- 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 · IPR2025-00027 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR on claims 1–16 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“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 ’241 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. 10.) Petitioner cites the ’241 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. 1001, 4:14–21; see Pet. 10.) According to Petitioner, this described function can be performed by any oligonucleotide. 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 ’241 patent for its disclosure that “appending the adaptor to the nucleic acid fragments generated by methods described herein can be achieved using a ligation reaction or a priming reaction.” (Ex. 1001, 9:34–37; see Pet. 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 McCloskey” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In summary, Petitioner presents evidence, which we find preliminarily persuasive, showing that McCloskey, Porreca, and Schmitt disclose aspects of the claims that were alleged in the prosecution to be missing in McCloskey 2007. For at least the reasons noted above, we determine that each of Porreca, McCloskey 2007, and Schmitt are not substantially the same as either McCloskey 2007 or Samuels. Accordingly, the first part of the framework of Advanced Bionics is not met and we are not persuaded there is a reason to exercise our discretion to deny institution of review at least on the basis of anticipation under 35 U.S.C. § 102(a) over Porreca, McCloskey, or Schmitt. Because we do not exercise discretion to deny institution of review on the basis of at least one ground of challenge raised by Petitioner, we institute trial on all claims and all grounds asserted in the Petition. See 35 U.S.C. § 314(a); SAS Inst., 584 U.S. at 362.” slip op. at 46
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are not persuaded at this point in the proceeding by Patent Owner’s arguments because Dr. Metzker testifies that McCloskey refers to the redundant hypermethylated and hypomethylated sequences, which one of ordinary skill in the art would have understood to mean both the identical target sequence and the identical barcode to be used to identify duplicates. (See Ex. 1003 ¶ 90.) At this point in the proceeding, in the absence of contradictory evidence, we are persuaded that Petitioner has provided sufficient evidence that McCloskey teaches “identifying sequence reads with identical identifier and target sequences as duplicates.”” slip op. at 15
Claim constructionDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,725,241 - 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 - Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.InstitutedPTAB · Feb 24, 2025 · IPR2024-01312 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1, 2, 4-6, 16, 17, and 19-21 on all asserted grounds, finding a reasonable likelihood of unpatentability over Lundahl and Larsen.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“justification for requiring a POSITA to have both an engineering degree and a medical degree. We agree, insofar as Petitioner has not clearly set out any particular explanation or evidence in support of its dual-degree requirement. In all other respects, we note that the parties’ proposed definitions are largely similar. Because we determine that Patent Owner’s proposed definition is reasonable and consistent with the ’028 patent and the cited art, we adopt Patent Owner’s definition for purposes of this Decision. In any event, our decision whether to institute does not turn on this level of skill determination.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“used to construe the claim in a civil action under 35 U.S.C. § 282(b); 37 C.F.R. § 100(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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)). Petitioner and Patent Owner assert that the Board need not construe any claims for the purpose of deciding whether to institute an inter partes review. Pet. 12; Prelim. Resp. 24. We agree.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Based on our review of the Petition, Petitioner explains that a driving motivation for a POSITA to modify Lundahl to include Larsen’s five panels is “to increase the flexibility of the device to ensure the light panels could be maintained at a distance of 2-4′′ from surface of the treatment area, whether the face, arm, or back, etc.” Pet. 29 (emphasis added). As Lundahl’s device is not flexible, and such flexibility would improve its ability to treat areas other than an average sized face, we determine, at this stage in the proceeding, that this motivation for the combination is sufficient.” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightInstituted
“would have been motivated to modify Lundahl’s device by incorporating Larsen’s use of LEDs on the surface of the light applicators in place of Lundahl’s fluorescent tubes with a reasonable expectation of success. Prelim. Resp. 55. Patent Owner argues that Petitioner’s modification is based on improper hindsight bias because “Petitioner cherry-picks Larsen’s LEDs (together with the five panels) and purports to arrange them according to the [sic] ‘the uneven spacing’ of Lundahl’s fluorescent tubes.” Id. at 56 (citing Pet. 46–49; Ex. 1015 ¶¶ 175–80). According to Patent Owner, “Petitioner cannot on the one hand argue that a ‘POSITA would have understood that Larsen’s applicator is configured to uniformly illuminate a treatment surface of the patient,’ while on the other ignore Larsen’s teaching that the ‘light sources 17 are placed in regular row arrangements.’” Id. Patent Owner asserts that Petitioner’s proposed modification “mish-mashes aspects of Lundahl and Larsen ([while] avoiding the overall teachings of [challenged] claims.” Id. at 56–57. As discussed above, based on our consideration of the current record, Petitioner has provided sufficient motivation for employing Larsen’s flexible five panel configuration. These panels in Larsen already use LEDs as their light source. So, in our view, Petitioner’s incorporation of the five panels includes the lighting source, i.e., LEDs, for those panels taught by Larsen. Further, we note that Petitioner has persuasively asserted that a skilled artisan would have been motivated to use Larsen’s LEDs as they are more cost-efficient and last longer. See Pet. 31.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,697,028 - PTAB · Feb 6, 2025 · IPR2024-01212 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–27 on all petitioned grounds after finding a reasonable likelihood that claim 1 would be obvious over Racz, Fitz, and Lee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“§ 314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a). After considering the evidence and arguments presented in the Petition, we determine that Petitioner demonstrates a reasonable likelihood of prevailing in showing that at least one of the challenged claims of the ’664 patent is unpatentable. Accordingly, we institute an inter partes review as to all the challenged claims of the ’664 patent on all the grounds of unpatentability set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Petitioner, the relevant technical field is “‘thermal ablation systems and methods,’ which includes ‘methods for performing Radio Frequency (RF) neurotomy.”’ Pet. 11 (citing Ex. 1003, 1:24–27). Relying on the testimony of Dr. Tucker, Petitioner contends that the ordinarily skilled artisan in this field would have had at least (i) a bachelor’s degree in biomedical engineering, or a related field, such as mechanical engineering, biomechanical engineering, or bioengineering, who also has at least 3 years of experience with thermal ablation system and methods; or (ii) an advanced degree in the same areas of academic study with at least 1 years of experience with thermal ablation systems and methods. Id. (citing Ex. 1034 ¶ 105) (paragraphing added). Absent evidence or argument to the contrary, we apply Petitioner’s proposed definition, as it appears consistent with the prior art and is supported by the presently unopposed testimony of Dr. Tucker. See Okajima v. Bourdeau, 261 F.3d 1350, 1355, (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself). We note, however, that Petitioner’s open-ended language “at least” expands the ranges of education and experience indefinitely with no upper bound, thereby encompassing those of extraordinary skill. Therefore, we do not adopt this aspect of Petitioner’s formulation. B.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Claim Construction The Board interprets claim terms in an inter partes review using the same claim construction standard that is used to construe claims in a civil action in federal district court. See 37 C.F.R. § 42.100(b)). In construing claims, district courts give claims 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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 11 (citing Ex. 1034 ¶ 106 (Dr. Tucker’s testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). On the presents record, we agree with Petitioner that no term requires express construction. C.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“through [1e]. Pet. 28–30. Petitioner further relies on “Racz as modified in view of Fitz and Lee,” with respect to elements [1e] through [1h]. See generally, id. at 30–47. Supported by the testimony of Dr. Tucker, Petitioner contends that one of ordinary skill in the art would have been motivated to combine the teachings of Racz, Fitz, and Lee with a reasonable expectation of success of arriving at the claimed invention. Id. at 1–6, 21–27; Ex. 1034 ¶¶ 132–149. In short, Petitioner contends that “[m]ost of the recited RF needle features—including an elongate cannula, a removable RF probe, a conductive tip, and a monopolar configuration—are conventional features disclosed in . . . Racz,” whereas Fitz discloses that a single-tip device, such as disclosed in Racz, “would produce limited ablation volumes and would have motivated a POSA to solve this problem by adding deployable filaments,” as recited in claim elements [1e] and [1f]. Id. at 4–5, 21–22. In addition to its reliance on the multiple electrode tips disclosed in Fitz, Petitioner contends that Lee would have “motivate[ed] a POSA to implement deployable filaments on the tip of Racz’s device using channels within the cannula,” and “also shows how the filaments can extend outwardly around the needle’s tip to advantageously expand and control the ablation volume.” Id. at 5–6. Accordingly, Petitioner contends, one of ordinary skill in the art “would have found it obvious to modify Racz’s device to include the well-known deployable filaments described in Fitz and Lee,” and would have implemented this combination as “a matter of routine engineering.” Id. at 6, 27.” slip op. at 20
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,925,664 - PTAB · Feb 6, 2025 · IPR2024-01211 · APJ John G New · IPR · Institution
The Board instituted IPR on claims 18–47 and 53–74 and all petition grounds, finding a reasonable likelihood that claims 18–25, 27, and 29–33 are obvious over Racz, Fitz, and Lee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“§ 314. An inter partes review may not be instituted unless “the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all of the claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Absent evidence or argument to the contrary, we apply Petitioner’s proposed definition, as it appears to be consistent with the level of skill of the prior art and is supported by the presently unopposed testimony of Dr. Tucker. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself). We note, however, that the open-ended language ‘at least’ expands the ranges of education and experience indefinitely with no upper bound, thereby also encompassing those of extraordinary skill as well. Therefore, we do not adopt this aspect of Petitioner’s formulation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 11 (citing Ex. 1033 ¶ 120 (Dr. Tucker’s testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). We agree with Petitioner that, on the record presently before us, no claim term requires express construction.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner argues that, in view of these teachings in Racz and Lee, a skilled artisan would have found implementing Lee’s perimeter filaments (22/1622) on Racz’s distal tip (14/38) to be a routine engineering task. Pet. 39 (citing Ex. 1033 ¶ 179). According to Petitioner, a person of ordinary skill in the arts would have recognized that it would be appropriate to implement Lee’s perimeter filaments (22/1622) without including Lee’s central filament. Id. Petitioner asserts that Lee discloses that any number and arrangement of filaments may be implemented to provide a desired ablation volume. Id. at 38 (citing Ex. 1010 ¶¶ 103, 105, 106). Additionally, Petitioner argues, because Racz’s tip (14/38) is already active, a skilled artisan would have recognized that Lee’s central filament would not be necessary. Id. (citing Ex. 1009, col. 3, ll. 60–63, col. 4, ll. 18–23; Ex. 1033 ¶ 179). Petitioner therefore argues that a person of ordinary skill in the art a person of ordinary skill in the art would have been motivated to implement Lee’s perimeter deployable filaments (22/1622) on the distal tip (14/38) of Racz’s cannula (10/33) for the purpose of expanding and controlling the energy coverage area of Racz’s device. Pet. 40. Specifically, Petitioner asserts that a skilled artisan would have been motivated to implement Lee’s perimeter filaments (22/1622) around Racz’s tip (14/38) to provide a desired ablation volume (e.g., in a full or partial “cone” shape) and omit Lee’s central filament. Pet. 38 (citing Ex. 1033 ¶¶ 179, 73–75, 79–83). Petitioner contends that, as both Lee and Fitz confirm, this would improve Racz’s device by providing an expanded and controlled energy coverage area. Id. (citing Ex. 1011 ¶¶ 9–10, Abstr.; Ex. 1010 ¶¶ 12, 84, 123–131; Ex. 1033 ¶ 179). Petitioner argues further that, in implementing Lee’s perimeter filaments (22/1622) on Racz’s distal tip (14/38), a person of ordinary skill in the art would have found it obvious to modify Racz’s tip (14/38) to include internal deflection surfaces (12/1612) (e.g., channels and ramps as disclosed in Lee) to guide the perimeter filaments (22/1622) outwardly around Racz’s tip (14/38). Pet. 41 (citing Ex. 1010 ¶¶ 16, 18, 92, 102, claims 8, 10; Ex. 1033 ¶ 180). Petitioner asserts that it would have been obvious to provide openings in Racz’s distal tip (14/38) (e.g., in communication the internal deflection surfaces as disclosed in Lee) such that Lee’s perimeter filaments (22/1622) can, when deployed, exit Racz’s distal tip (14/38). Id. (citing Ex. 1010 ¶ 92, 102; Ex. 1033 ¶ 180). Furthermore, argues Petitioner, and to preserve the functionality of Racz’s removable electrical probe (22/52) and active tip (14/38) (and consistent with Lee’s teachings) a skilled artisan would have arranged the perimeter filaments, channels, and ramps around the internal perimeter of Racz’s cannula (10/33). Pet. 41 (citing Ex. 1010 ¶¶ 91, 92, 98, 102; Ex. 1033 ¶ 181). Petitioner recapitulates that Racz’s probe (22/52) is configured to extend the full length of the cannula’s shaft (12/34) to supply RF energy to the tip (14/38) and measure tissue temperature. Pet. 42. According to Petitioner, by omitting Lee’s central filament and arranging the perimeter filaments, channels, and ramps around the inner perimeter of Racz’s cannula (10/33), a skilled artisan could have implemented Lee’s perimeter filaments (22/1622) without obstructing Racz’s cannula (10/33). Id. at 40. Petitioner contends that this modification would preserve the functionality of Racz’s electrical probe (22/52), which is needed to transmit RF energy. Id. (citing Ex. 1033 ¶ 181–182).” slip op. at 29
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,736,688 - PTAB · Feb 6, 2025 · IPR2024-01210 · APJ John G New · IPR · Institution
The Board instituted IPR on claims 1–17 and 48–52 on all asserted grounds, finding a reasonable likelihood that at least one claim was obvious over Racz, Fitz, and Lee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“§ 314. An inter partes review may not be instituted unless “the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all of the claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“Absent evidence or argument to the contrary, we apply Petitioner’s proposed definition, as it appears to be consistent with the level of skill of the prior art and is supported by the presently unopposed testimony of Dr. Tucker. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself). We note, however, that the open-ended language ‘at least’ expands the ranges of education and experience indefinitely with no upper bound, thereby also encompassing those of extraordinary skill as well. Therefore, we do not adopt this aspect of Petitioner’s formulation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 11 (citing Ex. 1032 ¶ 120 (Dr. Tucker’s testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). We agree with Petitioner that, on the record presently before us, no claim term requires express construction.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“person of ordinary skill in the art would have been motivated to implement Lee’s perimeter deployable filaments (22/1622) on the distal tip (14/38) of Racz’s cannula (10/33) for the purpose of expanding and controlling the energy coverage area of Racz’s device. Pet. 35. Specifically, Petitioner asserts that a skilled artisan would have been motivated to implement Lee’s perimeter filaments (22/1622) around Racz’s tip (14/38) to provide a desired ablation volume (e.g., in a full or partial “cone” shape) and omit Lee’s central filament. Pet. 38 (citing Ex. 1032 ¶¶ 179, 73–75, 79–83). Petitioner contends that, as both Lee and Fitz confirm, this would improve Racz’s device by providing an expanded and controlled energy coverage area. Id. (citing Ex. 1011 ¶¶ 9–10, Abstr.; Ex. 1010 ¶¶ 12, 84, 123–131; Ex. 1032 ¶ 179). Petitioner argues further that, in implementing Lee’s perimeter filaments (22/1622) on Racz’s distal tip (14/38), a person of ordinary skill in the art would have found it obvious to modify Racz’s tip (14/38) to include internal deflection surfaces (12/1612) (e.g., channels and ramps as disclosed in Lee) to guide the perimeter filaments (22/1622) outwardly around Racz’s tip (14/38). Pet. 39 (citing Ex. 1010 ¶¶ 16, 18, 92, 102, claims 8, 10; Ex. 1032 ¶ 180). Petitioner asserts that it would have been obvious to provide openings in Racz’s distal tip (14/38) (e.g., in communication the internal deflection surfaces as disclosed in Lee) such that Lee’s perimeter filaments (22/1622) can, when deployed, exit Racz’s distal tip (14/38). Id. (citing Ex. 1010 ¶ 92, 102; Ex. 1032 ¶ 180).” slip op. at 29
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,736,688 - PTAB · Feb 6, 2025 · IPR2024-01209 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–27 and all petition grounds, finding a reasonable likelihood that at least one claim is obvious over Racz, Fitz, and Lee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Absent evidence or argument to the contrary, we apply Petitioner’s proposed definition, as it appears consistent with the prior art and is supported by the presently unopposed testimony of Dr. Tucker. See Okajima v. Bourdeau, 261 F.3d 1350, 1355, (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself). We note, however, that Petitioner’s open-ended language “at least” expands the ranges of education and experience indefinitely with no upper bound, thereby encompassing those of extraordinary skill. Therefore, we do not adopt this aspect of Petitioner’s formulation. B.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 11 (citing Ex. 1031 ¶ 106 (Dr. Tucker’s testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). On the presents record, we agree with Petitioner that no term requires express construction.” slip op. at 12
Claim constructioncites Phillips · KSRPatents in suitUS 10,966,782 - PTAB · Jan 13, 2025 · IPR2024-01156 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all grounds, finding it more likely than not that the claims are unpatentable.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the current record, there is no controversy over the meaning of any of the claim terms and neither party identifies a claim construction that would impact our analysis. We therefore find that, at this stage of the proceeding, there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts (without opposition): A person of ordinary skill in the art (“POSA”) at the time of invention would have a working knowledge of microbiology and would have been involved in developing testing methodologies for analysis of samples such as food products (“validation methodologies”). The POSA would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies. The POSA would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The motivation-to-combine analysis is a flexible one. “[A]ny 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,” [but the] “analysis ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’” Intel Corp. v. PACT XXP Schweiz AG, 61 F.4th 1373, 1379–80 (Fed. Cir. 2023) (quoting KSR, 550 U.S. at 418, 420 (emphasis added)). “[I]f there’s a known technique to address a known problem using ‘prior art elements according to their established functions,’ then there is a motivation to combine,” because KSR explains that “if a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar devices [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1380 (quoting KSR, 550 U.S. at 417; and Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021)). If addressing a known problem, the prior art combination need not be “the best option, only . . . a suitable option.” Id. (quoting Intel, 21 F.4th at 800 (emphasis original)).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,845,486
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.