- PTAB · Sep 23, 2024 · IPR2024-00625 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR of claims 1–8 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundDecided for petitioner
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner argues that Pernot teaches treating colorectal cancer and that, therefore, because the MSI-H Study Record is directed to a clinical study treating colorectal cancer in a patient whose cancers are MSI-H with pembrolizumab, which is an anti-PD-1 antibody, one of ordinary skill in the art knowing the teachings of the MSI-H Study Record would have considered the teachings of Pernot. (See Pet. 36.) Petitioner argues that Pernot teaches that colorectal cancer patients that are MSI-H are “good candidates for immunotherapy,” such as PD-1 inhibitors. (See Pet. 36 (quoting Ex. 1006, 3741 (“[Colorectal cancer] associated with MSI could lead to a more intense immune response, but also to specific immunoregulatory phenomena, making [patients with colorectal cancer] good candidates for immunotherapy.”)).) Petitioner cites further to Dr. Neugut’s testimony to argue that one of ordinary skill in the art would have been motivated to combine the disclosure of Pernot with the methods taught in the MSI-H Study Record in order to obtain the results of the MSI-H Study Record’s study. (See Pet. 36 (citing Ex. 1003 ¶ 93).)” slip op. at 17
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 11,339,219 - PTAB · Sep 23, 2024 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–4, 6–10, and 12–15 on all petitioned grounds, finding a reasonable likelihood of success on at least one challenge and declining Fintiv denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–4, 6–10, and 12–15 of the ’975 patent are unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Obviousness is determined by looking to the scope and content of the prior art, differences between the prior art and the claims at issue, and the level of ordinary skill in the pertinent art resolved. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966). “[T]he 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.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“pending Maryland litigation has been stayed in its entirety pending resolution of IPR2024-00240, which involves a related patent that is also involved in the litigation. Reply, 1 (citing Order in Maryland litigation, dated June 29, 2024, Ex. 1100, 1); see Sur-Reply, 1 (acknowledging “the recent stay of the parties’ co-pending litigation involving the ’975 Patent.”). In its Memorandum Opinion, the court acknowledged that inter partes reviews of additional patents involved in the litigation could be instituted. See Ex. 1101, 3. Accordingly, the first Fintiv factor weighs heavily in favor of not exercising discretion to deny institution of inter partes review. Because of the stay, the second and third Fintiv factors also weigh heavily in favor of not exercising discretion to deny institution of inter partes review. The stay indicates that the court’s trial date will not be close to the Board’s projected statutory deadline for a final written decision and that neither the court nor the parties will invest further in the parallel proceeding. See Fintiv, at 6 (“A district court stay of the litigation pending resolution of the PTAB trial allays concerns about inefficiency and duplication of efforts. This fact has strongly weighed against exercising the authority to deny institution under NHK.”); see also Memorandum Opinion in Maryland litigation issued June 29, 2024, Ex. 1101, 2 (noting that the” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,325,975 - PTAB · Sep 23, 2024 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1, 6–11, 13–20, 22–24, and 26–28 on all petitioned grounds, finding a reasonable likelihood of success and declining discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Petitioner contends that the MSI-H Study Record is prior art under 35 U.S.C. § 102(a) and is not covered by an exception under 35 U.S.C. § 102(b). Pet. 8. The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. Id. at 7; Prelim. Resp. 19 (“JHU submitted the MSI-H Study Record on June 10, 2013, and it was posted on clinicaltrials.gov on approximately June 12, 2013”).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“summarized above, we determine that the information presented in the Petition establishes that Petitioner has a reasonable likelihood of prevailing in showing that claim 1 would have been obvious in view of the MSI-H Study Record. We are persuaded that the MSI-H Study Record discloses the limitations of claim 1. Pet. 16–24. We are further persuaded that a person of ordinary skill in the art would have been motivated to modify the MSI-H Study Record with Pernot and Benson to benefit from the improved outcomes in treating MSI-H colorectal patients with the drug therapeutic. Id. at 41–44. We are also persuaded that a person of ordinary skill would have been motivated to test patients to determine their MSI-H status as such testing was routine in the art. Id. at 44–45. We are also persuaded that a person of ordinary skill would have been motivated to combine the teachings of the MSI-H Study Record and Benson to treat patients with metastatic and advanced disease. Id. at 46–47.” slip op. at 27
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,934,356 - PTAB · Sep 5, 2024 · IPR2023-01300 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–13 and 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
“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). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a). A decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of the challenged claims is unpatentable. Accordingly, we institute an inter partes review of the challenged claims in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have possessed a strong understanding in the use and development of genetics and genomics approaches for detecting or monitoring human diseases, such as spatial detection of a target analyte (e.g., mRNA or DNA) in a tissue, and would typically have a Ph.D. in a relevant field (e.g., molecular biology, genetics, and bioinformatics) with two years of experience. Pet. 21–22 (citing Ex. 1044 ¶¶ 24–36). For the purposes of its Preliminary Response, Patent Owner does not provide its own proposed level of skill. Prelim. Resp. 7. For purposes of this Decision, we apply Petitioner’s unchallenged definition as it is consistent with the cited prior art and disclosure of the ’142 patent.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Thus, according to claim 1, to synthesize a first/second plurality of DNA products by performing a synthesis reaction, the “DNA products” must 1) use the oligonucleotides collected in steps (a) and (b) as templates from which the DNA is synthesized, and 2) incorporate a source location-identifying nucleic acid sequence.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner
“(2) Analysis Neither party has offered a construction for “collecting oligonucleotides under conditions that release them” in claim 1. We note that, in the related litigation, the district court determined that “under conditions that release” should have its plain and ordinary meaning. Ex. 1052, 38. For purposes of institution, we also apply the plain and ordinary meaning of this claim phrase and do not need to expressly construe the claim phrase for purposes of institution. On this record, for the reasons explained by Petitioner and as supported by its declarant testimony, we conclude Petitioner has sufficiently shown that So-456 discloses the “collecting oligonucleotides under conditions that release them” limitation recited in claim 1.” slip op. at 42
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,473,142 - PTAB · Aug 9, 2024 · IPR2024-00385 · APJ Michael L Woods · IPR · Institution
The Board instituted inter partes review of claims 1–4, 6, and 7 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“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.” 35 U.S.C. § 325(d). The Board evaluates discretionary denial under § 325(d) using a two-part framework: first, the Board considers whether the same or substantially the same art or arguments were previously presented to the Office; and if so, second, the Board considers whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). In determining whether the same or substantially the same art or arguments were previously presented to the Office, the Board considers the following nonexclusive factors: (1) the similarities and material differences between the asserted art and the prior art involved during examination; (2) the cumulative nature of the asserted art and the prior art evaluated during examination; and (3) the extent of the overlap between the arguments” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a), we have authority to institute an inter partes review if “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, the Reply, the PO Sur-reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the Challenged Claims of the ’332 patent. Accordingly, we institute an inter partes review of claims 1–4, 6, and 7 of the ’332 patent on the grounds asserted in the Petition.” slip op. at 2
- Skill levelSkill level board ownOther
“A person of ordinary skill in the art (POSITA) would have had: (i) a B.S. degree in Chemical Engineering, Petroleum Engineering, or an equivalent field and (ii) two or three years of academic or industry experience in chemical processing systems, oil and gas production and/or refining; or comparable experience. Additional work experience can substitute for educational or research experience, and vice versa. Pet. 8 (citing Ex. 1002 ¶¶ 26–29); see also Prelim. Resp. 16 (agreeing with Petitioner’s proposed definition of a POSITA). For purposes of this Decision, we adopt the parties’ assessment of the level of ordinary skill in the art.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“At this stage of the proceeding, we decline to adopt Patent Owner’s interpretation that cryogenic conditions occur only below 50°F. See Prelim. Resp. 19 (citing Ex. 2001 ¶ 55). For purposes of this Decision, we need not and do not formally determine the temperature at which cryogenic conditions occur, as our construction would not affect our decision to institute. 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)). We agree with Petitioner that “[e]xplicit construction of terms is unnecessary because it is not dispositive—the art teaches the claims under any reasonable construction.” Pet. 8 (citing Vivid Techs., 200 F.3d at 803). As explained below, for purposes of institution, Petitioner has shown a reasonable likelihood that Aycaguer does not disclose subjecting the recited streams to “cryogenic conditions” at any temperature, as recited in Limitation 1.6. See Pet. 34–36; see also infra § IV.D.2.g.” slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,505,332 - Jeisys Medical Inc. v. Serendia, LLCInstitutedPTAB · Jul 22, 2024 · IPR2024-00386 · APJ Michael L Woods · IPR · Institution
The Board instituted IPR on claims 1–29, finding a reasonable likelihood that claims 1–29 are unpatentable on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“D. Analysis The Director’s recent Videndum decision provides that where no “significant relationship [exists] under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” See Videndum, Paper 12 at 6. Moreover, the Director’s decision in Ford clarified that “court-ordered” coordination alone between parties having different accused products does not establish a significant relationship absent “other relevant or extenuating facts or circumstances” that might evidence a significant relationship, such as “interactions or agreements regarding the implementation of the accused [technology] into their respective accused products.” Ford, Paper 28 at 10–11. We do not find a significant relationship exists between the prior and current petitioners so as to warrant discretionary denial under General Plastic. First, like the parties in Ford, the prior and current petitioners are competitors selling different products, and there is no evidence of agreements regarding the implementation of the claimed technology into their respective accused products. See Ford, Paper 28 at 10; cf. Valve, Paper 11 at 10 (“Valve represented that ‘HTC’s VIVE devices incorporate certain Valve technologies under a technology license from Valve,’ and that ‘Valve employees did provide HTC with technical assistance during the development of the accused VIVE devices.’”). Second, and also like in Ford, the “Ground Rules” for the ITC Investigation required that “[p]arties with similar interests should coordinate and consolidate motion practice to the extent practicable” (Ex. 1041 § 2) and “must coordinate and consolidate depositions and all other discovery” (id. § 3.1). Indeed, we understand that all fourteen co-respondents in the ITC Investigation submitted the joint expert report of Dr. Jean Woloszko. See Ex. 2004, 1; see also Ford, Paper 28 at 3. Third, we do not find the current Petitioner’s mere knowledge of litigation—either in the ITC or district court—against competitors in RF microneedling to establish a significant relationship with those competitors. Cf. Ford, Paper 17 at 3 (noting that where the patent at issue had been asserted against multiple competitors regarding their respective accused products, “merely engag[ing] in court-ordered pretrial coordination” is by itself insufficient to establish a “significant relationship” between the parties). Fourth, we do not find the current Petitioner to have engaged in improper gamesmanship through “tactical delay.” As Petitioner explains, the Prior Petition was filed in response to a district court action filed by Patent Owner against the prior petitioners, but not Petitioner, while the current Petition was filed in response to an ITC Investigation initiated after the denial of the Prior Petition. Patent Owner’s remaining arguments are directed to other factors in the General Plastic analysis and do not evidence a significant relationship between the prior and current Petitioners. Accordingly, we do not exercise our discretion to deny institution under General Plastic.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a), we have authority to institute an inter partes review if “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the Challenged Claims of the ’836 patent. Accordingly, we institute an inter partes review of claims 1–29 of the ’836 patent on the grounds asserted in the Petition.” slip op. at 2
- Skill levelSkill level board ownOther
“IV. ANALYSIS A. Level of Ordinary Skill in the Art The parties agree that a person of ordinary skill in the relevant art (“POSITA”) would have had (1) 7–10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D. and may have worked as part of a multidisciplinary team and drawn upon not only his or her own skills, but also would have taken advantage of certain specialized skills of others on the team when solving a technical problem. Ex. 1028, 14–15; see also Pet. 9 (citing Ex. 1028, 15; Ex. 1003 ¶¶ 50, 51); see also Prelim. Resp. 29. For purposes of this Decision, we adopt the parties’ assessment of the level of ordinary skill in the art, as it is consistent with the prior art of record and the ’836 patent.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner nor Patent Owner expressly construe any term. See Pet. 9; see also Prelim. Resp. 30. For purposes of this Decision, we need not and do not formally construe any claim term. 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)).” slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,480,836 - 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 · IPR2024-00085 · APJ Michael L Woods · IPR · Institution
The Board instituted IPR on claims 1, 2, 4, 5, 7–11, 13, and 15 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
“Under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a), we have authority to institute an inter partes review if “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, the Preliminary Response, the Preliminary Reply, the Preliminary Sur-reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the Challenged Claims of the ’659 patent. Accordingly, we institute an inter partes review of the Challenged Claims on the grounds asserted in the Petition.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“We disagree with Patent Owner. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation.”8 The Director’s Memorandum explains that, when a petitioner makes a Sotera-type stipulation, “it mitigates concerns of potentially conflicting decisions and duplicative efforts between the district court and the PTAB” and “[w]ith such a stipulation, if an IPR or PGR is instituted, the grounds the PTAB resolves will differ from those present in 8 https://www.uspto.gov/sites/default/files/documents/interim_proc_discretio nary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (“Director’s Memorandum”). the parallel district court litigation.” Director’s Memorandum 7 (citing Sotera, IPR2020-01019, Paper 12 at 18–19). Pursuant to the Director’s Memorandum, we “will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation 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.” Id. Because Petitioner provides a Sotera-type stipulation, we do not exercise our discretion to deny institution under Fintiv.” slip op. at 8
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Upon review of the prior art of record and the parties’ arguments, we adopt Patent Owner’s definition of the person of ordinary skill in the art for purposes of this Decision as it appears consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). Petitioner’s proposed definition appears overly restrictive, as it requires a graduate degree in a narrow field of engineering or equivalent experience. We find that a bachelor’s degree with the accompanying experience proposed by Patent Owner more closely aligns with the prior art of record and the ’659 patent. We note, however, there is some overlap in the proposed levels of ordinary skill in the art because Patent Owner’s proposal includes “at least” a bachelor’s degree, which would encompass Petitioner’s master’s degree as well. Prelim. Resp. 19. Nonetheless, our determination herein would be the same under either party’s definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We disagree with Patent Owner’s claim construction. By using the word “or,” the plain and ordinary meaning of “prone, kneeling, or standing” is that only one must be satisfied to meet the claim. See, e.g., SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187, 1199 (Fed. Cir. 2013) (“The disjunctive ‘or’ plainly designates that a series describes alternatives.”). Furthermore, and although claims are read in light of the specification, limitations in a specification are not read into a claim. In re van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Even if the Specification describes embodiments in which the user can begin in a prone position and then transition to a kneeling or standing position, as Patent Owner points out (see Prelim. Resp. 20), the claim does not recite the term “transitioning,” and we do not read the terms “each of” or “substantially flat surface” into this claim limitation. For example, the claim does not recite a “substantially flat” top surface and Patent Owner’s attempt to infer this structure into the claim is not supported under the law. See id. at 29–30. For purposes of this Decision, we agree with Petitioner and construe “prone, kneeling, or standing” in accordance with its plain and ordinary meaning as alternatives, and the prior art need only show one to satisfy this aspect of the claim.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 9,586,659 - PTAB · May 28, 2024 · IPR2024-00086 · APJ Kevin W Cherry · IPR · Institution
The Board instituted IPR on claims 1, 2, 5-8, 10-15, 17, 18, 20, and 21 on all asserted grounds after finding a reasonable likelihood of success and declining Fintiv denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (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 an inter partes review). slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“1. “wherein a user can be disposed on the top surface of the flotation device in a prone, kneeling, or standing position” With respect to the claim term “wherein a user can be disposed on the top surface of the flotation device in a prone, kneeling, or standing position,” Patent Owner points to passages of the Specification, arguing that all three positions are possible. Prelim. Resp. 19–21 (citing Ex. 1001, Abstr., 4:13–17, 4:33–40; Ex. 2006 ¶ 18). We do not agree with Patent’s Owner proposed construction because even if the Specification discloses that all three positions are possible, that is not what the plain language of the claim requires. Claim 1 recites “or,” which means that a user can be disposed on the top surface of the flotation device in any one of the three positions. See, e.g., SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187, 1199 (Fed. Cir. 2013) (“The disjunctive ‘or’ plainly designates that a series describes alternatives.”). Patent Owner does not identify any definition or disclaimer that would modify this plain meaning. See Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). Thus, we agree with Petitioner and apply the plain and ordinary meaning of the phrase “wherein a user can be disposed on the top surface of the flotation device in a prone, kneeling, or standing position,” to construe “prone, kneeling, or standing” as alternatives, and the prior art need only show one to satisfy this aspect of the claim.” slip op. at 13
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Neither party explains how or why its particular proposal impacts the issues before us in this proceeding. We find that a bachelor’s degree with the accompanying experience proposed by Patent Owner more closely aligns with the prior art of record and the ’044 patent. We note, however, there is some overlap in the proposed levels of ordinary skill in the art because Patent Owner’s proposal includes “at least” a bachelor’s degree, which would encompass Petitioner’s master’s degree as well. Prelim. Resp. 10. Nonetheless, our determination herein would be the same under either party’s definition.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedInstituted
“As the Board has held in a precedential decision, “at 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.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,359,044 - PTAB · Apr 15, 2024 · IPR2024-00029 · APJ Amee A Shah · IPR · Institution
The Board instituted IPR on claims 1, 3–5, 7–8, 10–14, and 16–25 on all grounds in the Petition, finding a reasonable likelihood of unpatentability on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“It is not disputed that Sim, Doi, and Herz were not previously presented to the Office. And, the prosecution record indicates that Sim and Doi were not listed on an Information Disclosure Statement by Application nor in a List of References or in an Office Action by the Examiner. See Ex. 1002, 9–10, 20–25, 69–74, 196–197, 346–347. Petitioner’s asserted Grounds 1 and 2 rely substantially on Sim and Doi to teach the steps of the claimed system and method. Petitioner’s asserted Grounds 4, 5, and 6 substantially rely on Herz. Sim, Doi, and Herz are meaningful to the prior art combinations set forth in the Petition. Therefore, the asserted combinations regarding Sim and Doi, Sim, Doi, and Waytena, and Waytena and Herz were not previously presented to the Office. It is also not disputed that Waytena was previously presented to the Office and considered by the Examiner. The prosecution history shows that throughout prosecution, the Examiner heavily considered and relied on Waytena for rejections under 35 U.S.C. §§102 and 103 in evaluating the application of the ՚983 patent. See, e.g., Ex. 1002, 9–10, 20–24, 69–73. At this point and based on the present record, we do not discretionarily deny under 35 U.S.C. § 325(d) because Petitioner has 7 The terms “POSITA,” “PHOSITA” or “skilled artisan” refer to a person of ordinary sill in the art. reasonable likelihood that at least one of the Challenged Claims is unpatentable. PGS Geophysical, 891 F.3d at 1360. However, based on the record before us, and because we reach the same conclusion as the Examiner regarding Waytena’s teachings, we find that Patent Owner has, on this record, sufficient support for its contentions that Waytena was previously presented to the Office and the Examiner’s evaluation on the merits regarding Waytena’s teachings was not in error.” slip op. at 14
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“an inter partes review may not be instituted unless the information presented in the Petition and any response thereto shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Moreover, a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also 37 C.F.R. § 42.108(a) (2023) (“When instituting . . . review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a). Considering the Petition, the Preliminary Response, and the evidence of record, for the reasons set forth below, we determine that, at this stage based on the evidence presented, Petitioner has demonstrated that there is a reasonable likelihood that at least one of the Challenged Claims is unpatentable. Accordingly, we institute an inter partes review of all challenged claims and on all grounds asserted in the Petition. PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (stating that” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest or comment on Petitioner’s definition of the level of ordinary skill in the art or offer Patent Owner’s own definition of the level of ordinary skill. Prelim. Resp. 2. that the ’983 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of appropriate skill reflected in these references and in the ’983 patent is consistent with the level of skill proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Accordingly, for purposes of this Decision, we adopt Petitioner’s proposed definition for a person of ordinary skill in the art.” slip op. at 17
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesTerm construed petitioner constructionDecided for petitioner
“Petitioner contends the claimed “presentation means” is a means-plus- function term under § 112, ¶ 6, that “can perform the function of (a) ‘receiv[ing] said itinerary from said computer’ and (b) ‘present[ing] said itinerary to said party.’” Pet. 8–9. Petitioner further contends the corresponding structure for performing the recited functions is display screen 130. Pet. 9. Patent Owner presents no argument against this contention. We agree that “presentation means” is a means-plus-function claim term. Because it is necessary to know what the structure and function are encompassed by the claim term in order to make a determination that the disagreement, we adopt Petitioner’s construction. Should either party believe that a different construction should apply in the instituted trial, it should explain the proposed construction, how the construction is supported by the record, and how the construction affects our unpatentability analysis.” slip op. at 18
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,212,983
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.