- Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.Institution deniedPTAB · Nov 12, 2024 · IPR2024-00874 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was unpatentable, failing to show Bansal's claimed light intensity arrangement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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 success in doing so.’” CRFD Research, Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (quoting Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367– 68 (Fed. Cir. 2016)). Obviousness grounds must be supported with “articulated reasoning with some rational underpinning” and not by “mere conclusory statements.” See KSR Int’l Co., 550 U.S at 418. slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“agree with Patent Owner that Petitioner has not sufficiently shown for institution that Bansal teaches or suggests arranging light sources “such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges,” as required by the challenged claims. Instead, Petitioner demonstrates how Bansal describes varying the density of light source distribution throughout the array to provide a higher density of light in the entire peripheral area of the array, which includes the areas proximal to both the first and second edges, as compared to the central area of the array. See Pet. 36–37; Ex. 1005 ¶ 25. In this regard, Petitioner relies on Bansal’s Figure 9b, asserting that it “shows one embodiment where more light sources are placed near the edges of the panel compared to the light sources in the center.” Pet. 36–37. The comparison of Bansal’s light density between the entire periphery and the central area of the array is insufficient. What is missing from Petitioner’s argument and discussion of Bansal is how Bansal teaches or suggests a configuration that provides a higher density of light proximate to the second shorter edges of the periphery in comparison to the remaining areas of the array, which includes the first longer edges of the periphery. Without that discussion, we find that Petitioner has not shown sufficient for institution that Bansal is persuasively relied upon for the light source arrangement limitation of the challenged claims. likelihood of prevailing in its obviousness challenge of independent claims 1, 5, 16, 20, or 21, or dependent claims 2, 4, 6–8, and 17–19 over Larsen, Bansal, and Jones.” slip op. at 17
- Skill levelOther
“would have had at least a Bachelor of Science in electrical engineering, physics, biomedical engineering, computer engineering, chemical engineering, material science, or a related scientific or engineering field, and at least one year of work or research experience in optics, optoelectronics, radiometry, photometry, photodynamic diagnosis (PD), photodynamic therapy (PDT), phototherapy (PT), or a related field. Pet. 8. Petitioner asserts that, alternatively, a “POSITA in the relevant time frame would have had at least four years of industry or academic experience in optics, optoelectronics, radiometry, photometry, PD, PDT, PT, or a related field.” Id. (citing Ex. 1003 ¶ 37). According to Patent Owner, a person of ordinary skill in the art at the time the application for the ’028 patent was filed, “would have had a M.D. and/or a Ph.D. in an electrical engineering, physics, optical sciences, optical engineering, or a related scientific or engineering field, and at least one to two years of work or research experience in optical engineering, optics, optoelectronics, phototherapy (‘PT’), PDT, or a related field.” Prelim. Resp. 16. Patent Owner asserts that, “[a]lternatively, a POSITA could have a Bachelor’s degree in one of the above areas and at least three to four years of work or research experience in that area.” Id. (citing Ex. 2001 ¶¶ 30–31). We note that the parties’ proposed definitions are largely similar. To the extent that the proposed definitions differ, we do not need to resolve those differences as our findings and conclusion in this Decision would be the same under any of the proposed definitions.” slip op. at 9
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,697,028 - 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 - Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Sep 1, 2023 · IPR2023-00620 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution because claims 1–4 had been statutorily disclaimed.
RulingsInstitution decision- Adverse judgmentAdverse judgmentDenied
“Under 37 C.F.R. § 42.107(e), “patent owner may file a statutory disclaimer under 35 U.S.C. 253(a) in compliance with § 1.321(a) of this chapter, disclaiming one or more claims in the patent” and “[n]o inter partes review will be instituted based on disclaimed claims.” A disclaimer under 35 U.S.C. § 253(a) is “considered as part of the original patent” as of the date on which it is “recorded” in the Office. 35 U.S.C. § 253(a). For a disclaimer to be “recorded” in the Office, the document filed by the Patent Owner must:” slip op. at 2
NonePatents in suitUS 10,406,226 - Takeda Vaccines, Inc. v. Valneva Austria GmbHInstitution deniedPTAB · Jun 9, 2023 · IPR2023-00354 · APJ Wesley B Derrick · IPR · Institution
The Board denied institution because the Patent Owner disclaimed all challenged claims before institution; it declined to enter adverse judgment.
RulingsInstitution decision- Adverse judgmentDecided for patent owner
“Patent Owner’s statutory disclaimer of the challenged claims, Petitioner correctly notes that the Federal Circuit in Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345 (Fed. Cir. 2018), construed Rule 42.73(b) as permitting the Board to enter adverse judgment when a patent owner cancels all challenged claims prior to institution. Paper 6, 2‒3; Arthrex, 880 F.3d at 1350. Neither Arthrex nor Rule 42.73(b), while permitting us to do so, requires us to enter adverse judgment. In the present instance, and consistent with 35 U.S.C. § 253(a), Arthrex, Rule 42.107(e) and the Board’s precedential General Electric decision, we determine that a denial of institution is sufficient to dispose of this case. We acknowledge Petitioner’s request to treat the terminal disclaimer as a request for adverse judgment (see Ex. 3003), but determine that denying institution without entering adverse judgment against the Patent Owner is consistent with § 253(a), Rule 42.107(e), and General Electric, where there are no pending claims for us to consider following disclaimer of all challenged claims prior to institution of trial.” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“disclaiming all challenged claims of the ’681 patent, and paid the requisite fees. See Ex. 3002; see also 35 U.S.C. § 253(a) (providing that a patentee may disclaim); 37 C.F.R. § 1.321 (setting forth requirements for statutory disclaimer). In particular, based on our review of Ex. 3002 and Patent Office public records, we are satisfied that a disclaimer of the challenged claims of the ’681 patent under 35 U.S.C. § 253(a) has been recorded in the Office as of March 21, 2023. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1382 (Fed. Cir. 1998) (holding that a disclaimer filed under immediately “recorded” on the date the Office receives the disclaimer without any requirements of further action). Accordingly, we deny institution of the requested inter partes review. See 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims.”); see also General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (“General Electric”) (denying institution of inter partes review under 37 C.F.R. § 42.107(e) based on disclaimer).” slip op. at 3
NonePatents in suitUS 11,219,681 - Apotex Inc. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution
Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314.” slip op. at 19
- BurdenDecided for patent owner
“As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,253,572 - Zhejiang Crystal-Optech Co. Ltd. v. Viavi Solutions Inc.Institution deniedPTAB · Feb 7, 2023 · IPR2022-01184 · APJ Debra K Stephens · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim would have been obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“8. Conclusion Based on the record before us, we determine Petitioner’s proffered arguments, evidence, and supporting testimony fails to establish a reasonable likelihood that Petitioner would prevail in showing that claims 1–7, 9, 10, 12–14, 17, 18, 20–23, 27, 30, and 31 would have been obvious over Pilgrim, Gibbons, Lairson, and Yoda.” slip op. at 32
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“II. ANALYSIS A. Discretionary Denial – 35 U.S.C. § 314(a) Patent Owner argues that we should exercise discretion to deny institution under 35 U.S.C. § 314(a) because the factors identified in Apple, Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”), weigh in favor of denying institution (Prelim. Resp. 49–54). Petitioner argues we should not discretionarily deny institution under Fintiv (Pet. 66–67). Because we determine Petitioner fails to establish a reasonable likelihood of prevailing in showing any of the claims challenged would have been obvious as discussed below, we do not reach this issue.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“B. Discretionary Denial – 35 U.S.C. §325(d) Patent Owner contends we should exercise our discretion under 35 U.S.C. § 325(d) because of the Petition’s “reliance upon the secondary references Gibbons, Lairson, and Yoda. Gibbons and Lairson were considered by the Examiner, and Yoda does not contain any meaningful additional disclosure or basis for unpatentability that was not considered by the Examiner” (Prelim. Resp. 21–22). Because we determine Petitioner fails to establish a reasonable likelihood of prevailing in showing any of the claims challenged in those grounds would have been obvious as discussed below, we do not reach this issue.” slip op. at 9
- Skill levelSkill level board ownOther
“Based on the present record including the disclosure in the ʼ269 Patent, we apply a slightly modified version of Petitioner’s definition of the level of ordinary skill in the art that removes the qualification of “at least” and clarifies some statements (see Pet. 6). More specifically, we determine a POSITA would have had a Bachelor’s degree or equivalent in physics, or in a related science or engineering field, along with five years of experience in optical element design and optical filters although additional education (e.g., a Master’s degree with exposure to optical element design and optical filters) may substitute for some industrial experience in optical element and optical filter design, and more industrial experience can substitute for a different educational background. We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ269 Patent and the prior art of record (cf. Okajima, 261 F.3d at 1355 (the prior art itself may reflect an appropriate level of skill in the art)).” slip op. at 11
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,588,269 - Zhejiang Crystal-Optech Co. Ltd. v. Viavi Solutions Inc.Institution deniedPTAB · Feb 7, 2023 · IPR2022-01281 · APJ Sharon Fenick · IPR · Institution
Institution was denied because Petitioner failed to show a reasonable likelihood that claims 1–3, 6–11, 13–17, and 19 were obvious over the asserted prior-art combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Because we determine Petitioner fails to establish a reasonable likelihood of prevailing in showing any of the claims challenged would have been obvious as discussed below, we do not reach this issue.” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“institution under 35 U.S.C. § 314(a) because the factors identified in Apple, Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”), weigh in favor of denying institution. Prelim. Resp. 43–47. Petitioner argues we should not discretionarily deny institution under Fintiv. Pet. 58–59; Paper 9. 2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), amended 35 U.S.C. § 103. Petitioner uses the pre-AIA statutory framework in its analysis. Pet. 1 n.1. Patent Owner does not comment on this. The ’794 patent claims priority to a provisional filed before March 16, 2013, the effective date of the applicable AIA amendments. Thus, we refer to the pre-AIA version of 35 U.S.C. § 103. Our decision would be the same were we to apply the AIA version of the statute. Because we determine Petitioner fails to establish a reasonable likelihood of prevailing in showing any of the claims challenged would have been obvious as discussed below, we do not reach this issue.” slip op. at 8
- Skill levelSkill level board ownOther
“Patent Owner does not oppose or comment on Petitioner’s definition of a POSITA. See generally Prelim. Resp. Based on the present record including the disclosure in the ʼ526 patent, we apply a slightly modified version of Petitioner’s definition of the level of ordinary skill in the art that removes the qualification of “at least” and clarifies some statements. More specifically, we determine a POSITA would have had a Bachelor’s degree or equivalent in physics, or in a related science or engineering field, along with 3 In the present record, neither party presents arguments or evidence relating to secondary considerations. five years of experience in optical element design and optical filters although additional education (e.g., a Master’s degree with exposure to optical element design and optical filters) may substitute for some industrial experience in optical element and optical filter design, and more industrial experience can substitute for a different educational background. We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ794 patent and the prior art of record. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts the term “center wavelength” (recited in claims 8, 9, and 17) should be interpreted as “the average of the two half-power wavelengths (i.e., [full width half maximum]) in a passband.” Pet. 15 (citing Ex. 1001, 7:53–56, 9:1–4, FIGS. 7D, 8C, 9B; Ex. 1037, 5; Ex. 1039 ¶ 47). Petitioner asserts the term “passband” (recited in claim 14) should be interpreted as “a wavelength range within which a signal can pass through a filter and outside of which the signal is blocked,” as per Patent Owner’s construction Id. (citing Ex. 1037, 12–15). Patent Owner does not directly address Petitioner’s proposed interpretations or provide its own constructions for any claim term. See generally Prelim. Resp. Having considered the record, we conclude that no express claim construction is necessary for any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). E. Claims 1, 2, 3, 6, and 8 – Obviousness over Pilgrim, Yoda, and Thelen” slip op. at 12
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,131,794 - Zhejiang Crystal-Optech Co. Ltd. v. Viavi Solutions Inc.Institution deniedPTAB · Feb 7, 2023 · IPR2022-01183 · APJ Sharon Fenick · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 9–18, 20, 21, 24, 25, and 27–30 would have been obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“partes review. See 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the Petition and the Preliminary Response “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons that follow, we do not institute an inter partes review as to the challenged claims of the ’526 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“D. Claim Construction We construe claim terms according to the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc), i.e., as construed in a civil action under 35 U.S.C. § 282(b). See 37 C.F.R. § 42.100(b) (2020). Under Phillips, claim terms are afforded “their ordinary and customary meaning.” Phillips, 415 F.3d at 1312. “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips, 415 F.3d at 1313. “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips, 415 F.3d at 1313. An inventor may rebut that presumption by providing a definition of the term in the specification “with reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In the absence of such a definition, limitations are not to be read from the specification into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not directly oppose Petitioner’s definition of a POSITA. See generally Prelim. Resp. Patent Owner does, however, state that “Petitioner’s expert has proposed a definition of a POS[IT]A that does not include specific experience in the design of optical filters” and “[m]ere general experience in optical elements does not demonstrate that a POS[IT]A would have possessed the specific abilities to design a brand-new multilayer optical interference filter from scratch, or to recreate and modify the materials from Yoda, as would have been required” in the asserted combination of Pilgrim and Yoda. Prelim. Resp. 33. Based on the present record including the disclosure in the ʼ526 patent, we apply a slightly modified version of Petitioner’s definition of the level of ordinary skill in the art that removes the qualification of “at least” and clarifies some statements. More specifically, we determine a POSITA would have had a Bachelor’s degree or equivalent in physics, or in a related science or engineering field, along with five years of experience in optical element design and optical filters although additional education (e.g., a Master’s degree with exposure to optical element design and optical filters) may substitute for some industrial experience in optical element and optical filter design, and more industrial experience can substitute for a different educational background. We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ526 patent and the prior art of record. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“of lower refractive index layers, and two specific properties: 1) that at least one of the one hydrogenated silicon layers is thicker than one of the lower refractive index layers, and 2) that the plurality of hydrogenated silicon layers have at least a specified refractive index at a given wavelength. Ex. 1001, 11:8–16. Petitioner argues that Pilgrim teaches the desirability of an optical filter stack having specific properties, and that Yoda teaches an optical filter having the claimed layers. However, even if it would have been desirable to use Yoda’s Si:H filter layers and those layers would have had the recited refractive index properties, as Petitioner asserts, Petitioner fails to show that an ordinarily skilled artisan would have obtained Pilgrim’s cited filter properties for an optical filter stack when implementing Yoda’s filter layers in Pilgrim’s optical filter stack. The optical filter that Pilgrim discloses, and that Petitioner relies on to teach the claimed optical filter properties, has a passband that “is centered on 950 nm with a full bandwidth of approximately +/-25 nm” and a “shift in [passband] center between an [angle of incidence (AOI)] of 0 degrees and an AOI of 40 degrees [that] is approximately 15 nm.” Ex. 1004 ¶ 26. Yoda is silent with regard to whether its filter layers could be used in an optical filter having a limited shift at a passband center, as disclosed by Pilgrim. As Patent Owner points out, “no reference cited [in] the Petition describes a design for any optical filter with a center wavelength shift of 15 nm over the 0° to 40° AOI range.” Prelim. Resp. 3. And Yoda does not “consider how the center wavelength would shift based on AOI.” Id. at 22. Petitioner’s assertion that optical filter properties and the filter layer properties are “routinely optimized parameters” (Pet. 24) does not adequately explain that an ordinarily skilled artisan would have implemented the filter layer properties taught by Yoda in an optical filter to obtain the properties disclosed by Pilgrim. Still further, Petitioner’s assertion about routine optimization is conclusory and is not supported by evidence. Nor is Petitioner’s argument that one of ordinary skill in the art would have had a reasonable expectation of success in “optimizing parameters” to design a filter for Pilgrim’s application supported by adequate evidence. Petitioner must show not only “that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention,” but also “that the skilled artisan would have had a reasonable expectation of success in doing so.” Kinetic Concepts, Inc. v. Smith & Nephew, Inc. 688 F.3d 1342, 1360 (Fed. Cir. 2012). Petitioner’s assertion that a POSITA would have expected to succeed in optimizing the parameters and designing a filter for Pilgrim’s application and to meet Pilgrim’s design goals in light of the guidance about how various processes and parameters impacted the index of refraction and extinction coefficient of Si:H and the POSITA’s ability to simulate the performance of the filter designs using the optimized materials (Pet. 22) does not address whether a POSITA would have had a reasonable expectation of success in creating an optical filter with the required properties using the filter layers described by Yoda. Petitioner has not shown a POSITA would have had the “ability to simulate the performance of the filter designs using the optimized materials.” Pet. 22. For example, Petitioner has not discussed what specific simulation techniques or tools would have been used by a POSITA. Furthermore, although Petitioner’s expert asserts the POSITA would have been led to select hydrogenated silicon as the high-refractive index material and would have further found it obvious to design the material to increase the refractive index to meet the design goals, while still maintaining a low extinction coefficient. These goals would have been achieved by tailoring the deposition processes and conditions, as well as the hydrogen content of the hydrogenated silicon material, as was known to the POSITA (Ex. 1002 ¶ 145), that statement does not explain how the tailoring the deposition processes and conditions and the hydrogen content would have led to successfully maintaining the low extinction coefficient, let alone to successfully creating an optical filter with Pilgrim’s required passband characteristics. Rather, as Patent Owner points out, the evidence cited in the record before us suggests “the design of [an optical] bandpass interference filter with a narrow bandwidth and low center wavelength shift is not trivial.” Prelim. Resp. 31 (citing Ex. 1001, Fig. 7C). Specifically, in detailing the requisite filter layers for an exemplary filter, the ’526 patent describes a filter stack of 48 layers of materials having varying thicknesses, an “[antireflective] coating includ[ing] 5 layers, and the total coating thickness [being] about 5.7 µm.” Ex. 1001, 8:1–12, Figs. 7B–7C.” slip op. at 21
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,222,526 - Apple Inc. v. Masimo CorporationInstitution deniedPTAB · Feb 1, 2023 · IPR2022-01300 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–30, exercising § 314(a) discretion because Apple did not justify filing a second petition challenging the same claims.
RulingsInstitution decision- Parallel petitionsInstitution denied discretionary otherDenied
“’1299 Petition before the present Petition. Notice 2. Petitioner argues that both Petitions are warranted “[d]ue to word count constraints.” Id. at 5. In support of its position, Petitioner argues that the asserted grounds “are nonredundant at least in their reliance on different combinations of references that demonstrate the obviousness of the Challenged Claims in materially different ways.” Id. at 27. Petitioner contends, for example, that whereas the present Petition relies on Dietiker as its “primary reference,” the ’1299 Petition relies on Yamada. Notice, 2–3. To the extent this is true, we note that the present Petition also relies on Yamada, as well as the Leibowitz and Noguchi references asserted in the ’1299 Petition, thus, indicating a substantial degree of overlap between the two petitions. Moreover, in the Notice’s sole statement attempting to distinguish between the two “primary” references, Yamada and Dietiker, Petitioner asserts that “the Dietiker combinations describe active temperature regulation for LEDs in an oximetry instrument.” Id. at 3 (citing Ex. 1010 ¶¶ 24–25). At the high level of generality offered in the Notice, we see little difference between this description of Dietiker, and the ’1299 Petition’s description of Noguchi as “controlling the emission spectrum of an LED with high precision,” by “enabl[ing] the device to compensate for temperature-induced shifts in the wavelengths of light emitted by an LED.” See ’1299 Petition, 50–53. We further note that despite Petitioner’s designation of Dietiker as a primary reference, each ground in the present” slip op. at 9
Discretionary denialPatents in suitUS 7,761,127
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.