- 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 - New Balance Athletics, Inc. v. Nike, Inc.Institution deniedPTAB · Sep 26, 2024 · IPR2024-00778 · APJ Josiah C Cocks · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood of prevailing on any challenged claim: Clark and Mills each failed to disclose required limitations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“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.” 35 U.S.C. § 314(a); see also 37 C.F.R § 42.4(a) (“The Board institutes the trial on behalf of the Director.”).” slip op. at 2
- BurdenDecided for patent owner
“in a continuous fashion, as shown in Figure 5, and this will include the portion that will be used for the upper (the textile element) and the material that is trimmed away (the surrounding textile structure)” (citing Ex. 1003 ¶¶ 124–125)). Notably absent, however, from the above-identified portions of the Petition and testimony of Dr. Bookstein is any reference to material that is “trimmed away” or why any such material is regarded as surrounding a textile element, or any other component of Clark. In a later portion of the Petition addressing the second clause of limitation 1a, Petitioner makes reference to Clark’s column 4, lines 61 through 66, as disclosing a “trimming process.” Pet. 23–24 (citing Ex, 1003 ¶ 128). That portion of Clark generally expresses that “the exposed edge of the upper may be trimmed in any desired outline . . . and the trimmed edge may be bound or finished as desired.” E. 1004, 4:61–66. We agree with Patent Owner that, to the extent Petitioner and Dr. Brookstein rely on that portion of Clark to account for the first clause of limitation 1a, Petitioner does not meaningfully explain why Clark’s disclosure of “the potential trimming of an ‘exposed edge’ (singular)” of any textile element means that the textile element is regarded as “hav[ing] been knitted with a surrounding textile structure.” See Prelim. Resp. 15–16 (citing Ex. 2003 ¶ 38). We credit Dr. Pastore’s testimony to that end, over that of Dr. Brookstein (see, e.g., Ex. 1003 ¶ 128), as we find that Dr. Pastore’s testimony is more consistent with Clark’s actual disclosure and what it would have conveyed to one of ordinary skill in the art.” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states, “[f]or purposes of this Preliminary Response only, Nike applies New Balance’s proposed level of skill in the art.” Prelim. Resp. 13. Based on this record, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’749 patent and the asserted prior art, and we apply it in our patentability evaluations below.” slip op. at 11
- Expert testimonyPatent owner expert creditedDecided for patent owner
“in a continuous fashion, as shown in Figure 5, and this will include the portion that will be used for the upper (the textile element) and the material that is trimmed away (the surrounding textile structure)” (citing Ex. 1003 ¶¶ 124–125)). Notably absent, however, from the above-identified portions of the Petition and testimony of Dr. Bookstein is any reference to material that is “trimmed away” or why any such material is regarded as surrounding a textile element, or any other component of Clark. In a later portion of the Petition addressing the second clause of limitation 1a, Petitioner makes reference to Clark’s column 4, lines 61 through 66, as disclosing a “trimming process.” Pet. 23–24 (citing Ex, 1003 ¶ 128). That portion of Clark generally expresses that “the exposed edge of the upper may be trimmed in any desired outline . . . and the trimmed edge may be bound or finished as desired.” E. 1004, 4:61–66. We agree with Patent Owner that, to the extent Petitioner and Dr. Brookstein rely on that portion of Clark to account for the first clause of limitation 1a, Petitioner does not meaningfully explain why Clark’s disclosure of “the potential trimming of an ‘exposed edge’ (singular)” of any textile element means that the textile element is regarded as “hav[ing] been knitted with a surrounding textile structure.” See Prelim. Resp. 15–16 (citing Ex. 2003 ¶ 38). We credit Dr. Pastore’s testimony to that end, over that of Dr. Brookstein (see, e.g., Ex. 1003 ¶ 128), as we find that Dr. Pastore’s testimony is more consistent with Clark’s actual disclosure and what it would have conveyed to one of ordinary skill in the art.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,266,749 - PTAB · Sep 18, 2024 · IPR2024-00603 · APJ Sheldon M Mcgee · IPR · Institution
The Board instituted IPR on all challenged claims and all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on claim 1 over Honermann and Cline.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Pet. 5–6 (citing Ex. 1003 ¶ 50). Petitioner further states “that more education could compensate for less experience and vice versa.” Id. at 6. Petitioner’s position is, therefore, consistent with Patent Owner’s proffered level of skill in the art which reflects less education and more experience in substantially the same fields. Specifically, Patent Owner asserts that such a skilled artisan “would have at least a bachelor’s degree in mechanical or automotive engineering and/or five or more years of experience in the automotive industry designing, developing, testing, and engineering automotive components or practical experience servicing, assembling, repairing, and/or developing internal combustion engines and/or engine oil filters.” Prelim. Resp. 4. On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the 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, 163–64 (Fed. Cir. 1985))). A more specific definition is not necessary for purposes of deciding whether to institute review. To the extent a more specific definition is required, however, we adopt Patent Owner’s definition because it is consistent with the disclosures of the asserted prior art references. We note, however, that we would reach the same conclusion under either parties’ definition.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that all non-“means” terms in the challenged claims should be afforded their plain and ordinary meaning, and that the “means” limitations recited in claims 1 and 15 should not be construed as means-plus- function terms pursuant to 35 U.S.C. § 112(6). Pet. 7. According to Petitioner, claims 1 and 15 include additional limitations that denote structure for those “means” limitations and furthermore do not recite a function corresponding to the recited means. Id. Patent Owner asserts that “the Board need not make a determination on claim construction in assessing whether to institute” trial. Prelim. Resp. 5. After review of the preliminary record, we determine that no claim terms require an express construction for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”).” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“2. Advanced Bionics Prong One: whether “the same or substantially the same art or arguments previously were presented to the Office” As Petitioner acknowledges, a Japanese-language version of Yokoyama was cited in an IDS without an English translation. Pet. 19; Ex. 1002, 34 (indicating that an English translation was not provided by virtue of the absence of a checkmark in the “T” column on the far right of the PTO/SB/08a form).4 The Yokoyama reference relied on in the Petition (Ex. 1008) however, includes an English language translation of the text in 4 It is also not readily apparent that Patent Owner complied fully with the “Content Requirements for an Information Disclosure Statement” as set forth in MPEP § 609 in its IDS submission dated March 30, 2015. Specifically, § 609.04(a)(III) states that “[e]ach information disclosure statement must further include a concise explanation of the relevance . . . of the information listed that is not in the English language.” (italicized emphasis added, underlining in original); see also § 609.01 B.3 (stating this requirement). It does not appear that any concise explanation was filed with respect to either Japanese reference filed in the IDS. See Ex. 1002, 13–38 (IDS documents pertaining to Yokoyama reference); Semiconductor Energy Laboratory Co. v. Samsung Electronics Co., 204 F.3d 1368, 1376 (Fed. Cir. 2000) (“[A]lthough MPEP Section 609[] allows the applicant some discretion in the manner in which it phrases its concise explanation, it nowhere authorizes the applicant to intentionally omit altogether key teachings of the reference.”). addition to the Drawings that also appear in the untranslated Japanese-language version of Yokoyama submitted during prosecution. Compare Ex. 1007 (containing Japanese text with Figures 1–7c), with Ex. 1008 (containing English text along with Figures 1–7c). As such, the Yokoyama reference relied on in the Petition––being in English––contains roughly ten pages of more readily discernible information than the Japanese-language version of this reference submitted during prosecution. Significantly, Petitioner relies on textual disclosure in the English-translated version of Yokoyama in its challenges. Pet. 28–51, 54, 58, 59 (citing Ex. 1008 repeatedly). Such English-translated disclosure was not previously before the Examiner. Ex. 1002, 13–38. In view of this additional disclosure before us in English, i.e., disclosure that was not presented previously to the Office, we find that the English translated version of Yokoyama relied on here (Ex. 1008) is not “the same or substantially the same art” that was previously presented to the Office (Ex. 1007).” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“discretionary denial, we must also consider whether the Petition presents compelling merits. IPR2022-01242, Paper 23 at 4–5. As set forth above, we have considered the circumstances and facts before us in view of Fintiv factors 1–5, and determine that: Factor 1 is neutral, Factor 2 weighs heavily against discretionary denial, Factor 3 is neutral, Factor 4 weighs against discretionary denial, and Factor 5 weighs in favor of discretionary denial. Factors 1–5, considered as a whole, collectively weigh against exercising discretion to deny institution. As such, we need not undertake a “compelling merits” analysis as set forth under CommScope. The Merits Even though we do not consider here whether the merits are “compelling,” we do consider the merits of the Petition under Fintiv factor 6. As set forth below, we determine that Petitioner has satisfied the reasonable likelihood standard for purposes of institution. Such satisfaction weighs further against discretionary denial of the Petition.” slip op. at 19
Claim constructionDiscretionary denialcites PhillipsPatents in suitUS 9,023,203 - Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentablePTAB · Sep 17, 2024 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–6 are unpatentable: claims 1–4 and 6 as obvious over Linnarsson and McCloskey, and claim 5 as obvious over those references and ordinary skill.
RulingsFinal written decision- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1065 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s October, 27, 2023, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). Because it was not filed until March 29, 2024, Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration. In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 1–2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s October 27, 2023, objection to McCloskey. Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1065).” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“We find that both references are analogous art to the ’981 patent, as there is ample supporting evidence in the record, including that to which the Reply cites (citations identified in the immediately preceding paragraph). Indeed, Patent Owner does not dispute the merits of either argument. PO Sur-Reply 27–28. Rather, Patent Owner, argues that we “should not now permit Petitioner to rewrite its clearly-deficient Petition.” Id. at 28. Petitioner’s Reply does not re-write its Petition. What Petitioner’s Reply does, in response to Patent Owner’s arguments, is precisely what Sanofi-Aventis contemplates as being proper in a reply brief. Indeed, in ruling against the petitioner in Sanofi-Aventis, the Federal Circuit specifically noted that the petitioner could have used its reply brief “to explain how [the prior art reference] is analogous to the [challenged] patent” but did not do so. 66 F.4th at 1379–1380. Here, in contrast, Petitioner used its Reply brief to explain how Linnarsson and McCloskey are analogous to the ’981 patent. Petitioner’s explanation in its Reply brief was both proper and persuasive.” slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“That McCloskey is what it purports to be (a journal article) and that it was published in 2007 are corroborated by multiple pieces of evidence. McCloskey names four authors, all four of whom are named inventors of US 2007/0020640 A1, published Jan. 25, 2007 (“McCloskey ’640”). Ex. 1004, 1, Ex. 2001, code (76). Patent Owner concedes that McCloskey and McCloskey ’640 involve the same subject matter, having argued that the consideration of McCloskey ’640 supported discretionary denial of the Petition based on McCloskey. See, e.g., Prelim. Resp. 22 (“Petitioner’s secondary reference, an article by McCloskey, is at best cumulative of the far more detailed McCloskey ’640, which was raised by the Office and substantively discussed as the basis for a potential rejection using its asserted disclosure of a polynucleotide-specific tag—the same purported teaching for which Petitioner relies on McCloskey here.”). Notably, McCloskey ’640 was published on January 25, 2007. Ex. 2001, code (43). That is just days before McCloskey was received by BIOCHEMICAL GENETICS on January 31, 2007. See EX. 1004, 1 (“Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007”). In other words, it appears that the authors sought to have their research published in a scientific journal promptly after the subject matter of their research had been published by the Office. Further, the existence of McCloskey and its publication year of 2007 is confirmed by other sources in the record. See Ex. 1029, code (56) (United States Patent identifying as a cited reference: “McCloskey, et al. Encoding Pcr products with batch-stamps and barcodes. Biochem Genet. Dec. 2007;45(11-12):761-7. Epub Oct. 23, 2007.”); Ex. 1053, code (56) (same); Ex. 1060 (article’s bibliography citing “McCloskey ML, Stöger R, Hansen RS, Laird CD. Encoding PCR products with batch-stamps and barcodes. Biochem. Genet 2007;45:761–767. [PubMed: 17955361]”). Patent Owner’s Motion to Exclude is denied with respect to” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposed constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, in its Preliminary Response, stated that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 6. In the Patent Owner Response, Patent Owner repeats that it “does not believe any term needs construction,” but nonetheless “applies the Petition’s definitions for ‘MID’ and ‘sample.’” PO Resp. 19. The Petition defines MID as “‘a tag or combination of tags associated with a polynucleotide whose identity (e.g., the tag DNA sequence) can be used to differentiate polynucleotides in a sample.’” Pet. 36 (quoting Ex. 1001, 6:33–38). The Petition defines sample as “‘a quantity of material from a biological, environmental medical, or patient source in which detection, measurement, or labeling of target nucleic acids is sought.’” Id. (quoting Ex. 1001, 12:7– 10). We apply these same definitions in our analysis.” slip op. at 6
Patent outcomesUS 10,155,981 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,155,981 - Apotex Inc. v. Novo Nordisk A/SInstitutedPTAB · Sep 11, 2024 · IPR2024-00631 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood of unpatentability, and granted Apotex’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016); see also 35 U.S.C. § 314(a). In Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential), the Board set forth six non-exclusive factors for determining “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Id. at 6. These factors are as follows: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Id. at 5–6. In evaluating these factors, we take a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review. Id. at 6. The Director has also issued interim guidance to the Board on applying the factors. See Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition shows “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).” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Under 37 C.F.R. § 42.5(b), we “may waive or suspend a requirement of [part 42 of the Board’s rules] and may place conditions on the waiver or suspension.” Here, we agree with Petitioner that it has shown sufficient reason for us to waive the one-month from institution joinder motion deadline. See 37 C.F.R. § 42.122(b). Petitioner waited until it had a sufficient business reason to file this Petition, and subsequently promptly filed its Petition and Motion for Joinder. Most critically, Petitioner raises no new unpatentability grounds, the trial schedule for the Mylan IPR need not be adjusted, and Petitioner agrees to serve in a silent understudy role. We determine that joinder with the Mylan IPR is appropriate under the circumstances. Accordingly, we grant Petitioner’s Motion for Joinder.” slip op. at 13
Discretionary denialPatents in suitUS 10,335,462 - PTAB · Sep 10, 2024 · IPR2024-00563 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1, 12, and 28 because Petitioner showed a reasonable likelihood of prevailing on obviousness over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“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). “If a condition in the first part of the framework is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.” Id. at 8–9. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 17
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“the District of New Jersey is more than three years, argues that “a trial may not be held until 2026—well after a FWD would be expected in this proceeding.” Pet. 15 (citing Ex. 1027, 2); Reply 8. Based on this evidence of the median time to trial in the district, we find factor 2 weighs in favor of institution. See Fintiv Memo 3 (“[W]hen considering the proximity of the district court’s trial date to the date when the PTAB final written decision will be due, the PTAB will consider the median time from filing to disposition of the civil trial for the district in which the parallel litigation resides.”)” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther
“guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“In claim construction, “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,596,600 - Novartis Pharmaceuticals Corporation v. Regents Of The University Of Michigan And University Of South FloridaAdverse judgmentPTAB · Aug 28, 2024 · IPR2023-01347 · APJ Sheridan K Snedden · IPR · Adverse judgment
The Board granted Patent Owner’s unopposed request for adverse judgment and cancelled claim 16 after Patent Owner disclaimed all interest in it.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“DISCUSSION Under 37 C.F.R. § 42.73(b), “[a] party may request judgment against itself at any time during a proceeding.” While the motion for adverse judgment was initiated by Petitioner, Patent Owner does not oppose the motion and the record shows that Patent Owner has disclaimed all interest in claim 161 such that Patent Owner has no remaining claim in the trial, actions that are construed to be a request for adverse judgment. Id.” slip op. at 3
NonePatents in suitUS 10,633,344 - PTAB · Aug 22, 2024 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1, 3–6, and 8 on all asserted grounds, finding a reasonable likelihood that at least claim 1 would be shown obvious over the ’772 Publication and Snowdy.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Beginning with independent claim 1, we determine that Petitioner has met its burden for institution. Based on the current record, Petitioner has shown a reasonable likelihood of succeeding in establishing that the combination of the ’772 Publication and Snowdy renders at least claim 1 obvious.” slip op. at 18
- Skill levelSkill level petitioner adoptedOther
“Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not dispute this definition for purposes of the Preliminary Response. Prelim. Resp. 16. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’462 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., 200 F.3d at 803)).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundOther
“We agree with Patent Owner on the record before us that Petitioner does not appear to offer sufficient evidence and reasoning as to why a POSA would have modified AAVrh.10 at position 665 as described as opposed to other modifications based solely on the disclosure of the ’772 Publication. We do agree with Petitioner, however, that on the record before us, Snowdy provides such sufficient evidence and reasoning. See Pet. 47–52.” slip op. at 26
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,680,274 - Duration Media LLC v. Rich Media Club LLCNo claims unpatentablePTAB · Aug 19, 2024 · IPR2023-00953 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–10 were not proven unpatentable under either §103 ground because the evidence did not show the claimed viewability determination.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find Patent Owner’s argument persuasive. Indeed, it is unclear how Petitioner’s proposal accounts for the types of problems encountered in the art or prior art solutions to those problems. See Daiichi Sankyo, 501 F.3d at 1256 (identifying these factors, among others, as “a guide to determining the level of ordinary skill in the art”). Nor does Petitioner, in its Reply, address, let alone rebut, Patent Owner’s arguments that a person of ordinary skill in the art would have had some experience and/or knowledge in internet advertising. See generally Pet. Reply. Patent Owner proposes that a “person of ordinary skill in the art would have a bachelor’s degree in computer science or a similar major involving computer programming (or at least four years of practical computer programming experience) and at least two years of experience (in or out of college) in the field of internet advertising.” PO Resp. 12 (citing Ex. 2045 ¶54). We agree that a person of ordinary skill in the art would have some experience in internet advertising, although we fail to see why one year would not be enough to familiarize sufficiently a computer scientist and/or programmer with the types of problems encountered in the art or prior art solutions to those problems. Based on the competing proposals, arguments, and evidence before us, we adopt and apply the following level of skill in assessing Petitioner’s challenges to the patentability of the claims of the ’329 patent: a person that would have had a bachelor’s degree in computer science, computer engineering, or electrical (or similar) engineering with about three years of experience being in the field of internet advertising.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“Petitioner’s resurrected argument is based on a fundamental misunderstanding of § 311(b). Section 311(b) provides: “A petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed cancel the claims of the ’329 patent on the basis of Badros, Harkins, and Krassner. Pet. 11. Petitioner did not base its request, in whole or in part, on the Krassner publication. Id. Krassner clearly is a patent. It issued on August 13, 2019, far too late to be § 102(b) prior art. Even if we assume Krassner is also a “printed publication” withing the meaning of § 311(b), the same date would apply: August 13, 2019. Petitioner has not presented any evidence that the document that is Krassner was published prior to when it issued on August 13, 2019. That another document (the Krassner publication), which published much earlier, may contain the same or similar disclosure is not relevant to when Krassner was patented or published. In sum, Krassner is not prior art under 35 U.S.C. § 102(b). b) Whether Krassner is Prior Art Under 35 U.S.C. § 102(e) Although Krassner is not prior under 35 U.S.C.§ 102(b), we” slip op. at 13
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Petitioner responds that, contrary to Patent Owner’s argument, “Harkins teaches that its invention can be used in web pages.” Pet. Reply 18 (citing Ex. 1004 ¶30). Although Petitioner’s citation is off by one paragraph, Petitioner’s response about what Harkins teaches is correct. See Ex. 1004 ¶29 (“The present invention may be implemented for provision of virtually any type of advertising (e.g., print, radio, television, Internet, billboard, etc.) via any type of advertising medium (e.g., newspaper, magazine, radio broadcast, Web pages, billboards, etc.) without departing from the scope of the present invention.”). We find that Harkins is from the same field based on its express statement that it is applicable to “virtually any type of advertising” and “any type of advertising medium,” including “Web pages.” Ex. 1004 ¶29. Further, even if this were insufficient to place Harkins in the same field as the ’329 patent, we find that Harkins is reasonably pertinent to the particular problems with which the ’329 patent inventors were involved. In sum, we find that Harkins is analogous art to the ’329 patent.” slip op. at 19
- Strike new argumentNew argument disregardedGranted
“Paper 60 (“PO Mot. To Exclude”), 9–10.6 Patent Owner is correct in this regard and, thus, we grant Patent Owner’s Motion to Exclude with respect to the testimony in the second Smedley Declaration and the Madansky Declaration opining that Badros teaches the determination limitation. Paper 60, 9–12. Petitioner, in its Opposition to the Motion to Exclude, argues that Patent Owner’s arguments about the “viewability test” were “surprising.” Paper 62, 8. We are not persuaded by Petitioner’s argument. The “viewability test” is a claim limitation. Petitioner should have anticipated that Patent Owner would argue that limitation. See In re Gardner, 449 F. App’x 914, 916 (Fed. Cir. 2011) (“This court has held that when evaluating claims for obviousness under 35 U.S.C. § 103, all the limitations of the claims must be considered and given weight.” (citing Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed. Cir. 1983)); Univ. of Strathclyde v. 6 Patent Owner’s Motion to Exclude seeks to exclude, in part or in whole, Exhibits 1020–1022, 1025–1030, and 1034–1040, which were submitted with Petitioner’s Reply, of which Exhibits 1026 and 1027 are the declaration by Dr. Madansky and the second declaration by Dr. Smedley, respectively. Mot. To Exclude. The Motion to Exclude also seeks to exclude “Exhibits” 1017 and 1018, which are not filed or of record in this case but which are referenced in the Reply. Id. For example, Exhibit 1017 is the Krassner publication, which Petitioner unsuccessfully moved to add to the record as supplemental information. See Paper 21, 3 n.1 (expunging the Krassner publication and stating that it “need not -- and indeed may not -- be re-filed under a new exhibit number”). Apart from the portions of Dr. Smedley’s second declaration and Dr. Madansky’s declaration opining that Badros teaches the “determination” limitation, we dismiss the Motion to Exclude as moot. obviousness determination generally requires a finding that “all claimed limitations are disclosed in the prior art’.” (citing PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1194 (Fed. Cir. 2014)). Petitioner argues that “[v]iewability tests were well known for well over a decade prior to the ’329 patent’s priority date.” Reply 9. If that were the case, then Petitioner should have made its argument in the Petition. Section 312(a) of Title 35 is titled “Requirements of Petition,” and it specifies that a petition must identify, among other things, “the evidence that supports the grounds for the challenge to each claim, including . . . (B) affidavits or declarations of supporting evidence and opinions, if the petitioner relies on expert opinions.” 35 U.S.C. § 312(a)(3); see also 37 C.F.R. § 42.104(b)(4)–(5) (“The petition must specify where each element of the claim is found in the prior art patents or printed publications relied upon; and . . . the supporting evidence relied upon to support the challenge.”). Thus, “Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Board’s Consolidated Trial Practice Guide, 73 (Nov. 21, 2019).7 Dr. Smedley’s testimony in his second declaration, that “Badros discloses Patent Owner’s ‘viewability test’” (Ex. 1027 ¶11), is clearly evidence to make out a prima facie case of unpatentability. The same is true of Dr. Madansky’s testimony that she agrees with Dr. Smedley in this regard. Ex. 1026 ¶4.” slip op. at 25
Patent outcomesUS 11,443,329 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,443,329 - 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
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.