- Parse Biosciences, Inc. v. 10x Genomics, Inc.Rehearing grantedPTAB · Feb 5, 2024 · IPR2023-00958 · APJ Michael J Fitzpatrick · IPR · Rehearing
Rehearing was granted and IPR instituted on claims 1–28 because the petition showed a reasonable likelihood that claim 1 was obvious over Linnarsson, McCloskey, and ordinary skill.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“III. WHETHER REHEARING IS WARRANTED Petitioner argues that we misconstrued the claims “as requiring one to add tags in a way that can provide a distinction based on a ‘polynucleotide sequence.’” Req. 6 (quoting Dec. 14 (Petitioner’s emphasis)). Petitioner is correct. More specifically, we implicitly construed the claim language reciting “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell,” as requiring said “distinguishing” to be based on the sequences of the sample polynucleotides. See, e.g., Dec. 14 (“[E]ach strand of cDNA that is tagged in Linnarsson is tagged regardless of the polynucleotide sequence of the cDNA or its corresponding mRNA. Thus, Linnarsson’s tags do not distinguish between ‘sample polynucleotides,’ whether cDNA or mRNA, of different sequences.”). Based on that misunderstanding, we erroneously determined that the proposed modification could not achieve the claim language, stating the following: Petitioner’s proposal appears to defeat satisfaction of another portion of claim 1, namely a “second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell.” Ex. 1001, 30:62–64. For if the second tag is “added to the CDS or TSO after extension,” as opposed to the sample polynucleotide, as Petitioner argues (Pet. 39 (emphasis added)), it would appear that the second tag would be incapable of distinguishing any sample polynucleotide from other sample polynucleotides. Rather, the second tag would be ligated to each and every extension product bearing a CDS or TSO without regard to the sequence of any sample polynucleotide. Dec. 16. We now reconsider whether to institute.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Cited”). Because we find that the same or substantially the same art was previously presented to the Office, we proceed to part two of the analysis. 2. Advanced Bionics Part Two Patent Owner argues that the Petition “fails to show any error in the Examiner’s application during prosecution of the prior art teachings Petitioner now purports to invoke from . . . McCloskey.” Prelim Resp. 23; see also id. at 24–25 (“Revisiting the same art and arguments already overcome during prosecution is a waste of the Board’s limited resources and would unfairly burden PO.”). However, Petitioner argued that “the Examiner committed major error in Examination by erroneously stating that the prior art fails to teach a dual tagging approach when, in fact, this approach is plainly taught in both McCloskey and McCloskey II.” Pet. 67. The record supports Petitioner’s position, and we agree that the error was material to patentability. See Ex. 1005, 131 (Notice of Allowance). Accordingly, and having considered all of the Becton, Dickinson factors, we do not exercise discretionary denial.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are persuaded there is a reasonable likelihood that Petitioner would prevail in demonstrating that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Linnarsson and McCloskey with the knowledge of a person of ordinary skill in the art to obtain the claimed subject matter. 8. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable.” slip op. at 21
- Obviousness (§103) › Analogous artNot reached
“the three references is analogous art to the ’013 patent as opposed to each other. Prelim. Resp. 46 (citing Pet. 35; Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1374 (Fed. Cir. 2023)). As Sanofi- Aventis holds, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, the Petition should not be denied for failing to state explicitly that the cited prior art references are analogous art to the ’013 patent. Rather, as Sanofi-Aventis further held: “A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to ‘respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.’” Sanofi-Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23). Accordingly, we need not address this issue for purposes of deciding whether to institute trial.” slip op. at 15
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,697,013 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Rehearing grantedPTAB · Feb 5, 2024 · IPR2023-00955 · APJ Michael J Fitzpatrick · IPR · Rehearing
Rehearing granted and IPR instituted on claims 1–26; the Board found a reasonable likelihood that claim 1 would have been obvious over Linnarsson and McCloskey.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“III. WHETHER REHEARING IS WARRANTED Petitioner argues that we misconstrued the claims “as requiring one to add tags in a way that can ‘provide a distinction based on a polynucleotide’s sequence.’” Req. 6 (quoting Dec. 15 (Petitioner’s emphasis)). Petitioner is correct. More specifically, we implicitly construed the claim language reciting “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell,” as requiring said “distinguishing” to be based on the sequences of the sample polynucleotides. See, e.g., Dec. 14 (“[E]ach strand of cDNA that is tagged in Linnarsson is tagged regardless of the polynucleotide sequence of the cDNA or its corresponding mRNA. Thus, Linnarsson’s tags do not distinguish between ‘sample polynucleotides,’ whether cDNA or mRNA, of different sequences.”). Based on that misunderstanding, we denied the Petition because “adding a second tag sequence to Linnarsson’s CDS and/or TSO would do nothing to achieve such a distinction,” i.e., “a distinction based on a polynucleotide’s sequence.” Id. at 15. That was error. We now reconsider whether to institute.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“the ’197 patent. See Ex. 1001, code (56) (listing McCloskey II under “References Cited”). Because we find that the same or substantially the same art was previously presented to the Office, we proceed to part two of the analysis.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are persuaded there is a reasonable likelihood that Petitioner would prevail in demonstrating that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Linnarsson and McCloskey to obtain the claimed subject matter. 6. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable.” slip op. at 18
- Obviousness (§103) › Analogous artNot reached
“GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1374 (Fed. Cir. 2023)). As Sanofi-Aventis holds, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, the Petition should not be denied for failing to state explicitly that the cited prior art references are analogous art to the ’197 patent. Rather, as Sanofi-Aventis further held: “A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to ‘respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.’” Sanofi-Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23). Accordingly, we need not address this issue for purposes of deciding whether to institute trial.” slip op. at 15
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,240,197 - 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 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Dec 19, 2023 · IPR2023-01033 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution of IPR challenging claims 1–30, finding substantially the same art had been presented to the Office and no material error was shown under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached
“presented to the Office, and (2) Petitioner has not demonstrated that the Office erred. We therefore conclude that it is appropriate to exercise discretion under 35 U.S.C. § 325(d) to deny the Petition. III. CONCLUSION For the foregoing reasons, we exercise discretion under 35 U.S.C. § 325(d) to deny institution of an inter partes review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“enzyme complex” and “nucleic acid insert element.” Pet. 21. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 18. We determine that neither of the two limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears mentioning, however, that the ’357 patent states that “[t]he insertional enzyme can be a transposase.” Ex. 1001, 3:47–48. There is no dispute that Grunenwald discloses the use of a transposase and, thus, an insertional enzyme complex. See Pet. 16 (citing Ex. 1003 ¶¶ 17, 93–94, 162); Prelim. Resp. 13 (“Grunenwald further defines ‘transposase’ to mean ‘an enzyme that is capable of forming a functional complex . . . and catalyzing insertion or transposition of the transposon end-containing composition into the double-stranded target DNA with which it is incubated in an in vitro transposition reaction.” (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 ’357 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, 12:61–67. This is the meaning that we apply in this Decision.” slip op. at 6
Claim constructionDiscretionary denialPatents in suitUS 10,738,357 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Nov 14, 2023 · IPR2023-01030 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–29 would have been obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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). 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
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 15–16. Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. See generally, Prelim. Resp. For this Decision, we adopt and apply Petitioner’s proposal for the level of skill in the art, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Petitioner proposes constructions of four limitations: “insertional enzyme complex,” “nucleic acid insert element,” “adapter sequence,” “barcode sequence,” and “tagged fragments.” Pet. 20–23. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 15. We determine that none of the four limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears” slip op. at 7
- 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 ’207 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, 12:58–64. This is the meaning that we apply in this Decision.” slip op. at 8
Claim construction§ 103 obviousnesscites GrahamPatents in suitUS 10,619,207 - 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 - PTAB · Oct 13, 2023 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Institution
Instituted IPR on claims 1–6; the Board found a reasonable likelihood that claim 1 would be unpatentable as obvious over Linnarsson and McCloskey.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In sum, on the record presented, it appears that Petitioner is correct in stating that “no arguments were made during examination with respect to McCloskey or any similar reference disclosing an oligonucleotide with two tags.” Pet. 70 (underlining added).” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable on this ground.” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposes constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, for its part, states that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. On the record before us, and for purposes of institution, we find there is no need to provide an express construction of any claim term.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 21–22 (citations omitted). At this stage of the proceeding, Patent Owner does not dispute the level of skill proposed by Petitioner. Because Petitioner’s formulation of the level of ordinary skill in the art appears consistent with the disclosure of the ’981 patent and the asserted prior art, and because there is no argument to the contrary at this stage of the proceeding, we apply Petitioner’s formulation in our analysis below.” slip op. at 7
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 10,155,981 - 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 - 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 - Candela Corporation v. Nikolai TankovichInstitutedPTAB · Jun 8, 2023 · IPR2023-00234 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–28, finding a reasonable likelihood that the challenged claims would be unpatentable under the five asserted § 103 grounds.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“when no part of the distribution patterns of the two beams cross each other at the point of reference, identified above in Figure 2D–F as “in a tissue.” Id. As both claim 1 and claim 11 refer to tissue treatment, we interpret the point of reference for determining whether the beams overlap to be the point at which the beams first intersect the tissue being treated. This interpretation is supported by the diagrams in Figure 2 above and in the Specification. See, e.g., Ex. 1001, 1:67–2:4 (“The invention can avoid interference of the wavelengths by delivering the wavelengths simultaneously and in spatially separated and overlapping regions of the tissue being treated.”). In view of the above, we determine that the term “overlapping,” as used in the claims, refers to the crossing of the beam pattern at the point at which the beams intersect the tissue being treated.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“when no part of the distribution patterns of the two beams cross each other at the point of reference, identified above in Figure 2D–F as “in a tissue.” Id. As both claim 1 and claim 11 refer to tissue treatment, we interpret the point of reference for determining whether the beams overlap to be the point at which the beams first intersect the tissue being treated. This interpretation is supported by the diagrams in Figure 2 above and in the Specification. See, e.g., Ex. 1001, 1:67–2:4 (“The invention can avoid interference of the wavelengths by delivering the wavelengths simultaneously and in spatially separated and overlapping regions of the tissue being treated.”). In view of the above, we determine that the term “overlapping,” as used in the claims, refers to the crossing of the beam pattern at the point at which the beams intersect the tissue being treated.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Black discloses that its combined beam can be controlled to rotate the mirrors to “generate various different kinds of treatment patterns” and can “create any type of three-dimensional paths and treatment pattern.” See Ex. 1006 ¶¶ 61, 62; Ex. 1002 ¶ 69. On this record and at this stage, the ability to generate treatment patterns meets the limitations of the claims, which each require a pattern of “overlapping beams and non-overlapping beams. We credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have understood that a scanner could be used with or instead of a modulator to provide adjustability to one or more lasers, that the artisan would have been familiar with the control and programming of multiple scanners taught in Black, and that the artisan would have been able to implement these features in Hsia’s system without undue experimentation. Ex. 1002 ¶¶ 93, 95, 97, 98. Additionally, we credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have found it obvious from the teachings in Black to combine and scan multiple beams into a desired pattern, such as overlapping and non-overlapping in order to optimize treatment results and because the combination would have provided multiple potential benefits. Id. ¶¶ 98, 101, 112, 116, 118–128. We acknowledge Patent Owner’s argument that Dr. Milner’s testimony regarding the ordinary artisan’s motivation to combine references parrots the rationales identified and discussed in the ’481 patent. Prelim. Resp. 36–38. Dr. Milner, however, also cites disclosures in both Hsia and Black citing advantages of combined beams including improved treatment efficacy, improved healing, the ability to treat simultaneously at multiple depths, and reduction in the number of required treatments. Ex. 1002 ¶¶ 117–119. “[T]he motivation-to-combine analysis is a flexible one. Any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1379 (Fed. Cir. 2023) (citing KSR Int’l, 550 U.S. at 420 (alterations, emphasis, and internal quotation marks omitted).” slip op. at 21
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Black discloses that its combined beam can be controlled to rotate the mirrors to “generate various different kinds of treatment patterns” and can “create any type of three-dimensional paths and treatment pattern.” See Ex. 1006 ¶¶ 61, 62; Ex. 1002 ¶ 69. On this record and at this stage, the ability to generate treatment patterns meets the limitations of the claims, which each require a pattern of “overlapping beams and non-overlapping beams. We credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have understood that a scanner could be used with or instead of a modulator to provide adjustability to one or more lasers, that the artisan would have been familiar with the control and programming of multiple scanners taught in Black, and that the artisan would have been able to implement these features in Hsia’s system without undue experimentation. Ex. 1002 ¶¶ 93, 95, 97, 98. Additionally, we credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have found it obvious from the teachings in Black to combine and scan multiple beams into a desired pattern, such as overlapping and non-overlapping in order to optimize treatment results and because the combination would have provided multiple potential benefits. Id. ¶¶ 98, 101, 112, 116, 118–128. We acknowledge Patent Owner’s argument that Dr. Milner’s testimony regarding the ordinary artisan’s motivation to combine references parrots the rationales identified and discussed in the ’481 patent. Prelim. Resp. 36–38. Dr. Milner, however, also cites disclosures in both Hsia and Black citing advantages of combined beams including improved treatment efficacy, improved healing, the ability to treat simultaneously at multiple depths, and reduction in the number of required treatments. Ex. 1002 ¶¶ 117–119. “[T]he motivation-to-combine analysis is a flexible one. Any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1379 (Fed. Cir. 2023) (citing KSR Int’l, 550 U.S. at 420 (alterations, emphasis, and internal quotation marks omitted).” slip op. at 21
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,675,481
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.