bodor’s total dosage of cladribine ranges from 100–140 mg in the two-month treatment period. Ex. 1005 ¶ 104. The issue, as presented by Petitioner, is that the ’903 patent claims simply use a different way of reciting a total dose of cladribine administered during the treatment phase when compared to the methods and dosage taught by Bodor. We agree with Petitioner that the method and cladribine dosage in the ’903 patent claims overlap with the method and dosage taught by Bodor. To determine the total amount of cladribine administered as claimed in the ’903 patent requires knowledge of the weight of the patient. In the Petition, Petitioner relied on a patient weighing 70 kilograms (≈ 154 pounds) to be an acceptable average human weight as understood in the medical community. Pet. 32 (citing Ex. 1005 ¶ 105). Patients, however, come in all shapes and sizes as recognized in the ’903 patent disclosure and further supported by Dr. Greenberg’s testimony and referenced exhibit. See Ex. 1001, 3:8 (“patients of about 52 and about 75 kilos); see also Ex. 1005 ¶ 106 (“the average weight of individuals in the United States is higher than the global average, with an overall average weight (men and women combined) of roughly 177 lbs in 2002.”); Ex. 1030 (“the average weight for men aged 20-74 years rose dramatically from 166.3 pounds in 1960 to 191 pounds in 2002, while the average weight for women the same age increased from 140.2 pounds in 1960 to 164.3 pounds in 2002.”). To arrive at the average weight of 177 pounds means that there are patients in the population that are above and below that average. See generally Ex. 1030.” slip op. at 6

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 8,377,903
• Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing granted
  PTAB · Dec 20, 2023 · IPR2023-00049 · APJ Ulrike W Jenks · IPR · Rehearing

  The Board granted rehearing and instituted IPR on claims 36, 38, 39, and 41–48 on all petition grounds, finding a reasonable likelihood of unpatentability and declining § 325(d) denial.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315– 16 (Fed. Cir. 2000).” slip op. at 3

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

    “Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating multiple sclerosis by administering cladribine to a patient in the same claimed total amount for both the induction period and maintenance period to support Petitioner’s challenge to claim 36.” slip op. at 4

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

    “To summarize, Bodor teaches two treatment regimens for treating multiple sclerosis with a cladribine-cyclodextrin complex. 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex . . . would be administered [orally] once per day for a period of five to seven days in the first month, repeated for another period of five to seven days in the second month, followed by ten months of no treatment. Alternatively the patient would be treated with 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex in the instant dosage form once per day for a period of five to seven days per month for a total of six months, followed by eighteen months of no treatment. Ex. 1029, 13:20–30. Petitioner acknowledges that Bodor does not explicitly suggest applying the same regimen again after a cladribine-free period but finds that repeating the treatment protocol is reasonably inferred. Pet. 33 (citing Ex. 1005 ¶¶ 109, 111–113), see id. at 48 (citing Ex. 1005 ¶¶ 168–170); Ex. 1029, 18:45–19:3, 20:1–20 (Examples 4 and 5 each describing that treatment days are separated by cladribine-free days); Ex. 1003 at 389; Ex. 1004 at 141. Bodor also teaches that the dosing regimen can be tailored to suit the needs of the patient. Specifically, Bodor teaches that “one of skill will appreciate that the therapeutically effective amount of cladribine administered . . . may be lowered or increased by fine tuning and/or by administering cladribine . . . with another active ingredient.” Ex. 1029, 13:31–35, see also id. 13:37–40 (“Therapeutically effective amounts may be easily determined . . . empirically by starting at relatively low amounts and by step-wise increasing with concurrent evaluation of beneficial effect.”). Based on these disclosures, we agree with Petitioner that it would be reasonable to infer from Bodor’s teachings in conjunction with the knowledge of the ordinary artisan that the cladribine dosing protocol in Bodor is repeated. Pet. 33; see also Ex. 1005 ¶¶ 109–123, 119 (“common practice in the industry when prescribing a second round of an” slip op. at 4

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner

    “(1) [determining] whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, [determining] whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 9

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 7,713,947
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00257 · APJ John G New · IPR · Final written decision

  Claims 1 and 8–12 are unpatentable: Dixon anticipates claims 1 and 9–12 and claim 8, and the Board also finds the claims obvious over Dixon.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “On February 9, 2022, we instituted an inter partes review in IPR2022- 00257 and granted the motion for joinder with IPR2021-00880, adding Celltrion, Inc. as a petitioner in the instant proceeding. Paper 35. On the same date, we also instituted an inter partes in IPR2022-00301 and likewise granted the motion for joinder with IPR2021-00880, adding Apotex, Inc. as a petitioner in the instant proceeding. Paper 36. We refer to Mylan Pharmaceuticals, Inc., Celltrion, Inc. and Apotex, Inc., collectively, as “Petitioner.”” slip op. at 3

  • ExcludeMotion to exclude, deniedDenied

    “We are not persuaded by Petitioner’s argument that the challenged Exhibits are not authenticated. Federal Rule of Evidence 901 sets a relatively low bar for authentication. See Comcast, 2020 WL 4687062, at *28. Rule 901(a) states: “To satisfy the requirement of authenticating or identifying an item of evidence, the proponent must produce evidence sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a). By way of example, Rule 901(b)(1) states that a witness with knowledge can provide authenticating testimony that an item is what it is claimed to be. Fed. R. 901(b)(1).” slip op. at 15

  • Strike new argumentNew argument consideredDenied

    “We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30 for angiogenic eye disorders or treating angiogenic eye disorders including through the use of VEGF antagonists.” slip op. at 29

  Patent outcomesUS 9,669,069 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,669,069
• Laboratory Corporation Of America Holdings v. Ravgen, Inc.No claims unpatentable
  PTAB · Nov 1, 2022 · IPR2021-00902 · APJ Timothy G Majors · IPR · Final written decision

  Claims 81–96 and 133 were not shown unpatentable because a skilled artisan would not have been motivated to combine the asserted art with Chiu.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s proposed POSA level is too broad. Under that proposal, an individual with, for example, an undergraduate degree in microbiology and three years’ work experience studying the habitats of bacteria might qualify as a POSA. It is not clear that such person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal genetic abnormalities in maternal samples, as described in the ’277 patent and the prior art here. See, e.g., Ex. 1001, 1:31–5:59 (Field of Invention and Background Art); Ex. 1003 (Chiu). Petitioner’s proposal of the POSA level is more precise because it requires familiarity with techniques for detecting cell-free DNA in biological samples, which is relevant to the prior art and the claimed technology. Petitioner’s proposal also appears to be more consistent with the cited prior art. Okajima v. Bourdeau, 261 F.3d 1350, 14 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required where the prior art itself reflects an appropriate level and a need for testimony is not shown). Accordingly, we adopt Petitioner’s POSA level here, but note that our other determinations on this record would not change under Patent Owner’s POSA level.13” slip op. at 14

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

    “n.3; PO Sur-Reply 14–15; see generally Papers 51 and 52.14 It is not necessary for us to further construe those dependent claims to resolve this case. Petitioner relies on formaldehyde or formaldehyde donors, as disclosed in Bianchi, Granger, and Rao, to satisfy the claimed “agent” term, and urges the addition of such compounds to Chiu’s method for isolating and detecting cffDNA in a maternal sample. There is no dispute on this record that formaldehyde and formaldehyde donors meet the claimed “agent” term. We are, thus, able to determine if the asserted art discloses an “agent” as claimed and whether a POSA would have been motivated to add formaldehyde or a formaldehyde donor to Chiu, which issue we find is decisive here, without further interpreting dependent claims 90, 91, or 133. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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.”) (internal quotation marks omitted). 14 The disagreement on interpretation of this handful of dependent claims arose in relation to Rao’s prior-art status for those claims (Pet. Reply 5 n.3; PO Sur-Reply 14–15), and Patent Owner’s nexus showing for secondary considerations of nonobviousness (id. at 21). See Pet. Reply 3 n.2 (noting the priority “arguments are only relevant to Ground 3” because the prior art status of Chiu, Bianchi, or Granger is uncontested). But, as we discuss below, Petitioner’s challenge to the claims fails on this record regardless of the disagreement on Rao’s prior art status and, because Petitioner has not made the necessary threshold showing that a POSA would have combined the asserted art in the manner proposed, we need not reach secondary considerations of nonobviousness.” slip op. at 16

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “detection method of Chiu.27 More specifically, we find on this record that a POSA would have been dissuaded from adding Bianchi’s paraformaldehyde because the POSA would have expected Bianchi’s paraformaldehyde to create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample. We also find on this record that a POSA would have been dissuaded from adding paraformaldehyde to Chiu’s methods because formaldehyde was known to damage nucleic acids.28 Patent Owner’s reasoning and evidence on those issues, separately and cumulatively, outweigh Petitioner’s comparatively weak showing on whether a POSA would have combined the art in the manner proposed. We discuss in greater detail below. We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 27 WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (“Whether an ordinarily skilled artisan would have been motivated to modify the teachings of a reference is a question of fact.”) (citations omitted); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”). 28 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 38 ¶¶ 96–98; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 99–101. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 38

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

    “detection method of Chiu.27 More specifically, we find on this record that a POSA would have been dissuaded from adding Bianchi’s paraformaldehyde because the POSA would have expected Bianchi’s paraformaldehyde to create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample. We also find on this record that a POSA would have been dissuaded from adding paraformaldehyde to Chiu’s methods because formaldehyde was known to damage nucleic acids.28 Patent Owner’s reasoning and evidence on those issues, separately and cumulatively, outweigh Petitioner’s comparatively weak showing on whether a POSA would have combined the art in the manner proposed. We discuss in greater detail below. We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 27 WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (“Whether an ordinarily skilled artisan would have been motivated to modify the teachings of a reference is a question of fact.”) (citations omitted); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”). 28 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 38 ¶¶ 96–98; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 99–101. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 38

  Patent outcomesUS 7,332,277 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,332,277
• Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd.All claims unpatentable
  PTAB · Jan 20, 2022 · IPR2020-01053 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–75 are unpatentable as obvious over Saji; the Board did not reach the Latuda Information anticipation or Latuda Information and Loebel obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Indeed, as Patent Owner acknowledges, the parties’ proposed definitions of the ordinary skill level do “not differ significantly.” Id. at 25. Nevertheless, for purposes of this Decision, we adopt Patent Owner’s definition of the skill level, as it is consistent with the ’827 patent disclosures and the prior art of record, and more inclusively describes the suitable experience for one of ordinary skill in the art. We further note that, in this case, the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

    “On this record, we find Petitioner’s proposed constructions are supported by intrinsic and extrinsic evidence. See Pet. 18–23. We agree with Petitioner here that “a patient” or “the patient” should have its ordinary and customary meaning of “one or more patients,” as opposed to a “patient population” as Patent Owner has previously argued in a district court litigation involving another party. See id. at 19–20. Indeed, Patent Owner agrees. See Reply 19 (“There is no dispute that ‘a patient,’ as recited in the ’827 claims, refers to ‘one or more patients.’”). We also agree with Petitioner that the dependent claims requiring treating patients with schizophrenia and manic depressive psychosis supports the conclusion that “treating a patient with an antipsychotic” in independent claims 25, 40, and 56 includes treatment of a patient with these particular diseases. See Pet. 20–21. 10 On this record, we further agree with Petitioner that “manic depressive psychosis” would be interpreted by a person or ordinary skill in the art as “bipolar disorder,” which includes Bipolar I Disorder, Bipolar II Disorder, Cyclothymia, and Bipolar Disorder Not Otherwise Specified. See id. at 21–22 (citations omitted); see also PO Resp. 3 (“Bipolar disorder, once known as manic depressive psychosis.”). Thus, for purposes of this Decision, we adopt Petitioner’s proposed constructions.” slip op. at 10

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

    “On this record and for purposes of this Decision, we see no need to construe any other term expressly. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 11

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

  Patent outcomesUS 9,815,827 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,815,827
• Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd.All claims unpatentable
  PTAB · Dec 7, 2021 · IPR2020-01053 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–75 are unpatentable as obvious over Saji; the Board did not reach the Latuda Information anticipation and Latuda Information–Loebel obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Indeed, as Patent Owner acknowledges, the parties’ proposed definitions of the ordinary skill level do “not differ significantly.” Id. at 25. Nevertheless, for purposes of this Decision, we adopt Patent Owner’s definition of the skill level, as it is consistent with the ’827 patent disclosures and the prior art of record, and more inclusively describes the suitable experience for one of ordinary skill in the art.” slip op. at 9

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

    “On this record, we find Petitioner’s proposed constructions are supported by intrinsic and extrinsic evidence. See Pet. 18–23. We agree with Petitioner here that “a patient” or “the patient” should have its ordinary and customary meaning of “one or more patients,” as opposed to a “patient population” as Patent Owner has previously argued in a district court litigation involving another party. See id. at 19–20. Indeed, Patent Owner agrees. See Reply 19 (“There is no dispute that ‘a patient,’ as recited in the ’827 claims, refers to ‘one or more patients.’”).” slip op. at 10

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

    “On this record and for purposes of this Decision, we see no need to construe any other term expressly. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 11

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

    “Based on Saji’s preferred dose range of 5 to 100 mg/day, which overlaps with the “from 20 to 120 mg/day” range required by each challenged independent claim, Petitioner argues that an ordinarily skilled artisan would have been “motivated to conduct dose ranging studies and would find the claimed dosing regimens.” Pet. 62; see also id. at 55 (contending that “dose ranging was a routine part of drug development” (citing Ex. 1030)). Dr. Stahl’s testimony supports Petitioner’s argument. Indeed, Dr. Stahl testifies that, although with some drugs, it can be difficult to find a safe and effective dose, or to get an effective dose into the patient, neither is the case with lurasidone. Ex. 1054, 141:3–14; see also id. at 142:2–6 (“Q. [A]re you aware of any particular difficulties with lurasidone hydrochloride and finding a safe and effective dose for schizophrenia and manic depressive psychosis? A. No.”); 135:18–25 19 (Dr. Stahl testifying that he is “not aware of anything unusual about [lurasidone’s] dose range”). Thus, we agree with Petitioner that an ordinarily skilled artisan, starting from Saji’s preferred dosing range, would have conducted routine dose ranging studies and identified the claimed dosing regimens.” slip op. at 19

  Patent outcomesUS 9,815,827 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,815,827

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.