- PTAB · Nov 21, 2023 · PGR2023-00026 · APJ Susan L C Mitchell · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that claims 1–19 were unpatentable, including because the proposed prior-art combination lacked a sufficient reason to select Ruminococcus for skin …
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”1 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“7 Patent Owner requested that we exercise our discretion to deny institution under 35 U.S.C. § 325(d). See Prelim. Resp. 11–49. Because we determine on the merits that no post-grant review should be instituted, we will not address Patent Owner’s arguments concerning Section 325(d).” slip op. at 44
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner counters that Petitioner has set the level of skill of a person of ordinary skill in the art too low. Prelim. Resp. 9–11; Ex. 2001 ¶ 25. Patent Owner asserts that a POSA would have a more advanced degree than a bachelor of science and would have more specific work experience. Id. For instance, Patent Owner asserts: A POSA for the ’838 Patent typically would have an advanced degree, such as an M.D. or a Ph.D., with experience and training in oncology, have several years of experience with administering oncology treatments to subjects and evaluating results of such treatments, and have experience or knowledge in microbiome science and its modulation, inclusive of studies that involve stool microbiome profiling, as well as experience in, or knowledge of, related research and development of bacterial-based cancer treatments. A POSA may also have worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. For example, such a team may include a clinician, an immunologist, microbiologist, bioinformatician, molecular biologist, manufacturing specialist, and/or pharmaceutical formulator. Prelim. Resp. 9–10 (citing Ex. 2001 ¶¶ 26–27). Patent Owner concludes that by applying the inappropriately low level of skill of a POSA, “Petitioner overstates the amount of guidance needed in the specification to describe and enable the claimed methods.” Prelim. Resp. 11. Patent Owner confirms, however, that all arguments on all grounds presented in the Preliminary Response “apply regardless of which party’s POSA definition is used.” Prelim. Resp. 11 n.2. We disagree with Patent Owner that a POSA is required to have a” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“Patent Owner acted as its own lexicographer and expressly defined “isolated” and “purified” as follows. The term “isolated” encompasses a bacterium or other entity or substance that has been (1) separated from at least some of the components with which it was associated when initially produced (whether in nature or in an experimental 6 Available at https://www.uspto.gov/sites/default/files/documents/IndefinitenessMemo.pd f?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email& utm_name=&utm_source=govdelivery&utm_term=. setting), and/or (2) produced, prepared, purified, and/or manufactured by the hand of man. Isolated bacteria may be separated from at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or more of the other components with which they were initially associated. In some embodiments, isolated bacteria are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. As used herein, a substance is “pure” if it is substantially free of other components. The term “purify,” “purifying” and “purified” refer to a bacterium or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A bacterium or a bacterial population may be considered purified if it is isolated at or after production, such as from a material or environment containing the bacterium or bacteria population, and a purified bacterium or bacterial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60% about, 70%, about 80%, about 90% or above about 90% and still be considered “isolated.” In some embodiments, purified bacteria and bacterial populations are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. In the instance of bacterial compositions provided herein, the one or more bacterial types present in the composition can be independently purified from one or more other bacteria produced and/or present in the material or environment containing the bacterial type. Bacterial compositions and the bacterial components thereof are generally purified from residual habitat products. Ex. 1001, 28:40–29:11. In reviewing the express definitions of “isolated” and “purified,” it is not surprising that the two similar terms, “isolated” and “purified,” may have overlapping definitions. We agree with Patent Owner that such overlap does not mean the definitions lack “reasonable clarity, deliberateness, and precision” that would inform a POSA with reasonable certainty about the scope of claim 1. We also agree with Patent Owner that a POSA would understand the two parts of the definition of “isolated” set forth above.” slip op. at 30
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · NautilusPatents in suitUS 11,395,838 - PTAB · Oct 4, 2023 · IPR2023-00724 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–10, finding a reasonable likelihood that claim 1 is anticipated by WO421 and Lovshin and obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“The Examiner’s statement that NCT657 “does not teach or disclose a higher amount of 1 mg semaglutide” is incorrect and also fails to consider the teachings of the dosing ranges of WO421 and Lovshin, and the maximum dose of 1.2 mg of semaglutide taught in NCT773. For these reasons, we determine that Petitioner has sufficiently demonstrated a material error on the part of the Examiner, and we therefore decline to exercise our discretion to deny institution of inter partes review under 35 U.S.C. § 325(d).” slip op. at 15
- Other 314aInstitution denied discretionary otherDecided for petitioner
“Petition under Section 314(a), “particularly in light of the significant §325(d) concerns regarding Grounds 1 and 2—which address only claims 1–3—and in view of the substantive infirmities of Ground 3–5.” Prelim. Resp. 66–67. Patent Owner does not address Petitioner’s assertions that a trial here would most likely conclude before the parallel Delaware litigation, and Petitioner’s stipulation “that if the Board institutes, Petitioner will not pursue in the district court any instituted grounds against the originally-issued claims unless a change in law otherwise permits.” Pet. 65–66 (citing Sand Revolution II, LLC v. Cont’l Intermodal Grp., IPR2019-01393, Paper 24, 12 (PTAB June 16, 2020)). We do not agree with Patent Owner’s assertions concerning Section 325(d) as set forth above, and find nothing here that would warrant the exercise of our discretion to deny institution based on 35 U.S.C. § 314(a) to deny institution of an otherwise meritorious petition.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“VI. CONCLUSION Based on the current record, we determine Petitioner has shown a reasonable likelihood that it will prevail in establishing that at least one claim of the ’462 patent is unpatentable. Accordingly, we institute review of all claims challenged on all of the grounds in the Petition. See Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 64, available at https://www.uspto.gov/ sites/default/files/documents/tpgnov.pdf. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our view with regard to any conclusion reached in the foregoing analysis could change upon completion of the record. VII. ORDER Accordingly, it is: ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is hereby instituted as to claims 1–10 of the ’462 patent based on the unpatentability challenges presented in the Petition; and” slip op. at 39
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Here, we agree with the parties that the preamble of claim 1 is limiting. The preamble provides context for the requirement of claim 1 that administration of the semaglutide is “to a subject in need thereof.” See Ex. 1001, 35:42–44. The preamble, when read in the context of the entirety of claim 1, recites a limitation of administering semaglutide to a subject with type 2 diabetes. Based on the constructions of the preamble provided by the parties, it appears they agree that the preamble does not require any particular level of efficacy. We agree. The Specification of the ’462 patent makes clear that “treatment” or “treating” as used in the ’462 patent does not require any particular degree of efficacy as these terms include the “full spectrum” of treatments for a condition. See Ex. 1001, 5. For instance, the Specification of the ’462 patent provides: In one embodiment the term “treatment” or “treating” as used herein means the management and care of a patient for the purpose of combating a condition, such as a disease or a disorder. In one embodiment the term “treatment” or “treating” is intended to include the full spectrum of treatments for a given condition from which the patient is suffering, such as administration of the active compound to alleviate the symptoms or complications; to delay the progression of the disease, disorder or condition; to alleviate or relieve the symptoms and complications; and/or, to cure or eliminate the disease, disorder, or condition as well as to prevent the condition. Ex. 1001, 5:16–27.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,335,462 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], 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) (2012) (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). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). 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, a party that petitions the Board for a determination of unpatentability based on obviousness 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) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122 - Osteomed LLC v. Stryker European Operations Holdings LLCAll claims unpatentablePTAB · Aug 8, 2023 · IPR2022-00488 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–3 and 6–18 are unpatentable as obvious over Arnould and Zahiri, with claim 6 also relying on Myerson; the Board did not reach Grounds 1–3.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“While both parties’ descriptions are similar, we find that Patent Owner’s description is better supported by the record. As Patent Owner points out, the main distinction between the parties’ proposals is that Patent Owner’s description is broader because it includes orthopedic surgeons. The record supports the inclusion of such individuals in the description of a POSITA. See Ex. 2005 ¶¶ 37, 41; Ex. 2009, 38:21–39:7 (Petitioner’s declarant testifying that he would “include an orthopedic surgeon that has some experience developing implants as a person of ordinary skill in the art”). Thus, we apply Patent Owner’s description of a POSITA for our analysis.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“That said, we do not agree with Patent Owner that the Specification defines “bone plate” as it contends. In the background of the invention, the Specification states that “[t]he invention relates to the technical field of orthopedic implants. More particularly, the invention relates to a plate for arthrodesis or osteosynthesis adapted to be fixed between two bone parts.” Ex. 1001, 1:27–31. Contrary to Patent Owner’s argument, this passage does not “define” the term “bone plate” nor otherwise suggest that the patentee acted as its own lexicographer. See Resp. 9. Moreover, nothing in the record suggests that the ordinary meaning of “bone plate” requires the plate to be fixed between two bone parts. The medical dictionaries Patent Owner cites do not include such a requirement in their definitions. See Ex. 2012, 1478 (defining “bone plate” as “a metal bar with perforations for the insertion of screws, used to immobilize fractured segments”); Ex. 2013, 241 (defining “bone plate” as “a metal plate used to reconstruct a bone that has been fractured” and “designed to hold the bone fragments in apposition”). Both of these definitions are consistent with Mr. Sherman’s testimony that a bone plate is “not always” placed across the fracture. See Ex. 2009, 52:9–53:1 (identifying particular instances in which a plate is not placed across the fracture). We credit that testimony over the competing testimony of Patent Owner’s declarant, Mr. Leinsing. Ex. 2005 ¶ 34 (referring to the statements from the Specification and dictionary definitions discussed above). For these reasons, we agree with Petitioner that the term “bone plate” as recited in the challenged claims has its ordinary meaning and that meaning does not exclude plates located on only one side of a joint or fracture.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We do not agree that the ordinary meaning of “between” is as restrictive as Patent Owner contends. First, Patent Owner’s definition of “between” does not require an object that is “between” two others to lie along the same axis defined by the two other objects. A “space separating two objects” is not so restrictive. Instead, a more expansive ordinary meaning of “between” is evidenced by the intrinsic evidence of the ’751 patent as Petitioner explained with reference to Figure 2 of the ’751 patent, which shows a third hole 1a1 between the other holes even though it is “offset” and in a different plane from the longitudinal axis of the bone plate. Patent Owner attempts to draw a distinction between Arnould’s Figure 2 and Figure 2 of the ’751 patent, by asserting “like Arnould, a hand is in a different plane and offset and its axis is not in relation to the body. In contrast, the angled tab shown in Figure 2 of the ’751 patent is not in a different plane and offset from the plate, and the hole axis forms an angle with the plate.” Sur-reply 8. Patent Owner’s distinction here appears to be whether the third hole lies at an angle below or above the bone plate as shown in Figure 2 of the ’751 patent (which would be “between” according to Patent Owner) versus also being positioned to either side of the bone plate as shown in Figure 2 of Arnould (which in Patent Owner’s view would mean that hole is no longer “between” the others). We see no basis for drawing such a fine distinction regarding the meaning of “between,” especially when the narrower definition Patent Owner seeks is not made explicit in the Specification of the ’751 patent. To the extent any further claim construction is necessary to resolve” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“contends. A reference is considered to be analogous art if it is in the “same field of endeavor” as the patent at issue. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Here, the Specification states that “[t]he invention relates to the technical field of orthopedic implants.” Ex. 1001, 1:27–28. Zahiri falls squarely within this field, describing “fixation devices for compressing bone fractures of a human being.” Ex. 1007, 1:9–11; see also, e.g., id. at Fig. 1 (depicting the use of Zahiri’s plate as an orthopedic implant to fix two bone parts). The differences Patent Owner identifies in Zahiri’s device do not show otherwise. In this regard, we find the testimony of Mr. Sherman (Ex. 1002 ¶ 245) on this point to be more credible than the competing testimony offered by Mr. Leinsing (see Ex. 2005 ¶¶ 121–29, 238). Mr. Sherman persuasively testifies that “Arnould and Zahiri disclose bone plates with diagonal fixation members configured to compress the intersection of a first and second bone,” demonstrating Arnould and Zahiri “are therefore in analogous fields of invention” to the ’751 patent. Ex. 1002 ¶ 245. Mr. Leinsing, on the other hand, continues to assert that Zahiri discloses only “a guide that directs a lag screw at a precise angle into a humeral head, not a bone plate” because it is located on only one side of the joint or fracture. Ex. 2005 ¶ 238. Therefore, Mr. Leinsing concludes that the “Zahiri device is directed to a completely different function than Arnould,” and is non-analogous art. Id. Because we find Zahiri discloses a “bone plate” according to the ordinary meaning of that term, Mr. Leinsing’s testimony is unconvincing. See supra § III.C.i (explaining that the ordinary meaning of “bone plate” does not exclude plates located on only one side of a joint or fracture). But even if we agreed with Patent Owner’s and Mr. Leinsing’s interpretation of bone plate, Zahiri’s plate is still an orthopedic implant and therefore analogous art because it is within the same field of endeavor as the ’751 patent.” slip op. at 34
Patent outcomesUS 10,993,751 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,993,751 - Osteomed LLC v. Stryker European Operations Holdings LLCAll claims unpatentablePTAB · Aug 4, 2023 · IPR2022-00487 · APJ Michael A Valek · IPR · Final written decision
Claims 32–39 are unpatentable: claims 32–39 over Arnould and Zahiri, and claims 34–35 also over Arnould and Myerson, with or without Zahiri.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“While both parties’ descriptions are similar, we find that Patent Owner’s description is better supported by the record. As Patent Owner points out, the main distinction between the parties’ proposals is that Patent Owner’s description is broader because it includes orthopedic surgeons. The record supports the inclusion of such individuals in the description of a POSITA. See Ex. 2005 ¶¶ 37, 41; Ex. 2009, 38:21–39:7 (Petitioner’s declarant testifying that he would “include an orthopedic surgeon that has some experience developing implants as a person of ordinary skill in the art”). Thus, we apply Patent Owner’s description of a POSITA for our analysis.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“That said, we do not agree with Patent Owner that the Specification defines “bone plate” as it contends. In the background of the invention, the Specification states that “[t]he invention relates to the technical field of orthopedic implants. More particularly, the invention relates to a plate for arthrodesis or osteosynthesis adapted to be fixed between two bone parts.” Ex. 1001, 1:18–22. Contrary to Patent Owner’s argument, this passage does not “define” the term “bone plate” nor otherwise suggest that the patentee acted as its own lexicographer. See Resp. 12–13. Moreover, nothing in the record suggests that the ordinary meaning of “bone plate” requires the plate to be fixed between two bone parts. The medical dictionaries Patent Owner cites do not include such a requirement in their definitions. See Ex. 2012, 1478 (defining “bone plate” as “a metal bar with perforations for the insertion of screws, used to immobilize fractured segments”); Ex. 2013, 241 (defining “bone plate” as “a metal plate used to reconstruct a bone that has been fractured” and “designed to hold the bone fragments in apposition”). Both of these definitions are consistent with Mr. Sherman’s testimony that a bone plate is “not always” placed across the fracture. See Ex. 2009, 52:9–53:1 (identifying particular instances in which a plate is not placed across the fracture). We credit that testimony over the competing testimony of Patent Owner’s declarant, Mr. Leinsing. Ex. 2005 ¶ 33 (referring to the statement from the Specification and dictionary definitions discussed above). For these reasons, we agree with Petitioner that the term “bone plate” as recited in the challenged claims has its ordinary meaning and that meaning does not exclude plates located on only one side of a joint or fracture. To the extent any further claim construction is necessary to resolve the issues presented in this proceeding, we consider such in our analysis below.” slip op. at 10
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“We disagree with Patent Owner for several reasons. First, the narrow construction of “bone plate” that Patent Owner proposes to distinguish Zahiri is not supported by the record. See supra § III.C. We agree with Petitioner that the ordinary meaning of “bone plate” includes plates like those described in Zahiri. Id. Second, even if Patent Owner’s construction were correct, the scope of analogous art is broader than Patent Owner contends. A reference is considered to be analogous art if it is in the “same field of endeavor” as the patent at issue. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Here, the Specification states that “[t]he invention relates to the technical field of orthopedic implants.” Ex. 1001, 1:18–19. Zahiri falls squarely within this field of endeavor, describing “fixation devices for compressing bone fractures of a human being.” Ex. 1007, 1:9–11; see also, e.g., id. at Fig. 1 (depicting the use of Zahiri’s plate as an orthopedic implant to fix two bone parts). The differences Patent Owner identifies in Zahiri’s device do not show otherwise. In this regard, the testimony of Mr. Sherman (Ex. 1002 ¶ 191) on this point to be more credible than the competing testimony offered by Mr. Leinsing (see Ex. 2005 ¶¶ 124–31, 166). Mr. Sherman persuasively testifies that “Arnould and Zahiri disclose bone plates with diagonal fixation members configured to compress the intersection of a first and second bone or across a fracture,” demonstrating Arnould and Zahiri “are therefore in analogous fields of invention” to the ’713 patent. Ex. 1002 ¶ 191. Mr. Leinsing, on the other hand, asserts that Zahiri’s plate is not a bone plate because it is located on only one side of a fracture and therefore does not “span[] both sides of a bone discontinuity.” See Ex. 2005 ¶¶ 124–26, 131. For this reason, Mr. Leinsing concludes Zahiri is non-analogous art. Id. ¶ 131. Because we find Zahiri discloses a “bone plate” according to the ordinary meaning of that term, Mr. Leinsing’s testimony is unconvincing. See supra § III.C. (explaining that the ordinary meaning of “bone plate” does not exclude plates located on only one side of a joint or fracture). But even if we agreed with Patent Owner’s and Mr. Leinsing’s interpretation of bone plate, Zahiri’s plate is still an orthopedic implant and therefore analogous art because it is within the same field of endeavor as the ’713 patent.” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundMotivation foundDecided for petitioner
“Patent Owner’s argument that Zahiri teaches away from a combination with Arnould is also unavailing. See Resp. 54–57. Patent Owner asserts that unlike Arnould’s plate, Zahiri’s “rigid guide plate . . . does not allow a surgeon to conform the plate to the anatomy” and “[d]ue to the fixed angle design of Zahiri’s device, the surgeon cannot select the angle of insertion of the lag screw to adapt to the individualized needs of a particular patient.” Id. at 56. But those distinctions do not rise to the level of a teaching away. See Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)) (“A reference does not teach away . . . if it . . . does not criticize, discredit, or otherwise discourage investigation into the invention claimed.”). Moreover, Petitioner’s combination is premised on modifying hole 25 in Arnould’s plate to have Zahiri’s angled holed configuration. That combination would retain Arnould’s flexible plate, while fixing or at least limiting the angle of screw 30 through the hole. However, Petitioner explains that “Zahiri discloses providing plates with a variety of angles in a kit so the surgeon can choose the plate that will maximize fixation based on the particular needs of the patient.” Reply 21; see also Ex. 1007, 3:59–64, 9:1–4 (teaching that the hole may configured in a range of angles to accommodate the device’s use “for a variety of fractures, fusion procedures and osteotomies”). Thus, a POSITA could compensate for the fixed angle and, in any event, the fact that one embodiment may be preferable in some instances does not teach away from the proposed combination. See UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 692 (Fed. Cir. 2023) (explaining that a teaching that one composition is “optimal or standard” or that expresses a “preference” for something does not teach away from other options) (internal quotations omitted).” slip op. at 24
Patent outcomesUS 9,078,713 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,078,713 - Syngenta Crop Protection AG v. Upl Ltd.InstitutedPTAB · Jul 31, 2023 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Institution
Instituted PGR on claims 1–10 and all asserted grounds because the Board found it more likely than not that Tobler anticipates and renders obvious at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We review the Petition under 35 U.S.C. § 324, which provides that a post-grant review may not be instituted unless “it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 324(a). Accordingly, we institute a post-grant review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PTAB Consolidated Trial Practice Guide (“Practice Guide”),1 5–6 (Nov. 2019).” slip op. at 2
- Other 314aInstitution denied discretionary otherDenied
“We disagree. It is unclear which aspect of the Petition that Patent Owner takes issue with. If it is the “multitudinous grounds” presented in the Petition, Patent Owner points to no authority that permits us to deny institution merely because a petition presents numerous grounds. In any event, on the facts of this case, we do not view eight grounds asserted in the Petition to be excessive.6 To the extent Patent Owner urges that we should deny institution because Petitioner’s grounds are “futil[e],” we understand that to be an argument on the merits, and not related to our discretion. See Prelim. 6 The Petition presents five grounds. See generally Pet. We agree with Patent Owner, however, the ground based on Tobler, in fact, encompasses three grounds, and the ground based on De Oliveira, in fact, encompasses two grounds. See Prelim. Resp. 2. Resp. 45. As explained below, we find Petitioner has established that it is more likely than not that claims 1–10 of the ’727 patent are unpatentable over Tobler. See infra Section II.D.2. Because the grounds based on Tobler apply to all challenged claims,7 at least these grounds are not, as Patent Owner asserts, futile. Thus, we decline to exercise discretion to deny the Petition under § 324(a).” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review, we “may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. 7 The cases Patent Owner cites do not support its argument on discretionary denial under § 324(a). See Prelim. Resp. 45–46. In those cases, the Board exercised discretion to deny institution because the petitions only met the threshold requirement for institution with regard to a small percentage of the challenged claims. See Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 11 (PTAB Nov. 7, 2018) (stating “instituting a trial with respect to all twenty claims based on evidence and arguments directed to dependent claims 3 and 4 is not an efficient use of the Board’s time and resources”); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 2 (PTAB Jan. 24, 2019) (denying institution because the petitioner only “demonstrated a reasonable likelihood of prevailing with respect to only two of twenty-three challenged claims as to only one of four asserted grounds of unpatentability”). MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). The parties agree that, during prosecution, the relevant disclosure in Tobler was before the Examiner in U.S. Patent Application Publication 2010/0216640, which was cited in an Information Disclosure Statement (“IDS”). Pet. 12; Prelim. Resp. 46. In other words, the first prong of the Advanced Bionics analysis is satisfied. Thus, we must determine whether Petitioner has shown a material error by the Office. We find Petitioner has met its burden on this issue.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, all claim terms should be given their plain and ordinary meaning. Pet. 18; Prelim. Resp. 13. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,445,727 - PTAB · Jul 20, 2023 · IPR2023-00462 · APJ Jamie T Wisz · IPR · Institution
The Board instituted IPR on claims 1–18 because Petitioner showed a reasonable likelihood of prevailing on anticipation by Fraser and obviousness over the asserted combination.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In evaluating the exercise of discretion to deny institution under Section 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), the Board “may not authorize an inter partes review to be instituted unless . . . the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the Petition, the Preliminary Response, the Reply, the Sur-reply, and the evidence of record, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–18 of the ’992 patent, based on all of the grounds identified in the Petition. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) at the time of the invention “would have had a Ph.D. in pharmaceutical sciences or a similar field, with at least several years of experience in the development, manufacture and characterization of formulations of therapeutic proteins, including, for example, fusion proteins or antibodies.” Pet. 30 (citing Ex. 1002 ¶¶ 39–43). Petitioner further asserts that the POSA “would have understood how to combine proteins with compatible excipients such as surfactants, stabilizers, salts and buffers of various pH values, and how to adjust these combinations in order to optimize their stability in liquid or solid form.” Id. at 30–31. Petitioner asserts that the Because Fraser uses the term “VEGF TrapR1R2” (Ex. 1009, 1115), we use the same nomenclature in this Decision. POSA would have been able to assess stability and compatibility by using “state-of-the-art analytical methods, such as SEC.” Id. at 31. Patent Owner does not contest the characterization offered by Petitioner. See Prelim. Resp. 16. For purposes of this Decision, we adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’992 patent and the cited 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 shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner proposes claim construction for three terms under their plain and ordinary meaning. See Pet. 41–42. First, Petitioner asserts that the “POSA would have understood that the term ‘native’ in the phrase ‘native conformation’ in claims 1, 2, 10 and 11 refers to the fully intact and functional conformation of the protein.” Id. at 42 (citing Ex. 1002 ¶ 22). Second, Petitioner asserts that the “POSA would have understood the term ‘vial’ in claims 1–9 to refer to a small closed or closable vessel, especially for liquids.” Id. (citing Ex. 1031; Ex. 1002 ¶¶ 23, 190). Third, Petitioner asserts that the “[t]he POSA would have understood the term ‘multimerizing component’ in claims 1 and 10 to refer to a protein moiety that joins two or more protein domains together to form a multimer, such as a dimer or trimer.” Id. (citing Ex. 1002 ¶ 24). Patent Owner does not challenge Petitioner’s proposed claim constructions. Prelim. Resp. 16. For purposes of this Decision, however, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,464,992 - Eyenovia, Inc. v. Sydnexis, Inc.All claims unpatentablePTAB · Jul 13, 2023 · IPR2022-00384 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1, 2, 4–9, and 12–19 are unpatentable under § 103 over Chia, Akorn, and Kondritzer; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not agree with Patent Owner that the level of ordinary skill in the art should be limited to experience with ophthalmic formulation. The claims at issue generally require a liquid ophthalmic formulation of a small amount of atropine that is stabilized using buffers that can be stored for at least two weeks under certain temperature and humidity conditions. See Ex. 1001, 97:32–44 (claim 1). As Dr. Byrn points out, the technology surrounding use of atropine, a nonselective muscarinic antagonist, to treat myopia, has been extensively studied for over a hundred years and is known as “the oldest and most effective pharmacological treatment to inhibit the development of myopia.” See Ex. 1002 ¶ 26 (quoting Ex. 1008, 1) (citing Ex. 1003, 1; Ex. 1012, 2). The degradation of atropine is also well known to primarily result from cleavage of the acyl-oxygen bond during ester hydrolysis, see id. ¶ 43 (citing Ex. 1017, 1; Ex. 1024, 5), with the rate of acid-catalyzed reaction being much slower than that of the base-catalyzed reaction, leading to stability of atropine at a lower pH range (pH < ~3), see id. ¶ 45 (citing Ex. 1005, 1,4–5). Concerning specifically the use of atropine in the eye, Dr. Byrn points out that it is well known that ophthalmic solutions should be “formulated to be sterile, isotonic and buffered for stability and comfort.” See id. ¶ 47 (quoting Ex. 1019, 52) (noting Ex. 1019, 54 (pH of tear fluid is 7.4).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner states that “[f]or the purposes of this proceeding only, Petitioner does not believe that any claim terms need to be construed.” Pet. 22. Patent Owner “agrees that the claims should be understood according to their ordinary and customary meaning.” PO Resp. 25–26. In reply, Petitioner asserts that the ordinary meaning of “about” is” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find that Patent Owner’s criticism misses the mark. Petitioner is using the DailyMed exhibit as further evidence that Akorn was publicly available as of the revision date of 7/2014 as shown on Akorn, Ex. 1004. See Reply 1 (“As set forth in the Petition, EX1004, a drug label to Akorn, bears July 2014 revision dates that comport with its FDA approval and publication well before the critical date. See Pet., 9; Hulu, 13. It also bears Akorn’s corporate insignia. EX1004, 5. Additional evidence confirms these dates are reliable. EX1056-58.”); 3 (“Public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on July 24, 2014.”). Whether a POSA could have searched this way for labels published before the critical date is irrelevant; Petitioner is only using the evidence to show that Akorn was, in fact, published in July 2014, before the critical date on a searchable website. See id. Patent Owner does not dispute that DailyMed was searchable by drug name, which would be the logical way a POSA would search such a database for information for a drug of interest.” slip op. at 24
- ExcludeMotion to exclude, deniedDenied
“sufficiency of the support for Dr. Byrn’s opinions goes more to the weight to be accorded such opinions rather than a need to exclude such opinions. See TPG 40–41, 79 (“A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.”). We also note that the findings in the district court litigation are based on a different record that is not before us here. For instance, the district court relies on a Lewis reference and a Harris reference that is not before us and testimony from Dr. Richard Moreton that is also not before us here. See Ex. 2010 ¶¶ 63–69. Therefore, we determine that the district court’s findings are not sufficiently probative of the questions before us here.” slip op. at 31
Patent outcomesUS 10,842,787 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,842,787 - Eyenovia, Inc. v. Sydnexis, Inc.All claims unpatentablePTAB · Jul 13, 2023 · IPR2022-00414 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–7 and 11–20 are unpatentable as obvious over Chia and Akorn; the Board did not reach the Wu and Akorn ground.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not agree with Patent Owner that the level of ordinary skill in the art should be limited to experience with ophthalmic formulation. The claims at issue generally require a kit with a vial of a pharmaceutical composition of atropine, water, and buffer, and instructions for use. See Ex. 1001, 99:12–19 (claim 1). As Dr. Byrn points out, the technology surrounding use of atropine, a nonselective muscarinic antagonist, to treat myopia, has been extensively studied for over a hundred years and is known 7 Although Patent Owner disagrees with Petitioner’s definition of a POSA, Patent Owner does not provide its own definition apart from including expertise in ophthalmic formulation. See PO Resp. 4–7. development of myopia.” See Ex. 1002 ¶ 26 (quoting Ex. 1008, 1) (citing Ex. 1003, 1; Ex. 1012, 2). The degradation of atropine is also well known to primarily result from cleavage of the acyl-oxygen bond during ester hydrolysis, see id. ¶ 43 (citing Ex. 1017, 1; Ex. 1024, 5), with the rate of acid-catalyzed reaction being much slower than that of the base-catalyzed reaction, leading to stability of atropine at a lower pH range (pH < ~3), see id. ¶ 45 (citing Ex. 1005, 1,4–5). Concerning specifically the use of atropine in the eye, Dr. Byrn points out that it is well known that ophthalmic solutions should be “formulated to be sterile, isotonic and buffered for stability and comfort.” See Ex. 1002 ¶ 47 (quoting Ex. 1019, 52) (noting Ex. 1019, 54 (pH of tear fluid is 7.4). None of this chemistry concerning the stability of atropine or its administration in the eye is remarkable or not well understood by a POSA as defined by Petitioner. See PO Resp. 10 (stating “the stability of atropine was understood to be a ‘predictable function,’ and a ‘routine matter,’ of temperature and solution pH”), 40–41 (same). We see no reason why someone with drug formulation experience, but not specific experience with ophthalmic solutions, would not qualify as a POSA. Therefore, we continue to apply Petitioner’s definition of a POSA in this final written decision.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “[f]or the purposes of this proceeding only, Petitioner does not believe that any claim terms need to be construed.” Pet. 21. Patent Owner “agrees that the claims should be understood according to their ordinary and customary meaning.” PO Resp. 25. In reply, Petitioner asserts that the ordinary meaning of “about” is “approximately,” and the ordinary meaning of “buffering agent” or “buffer” “is nothing more than an excipient that helps control pH.” Reply 2. Petitioner asserts that Patent Owner agrees with the definition of “buffering agent” and “buffer” by stating that “[t]he patent uses terms buffer and buffering in their normal sense, which entails providing pH control or maintenance.” Id. (quoting PO Resp. 28). Based upon our review of the evidence of record, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”). Insofar as the parties dispute whether Akorn discloses a buffer, we address those contentions in our discussion below of the challenged claims.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find that Patent Owner’s criticism misses the mark. Petitioner is using the DailyMed exhibit as further evidence that Akorn was publicly available as of the revision date of 7/2014 as shown on Akorn, Ex. 1004. See Opp. to Mot. to Exclude 8 (“Moreover, public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on that site at least by July 24, 2014. See EX1057, 3.”) As set forth in the Petition, EX1004, a drug label to Akorn, bears July 2014 revision dates that comport with its FDA approval and publication well before the critical date. See Pet., 10–22; Hulu, 13. It also bears Akorn’s corporate insignia. EX1004, 5. Additional evidence confirms these dates are reliable. EX1056-58.”); 3 (“Public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on July 24, 2014.”). Whether a POSA could have searched this way for labels published before the critical date is irrelevant; Petitioner is only using the evidence to show that Akorn was, in fact, published in July 2014, before the critical date on a searchable website. See id. Patent Owner does not dispute that DailyMed was searchable by drug name, which would be the logical way a POSA would search such a database for information for a drug of interest. Petitioner also provides further evidence that the Akorn label was published on July 24, 2014, through a response by the National Library of Medicine (“NLM”) to a Freedom of Information Act request. See Ex. 1071. confirmation that the substance of the Akorn label was posted on July 24, 2014, on the DailyMed website. Id. The National Institutes of Health (“NIH”) responded that version 7 of the Akorn label was published on DailyMed on July 24, 2014, and provided the URL that is reflected in the Akorn label in Exhibit 1057 from the DailyMed website. See Ex. 1072, 6; Ex. 1057, 4–7. NIH also confirmed that NLM “received version 7 of this label from the FDA on 07/24/2014 @ 2:15:04 PM,” “published version 7 on DailyMed on the same day, 07/24/2014 @ 14:59:48 PM,” and confirmed that “NLM does not make changes to the content contained within any SPL [or structured product labeling] records that it receives from the FDA.” Ex. 1072, 6. We find that Petitioner has provided more than sufficient evidence that the Akorn label reflected in Ex. 1004 was publicly available before the critical date. For the reasons set forth above, we determine that Petitioner has shown by a preponderance of the evidence that Akorn, Ex. 1004, is a printed publication that was publicly available before the critical date.” slip op. at 21
- ExcludeMotion to exclude, deniedDenied
“We agree with Petitioner here that Patent Owner’s concerns about the sufficiency of the support for Dr. Byrn’s opinions goes more to the weight to be accorded such opinions rather than a need to exclude such opinions. See TPG 40–41, 79 (“A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.”). We also note that the findings in the district court litigation are based on a different record that is not before us here. For instance, the district court relies on a Lewis reference and a Harris reference that is not before us and testimony from Dr. Richard Moreton that is also not before us here. See Ex. 2010 ¶¶ 63–69. Therefore, we determine that the district court’s findings are not sufficiently probative of the questions before us here. Also, the district court’s findings are not as definitive as Patent Owner states. The patent owner in the district court case attempted to prove infringement by the doctrine of equivalents for a formulation that did not expressly contain a buffer, but that it argued inherently contained a buffer from the chemical disassociation of the active ingredient in the product. See Ex. 2010, 64–65. The district court found that patent owner failed to prove case is in stark contrast with the underlying facts of this proceeding in which the prior art formulation expressly contains the same buffers as claimed in the ’145 patent. See Ex. 1001, 99:33–35 (claim 5); Ex. 1004, 3. (c) Conclusion Based on the foregoing, we deny Patent Owner’s motion to exclude Exhibit 1002, Dr. Byrn’s testimony.” slip op. at 28
Patent outcomesUS 10,940,145 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,940,145
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.