- 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 - 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 - Vifor (International) AG v. Biofer S.P.A.Institution deniedPTAB · Apr 24, 2023 · IPR2022-01608 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–16, 19–21, and 23–25 were unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“step of reacting a sugar with bromine occurs “in a solution at a pH between 7.0 and 9.0.” Ex. 1001, 16:46–47. A dispositive question arises, on this record, as to whether Petitioner’s information, directed to this pH range limitation, is sufficient to support institution of review. For reasons that follow, we determine that Petitioner’s information is not sufficient and deny the Petition on that basis.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“and 12 and that Stoll suggests a pH range of 7 or greater. Pet. 29–30 and n.7, 39. Those prior art pH ranges overlap or encompass the specified pH range of “between 7.0 and 9.0.” Pet. 38–39 and n.10. Under these circumstances, the burden of production shifts to Patent Owner to come forward with evidence of the criticality of the specified pH range limitation. See id. at 39–40 (quoting E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018). Patent Owner meets that burden by directing us to the Marchi Declaration. Resp. 9–12; Ex. 1004, 432–440. That evidence contains experimental results that support Dr. Marchi’s opinion that the claimed method, when performed at a pH of 8, “can be run with equimolar amounts of oxidant without increasing depolymerization,” but when performed at a pH of 10, results in an undesirable “depolymerizing attack on the main chain, even employing only 0.9 equivalents of oxidant.” Ex. 1004, 434–435 (¶ 7). As Patent Owner points out, moreover, the oxidation reaction in each of the examples in Geisser is carried out at a pH of 10. see Prelim. Resp. 26 and n.8 (citing Ex. 1006, Examples 1–8).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We assess the ground based on anticipation by Geisser in view of the principle that a prior art reference anticipates a patent claim “if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). The ground based on anticipation by Geisser rests on a conclusory opinion that Geisser’s disclosure of a pH range between 8 and 12 “describes” an oxidation reaction that occurs “at a pH between 7.0 and 9.0.” Pet. 63 (citing Ex. 1002 ¶ 178, which repeats that conclusory opinion verbatim without objective evidence or analysis). It is unclear on this record, and Petitioner does not explain adequately, how or why Geisser anticipates the pH range limitation of claim 1, which is “critical” for reasons explained above in our analysis of the ground based on obviousness over Geisser and Stoll. Ex. 1004, 435 (the Marchi Declaration, ¶ 7). Accordingly, on this record, we determine that Petitioner does not establish a reasonable likelihood of prevailing “with respect to at least [one] of the claims” based on any ground asserted in the Petition. 35 U.S.C. § 314(a).” slip op. at 13
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that an ordinarily skilled artisan “would hold an advanced degree, such as an M.S. or doctorate, in chemistry, medicine, pharmacy, or a related degree,” as well as post-graduate experience “in areas of carbohydrate chemistry, synthetic chemistry, medicinal chemistry, inorganic chemistry, and/or metal carbohydrate complexes, or the clinical use of such complexes.” Pet. 16. Patent Owner does not contest Petitioner’s proposed definition in the Preliminary Response. Prelim. Resp. 17–18. Based on the information presented, we find 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). To the extent a more precise definition is required, we apply Petitioner’s unopposed proposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 7
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,759,320 - Restem, LLC. v. Jadi Cell, LLCNo claims unpatentablePTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64
Patent outcomesUS 9,803,176 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,803,176 - PTAB · Mar 30, 2023 · IPR2023-00026 · APJ Grace Karaffa Obermann · IPR · Institution
The Board instituted IPR of claims 1–8 on all asserted grounds, finding a reasonable likelihood that claims 1 and 5 are anticipated by Prevost-2006.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We understand “filled” to have a broad plain and ordinary meaning. That is, “filled” broadly embraces the circumstances where something is fully filled or partially filled. Here, Petitioner’s declarant, Dr. Hoare, provides an opinion that is consistent with our understanding of the regular meaning of the word. Pet. 23; Ex. 1002, ¶ 142. We understand that Patent Owner’s position essentially contends that “filled” does not include “fully filled”—arguing that Prevost-2006 does not describe the extent to which the core material “filled” the shell structure, or that Petitioner does not show sufficiently that “filled” means “completely occupies.” Prelim. Resp. 8–10; Ex. 2001, ¶ 39. As an initial matter, we observe that neither Petitioner’s nor Patent Owner’s declarant directs us to information that would help us understand why an ordinarily skilled artisan would have understood “filled” to exclude the circumstance of being completely filled. Because of this, for purposes of deciding whether to institute review, we see no reason to interpret “filled” in a manner inconsistent with the term’s plain and ordinary meaning, which broadly includes the circumstance of being completely filled. Patent Owner is free to develop this issue in timely filed response to the Petition. On this record, however, we preliminarily find that Prevost-2006 meets the “completely occupies” limitation of claim 1 because its fiber is described as a shell structure that is “filled” with a core structure. Ex. 1010, 345, 349. That circumstance distinguishes Provost-2006 from the Lee reference, which unlike Provost-2006 concerned “hollow fibers” and, during examination, was overcome by an amendment that added the “completely occupies” limitation. Prelim. Resp. 9 (quoting Ex. 1004, 616) (emphasis omitted).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We understand “filled” to have a broad plain and ordinary meaning. That is, “filled” broadly embraces the circumstances where something is fully filled or partially filled. Here, Petitioner’s declarant, Dr. Hoare, provides an opinion that is consistent with our understanding of the regular meaning of the word. Pet. 23; Ex. 1002, ¶ 142. We understand that Patent Owner’s position essentially contends that “filled” does not include “fully filled”—arguing that Prevost-2006 does not describe the extent to which the core material “filled” the shell structure, or that Petitioner does not show sufficiently that “filled” means “completely occupies.” Prelim. Resp. 8–10; Ex. 2001, ¶ 39. As an initial matter, we observe that neither Petitioner’s nor Patent Owner’s declarant directs us to information that would help us understand why an ordinarily skilled artisan would have understood “filled” to exclude the circumstance of being completely filled. Because of this, for purposes of deciding whether to institute review, we see no reason to interpret “filled” in a manner inconsistent with the term’s plain and ordinary meaning, which broadly includes the circumstance of being completely filled. Patent Owner is free to develop this issue in timely filed response to the Petition. On this record, however, we preliminarily find that Prevost-2006 meets the “completely occupies” limitation of claim 1 because its fiber is described as a shell structure that is “filled” with a core structure. Ex. 1010, 345, 349. That circumstance distinguishes Provost-2006 from the Lee reference, which unlike Provost-2006 concerned “hollow fibers” and, during examination, was overcome by an amendment that added the “completely occupies” limitation. Prelim. Resp. 9 (quoting Ex. 1004, 616) (emphasis omitted). Claim 5 further recites that “a cell or cell culture is contained in the micro gel fiber.” As we observe above, Prevost-2006 discloses that its “hollow fibers were filled with islets [cells] suspended in agarose.” Ex. 1010, 345; Pet. 24. Thus, on this record, we also find that Prevost-2006 discloses the claimed microfiber containing “a cell or cell culture” within the micro gel fiber. Accordingly, we determine that Petitioner has established a reasonable likelihood that it “would prevail with respect to” claim 1 and claim 5 based on anticipation by Provost-2006. 35 U.S.C. § 314(a). To provide guidance to the parties and streamline the issues for trial, we discuss below the other challenges asserted in the Petition.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundInstituted
“For example, Petitioner does not identify a reason why an ordinarily skilled artisan would have combined the teachings of double-layer and single-layer fibers. We recognize that “it is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.” In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Nevertheless, to support a conclusion of obviousness when combining the teachings of multiple references, an articulated reason with some rational underpinning to combine the known elements in the fashion claimed must be provided. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (It is the petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention[s], and that the skilled artisan would have had a reasonable expectation of success in doing so.”) (citation and internal quotation omitted). Having reviewed the parties’ arguments and evidence of record, we have doubts that Petitioner provides sufficient reasons an ordinarily skilled artisan would have combined the teachings of the multiple references asserted in this challenge to achieve the claimed invention or would have reasonably believed they would have been successful in doing so. Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350, 1360–61 (Fed. Cir. 2017) (showing of a motivation to combine references must include evidence that a skilled artisan would have reasonable expectation of success in doing so).” slip op. at 19
- Expert testimonyPetitioner expert discountedOther
“We have concerns about whether Petitioner shows sufficiently that Nelson- 603’s disclosures would have led an ordinarily skilled artisan to create an “alginate-alginate bicomponent fiber.” Petitioner’s arguments and Dr. Hoare’s opinions contain similar wording and do not explain adequately why an ordinarily skilled artisan would have created such a fiber—beyond Nelson-603’s general disclosure that “it will be apparent to those of skill in the art that variations may be applied to the compositions and methods.” Pet. 39–40; Ex. 1002, ¶¶ 162, 199, 120; Ex. 1011, 12:57–66; 33:58–66. Without additional evidence and reasoning, we assign Dr. Hoare’s testimony on this issue little weight. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (designated: February 10, 2023) (holding declaration is entitled to little weight when it contains an exact restatement of the petition’s arguments without any additional supporting evidence or reasoning). On this record, that general instruction is not sufficient to establish that Nelson-603 would have prompted an ordinarily skilled artisan to modify any fiber disclosed in the reference to achieve the claimed invention.” slip op. at 15
§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 8,785,195 - Neuroderm Ltd. v. Abbvie Inc.InstitutedPTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution
The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19
- Skill levelSkill level board ownOther
“Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,091,507
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.