- Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“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.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 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)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166 - Symrise AG / Symrise Inc. v. Inolex Investment CorporationAll claims unpatentablePTAB · Nov 1, 2024 · IPR2023-01035 · APJ Tina E Hulse · IPR · Final written decision
The Board granted cancellation of claims 1–6, 8–10, and 22–28, and denied substitute claims 29–44 because Wright ’451 rendered them obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention (“POSA” or “POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner took no position on the level of ordinary skill in the art in its Preliminary Response. Prelim. Resp. 8. In our Institution Decision, we adopted Petitioner’s definition. Dec. Inst. 6–7. In its Motion to Amend, Patent Owner states that it accepts the Board’s definition for purposes of this proceeding. MTA 24. We, therefore, see no reason to disturb our definition of the level of ordinary skill in the art as it appears to be consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Although neither party expressly proposes a construction for the term “conversion,” the parties appear to differ in their interpretations of that term. Petitioner interprets “conversion” to mean the percent conversion of the 1- alcohol. See Pet. Opp. RMTA 6–7 (interpreting “conversion” as percentage of remaining 1-alcohol); Ex. 1040, 109:2–11. Patent Owner, on the other hand, interprets “conversion” to mean the total percentage of alkenes that have been produced. Ex. 2010 ¶ 123 (interpreting “conversion” as percentage of total alkenes). During oral argument, counsel for Patent Owner conceded that “conversion can mean either.” Tr. 27:18–28:13. Without the benefit of briefing by the parties, we decline to expressly construe the term “conversion,” as our Decision would be the same under either interpretation, as discussed further below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (finding only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). Moreover, we do not find it necessary to expressly construe any other claim terms for purposes of this Decision. Id.” slip op. at 10
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“2. Analysis A patent 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 said claimed invention pertains. See also 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 skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Objective evidence of nonobviousness may include” slip op. at 13
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner
“We are not persuaded. “[A]ny superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). We must, therefore, first consider what results were expected to determine what a POSA would have considered to be unexpected. Id. As seen by the table below, Wright ’451’s disclosure fully encompasses the temperature ranges and purported unexpected results recited by substitute claim 29 and shown in Table 2 of the ’048 Patent: Reference Reaction Calcination Conversion Regioselectivity Rate13 Temperature Temperature Wright ’451 about 220 °C about 200 °C greater than about 90% to to about to 600 °C about 95% about 99% 440 °C Substitute 240 °C to about 420 °C at least 95% to about Claim 29” slip op. at 23
Patent outcomesUS 10,995,048 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,995,048 - Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentablePTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision
Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32
Patent outcomesUS 11,278,505 unpatentableClaim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,278,505 - Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.”” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - Foresight Diagnostics, Inc. v. Personalis, Inc.All claims unpatentablePTAB · Jun 12, 2024 · IPR2023-00317 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–23 are unpatentable: claims 1–7 and 10–23 as anticipated by Forshew, and claims 1–23 and 1–9 and 11–23 as obvious over Forshew with Wagle and Wagle with Chan, respectively.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner has not subsequently challenged the above definition. See Ex. 2031 ¶ 48 (Dr. Furneaux applying the above definition). For the reasons set forth in our Institution Decision, and because Petitioner’s proposed level is commensurate with the level of skill reflected in the prior art of record, we apply the same definition here. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). C. Claim Construction” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“adopt Petitioner’s proposed definition of “capture probes” as encompassing at least, “PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” See DI 18–24. For the reasons set forth in our Institution Decision, and as further addressed below, we apply that definition here—albeit with a minor modification in wording. In particular, we credit Patent Owner’s argument that the phrase “PCR primer capture probe” is not a recognized term of art and its use in our construction “would improperly inject ambiguity into the claim.” POR 58– 59 (citing, e.g., Ex. 2018, 166:10–169:1, 171:16–175:2; Liquid Dynamics Corp. v. Vaughan Co., 355 F.3d 1361, 1367 (Fed. Cir. 2004)). Although we recognize Petitioner’s use of “PCR primer capture probe” as a shorthand for its position that, as read in light of the Specification, PCR primers are a species of, and/or indistinguishable from, the genus of capture probes, Patent Owner’s point is well taken. Accordingly, we clarify the meaning of “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). We do not view this modification as altering the substance of our provisional construction or the analysis in our Institution Decision.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“Ex2112, slide 5 for the ‘plurality of capture probes’ limitation of step 1(a),” Petitioner contends that its “bare reference to ‘pullout’” suggests at most, “that by May 2012, Mr. West contemplated that a particular type of capture probe would be among many other ‘lab solutions’ for addressing accuracy.” Reply 7–8; see Ex. 1225 ¶¶ 123–126. In this respect we note Mr. West’s testimony that he understood “pullout” in Slide 5, as a reference to Agilent SureSelect biotinylated probe system. See Ex. 1222, 83:8–85:22, 88:7–16. We, nevertheless, find persuasive Dr. Quackenbush’s testimony that “a POSA reviewing Slide 5 in light of the overall record on conception would have insufficient information to determine how, specifically, Personalis intended to use the ‘Pullout,’ other than that their purpose was to provide a laboratory solution to improve the accuracy of 2012 sequencing technology in some way.” Ex. 1225 ¶ 125. Considering the evidence of record, we credit Dr. Quackenbush’s testimony that a person of ordinary skill in the art reading Personalis’ conception exhibits, including Exhibit 2112, “would have found, at most, an incipient research project for improving the accuracy of sequencing technology that would involve the use of an undefined combination of various conventional techniques.” Ex. 1225 ¶ 128. In addition to Dr. Quackenbush’s testimony as to claim steps involving capture probes (elements 1(a)–1(c)), we further find persuasive his testimony that Patent Owner provides no corroboration of the conception of steps 1(d)–1(f), which require assaying samples obtained from the same individual obtained at different time points. See id. ¶¶ 120–121, 126–127; Reply 9–10; Sur-Reply 6–8 (citing, e.g., Ex. 2032 ¶¶ 91–134; Ex. 2109; Ex. 2112; Ex. 2036). In sum, we find that Personalis’ exhibits and related testimony do not evidence sufficient conception of the invention set forth in the challenged claims. See, e.g., Ex. 1225 ¶¶ 120–128 (Dr. Quackenbush’s testimony about missing aspects of the claims in Patent Owner’s proofs, such that the “completed thought” is not shown).15 Considering the above, we find that Patent Owner has not satisfied the burden of establishing that its claimed invention is entitled to a priority date that precedes either of the respective publication dates of Forshew and Chan. Accordingly, Forshew and Chan qualify as prior art to the ’033 patent.” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In Section II.C. above, we construe “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). Accordingly, in disclosing the use of PCR primers, Forshew discloses “capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification. See Pet. 29–33 (citing Ex. 1020 ¶¶ 117–122; Ex. 1030, 2–3). Forshew further satisfies the “plurality of capture probes” “COSMIC: mining complete cancer genomes in the Catalogue of Somatic Mutations in Cancer,” 39 NAR D945-950 (2011)). limitation in disclosing the use of PCR primers for the detection and monitoring of cancer-associated alleles. See, e.g, id.; Ex. 1020, 3 (“We designed 48 primer pairs to amplify 5995 bases of genomic sequence covering coding regions (exons and exon junctions) of TP53 and PTEN, and selected regions in EGFR, BRAF, KRAS, and PIK3CA (table S1) by overlapping short amplicons (Fig. 1A).”). For the reasons set forth above, Petitioner has sufficiently shown that Forshew discloses “capture probes” and “a plurality of capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification.” slip op. at 36
Patent outcomesUS 11,408,033 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,408,033 - Foresight Diagnostics, Inc. v. Personalis, Inc.All claims unpatentablePTAB · Jun 12, 2024 · IPR2023-00224 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over Leary, Chan, and Liao; the Board also found claims 1–11 and 13–19 unpatentable over Leary.
RulingsFinal written decision- Skill levelDecided for petitioner
“B. Level of Ordinary Skill in the Art” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“7. Objective Indicia of Non-Obviousness Objective indicia of non-obviousness may include long-felt but unsolved need, failure of others, unexpected results, commercial success, copying, licensing, industry praise, and expert skepticism. Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1379 (Fed. Cir. 2012). “[O]bjective indicia ‘may often be the most probative and cogent evidence of nonobviousness in the record,’” and “help turn back the clock and place the claims in the context that led to their invention.” Id. at 1378. Evidence of objective indicia of non-obviousness “must always when present be considered en route to a determination of obviousness.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012); see also Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048 (Fed. Cir. 2016) (en banc). Such evidence, however, does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 1372 (Fed. Cir. 2007). (“Here, the record establishes such a strong case of obviousness that Pfizer’s alleged unexpectedly superior results are ultimately insufficient.”)” slip op. at 53
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826 (CCPA 1968). Moreover, a precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. KSR, 550 U.S. at 418. 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) (quotations and citations omitted).” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826 (CCPA 1968). Moreover, a precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. KSR, 550 U.S. at 418. 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) (quotations and citations omitted).” slip op. at 9
Patent outcomesUS 11,384,394 unpatentable§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,384,394 - Platinum Optics Technology, Inc. v. Viavi Solutions Inc.All claims unpatentablePTAB · Apr 11, 2024 · IPR2022-01489 · APJ Sharon Fenick · IPR · Final written decision
Claims 1–19 are unpatentable: Hendrix anticipates them, and the listed combinations also render their respective claims obvious.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“In the Decision on Institution, we adopted a slightly modified version of this definition in which we removed the open-ended term “at least.” Inst. Dec. 10–11. Patent Owner does not address the definition of a POSA. See generally PO Resp. Patent Owner’s declarant Dr. Clemens applies Petitioner’s definition, but does not opine on whether it is correct. Ex. 2001 ¶¶ 22–23. As in the Decision on Institution (Inst. Dec. 10), we apply the same slightly modified version of Petitioner’s definition of the level of ordinary skill in the art that removes the open-ended term “at least.” 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” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“filter comprises “a third set of layers on the second side, whether the third set of layers includes oxygen.” Ex. 1001, 10:41–49. Petitioner argues that the proper construction of this limitation “means that there is a third set of layers on the opposite side of the substrate, whether or not [the layers] include oxygen” – i.e., that the third set of layers do not need to include oxygen. Pet. 7–8. Patent Owner agrees that this is the “literal” reading of the language, but contends that one of ordinary skill in the art “would have appreciated that this language was intended to read ‘wherein’ rather than ‘whether’” and that the claim requires that this set of layers must include oxygen. PO Resp. 24–26 (citing Ex. 2001 ¶¶ 53–55). We agree with Petitioner’s representation that each of the challenges presented either anticipates or renders obvious a third set of layers with oxygen on a second side of a substrate (Pet. 8) and therefore, no claim construction is necessary for this term. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“415 F.3d at 1314): “a first set of layers on the first side, wherein the first set of layers includes silicon and hydrogen” (claim 1) and “a first set of layers including silicon and hydrogen” (claims 9 and 15). Ex. 1001, 10:41–49, 10:65–11:4, 11:17–12:5. As the parties agree, these recitations are broadly worded. See Pet. 14 (describing the recitations of the claims as “broad” and directed to “layers of any material that has both ‘silicon and hydrogen’”); PO Resp. 42 (describing the claims as “simply specifying physical layers including silicon and hydrogen in them”), 44 (describing the disputed terms as “open-ended claiming of layers including hydrogen and silicon”). Despite this broad language, Patent Owner contends that we must read “layers including silicon and hydrogen” in conjunction with other limitations in the claims reciting a “near infrared bandpass filter.” PO Resp. 35–37 (citing Ex. 2001 ¶¶ 65–66). For purposes of our analysis, we limit “layers including silicon and hydrogen” to only materials suitable for NIR bandpass filters, as suggested by Patent Owner. We next examine the rest of the intrinsic evidence. The specification of the ’794 patent does not contain language that generally describes “layers including silicon and hydrogen.” Instead, the specification describes only layers of hydrogenated silicon: its abstract is directed to an “optical filter” that “includes a filter stack formed of hydrogenated silicon layers” (Ex. 1001, code (57)); the technical field of the invention is described as “relat[ing] to optical filters including hydrogenated silicon layers and to sensor systems comprising such optical filters” (id. at 1:20–23); the summary of the invention describes “the present invention” as an optical filter or sensor system “comprising” “a plurality of hydrogenated silicon layers” (id. at 2:57–3:19); and the detailed description begins with a hydrogenated silicon (Si:H) layers” (id. at 4:19–20). The specification only mentions silicon and hydrogen separately with respect to the disclosed sputter-deposition system “used to produce the hydrogenated silicon material.” Id. at 4:35–5:61, 7:10–19. In particular, the specification describes how “cathode 430 includes a silicon target 431, which is sputtered in the presence of hydrogen (H2), as well as an inert gas such as argon, to deposit the hydrogenated silicon material as a layer on the substrate 420.” Id. at 4:44–47. The specification also describes how altering the hydrogen flow rate in the deposition process affects the optical properties of hydrogenated silicon produced by the deposition system. See id. at 5:1–61. But the only end product described from the sputter-deposition process using silicon and hydrogen is hydrogenated silicon. See id. at 4:35–5:61, 7:10–19. As such, the specification does not provide any indication of materials beyond hydrogenated silicon that are within the scope of “layers including silicon and hydrogen.”” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“hydrogen” defines a genus. The test for providing a written description that supports a genus claim is whether the description provides “either a representative number of species falling within the scope of the genus or in the art can ‘visualize or recognize’ the members of the genus.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc). “Regarding whether common structural features must exist between a claim and a putative priority disclosure, those features must constitute the near-entirety of the structures being compared.” Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 1358 (Fed. Cir. 2023). Yet the patentees only disclosed hydrogenated silicon as a possible species. Indeed, the specification focuses on a singular example of a sputterdeposition system that is used to produce an improved hydrogenated silicon material. See Ex. 1017 ¶¶ 36–38. Patent Owner cites this deposition process as written description support for “the claimed layers containing silicon and hydrogen.” See PO Resp. 44. But this example supports only how to make hydrogenated silicon and does not include any indication about what other materials would be within the scope of the claimed genus. Under these circumstances, the specification’s disclosure of a single species is not an adequate number to show possession of the entire genus of “layers including silicon and hydrogen.” Beyond the disclosure of the sputter-deposition process for producing hydrogenated silicon, Patent Owner does not identify—and we cannot discern—any other examples of a “structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Ariad, 598 F.3d at 1350. This is particularly noteworthy given that undisputed record evidence shows numerous other potential filter materials “including silicon and hydrogen.” See supra § II.D.1.a. In the absence of structural description supporting “layers including silicon and hydrogen,” we determine that an” slip op. at 19
Patent outcomesUS 11,131,794 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites GrahamPatents in suitUS 11,131,794 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00566 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Owner and its experts proposed claim construction of “effectively treating” as meaning “noninferior,” “statistically noninferior,” or “comparable.” Pet. Reply 4. Petitioner asserts that Patent Owner, and its expert, Dr. Do, advance the proposed construction of “effectively treating, ” with no explanation for what that means, or how it comports with the challenged dependent claims that recite visual acuity limitations ranging from losing less than 15 letters to gaining more than 15 letters. Id. at 4–5.” slip op. at 32
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00533 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Id. at 18. The similar language of the challenged claims of the ’601 patent, and our reasoning in the related -00881 Decision, compel the same conclusion here, i.e., that the preamble is limiting upon the claims.” slip op. at 43
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01226 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the remaining grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“challenged claims are thus anticipated, we do not reach the additional Grounds 2–7 proposed in the Petition. Furthermore, Petitioner’s Motion to Exclude Evidence is granted-in-part, denied-in-part and dismissed-in-part. Patent Owner’s Motion to Exclude Evidence is denied-in-part and dismissed-in-part.” slip op. at 92
Patent outcomesUS 10,888,601 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601
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.