- 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 - Neogenomics Laboratories, Inc. v. Natera, Inc.Institution deniedPTAB · Jun 21, 2024 · IPR2024-00346 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution for claims 1–28 under § 325(d), finding the same or substantially the same art had been presented to the Office and no material examination error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“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 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that the examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.10 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“erred when considering the multiplex-amplification limitation. See Advanced Bionics, 9 (“If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”). Under the asserted grounds, Petitioner relies on Forshew as the sole reference to teach this limitation, which is required in all challenged claims. Thus, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’454 patent.” slip op. at 13
§ 103 obviousnessDiscretionary denialPatents in suitUS 11,530,454 - 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 · Apr 24, 2024 · IPR2024-00028 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted IPR on claims 1–19 because Petitioner showed a reasonable likelihood that claim 1 would have been obvious over Flusberg, Flusberg ’338, and PacBio-BAM.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In assessing whether to exercise the Board’s authority to deny institution under § 325(d), the Board considers a two-part analysis. Advanced Bionics at 8–9. First, the Board considers whether “the same or substantially the same” art or arguments were previously presented to the Office. Id. at 8. If so, the Board then considers whether the petition demonstrates that the Office “erred in a manner material to the patentability of the challenged claims.” Id. In applying the two-part framework, the Board considers several nonexclusive factors set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, No. IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph).” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“G. Conclusion Regarding Claim 1 Petitioner has demonstrated a reasonable likelihood of prevailing on its challenge to claim 1 as unpatentable under 35 U.S.C. § 103 due to obviousness over Flusberg, Flusberg ’338, and PacBio-BAM. H. Remaining Claims of Ground 1 and Grounds 2–4 Patent Owner does not present any arguments specific to any claim beyond claim 1. See, e.g., Prelim. Resp. 1 (“Because all other asserted Grounds rely upon prevailing on Ground 1 for claim 1, all other grounds fail for the same reasons.”). In any event, the threshold for institution is a reasonable likelihood of Petitioner prevailing as to any single claim. 35 U.S.C. § 314(a). “Once that single claim threshold is satisfied, it doesn’t matter whether the [P]etitioner is likely to prevail on any additional claims.” SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018). Thus, because we have decided to grant review of claim 1, we do the same for all claims challenged and all grounds raised. Id.; see also 37 C.F.R. § 42.108(a) (“When instituting inter partes 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.”). III. CONCLUSION For the reasons discussed above, we are persuaded that Petitioner has demonstrated a reasonable likelihood of prevailing in establishing that at least one of the challenged claims is unpatentable. IV. ORDER In consideration of the foregoing, it is hereby ORDERED that the Petition is granted and inter partes review is hereby instituted as to claims 1–19 of U.S. Patent No. 11,091,794 B2 on the grounds presented; and” slip op. at 35
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Other
“Petitioner argues that an input data structure having the recited combination of properties would have been obvious, in part, because all such properties were identified and could be measured in the prior art. For example, according to Petitioner, “[i]n addition to encoding the identity and relative locations of each nucleotide, PacBio-BAM encodes the PW and IPD of each nucleotide as integer arrays.” Pet. 43 (citing Ex. 1011, 8). This argument is supported by the cited evidence. Under a section titled “Encoding of kinetics pulse features,” PacBio-BAM states: “Interpulse duration (IPD) and pulsewidth are measured in frames [and] . . . may be encoded in BAM read tags” and further states such information relates to “base modification detection.” Ex. 1011, 8. Petitioner also notes that Flusberg and Flusberg ’338 teach that PW and IPD are affected by nucleotide modifications. Pet. 43–44 (citing Ex. 1007, 66:46–67:4, 9:41–46; 22:49–54; Figs. 12, 13, and 15–19; Ex. 1006, 462, Fig. 3). For example, Flusberg ’338 teaches: In certain aspects, the invention provides a general-purpose approach to discriminating between Me+ and Me- using features in a real-time sequencing-by-synthesis trace comprising signals emitted during the incorporation of optically detectable nucleotides into a nascent strand by a polymerase enzyme. . . . A first stage of this approach includes the development of a classifier for distinguishing methylated from unmethylated cytosines in a nucleic acid template. A set of features is measured for every pulse (discrete event or signal) in the trace. For example, a set of measurable features might be {pulse width, pulse duration, pulse height, pulse amplitude variability}. Ex. 1007, 64:46–59 (emphasis added). Similarly, Flusberg states: Fluorescence pulses in SMRT sequencing are characterized not only by their emission spectra but also by their duration and by the interval between successive pulses. These metrics, defined here as pulse width and interpulse duration (IPD), add valuable information about DNA polymerase kinetics. Pulse width is a function of all kinetic steps after nucleotide binding and up to fluorophore release, and IPD is determined by the kinetics of nucleotide binding and polymerase translocation. We have previously demonstrated that SMRT sequencing polymerase synthesis rates are sensitive to DNA primary and secondary structure. Therefore, we hypothesized that methylated bases in a DNA template might be detected directly on the principle that their presence affects polymerase kinetics during SMRT sequencing. Ex. 1006, 462 (emphasis added; end notes omitted). Petitioner argues that “PacBio-BAM teaches creating an input data” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“4. Reason To Combine Petitioner points out that (1) each of Flusberg and Flusberg ’338 teach methods of detecting nucleotide modifications using SMRT sequencing, and (2) PacBio-BAM teaches a BAM file containing values for all claimed properties generated in the course of SMRT sequencing. Pet. 29. Petitioner argues with supporting evidence, that it would have been obvious “to use PacBio’s BAM file containing the recited properties as an input data structure, as expressly suggested in PacBio-BAM.” Id. at 29–30; see also Ex. 1002 ¶82 (Dr. Dessimoz providing his opinion in support of the combination); Pet. 30–33 (providing additional arguments and evidence to support the combination). Patent Owner argues that “Petitioner fails to provide motivation to combine Flusberg with the other two references of Ground 1 to arrive at the claimed invention.” Prelim. Resp. 45. According to Patent Owner, “Petitioner makes no argument for why Flusberg and the ’338 patent would be combined, let alone why a POSITA would selectively combine various aspects of each reference and include features not used in either reference to arrive.” Id. Patent Owner premises its argument on a purported failure by Flusberg ’338 to incorporate by reference the entire Flusberg reference as opposed to limited aspects of its. Id. at 45–46. Flusberg ’338 patent twice states that Flusberg is “incorporated herein by reference in its entirety for all purposes.” Ex. 1007, 77:30–24, 78:58–66. Patent Owner argues that what is incorporated by reference is only the specific content of Flusberg that is mentioned by Flusberg ’338. Prelim. Resp. 46. Patent Owner cites Nautilus, Inc. v. Icon Health & Fitness Inc., No. IPR2017-01407, 2018 WL 6321395, at *18–19 (PTAB Dec. 3, 2018) in support. Id. Patent Owner additionally points out that, if either incorporation by reference successfully incorporated the entire Flusberg disclosure, then the other incorporation by reference would be superfluous. Prelim. Resp. 46–47. This last point is logical, but the totality of the facts, as discussed below, better support Petitioner’s position. In Nautilus, the Board interpreted the following incorporation by reference language: “The ’088 Application provides ‘One example of customizing a work-out that may be utilized in conjunction with the exercise apparatus described herein is set forth in U.S. Patent Application No. 13/754,361, filed on Jan. 30, 2013, the disclosure of which is incorporated by reference herein in its entirety.’” Nautilus, 2018 WL 6321395, at *19. The Board found that the word “disclosure” could refer to either the example being discussed or the entire disclosure of the ’088 Application, and the Board ultimately held that what was incorporated by reference was the example of customizing a work-out only and not the entirety of the ’088 Application. Id. Nautilus is not precedential. Moreover, its facts are different. Here, we have statements that Flusberg is incorporated by reference both “in its entirety” and “for all purposes.” Ex. 1007, 77:30–24, 78:58–66. Further, the Board’s holding in Nautilus explicitly hinged on its understanding of the word “disclosure” in the following phrase: “the disclosure of which is incorporated by reference herein in its entirety.” Nautilus, 2018 WL 6321395, at *19. The Board held that, “as a matter of grammar, the antecedent of the ‘disclosure’ being incorporated could be either the application or ‘one example’ that is described in the application.” Id. Here, the rules of grammar contradict Patent Owner’s position, rather than support it. For example, the first incorporation by reference states: “Further details on the detection of N6-MeA, as well as other modifications within a template nucleic acid, are provided in Flusberg, et al. (2010) Nature Methods 7(6):461–465, incorporated herein by reference in its entirety for all purposes.” Ex. 1007, 77:30–24 (emphasis added). The word “its” can refer to only one thing, Flusberg itself, as the alternative would be plural nouns, namely “details” and “other modifications,” and thus inconsistent with the singular “its.” In sum, we find that, on the current record, Petitioner has sufficiently shown a motivation to combine Flusberg and Flusberg ’338 with PacBio- BAM.” slip op. at 25
§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 11,091,794 - Kinderfarms LLC v. Genexa Inc.InstitutedPTAB · Mar 25, 2024 · PGR2023-00051 · APJ Deborah Katz · PGR · Institution
Instituted PGR of claims 1–24 on all asserted grounds; the Board found the §103 challenges more likely than not to render claim 1 unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” See 35 U.S.C. § 324(a).” slip op. at 6
- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Level of Skill Each party puts forth a characterization of the ordinarily skilled artisan in the field of the claims of the ’795 patent. (See Pet. 13 (citing Crowley Decl., Ex. 1003, ¶¶ 90–91); see Prelim. Resp. 3–4.) The parties’ proposed characterizations of the ordinarily skilled artisan are sufficiently similar that adoption of either would lead to the same result, institution. Thus, for the purposes of this Decision only, we adopt Patent Owner’s characterization of the ordinarily skilled artisan as having a bachelor of science degree in a relevant life sciences field, such as, chemistry, biochemistry, or pharmacy, with at least two years of work or laboratory experience in pharmaceutical formulations, and access to one or more team members having experience in pharmaceutical formulation and pharmaceutical regulatory approvals, or, in the alternative, at least three to four years of work or laboratory experience in pharmaceutical formulations, and access to one or more team members having experience in pharmaceutical formulation and pharmaceutical regulatory approvals. (See Prelim. Resp. 3–4.) We also note that the level of skill of an ordinarily skilled artisan is revealed by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (holding that the absence of specific findings on the level of skill in the art does not give rise to reversible error “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, 225 USPQ 34, 38 (Fed.Cir.1985)).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Petitioner puts forth constructions of certain terms used in the claims of the ’795 patent. (See Pet. 14–19.) Patent Owner does not dispute any of these constructions specifically, but at this point, argues that we need not construe any terms “to resolve the present controversy.” (Prelim. Resp. 2.) We agree that an express construction is not required at this point in the proceeding. 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 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Thus, at this point in the proceeding, Patent Owner’s argument is not persuasive because it does not address the teachings in the prior art that Petitioner asserts would render the formulations claimed in the ’795 patent obvious.” slip op. at 20
Claim construction§ 103 obviousness§ 112 disclosurecites KSRPatents in suitUS 11,617,795 - ROKU, Inc. v. Universal Electronics Inc.Adverse judgmentPTAB · Dec 28, 2023 · IPR2021-00263 · APJ Russell E Cass · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on claims 1–11 because Patent Owner cancelled all challenged claims in a co-pending reexamination.
RulingsAdverse judgment- RehearingRehearing, grantedGranted
“After our Denial Decision, the Director issued an Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Interim Fintiv Guidance”)1, directing that “[t]he PTAB will not discretionarily deny petitions based on applying Fintiv to a 1 The Interim Fintiv Guidance is available at https://www.uspto.gov/ sites/default/files/documents/interim_proc_discretionary_denials_ aia_parallel_district_court_litigation_memo_20220621_.pdf. parallel ITC proceeding.” Interim Fintiv Guidance, 7. Following the Federal Circuit’s decision, we conducted a conference call with counsel for the parties and allowed the parties to submit additional briefing to address the status of the case, the status of any related proceedings, the Interim Fintiv Guidance, and any actions that should be taken by the panel at this point concerning this proceeding. Papers 16–18. After considering the parties’ arguments, we granted Petitioner’s Request for Rehearing on February 8, 2023, concluding that, in light of the Interim Fintiv Guidance, exercising discretion to deny institution under 35 U.S.C. § 314(a) was not warranted in this case. Paper 19, 5–12. We also determined that Petitioner had demonstrated a reasonable likelihood of success in proving that the challenged claims were unpatentable, and instituted an inter partes review of claims 1–11 of the ’317 patent with respect to all grounds set forth in the Petition. Id. at 12–37.” slip op. at 2
- Adverse judgmentAdverse judgmentGranted
“(b) Request for adverse judgment. A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: . . . (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial. 37 C.F.R. § 42.73(b). In the ’074 Reexam, Patent Owner cancelled all of challenged claims 1–11, and the USPTO has issued a Reexamination Certificate indicating that these claims are cancelled. Ex. 2100, 2; Ex. 1046, 1:15. The Board has previously construed a patent owner’s cancellation in a reexamination of all claims challenged in a pending IPR as a request for adverse judgment under § 42.73(b). See Tarsco Bolted Tank Inc. v. Tank Connection, LLC, IPR2016-01634, Paper 16 at 2 (PTAB Aug. 24, 2017) (“Cancellation of claims 1–11” in an ex parte reexamination “is construed as a request for adverse judgment” in the corresponding IPR proceeding.); Mercedes-Benz USA, LLC v. Signal IP, Inc., IPR2015-00941, Paper 21 at 2–3 (PTAB Apr. 14, 2016) (“Pursuant to 37 C.F.R. § 42.73(b), we construe cancellation of all claims involved in this proceeding” in “a concurrent Reexamination of the” patent at issue “as a request for adverse judgment.”). We agree with the prior decisions in Tarsco and Mercedes-Benz that a patent owner’s cancellation of all challenged claims in an IPR in a co-pending ex parte reexamination is properly construed as a request for adverse judgment under 37 C.F.R. § 42.73(b). Consequently, we construe Patent Owner’s cancellation of all of the claims challenged in this IPR in the ’074 Reexam as a request for adverse judgment.” slip op. at 5
NonePatents in suitUS 10,600,317 - Unified Patents, LLC v. VL Collective IP LLCSome claims unpatentablePTAB · Dec 18, 2023 · IPR2022-01086 · APJ Patrick M Boucher · IPR · Final written decision
Claims 1, 3, 5, 9, 12, 13, and 15 are unpatentable over Sonohara; claims 20 and 21 were not shown unpatentable because Sonohara’s assignment rule is based on timestamps.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s expert, Dr. Goodrich, proposes what Patent Owner characterizes as “a somewhat different level,” namely “an individual with at least a bachelor’s degree in Computer Science or related area and two years of experience developing software tools and/or computer systems for use in the area of audio or video creation, encoding, and/or distribution.” PO Resp. 13; Ex. 2007 ¶ 50. Although we agree that the respective articulations are “somewhat different,” they are generally similar, and our Decision does not depend on nuanced distinctions regarding the level of ordinary skill. Indeed, Dr. Goodrich describes his proposed articulation as “approximate,” such that “more work experience could compensate for less education or more education could compensate for less work experience.” Ex. 2007 ¶ 50. Because we find Petitioner’s proposal reasonable, consistent with the level of skill reflected by the prior art, and supported by Dr. Freedman’s testimony, we adopt it for this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art). We nevertheless note that we would reach the same ultimate conclusion that claims 1, 3, 5, 9, 12, 13, and 15 (but not claims 20 and 21) have been shown to be unpatentable by a preponderance of the evidence were we to adopt Patent Owner’s proposal. See PO Resp. 13 (“this Response establishes that Petitioner’s arguments fail even under its preferred definition of the level of ordinary skill”).” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached
“We need not resolve this dispute because we reach the same ultimate conclusion that Petitioner shows, by a preponderance of the evidence, that claims 1, 3, 5, 9, 12, 13, and 15 are unpatentable, but not that claims 20 and 21 are unpatentable, even if we apply Patent Owner’s proposed construction that the preambles are limiting and the first and second data files must be different. See Reply 15 (Petitioner asserting that “there is no need to construe the preambles as the prior art meets them even if construed”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). For purposes of this Decision, we accordingly treat the preambles of independent claims 1 and 9 as limiting, and with the recited “first data file” and “second data file” as distinct data files.4” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“We agree with Patent Owner’s contention that the emphasized sentence defines the term “content-related.” See PO Resp. 15–16 (Patent Owner arguing that “[t]here are thus three strong indications of lexicography: (1) ‘content-related’ is set off by quotation marks; (2) the patentee used the word ‘is’ to describe the term ‘content-related’; and (3) the patentee states what ‘content-related’ is ‘understood to mean.’” Nor does Petitioner disagree that the sentence is definitional. See Tr. 8:15–16 (referring to the “term content-related as it’s defined in the specification”). Indeed, in the Starz litigation, the district court also treated the sentence as definitional, a fact that we find significant as a matter of comity. See Ex. 1018, 111:24–112:1 (district court judge stating at Markman hearing, “I’m going to adopt . . . the express definition provided in the specification”). But like the district court, we discern insufficient reason to adopt the additional gloss that Patent Owner seeks to apply to the definition of “content-related.” That is, Patent Owner proposes that we additionally construe the phrase “syntactical meaning” within the definitional statement to arrive at Patent Owner’s proposed construction. PO Resp. 16–20. According to Patent Owner, “[t]he specification makes clear, through its use of consistent and repeated examples, that ‘syntactical meaning’ requires a specific relationship between the data segments within a data file: succeeding data segments within a data file must be ordered so as to present the content in its intended sequence when rendered.” Id. at 17 (citing VirnetX Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1317–19 (Fed. Cir. 2014); Alloc, Inc. v. ITC, 342 F.3d 1361, 1368–71 (Fed. Cir. 2003)). Patent Owner adds that the claims, the context provided by the problems solved by the ’794 patent, and the cross-examination testimony of Petitioner’s expert, Dr. Freedman, all support this additional aspect of Patent Owner’s proposed construction. Id. at 18–20. Relying on additional direct testimony by Dr. Freedman, Petitioner counters this position as “improperly import[ing] limitations from the specification that are not required by the claims” and “render[ing] other portions of claim 1 superfluous.” Reply 3 (citing Ex. 1016 ¶ 22); see Tr. 10:18–20 (Petitioner explaining at oral hearing that “the syntax information is simply just identification information which is used to find out what the order of the files is. But the identification information does not by itself indicate the order. It’s just an identifier.”). We agree with Petitioner that it would be imprudent to adopt Patent Owner’s additional gloss because, “[w]hile claims must be construed in light of the specification, . . . limitations from the specification are not to be read into the claims, . . . for ‘[i]t is the claims that measure the invention.’” Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327 (Fed. Cir. 2004) (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (other citations omitted). It is apparent that the Applicant for the ’794 patent understood how to define terminology recited in the claims, but chose to limit its definition of “content-related” in terms of the broader phrase “syntactical meaning” rather than through narrower specific reference to presentation order. In addition, claims 1 and 9 already specify “sequentially outputting the first and second data segments according to their chronological sequence,” which supports Petitioner’s observation that requiring an additional sequential order to “content-related . . . data segments” renders other portions of claim 1 superfluous. See Reply 3. We accordingly adopt the definitional construction provided by the” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for petitioner
“As a basic principle of claim interpretation, prosecution disclaimer promotes the public notice function of the intrinsic evidence and protects the public’s reliance on definitive statements made during prosecution.” Omega Engineering, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed Cir. 2003) (citing Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1347 (Fed. Cir. 1998)) (emphasis added). As such, a statement during prosecution qualifies as a disavowal of claim scope only if it is “so clear as to show reasonable clarity and deliberateness” and “so unmistakable as to be unambiguous evidence of disclaimer.” Id. at 1325 (citations omitted). “Consequently, for prosecution disclaimer to attach, [Federal Circuit] precedent requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable.” Id. at 1325–26. “The party seeking to invoke prosecution history disclaimer bears the burden of proving the existence of a clear and unmistakable disclaimer that would have been evident to one skilled in the art.” Mass. Inst. of Tech. v. Shire Pharms., Inc., 839 F.3d 1111, 1119 (Fed. Cir. 2016). And “[s]tatements by the patent owner are not considered in a vacuum; rather, the skilled artisan would look at the record as a whole in assessing claim scope.” Galderma Lab’s v. Amneal Pharma, 806 F. App’x 1007, 1010 (Fed. Cir. 2022) (citing Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 867 (Fed. Cir. 1993) (“The prosecution history must be examined as a whole in determining whether estoppel applies.”)). We have reviewed the prosecution history, which we summarize supra § I.A.3., and we have particularly reviewed those portions highlighted by Patent Owner. See PO Resp. 32–40. We reach the same conclusion as the district court in the Starz litigation that the standard for attachment of prosecution disclaimer is not met. See Ex. 1018, 109:15–22 (district court stating at Markman hearing, “I’ve also carefully reviewed the portions of the prosecution history relied on by VideoLabs, including the patentee’s arguments regarding the Shin and Rosenau references, and I’m up [sic: not6] persuaded there was a clear and unmistakable disclaimer of all assignment rules that perform assignments by using exact timing information”). slip op. at 20
Patent outcomesUS 8,605,794 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,605,794 - Samsung Electronics Co., Ltd. / Micron Technology, Inc. et al. v. Netlist, Inc.All claims unpatentablePTAB · Dec 6, 2023 · IPR2023-00406 · APJ Jon M Jurgovan · IPR · Final written decision
Claims 1–30 are unpatentable as obvious over Grounds 1–3; the Board did not reach Grounds 4–5 and dismissed Petitioner’s motion to exclude as moot.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“e) Conclusion on Motivation to Combine Harris and the FBDIMM Standards On this record, Petitioner has shown by a preponderance of the evidence that a person of ordinary skill in the art would have combined Harris and the FBDIMM standards since Harris states that its memory module may include fully buffered DIMMs (FBDs). Ex. 1023 ¶ 9. We agree that one of ordinary skill in the art would have recognized Harris’s mention of FBDIMMs as a standard and looked to the FBDIMM Standards for information concerning the voltage values standardized for use in an FBDIMM. Ex. 1027, 83; Ex. 1028, 9. For these reasons and others set forth above, we determine that one of ordinary skill in the art would have combined Harris and the FBDIMM Standards with a reasonable expectation of success.” slip op. at 41
- ExcludeMotion to exclude, deniedDenied
“H. Motion to Exclude Petitioner seeks to exclude materials referenced in three URLs submitted with Patent Owner’s Sur-Reply on August 4, 2023. Paper 33 (citing Paper 31, 1 n.2, 24, 26). Because we do not rely on any of these URLs in a manner adverse to Petitioner, we dismiss the Motion to Exclude as moot.” slip op. at 89
Patent outcomesUS 11,016,918 unpatentable§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,016,918
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.