- PTAB · Jun 3, 2025 · IPR2025-00055 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–42 on all asserted grounds, finding a reasonable likelihood that Dohil renders claim 35 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On this record and for purposes of institution, we find Petitioner’s analysis persuasive and adopt it as our own. Thus, we find Petitioner has established a reasonable likelihood of prevailing on its assertion that Dohil renders claim 35 obvious. We thus institute an inter partes review as to all challenges raised in the Petition. See SAS Institute, Inc. v. Iancu, 584 U.S. 357, 365–71 (2018); see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Petitioner notes that the ’407 patent defines (1) “orally disintegrating tablet,” “orally dispersing tablet,” or “ODT;” (2) “about;” and (3) “having no significant systemic glucocorticoid or mineralocorticoid activity.” Pet. 17–19 (citing Ex. 1001, 2:46–49; 2:62–3:3, 3:16–21). We adopt the express definitions of these terms as set forth in the ’407 patent Specification. See Multiform Dessicants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998) (“When 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.”).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe these or any other claim terms.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner contends that a POSA would have been motivated to follow the FDA Guidance (i.e., the guidance on the matter from the U.S. regulatory agency concerned with pharmaceuticals) in formulating Dohil’s rapidly dissolving lozenge or tablet containing budesonide. Id. at 25. According to Petitioner, a POSA seeking to formulate budesonide into an orally disintegrating pharmaceutical composition would have been motivated to follow the FDA Guidance that such a composition should disintegrate within thirty seconds or less when tested using the USP <701> Disintegration Test. Id. (citing Ex. 1053 ¶ 128). Petitioner also argues that a POSA would have had a reasonable expectation of success in doing so based on Dohil’s detailed description of how to formulate budesonide into a rapidly disintegrating lozenge or tablet. Id. (citing Ex. 1002 ¶¶ 27–41). According to Petitioner, formulating orally disintegrating tablets that dissolve within “several seconds to about a minute” would have been a routine exercise by 2009, the earliest possible priority date of the ’407 patent. Id. at 26 (citing Ex. 1005, 2; Ex. 1018, 434). Petitioner contends that, at that time, there were many orally disintegrating systems and products that were commercially available, which would have bolstered a POSA’s expectation of success. Id. (citing Ex. 1017, 179–181; Ex. 1018, 436–439; Ex. 1053 ¶ 129). Thus, Petitioner concludes that Dohil would have suggested to a POSA limitation 35[iv]. Id.” slip op. at 9
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 9,486,407 - PTAB · Jun 3, 2025 · IPR2025-00056 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–30 and all three grounds, finding a reasonable likelihood that at least one claim would have been obvious over Perrett.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In determining whether to deny institution under § 325(d), we use 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 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). 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-” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted if the information presented by a petitioner in the petition, in view of the patent owner’s preliminary response and the preliminary record, shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A person of ordinary skill in the art (“POSA”) related to the ’061 patent would have a Ph.D., another advanced degree, or its equivalent, in areas related to pharmaceutics, chemistry, biology, medicine, or a related discipline, and 2-3 years of experience in formulation development. Alternatively, a POSA would have a lesser degree in those fields, with at least five or more years of experience in formulation development. The 8 See infra Section II.C. 9 At this stage of the proceeding, there is no evidence of objective indicia of obviousness or non-obviousness. POSA would also have had access to a medical doctor with a specialty in gastroenterology, and other individuals with expertise related to the above subjects. EX1070 ¶30. Pet. 5. At this stage of the proceeding, Patent Owner neither contests Petitioner’s proposed definition of the ordinarily skilled artisan nor provides an alternative definition. See generally Prelim. Resp. For the purposes of this Decision, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the high level of skill in the art reflected in the prior art of record and the ’061 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). D.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownNo construction neededOther
“When 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). The Specification expressly states that “[t]he terms ‘orally disintegrating tablet’, ‘orally dispersing tablet’, or ‘ODT’ refer to a solid dosage form of the present invention, which disintegrates rapidly in the oral cavity of a patient after administration, without chewing.” Ex. 1001, 5:12–15. At this stage of the proceeding, we interpret the language “orally disintegrating tablet” / “orally dispersing tablet” / “ODT” to have the meaning as expressly set forth in the Specification, as noted above. slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,260,061 - PTAB · May 21, 2025 · IPR2025-00193 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, or 30 were unpatentable on any asserted ground.
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). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’030 patent is unpatentable.” slip op. at 2
- BurdenNot shown unpatentable
“What is missing from Petitioner’s stated motivation for modifying the array of Cantor is a reason why a POSA would seek to correlate the identification sequence with a location on the array at all. Prelim. Resp. 72. Indeed, the location of a bead on the substrate is not pertinent to the analysis disclosed in Cantor. Ex. 2002 ¶ 172; see also id. at ¶ 31 (Cantor “does not relate to the [spatial] analysis of tissue samples . . . .”). “[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Here, Cantor fails to teach or suggest capture probes distributed randomly on a substrate comprising a nucleic acid sequence that identifies a unique location on the substrate as required by the challenged claims, and Petitioner fails to adequately articulate why a person of ordinary skill in the art would have modified Cantor to make the recited capture probes. In view of the above, we find that, on this record, Petitioner has failed to establish that Cantor teaches or suggests each element of the challenged claims. Accordingly, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge that any of claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, and 30 would have been obvious over Cantor.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not argue that any claim term requires construction. Pet. 22–23. Likewise, Patent Owner takes the position that “no claim terms 2 Person of ordinary skill in the art. require explicit construction” for purposes of determining whether to institute inter partes review. Prelim. Resp. 19. Having considered the parties’ positions and evidence of record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“What is missing from Petitioner’s stated motivation for modifying the array of Cantor is a reason why a POSA would seek to correlate the identification sequence with a location on the array at all. Prelim. Resp. 72. Indeed, the location of a bead on the substrate is not pertinent to the analysis disclosed in Cantor. Ex. 2002 ¶ 172; see also id. at ¶ 31 (Cantor “does not relate to the [spatial] analysis of tissue samples . . . .”). “[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Here, Cantor fails to teach or suggest capture probes distributed randomly on a substrate comprising a nucleic acid sequence that identifies a unique location on the substrate as required by the challenged claims, and Petitioner fails to adequately articulate why a person of ordinary skill in the art would have modified Cantor to make the recited capture probes. In view of the above, we find that, on this record, Petitioner has failed to establish that Cantor teaches or suggests each element of the challenged claims. Accordingly, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge that any of claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, and 30 would have been obvious over Cantor.” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 11,761,030 - PTAB · May 21, 2025 · IPR2025-00192 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 5, 17, 20, 23, 28, or 29 were unpatentable over the asserted grounds.
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). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’138 patent is unpatentable.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Here, Cantor fails to teach or suggest capture probes distributed randomly on a substrate comprising a nucleic acid sequence that identifies a unique location on the substrate as required by the challenged claims, and Petitioner fails to adequately articulate why a person of ordinary skill in the art would have modified Cantor to make the recited capture probes. In view of the above, we find that, on this record, Petitioner has failed to establish that Cantor teaches or suggests each element of the challenged claims. Accordingly, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge that any of claims 1, 5, 17, 20, 23, 28, and 29 would have been obvious over Cantor. slip op. at 21
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“3. Discussion Petitioner challenges whether certain elements of independent claims 1 and 17 are supported by the ’124 provisional and/or whether the ’138 patent’s priority chain is intact. Pet. 52–60. Having considered the parties’ positions and evidence of record, however, we agree with Patent Owner’s written description analysis, summarized above, and find (1) that the ’124 Provisional provides adequate written description support for each of the challenged claim elements; (2) that the ’138 patent’s priority chain is intact; and (3) that the ’138 patent is therefore entitled to the priority date of April 5, 2010. Consequently, Frisen is not prior art to the challenged claims.” slip op. at 28
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“3. Discussion Petitioner challenges whether certain elements of independent claims 1 and 17 are supported by the ’124 provisional and/or whether the ’138 patent’s priority chain is intact. Pet. 52–60. Having considered the parties’ positions and evidence of record, however, we agree with Patent Owner’s written description analysis, summarized above, and find (1) that the ’124 Provisional provides adequate written description support for each of the challenged claim elements; (2) that the ’138 patent’s priority chain is intact; and (3) that the ’138 patent is therefore entitled to the priority date of April 5, 2010. Consequently, Frisen is not prior art to the challenged claims.” slip op. at 28
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 11,549,138 - SML Intelligent Inventory Solutions LLC / SML (USA) Inc. v. Adasa Inc.Institution deniedPTAB · May 20, 2025 · IPR2025-00125 · APJ Devon Zastrow Newman · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that Petitioner has not established a reasonable likelihood of prevailing on its assertion that at least one challenged claim is unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1–20 of the ’967 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)). Petitioner adopts the following definition of a person of ordinarily skill in the art (hereafter, sometimes “POSITA”) of the ’967 patent proposed by Patent Owner in the Avery Dennison litigation: [A]t least a bachelor’s degree in electrical engineering, computer science, or computer engineering, or a related discipline, and at least five years of experience which would consist of, A, designing, developing, evaluating and/or using RFID or other AIDC [automatic identification and data capture] technologies in inventory management, unique object identification, and/or security; or B, studying and conducting research related to RFID technologies and using RFID and other AIDC technologies in inventory management, unique object identification, and/or security. Pet. 6 (citing Ex. 1030, 707:3–13). Patent Owner does not offer a definition of an ordinarily skilled artisan of the ’967 patent at this time. See generally Prelim. Resp. 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 and the problems addressed in the ’967 patent.” slip op. at 17
- Prior constructionPrior construction adoptedDecided for patent owner
“Petitioner proposes the following claim constructions: “an allocated block of serial numbers” as “a pre-authorized range of binary serial numbers” and “uniquely corresponding” as the “term’s plain and ordinary meaning, consistent with the articulation of the plain and ordinary meaning” in the Avery Dennison litigation. Pet. 8–12. As to the remaining claim terms, Petitioner applies the district court’s constructions in the Avery Dennison litigation. Id. at 12 (citing Ex. 1028). Patent Owner applies the following constructions that were entered during in the Avery Dennison litigation: “object class information space” as “data field within the memory of the RFID integrated circuit chip for information identifying the class of an object, such as a company prefix, item reference code, partition value, and/or filter value,” “unique serial number space” as “data field within the memory of the RFID integrated circuit for information identifying a unique serial number,” “being assigned a limited number of most significant bits” as “includes a limited, predefined sequence at the leading end,” “remaining bits of lesser significance” as “the remaining lower order bits at the trailing end,” “is encoded with one serial number instance” as “has stored within it one serial number instance,” “an allocated block of serial numbers” as “a pre-authorized range of serial numbers,” and “uniquely corresponding” as its plain and ordinary meaning. Prelim. Resp. 32. For purposes of resolving whether to institute trial, we adopt and apply the interpretations stated in the district court’s claim construction order and applied by the Federal Circuit on appeal, Ex. 1028.11 See 55 F.4th 900, 908–909, 912–913 (Fed. Cir. 2022) (citing the district court’s claim construction order).” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“IBM200 and Kuhno would have made it obvious for a POSITA to commission RFID tags with unique serial numbers partitioned into MSBs and bits of lesser significance. See Pet. 34–39; Ex. 1005 ¶¶ 167–176. However, on this record, Petitioner has not sufficiently shown that the POSITA, having read IBM200 and Kuhno, would have been led to create a serial number space in which the limited number of “most significant bits” uniquely corresponds to those bits assigned to an allocated block of serial numbers, as recited in limitation [f].” slip op. at 25
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,798,967 - PTAB · May 15, 2025 · IPR2025-00029 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–12 and 14–19 on all asserted grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the art or arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of the art or arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 6
- Skill levelSkill level board ownOther
“We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:49–51 (claim 1 reciting “sequencing the amplified products comprising the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS sequencing now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’108 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 19
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,876,108 - PTAB · May 15, 2025 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–15 and 17–22 on all asserted obviousness grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“To accord substantial weight to evidence of secondary considerations, it “must have a nexus to the claims, i.e., there must be a legally and factually sufficient connection between the evidence and the patented invention.” Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417 (Fed. Cir. 2022) (internal quotation marks omitted); see also In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (instructing that “the Board, in considering the evidence of unexpected results, should determine whether there is a nexus between the unexpected [results] and aspects of the claimed invention not already present in the prior art”). Moreover, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Laboratories, 952 F.2d 388, 392 (Fed. Cir. 1991). On this record, it is unclear what Dr. Brooks considered to be the closest prior art when he alleged unexpected results. See Ex. 1002, 2013–17. We also find no persuasive evidence in either Brooks Declaration or the Examiner’s analysis on the requisite nexus. See id., 2055–56. As a result, we agree with Petitioner that “the Examiner erred in exclusively relying on Dr. Brooks’ declaration” to withdraw the obviousness rejection based on Jones and Tucker. See Pet. 58.” slip op. at 16
- Skill levelSkill level board ownDecided for petitioner
“We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:56–57 (claim 1 reciting “sequencing the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. Prelim. Resp. 5 (internal citations omitted). As such, we disagree with Patent Owner that a POSA only need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art. We further note” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 22
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,036,012 - PTAB · May 14, 2025 · IPR2025-00026 · APJ Deborah Katz · IPR · Institution
Instituted IPR of claims 1–10 on all asserted grounds after finding a reasonable likelihood that claim 1 is unpatentable over Porreca and declining § 325(d) denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“(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 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.” slip op. at 42
- Skill levelSkill level board ownOther
“Patent Owner asserts that Petitioner’s definition requiring a Ph.D. or a Master’s degree and several years of experience indicates higher than ordinary skill because by 2008 next generation sequencing was performed in laboratories according to published protocols and would have been accessible to experienced laboratory technicians and graduate students. (Prelim. Resp. 8.) Patent Owner proposes that, instead, the appropriate level of ordinary skill in the art was a Ph.D. in a field related to molecular biology, or a B.S. or M.S. degree with three to five years of experience working in a molecular biology lab. (See id.) On this preliminary record, having considered Dr. Metzker’s testimony and Patent Owner’s reasoning, we agree that one of ordinary skill in the art would have had experience with next generation sequencing, but are not persuaded that this would only be possible in the field of molecular biology. For the purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry or a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review. C. Claim Construction” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Petitioner argues that we should construe the claim term “adaptor” as “any oligonucleotide that is attached to the target sequence.” (See Pet. 9.) Petitioner cites the ’357 patent as referring to an “adaptor” as “an oligonucleotide sequence, the ligation of which to a target polynucleotide or a target polynucleotide strand of interest enables the generation of amplification-ready products of the target polynucleotide or the target polynucleotide strand of interest.” (Ex. 1002, 4:20-25; see Pet. 9–10.) According to Petitioner, this described function can be performed by any oligonucleotide. (See Pet. 10.) Petitioner also cites the Examiner’s reasoning during prosecution that “since any oligonucleotide can perform such function, any oligonucleotide is considered to anticipate this term.” (See Pet. 10 (citing Ex. 1013, 77).) Petitioner further cites the specification of the ’357 patent and claims of the ’241 patent, which is a continuation of the ’357 patent, in support of this construction. (See Pet. 9–10 (citing Ex. 1002, 9:43–46 (“appending the adaptor to the nucleic acid fragments generated by methods described herein can be achieved using a ligation reaction or a priming reaction.”) (emphasis omitted); Ex. 1001, claim 10).) Patent Owner does not dispute this construction at this stage, arguing only that the term need not be construed beyond its plain and ordinary meaning and reserving the right to propose constructions and identify terms needing construction later in the proceeding. (See Prelim. Resp. 9.) For the purposes of this decision, we adopt Petitioner’s construction of the term “adaptor,” although we note that it does not affect our decision to institute review. D. Ground I – Anticipation by Porreca” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,098,357 - Aardevo North America, LLC v. Agventure B.V.Institution deniedPTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution
Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable
“Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,140,841 - PTAB · Apr 25, 2025 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR of claims 1–9 on all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Chee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial.” slip op. at 13
- BurdenDecided for petitioner
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededDecided for petitioner
“tags,” and “locus of origin” need be addressed at this stage of the proceeding. We determine that no express construction of “consensus base call” is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). 1. “Set of [Unique] Differentiator Tags” Petitioner asserts that both “set of differentiator tags” as used in claim 1 and “set of unique differentiator tags” as used in claim 9 should be given the same construction—“set of prepared tags where each tag includes a unique sequence as compared to the other tags.” See Pet. 16 (citing Ex. 1005 ¶ 89; Ex. 1001, 28:25–29, 28:53–57). Petitioner further asserts that “[t]hese unique differentiator tags are associated with target nucleic acids so that each nucleic acid is uniquely identifiable.” Pet. 16. Petitioner also points to the prosecution history of the ’730 patent in which Petitioner asserts the Patent Owner argued and the Board acknowledged that each differentiator tag is unique. Id. at 16–17. Petitioner concludes that “[a]n interpretation of ‘differentiator tags’ to include non-unique tags is not possible, and if it were, Applicant disclaimed any interpretation that would allow non-unique tags.” Id. at 17.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,840,730
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.