• Dexcom, Inc. v. Abbott Diabetes Care Inc.Some claims unpatentable
  PTAB · Jul 10, 2023 · IPR2022-00605 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–6, 8–10, and 12–17 are unpatentable over Gravesen and Brister; claims 7, 11, and 18–28 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The person of ordinary skill in the art as of the earliest possible effective filing date (“POSITA”) would have had a Bachelor’s degree in Bioengineering, Mechanical Engineering, Electrical Engineering, or a related subject, and one or more years of experience researching, developing and/or designing insertable medical devices, including, e.g., systems for implanting wearable medical devices such as cannulas, infusion sets, and analyte sensors, or equivalent experience. Less work experience may be compensated by a higher level of education, such as a Master’s Degree, and vice versa. Pet. 14–15 (citing Ex. 1003 (Fletcher Decl.) ¶ 22). Patent Owner does not dispute Petitioner’s proposal. PO Resp. 11 n.1. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision.” slip op. at 8

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

    “Second, turning to the extrinsic evidence of record, Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 (Fletcher Decl.) ¶ 81 (citing Ex. 1025 (dictionary excerpts), 1). In contrast, Dr. Cima provides no evidence corroborating his evidence. The language Patent Owner quotes from the Petition comes from a “Dictionary of Mechanical Engineering.” See Pet. 38 n.9 (quoting Ex. 1024, 328). This contradicts Patent Owner’s argument that Petitioner’s proposed construction “has no basis in mechanical engineering.” PO Resp. 19. view that a rotor must rotate on a central axis. He cites a textbook indicating that “[r]otational motion needs to take place around an appropriate axis,” but he does not explain whether or why the “appropriate axis” must necessarily be a “central axis.” Ex. 2024 (Cima Decl.) ¶ 179 (quoting Ex. 2040 (Rotordynamics) 2 (emphasis added)). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).” slip op. at 11

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

    “On the full trial record, we again find that Patent Owner’s proposed narrowing is unwarranted. First, the intrinsic record does not support Patent Owner’s required “central” axis. Patent Owner argues that the Specification describes two inserter embodiments as having “rotors,” and those rotors have a central axis. PO Resp. 17–18 (citing Ex. 1001, 29:25–28, 29:55–59, Figs. 32, 45). Patent Owner, however, fails to explain why those embodiments should be understood to limit the claims. For example, in Phillips, the Federal Circuit “expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.” Phillips, 415 F.3d at 1323; see also SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“[A] particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.”). Second, turning to the extrinsic evidence of record, Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 (Fletcher Decl.) ¶ 81 (citing Ex. 1025 (dictionary excerpts), 1). In contrast, Dr. Cima provides no evidence corroborating his evidence. The language Patent Owner quotes from the Petition comes from a “Dictionary of Mechanical Engineering.” See Pet. 38 n.9 (quoting Ex. 1024, 328). This contradicts Patent Owner’s argument that Petitioner’s proposed construction “has no basis in mechanical engineering.” PO Resp. 19. view that a rotor must rotate on a central axis. He cites a textbook indicating that “[r]otational motion needs to take place around an appropriate axis,” but he does not explain whether or why the “appropriate axis” must necessarily be a “central axis.” Ex. 2024 (Cima Decl.) ¶ 179 (quoting Ex. 2040 (Rotordynamics) 2 (emphasis added)). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).” slip op. at 11

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Although the Petition does state that a person of ordinary skill in the art “would understand the plain and ordinary meaning of a ‘recess’ to include ‘an indentation in a line or surface (as an alcove in a room),’” the Petition does not specify what else is “include[d]” in this term, nor does it specify that the plain and ordinary meaning of “recess” includes the entire interior of a housing. The Petition also does not invoke the Specification as demonstrating that the plain and ordinary meaning of “recess” includes the entire housing.13 Pet. 64 (emphasis added). Petitioner’s belated proposal also conflicts with the language of the claims themselves. Independent claim 1 recites “a rotor disposed within the inserter housing.” Ex. 1001, 43:42. Dependent claim 7 narrows claim 1 by reciting that “the housing comprises a recess in which the rotor is received.” Id. at 44:11–12. If the interior of the inserter housing and the recess could be one and the same as Petitioner proposes, there would be no need for claim 7, because it would not further limit claim 1. See 35 U.S.C. § 112(d) (“a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed”); see also Nazomi Commc’ns, Inc. v. Arm Holdings, PLC, 403 F.3d 1364, 1370 (Fed. Cir. 2005) (“The concept of claim differentiation ‘normally means that limitations stated in dependent claims are not to be read into the independent claim from which they depend.’”) (quoting Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971–72 (Fed. Cir. 1999)). Accordingly, we decline Petitioner’s belated request to construe “recess” to include “an entire cavity of a housing or a cylinder.” 13 We acknowledge that Petitioner argued that the entire interior of Gravesen’s housing maps to the claimed “recess,” but this was in the context of comparing the prior art to the claim as construed. Indeed, Petitioner asserted that “the space within [Gravesen’s] housing is an alcove.” Pet. 64– 65 (emphasis added). In sum, Petitioner did not timely argue that the plain and ordinary meaning of the term “recess” includes an entire cavity of a housing or a cylinder. We adopt the only construction Petitioner offered and supported in the Petition. In view of the above, we construe “recess” as meaning “an indentation in a line or surface (as an alcove in a room).”” slip op. at 16

  Patent outcomesUS 10,945,649 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,945,649
• Rassini Suspensiones, S.A. De C.V. v. Muhr Und Bender KGAll claims unpatentable
  PTAB · Jul 5, 2023 · IPR2022-00278 · APJ Scott A Daniels · IPR · Final written decision

  Claims 1–5, 8, 10–14, and 17 are unpatentable as obvious over Enomoto; claim 15 is unpatentable as obvious over Enomoto and Glover.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “and, undoubtedly, advanced principles of mechanical engineering and materials testing, including those for the testing and analysis of materials and structures for vehicle leaf springs such as FE analysis. See Kyocera, 22 F.4th at 1377 (“[I]t would be improper to require an expert witness to possess ordinary skill in the art and nothing more. If that were the case, ‘a person of exceptional skill in the art would be disqualified from testifying as an expert because [he is] not ordinary enough.’” (quoting Endress + Hauser, Inc. v. Hawk Measurement Systems Pty., 122 F.3d 1040, 1042 (Fed. Cir. 1997)). Accordingly, Patent Owner does not persuade us that Dr. Wagoner is not sufficiently qualified to provide helpful testimony and evidence in this proceeding.” slip op. at 16

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “and, undoubtedly, advanced principles of mechanical engineering and materials testing, including those for the testing and analysis of materials and structures for vehicle leaf springs such as FE analysis. See Kyocera, 22 F.4th at 1377 (“[I]t would be improper to require an expert witness to possess ordinary skill in the art and nothing more. If that were the case, ‘a person of exceptional skill in the art would be disqualified from testifying as an expert because [he is] not ordinary enough.’” (quoting Endress + Hauser, Inc. v. Hawk Measurement Systems Pty., 122 F.3d 1040, 1042 (Fed. Cir. 1997)). Accordingly, Patent Owner does not persuade us that Dr. Wagoner is not sufficiently qualified to provide helpful testimony and evidence in this proceeding.” slip op. at 16

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

    “does not require that the wheel carrier is physically on the leaf spring, or that a load is actively applied to the leaf spring via the wheel carrier, only that the leaf spring is capable of supporting a wheel carrier and receiving forces through the wheel carrier that cause tensile loading.” Section II.C. In other words, where Enomoto has the capability to be deflected in such a way as to transition from compression into tension, then Enomoto’s leaf spring encompasses this limitation regardless of whether or not the function is activated or utilized in any way. See Silicon Graphics, Inc. v. ATI Techs., Inc., 607 F.3d 784, 794 (Fed. Cir. 2010) (The Federal Circuit explaining that whether or not the functional aspects of the claim were “activated or utilized in any way,” a product that included the structure for performing the claimed function can still infringe.). Accordingly, Patent Owner’s contention that Enomoto’s leaf spring might fail, or must be considered as installed on a vehicle with an air spring and actively subject to vertical displacement is incorrect from the outset based on the proper claim construction, and in this case, overcome by Petitioner’s persuasive evidence that the structure and capabilities of a leaf spring are well known, regardless of whether the leaf spring is installed with a wheel carrier in a complete vehicle suspension system. See, e.g., Ex. 1030 (British Patent No. 1,077,968 to Oldfield explaining that “[t]his spring deflection is accompanied by a shortening of the main part of the spring which in turn tends to straighten out the bend 17” slip op. at 63

  Patent outcomesUS 9,868,330 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,868,330
• Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentable
  PTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision

  The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

    “VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77

  • ExcludeMotion to exclude, deniedDenied

    “A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29

  • Skill levelSkill level board ownOther

    “Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25

  Patent outcomesUS 10,766,685 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,766,685
• Transgene / Bioinvent International AB v. Replimune LimitedNo claims unpatentable
  PTAB · May 25, 2023 · PGR2022-00014 · APJ Christopher G Paulraj · PGR · Final written decision

  The Board held claim 13 not unpatentable over Silvestre or Du, Choi, and Zitvogel, finding insufficient motivation to combine and reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “or “POSITA”) “would have had a Ph.D. in molecular biology, or a related field, with expertise in virology (including expertise growing, isolating, and rescuing viruses), immunology, and cancer biology with at least four years of post-Ph.D. experience in those areas.” Pet. 6 (citing Ex. 1007 ¶¶ 35, 96). Patent Owner does not argue otherwise. See PO Resp. 5. We adopt Petitioner’s uncontested definition as that definition is consistent with the level of skill in the art reflected by the prior art. See 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” slip op. at 11

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

    “claim terms of the ’513 patent for purposes of determining whether to institute trial. For purposes of our analysis in this Final Written Decision, however, we find that it would be useful to clarify the scope of “oncolytic virus.” We agree with Petitioner that the Specification defines an “oncolytic virus” as “a virus that infects and replicates in tumor cells, such that tumor cells are killed.” Ex. 1001, 9:10–12. The Specification further clarifies that “the virus is replication competent,” and is preferably selectively replication competent in tumor tissue. Id. at 9:12–13. “A patentee is free to be his own lexicographer.” Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, consistent with its express definition in the Specification, to be a virus that infects and replicates in tumor cells, such that tumor cells are killed, wherein such a virus is replication competent.” slip op. at 12

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

    “but contends that “oncolytic virus” should not be construed to encompass “viral vectors” such as those disclosed in Zitvogel. PO Resp. 5. Although Petitioner does not expressly contend otherwise, we agree with Patent Owner that “oncolytic virus” would not encompass Zitvogel’s “viral vectors,” which are defined in that reference to be “replication-defective” or “replication-impaired.” Ex. 1004, 19:26–29. We do not construe any other claim terms. See Vivid Techs., Inc. v.” slip op. at 13

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

    “Petitioner acknowledges that “while the bulk of Silvestre’s disclosure, including the working examples, is directed towards creating an oncolytic poxvirus, Silvestre discloses preparing modified oncolytic virus using other virus types, including HSV.” Pet. 44. It is undisputed, however, that Silvestre does not disclose a single embodiment of an oncolytic HSV that includes both a heterologous GM-CSF encoding gene and a heterologous CTLA-4 inhibitor encoding gene. Rather, Petitioner points to where each element could be found among broader lists of possible oncolytic virus classes, immune checkpoint targets, and therapeutic genes. Ex. 1002, 7:10– 15:49. As noted by Dr. Chiocca, if one were to randomly select any of the 11 We need not decide whether Silvestre anticipates independent claim 1, as the sole challenged claim 13 depends directly from claim 11. Thus, our determination that Petitioner has not shown that claim 11 is anticipated is sufficient to establish that Petitioner has not met its prerequisite burden for claim 13. Ex. 2009 ¶ 29. This type of picking and choosing is not anticipation. See Arkley, 455 F.2d at 587–88.” slip op. at 19

  Patent outcomesUS 10,947,513 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,947,513
• Slayback Pharma LLC v. Eye Therapies, LLCAll claims unpatentable
  PTAB · May 15, 2023 · IPR2022-00142 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–6 are unpatentable as obvious over Gil, Norden, Dean, Alphagan, and Federal Register; anticipation over Gil and Walters was not shown for claims 1–2.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Although the parties disagree as to the specific qualifications of a person of ordinary skill in the art, the parties’ experts agree that their Ex. 1049 ¶ 6 (Sher); Ex. 2020 ¶ 28 (Noecker); Ex. 2021 ¶ 34 (Williams); Ex. 2022 ¶ 23 (Davies). Both parties’ proposed definitions and the prior art of record indicate a high level of skill in the relevant art. Because the parties’ respective experts agree that any dispute as to the level of ordinary skill in the art is not material to their opinions, we adopt Patent Owner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Ex. 2020 ¶¶ 28–31; 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))).” slip op. at 8

  • Expert testimonyPetitioner expert creditedOther

    “We are not persuaded. We credit the testimony of Petitioner’s expert, Dr. Sher, who explains that because of the “high degree of imprecision of Figures 2 and 6,” a POSA would be unable to reach any quantitative conclusions from the figures or “clinically distinguish” between brimonidine concentrations that differ by only five-thousandths of a percent. Ex. 1049 ¶¶ 10–18. For example, as Dr. Sher notes, there are no incremental hash marks that indicate where any non-enumerated concentrations such as 0.02% or 0.025% would fall. Id. ¶¶ 11–12. Moreover, the x-axis of both figures appears to be neither linear nor logarithmic. Id. The uncertainty of the scale of the x-axis calls into question the assumption by Dr. Noecker that the blue dot on the x-axis of Figure 6 is necessarily 0.025% as opposed to, for example, 0.02%, which is specifically called out in the Specification’s description of Figure 6 as a preferred concentration. See Ex. 1001, 19:57 (stating Figure 6 demonstrates that “the net effectiveness of brimonidine as a decongestant is greatest between about 0.01% and about 0.03%; preferably between about 0.012% and about 0.02%”) (emphasis added). Moreover, like Dr. Sher, we question the accuracy of Dr. Noecker’s statement that concentrations less than 0.03% have no rebound hyperemia. See Ex. 1049 ¶ 19 (citing Ex. 2020 ¶ 94). As seen by a magnified portion of Figure 2, reproduced below, the dark gray, solid line indicating rebound hyperemia appears to show at least some amount of rebound hyperemia below 0.03%: That is, the magnified portion of Figure 2 depicts the dark gray rebound hyperemia curve between 0.01% and 0.03% to be above the x-axis, indicating—on its face—that some rebound hyperemia occurs, contrary to Dr. Noecker’s testimony. Id. We, therefore, credit the reasoning of Dr. Sher, who explains that, in light of the imprecision of the figures, a POSA would not rely on the figures to discern when rebound hyperemia begins, but would rather rely on the Specification, which states “rebound hyperemia begins at around 0.03%.” Id. We are persuaded that those words of approximation suggest that rebound hyperemia could begin either a little less than, at, or a little more than 0.03% brimonidine. See Ex. 1049 ¶ 25. Thus, we agree with Dr. Sher that “a POSA would read the ’742 patent’s description of Figure 6 and reasonably conclude that ‘at around 0.03%’ includes 0.025%.” Id.” slip op. at 25

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

    “As an initial matter, we agree with the parties that the preamble of the claims is limiting. “Whether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.” Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003). The Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to methods of using a composition for a specific purpose (i.e., reducing eye redness), and the method comprises a single step of administering that composition, the Federal Circuit “has generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. agree with Petitioner that it does not and find Eli Lilly to be instructive. In Eli Lilly, the preambles of the claims recite a “method for reducing incidence of or treating at least one vasomotor symptom in an individual” and a “method for treating headache in an individual.” 8 F.4th at 1335. There, the Federal Circuit held that the preambles “are not merely statements of effect but rather statements of the intentional purpose for which the methods must be performed.” Id. at 1342. Thus, the Federal Circuit did not require proof of actual clinical results from performing the claimed method, even though the claims also recited an “effective amount.” Id. The Federal Circuit held that because the specification defined an “effective amount” as an “an amount sufficient to effect beneficial or desired results” and provided examples of such results in the context of prophylactic or therapeutic uses, the claims “encompass a clinical result, [but] they do not require such a result.” Id. Here, similarly, the ’742 patent claims simply recite administering the brimonidine composition (at a concentration range) and do not recite any efficacy requirement, nor even the “effective amount” of note in the Eli Lilly claims. But, like Lilly and as explained below, the “ocular conditions” of the claims encompass prophylactic reduction of hemorrhage and hyperemia in addition to therapeutic uses. See Ex. 1001, 12:13–19. We, therefore, find the claims here do not require actual redness reduction and, thus, no clinical result is required to satisfy the claimed method. Thus, having considered the arguments and evidence presented at trial, we determine that the preamble of the claims is limiting and requires that the claimed brimonidine composition be administered with the actually reduced.” slip op. at 10

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

    “evidence presented at trial, we agree with Petitioner that the term “about 0.025%” includes 0.03%. Our construction is supported not only by intrinsic evidence, but also by extrinsic evidence that demonstrates the alleged criticality of the “about 0.025%” limitation. terms of a specific numerical range. We must, therefore, determine how broadly a POSA reading the ’742 Specification would extend the numerical range around 0.025%. In doing so, we consider the described criticality of “about 0.025%” brimonidine and its purpose to the claimed invention. See Cohesive, 543 F.3d at 1368. The ’742 patent makes clear that the purpose of the “about 0.025%” limitation in the claims is to use “low doses of highly selective a-2 adrenergic receptor agonists to achieve vasoconstriction with significantly reduced hyperemia.” Ex. 1001, 2:39–41. Furthermore, the Specification explains that there is a need for methods that provide “safe and long term vasoconstriction with reduced or minimized side effects, such as rebound hyperemia.” Id. at 2:30–33. There is no dispute that both 0.025% and 0.03% constitute low doses of brimonidine, as described by the Specification. See id. at 3:60–65 (defining “low concentrations” as “between about 0.0001% to about 0.05%”). Thus, the question is whether there is a critical distinction between the two concentrations and their ability to provide vasoconstriction with reduced rebound hyperemia. Patent Owner argues they are clinically distinct, whereas Petitioner argues they are not. In light of the intrinsic evidence discussed below, we agree with Petitioner.” slip op. at 22

  Patent outcomesUS 8,293,742 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,293,742
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCSome claims unpatentable
  PTAB · Apr 24, 2023 · IPR2022-00193 · APJ John G New · IPR · Final written decision

  Claims 1–8, 10–18, and 20 are unpatentable as obvious over Spenser and Spenser II; claims 9 and 19 were not shown unpatentable.

  RulingsFinal written decision

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

    “Spenser II provides that its cloth “has a thickness ranging from about 1 to 5 mm.” Spenser and Levi both teach a valve that has a diameter of 25 mm and 26 mm respectively when fully expanded. Accordingly, even if we were to assume a POSITA used the thinnest possible cloth in Spenser II, Petitioner’s proposed combination using the smaller Spenser 25 mm diameter (12.5 mm radius) expanded valve covered by a 1 mm cloth resulting in a 27 mm diameter (13.5 mm radius) valve…. From this we can conservatively estimate how much cloth is required for a cross-section of the proposed device (Acloth) by calculating the total area of a cross-section of the cloth-covered valve (π*(13.5 mm)2) and subtracting the area of a cross-section of just the valve (π*(12.5 mm)2). Acloth = π*(13.5 mm)2 - π*(12.5 mm)2 = 81.68 mm2 Accordingly, Petitioner’s proposed combination requires 81.68 mm2 of outer cloth in a given cross-section of the device.” slip op. at 78

  • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia no nexusDecided for petitioner

    “that the claims are not obvious over Spenser and Spenser II because Petitioner fails to demonstrate that any of its proposed prior art combinations disclose or render obvious a valve with a “sealing material” that is delivered “endovascularly.” PO Resp. 11. Patent Owner also argues Petitioner fails to prove that any of its combinations disclose or render obvious a “fibrous network” “in overlapping radial alignment with native valve leaflets.” Id. at 73. Additionally, Patent Owner contends that objective indicia of non-obviousness (also called secondary considerations) support a conclusion that the challenged claims are nonobvious. Id. at 2. Finally, Patent Owner contends that the testimony of Petitioner’s expert, Dr. Buller, should be given little or no weight, because, Patent Owner argues, he has no expertise in the issues at hand. Id. at 90.” slip op. at 16

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “that the claims are not obvious over Spenser and Spenser II because Petitioner fails to demonstrate that any of its proposed prior art combinations disclose or render obvious a valve with a “sealing material” that is delivered “endovascularly.” PO Resp. 11. Patent Owner also argues Petitioner fails to prove that any of its combinations disclose or render obvious a “fibrous network” “in overlapping radial alignment with native valve leaflets.” Id. at 73. Additionally, Patent Owner contends that objective indicia of non-obviousness (also called secondary considerations) support a conclusion that the challenged claims are nonobvious. Id. at 2. Finally, Patent Owner contends that the testimony of Petitioner’s expert, Dr. Buller, should be given little or no weight, because, Patent Owner argues, he has no expertise in the issues at hand. Id. at 90.” slip op. at 16

  Patent outcomesUS 10,881,538 mixed
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,881,538
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCAll claims unpatentable
  PTAB · Mar 28, 2023 · IPR2021-01584 · APJ John G New · IPR · Final written decision

  Claims 7 and 12 are unpatentable as obvious over Spenser and Spenser II; the Board did not reach the remaining grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art in November 2012 would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. 11 Pet. 24. Petitioner asserts that such a skilled artisan would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve. Id. (citing Ex. 1003 ¶ 45). Patent Owner does not expressly challenge Petitioner’s definition. We consequently adopt Petitioner’s definition of a person of ordinary skill in the art as an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses, that would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve. 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).” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We conclude that Dr. Buller has sufficient experience to qualify as an expert and to testify as to the perspective of a person of ordinary skill in the art. We find that Dr. Buller has experience as an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses, as required by our definition of one of skill in the art. See Section II.A above. We find this particularly so in view of Dr. Buller’s 20 Dr. Buller was awarded a B.Sc. in 1977 and a M.B. B.S. in 1980. M.B. B.S. (Bachelor of Medicine, Bachelor of Surgery) is the primary medical schools in the United Kingdom. See MBBS (Bachelor of Medicine & Bachelor of Surgery), available at: https://scholar.harvard.edu/ narender/classes/mbbs-bachelor-medicine-bachelor-surgery (last visited January 30, 2023). It is the professional equivalent of an M.D. in the United States. 56 extensive experience with endovascular catherization and stent implantation, which relate intimately to a central issue of this inter partes review, viz., whether the device claimed in the ’011 patent can be delivered endovascularly. We acknowledge that Dr. Buller appears never to have personally performed a TAVR, but his knowledge of the device and the procedures appears to be intimate and thorough. As Petitioner points out, the same arguments presented by Patent Owner here have been previously considered by the Board in the ’060 IPR. In that related proceeding, we found that the Patent Owner had failed to sufficiently demonstrate why Dr. Buller should not be considered to qualify as an expert or to testify as to the perspective of a person of ordinary skill in the art. See ’060 IPR, Paper 64 at 10–11. We find the same reasoning applies in the present proceeding. Furthermore, with respect to the weight we should accord Dr. Buller’s” slip op. at 56

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

    “We disagree. Both Spenser II and the evidentiary prior art reference Norris provide ample motivation for combining Spencer II’s compressible cloth, as a sealing material, to the TAVR disclosed by Spenser. For example, Spenser II teaches (and Patent Owner concedes) that the problem of PVL was well known in the art at the time of invention: “Cardiac valve implantation is well known in the art. Less well addressed is how to detect possible leaks between the valve and surrounding blood vessel, how to seal 68 such leaks, or how to design the valve such that it automatically seals the leaks.” Ex. 1011 ¶ 2. Figure 22 depicts Spenser II’s compressible cloth, which, added to the external surface of a TAVR, acts “to reduce or prevent paravalvular leaks.” Id. at ¶ 144; see also id. at ¶¶ 55, 145 (“To reduce or prevent paravalvular leakage, a layer of compressible material 256 is disposed along an outer surface of the stent 15 structure 252). Similarly, Norris also provides motivation to a skilled artisan to add a compressible outer cloth to a TAVR in expressly stating: Medical devices such as vascular and endovascular grafts and stent-grafts can include fabric components that function to promote sealing of the device to the lumen or structure in which it is implanted.… Regaining its [i.e., the fabric’s] original shape, structure, and dimensions [once implanted] is important to achieve an adequate seal between the exterior of the device and the lumen or structure in which it is implanted. This is critical because any gaps or voids between the device and the implant site can prevent a reliable seal, which can lead to complications and/or device failure. Ex. 1074, col. 1, ll. 20–35. We conclude that both Spenser II and the prior art Norris reference show there would have been motivation for a person of ordinary skill in the art to combine the compressible outer cloth of Spenser II with the TAVR disclosed by Spenser so as to reduce PVL and its associated serious problems.” slip op. at 68

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

    “Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). As we have explained above, both Spenser II and the prior art Norris reference expressly teach the combination of a compressible outer cloth with a TAVR for heart valve replacement procedures, with the explicit purpose of reducing or eliminating PVL. See, e.g., Ex. 1011 ¶¶ 55, 145, 155; Ex. 1074, col. 9, ll. 18–26. Furthermore, Norris teaches that it was well known in the art, at the time of invention, that “[m]edical devices such as vascular and endovascular grafts and stent-grafts can include fabric components that function to promote sealing of the device to the lumen or structure in which it is implanted.” Ex. 1011, col. 1, ll. 20–23. Norris further teaches that a compressible cloth was known to be used with endovascularly-delivered “cardiovascular applications, such as with a heart valve or stent-graft.” Id. at col. 9, ll. 20–21. In short, Patent Owner points to no requisite knowledge on the part of a skilled artisan that could have been gleaned only from the disclosures of the ’011 patent’s Specification or claims. McLaughlin, 443 F.2d at 1395. We consequently conclude that Patent Owner’s arguments in this respect are without merit.” slip op. at 70

  Patent outcomesUS 10,857,011 unpatentable
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,857,011
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCNo claims unpatentable
  PTAB · Mar 24, 2023 · IPR2022-00034 · APJ John G New · IPR · Final written decision

  Petitioner failed to show claim 6 unpatentable because none of the seven asserted grounds established the required absence of an outer graft covering between the fibers and outer frame.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “November 2012 would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses.” slip op. at 11

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

    “We determine that, as the plain language of the claim term suggests, an “outer graft covering” must circumferentially cover some, or all, of the metallic outer frame of the prosthetic heart valve. See Merriam-Webster, Cover, available at: https://www.merriam-webster.com/dictionary/cover (last visited March 2, 2023) (defining “cover,” relevantly, as “something that is placed over or about another thing”). See Ex. 3004. Consequently, we understand an “outer graft covering” to be a structure, such as a cloth or fabric or other material, that circumferentially covers all or part of, the metallic outer frame. Importantly, because an outer graft covering must cover the external surface of the outer frame, we understand this claim term to mean that the cover must extend over (i.e., “cover”) not only the struts and members of the metallic outer frame, but must also cover the open spaces, or interstices, in the intervals between those struts and members. Consequently, we construe the limitation reciting “free of an outer graft covering between the fibers and the outer frame” to mean that there can be no such outer graft covering present anywhere between the outwardly extending fibers and the metallic outer frame.” slip op. at 40

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

    “Reply to Patent Owner’s Response, or otherwise provide any additional argument or evidence to demonstrate that the outer skirt of Levi does not constitute the outer graft covering prohibited by claim 6. Consequently, our initial determinations stand. Furthermore, our definition of outer graft covering herein as “a material or structure that circumferentially covers at least a portion of the outer surface of the prosthetic heart valve, such that both the struts and members of the metallic outer frame, as well as the 45 interstices between those struts and members, is covered by the outer graft covering” reinforces our prior conclusion that the outer skirt of Levi constitutes an outer graft covering that is prohibited by claim 6. We consequently conclude that Petitioner has not met its burden with respect to demonstrating, by a preponderance of the evidence, that Levi teaches or suggests the limitation reciting “wherein the outer seal is free of an outer graft covering between the fibers and the outer frame.”” slip op. at 45

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

    “Both the descriptions and Figure 22 of Spenser II show a cloth covering the proximal outer surface of the metallic outer frame of the prosthetic heart valve, including the spaces between the struts and members of the frame. Furthermore, the reference discloses that any fibers extending outwardly from the cloth arise from the surface of the cloth, and are not attached directly to the frame, as depicted in Figure 11 of the ’846 Specification. Thus, even were such fibers made of the same material as the cloth, which is not clear from the reference’s disclosure, the cloth would be between the surface-residing fibers and the metallic outer frame. We conclude that a person of ordinary skill in the art would have recognized that the sleeve-like cloth or fabric of Spenser II corresponds to an outer graft covering between its fibers and its outer frame, and such a covering would be between Spencer II’s surface fibers and its metallic outer frame. Such an outer graft cover is expressly prohibited by the language of claim 6, even if it and associated extending fibers are of the same material.” slip op. at 48

  Patent outcomesUS 10,966,846 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,966,846
• Ford Motor Company v. Safe Driving Technologies LLCSome claims unpatentable
  PTAB · Mar 10, 2023 · IPR2021-01446 · APJ Alyssa A Finamore · IPR · Final written decision

  Claims 1–4, 6, 10, 12–14, 16, 17, and 19–21 are unpatentable under §103; claim 15 was not shown unpatentable.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedGranted

    “Our rules and Consolidated Trial Practice Guide are clear on this prohibition. And, the Consolidated Trial Practice Guide explains: “[w]here a party believes it has a basis to request relief on a ground not identified in the rules, the party should contact the Board and arrange for a conference call with the Board and opposing party to discuss the requested relief with the judge handling the proceeding.” CTPG 75. Thus, the Board identifies appropriate ways for a party to address matters that it considers to be beyond the specific procedures outlined in the rules. Merely submitting new evidence was not authorized by Board rules or guidance and Patent Owner did not seek authorization to file the new evidence. The facts warrant excluding Exhibits 2030–2032 and we grant the Motion. See CTPG 81.” slip op. at 83

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

    “underpinnings, why a person of ordinary skill would have been motivated to modify the prior art to achieve the claimed invention. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner . . . must . . . articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” (citing KSR, 550 U.S. at 418)). Nonetheless, “a disclosure that anticipates under § 102 also renders the claim invalid under § 103, for ‘anticipation is the epitome of obviousness.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (quoting In re Fracalossi, 681 F.2d 792 (CCPA 1982)); see also Application of Pearson, 494 F.2d 1399, 1402 (CCPA 1974) (“[T]his court has sanctioned the practice of nominally basing rejections on § 103 when, in fact, the actual ground of rejection is that the claims are anticipated by the prior art. The justification for this sanction is that a lack of novelty in the claimed subject matter, e.g., as evidenced by a complete disclosure of the invention in the prior art, is the ‘ultimate or epitome of obviousness.’” (citations and footnote omitted)).” slip op. at 14

  Patent outcomesUS 9,047,170 mixed
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,047,170
• Apotex Inc. v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution

  Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.

  RulingsInstitution decision

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

    “APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314.” slip op. at 19

  • BurdenDecided for patent owner

    “As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation.” slip op. at 17

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

    “A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,253,572

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.