- PTAB · Jan 27, 2025 · IPR2024-00965 · APJ Zhenyu Yang · IPR · Institution
Instituted review of claims 1–6 on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedInstituted
“We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 20; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for purposes of institution, Petitioner has met its burden to show a reasonable likelihood that Gloor was publicly accessible before the priority date of the ’200 patent. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“institution under § 325(d). Prelim. Resp. 21–29. Under 35 U.S.C. § 325(d), in determining whether to institute an inter partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 11
§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 11,768,200 - PTAB · Jan 27, 2025 · IPR2024-00964 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–8 based on both asserted obviousness grounds: Parameswaran with Gloor and Parameswaran with Bentley.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 27; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for the purposes of institution, with Dr. Gloor’s declaration and the supporting exhibits attached therein, Petitioner has met this burden. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“detailed analysis to support its argument that the combination of Parameswaran and Gloor teaches or suggests each limitation of claim 1. Pet. 23–36. Petitioner also contends that an ordinarily skilled artisan would have been motivated combine the teachings of the two references and would have had a reasonable expectation of success in doing so. Id. at 36–45. Patent Owner counters that the combination does not teach or suggest two limitations, namely the amplifying and discarding steps of the method. Prelim. Resp. 18–24. Patent Owner also challenges Gloor’s prior art status. Id. at 24–28. Based on the current record, we find Petitioner’s argument with respect to the amplifying and discarding steps more persuasive. With respect to the remaining limitations, we find persuasive Petitioner’s analysis on the prior art’s teachings. We also find persuasive Petitioner’s analysis on the motivation to combine and reasonable expectation of success. For the purposes of institution, we adopt those analyses as our own. We address Patent Owner’s counterarguments below.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“cross-over events (id. at 18–21). Based on the current record, we find Petitioner’s argument more persuasive. Petitioner relies on the combination of Parameswaran and Gloor as teaching the amplifying step. See Pet. 31–33. As such, Patent Owner cannot show non-obviousness “by attacking references individually.” In re Keller, 642 F.2d 413, 426 (CCPA 1981). Patent Owner argues that “because Parameswaran used pyrosequencing on the surface of beads in a Roche 454 sequencer, it does not disclose the formation of clusters.” Prelim. Resp. 21 (citing Pet. 31). Petitioner, however, relies on Gloor for teaching “amplifying said nucleic acid templates on a surface of a flow cell thereby to form clusters.” Pet. 31–32. Patent Owner does not challenge this reliance. See generally Prelim. Resp. Patent Owner contends that Petitioner “equat[es] the claimed chimeric sequences with ‘mismatched’ or ‘misassigned’ sequences containing an ‘unexpected’ pair of forward and reverse barcode motifs identified in Parameswaran.” Prelim. Resp. 18–19. But, according to Patent Owner, “Petitioner does not point to any disclosure in Parameswaran identifying these “mismatched” motifs as chimeric sequences—as opposed to mere sequencing or sample handling error—nor does Petitioner cite any disclosure in Parameswaran regarding such sequences resulting from cross-over events.” Id. at 19. We find Patent Owner’s characterization of Petitioner’s argument inaccurate. As we understand it, Petitioner does not “equat[e]” the claimed chimeric sequences with “mismatched” sequences in Parameswaran. Instead, as Patent Owner acknowledges, “Petitioner argues that ‘sequences with mismatched barcode motifs’ in Parameswaran ‘include chimeric sequences resulting from cross-over events.’” Id. (quoting Pet. 32) (emphasis added).” slip op. at 14
§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 11,041,852 - PTAB · Jan 13, 2025 · IPR2024-01156 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all grounds, finding it more likely than not that the claims are unpatentable.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the current record, there is no controversy over the meaning of any of the claim terms and neither party identifies a claim construction that would impact our analysis. We therefore find that, at this stage of the proceeding, there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts (without opposition): A person of ordinary skill in the art (“POSA”) at the time of invention would have a working knowledge of microbiology and would have been involved in developing testing methodologies for analysis of samples such as food products (“validation methodologies”). The POSA would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies. The POSA would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The motivation-to-combine analysis is a flexible one. “[A]ny 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,” [but the] “analysis ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’” Intel Corp. v. PACT XXP Schweiz AG, 61 F.4th 1373, 1379–80 (Fed. Cir. 2023) (quoting KSR, 550 U.S. at 418, 420 (emphasis added)). “[I]f there’s a known technique to address a known problem using ‘prior art elements according to their established functions,’ then there is a motivation to combine,” because KSR explains that “if a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar devices [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1380 (quoting KSR, 550 U.S. at 417; and Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021)). If addressing a known problem, the prior art combination need not be “the best option, only . . . a suitable option.” Id. (quoting Intel, 21 F.4th at 800 (emphasis original)).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,845,486 - PTAB · Nov 8, 2024 · IPR2024-00834 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood of unpatentability and declining discretionary denial under §§ 325(d) and 314.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“anticipated by Sonti. Pet. 3. To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). The prior art need not, however, use the same words as the claims to find anticipation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res. Inst. At Harbor-UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed. Cir. 2017) (holding that the “dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that reference”). As such, “a reference can anticipate a claim even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (internal quotation and alteration marks omitted).” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“b. Reasonable Expectation of Success Petitioner asserts that an ordinarily skilled artisan would have been motivated, with a reasonable expectation of success, to topically administer 1% tapinarof composition once a day to treat mild to severe plaque psoriasis in view of Sonti’s teaching to apply its compositions (including 1% tapinarof compositions) in various application frequencies (including once daily) to treat moderate to severe plaque psoriasis. Pet. 29–30 (citing, e.g., Ex. 1003 ¶¶ 182–184, 187–188; Ex. 1005 Abstract, ¶¶ 55, 196, 288, 387).” slip op. at 32
- Obviousness (§103) › Objective indicia / secondary considerationsInstituted
“d. Objective Indicia of Non-obviousness Patent Owner asserts that, although the “Petition notes the patent’s ‘surprising[] and unexpected[]’ finding that once daily application of 1% tapinarof cream was just effective as twice daily application, . . . the Petition does not analyze, as the law requires, this surprising, unexpected finding in its obviousness arguments.” Prelim. Resp. 52. We are not persuaded by this argument. Immediately after the Petition’s acknowledgement that “[t]he specification [of the ’088 patent] contends that it was ‘surprisingly’ found that once daily application was just as effective as twice daily,” the Petition notes that, “[h]owever, during prosecution the examiner cited a set of prior art by Chen et al. disclosing treating plaque psoriasis by topically applying a composition containing 1% tapinarof once a day.” Pet. 1 (footnote omitted). Indeed, Patent Owner acknowledges that Petitioner counters “Applicant’s surprising and unexpected findings” by referring to the Chen references cited during prosecution, but asserts that “Chen . . . does not undermine Applicant’s surprising and unexpected findings” because “Chen discloses applying a composition containing 1% mixture of cis and trans 3,5-dihydroxy-4-isopropylstilbene, and not one containing 1% tapinarof (3,5-dihydroxy-4-isopropyl-trans-stilbene).” Prelim. Resp. 52–53.16 As 16 Patent Owner refers to its earlier discussion on this issue. Prelim. Resp. 53 (“As already discussed . . .”). That earlier discussion is with respect to the Chen references cited in Sonti (i.e., Exs. 1012 & 1013), not the Chen 40” slip op. at 40
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,590,088 - PTAB · Oct 11, 2024 · IPR2024-00771 · APJ Grace Karaffa Obermann · IPR · Institution
The Board instituted IPR on claims 1–6 of the ’195 patent on all asserted grounds and granted Texas Instruments’ motion to join the Cirrus IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because the Preliminary Response in the instant case includes arguments pertaining to the sufficiency of the asserted prior art references, which were not raised in the preliminary response in the Cirrus IPR, we briefly address below the patentability of the challenged claims.” slip op. at 6
- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“II. TIMELINESS OF THE PETITION UNDER 35 U.S.C. § 315(B) Pursuant to 35 U.S.C. § 315(b), “[a]n inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.” Patent Owner argues that the Petition is untimely under 35 U.S.C. § 315(b) because Petitioner is in privity with time-barred entities. Prelim. Resp. 10– 30. However, 35 U.S.C. § 315(b) also provides that the one-year time bar “shall not apply to a request for joinder under subsection (c).” See also 37 C.F.R. § 42.122(b). Because the Petition is accompanied by a timely request for joinder (Paper 2) to the instituted proceeding (IPR2024-00017), which we grant as further discussed below, Patent Owner’s argument that the Petition is time-barred under 35 U.S.C. § 315(b) is moot, irrespective of whether Petitioner is in privity with time-barred entities.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“B. Whether to Join Petitioner as a Party to the Cirrus IPR Joinder may be authorized when warranted, but the decision to grant joinder is discretionary. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. A motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See, e.g., Kyocera Corp. v. Softview LLC, IPR2013- 00004, Paper 15 (PTAB April 24, 2013). As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). As an initial matter, we find the Motion for Joinder meets the timing requirements of 37 C.F.R. § 42.122(b) because Petitioner filed it on April 4, 2024, no later than one month after the Cirrus IPR was instituted on May 1, 2024.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“5. “Aid the Movement of Minority Carriers” Patent Owner argues that the Petition fails to show that the applied prior art references disclose the claim limitations “requiring ‘aid the movement of minority carriers,’” as twice recited in claim 1. Prelim. Resp. 8. Patent Owner summarizes this dispute as follows: The challenged patent discloses and claims a semiconductor device with (among other things) a “drift layer having a graded concentration of dopants . . . [and] further having a first static unidirectional electric drift field to aid the movement of minority carriers.”[] The Petition should not be instituted, because (among other deficiencies) it fails to show that the prior art discloses the “aid the movement of minority carriers” claim limitation. Rather than pointing to anything in the prior art that would teach this claim limitation, the Petition assumes that any “graded concentration of dopants” would necessarily “aid the movement of minority carriers.” The Petition contains no analysis explaining why the “graded concentration of dopants” in the prior art meet the “aid the movement of minority carriers” limitation, apart from the fact that they are “graded concentration of dopants.” In other words, Petitioner reads the “aid the movement of minority carriers” limitation out of the claims completely. Id. at 1–2. Patent Owner includes additional details in support of its view that the asserted prior art fails to establish obviousness of the “aid carrier movement” limitations of claim 1. Prelim. Resp. 1–10.” slip op. at 8
§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,421,195 - PTAB · Sep 27, 2024 · IPR2024-00650 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR of claims 1–38 on all asserted 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
“Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute an inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“determined to be microsatellite instability high or DNA mismatch repair deficient were placed into a study arm and then treated with pembrolizumab. (See Ex. 1005, Ex. 1003 ¶¶ 60–73.) Because treatment of the patients was performed only after MSI-H status was determined, the MSI-H Study Record teaches treating the patients “in response to” determining their MSI- H status.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“have been expected, Petitioner cites to Brown as teaching that PD-1 inhibitors are inherently more effective when treating tumors comprised of cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1034, 747).) Petitioner argues further that Duval teaches that MSI-H cancers have cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1087, 5002).) Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. (See Ex. 1003 ¶¶ 124, 130, 132; see Pet. 41.) Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. (See Pet. 41 (citing Ex. 1003 ¶ 130).) Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were successfully treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. (See Pet. 42 (citing Ex. 1003 ¶¶ 131, 132).)” slip op. at 18
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that one of ordinary skill in the art relevant to the ’219 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. (See Pet. 11 (citing Neugut Decl., Ex. 1003 ¶19).) Petitioner argues further that the ordinarily skilled artisan would have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. (See id.) Dr. Neugut’s testimony supports Petitioner’s arguments regarding the level of skill that an ordinarily skilled artisan in the relevant field would have. (See Ex. 1003 ¶ 19.) Accordingly, in the analysis below, and in the absence of argument by Patent Owner to the contrary, we apply the level of skill set forth by Petitioner and refer to Dr. Neugut’s testimony of what one of ordinary skill in the art would have understood at the time the application that became the ’491 patent was filed, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491 - PTAB · Aug 13, 2024 · IPR2024-00467 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on all challenged claims based on the asserted obviousness ground over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Advanced Bionics, 8. As explained above, during prosecution of the ’245 patent, the examiner issued a nonstatutory double patenting rejection because the claims were “not patentably distinct from” the ’742 patent claims.13 See supra Section I.H (citing Ex. 1010, 96). Petitioner argues that “[i]t was material error for the Examiner to both acknowledge that the ’245 claims were patentably indistinct from the ’742 claims and yet ignore the FWD and allow the claims despite the Board’s prior findings.” We find Petitioner’s argument persuasive. To determine whether Petitioner has sufficiently shown material error, we look at, for example, “the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection.” Advanced Bionics, 9 (citing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 10–11 (Dec. 15, 2017)). Petitioner asserts Gil, Norden, Dean, Alphagan, and Federal Register in this” slip op. at 18
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“previously denied its motion to stay. Ex. 2029. Thus, factor 1 weighs in favor of denying institution.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe any claim term. Patent Owner appears to suggest, although it does not explicitly argue, that the claims require “a single drop of [0].025% brimonidine.” See Prelim. Resp. 6; see also id. at 27 (arguing Gil is “with multi-dosed 0.03% brimonidine”); id. at 28 (arguing Dean is with “multi-dosed concentrations”). To the extent our understanding is correct, Patent Owner should expressly discuss at trial any construction that would so limit the claim. Such discussion should be set forth in a separate section of a response, if filed, designated for claim construction; claim construction positions should not be merely included in arguments over the merits on patentability.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art Petitioner asserts that: A person of ordinary skill in the art (“POSA”) would have been a composite person (or team) that included a medical doctor and pharmaceutical formulator. EX-1014, ¶¶60-61; EX-1013, ¶¶16, 22-24. The medical doctor would be an ophthalmologist with at least three to four years of experience in clinical trials and FDA regulation of eye products and would have experience in the use of topical brimonidine and apraclonidine and topical vasoconstrictors such as naphazoline and tetrahydrozoline. EX-1014, ¶60. The pharmaceutical formulator would have a doctorate in pharmaceutics or a related degree and at least three to five years of experience developing eye drop formulations for clinical trial and regulatory approval. EX-1013, ¶16. Pet. 16–17. Patent Owner does not, at this point, dispute this proposed definition of the ordinarily skilled artisan. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s definition of the person of ordinary skill in the art as it appears consistent with the skill level reflected in the prior art of record and the disclosure of the ’245 patent.” slip op. at 24
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,833,245 - PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five asserted 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 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. 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)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] 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)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - Opticis Co., Ltd. v. Inneos LLCInstitutedPTAB · Feb 2, 2024 · IPR2023-01256 · APJ Terry J Owens · IPR · Institution
The Board instituted review of claims 1, 2, 6, 7, and 9 on all five §103 grounds in the petition.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes review. 37 C.F.R. § 42.4(a) (2023). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted “unless . . . 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 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. 37 C.F.R. § 42.108(a) (implemented as a result of SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018)). Upon consideration of the arguments and evidence presented by Petitioner and Patent Owner, we are persuaded that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. See 35 U.S.C. § 314(a). For the reasons explained below, we institute an inter partes review of all challenged claims.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Ground 1 is based upon obviousness, not anticipation. Patent Owner’s argument is not well taken because it does not address what fixing Kurita’s single optical fiber (40) in place.” slip op. at 13
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedInstituted
“The purpose of requiring reasonable diligence by the first to conceive the invention but second to reduce to practice is to assure that the invention was not abandoned or unreasonably delayed by the first inventor during the period after the second inventor entered the field.” Brown v. Barbacid, 436 F.3d 1376, 1379 (Fed. Cir. 2006). “A patent owner need not prove the inventor continuously exercised reasonable diligence throughout the critical period; it must show there was reasonably continuous diligence.” Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1009 (Fed. Cir. 2016). “[T]here need not necessarily be evidence of activity on every single day if a satisfactory explanation is evidenced.” Monsanto Co. v. Mycogen Plant Sci., Inc., 261 F.3d 1356, 1369 (Fed. Cir. 2001). Thus, Patent Owner must provide an explanation that is satisfactory to indicate that the relied-upon computer modeling and prior art search update show reasonably continuous diligence from November 10, 2003 to January 15, 2004. Patent Owner has provided some evidence to show diligence from November 10, 2003 to January 15, 2004, but Patent Owner has not explained why, under the facts of this case, the evidence is sufficient to establish reasonably continuous diligence for the period before Bhandarkar’s effective filing date to the date of constructive reduction to practice. We have reviewed Petitioner’s contentions as to how Bhandarkar teaches the subject matter of the claims, and we find them sufficiently persuasive at this stage. Based upon the above-discussed evidence and that the optical combiner claimed in claims 1, 2, 6, 7, and 9 would have been obvious to one of ordinary skill in the art over Bhandarkar. slip op. at 26
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“institution under 35 U.S.C. § 314(a) because the factors identified in Apple, Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”), weigh in favor of denying institution in view of the district court litigation (Prelim. Resp. 68–69). A Memorandum from Director Vidal titled Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (USPTO June 21, 2022) (“Interim Procedure”)2 provides that “the PTAB will not deny institution of an IPR or PGR under Fintiv . . . where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition” (Interim Procedure 9). Petitioner has submitted such a stipulation (Paper 11). Thus, we do not exercise discretion to deny institution under 35 U.S.C. § 314(a).” slip op. at 27
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 7,198,416
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.