• Celltrion, Inc. v. Chugai Seiyaku Kabushiki Kaisha, Genentech, Inc., And Hoffmann-La Roche Inc.All claims unpatentable
  PTAB · Aug 29, 2023 · IPR2022-00579 · APJ John G New · IPR · Final written decision

  Claims 1–8 are unpatentable as obvious over NCT ’653, Kivitz, and Morichika; NCT ’653 alone does not anticipate claims 1 or 5.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “We are not persuaded that a person of ordinary skill in the art could be thought of as a “team of individuals.” We find no support in Sankyo for Patent Owner’s contention that “a person of ordinary skill in the art can have the knowledge and experience of multiple individuals working across different arts.” See PO Resp. 8. Rather, in Sankyo, the Federal Circuit looked to the qualifications of the inventors of the patent at issue, all of whom were specialists in drug and ear treatments and noted that others working in the same field as the inventors were of the same skill level. Sankyo, 501 F.3d at 1257. Finding that such specialty training was a 9 requisite for ordinary skill in the art, the court defined the level of ordinary skill in the art in that case as “a person engaged in developing pharmaceutical formulations and treatment methods for the ear or a specialist in ear treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also has training in pharmaceutical formulations.” Id. We conclude that there is, as Petitioner acknowledges, little substantial difference between the qualifications of the “team” proposed by the parties, and those of the individual skilled artisan defined in our Decision to Institute. Such an individual would have had not only several years of experience researching treatments for autoimmune disorders, including rheumatoid arthritis, but would additionally have access to individuals skilled in clinical medicine, pharmacokinetics and formulation. Indeed, Petitioner’s expert, Dr. Shah, acknowledges that an individual person of skill in the art “would have had access to individuals skilled in clinical medicine, pharmacokinetics and formulation.” Ex. 1032 ¶ 27. This is consistent with our prior definition. We consequently adopt, for this Final Written Decision, the definition of a person of ordinary skill in the art as defined in our Decision to Institute and quoted above because it appears consistent with the problems addressed in the ’677 Patent and the prior art of record. See Dec. 6. Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Regardless of the level of skill adopted, our analysis and findings would remain the same.” slip op. at 9

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

    “Fixed dose” Petitioner asserts that the claim term “fixed dose” is defined in the Specification as “a dosage of a drug, such as an anti-IL-6R antibody which is administered without regard to the patient’s weight or body surface area (BSE), i.e., it is not administered as either a mg/kg or mg/m2 dose.” Pet. 27 (quoting Ex. 1001, col. 15, ll. 15–18). Patent Owner does not dispute this definition. PO Resp. 9 n.9. Because the term “fixed dose” is defined by the 11 Specification and is not disputed by the parties, we determine, based on the current record, that this term requires no further construction. slip op. at 11

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

    “natural reading of this claim language shows a functional limitation that simply requires that the claimed subcutaneous administration device be capable of containing and delivering to a patient a fixed dose of the drug. As such, we conclude that this functional language is limiting upon the claim. See, e.g., K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1363 (1999) (holding that functional language is limiting upon an apparatus claim). We decline to adopt, however, Patent Owner’s construction of a patient as being a person “with an IL-6-mediated disorder” or requiring the claimed device to “safely and effectively deliver that amount of drug subcutaneously to a patient” and to accommodate the risk of serious immunogenic reactions due to aggregation and viscosity[,] … as well as the obstacles of aggregation instability, injection difficulties, and patient discomfort.” See PO Resp. 12. To adopt these definitions is to impermissibly extend the scope of the claims through claim construction beyond the language of the claims, which do not recite this language. To require that the patient be in need of treatment for an IL-6 mediated disease, as suggested by Patent Owner, is to place an additional limitation on the device that is not functional, but rather relates to the nature of the individual receiving the subcutaneous administration. To the contrary, we interpret this functional language as requiring the claimed device to be capable of delivering the contained dosage to any “patient” whether or not they have a specific medical condition or without respect to ancillary conditions or concerns that may apply. If the device is capable of delivering the dosage subcutaneously to any patient, that is 15 sufficient for this functional limitation, and we decline to import additional limitations into the claim, as Patent Owner urges us to do. We therefore construe the claim phrase “delivers to a patient” as a functional limitation of the claims that requires that the claimed device be capable of subcutaneously delivering the dose contained within it to a person.” slip op. at 15

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

    “device, which contains and delivers to a patient a 162 mg fixed dose” of tocilizumab within the four corners of NCT ’653, we next inquire whether NCT ’653 inherently discloses the claimed device. A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”). There can be little logical doubt that NCT ’653 necessarily teaches “a subcutaneous administration device” for the simple reason that the reference teaches that randomized subjects receive “tocilizumab 162 mg [subcutaneously]” and a person of ordinary skill in the art would have understood that a suitable device is required to do this. But the claims also 27 require that the subcutaneous administration device also “contains and delivers to a patient a 162 mg fixed dose of tocilizumab.” Petitioner contends that a person of ordinary skill in the art would have understood that the “subcutaneous administration device” used in the study contained and delivered a 162 mg fixed dose of tocilizumab to the patient. Pet. 31. We are not persuaded, however, that an ordinarily skilled artisan would understand that NCT ’653 necessarily discloses that the subcutaneous administration device was one capable of containing and delivering 162 mg of tocilizumab. Certainly, it would be logical for a person of ordinary skill in the art to assume that a device used to administer the dose was capable of delivering the whole dose in a single administered injection. But the reference does not rule out the possibility that another method could be used, e.g., two injections, each from a device capable of containing and delivering a dose only of 81 mg. Such an administration, though perhaps unlikely, is not categorically excluded by the disclosures of NCT ’653. As such, we conclude that NCT ’653 does not inherently disclose “a subcutaneous administration device, which contains and delivers to a patient a 162 mg fixed dose” of tocilizumab because it does not disclose that the subcutaneous administration device[s] necessarily “contains and delivers” the 162 mg fixed dose. Because we find that NCT ’653 neither expressly not inherently discloses all of the limitations of claims 1 and 5, we conclude that the reference does not anticipate independent claims 1 and 5. Consequently, 28 Petitioner has failed to meet its burden of showing, by a preponderance of the evidence, that claims 1 and 5 are unpatentable under 35 U.S.C. § 102.” slip op. at 27

  Patent outcomesUS 10,874,677 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,874,677
• Celltrion, Inc. v. Chugai Seiyaku Kabushiki Kaisha, Genentech, Inc., And Hoffmann-La Roche Inc.All claims unpatentable
  PTAB · Aug 29, 2023 · IPR2022-00578 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–12 are unpatentable: claims 1–3 and 6–11 are anticipated by NCT ’653, and claims 4, 5, and 12 are obvious over combinations including NCT ’653.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “of individuals” is not conventional. Dec. Inst. 8. We therefore found a POSA “would have been an individual with an M.D. specializing in the treatment of autoimmune disorders and having several years of experience treating patients with such disorders, including rheumatoid arthritis, or having several years of experience researching treatments for autoimmune disorders, including rheumatoid arthritis.” Id. We also clarified that such a POSA “may alternatively (or also) have a Ph.D. and would have access to individuals skilled in clinical medicine, pharmacokinetics and formulation.” Id. Patent Owner agrees with Petitioner’s definition and notes that a POSA according to our definition from the Institution Decision “would be unable to develop [the claimed inventions] without assistance from other individuals.” PO Resp. 7–8 (citing Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256–57 (Fed. Cir. 2007). Patent Owner, however, fails to consider the full scope of our definition. Specifically, Patent Owner does not account for the clarification that a POSA “would have access to individuals skilled in clinical medicine, pharmacokinetics and formulation.” Dec. Inst. 8. When considering our complete definition, we do not discern a substantive difference between our definition and the parties’ definition of a POSA. Petitioner appears to agree. Pet. Reply. 1 n.1 (“The challenged claims are unpatentable no matter which definition of a POSA is used.”).” slip op. at 10

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

    “Here, the Specification reveals that “per dose” does not mean “per injection.” Indeed, the Specification treats those terms differently. For example, in describing “the invention,” the Specification repeatedly follows “per dose” with an exemplary parenthetical or clause specifying the frequency of administration. For example, the Specification states that “the invention concerns a method of treating an IL-6-mediated disorder . . . wherein the anti-IL-6R antibody is administered as a fixed dose of 162 mg per dose (e.g. administered every week or every two weeks).” See Ex. 1001, 4:33–38 (emphasis added); see also id. at 5:4–8 (stating “[t]he invention also concerns a method of treating an IL-6-mediated disorder . . . wherein the anti-IL-6R antibody is administered as a fixed dose of 324 mg per dose or 648 mg per dose (e.g. every four weeks or once every month)”) (emphasis added); 24:54–59 (stating “the invention provides a method of treating an IL-6 mediated disorder . . . wherein the anti-IL-6R antibody is administered as a fixed dose of 162 mg per dose (e.g. every week, every two weeks, or every ten days)”) (emphasis added). Thus, the Specification repeatedly interprets the term “per dose” to describe the frequency of the dose, and not the number of injections to administer the dose. In contrast, when specifying a single injection, the Specification uses the terms “per injection” or a “single dose.” For example, the Specification states, “[a]vailable subcutaneous formulation is in a 1 mL prefilled syringe delivering 0.9 mL 162 mg TCZ per injection.” Id. at 49:55–56 (emphasis dose of 0.9 mL corresponding to a dose of TCZ 162 mg TCZ”) (emphasis added). Thus, although the Specification makes clear when a single injection is used by stating “per injection” or “single dose,” the ’264 Patent does not use either of those terms in the claims.” slip op. at 14

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

    “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 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). Where, as here, the claims are directed to methods of using a composition for a specific purpose (i.e., treating rheumatoid arthritis), 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. Moreover, as Patent Owner notes, the preamble provides antecedent basis for terms in the body of the claims. That is, the preamble recites “treating rheumatoid arthritis (RA) in a patient” and the claims recite “administering to the patient” (claims 1 and 10), “the RA patient” (claims 3– 5), and “administering to the RA patient one or more additional drug which treats the RA” (claim 6). Thus, considering the claims as a whole and the invention described in the patent, we determine the preamble of the claims to be limiting. See Eli Lilly, 8 F.4th at 1343 (finding preamble limiting where it provides antecedent basis for terms in the body of the claims). slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for patent owner

    “benefit.” Ex. 2009 ¶ 54. Patent Owner and Dr. Silverman, however, ignore the other half of the Specification’s definition of “treatment,” which states: “‘Treatment’ of a subject herein refers to both therapeutic treatment and prophylactic or preventative measures.” See Ex. 1001, 15:1–2 (emphasis added). Thus, limiting the definition of “treatment” to mean only “therapeutic treatment,” as Patent Owner asserts, is inconsistent with the express definition in the Specification and, therefore, incorrect on its face. See Phillips, 415 F.3d at 1316 (stating “the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). Moreover, the Specification defines the term “effective amount” as “an amount of the antibody that is effective for treating the IL-6 disorder.” Id. at 15:3–4. If “treatment” of the IL-6 disorder required efficacy, it would not be necessary for the Specification to define an “effective amount” for treating the disorder separately, as efficacy would be implicit in the term “treatment.” Consistent with this, the Specification defines certain subjects as “inadequate responder[s]” to various medications because they have experienced “an inadequate response to previous or current treatment . . . because of toxicity or inadequate efficacy.” Id. at 14:46–61 (emphasis added). Thus, the Specification uses the term “treatment” to encompass treating a patient with a certain medication, regardless of safety or efficacy.” slip op. at 19

  Patent outcomesUS 8,580,264 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,580,264
• Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentable
  PTAB · Jul 28, 2023 · IPR2022-01513 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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 shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Even if there were a distinction between the parties’ respective definitions of the level of ordinary skill in the art, Patent Owner’s expert, Dr. Weitz, notes that his opinion would not change regardless of which definition is applied. See Ex. 2060 ¶ 26. Moreover, we find both Dr. Zusman and Dr. Weitz qualified to opine from the perspective of a POSA for purposes of this Decision as both possess at least the level of ordinary skill in the art. See Ex. 1002 ¶¶ 1–11; Ex. 2060 ¶¶ 1–11; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369,” slip op. at 10

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

    “3. Remaining Claim Terms Patent Owner also offers constructions for “coronary artery disease,” and the preamble (PO Resp. 23–32, 39–40), but none of these claim phrases Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We now turn to the patentability challenges presented by Petitioner.” slip op. at 21

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

    “construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13

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

    “Patent Owner again, however, misses the point. The question is not whether clinical trials may exist where the disclosed dosing regimen may not be clinically proven effective, or whether a POSA would necessarily recognize clinical proof of efficacy from the COMPASS protocol taught by Foley. Id. at 53–54. On the contrary, the question is whether “the [prior art] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010) (citation omitted). If it is, the Federal Circuit has held that it is “well-settled that the disclosure should be regarded as sufficient.” Id. As such, here, we consider whether the disclosure in Foley is sufficient to show that the natural result of the disclosed dosing regimen would be “clinically proven effective” by the COMPASS study disclosed by Foley. In this case, we know that to be true because the claimed process was confirmed by the same COMPASS study disclosed by Foley. See Bristol- Myers, 246 F.3d at 1376; see also Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1369 (Fed. Cir. 2006) (finding method claims anticipated where prior art method disclosed the same steps in furtherance of the same purpose, and all that was contributed by the patent claims is the the claim term were limiting, we find Foley inherently discloses “clinically proven effective” amounts of rivaroxaban and aspirin. Having considered the arguments and evidence presented at trial, we find Petitioner has shown by a preponderance of the evidence that claims 1 and 2 are anticipated by Foley.” slip op. at 26

  Patent outcomesUS 10,828,310 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,828,310
• Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentable
  PTAB · Jul 28, 2023 · IPR2022-01515 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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 shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 10

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

    “construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13

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

    “2. Analysis “A claim is anticipated if each and every element as set forth in the claim is found, either expressly or inherently, in a single prior art reference.” Arbutus Biopharma Corp. v. ModernaTX, Inc., 65 F. 4th 656, 662 (Fed. Cir. 2023). The Federal Circuit explains that “[a]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation.” Monsanto Tech. LLC v. Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 23

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

    “In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, Petitioner must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 28

  Patent outcomesUS 10,828,310 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,828,310
• Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentable
  PTAB · Jul 28, 2023 · IPR2022-00517 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2 and 5–8 as obvious over Foley, and claims 3–4 and 6–7 as obvious over Foley and Plosker.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner disagrees with Petitioner’s definition and contends that a POSA would have been a “clinician with experience in the design, conduct, analysis, and interpretation of results from clinical trials involving antithrombotic agents (anticoagulants and antiplatelet agents), as well as experience with the treatment of patients with anticoagulants and antiplatelet 7 Although we find certain of Patent Owner’s arguments not persuasive, this should never be taken as an indication that we have assigned Patent Owner the burden of proof on patentability. patients with coronary artery disease and/or peripheral artery disease.” PO Resp. 22 (citing Ex. 2060 ¶¶ 24–26). In response, Petitioner asserts that its definition encompasses Patent Owner’s definition, as the experience of an M.D. includes the ability to interpret the results of clinical trials to evaluate therapies. Pet. Reply 2–3 (citing Ex. 1037 ¶ 7). We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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 shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9

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

    “construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13

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

    “Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 24

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

    “aspirin was taken with the first 2.5 mg dose of rivaroxaban, with the second 2.5 mg dose of rivaroxaban, or at a different time than either dose of rivaroxaban. Pet. 67 (citing Ex. 1002 ¶¶ 336–338). Nevertheless, Petitioner asserts that a POSA would have understood that “unless there is a cause for concern in terms of potential drug interactions, concomitant administration of multiple drugs in a dosing regimen is preferred for patient-compliance reasons.” Id. (citing Ex. 1002 ¶¶ 337–338). 13 We further note that we have considered, but are not persuaded that Patent Owner’s objective evidence of nonobviousness, discussed below, outweighs this strong evidence of obviousness. “first product,” Patent Owner does not argue that Foley does not teach a “first product.”14 See PO Resp. 51–56; PO Sur-reply 19–24. As set forth above, we agree with Petitioner’s construction of “first product” as not requiring, although allowing, a single combination dosage form. See supra Section II.B.2. We, therefore, find Petitioner has shown that a POSA considering Foley would have found it obvious to administer aspirin together with one of the rivaroxaban doses. We credit the testimony of Petitioner’s expert, Dr. Zusman, who notes that a POSA would have known that there were no concerns about administering rivaroxaban and aspirin together, and that it is easier for patients to take two drugs at the same time rather than at different times throughout the day. See Ex. 1002 ¶¶ 337–338; see also Ex. 1009,15 981 (noting “there is no clinically relevant interaction between rivaroxaban and aspirin and that the 2 drugs could be administered concomitantly”). We, therefore, find Petitioner has shown that Foley teaches or suggests each limitation of claims 5 and 8 and that a POSA would have had a reason to modify Foley to administer rivaroxaban together with aspirin with a reasonable expectation of success.” slip op. at 29

  Patent outcomesUS 10,828,310 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,828,310
• Apotex Inc. v. Cellgene CorporationInstituted
  PTAB · Jul 20, 2023 · IPR2023-00512 · APJ Ryan H Flax · IPR · Institution

  The Board instituted IPR on claims 1, 2, 6–9, 11–28, 32–36, and 38–43 on all asserted grounds, finding a reasonable likelihood of success on obviousness.

  RulingsInstitution decision

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

    “IV. CONCLUSION Petitioner demonstrates a reasonable likelihood of prevailing at trial in showing that at least one of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent is unpatentable over the cited prior art. Our decision derives from our review of the preliminary record before us. Accordingly, we institute inter partes review of each challenged claim the ’628 patent on each of the grounds asserted by Petitioner. This decision does not reflect a final determination on the patentability of the claims. ORDER Accordingly, it is hereby: ORDERED that the Petition is granted and we institute inter partes review of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent based on the grounds asserted in the Petition.” slip op. at 53

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

    “patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316 (citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). Moreover, “[w]hen the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.” Multiform Dessicants, Inc. v. Medzam Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). We agree with the parties that the ’628 patent expressly defines this term in stating “[t]he term ‘non-enteric-coated,’ when used herein, refers to a pharmaceutical composition, formulation, or dosage form that does not comprise a coating intended to release the active ingredient(s) beyond the stomach (e.g., in the intestine),” and we adopt this express definition herein with regard to “nonenteric coated tablet.”9 Ex. 1001, 11:42–48 (emphasis added).” slip op. at 14

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

    “to, and sometimes associated with, but not identical to the claim term “subject”), which appears in claims 11, 12, 18–22, and 38–43, means “a human or other animal who received the recited pharmaceutical composition in connection with a test of the recited parameter.” Prelim. Resp. 18–19 (also asserting Petitioner does not appear to dispute this construction). We first note that the term “test subject” appears in the ’628 patent only in the claims. See generally Ex. 1001. However, we find Patent Owner’s definition comports with the Specification’s express definition of “subject,” a term the Specification appears to use synonymously with the claim term “test subject” and the word patient, and that Patent Owner’s definition adds that the subject received the pharmaceutical composition in connection with a test of the recited parameter, which we find to be a reasonable interpretation of the claim term “test subject,” in accordance with the plain language of the claims on their face, and as supported by the relevant portions of the Written Description that describe testing parameters relating to drug administration. Ex. 1001, 35:45–36:62, 67:61–81:48. We adopt Patent Owner’s definition herein.” slip op. at 16

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

    “A single prior art reference may anticipate without disclosing a feature of the claimed invention if such feature is necessarily present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014). However, “‘[i]nherency . . . may not be established by probabilities or possibilities.’” In re Montgomery, 677 F.3d 1375, 1379–80 (Fed. Cir. 2012) (citations omitted, alterations in original). “The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency.” Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999). slip op. at 38

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 8,846,628
• Candela Corporation v. Nikolai TankovichInstituted
  PTAB · Jun 8, 2023 · IPR2023-00234 · APJ Devon Zastrow Newman · IPR · Institution

  The Board instituted IPR on claims 1–28, finding a reasonable likelihood that the challenged claims would be unpatentable under the five asserted § 103 grounds.

  RulingsInstitution decision

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

    “when no part of the distribution patterns of the two beams cross each other at the point of reference, identified above in Figure 2D–F as “in a tissue.” Id. As both claim 1 and claim 11 refer to tissue treatment, we interpret the point of reference for determining whether the beams overlap to be the point at which the beams first intersect the tissue being treated. This interpretation is supported by the diagrams in Figure 2 above and in the Specification. See, e.g., Ex. 1001, 1:67–2:4 (“The invention can avoid interference of the wavelengths by delivering the wavelengths simultaneously and in spatially separated and overlapping regions of the tissue being treated.”). In view of the above, we determine that the term “overlapping,” as used in the claims, refers to the crossing of the beam pattern at the point at which the beams intersect the tissue being treated.” slip op. at 13

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

    “when no part of the distribution patterns of the two beams cross each other at the point of reference, identified above in Figure 2D–F as “in a tissue.” Id. As both claim 1 and claim 11 refer to tissue treatment, we interpret the point of reference for determining whether the beams overlap to be the point at which the beams first intersect the tissue being treated. This interpretation is supported by the diagrams in Figure 2 above and in the Specification. See, e.g., Ex. 1001, 1:67–2:4 (“The invention can avoid interference of the wavelengths by delivering the wavelengths simultaneously and in spatially separated and overlapping regions of the tissue being treated.”). In view of the above, we determine that the term “overlapping,” as used in the claims, refers to the crossing of the beam pattern at the point at which the beams intersect the tissue being treated.” slip op. at 13

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

    “Black discloses that its combined beam can be controlled to rotate the mirrors to “generate various different kinds of treatment patterns” and can “create any type of three-dimensional paths and treatment pattern.” See Ex. 1006 ¶¶ 61, 62; Ex. 1002 ¶ 69. On this record and at this stage, the ability to generate treatment patterns meets the limitations of the claims, which each require a pattern of “overlapping beams and non-overlapping beams. We credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have understood that a scanner could be used with or instead of a modulator to provide adjustability to one or more lasers, that the artisan would have been familiar with the control and programming of multiple scanners taught in Black, and that the artisan would have been able to implement these features in Hsia’s system without undue experimentation. Ex. 1002 ¶¶ 93, 95, 97, 98. Additionally, we credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have found it obvious from the teachings in Black to combine and scan multiple beams into a desired pattern, such as overlapping and non-overlapping in order to optimize treatment results and because the combination would have provided multiple potential benefits. Id. ¶¶ 98, 101, 112, 116, 118–128. We acknowledge Patent Owner’s argument that Dr. Milner’s testimony regarding the ordinary artisan’s motivation to combine references parrots the rationales identified and discussed in the ’481 patent. Prelim. Resp. 36–38. Dr. Milner, however, also cites disclosures in both Hsia and Black citing advantages of combined beams including improved treatment efficacy, improved healing, the ability to treat simultaneously at multiple depths, and reduction in the number of required treatments. Ex. 1002 ¶¶ 117–119. “[T]he motivation-to-combine analysis is a flexible one. Any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1379 (Fed. Cir. 2023) (citing KSR Int’l, 550 U.S. at 420 (alterations, emphasis, and internal quotation marks omitted).” slip op. at 21

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Black discloses that its combined beam can be controlled to rotate the mirrors to “generate various different kinds of treatment patterns” and can “create any type of three-dimensional paths and treatment pattern.” See Ex. 1006 ¶¶ 61, 62; Ex. 1002 ¶ 69. On this record and at this stage, the ability to generate treatment patterns meets the limitations of the claims, which each require a pattern of “overlapping beams and non-overlapping beams. We credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have understood that a scanner could be used with or instead of a modulator to provide adjustability to one or more lasers, that the artisan would have been familiar with the control and programming of multiple scanners taught in Black, and that the artisan would have been able to implement these features in Hsia’s system without undue experimentation. Ex. 1002 ¶¶ 93, 95, 97, 98. Additionally, we credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have found it obvious from the teachings in Black to combine and scan multiple beams into a desired pattern, such as overlapping and non-overlapping in order to optimize treatment results and because the combination would have provided multiple potential benefits. Id. ¶¶ 98, 101, 112, 116, 118–128. We acknowledge Patent Owner’s argument that Dr. Milner’s testimony regarding the ordinary artisan’s motivation to combine references parrots the rationales identified and discussed in the ’481 patent. Prelim. Resp. 36–38. Dr. Milner, however, also cites disclosures in both Hsia and Black citing advantages of combined beams including improved treatment efficacy, improved healing, the ability to treat simultaneously at multiple depths, and reduction in the number of required treatments. Ex. 1002 ¶¶ 117–119. “[T]he motivation-to-combine analysis is a flexible one. Any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1379 (Fed. Cir. 2023) (citing KSR Int’l, 550 U.S. at 420 (alterations, emphasis, and internal quotation marks omitted).” slip op. at 21

  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,675,481
• 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
• Bausch & Lomb Incorporated v. Zeavision, LLCAll claims unpatentable
  PTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision

  Claims 12–14, 16–21, 23, and 24 are unpatentable: Lang anticipates some claims, and the asserted Lang-based combinations render all challenged claims obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’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 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))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7

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

    “Similarly, here, the Specification consistently states that the invention relates to oral formulations for protecting eye health and that the benefits of carotenoids, such as zeaxanthin and lutein, include the ability to absorb UV and blue light. See, e.g., Ex. 1001, Abstract (“Oral formulations for promoting eye health”), 4:25–31 (stating carotenoids such as zeaxanthin are “very good at absorbing ultraviolet (UV) and blue light”), 15:45–47 (“one object of this invention is to disclose multi-component orally-ingestible formulations for protecting eye health in mammals”). Like the preamble in Proveris, the preamble in claim 12 is the only reference in any of the independent claims to the allegedly inventive concept of protecting eye health from the harmful effects of blue light. Proveris, 739 F.3d at 1373. Moreover, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of claim 12 for antecedent basis for the limitation “wherein the user has macular degeneration and a lens-related disorder.” Id. at 38:21 (emphasis added). Thus, “the nutrient formulation” and “the user” in the claim body derives antecedent basis from the “nutrient formulation” and “user” that is “defined in greater detail in the preamble.” See Proveris, 739 F.3d at 1373. Accordingly, reading the patent as a whole, because the inventor clearly relied on both the preamble and the body of claim 12 to define the claimed invention, the preamble of claim 12 should be construed as limiting. See id.” slip op. at 10

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

    “stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would understand this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not address either of these claim terms in its Response. See generally PO Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as they are consistent with the plain and ordinary meaning of the terms. See Wellman, terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 13

  Patent outcomesUS 10,307,384 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,307,384
• Twi Pharmaceuticals, Inc. v. Merck Serono SAInstitution denied
  PTAB · Mar 28, 2023 · IPR2023-00050 · APJ Erica A Franklin · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 17, 19, 20, and 22–29 were unpatentable over Bodor alone or with asserted knowledge in the art or Rice.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314 (2018). Upon considering the parties’ arguments and evidence, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we do not institute an inter partes review of the challenged claims.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that “[a] person having ordinary skill in the art at the time of the alleged invention would have a Doctor of Medicine and at least two-years’ experience treating neurological conditions and prescribing immunotherapies to treat neurological conditions.” Pet. 8 (citing Ex. 1005 ¶¶ 1–14, 17–19). Patent Owner does not dispute Petitioner’s definition for one of ordinary skill in the art but “reserves the right to challenge Petitioner’s definition of a POSA at a later stage in this proceeding, should the Board institute trial.” Prelim. Resp. 7. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’903 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 6

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

    “Petitioner “asserts that all claim terms should be given their plain and ordinary meaning.” Pet. 25 (citing Ex. 1005 ¶¶ 34–35). Patent Owner notes Petitioner’s assertion in its challenge of the claims that “limitations regarding treatment of or administering to patients having ‘RRMS or early SPMS’ have no patentable weight.” Prelim. Resp. 7 (quoting Pet. 27–28). Patent Owner disagrees because the portion of the preamble regarding the oral administration of cladribine to an individual having RRMS or early SPMS is limiting. Id. at 7–8. Based upon our review of the current record and our analysis of the issues, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating only those terms” slip op. at 7

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

    “based dosages relied upon by Petitioner expressly refers to “[t]herapeutically effective dosages described in the literature,” i.e., in the prior art. See Ex. 1029, 12:55–59; Pet. 28; Prelim. Resp. 27. In that passage, Bodor describes the prior art dosage approach for MS was “from about 0.04 to about 1.0 mg/kg/day.” Ex. 1029, 12:57–59 (citing U.S. Patent No. 5,506,214). Petitioner has not shown, nor do we see, any description in Bodor implementing that weight-based dosage approach for Bodor’s treatment method. Instead, after recognizing the prior art approach, Bodor expressly discloses that it envisions treating MS by orally administering 10 mg of the cladribine-cyclodextrin complex for a period of five to seven days in the first month, and five to seven days in the second month. Id. at 13:19–25. Whether administered for 10 days or up to 14 days during the treatment period, the daily dosage remains a fixed amount. Even when explaining that the invention “provides a method to tailor the administration/treatment,” Bodor does not refer to any consideration of the weight of a patient. Ex. 1029, 13:31–40. Rather, Bodor describes tailoring the administration/treatment “to the particular exigencies specific to a given mammal,” as Bodor’s treatment method is intended for use with human and non-human subjects, e.g., domesticated animals. Id. at 13:35– 37; 14:54–57. Bodor explains that “[t]herapeutically effective amounts may be easily determined, for example, empirically by starting at relatively low amounts and by step-wise increments with concurrent evaluation of beneficial effect.” Id. at 14:54–57. Bodor further explains that the methods “are to be used in concomitance with continuous clinical evaluations by a therapy. Such evaluation will aid and inform in evaluating whether to increase, reduce or continue a particular treatment dose, and/or to alter the mode of administration.” Id. at 14:43–50. There again, Bodor’s disclosure regarding a treatment dose does not include any consideration of a patient’s weight. Thus, Bodor does not support Petitioner’s assertion that a patient’s weight is considered in Bodor’s method of treating MS with a cladribine complex, or that a skilled artisan would have inferred such a teaching from Bodor. To the extent that Petitioner provides examples to show that under certain very specific circumstances, Bodor’s total dose of cladribine could reach an amount that equals about 1.7 mg/kg at the end of a treatment period for a particular patient, we do not find that showing persuasive in terms of establishing a reasonable likelihood of prevailing on an anticipation challenge. It is apparent to us that Petitioner’s examples involve a strategic selection of patient weight and treatment duration that support a calculation that yields a 1.7 mg/kg total dosage for the treatment period. We agree with Patent Owner that such a strategy is insufficient to establish inherency as it demonstrates only the total dose that is possible for some patients. It is a long-standing principle that inherent anticipation requires the missing descriptive element to be “necessarily present,” and not merely possibly present. In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999).” slip op. at 13

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,377,903

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.