- 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 - Chongqing HKC Optoelectronics Technology Co., Ltd. v. 138 East LCD Advancements LimitedInstitution deniedPTAB · Aug 28, 2023 · IPR2023-00476 · APJ Wesley B Derrick · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood of proving claims 1–11 unpatentable, principally failing to establish distinct lead wiring lines.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority to determine whether to institute an inter partes review. See 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition 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.” 35 U.S.C. § 314(a). We deny inter partes review, for example, where a petition fails to identify “with particularity” the challenges or evidence supporting them. Harmonic Inc. v. Avid Tech., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) as “requiring [inter partes review] petitions to identify ‘with particularity . . . the evidence that supports the grounds for the challenge to each claim’”); Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” (quoting 35 U.S.C. § 312(a)(3))). For the reasons discussed below, we deny institution of inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“display electrodes” and “a plurality of lead wiring lines provided on the extending portion and that are led from one of the sides of the wiring lines to the extending portion.” Ex. 1001, 16:40‒44. Separately listing “wiring lines” and “a plurality of lead wiring lines” clearly implies that wiring lines Healthcare Group, LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (internal quotation omitted) (“Where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct component[s] of the patented invention.”); Engel Indus., Inc. v. Lockformer Co., 96 F.3d 1398, 1404‒05 (Fed. Cir. 1996) (concluding that two separately recited elements could not be the same element because it would contradict the plain language of the patent and “they logically cannot be one and the same”). Here, the claim language identifies wiring lines and lead wiring lines as separate elements in that the “lead wiring lines . . . are led from one of the sides of the wiring lines to the extending portion.” Ex. 1001, 16:42‒ 44. Here also, the ’913 patent’s specification separately identifies and describes both lead wiring lines 103a and wiring lines 105 in a single embodiment. See, e.g., id. at Fig. 1, 7:42‒46 (“In FIG. 1, . . . [t]he wiring lines 105 are relayed on the upper side of the frame light-shielding film 53 so as to connect the two scanning line driving circuits 104.”), 8:26‒29 (“the data line driving circuit 101a is connected to the plurality of external connecting terminals 102a through the lead wiring lines 103a at both ends of the extending portion 201” (referring to the embodiment depicted in Figure 1)).” slip op. at 12
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentable
“display electrodes” and “a plurality of lead wiring lines provided on the extending portion and that are led from one of the sides of the wiring lines to the extending portion.” Ex. 1001, 16:40‒44. Separately listing “wiring lines” and “a plurality of lead wiring lines” clearly implies that wiring lines Healthcare Group, LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (internal quotation omitted) (“Where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct component[s] of the patented invention.”); Engel Indus., Inc. v. Lockformer Co., 96 F.3d 1398, 1404‒05 (Fed. Cir. 1996) (concluding that two separately recited elements could not be the same element because it would contradict the plain language of the patent and “they logically cannot be one and the same”). Here, the claim language identifies wiring lines and lead wiring lines as separate elements in that the “lead wiring lines . . . are led from one of the sides of the wiring lines to the extending portion.” Ex. 1001, 16:42‒ 44. Here also, the ’913 patent’s specification separately identifies and describes both lead wiring lines 103a and wiring lines 105 in a single embodiment. See, e.g., id. at Fig. 1, 7:42‒46 (“In FIG. 1, . . . [t]he wiring lines 105 are relayed on the upper side of the frame light-shielding film 53 so as to connect the two scanning line driving circuits 104.”), 8:26‒29 (“the data line driving circuit 101a is connected to the plurality of external connecting terminals 102a through the lead wiring lines 103a at both ends of the extending portion 201” (referring to the embodiment depicted in Figure 1)).” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“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); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). 7 Yoneda, JP2000267590A, published Mar. 19, 1999. Ex. 1011. 8 Tanaka, JP2004094020A, published Mar. 25, 2004, with exhibit including certified English language translation. Ex. 1012. 9 Hirosue, US 2003/0189686 A1, published Oct. 9, 2003. Ex. 1013. have either a bachelor’s degree in electrical or computer engineering with three years of experience in the field of display technology or a master’s degree with one year of experience in the field of display technology.” Pet. 5 (citing Ex. 1002 ¶¶ 41‒44). Patent Owner, “[f]or purposes of th[e] Preliminary Response . . . does not dispute the level of skill for a person of ordinary skill in the art.” Prelim. Resp. 7. On this record, we find Petitioner’s definition of the level of ordinary skill reasonable and, therefore, adopt it for the purposes of this Decision.” slip op. at 6
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,335,913 - Chongqing HKC Optoelectronics Technology Co., Ltd. v. 138 East LCD Advancements LimitedInstitution deniedPTAB · Aug 28, 2023 · IPR2023-00475 · APJ Wesley B Derrick · IPR · Institution
Institution was denied because the petition did not sufficiently show that the counter-electrode potential line was one of the claimed main wiring lines coupled to peripheral driving circuits.
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, 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) as the evidence that supports the grounds for the challenge to each claim’”). When challenging claims based on obviousness, the Petitioner must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (citations omitted). The burden of persuasion, whether for anticipation or for unpatentability for obviousness, never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1326–27 (Fed. Cir. 2008)) (discussing the burden of proof in inter partes review). slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“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); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner contends that a person of ordinary skill in the art “would have either a bachelor’s degree in electrical or computer engineering with three years of experience in the field of display technology or a master’s degree with one year of experience in the field of display technology.” Pet. 8 (citing Ex. 1002 ¶¶ 38‒41). Patent Owner, “[f]or purposes of th[e]” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“5. Analysis Claim 1 recites “in a peripheral region of the image display region on the element substrate, a plurality of external circuit connection terminals, a plurality of main wiring lines . . . and peripheral driving circuits.” Ex. 1001, 21:55‒60. The plain and ordinary meaning of this phrase includes that the plurality of main wiring lines and peripheral driving circuits are formed on the element substrate. Claim 1 further recites, for the main wiring lines, “each having one end coupled to each of the plurality of external circuit connection terminals, and peripheral driving circuits coupled to the other ends of the main wiring lines.” Id. at 21:57‒59. The plain and ordinary meaning of this phrase is that each main wiring line is connected at one end to an external circuit connection terminal and, at the other end, to the peripheral driving circuits; this is how Petitioner addresses “a plurality of main wiring lines” as to this portion of claim 1 in accordance with the plain and ordinary meaning. Pet. 15 (“Figure 4 shows wiring lines coupled to the external connection terminals 102 at one end and coupled to peripheral circuits, including data line driving circuit 101, and scanning line driving circuit 104, at the other.”); see also Ex. 1002 ¶ 59. Petitioner and its driving circuit 104 as peripheral circuits. Pet. 15‒16 (citing Ex. 1005 ¶¶ 1, 78‒80, Fig. 4; reproducing Fig. 4 without annotation); Ex. 1002 ¶¶ 56‒59.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“Petitioner fails, however, to address the clause, “which is at least one of the plurality of main wiring lines,” and the implication that follows from the plain language of the claim. Id. Specifically, as set forth above, the “plurality of main wiring lines” are coupled at one end to peripheral circuits, and Petitioner provides no basis for the wiring 400 (LCCOM) to be coupled to any element identified by Petitioner as a peripheral circuit. Id. at 15‒17 (identifying data line driving circuit 101 and scanning line driving circuit 104 as peripheral circuits). Rather, Petitioner sets forth that wiring 400 (LCCOM) “supplies potential from the external input terminal 102 to the vertical conduction terminal 106 and then to the counter electrode 21 on the counter substrate 20.” Id. at 17 (citing Ex. 1005 ¶ 85, Figs. 3, 4; Ex. 1002 ¶¶ 63‒65). Further, to the extent Petitioner states that Muraide “discloses a counter electrode provided in the peripheral region on a counter substrate that is arranged to face the element substrate” (id. at 16 (citing Ex. 1005 ¶ 41; Ex. 1002 ¶¶ 60‒62)), Petitioner does not clearly identify the counter electrode as a peripheral circuit (id.) and, further, the counter electrode on the counter substrate is not a peripheral driving circuit on the element (“in a peripheral region of the image display region on the element substrate, . . . peripheral driving circuits” (emphasis added))). Accordingly, on this record, we determine that Petitioner fails to sufficiently establish “a counter electrode potential line that supplies counter electrode potential to the counter electrode, which is at least one of the plurality of main wiring lines.” Although Patent Owner did not clearly raise this particular issue, “[i]n an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic, 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3)). The burden of persuasion, whether for anticipation or for unpatentability for obviousness, never shifts to Patent Owner. See Dynamic Drinkware, 800 F.3d at 1378. Further, our role is not to remedy the deficiencies in Petitions that fall short. Sirona Dental Sys. GMBH v. Institut Straumann AG, 892 F.3d 1349, 1356 (Fed. Cir. 2018) (quoting SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1356–57 (2018)) (explaining that because “‘the petitioner’s contentions, not the Director’s discretion, define the scope . . . [,]’ [i]t would thus not be proper for the Board to deviate from the grounds in the petition and raise its own obviousness theory” “institut[ing] a different inter partes review”); cf. Magnum Oil Tools, 829 F.3d at 1380–81 (rejecting an argument that the Board properly “ma[de] an obviousness argument on behalf of [petitioner]” that “could have been included in a properly-drafted petition,” because “petitioner . . . bears the burden of proof”).” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,116,390 - 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 - Apple Inc. v. Masimo CorporationInstitution deniedPTAB · Jan 24, 2023 · IPR2022-01274 · APJ Josiah C Cocks · IPR · Institution
The Board denied institution because Apple did not show a reasonable likelihood that claims 1–30 were obvious over the proposed prior-art combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“under the statutory grounds it identifies. 37 C.F.R. § 42.104(b)(4). Petitioner bears the burden of demonstrating a reasonable likelihood that it would prevail with respect to at least one challenged claim for a petition to be granted. 35 U.S.C. § 314(a).” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not dispute this proposed level of skill. Prelim. Resp. 10. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the prior art and the ’502 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“in light of the specification. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1279–80 (Fed. Cir. 2017). Thus, we give claim terms their ordinary and customary meaning as understood by an ordinarily skilled artisan. See Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Only terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017). Neither party offers any express construction for any claim term. See Pet. 4; Prelim. Resp. 9. We determine that all claim terms should be given their ordinary and customary meaning and that it is unnecessary to make that meaning explicit for any term.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentableNot shown unpatentable
“Although it is certainly the case that an obviousness analysis may take into account the inferences and creative steps that a skilled artisan might glean from the teachings of the prior art (see, e.g., KSR , 550 U.S. at 418), one must be cognizant that “hindsight is not an available analytical mechanism to show obviousness.” See In re Omeprazole Patent Litig., 483 F.3d 1364, 1381 (Fed. Cir. 2007) (Newman, J., dissenting). Indeed, “we patches into something that is the claimed invention.” See Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017). Without the guidance provided by the claims of the ’502 patent, it is difficult to conclude that Petitioner’s postulation as to a particular structure that results from combining the teachings of Lumidigm, Kotanagi, and Scharf is based on an objective assessment of what those teachings would have conveyed to a skilled artisan. It is clear from the Petition, however, that such structural configuration is necessary as the basis for Petitioner’s approach to arriving at the structural requirements of the claims.9 At the outset, we share Patent Owner’s view, and that of its declarant, Dr. Duckworth (Ex. 2002), that none of the prior art on which Petitioner relies discloses a convex protrusion with multiple openings or windows for multiple detectors. See, e.g., Prelim. Resp 28–29; Ex. 2002 ¶ 76. As discussed above, Petitioner attempts to arrive at such structure through a proposed amalgamation of prior art teachings that must include, for instance, arranging a convex protrusion with multiple openings or separate glass windows over Lumidigm’s optical sensors. In our view, however, Petitioner simply does not explain adequately why such configuration results from the actual teachings of the prior art.” slip op. at 15
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,912,502 - Apple Inc. v. Masimo CorporationInstitution deniedPTAB · Jan 24, 2023 · IPR2022-01273 · APJ Josiah C Cocks · IPR · Institution
Institution was denied for claims 1–30 because Apple did not show a reasonable likelihood of prevailing on either proposed obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Based on the record here, we conclude that Petitioner has not shown a reasonable likelihood of success based on any of the proposed grounds that involve the combined teachings of Mendelson-799, Aizawa, Ohsaki, and Scharf.12” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends the following in connection with a person of ordinary skill in the art: A person of ordinary skill in the art relating to the subject matter of the ’502 Patent as of July 3, 2008 (“POSITA”) would have been a person with a working knowledge of physiological monitoring technologies. The person would have had a Bachelor of Science degree in an academic discipline emphasizing the design of electrical, computer, or software technologies, in combination with training or at least one to two years of related work experience with capture and processing of data or information, including but not limited to physiological monitoring technologies. Alternatively, the person could have also had a Master of Science degree in a relevant academic discipline with less than a year of related work experience in the same discipline. Pet. 4 (citing Ex. 1003 ¶¶ 22–23). Resp. 10. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the prior art and the ’502 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“35 U.S.C. § 282(b) “including construing 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.” 37 C.F.R. § 42.100(b). When applying that standard, we interpret the claim language as it would have been understood by one of ordinary skill in the art in light of the specification. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1279–80 (Fed. Cir. 2017). Thus, we give claim terms their ordinary and customary meaning as understood by an ordinarily skilled artisan. See Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Only terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017). Neither party offers any express construction for any claim term. See Pet. 4; Prelim. Resp. 9. We determine that all claim terms should be given their ordinary and customary meaning and that it is unnecessary to make that meaning explicit for any term.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableMotivation not foundNot shown unpatentable
“Although it is certainly the case that an obviousness analysis may take into account the inferences and creative steps that a skilled artisan might glean from the teachings of the prior art (see, e.g., KSR , 550 U.S. at 418), one must be cognizant that “hindsight is not an available analytical mechanism to show obviousness.” See In re Omeprazole Patent Litig., 483 F.3d 1364, 1381 (Fed. Cir. 2007) (Newman, J., dissenting). Indeed, “we cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention.” See Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017). Without the guidance provided by the claims of the ’502 patent, it is difficult to conclude that Petitioner’s postulation as to a particular structure that results from combining the teachings of Mendelson-799, Aizawa, Ohsaki, and Scharf is based on an objective assessment of what those teachings would have conveyed to a skilled artisan. It is clear from the Petition, however, that such structural configuration is necessary as the basis for” slip op. at 18
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,912,502 - Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research FoundationInstitution deniedPTAB · Jul 15, 2022 · PGR2022-00021 · APJ Sheridan K Snedden · PGR · Institution
The Board denied institution on Grounds 1–5 under § 325(d) and found Ground 6 had not shown any challenged claim more likely than not unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“met (e.g., substantially the same art is presented), we move to part two of the framework, asking “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. at 8. Factors (c), (e), and (f) of Becton, Dickinson fall within part two of the framework. Id. at 10 (“[F]actors (c), (e), and (f) relate to whether the petitioner has demonstrated material error by the Office.”). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Id. at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute.” Id. at 8–9. “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9 (“If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“specific citations to evaluate its assertions, Petitioner does not direct our attention to any portion of the Nordgren Declaration providing information on why the partial sequences disclosed by the references teach or suggest the claimed 90% sequence homology. Pet. 76, 79 (citing Ex. 1026 at VII.C, ¶¶ 247–269). For example, Dr. Nordgren’s assertion “a POSITA would anticipate natural genetic variation of PorkNW2/USA/2009 ORF2 would bring it within the scope of the Claim 1 genera” is not supported by substantial evidence. Ex. 1026 ¶ 256. Claim 1, for example, recites a PCV3 protein and does not recite partial proteins. Without knowing what portion of complete proteins are disclosed by the references, we are not persuaded that a person of ordinary skill in the art would have been able to predict the variation expected among a group of complete proteins to arrive at the claimed subject matter as is implied by Petitioner. Petitioner’s conclusory statements are insufficient to support a legal conclusion of obviousness. And while we agree with Petitioner that the protein sequences disclosed in the cited references do not necessarily have to be designated as PCV3 sequences, we determine that Petitioner has failed to meet its burden to demonstrate that any of the PCV3 deposit references teach or suggest the recited sequences within the claimed range. Pet. 79. Therefore, Petitioner has not met its burden in showing that every claimed element is taught by its cited references, and we need not reach Petitioner’s argument on motivation to combine. Accordingly, we determine that Petitioner fails to carry its burden to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable based on Petitioner’s Ground 6.” slip op. at 25
- Skill levelSkill level petitioner adoptedOther
“A person of ordinary skill in the art (or “POSITA”) in the field of the ’274 Patent in the October 2015 to October 2019 timeframe would have held a Doctorate in Veterinary Medicine (D.V.M.) or equivalent, or a Ph.D. or equivalent in immunology, vaccinology, virology, molecular biology, animal science, and/or husbandry, or a closely related field. A POSITA would also have practical knowledge of immunology, including how vaccine candidates are first identified and then subsequently developed. The knowledge may come from the POSITA’s own experience, or it may come through research or work collaborations with other experienced individuals in the medical, pharmaceutical, or biotech industry, e.g., as members of a research team or group. Pet. 16 (citing Ex. 1026 ¶ 34). Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Board applies 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. § 42.200(b) (2019). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that it “does not believe any term of the ’274 Patent needs to be construed in this proceeding.” Pet. 29. We agree and independently determine that it is unnecessary to expressly construe any claim term for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,954,274 - Jupiter Research, LLC v. VPR Brands, L.P.Institution deniedPTAB · Jul 12, 2022 · IPR2022-00299 · APJ Jo-Anne M Kokoski · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 13–18 were unpatentable over the asserted prior-art grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“It is the petitioner’s burden from the outset to show with particularity why a challenged claim is unpatentable. Harmonic Inc. v. Avid Tech. Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). In that regard, a petition for inter partes review must identify how the challenged claims are unpatentable, and must specify where each element of the claim is found in the relied-upon prior art. 37 C.F.R. § 42.104(b); see also 35 U.S.C. § 312(a)(3) (a petition must identify “with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for challenge to each claim”). A petition must also include “a detailed explanation of the significance of the evidence including material facts, and the governing laws, rules, and precedent.” 37 C.F.R. § 42.22(a)(2). Here, Petitioner contends that the “airflow sensor having elements (401), (403), (404), (405), and (406)” is “electronic at least in that it includes contact piece (404) and piece (403) that is connected to the integrated circuit board (3),” but does not provide a detailed explanation of the significance of the location of contact pieces 403 and 404, or how elements 401, 403, 404, 405, and 406 form an electric airflow sensor. Pet. 47–48 (citing Ex. 1009, 8), 54–55 (same). Zhu teaches that “integrated circuit board 3 is provided with two fixed contact pieces 403 and 404 that extend toward the elastic ring 401.” Ex. 1009, 8. Zhu further teaches that elastic ring 401 is fixed in plastic base 405, and that “fixed contact pieces 403 and 404 are fixed outside the plastic base 405.” Id. Considering the disclosures in Zhu regarding the arrangement and operation of these elements, Petitioner’s conclusory statement that Zhu teaches an electric airflow sensor simply because contact” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A. Level of Ordinary Skill in the Art Petitioner contends that a person having ordinary skill in the art “would have had a bachelor’s degree in electrical engineering, mechanical engineering, chemical engineering, or a closely related field and one to two years of experience working in the consumer electronics or computer industry in the capacity of a design, application, customer marketing or technical marketing engineer.” Pet. 11 (citing Ex. 1004 ¶ 58). At this stage of the proceeding, Patent Owner neither responds to Petitioner’s proposed definition, nor provides a definition of its own. See generally, Prelim. Resp. Petitioner’s undisputed proposed definition appears to be consistent with the cited prior art and the disclosure of the ’622 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“The parties stipulated to the construction of many claim terms in their related litigation currently pending in the District of Arizona. Pet. 11–12; Prelim. Resp. 12; Ex. 1006. Based on the parties’ apparent agreement, and considering the record before us, we adopt the parties agreed-upon claim constructions for purposes of this Decision. See Ex. 1006 (stipulated claim construction proposed in the district court). We provide the constructions of “electric airflow sensor” and “detecting an airflow,” which are of particular relevance to this Decision, below. “electric airflow sensor” an electric sensor to detect air movement generated by a user’s inhaling or puffing act “detecting an airflow” determining that a user is inducing airflow into or out of the device Ex. 1006, 2, 3.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“To establish anticipation, each and every element in a claim, arranged as recited in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008); Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). Here, Petitioner neither directs us to an express disclosure in Cox that air flow detecting device 51 is an electric airflow sensor as required by claim 13, nor adequately explains that a person of ordinary skill in the art would have understood Cox as disclosing an electric airflow sensor, and could have combined Cox’s disclosures with their own knowledge to make the claimed invention. See Helifix Ltd. v. Bloc-Loc, Ltd., 208 F.3d 1339, 1347 (Fed. Cir. 2000) (A reference that does not expressly disclose a claimed limitation “might nevertheless be anticipating if a person of ordinary skill in the art would understand [the reference] as disclosing [the limitation] and if such a person could have combined the [reference’s] description of the invention with his own knowledge to make the claimed invention.”). We also do not understand Petitioner to be arguing that Cox inherently discloses an electric airflow sensor. See In re Montgomery, 667 F.3d 1375, 1379 (Fed. Cir. 2012) (“A reference may anticipate inherently if a claim limitation that is not expressly disclosed is ‘necessarily present, or v. Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010))). For these reasons, we are not persuaded that Petitioner sufficiently establishes that Cox discloses “an electric air flow sensor that is used to turn on and off the electric power source by way of detecting an airflow” as recited in independent claim 13. Accordingly, we determine that the Petition does not establish a reasonable likelihood that Petitioner will prevail in showing that claim 13, and claims 14 and 15 that depend therefrom, are anticipated by Cox.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 8,205,622 - 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.
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
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.