- 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 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28
Patent outcomesUS 9,956,087 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,956,087 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Apr 18, 2024 · IPR2022-01435 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–11 are unpatentable: Chung anticipates claim 10, and the Olmos-based obviousness grounds establish unpatentability of claims 1–11.
RulingsFinal written decision- Skill levelOther
“B. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 11
- Strike new argumentNew argument consideredDenied
“9 Patent Owner asserts that Petitioner’s Reply brief “presents copious new evidence and theories that exceed the scope of proper reply” and “[t]he Board should refuse to consider” it. Sur-reply 7–9. This generic objection to the entire Reply fails to provide adequate notice regarding which of Petitioner’s theories and arguments Patent Owner contends are allegedly new and improper. See, e.g., Rembrandt Diagnostics, LP v. Alere, Inc., 76 F.4th 1376, 1383 (Fed. Cir. 2023) (rejecting generic objection to alleged new theories in reply as failing to provide adequate notice of which theories are allegedly new). Accordingly, we reject Patent Owner’s request that we “refuse to consider” the entirety of the Reply. Where Patent Owner’s Sur-reply raises more particularized complaints regarding Petitioner’s allegedly improper new arguments, we address those complaints as appropriate below.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningOther
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, we find Petitioner has not shown that claim 1 is unpatentable as anticipated by Chung.” slip op. at 65
Patent outcomesUS 10,137,001 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,137,001 - Life Spine, Inc. v. Globus Medical, Inc.Some claims unpatentablePTAB · Mar 20, 2024 · IPR2022-01434 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1–9 and 15 are unpatentable over Chung and Olmos-based obviousness grounds; claims 10–14 were not shown unpatentable because the asserted references did not teach the claimed complementary relationship.
RulingsFinal written decision- Expert testimonyOther
“improperly incorporates-by-reference 12 pages of expert testimony via a single sentence.” PO Sur-reply 16 n.2 (citing Pet. Reply 17, which in turn cites Ex. 1026 (Hatch Decl.) ¶¶ 49–66). We find that many of the paragraphs within the cited range (i.e., Hatch Declaration paragraphs 49–66) appear to have a tenuous connection to the proposition for which Petitioner cites these paragraphs. See Pet. Reply 17. That said, we find that paragraphs 53–55 directly relate to Petitioner’s proposition in the Reply, i.e., that “Petitioner’s experts explain why a [person of ordinary skill in the art] would rely on a cross-sectional view over a perspective view for making the determination in question, because only the cross-sections provide the needed side view directly orthogonal to the positions of the yellow expansion portion and the end of the dovetail.” Id. Accordingly, we find that paragraphs 53–55—the only paragraphs we cite from Petitioner’s range in reaching our conclusion—are not improperly incorporated by reference into Petitioner’s Reply.” slip op. at 66
- Strike new argumentNew argument consideredDenied
“provide Petitioner an opportunity to respond under the new construction, and decline to strike Petitioner’s relevant argument and evidence. Cf. Axonics, 75 F.4th at 1383 (“[W]hen the Board adopts a new claim construction following institution, an IPR petitioner must have adequate notice and an opportunity to respond under the new construction.”). Like in Axonics, in its new arguments on Reply, Petitioner here relies on the same embodiment from the same prior art reference that it relies on in the Petition to support the same legal argument, i.e., that Olmos’s Figure 16 embodiment discloses the “complementary with one another” limitation of challenged claims 10– 14. See Axonics, 75 F.4th at 1384; see also Apple Inc. v. Andrea Elecs. Corp., 949 F.3d 697, 706 (Fed. Cir. 2020) (permitting petitioner to elaborate in reply on an unpatentability theory presented in the petition). Moreover, we permitted Patent Owner to file (and it indeed did file) a sur-reply brief and expert declaration that addressed Petitioner’s new obviousness theories. Accordingly, both parties had adequate notice of our preliminary construction and an opportunity to respond under that new construction. For these reasons, we deny Patent Owner’s motion to strike.” slip op. at 124
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“from the expansion portion. We agree with Patent Owner that the wording of this limitation as a whole requires that the “extension necessarily must protrude beyond a longitudinal end of the expansion portion.” Id. at 11. We also agree with Patent Owner that “[u]nder Petitioner’s tenuous theory, an extension in any direction except 90 or 180 degrees would satisfy the claim language since any such direction has a so-called ‘longitudinal component.’” Id. at 13. For these reasons, we disagree with Petitioner’s argument that the purported “longitudinal component” of Chung’s extension satisfies limitation 1[h].” slip op. at 55
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“would have been motivated to add an extension to the Figure 16 embodiment because “an integrally-formed extension advantageously requires fewer parts, which facilitates both manufacturing and use.” Pet. 118. We agree with Patent Owner that this argument is unavailing. PO Resp. 50. Petitioner’s combination entails adding an extension (from Figure 8) to an embodiment lacking one (Figure 16). We agree with Patent Owner that adding a new component (whether separately or integrally) can in some instances complicate manufacturing/assembly and increase costs. See id. (citing Ex. 2013 (Culbert Decl.) ¶ 115). Petitioner has not sufficiently demonstrated that the proposed combination in this instance would reduce complexity or facilitate the manufacturing process. Accordingly, we do not rely on this argument offered by Petitioner.” slip op. at 106
Patent outcomesUS 8,845,731 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,845,731 - PTAB · Feb 1, 2024 · IPR2023-01298 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–30 and all asserted grounds, finding a reasonable likelihood that Chell anticipates at least one claim.
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).” 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. 14 (citing Ex. 1002 ¶¶ 24–25). For the purposes of its Preliminary Response, Patent Owner does not provide its own proposed level of skill. Prelim. Resp. 10. For purposes of this Decision, we apply Petitioner’s unchallenged definition as it is consistent with the cited prior art and disclosure of the ’689 patent.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“a) contacting the tissue sample with a plurality of nucleic acid probes, wherein each of the nucleic acid probes comprise a target binding domain that binds to the at least one target analyte, wherein the tissue sample [has been] is treated to facilitate binding of the nucleic acid probes to the target analyte b/c) collecting the nucleic acid probes, or portions thereof, bound to the at least one target analyte in a first/second location of the tissue sample under conditions that release the nucleic acid probes, or portions thereof, from the first/second location of the tissue sample d/e) performing an extension reaction that incorporates at least one nucleic acid sequence that identifies the first/second location of the tissue sample into each of the nucleic acid probes, or portions thereof, collected in step (b), thereby forming a first plurality of extension products that comprise the nucleic acid probes, or portions thereof, collected in step (b) and the at least one nucleic acid sequence that identifies the first/second location of the tissue sample Ex. 1001, 145:51–147:11 (emphasis added). Thus, according to claim 1, the “nucleic acid probe” must 1) comprise a target binding domain that binds to the at least one target analyte, 2) be bound to the at least one target analyte; 3) be released in whole or as a portion, and 4) have a location-identifying nucleic acid sequence incorporated into it through an extension reaction. Steps a), b), and c) occur in relation to the target analyte, while steps d) and e) occur after the probe is” slip op. at 21
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We further interpret “collecting the nucleic acid probes” to mean “releasing all or a portion of the nucleic acid probe bound to the at least one target analyte through application of a force followed by retrieval of the released probe or portion of the probe.” The question then becomes whether So-465, which teaches replication of a probe that was bound and then at least partially released to make genomic amplicons, followed by collection of those genomic amplicons, anticipates collection of probes as recited in claims 1 and 16. On this record, we do not see sufficient evidence that the genomic amplicons disclosed in So-456 that Petitioner identifies as “captured” were ever “bound to the analyte” in part or in whole as required by the claim language, but rather were amplified in situ from the probe or partial probe that was released. Ex. 1005 ¶¶ 181–183. In particular, the process of So-456 differs from the ’689 patent claims in that the extension reaction to incorporate the tissue-identifying nucleic acid sequence in So-465 occurs after the identifier nucleotide is cleaved from the tissue sample. “Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). Petitioner has not demonstrated that So-456 teaches this claim limitation or otherwise demonstrates that this limitation would have been inherent in the disclosure of So-456 for claims 1 and 16. For these reasons, on this record we determine that Petitioner has not shown a reasonable likelihood that So-456 anticipates either of independent claims 1 or 16.” slip op. at 24
Claim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,377,689 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Oct 19, 2023 · IPR2023-00878 · APJ Michael J Fitzpatrick · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that Grunenwald anticipates claim 1 or that the asserted combinations cure its failure to disclose contacting chromatin.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review requires 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). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that the information presented does not show a reasonable likelihood that Petitioner would prevail with respect to any claim. See 35 U.S.C. § 314(a). Accordingly, we deny the Petition.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“Petitioner proposes constructions of four limitations: “insertional enzyme complex,” “nucleic acid insert element,” “adapter sequence,” and “barcode sequence.” Pet. 21–25. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 16. We determine that none of the four limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears mentioning, however, that the ’995 patent states that “[t]he insertional enzyme can be a transposase.” Ex. 1001, 3:41–42. There is no dispute that Grunenwald discloses the use of a transposase and, thus, an insertional enzyme complex. See Pet. 27 (citing Ex. 1003 ¶¶98, 161); Prelim. Resp. 34 (“Grunenwald defines ‘transposase’ to include any transposase, thus including those that comprise antibodies that are specific to a protein that is part of said chromatin.” (citing Ex. 1003 ¶93)).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“express construction of the term “chromatin.” The ’995 patent itself provides a definition, stating: The term “chromatin,” as used herein, refers to a complex of molecules including proteins and polynucleotides (e.g. DNA, RNA), as found in a nucleus of a eukaryotic cell. Chromatin is composed in part of histone proteins that form nucleosomes, genomic DNA, and other DNA binding proteins (e.g., transcription factors) that are generally bound to the genomic DNA. Ex. 1001, 12:54–60. This is the meaning that we apply in this Decision.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“B. Ground 1 Petitioner asserts that Grunenwald anticipates independent claim 1, as well some of the dependent claims. Pet. 25. “Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). Patent Owner argues that Grunenwald fails to anticipate claim 1, which failure undermines the entire Petition. Prelim. Resp. 16–17 (“Petitioner has failed to show that Grunenwald discloses each and every limitation as arranged in the claims, including, e.g., ‘contacting chromatin of a genome region,’ and thus cannot meet its burden as to any claim in Ground 1.” (quoting claim 1)), 38 (“Petitioner cannot meet its burden as to Grounds 2–8 for the same reasons Petitioner cannot meet its burden for Ground 1.”). Accordingly, we turn first to claim 1.” slip op. at 7
Claim construction§ 102 anticipationPatents in suitUS 10,150,995 - PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted PGR on claims 1–33 under all petition grounds, finding it more likely than not that at least one claim lacks written description and enablement.
RulingsInstitution decision- Skill levelSkill level board ownOther
“Based on the information presented, we agree with Patent Owner that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). We do not find it necessary to define the level of skill in the art at the time of the invention at this time. However, for purposes of deciding whether to institute trial, we find that Dr. Silverstone is qualified to provide helpful opinion testimony on the issues regarding which we cite his testimony in this decision. See Ex. 1003 ¶¶ 6–15.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on the above, we agree with Patent Owner that many of the arguments raised by the Examiner are highly similar to the challenges in this proceeding, particularly the written description challenge. However, some arguments differ. For instance, Petitioner’s enablement argument identifies that, contrary to Applicant’s statement during prosecution reproduced above, amino acids and protein structure outside the disclosed AAD-12 motif can also affect the activity of the claimed dioxygenases to degrade phenoxy auxin and pyridyloxy auxin. See Ex. 1003 ¶¶ 42–50, 79 (Dr. Silverstone describing the mechanics of protein binding and explaining why the ’055 patent disclosure fails to provide sufficient information to the skilled artisan to know which amino acids could be changed while retaining the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides). See also Pet. 27–34 (asserting, e.g., 85% homology to AAD-12 motif alone is insufficient to predict enzymatic degradation activity). While the Examiner’s rejections regarded the disclosure corresponding to the ability to degrade herbicides, the Examiner plainly relied on Applicant’s statements that the AAD-12 motif’s structure alone was responsible when deciding to withdraw the rejection. Ex. 1002, 355. The Examiner did not have the additional testimony supplied by the Silverstone declaration explaining otherwise. See Ex. 1003 ¶¶ 42–50, 79. Petitioner, through Dr. Silverstone, also addresses the effort the skilled artisan would have needed to undertake to determine what proteins outside of the AAD-12 motif would affect the ability of homologues to enzymatically degrade the recited herbicides, and provides evidence for consideration regarding the lack of a clear link between the AAD-12 motif and the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides. Ex. 1003, 347. Therefore, the arguments are not entirely overlapping. And while these issues do in part overlap with Petitioner’s arguments pertaining to enablement, we agree with Petitioner that the Examiner did not complete a written Wands analysis. Although we conclude that the arguments are not entirely overlapping, we proceed to the second step in the analysis, for completeness.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because Petitioner has shown that it is more likely than not that Petitioner will prevail in showing that at least one claim lacks sufficient written description and is not enabled, we conclude the challenged claims are eligible for post-grant review. V. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has shown it is more likely than not that at least one challenged claim of the ’055 patent lacks written description and is unpatentable. Accordingly, we institute a post-grant review. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review of claims 1–33 of the ’055 patent is instituted with respect to all grounds set forth in the Petition; and” slip op. at 57
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“85% identity as “highly identical” in this field and that the “conserved motif residues comprise ‘the active site that is essential for catalytic activity.’” Prelim. Resp. 31 (citing Ex. 1001, 11:1–6)). However, on the record before us, we are unpersuaded that this is sufficient because the Specification lacks disclosure supporting that a polypeptide of, for example, 86% identity to SEQ ID NO: 2 would retain the ability to degrade herbicides if the 5 amino acids in the general formula of HX109D(X)111-134 T(X)136-261H(X)263-272R, and the required chain lengths are present. In this regard we are persuaded by the testimony of Dr. Silverstone (Ex. 1003 ¶¶ 48–93) regarding the limitations of the disclosure of the ’055 patent and the lack of information supporting the skilled artisan in understanding that the inventor possessed the entire claimed genus (e.g., lack of example at lower end of sequence identity and lack of information to assist the skilled artisan in predicting whether an α-ketoglutarate-dependent dioxygenase would interact with or degrade either phenoxy auxin herbicides and/or pyridyloxy auxin herbicides). Dr. Silverstone testifies, and we are persuaded on this record, that the skilled artisan would not have read the guidance in the disclosure and understood that the inventors possessed the ability to design a modified SEQ ID NO: 2 at the 85% identity level that retained the function of degrading the recited herbicides, let alone the full scope of the claimed genus. Id. Patent Owner argues that Dr. Silverstone’s testimony that conserved amino acids of the AAD-12 motif are present in other α- ketoglutarate-dependent dioxygenases but do not have the claimed dual activity (Ex. 1003 ¶ 48) is misplaced because it “ignores that the location and spacing of those residues in other αKG-dependent dioxygenases differ from those in the AAD-12 motif.” Prelim. Resp. 38. However, Patent Owner offers no evidence that supports its argument. Id. It is thus unpersuasive.” slip op. at 36
§ 112 disclosureDiscretionary denialPatents in suitUS 11,371,055 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Institution deniedPTAB · Aug 22, 2023 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Institution
Institution was denied for claims 1–17, 20–21, 24–26, and 29–34 because petitioner did not show a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] 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) (2018). Upon consideration of the briefing and the evidence of record, we conclude that Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“Ex. 1018, 42–43. The Examiner found that Lees discloses NHS vinyl sulfone as a heterobifunctional linker used to attach a derivatized polysaccharide to one end and a protein to the other and found that this compound anticipated formula 55 of the Specification, which was encompassed by claim 1. Id. at 42–43.” slip op. at 22
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“For the reasons discussed above regarding claim interpretation of Y, Z, Q and T, Patent Owner has the better argument for claims 1 and 2. Specifically, Y and Z are independent groups that function without reliance this ground for claims 1 and 2 rely on sulfone to assist vinyl to enable the reaction above, Petitioner is unlikely to prevail in establishing that Morales- Sanfrutos discloses the Y or Z limitations and has therefore not established a reasonable likelihood of prevailing in showing that the disclosures of Morales-Sanfrutos in light of Straus anticipate claims 1 and 2. With regard to claims 3, 6, 24, 25, and 33 we are persuaded by Patent Owner’s argument that Petitioner’s assignment of sulfone for the Q moiety is incorrect because that group becomes complexed to HRP through a vinylsulfone mediated reaction, making a derivatized protein, e.g., HRP-11. Prelim. Resp. 48 (citing Ex. 1005, 4046). In this structure, sulfone is no longer an independent group available to be identified as Q because it has been complexed to the Cb moiety, making the Q moiety limitation not shown in the HRP-11 conjugate. Thus, Petitioner has not established a reasonable likelihood of prevailing in showing that Morales-Sanfrutos discloses the Q limitation and has therefore not established a reasonable likelihood of prevailing in showing that the disclosures of Morales-Sanfrutos in light of Straus anticipate claims 3, 6, 24, 25, and 33.17” slip op. at 28
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentable
“d) Petitioner’s allegations of obviousness A patent claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which the subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). In this section, we determine whether Petitioner shows sufficiently, for purposes of institution, that claims 1, 20, 21, and 29–31 would have been rendered obvious by Harris.” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Apotex Inc. v. Cellgene CorporationInstitutedPTAB · Jul 20, 2023 · IPR2023-00512 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1, 2, 6–9, 11–28, 32–36, and 38–43 on all asserted grounds, finding a reasonable likelihood of success on obviousness.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“IV. CONCLUSION Petitioner demonstrates a reasonable likelihood of prevailing at trial in showing that at least one of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent is unpatentable over the cited prior art. Our decision derives from our review of the preliminary record before us. Accordingly, we institute inter partes review of each challenged claim the ’628 patent on each of the grounds asserted by Petitioner. This decision does not reflect a final determination on the patentability of the claims. ORDER Accordingly, it is hereby: ORDERED that the Petition is granted and we institute inter partes review of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent based on the grounds asserted in the Petition.” slip op. at 53
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316 (citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). Moreover, “[w]hen the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.” Multiform Dessicants, Inc. v. Medzam Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). We agree with the parties that the ’628 patent expressly defines this term in stating “[t]he term ‘non-enteric-coated,’ when used herein, refers to a pharmaceutical composition, formulation, or dosage form that does not comprise a coating intended to release the active ingredient(s) beyond the stomach (e.g., in the intestine),” and we adopt this express definition herein with regard to “nonenteric coated tablet.”9 Ex. 1001, 11:42–48 (emphasis added).” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“to, and sometimes associated with, but not identical to the claim term “subject”), which appears in claims 11, 12, 18–22, and 38–43, means “a human or other animal who received the recited pharmaceutical composition in connection with a test of the recited parameter.” Prelim. Resp. 18–19 (also asserting Petitioner does not appear to dispute this construction). We first note that the term “test subject” appears in the ’628 patent only in the claims. See generally Ex. 1001. However, we find Patent Owner’s definition comports with the Specification’s express definition of “subject,” a term the Specification appears to use synonymously with the claim term “test subject” and the word patient, and that Patent Owner’s definition adds that the subject received the pharmaceutical composition in connection with a test of the recited parameter, which we find to be a reasonable interpretation of the claim term “test subject,” in accordance with the plain language of the claims on their face, and as supported by the relevant portions of the Written Description that describe testing parameters relating to drug administration. Ex. 1001, 35:45–36:62, 67:61–81:48. We adopt Patent Owner’s definition herein.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“A single prior art reference may anticipate without disclosing a feature of the claimed invention if such feature is necessarily present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014). However, “‘[i]nherency . . . may not be established by probabilities or possibilities.’” In re Montgomery, 677 F.3d 1375, 1379–80 (Fed. Cir. 2012) (citations omitted, alterations in original). “The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency.” Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999). slip op. at 38
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,846,628
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.