- 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.
In the decision…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…
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.
In the decision…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…
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 - Petiq, Inc. v. Bayer Intellectual Property GmbHInstitution deniedPTAB · Jun 23, 2022 · IPR2022-00304 · APJ Jamie T Wisz · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–3 were obvious over Dorn and Reul or Dorn and Choi.
In the decision…Inc., 550 U.S. 398, 406 (2007). “An obviousness determination requires finding both ‘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…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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.” For the reasons explained below, upon consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented in the Petition does not show that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. Accordingly, we do not institute an inter partes review. A.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“of ordinary skill in the art would have been motivated to substitute Miglyol 840 from Reul into the solid preparations of Dorn. Petitioner argues that the similarities between Miglyol 840 and dipropylene glycol pelargonate, and dipropylene glycol pelargonate’s use in the art as a spreading agent, would have led one of ordinary skill in the art to have a reasonable expectation of success in substituting the spreading agent in Dorn with Miglyol 840. Pet. 31–32. However, as discussed by Patent Owner, Dorn’s discussion of dipropylene glycol pelargonate (and spreading oils generally) is in the context of adjuvants that may be used in liquid solutions for use as “pour-on and spot-on formulations.” See Prelim. Resp. 10–17, 20–23; Ex. 1004, 7:4– 7, 8:1–2. These pour-on formulations are different than Dorn’s solid preparations, which include shaped articles made of PVC. See Ex. 1004, 7:15–8:10 (discussing solutions for pour-on formulations), 9:9–22:31 (discussing solid preparations). While Dorn also discusses the use of adjuvants that can be used with its solid preparations, this discussion mentions preservatives, antioxidants, colorants, lubricants, and glidants, but does not include the use of spreading agents.5 Ex. 1004, 9:18–22. Thus, Petitioner has not sufficiently explained how or why one of ordinary skill in the art would have swapped out the dipropylene glycol pelargonate from” slip op. at 16
- Expert testimonyPatent owner expert creditedDecided for patent owner
“its use as a release-promoting substance or spreading agent. See, e.g., Pet. 31, 34 (citing Ex. 1003 ¶ 157; Ex. 1006, 1:44–50, 2:63–3:37). Petitioner does not show that Miglyol 840 is being used as a plasticizer in Reul such that one of ordinary skill in the art would have been motivated to use it in the compositions of Dorn in the amounts specified by Dorn for plasticizers. We credit the testimony of Patent Owner’s declarant, Dr. Jacobs, that a “uniformly accepted definition of plasticizer” is “a substance or material incorporated in a material … to increase its flexibility, workability, or distensibility.” Ex. 2001 ¶ 12 (citing Ex. 2012, 173). In contrast, Reul states that its release-promoting substances (including Miglyol® 840) “either do not affect the mechanical properties of the silicon rubber at all or only to an insignificant extent.” Ex. 1006, 2:38–40. We further credit the testimony of Dr. Jacobs that Reul’s “release-promoting substances … do not function as a plasticizer in silicone rubber, at least under the ‘universally accepted definition’ of a ‘plasticizer’ discussed above.” Ex. 2001 ¶ 39 (further testifying that “Reul does not mention any ‘plasticizer’ in general, and does not teach or suggest that caprylic/capric acid-1,2-propanediol diester or Miglyol® 840 functions as a plasticizer in silicone rubber.”).” slip op. at 18
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentable
“from Reul in the solid PVC compositions of Dorn, Petitioner has not presented sufficient evidence to show that these references teach the presence of Miglyol 840 at the recited weight limitation of “about 5% to about 17.5% by weight of the solid moulded body.” As discussed above, Petitioner relies on Dorn’s disclosure of spreading agents (such as dipropylene glycol pelargonate) in arguing that one of ordinary skill in the art would have had a reasonable expectation of success in substituting the Miglyol 840 in the compositions of Dorn. See Pet. 31–32. However, Dorn does not disclose any weight percentage for dipropylene glycol pelargonate or any of the disclosed spreading agents. Petitioner instead relies on Dorn’s disclosure of plasticizers in amounts of 10 to 50%, preferably approximately from 25% to 45% by weight, to supply this disclosure. Pet. 41–42. In order for this argument to be persuasive, Petitioner must show that one of ordinary skill in the art would have been motivated to, and would have had a reasonable expectation of success in, substituting the plasticizers of Dorn with Miglyol 840 as disclosed in Reul. For the reasons explained below, we find that Petitioner has failed to do so.” slip op. at 17
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 7,910,122 - Lassen Therapeutics 1, Inc. v. Singapore Health Services Pte Ltd., And National University Of SignaporeInstitution deniedPTAB · Feb 6, 2020 · PGR2019-00053 · APJ Jamie T Wisz · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that claims 1–10 were unpatentable on any asserted ground.
In the decision…points out that Petitioner’s enablement arguments ignore the ’603 patent’s disclosure of two antibody clones from Edwards and also ignores Edwards’ teaching of sixty-two other anti-IL-11Rα antibodies that are capable of binding to IL-11Rα and neutralizing IL-11 signaling. Prelim. Resp. 47. (citing…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4(a). We may not institute a post-grant review unless “the information presented in the petition . . . , if such information is not rebutted, would demonstrate that 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). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we determine that the information presented fails to demonstrate it is more likely than not that at least 1 of the challenged claims of the ’603 patent is unpatentable. Accordingly, we deny institution of post-grant review of claims 1–10 of the ’603 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of the preliminary response only, it does not challenge Petitioner’s definition of a person of ordinary skill in the art. Prelim. Resp. 19. Based on the current record and for the purposes of this Decision, we adopt Petitioner’s proposed description of the person of ordinary skill in the art. Furthermore, we find that the prior art of record reflects this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that “Interleukin 11 receptor α (IL- 11Rα) antibody” should not be construed to include antibodies that bind to IL-11Rα of non-human species but not to the human version of this protein because such a construction does not comport with the language of claim 1, which is clearly directed to treating a human subject. See Pause Tech. v. TiVo, 419 F.3d 1326, 1331 (Fed. Cir. 2005) (rejecting interpretation of claim element that ignored “other language appearing later in the claim” in stating that ‘“[p]roper claim construction . . . demands interpretation of the entire claim in context, not a single element in isolation.’”) (citing Hockerson– Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed.Cir.1999)). Construing this term to include antibodies that bind solely to non-human IL- 11Rα would be inconsistent with a claim directed to treatment of a human. Accordingly, for purposes of this decision, we construe “Interleukin 11 receptor α (IL-11Rα) antibody” to mean “any natural or synthetic, monoclonal or polyclonal antibody made using any animal system including phage, or fragment or derivative thereof, that binds to human IL-11Rα.”” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“We agree with Patent Owner that Petitioner appears to have overlooked the ’603 patent Specification’s disclosure of anti-IL-11Rα antibodies. Specifically, the ’603 patent lists “monoclonal antibody clone 025 (Sino Biological), clone EPR5446 (Abcam), clone 473143 (R & D Systems), clones 8E2 and 8E4 described in US 2014/0219919 A1 [Edwards] and the monoclonal antibodies described in Blanc et al (J. Immunol Methods. 2000 Jul. 31; 241(1–2); 43–59).” Ex. 1001, 18:41–46; Ex. 1003 ¶ 176.6 Edwards, which Petitioner relies on for its obviousness and anticipation grounds, is directed to antibodies “that bind to IL-11Rα and neutralize IL-11 signaling.” Ex. 1008 ¶ 13. Table 1 of Edwards lists clones 8E2 and 8E4 and sixty-three other antibodies (including variants of 8E2) as “exemplary IL-11Rα-binding proteins.” Id. ¶ 362. Table 1 of Edwards also includes the sequence ID numbers for the heavy and light chains of the variable regions of each of these sixty-five clones and the amino acid sequences for each are disclosed in the sequence listing. Id. ¶ 362, p. 46– 104.7” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,106,603 - Fustibal LLC v. Bayer Healthcare LLCInstitution deniedPTAB · Feb 8, 2017 · IPR2016-01490 · APJ Robert A Pollock · IPR · Institution
The Board denied institution because Riedl was repeatedly considered during prosecution and the petition did not show a reasonable likelihood that claims 1–16 were unpatentable.
In the decision…v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006). Therefore, to anticipate a later-claimed species, a pattern of preferences or other related teaching or suggestion must 12 Case IPR2016-01490 Patent 8,637,553 B2 lead to a genus small enough that a person of ordinary skill in the art would at…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is guided, in part, by 35 U.S.C. § 325(d), which states that “the Director 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.” Patent Owner requests that the Board exercise its discretion to deny institution with respect to Ground 1 because Riedl was expressly considered by the Examiner during the prosecution of the ’553 Patent. Prelim. Resp. 7–8. As noted in section I(E), above, in allowing claims 1–16 of the ’533 Patent, the Examiner expressly referred to Riedl as the closest prior art, yet found that it “fails to teach . . . the instant claimed compounds.” Ex. 2006, 913; see also Ex. 2005, 397, 569; Ex. 2006, 855 (same, with respect to similar claims).” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As an initial matter, the above argument fails because, as discussed in section I(C)(iii), above, Riedl does not “expressly disclose[] the rografenib compound,” as Petitioner contends. We further agree with Patent Owner’s observation “that the Petition nowhere engages in a ‘lead compound’ analysis” and, at least with respect to Ground 2, “merely assumes—without explanation—that the POSA would select sorafenib for modification.” Prelim. Resp. 22–23. A lead compound comprises “a natural choice for further development efforts” (Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 10 Petitioner provides similar arguments with respect to claims 1–12, 14, and 16. Id. at 22–25. (Fed. Cir. 2009)), i.e., a prior art compound “that would be most promising to modify in order to improve upon its . . . activity and obtain a compound with better activity” (Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). “In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by evidence of the compound’s pertinent properties.” Otsuka Pharm., 678 F.3d at 1292. “Absent a reason or motivation based on such prior art evidence, mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection.” Id. In setting forth Ground 2, Petitioner invokes a person of ordinary skill in the art “who was looking to modify sorafenib.” Prelim. Resp. 22. Neither Petitioner nor Petitioner’s expert address why a skilled artisan reading Riedl would select that compound for further development. Given that Riedl does not highlight any of the vast number of disclosed compounds as having particularly beneficial properties or present any enzymatic or biological data, we also do not discern from this reference why a person of ordinary skill in the art would have selected sorafenib as “a natural choice for further development efforts.”” slip op. at 17
- Skill levelSkill level petitioner adoptedOther
“Person of Ordinary Skill in the Art. Petitioner contends that a person of ordinary skill in the art “typically would have a PhD, MD, MS, or another degree relating to pharmaceutical chemistry (e.g. biology, chemistry, medicinal chemistry, medicine, pharmacology, or a closely related discipline), and . . . would have substantial familiarity, training, or experience with pharmaceutical compositions.” Pet. 6. Patent Owner has not challenged Petitioner’s proposed interpretation of a skilled artisan. We adopt Petitioner’s proposed interpretation for purposes of this opinion. See Prelim. Resp. 6 & n.1; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evident from the prior art). B.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Petitioner (correctly) contends that the ’553 Patent expressly defines the claim term “pharmaceutically acceptable salt” as “‘a relatively non-toxic, inorganic or organic acid addition salt of a compound of the present invention.’” Pet. 7 (quoting Ex. 1001, 9:56–62). Patent Owner does not presently object to this definition. Based on the specification’s express disclosure, we agree that the cited definition applies. See Prelim. Resp. 6 & n.2. The parties agree that all other terms should be accorded their ordinary and customary meaning. Id.; Pet. 6–7. Our reviewing court counsels that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Accordingly, for purposes of this decision, we determine that no further construction is necessary. C.” slip op. at 7
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 8,637,553 - Par Pharmaceutical, Inc. v. Novartis AGInstitution deniedPTAB · Apr 28, 2016 · IPR2016-00078 · APJ Christopher L Crumbley · IPR · Institution
The Board denied institution because Par did not show a reasonable likelihood that claim 7 was obvious over Cottens, Kimball, Kahan, and Morris.
In the decision…a person of ordinary skill in the art “would not have been motivated to add everolimus to an existing [cyclosporin A] treatment protocol, absent a teaching that this would have been at least safe for patients.” Id. at 10. 10 IPR2016-00078 Patent 6,455,518 Furthermore, Novartis contends that the…
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“effective amounts of two compounds. As Novartis points out, the term “coadministration” is explicitly defined in the specification of the ’518 patent, as follows: By “co-administration” is meant administration of the 40-O-(2- hydroxyethyl)-rapamycin and the IL-2 transcription inhibitor, e.g., cyclosporin A, together or at substantially the same time (e.g., within fifteen minutes or less), either in the same vehicle or in separate vehicles, so that upon oral administration, for example, both compounds are present simultaneously in the stomach. Prelim. Resp. 4 (quoting Ex. 1001, 6:29–35) (emphasis omitted). We agree with Novartis that the patentee acted as its own lexicographer, defining “co-administration” with reasonable clarity, deliberateness, and precision as “administration . . . together or at substantially the same time.” The specification also provides two guideposts for determining what is “at substantially the same time”: either within fifteen minutes or less, or so that both compounds are present simultaneously in the stomach. We, therefore, determine that the broadest reasonable interpretation of the claim term co-administering is “administering together or at substantially the same time.”” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“Upon review of the record, we are persuaded by Novartis’ arguments that the prior art insufficiently discloses co-administering, as explicitly defined in the specification of the ’518 patent. Par’s Petition simply states at various points that the references “disclose co-administering,” without specifically indicating what disclosure in the reference is being relied on, or why a person of ordinary skill in the art would have understood the disclosure to be administration “together or at substantially the same time.” In its element-by-element analysis of the proposed ground of unpatentability, Par identifies where each prior art reference allegedly discloses element [7b], “co-administering synergistically effective amounts of.” Pet. 47–50. We address each in turn. First, Par states that Cottens “directs that the disclosed rapamycin derivatives . . . should be co-administered with cyclosporin A.” Id. at 47 (citing Ex. 1006, 8). This overstates the disclosure of Cottens, especially given the specific definition of co-administering in the ’518 patent. Cottens only states that its derivatives (including everolimus) “may be administered . . . together with other drugs,” and “may be used in combination with” cyclosporin A. Ex. 1006, 8 (emphasis added). Par does not explain why use “in combination with” would be understood by those of skill in the art to mean “administering together or at substantially the same time.” To the contrary, Cottens’ disclosure could reasonably be read as simply referring to administering both drugs “together” as part of a single treatment regimen, but spaced apart in time to avoid possible toxic effects.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As we have found that the combined disclosures of Cottens, Kimball, Kahan, and Morris fail to disclose co-administering either rapamycin or everolimus with cyclosporin A, we are unpersuaded that the record sufficiently establishes that Par would prevail in demonstrating the unpatentability of claim 7 over these references. We, therefore, decline to institute trial on Par’s proposed ground of unpatentability. III. CONCLUSION For the foregoing reasons, we conclude that the information presented in the Petition and Preliminary Response does not establish that there is a reasonable likelihood that Par will prevail in challenging claim 7 of the ’518 patent as unpatentable under § 103(a). IV. ORDER In consideration of the foregoing, it is hereby ordered that the Petition is denied.” slip op. at 13
Claim construction§ 103 obviousnessPatents in suitUS 6,455,518 - Benitec Biopharma Limited v. Cold Spring Harbor LaboratoryInstitution deniedPTAB · Apr 6, 2016 · IPR2016-00017 · APJ Toni R Scheiner · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that any of claims 1–10 was unpatentable over the asserted references.
In the decision…currently used to induce RNAi. Ex. 1004, 8:11–15. In light of this statement, Petitioner argues that [O]ne of ordinary skill in view of the cited teachings and knowledge in the art would understand that in the ’185 provisional (Ex. 1004[)], Zamore had possession of the means to avoid PKR when…
RulingsInstitution decision- 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 established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’264 patent. See 35 U.S.C. § 314(a). We, therefore, deny the Petition for an inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“unexpired patent according to its broadest reasonable construction in light of the specification of the patent in which it appears. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79 (Fed. Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under that standard, and absent any special definitions, we assign claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention,16 in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms which are in controversy need to be construed, however, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 6
- BurdenNot shown unpatentable
“[T]he hallmark of written description is disclosure.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The test for written description “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id. No particular form of disclosure is required, but “a description that merely renders the invention obvious does not satisfy the requirement.” Id. at 1352. To find an element inherently disclosed demands that “the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art.” Ex parte Levy, 17 USPQ2d 1461, 1464 (BPAI 1990). “The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (emphasis added). In the present case, Petitioner presents no expert opinion with respect to the understanding of one of ordinary skill in the art, much less with respect to the disclosure of the Zamore ’185 provisional application. Petitioner’s assertion that “Zamore had possession of the means to avoid PKR when utilizing the gene silencing technology, based on his reference to the ‘length, sequence, and/or structure’ of the constructs . . . and their effect on ‘induction of the interferon response’” (Pet. 26) fails to convince us that one of ordinary skill in the art would understand that the ’185 provisional application inherently discloses the ranges claimed in the Zamore patent. Accordingly, we are not persuaded that the Zamore patent qualifies as prior art under 35 U.S.C. § 102(e). Absent such a showing, Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’264 patent based on this reference. slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“ʼ264 patent is January 22, 2002. See Ex. 1001, 1; Pet. 4–5; Prelim. Resp. 28. Zamore issued from a non-provisional application filed on July 12, 2002, and claimed benefit of priority under 35 U.S.C. § 119(e) of the ’185 provisional application, filed on July 12, 2001. Ex. 1003, [21], [22], [60], 1:5–7. Accordingly, Zamore is only available as prior art under § 102(e) if Petitioner can show that Zamore is entitled to the earlier filing date of the ʼ185 provisional application. To make such a showing, Petitioner must demonstrate that the ʼ185 provisional application provides written description support for at least one claim of the Zamore patent. See, e.g., Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) (“A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112 ¶ 1.”).” slip op. at 7
§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,829,264 - Benitec Biopharma Limited v. Cold Spring Harbor LaboratoryInstitution deniedPTAB · Mar 31, 2016 · IPR2016-00016 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution on claims 1–10 because Benitec did not establish a reasonable likelihood of showing any challenged claim unpatentable over the asserted references.
In the decision…and structures known to trigger PKR were widely known prior to the filing of Zamore’s ’185 provisional” “one of ordinary skill in view of the cited teachings and knowledge in the art would understand that Zamore had possession of the means to avoid PKR when utilizing the gene silencing…
RulingsInstitution decision- 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 established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’776 patent. See 35 U.S.C. § 314(a). We, therefore, deny the Petition for an inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior art
“Ex. 1001, 1; Pet. 8; Prelim. Resp. 23. Zamore issued from a non-provisional application filed on July 12, 2002, and claiming benefit of priority under 35 U.S.C. § 119(e) of the ’185 provisional application, filed on July 12, 2001. Ex. 1003, [21], [22], [60], 1:5–7. Accordingly, Zamore is only available as prior art under § 102(e) if Petitioner can show that Zamore is entitled to the earlier filing date of the ʼ185 provisional application. To make such a showing, Petitioner must demonstrate that the ʼ185 provisional application provides written descriptive support for at least one claim of the Zamore patent. See, e.g., Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) (“A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1.”). The claims of the Zamore patent are generally directed to nucleic acids “capable of inducing RNA interference (RNAi) in a mammalian cell in vivo.” See Ex. 1003, claim 1. Independent claims 1 and 41 require first and second stem portions comprising complementary RNA sequences of “about 18 to about 40 nucleotides” in length. Id. at claims 1, 41. Various dependent claims further recite stem portions of “18 to 40 nucleotides” (id. at claims 20, 58), “22 to 28 nucleotides,” (id. at claims 21, 59), “18 to 30 nucleotides,” (id. at claim 22), and “18 to 40 nucleotides” (id. at claim 58). The Zamore ʼ185 provisional application, by contrast, describes stem portions of “19 to 22,” “21 or 22,” and “21 or 40” nucleotides in length. Ex. 1004, 2, 7. For the reasons discussed on pages 24 through 27 of Patent Owner’s Preliminary Response, we agree that these disclosures do not provide written descriptive support for the ranges claimed in the issued patent.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)
“genes using genetic elements known to be active in eukaryotic cells. See, e.g., Ex. 1005, 17:39–51 (“Plasmid pEGFP.BEV.1 (FIG. 9) is capable of expressing the BEV polymerase structural gene as a GFP fusion polypeptide under the control of the CMV-IE promoter sequence.”); see id. at 8:4–34. Petitioner, however, points to no evidence indicating that such constructs were ever introduced into mammalian cells; nor do we discern in Graham any evidence that the disclosed constructs were successfully expressed in mammalian cells, or that they subsequently produced a measurable effect on a target gene in accord with the claim language. Based on our review of the record to date, we acknowledge the substantial complexity of the subject matter16 and unpredictability of the art. See Mycogen Plant Sci. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001) (recognizing the unpredictability of the biological arts); In re Fisher, 16 See e.g., Ex. 1002, 854 ¶ 43 (cited in full, infra) (“Further evidence of the non-obviousness of the Hannon et al. invention is evidenced in the complicated nature of the methods provided in the cited references.”). 427 F.2d 833, 839 (CCPA 1970) (2008) (contrasting predictable factors involving mechanical or electrical elements with “cases involving unpredictable factors, such as most chemical reactions and physiological activity”). Given this background, and Petitioner’s lack of testimonial evidence, we do not find that Petitioner has established that Graham expressly or inherently discloses a molecule “stably expressed in the mammalian cell in an amount sufficient to attenuate expression of the target gene in a sequence specific manner . . . whereby expression of the target gene is inhibited,” as required by claim 1. For at least this reason, Petitioner has not shown that Graham anticipates the challenged claims.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away found
“i. Graham Petitioner relies on Graham as teaching shRNAs, in particular, “short dsRNA constructs for gene silencing” (Pet. 45 (citing Ex. 1005, 6:25–40, 10:22–32), and the “desirability of using short hairpin sequences to avoid cellular responses” (id. at 38–39 (citing Ex. 1005, 6:25–40)). As discussed above in the context of anticipation, however, Graham teaches that the potential of hairpin formation was a problem to be solved. Indeed, rather than teaching the “desirability” of using hairpin sequences, as Petitioner contends, Graham indicates that hairpins should be avoided and, thus, teaches away from the use of shRNAs for gene silencing in mammalian cells. Accordingly, Graham does not teach or suggest the use of “a sequence encoding a short hairpin RNA molecule comprising a double-stranded region wherein the double-stranded region consists of at least 20 nucleotides but not more than 29 nucleotides,” as required by claim 1.” slip op. at 15
§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,153,776 - Benitec Biopharma Limited v. Cold Spring Harbor LaboratoryInstitution deniedPTAB · Mar 23, 2016 · IPR2016-00014 · APJ Robert A Pollock · IPR · Institution
The Board denied institution for claims 1–10 because the petition did not establish a reasonable likelihood of proving unpatentability over the asserted anticipation and obviousness grounds.
In the decision…and structures known to trigger PKR were widely known prior to the filing of Zamore’s ’185 provisional” “one of ordinary skill in view of the cited teachings and knowledge in the art would understand that Zamore had possession of the means to avoid PKR when utilizing the gene silencing…
RulingsInstitution decision- 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 established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’846 patent. See 35 U.S.C. § 314(a). We, therefore, deny the Petition for an inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“Ex. 1001, 1; Pet. 8; Prelim. Resp. 22. Zamore issued from a non-provisional application filed on July 12, 2002, and claiming benefit of priority under 35 U.S.C. § 119(e) of the ’185 provisional application, filed on July 12, 2001. Ex. 1003, (21), (22) (60), 1:5–7. Accordingly, Zamore is only available as prior art under § 102(e) if Petitioner can show that Zamore is entitled to the earlier filing date of the ʼ185 provisional application. To make such a showing, Petitioner must demonstrate that the ʼ185 provisional application provides written descriptive support for at least one claim of the Zamore patent. See, e.g., Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) (“A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112 ¶ 1.”).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“genes using genetic elements known to be active in eukaryotic cells. See, e.g., Ex. 1005, 17:39–51 (“Plasmid pEGFP.BEV.1 (FIG. 9) is capable of expressing the BEV polymerase structural gene as a GFP fusion polypeptide under the control of the CMV-IE promoter sequence.”); see id. at 8:4–34. Petitioner, however, points to no evidence indicating that such constructs were ever introduced into mammalian cells; nor do we discern in Graham any evidence that the disclosed constructs were successfully expressed in mammalian cells, or that they subsequently produced a measurable effect on a target gene in accord with the claim language. Based on our review of the record to date, we acknowledge the substantial complexity of the subject matter16 and unpredictability of the art. See Mycogen Plant Sci. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001) (recognizing the unpredictability of the biological arts); In re Fisher, 427 F.2d 833, 839 (CCPA 1970) (2008) (contrasting predictable factors involving mechanical or electrical elements with “cases involving unpredictable factors, such as most chemical reactions and physiological activity”). Given this background, and Petitioner’s lack of testimonial evidence, we do not find that Petitioner has established that Graham expressly or inherently discloses a molecule “stably expressed in the mammalian cell in an amount sufficient to attenuate expression of the target gene in a sequence specific manner . . . whereby expression of the target gene is inhibited,” as required by claim 1. For at least this reason, Petitioner has not shown that Graham anticipates the challenged claims.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away foundDecided for patent owner
“The above passage contains Graham’s sole reference to a “hairpin.” Given the evidence of record, we agree with Patent Owner that Graham’s discussion of “hairpin loops” refers to a problem that may occur when using inverted repeat sequences. See Prelim. Resp. 18–20. Thus, rather than disclosing the use of such structures for attenuating expression of a target gene, Graham teaches that hairpin loops should be avoided. Petitioner presents no evidence suggesting that one of ordinary skill in the art would read Graham in any other way. Accordingly, Petitioner fails to show that Graham discloses the use of “a short hairpin RNA molecule comprising a double-stranded region, wherein the double-stranded region consists of at least 20 nucleotides but not more than 29 nucleotides . . . wherein the double-stranded region of the short hairpin RNA molecule comprises a sequence that is complementary to a portion of the target gene,” as required by the challenged claims. This provides an independent reason why Petitioner has not established a reasonable likelihood that it would prevail in showing that at least one challenged claim of the ’846 patent is anticipated by Graham.” slip op. at 13
§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,202,846 - Benitec Biopharma Limited v. Cold Spring Harbor LaboratoryInstitution deniedPTAB · Mar 23, 2016 · IPR2016-00015 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1–20 because Petitioner did not show a reasonable likelihood of proving unpatentability based on Zamore, Graham, or the asserted obviousness combinations.
In the decision…bp) currently used to induce RNAi. See Pet. 26–27 (referencing Ex. 1004, 8:11–15). Petitioner argues that “[o]ne of ordinary skill in view of the teachings of Zamore and knowledge in 8 Case IPR2016-00015 Patent 8,383,599 B2 the art would understand that Zamore had possession of the means to…
RulingsInstitution decision- 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 established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’599 patent. See 35 U.S.C. § 314(a). We, therefore, deny the Petition for an inter partes review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In the present matter, the parties do not dispute the meaning of any claim term, nor, for the purposes of our decision, do we find that any term requires express construction. See Pet. 5; Prelim. Resp. 9.” slip op. at 6
- Skill levelSkill level patent owner adoptedDecided for patent owner
“unexpired patent according to its broadest reasonable construction in light of the specification of the patent in which it appears. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79 (Fed. Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under that standard, and absent any special definitions, we assign claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention,15 in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms which are in controversy need to be construed, however, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 6
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“Ex. 1001, 1; Pet. 8: Prelim. Resp. 22. Zamore issued from a non-provisional application filed on July 12, 2002, and claiming benefit of priority under 35 U.S.C. § 119(e) of the ’185 provisional application, filed on July 12, 2001. Ex. 1003, (21), (22) (60), 1:5–7. Accordingly, Zamore is only available as prior art under § 102(e) if Petitioner can show that Zamore is entitled to the earlier filing date of the ʼ185 provisional application. To make such a showing, Petitioner must demonstrate that the ʼ185 provisional application provides written descriptive support for at least one claim of the Zamore patent. See, e.g., Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) (“A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1.”).” slip op. at 7
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,383,599
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.