- Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision
The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77
- ExcludeMotion to exclude, deniedDenied
“A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29
- Skill levelSkill level board ownOther
“Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26
- Expert testimonyPetitioner expert discountedDecided for patent owner
“With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25
Patent outcomesUS 10,766,685 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685 - PTAB · Jun 13, 2023 · IPR2023-00224 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–19 on all three asserted § 103 grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Contrary to Patent Owner’s assertion that Petitioner seeks to describe “a person of exceptional skill,” Petitioner’s proposed definition merely indicates that one of ordinary skill in the art would have “an understanding” of relevant techniques and methods in the art. See id. at 12; Pet. 8. In particular, we read the “understanding” language of Petitioner’s proposed definition to take into account the level of skill in the art as reflected in the prior art of record—including the asserted art and that cited on pages 12–14 of Patent Owner’s Preliminary Response. Cf. 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)). In addition to an understanding of the relevant art, the parties are, nonetheless, welcome to address at trial whether one of ordinary skill in the art would have had actual experience with next generation sequencing techniques, the analysis of NGS data, and/or some level of specialization in the field of bioinformatics.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In considering the scope of “whole genome sequencing” we take particular note of the Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35–58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42). In this respect, we find it pertinent that Leary’s PARE studies began with sheared genomic DNA, and presumably resulted in non-targeted, randomly-distributed sequencing reads throughout the genome.10 We also find it pertinent that Forshew, a contemporary of Leary, described the matepaired technique as employed in Leary’s PARE approach as whole genome sequencing. Ex. 1030, 10. In light of the evidence and argument presently of record, we preliminarily interpret “whole genome sequencing,” as used in claim step 1(b), to mean “a non-targeted approach to sequencing all or almost all of a genome.” The panel may reconsider on the more complete record developed at trial, whether one of ordinary skill in the art would have understood that Leary’s mate-paired / PARE approach to detecting genomic rearrangements to teach or suggest sequencing all or almost all of the genome. See Ex. 1020” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“More importantly, in determining obviousness, “a reference . . . is prior art for all that it teaches.” Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989). Considering the comparison of serial tumor samples illustrated in Ley’s Figure 3, and the related testimony of Dr. Quackenbush (Ex. 1020 ¶¶ 81–82), we presently agree with Petitioner that one of ordinary skill in the art reading Ley, “would have been motivated to include known mutations (such as those derived from a database of known cancer mutations) in a panel of polymorphisms for serial monitoring at multiple time points; and (ii) that a POSA would have had a reasonable expectation of success in successfully monitoring such polymorphisms.” See Pet. 56–57. And to be clear, at this stage of the proceeding, Patent Owner presents no credible evidence of teaching away. For the reasons set forth with respect to Leary in Ground 1, and having further considered the arguments and evidence with respect to the combination of Leary and Ley in Ground 2, we determine that Petitioner has demonstrated a reasonable likelihood that claims 1–11 and 13–19 are unpatentable in view of Leary and Ley.” slip op. at 36
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,384,394 - PTAB · Jun 13, 2023 · IPR2023-00317 · APJ Robert A Pollock · IPR · Institution
The Board instituted inter partes review of claims 1–23 on all petitioned grounds after finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“record, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one challenged claim of the ’033 patent is unpatentable. We therefore institute trial on all challenged claims under the grounds raised in the Petition. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (indicating that a decision whether to institute an inter partes review “require[s] a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.”); Guidance, 2–3; 37 C.F.R. § 42.108. At this stage of the proceeding, we have not made a final determination with respect to the patentability of any of the challenged claims.” slip op. at 40
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Contrary to Patent Owner’s assertion that Petitioner seeks to describe “a person of exceptional skill,” Petitioner’s proposed definition merely indicates that one of ordinary skill in the art would have “an understanding” of relevant techniques and methods in the art. See id. at 10; Pet. 6. In particular, we read the “understanding” language of Petitioner’s proposed definition to take into account the level of skill in the art as reflected in the prior art of record—including the asserted art and that cited on pages 10–12 of Patent Owner’s Preliminary Response. Cf. 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)). In addition to an understanding of the relevant art, the parties are, nonetheless, welcome to address at trial whether one of ordinary skill in the art would have had actual experience with next generation sequencing techniques, the analysis of NGS data, and/or some level of specialization in the field of bioinformatics.” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In view of the above, we preliminarily conclude that one of ordinary skill reading the ’033 patent would understand that there is no discernable physical distinction between capture probes and amplification primers, and that Patent Owner’s functional distinction—hybridizing to target DNA so as to form subsets of molecules that are/are not hybridized—is a commonly desired trait for nucleotides used as in hybridization-based methods including PCR. Considering the argument and evidence presently of record, we agree with Petitioner that the claimed “capture probes” encompass, at a minimum,10 PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Forshew’s capture probes hybridize to a plurality of polymorphisms because, upon replication, its PCR primers hybridize to DNA fragments containing a plurality of polymorphisms, for example, known point mutations in cancer-related genes. Patent owner, by contrast, more narrowly interprets claim step 1a as requiring that, absent replication, the nucleotide sequence of Forshew’s PCR primers must, encompass and hybridize to, polymorphic target sites. This issue may benefit from further exploration at trial. For the purpose of institution, however, we rely on Dr. Quackenbush’s testimony that one of ordinary skill in the art would have “understood that Forshew’s PCR primer capture probes are the claimed ‘capture probes’ because they are nucleic acid sequences that ‘hybridize to’ the complementary sequences on the nucleic acid harboring the polymorphic gene.” Ex. 2020 ¶ 121; see also id. ¶¶ 119–120, 122–123.” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,408,033 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision
Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “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 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24
Patent outcomesUS 10,900,034 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,900,034 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00402 · APJ Michael A Valek · IPR · Final written decision
Claims 1–30 are unpatentable: claims 1–7, 9, 10, 12–15, 17, 18, 20–25, and 27–30 are anticipated; the remaining challenged claims are obvious.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Petitioner further asserts that “[a] POSA would have understood the chemical structure of nucleic acids, such as DNA and RNA, and would have understood the role of such nucleic acids in cellular biology” and been aware of various prior art “methods to chemically modify RNA, including gRNAs for use in gene regulation.” Id. at 12–13 (citing Ex. 1003 ¶¶ 61–72, 80). Patent Owner agrees that a POSA would have this educational level. Resp. 24. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties may disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“Independent claims 1 and 12 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to a target polynucleotide.” Ex. 1001, 243:20–22, 244:28–31. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 17 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 17. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:36–40. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 12. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24–25. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “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 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We find Petitioner’s arguments and evidence persuasive. It is well established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 24–26. There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. Smithkline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 21
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional. Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 79 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 79, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 23
Patent outcomesUS 10,337,001 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,337,001 - Slayback Pharma LLC v. Eye Therapies, LLCAll claims unpatentablePTAB · May 15, 2023 · IPR2022-00142 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–6 are unpatentable as obvious over Gil, Norden, Dean, Alphagan, and Federal Register; anticipation over Gil and Walters was not shown for claims 1–2.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Although the parties disagree as to the specific qualifications of a person of ordinary skill in the art, the parties’ experts agree that their Ex. 1049 ¶ 6 (Sher); Ex. 2020 ¶ 28 (Noecker); Ex. 2021 ¶ 34 (Williams); Ex. 2022 ¶ 23 (Davies). Both parties’ proposed definitions and the prior art of record indicate a high level of skill in the relevant art. Because the parties’ respective experts agree that any dispute as to the level of ordinary skill in the art is not material to their opinions, we adopt Patent Owner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Ex. 2020 ¶¶ 28–31; see also 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
- Expert testimonyPetitioner expert creditedOther
“We are not persuaded. We credit the testimony of Petitioner’s expert, Dr. Sher, who explains that because of the “high degree of imprecision of Figures 2 and 6,” a POSA would be unable to reach any quantitative conclusions from the figures or “clinically distinguish” between brimonidine concentrations that differ by only five-thousandths of a percent. Ex. 1049 ¶¶ 10–18. For example, as Dr. Sher notes, there are no incremental hash marks that indicate where any non-enumerated concentrations such as 0.02% or 0.025% would fall. Id. ¶¶ 11–12. Moreover, the x-axis of both figures appears to be neither linear nor logarithmic. Id. The uncertainty of the scale of the x-axis calls into question the assumption by Dr. Noecker that the blue dot on the x-axis of Figure 6 is necessarily 0.025% as opposed to, for example, 0.02%, which is specifically called out in the Specification’s description of Figure 6 as a preferred concentration. See Ex. 1001, 19:57 (stating Figure 6 demonstrates that “the net effectiveness of brimonidine as a decongestant is greatest between about 0.01% and about 0.03%; preferably between about 0.012% and about 0.02%”) (emphasis added). Moreover, like Dr. Sher, we question the accuracy of Dr. Noecker’s statement that concentrations less than 0.03% have no rebound hyperemia. See Ex. 1049 ¶ 19 (citing Ex. 2020 ¶ 94). As seen by a magnified portion of Figure 2, reproduced below, the dark gray, solid line indicating rebound hyperemia appears to show at least some amount of rebound hyperemia below 0.03%: That is, the magnified portion of Figure 2 depicts the dark gray rebound hyperemia curve between 0.01% and 0.03% to be above the x-axis, indicating—on its face—that some rebound hyperemia occurs, contrary to Dr. Noecker’s testimony. Id. We, therefore, credit the reasoning of Dr. Sher, who explains that, in light of the imprecision of the figures, a POSA would not rely on the figures to discern when rebound hyperemia begins, but would rather rely on the Specification, which states “rebound hyperemia begins at around 0.03%.” Id. We are persuaded that those words of approximation suggest that rebound hyperemia could begin either a little less than, at, or a little more than 0.03% brimonidine. See Ex. 1049 ¶ 25. Thus, we agree with Dr. Sher that “a POSA would read the ’742 patent’s description of Figure 6 and reasonably conclude that ‘at around 0.03%’ includes 0.025%.” Id.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“As an initial matter, we agree with the parties that the preamble of the claims is limiting. “Whether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.” Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003). The Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to methods of using a composition for a specific purpose (i.e., reducing eye redness), and the method comprises a single step of administering that composition, the Federal Circuit “has generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. agree with Petitioner that it does not and find Eli Lilly to be instructive. In Eli Lilly, the preambles of the claims recite a “method for reducing incidence of or treating at least one vasomotor symptom in an individual” and a “method for treating headache in an individual.” 8 F.4th at 1335. There, the Federal Circuit held that the preambles “are not merely statements of effect but rather statements of the intentional purpose for which the methods must be performed.” Id. at 1342. Thus, the Federal Circuit did not require proof of actual clinical results from performing the claimed method, even though the claims also recited an “effective amount.” Id. The Federal Circuit held that because the specification defined an “effective amount” as an “an amount sufficient to effect beneficial or desired results” and provided examples of such results in the context of prophylactic or therapeutic uses, the claims “encompass a clinical result, [but] they do not require such a result.” Id. Here, similarly, the ’742 patent claims simply recite administering the brimonidine composition (at a concentration range) and do not recite any efficacy requirement, nor even the “effective amount” of note in the Eli Lilly claims. But, like Lilly and as explained below, the “ocular conditions” of the claims encompass prophylactic reduction of hemorrhage and hyperemia in addition to therapeutic uses. See Ex. 1001, 12:13–19. We, therefore, find the claims here do not require actual redness reduction and, thus, no clinical result is required to satisfy the claimed method. Thus, having considered the arguments and evidence presented at trial, we determine that the preamble of the claims is limiting and requires that the claimed brimonidine composition be administered with the actually reduced.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“evidence presented at trial, we agree with Petitioner that the term “about 0.025%” includes 0.03%. Our construction is supported not only by intrinsic evidence, but also by extrinsic evidence that demonstrates the alleged criticality of the “about 0.025%” limitation. terms of a specific numerical range. We must, therefore, determine how broadly a POSA reading the ’742 Specification would extend the numerical range around 0.025%. In doing so, we consider the described criticality of “about 0.025%” brimonidine and its purpose to the claimed invention. See Cohesive, 543 F.3d at 1368. The ’742 patent makes clear that the purpose of the “about 0.025%” limitation in the claims is to use “low doses of highly selective a-2 adrenergic receptor agonists to achieve vasoconstriction with significantly reduced hyperemia.” Ex. 1001, 2:39–41. Furthermore, the Specification explains that there is a need for methods that provide “safe and long term vasoconstriction with reduced or minimized side effects, such as rebound hyperemia.” Id. at 2:30–33. There is no dispute that both 0.025% and 0.03% constitute low doses of brimonidine, as described by the Specification. See id. at 3:60–65 (defining “low concentrations” as “between about 0.0001% to about 0.05%”). Thus, the question is whether there is a critical distinction between the two concentrations and their ability to provide vasoconstriction with reduced rebound hyperemia. Patent Owner argues they are clinically distinct, whereas Petitioner argues they are not. In light of the intrinsic evidence discussed below, we agree with Petitioner.” slip op. at 22
Patent outcomesUS 8,293,742 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,293,742 - PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denialInstitutedDenied
“This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless 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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed
“reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22
§ 102 anticipation§ 112 disclosureDiscretionary denialPatents in suitUS 11,110,087 - Restem, LLC. v. Jadi Cell, LLCNo claims unpatentablePTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64
Patent outcomesUS 9,803,176 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,803,176 - PTAB · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision
The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20
- 112 supportMotion to amend, deniedDenied
“In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26
§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,596,190 - Bausch & Lomb Incorporated v. Zeavision, LLCAll claims unpatentablePTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision
Claims 12–14, 16–21, 23, and 24 are unpatentable: Lang anticipates some claims, and the asserted Lang-based combinations render all challenged claims obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Similarly, here, the Specification consistently states that the invention relates to oral formulations for protecting eye health and that the benefits of carotenoids, such as zeaxanthin and lutein, include the ability to absorb UV and blue light. See, e.g., Ex. 1001, Abstract (“Oral formulations for promoting eye health”), 4:25–31 (stating carotenoids such as zeaxanthin are “very good at absorbing ultraviolet (UV) and blue light”), 15:45–47 (“one object of this invention is to disclose multi-component orally-ingestible formulations for protecting eye health in mammals”). Like the preamble in Proveris, the preamble in claim 12 is the only reference in any of the independent claims to the allegedly inventive concept of protecting eye health from the harmful effects of blue light. Proveris, 739 F.3d at 1373. Moreover, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of claim 12 for antecedent basis for the limitation “wherein the user has macular degeneration and a lens-related disorder.” Id. at 38:21 (emphasis added). Thus, “the nutrient formulation” and “the user” in the claim body derives antecedent basis from the “nutrient formulation” and “user” that is “defined in greater detail in the preamble.” See Proveris, 739 F.3d at 1373. Accordingly, reading the patent as a whole, because the inventor clearly relied on both the preamble and the body of claim 12 to define the claimed invention, the preamble of claim 12 should be construed as limiting. See id.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would understand this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not address either of these claim terms in its Response. See generally PO Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as they are consistent with the plain and ordinary meaning of the terms. See Wellman, 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
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 13
Patent outcomesUS 10,307,384 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,307,384
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.