- Salvacion USA, Inc. v. Trutek CorpAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - PTAB · Sep 10, 2025 · IPR2025-00141 · APJ Ken B Barrett · IPR · Remand
The Board instituted IPR of claims 1–21 on all asserted grounds after finding a reasonable likelihood of prevailing on the Nishida-based challenges.
RulingsRemand decision- Director reviewDirector review, grantedGranted
“partes review of U.S. Patent No. 8,266,749 B2 (“the ’749 patent,” Ex. 1001). Paper 1 (“Pet.”). The Petition challenges the patentability of claims 1–21 of the ’749 patent. Nike, Inc. (“Patent Owner”)2 filed a Preliminary Response to the Petition. Paper 6 (“Prelim. Resp.”). With our authorization, Petitioner filed a Reply to Patent Owner’s Preliminary Response (Paper 10) and Patent Owner filed a Sur-reply (Paper 13). We discretionarily denied institution under 35 U.S.C. § 325(d). Paper 20. Petitioner filed a request for Director Review of the Decision denying institution. Paper 21. Director Review was granted, the Decision denying institution of inter partes review was vacated, and the case was remanded to the Board. Id. at 4. Specifically, the case was “remanded to the Board with instructions to consider Petitioner’s Nishida grounds and to determine whether the Petition should be instituted.” Id. at 3–4.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the Petition and the Preliminary Response “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’749” slip op. at 2
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In support of Petitioner’s position, Dr. Adanur testifies that “Nishida discloses that the unfinished surface area 1.1 is part of the web 1 itself,” that Nishida discloses that the computer-controlled process can (using Nishida’s phrase) “put in” up to seven different textile fibers or yarns into the web of material in one operation, and that, “[t]hus, Nishida discloses simultaneously knitting its layouts 2 and tongue 40 (each a ‘textile element’) with the unfinished surface area 1.1 (a ‘surrounding textile structure’).” Ex. 1002 ¶ 216 (citing Ex. 1022, 2:12–20, 4:47–55, 5:45–49). For purposes of institution, we credit that testimony over the testimony of Dr. Pastore, because, on the current record, we regard Dr. Adanur’s testimony as more consistent with the evidence. This and the other related issues may be explored more fully during the trial.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that: A person of ordinary skill in the art (“POSITA”) in the field of the ’749 patent in March 2004 would have been someone with at least a few years of experience in knit materials and knitting methods and machines that can be used in making footwear, or a bachelor’s degree in textile-related sciences, engineering, or industrial product design, or equivalent academic or work experience, including in the footwear industry. EX1002, ¶68. Such a person of ordinary skill would have at least a general understanding of general construction processes and materials used in the manufacturing process of fabric-based articles. For individuals with a lower educational level, a person could still be of ordinary skill in the art provided that person’s working experience compensates for any such lower educational level, or vice versa. See id. Pet. 23–24. Patent Owner states that, “[f]or purposes of this Preliminary Response, Nike applies Skechers’ definition for a person of ordinary skill in the art.” Prelim. Resp. 14. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,266,749 - Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 9,669,069 - Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,815,827 - Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,815,827 - Eis GmbH v. Novoluto GmbHRehearing grantedPTAB · 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 denialPatents in suitUS 9,849,061 - Reactive Surfaces Ltd., LLP v. LG Chem Ltd.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Graham · NautilusPatents in suitUS 8,932,717 - Hyperbranch Medical Technology, Inc. v. Incept LLCAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,009,034 - Boehringer Ingelheim International GmbH / Boehringer Ingelheim Pharmaceuticals, Inc. v. Abbvie Biotechnology Ltd.All claims unpatentablePTAB · Jul 6, 2017 · IPR2016-00409 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–5 are unpatentable under § 103 as obvious over van de Putte 1999 and Kempeni 1999; the Board also found the alternative Rau 1998, Schattenkirchner 1998, and van de Putte 1999 ground established.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner asks that we adopt the definition of the level of ordinary skill in the art utilized by both the Petitioner and Patent Owner in the 172 IPR that includes “the skill sets of both a physician treating RA patients and a pharmacokineticist with experience in monoclonal antibodies.” Resp. 17–18; Coherus, Case IPR2016-00172, slip op. at 5–6. Petitioner notes that “[t]o the extent that the level of ordinary skill would have included the skills of a pharmacokineticist, this Petition provides that perspective through the Declaration of Dr. Jusko (Ex. 1004), a world-renowned expert in this field.” Pet. 17–18. As both parties have applied a definition of the level of ordinary skill that includes a pharmacokineticist, and such a level of ordinary skill in the art is reflected in the sophistication of the technology and the educational level of those working in the field of the invention, we adopt the level of ordinary skill in the art for the ’135 patent set forth in the 172 IPR. See In re GPAC, 57 F.2d 1573, 1579 (Fed. Cir. 1995) (setting forth factors to be considered in determining the level of ordinary skill in the art); Coherus, Case IPR2016-00172, slip op. at 5–6.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“the 172 IPR, we discussed the meaning of the term “for a time period sufficient to treat the rheumatoid arthritis” citing extensively to the Specification of the ’135 patent. See Coherus, Case IPR2016-00172, slip op. at 6–9 (Paper 60). We adopt here the discussion and the findings set forth in that inter partes proceeding construing the claim term “for a time period sufficient to treat the rheumatoid arthritis.” The construction of this term, as set forth in the companion proceeding, i.e., “for a time period sufficient to reduce the signs, symptoms, and/or progression of RA,” is consistent with our Decision on Institution, where we stated that the claims do not require a particular level of efficacy and with the description in the Specification of the ’135 patent of administering the antibody for therapeutic purposes to alleviate the symptoms and/or progression of RA. See Ex. 1001, 24:25–60. Nothing in Patent Owner’s discussion set forth above concerning its proffered construction alters our view that the claim term does not require a particular level of efficacy. As we found in the 172 IPR, Patent Owner’s proposed construction introduces ambiguity in the claims. Patent Owner discusses “meaningful reduction” in or reducing “significantly” a patient’s signs, symptoms, and disease progression without providing any specific measure for achieving such a goal. See Resp. 64–65. We agree with the 172 IPR finding that such ambiguity arises because “Patent Owner’s construction does not indicate whether reducing ‘significantly’ the signs and symptoms of RA means that patients self-report better overall health status on a health survey, or that patients must achieve an ACR20 response, or even an ACR70 response, or a combination of all of the reported outcome measures.” Coherus, Case IPR2016-00172, slip op. at 9 (Paper 60). Therefore, consistent with our decision in the 172 IPR and with our Decision on Institution, we determine that the phrase “for a time period sufficient to treat the rheumatoid arthritis” does not require any particular level of efficacy and, under the broadest reasonable construction, means “for a time period sufficient to reduce the signs, symptoms, and/or progression of RA.”” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“One question before us then, is whether a person of ordinary skill in the art would have had a reason to modify van de Putte 1999’s 20 mg weekly dose to a 40 mg biweekly dose based on the express teaching of Kempeni 1999 of a two-week interval for dosing. As with other factual questions, Petitioner bears the burden of proving that the skilled artisan would have been motivated to modify the dosing regimen of van de Putte 1999 to arrive at the claimed invention. In re Magnum Oil Tools Int’l, 829 F.3d 1364, 1375 (Fed. Cir. 2016) (burden-shifting “does not apply in the adjudicatory context of an IPR”). As explained below, we are persuaded by Petitioner’s arguments that it has carried this burden.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“A reference teaches away from the claimed invention if it criticizes, discredits, or would have discouraged a person of ordinary skill in the art from “following the path set out in the reference,” or if a person of ordinary skill “would [have been] led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994); see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). The mere disclosure of alternative designs, however, does not teach away. In re Mouttet, 686 F.3d 1322, 1333–34 (Fed. Cir. 2012). Patent Owner fails to view what the references as a whole teach one of skill in the art. First, van de Putte 1999 teaches subcutaneous administration of fixed doses, 20/40/80 mg doses, of D2E7. Ex. 1008, 7; Ex. 1037, 159:10–160:20. Patent Owner attempts to make efficacy comparisons between these doses as explained above, see Resp. 32–33, but as Dr. Weisman testifies and Dr. Gibofsky and Patent Owner agree, these studies were “not powered to provide statistically meaningful comparisons between doses.” Resp. 11–12; Ex. 2071 ¶ 79 (stating a “POSA would have known that the study was not designed to provide statistically meaningful comparisons between doses, a point Dr. Weisman does not appear to dispute”); Ex. 1037, 155:11–160:20; Ex. 1003 ¶ 35 (stating “the data in van de Putte 1999 suggests that each dose was superior to placebo, but not that any dose was better or worse than another dose”). Kempeni 1999 discloses several clinical studies that utilized different dosing protocols. DE003 was one of those clinical studies. In the DE003 study, patients received 0.5 to 10 mg/kg of D2E7 intravenously “every two weeks” until DAS (Disease Activity Score) responses could be rated as “good.” Ex. 1011, 4 (emphasis added). Thus, far from criticizing, discrediting, or discouraging the person of ordinary skill from pursuing a biweekly regimen, Rau 2000 and Kempeni 1999 expressly disclose such dosing frequency. By the same token, Rau 2000’s conclusion that “D2E7, with a half-life of 12 days, can be administered every two weeks as an intravenous injection over 3-5 minutes or subcutaneously” does not specify any particular dosage level, much less exclude any dosage level described in Rau 2000 to provide a teaching away. See Ex. 2040, 8. Also, Kempeni 1999 does not criticize or disparage the effectiveness of the 0.5 mg/kg biweekly dose. Rather Kempeni 1999 expressly concludes that the biweekly treatment of D2E7 “in the dose range from 0.5 to 10 mg/kg was well tolerated.” Ex. 1011, 4; see Ex. 1037, 167:9–168:2; 170:8–19.” slip op. at 31
Patent outcomesUS 8,889,135 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,889,135 - Enovate Medical, LLC v. Intermetro Industries CorporationAll claims unpatentablePTAB · May 11, 2016 · IPR2015-00300 · APJ Jennifer S Bisk · IPR · Final written decision
Claims 27, 28, 88, 101, and 108 are unpatentable as obvious over Dell, Sweere, and Allan, with Planar additionally applied to claim 108.
RulingsFinal written decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012) (internal citations omitted). Generally, “the ‘real party-in-interest’ [on the petitioner side] is the party that desires review of the patent. Thus, the ‘real party-in-interest’ may be the petitioner itself, and/or it may be the party or parties at whose behest the petition has been filed.” Id.” slip op. at 8
- ExcludeMotion to exclude, grantedGranted
“IV. MOTIONS TO EXCLUDE Petitioner filed a Motion to Exclude Exhibits 2003–2006. Paper 33. Each of Exhibits 2003–2005 is a license agreement, and Exhibit 2006 is a Declaration by Robert A. Sobie. All of this evidence was submitted by Patent Owner as objective evidence of secondary considerations. Because we do not rely on any of that evidence in a manner adverse to Petitioner, we dismiss the Motion as moot. Patent Owner filed a Motion to Exclude Exhibit 1007, which is a declaration by T.E. Schlesinger, Ph.D., which Petitioner filed with its Reply. Paper 35. Because we do not rely on Exhibit 1007 in any manner, we dismiss the Motion as moot.” slip op. at 28
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Other
“entity. It was filed without our authorization because it was filed with Patent Owner’s Opposition to Petitioner’s Motion to Exclude despite that Exhibit 202316 is not responsive to the Motion to Exclude. Paper 42 (“Opp. to Pet. Mot. to Excl.”). In fact, Patent Owner’s Opposition requests that we enter into the record “new Exhibit 2023, which was finalized subsequent to Patent Owner’s Response.” Opp. to Pet. Mot. to Excl. 1. A request for relief should not be made in an opposition brief. It should be made in a motion. 37 C.F.R. § 42.20(a) (“Relief, other than a petition requesting the institution of a trial, must be requested in the form of a motion.”). Further, a motion (and, thus, a request for relief) may be filed only if authorization has been obtained. 37 C.F.R. § 42.20(b) (“A motion will not be entered without Board authorization. Authorization may be provided in an order of general applicability or during the proceeding.”). Consequently, Exhibit 2023 shall be expunged because it was filed without our authorization. See 37 C.F.R. § 42.7.” slip op. at 29
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“No limitation requires an express construction for purposes of the patentability challenge at issue here. See Pet. 6–7 (offering only one proposed construction, which was not material to the patentability challenge);8 PO Resp. 11 (“Patent Owner agrees that the claim terms involved in the [instituted Grounds] do not require construction for purposes of resolving this [inter partes review (IPR)].”).” slip op. at 7
Patent outcomesUS 6,721,178 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,721,178
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.