• 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
• Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentable
  PTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9

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

    “Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe 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 10

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

    “established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24

  Patent outcomesUS 10,900,034 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,900,034
• 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
• 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
• Eis GmbH v. Novoluto GmbHRehearing granted
  PTAB · Sep 25, 2020 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Rehearing

  Granted EIS GMBH’s rehearing request and instituted IPR of claims 1–3, 5, 7, 8, 11, 14, 15, 17–21, and 23–26 on all asserted grounds.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

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

    “We conclude from a review of Fang and Taylor that they are not substantially the same art nor is Petitioner making substantially the same argument as was presented the Office during prosecution of the ’061 Patent based on Fang. We find that the way in which Fang and Taylor work appear to be materially different. Fang appears to apply only suction to the skin whereas Taylor, with the sealingly connected suction cup, appears to apply a cyclical vacuum that Dr. Prisco testifies meets the claim limitations requiring generation of a pattern of negative and positive pressures, modulated with respect to a reference pressure. Ex. 1002 ¶¶ 62–64, 75. Thus Taylor appears to teach the claim element Patent Owner argued during prosecution was missing from Fang. Also, in applying factors (b) and (d) of Becton, Dickinson, because of such differences noted above, we find that Taylor is not cumulative of Fang, which was considered and applied by the Office during prosecution of the ’061 Patent. 4. Conclusion Thus, we find that Taylor and Fang are not substantially the same art, nor were substantially the same arguments based on these references presented in the Petition and during prosecution of the ’061 Patent, respectively. As discussed above, because Petitioner primarily relies on Taylor in all four grounds for teaching the modulation of positive and negative pressures with respect to a reference pressure as required by all of the challenged claims, we also find that, overall, the same or substantially the same art was not previously presented to the Office nor were the same or substantially the same arguments previously presented to the Office. Therefore, we do not need to reach the application of the remaining Becton, Dickenson factors relating to whether the Petitioner has demonstrated a material error by the Office. Thus, we decline to exercise our discretion under § 325(d) to deny institution of an inter partes review here.” slip op. at 12

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

    “how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

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

    “We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
  Patents in suitUS 9,849,061
• Eis GmbH v. Novoluto GmbHRehearing granted
  PTAB · Jun 17, 2020 · IPR2019-01302 · APJ John E Schneider · IPR · Rehearing

  Granted rehearing and instituted inter partes review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Guan, Lee, and Hovland.

  RulingsRehearing decision

  • RehearingRehearing, grantedGranted

    “decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs if the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision.” Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015). With this in mind, we address the arguments presented by Petitioner in turn.” slip op. at 3

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

    “Request for Rehearing and conclude there are genuine issues of material fact about the teachings of Guan that warrant institution and resolution at trial.” slip op. at 2

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

    “Patent Owner contends that Guan is non-analogous art in that it is not related to stimulation of the clitoris. Prelim. Resp. 59. Patent Owner also contends that there is no motivation to combine the teachings of Lee and Guan. Id. at 60–63. Patent Owner argues that one skilled in the art would not consider using the indirect stimulator of Guan in the dildo of Lee as it would require a modification of Lee beyond a simple substitution of elements. Id.” slip op. at 5

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

    “Petitioner has also provided a reasonable motivation to combine the teachings of Lee and Guan. Lee comprises a dildo with an extension which directly stimulates the clitoris, a body part. Ex. 1006, Fig. 1; Ex. 1002, ¶¶ 72, 134–137. Guan discloses an apparatus, which indirectly stimulates a body part. Ex. 1007, 3; Ex. 1002 ¶ 137. Given the teaching in the art of the problems with direct stimulation versus indirect stimulation, we agree on this record with Dr. Prisco that one skilled in the art would have had a reason to substitute the indirect stimulation device of Guan for the direct intensive and is best decided on a full record. Cf. Monark Knitting Mach, Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 886 (Fed. Cir. 1998) (determining that issues of fact concerning secondary considerations precluded grant of summary judgment) reasonable expectation of success. Ex. 1002 ¶¶ 132–137.” slip op. at 6

  § 103 obviousness
  Patents in suitUS 9,937,097
• Reactive Surfaces Ltd., LLP v. LG Chem Ltd.All claims unpatentable
  PTAB · Feb 24, 2020 · IPR2018-01520 · APJ Timothy G Majors · IPR · Final written decision

  Claims 1–8 are unpatentable as obvious; the contingent motion to amend is granted for substitute claims 9–16.

  RulingsFinal written decision

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

    “1. “anti-fingerprint coating” The phrase “anti-fingerprint coating” appears twice in claim 1: first in” slip op. at 16

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

    “fingerprint must “vaporize” from the coated surface.30 As discussed above (Section III(C)), the claimed “anti-fingerprint” functionality encompasses a coating that is capable of actively reducing transfer of a fingerprint or decomposing a fingerprint transferred to a surface of the coated substrate. Accordingly, notwithstanding Buchanan’s shortcomings in evidencing inherent vaporization of enzymatically decomposed fingerprint components, we are unpersuaded this is fatal to Petitioner’s challenge. Rather, for” slip op. at 43

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “conclusory” lack merit. Dr. Cairns has relevant expertise in this area, whereas Petitioner’s declarant, Dr. Rozzell, does not. Ex. 2035 (Rozzell dep.), 128:15–20 (“[Y]ou are not a person of ordinary skill in the art as it pertains to the use of haze values to assess visibility, are you? A. No.”); Ex. 2033 (Cairns Decl.) ¶¶ 2–9 (describing, inter alia, Dr. Cairns’s many years of experience working with and researching specialized coatings for display and touch-sensor applications and optical properties for such devices). Accordingly, Dr. Cairns’s testimony about there being a recognized and sufficiently definite correlation between haze and contaminant (including fingerprint) visibility on display devices is entitled to greater weight than Dr. Rozzell’s opinions on the topic. See, e.g., Ex. 2036 ¶¶ 62–67 (analyzing portions of the patent and prior art to support the opinion that haze is correlated to visibility); Ex. 2035 (Rozzell dep.) 125:1– 16 (“[W]hatever familiarity you have acquired with respect to the utilization of haze as a measurement of visibility has been acquired in the context of this IPR; correct? A That’s correct.”). Dr. Cairns’s opinions are also not conclusory as argued, but are supported with evidence from the patent and the prior art as noted. Ex. 2036 ¶¶ 62–67. slip op. at 83

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “have wanted to combine Amin’s and Wang’s coatings, Petitioner simply does not provide an adequate, evidence-backed analysis of how such person would have predictably done so. As Patent Owner points out, the evidence on this record raises doubts that the two coatings could have been successfully combined. MTA Reply 6–8. Specifically, evidence of record supports Patent Owner’s argument that a skilled artisan would not have reasonably expected “that the digestive enzymes of Wang could be successfully immobilized on the fluorine-coated surface of Amin.” Id.; Ex. 2036, ¶¶ 6–10; Ex. 2035, 15:5˗19:2. Notably, the testimony of Petitioner’s own declarant supports the conclusion that the combination Petitioner proposes would not have been reasonably predictable—if even possible at all. When Dr. Rozzell was asked if there were other materials (like enzymes) that could be adhered to the surface of Amin’s coatings, he did not know. Ex. 2035: 15:16–17:13 (“[Y]ou don’t know what any of those materials [that might adhere] are, sitting here today? A Not without doing some research on my end.”) (“So turning back to our discussion of immobilizing an enzyme on this [Amin’s coating], you don’t know of a way, today, that you could immobilize an enzyme on top of a fluorine-coated layer. A Well, I’ve personally not done exactly that type of experiment, but I can imagine that there would be approaches that would allow you to do that. Q But you don’t know any of them today? A I can’t tell you one as I’m sitting here today. Q Okay. And you’ve not recalled seeing this in a publication? A No.”).” slip op. at 87

  Patent outcomesUS 8,932,717 unpatentable
  Claim construction§ 103 obviousnesscites Graham · Nautilus
  Patents in suitUS 8,932,717
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

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

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

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

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Hyperbranch Medical Technology, Inc. v. Incept LLCAll claims unpatentable
  PTAB · Apr 9, 2018 · IPR2016-01836 · APJ Kristi L R Sawert · IPR · Final written decision

  Claims 1–6 and 8–12 are unpatentable as obvious under § 103 over Rhee ’500 or Rhee ’587, each combined with Bass or Tse.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Upon review of the parties’ respective definitions of a person of ordinary skill in the art, we adopt Petitioner’s definition as a person with either: (1) a Ph.D. in the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and having at least one year of educational or work experience in the synthesis and development of biocompatible polymer materials; (2) a bachelor’s degree in in [sic] the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and at least two years of work experience in the synthesis and development of biocompatible polymer materials; or (3) any education and experience equivalent to (1) or (2). Pet. 22 (citing Ex. 1003 ¶ 49). We find that Patent Owner’s definition of the ordinarily skilled artisan, i.e., a person having “a Ph.D. degree, or equivalent education, in polymer chemistry, or a bachelor of science degree in chemistry or a closely related field and several years of experience in the development and manufacture of polymer materials for use as tissue sealants,” PO Resp. 15–16 (citing Ex. 2006 ¶ 27), does not differ materially from Petitioner’s definition. Furthermore, our analysis would be the same under either parties’ definition.” slip op. at 9

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

    “1. “visualization agent” In its Petition, Petitioner proposed interpretations of certain claim terms. Pet. 18–22. The Board determined in its Institution Decision, however, that only the term “visualization agent” required express interpretation. Inst. Dec. 8 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). The Board set forth the broadest reasonable interpretation of “visualization agent” as “an agent that reflects or emits light at a wavelength detectable to a human eye so that a human eye may visualize the hydrogel coating.” Id. at 9. Neither party challenges that interpretation. See, e.g., Third Tr. 6:15–17. We have reassessed that determination in light of the arguments and evidence adduced at trial, and maintain that determination based on the full record.” slip op. at 11

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

    “In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation omitted). “Conversely, a preamble is not limiting where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Id. Here, we determine that the preamble phrase “suitable to coat a tissue of a patient” is not merely a statement of purpose, but instead represents the “essence or a fundamental characteristic of the claimed invention.” Vizio, Inc. v. Int’l Trade Com’n, 605 F.3d 1330, 1340 (Fed. Cir. 2010). In Vizio, the Federal Circuit held that a preamble reciting “for decoding” certain data “is properly construed as a claim limitation” because the apparatus and method claims reciting that preamble “would have little meaning without the intended objective of decoding.” Id. at 1341. Similarly here, we determine that the method step of claim 1—namely, mixing reactive nucleophilic precursor species, electrophilic precursor species, and a visualization agent—would have little meaning without the intended objective of forming a hydrogel coating on the tissue of a patient. Put differently, there would be no reason to perform the method step of claim 1 but for forming a hydrogel coating on the patient’s tissue. See Ex. 1001, 39:56–40:2 (claim 1) (providing that the reactive precursors crosslink after contact with the tissue to form a hydrogel in the form of a coating). Thus, we determine that “suitable to coat a tissue of a patient” is limiting in this case because it gives “life and meaning” to method claim 1. We further find that the arguments and evidence in this case show that skilled artisans would reasonably interpret “suitable to coat a tissue of a patient” as encompassing a biocompatibility requirement. Although Petitioner correctly notes that “[n]one of challenged claims recite the term ‘biocompatible,” Petitioner acknowledges that skilled artisans understand “that hydrogels are, by their nature as water-swelled materials, known to be biocompatible.” Pet. Suppl. Br. 4–5. Petitioner’s expert, Dr. Lowman, declared that “biocompatibility is presumed as a fundamental aspect of the claimed and disclosed inventions.” Ex. 2018 ¶ 40. And in his deposition, Dr. Lowman testified that skilled artisans would understand “biocompatible” to mean that the hydrogel composition is “suitable for use and tolerated by a patient.” Ex. 2019, 13:2–11 (emphasis added). Thus, we agree with Patent Owner that “suitable to coat a tissue of a patient” reasonably encompasses a biocompatibility requirement for the hydrogel composition. slip op. at 12

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

    “3. Motivation to combine the prior art references and reasonable expectation of success Even “[i]f all elements of the claims are found in a combination of prior art references,” “the factfinder should further consider whether a person of ordinary skill in the art would [have been] motivated to combine those references, and whether in making that combination, a person of ordinary skill would have [had] a reasonable expectation of success.” Merck & Cie v. Gnosis S.P.A., 808 F.3d 829, 833 (Fed. Cir. 2015). The “motivation to combine” and “reasonable expectation of success” factors are subsidiary requirements for obviousness subsumed within the Graham factors. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007).” slip op. at 28

  Patent outcomesUS 7,009,034 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,009,034

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.