- 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 - 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 · Mar 19, 2025 · IPR2024-01289 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–7, 11–15, 17, 19, and 27–29 were unpatentable over Cantor, Cantor and Armani, or Frisen.
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 ’022 patent is unpatentable.” slip op. at 2
- 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. 20. Likewise, Patent Owner takes the position that “no claim terms require explicit construction” for purposes of determining whether to institute inter partes review. Prelim. Resp. 20. 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., 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))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest the level of ordinary skill in the art set forth in the Petition. Prelim. Resp. 20. Because Petitioner’s unopposed definition is consistent with the ’022 patent and the prior art of record, we adopt that definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“In particular, we agree with Patent Owner that “[n]ot only does Cantor not teach contacting a ‘tissue sample’ with beads, but Cantor comes nowhere close to suggesting that its beads could be contacted with a tissue sample to identify spatial location.” Prelim. Resp. 50. Here, we are persuaded by the testimony of Dr. Cantor, sole inventor of Cantor (Ex. 2002 ¶ 29), that Cantor’s nucleic acid samples are made in bulk from the extraction of nucleic acids from biological material and mixed together “to create the sample nucleic acid prior to mixing that with the solid phase nucleic acids to capture molecule(s) from the sample nucleic acid.” Id. at ¶ 17. More specifically, “nucleic acids are extracted from the different types of cells within a tissue sample without preserving their spatial distribution.” Id. at ¶ 19. Thus, these types of “bulk-analysis techniques provide no information about spatial location of biological molecules in tissue samples.” Id. at ¶ 17. While we recognize that Cantor discloses “providing the beads according to an (X,Y) array” (Pet. 39, citing to Dr. Puglisi, Ex. 1100 ¶¶ 65– 66), this disclosure makes no mention of using this array to map where the nucleic acids of Cantor came from relative to the original sample, let alone when that original sample is a tissue. See e.g. Ex. 1031, 17. The only mentions of “tissue” made in Cantor are in reference to where the sample may be obtained, for example, “[t]he biological sample can be in any form, including without limitation a solid material such as a tissue.” Id. at 6. Cantor provides no teaching, however, regarding how to use a tissue sample with the probes and methods described in Cantor to identify where the target nucleic acids of Cantor were spatially located within the tissue sample itself. Incidental to the parties’ dispute is whether Petitioner’s reliance on and characterization of Cantor’s use of the terms “sample” and “nucleic acid sample” as equivalent in meaning to “tissue sample” recited in the challenged claims is persuasive. Pet. 21 (citing Ex. 1031, 6). Here, we note that Cantor discloses that “[s]ample nucleic acid may be derived from one or more samples or sources.” Ex. 1031, 5; Ex. 2002 ¶¶ 35, 149. Cantor refers to “sample” as the thing that contains the sample nucleic acid. Ex. 1031, 5. For example, Cantor discloses that “[a] sample may be collected from an organism.” Ex. 1031, 6; Ex. 2002 ¶ 42. When a “sample” comes from a living (or formerly living) source, Cantor refers to that sample as a “biological sample,” which can “be in any form, including without limitation a solid material such as a tissue, cells, a cell pellet, a cell extract, or a biopsy, or a biological fluid . . . .” Id. Those samples, however, are further processed in bulk to obtain the nucleic acid sample. For example, Cantor discloses that the “sample nucleic acid may be a result of nucleic acid purification or isolation and/or amplification of nucleic acid molecules from the sample.” Ex. 1031, 7; see also id. at 54 (The “sample nucleic acid” is derived from a sample or source “by any means commonly known in the art, including but not limited to cell lysis procedures using chemical, physical or electrolytic lysis methods.”); Ex. 2002 ¶ 39. In view of the above, we are not persuaded by Petitioner’s attempts to characterize Cantor’s “nucleic acid sample” as synonymous to “tissue sample” recited in the challenged claims. Rather, we agree with Dr. Cantor that “[a] tissue is simply the source of the sample nucleic acid used in [Cantor’s] methods”—it is not the sample nucleic acid itself. Ex. 2002 ¶¶ 36, 150. Petitioner does not direct us to any persuasive evidence to the contrary.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,480,022 - Ovid Therapeutics Inc. v. Marinus Pharmaceuticals, Inc.Institution deniedPTAB · Sep 20, 2024 · IPR2024-00726 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–21 were unpatentable under any of the three asserted obviousness grounds.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Based upon our review of the arguments and an examination of the claim language itself, the written description, and the prosecution history, we determine that the record supports finding that the entire “wherein” clause recited in independent claim 1 is limiting. This clause recites, wherein the effective amount of ganaxolone is administered as an intravenous bolus plus continuous infusion to produce and maintain a ganaxolone plasma concentration of about 500 ng/ml to about 1000 ng/ml for about 8 hours to about 12 hours.” slip op. at 10
- Skill levelOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) at the time the application for the ’100 patent was filed “would have had a medical degree or a Ph.D. in pharmacology or fields related to the development of pharmaceuticals and would have been familiar with the PK [pharmacokinetics] and PD [pharmacodynamics] of pharmaceuticals.” Pet. 18. Additionally, Petitioner asserts “[a] POSA also would have had several years of experience as a practicing neurologist treating patients who suffer from seizure disorders, including SE, and/or several years of experience in researching treatments for such seizure disorders.” Id. (citing Ex. 1002 ¶ 50). According to Patent Owner, a person of ordinary skill in the art at the time the application for the ’100 patent was filed, “would have had a medical degree, or a Ph.D. in pharmacology or other field related to the development of pharmaceuticals, or equivalent degree, and several years of with Refractory Status Epilepticus, Poster Abstract F53, 37 J. CLIN. NEUROPHYSIOLOGY 332 (July 2020) (Ex. 1009, “Husain 2020”). experience as a practicing neurologist treating patients who suffer from seizure disorders including status epilepticus and/or several years of experience in researching treatments for such seizure disorders.” Prelim. Resp. 17–18 (citing Ex. 2011 ¶ 44). We note that the parties’ proposed definitions are largely similar, except that Patent Owner additionally recognizes “an equivalent degree” as an alternative to a medical degree or Ph.D. in pharmacology or other field related to the development of pharmaceuticals. Compare Pet. 18 with Prelim. Resp. 17–18. We do not need to resolve this issue as our findings and conclusion in this Decision would be the same under either proposed definition.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“agree with Patent Owner that Petitioner has not shown sufficiently for institution that the claimed invention would have been obvious over the combined teachings of During and NCT03350035. As discussed above, in Section II.B., we have determined that the “wherein” clause of independent claim 1 is liming. In other words, the claim requires that the effective amount of ganaxolone is administered as an IV bolus plus continuous infusion and that such administration produces and maintains a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. With respect to the recited plasma concentration limitation, Petitioner has alleged only that it is met inherently. Dr. Sankar has only offered the same conclusory position in his declaration. See Ex. 1002 ¶¶ 113, 115. While “inherency may supply a missing claim limitation in an obviousness analysis,” this doctrine “must be carefully circumscribed in the context of obviousness.” PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1194–1195 (Fed. Cir. 2014). As the Federal Circuit has explained: The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. Id. at 1195 (quoting In re Oelrich, 666 F.2d, 578, 581 (C.C.P.A. 1981). Here, Petitioner and Dr. Sankar have not explained or demonstrated why or how the natural result of administering the dosages in During according to the method disclosed in NCT03350035 would produce and maintain a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. This deficit is more pronounced in view of the Specification disclosure of a Phase 2 Open-Label Dose Range Study that exemplifies how some ganaxolone dosages that suppressed SE did not produce and maintain ganaxolone plasma concentrations ≥ 500 ng/ml for about 8 to 12 hours. See Ex. 1001, Fig 15; see also Ex. 1001, 55:13–56:30. Thus, because Petitioner relies on inherency for the plasma concentration limitation without providing evidence that such inherency exists, Petitioner has failed to establish sufficiently for institution that During and NCT03350035 teach or suggest each limitation of the claim 1. Accordingly, we determine that Petitioner has not shown a reasonable” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“agree with Patent Owner that Petitioner has not shown sufficiently for institution that the claimed invention would have been obvious over the combined teachings of During and NCT03350035. As discussed above, in Section II.B., we have determined that the “wherein” clause of independent claim 1 is liming. In other words, the claim requires that the effective amount of ganaxolone is administered as an IV bolus plus continuous infusion and that such administration produces and maintains a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. With respect to the recited plasma concentration limitation, Petitioner has alleged only that it is met inherently. Dr. Sankar has only offered the same conclusory position in his declaration. See Ex. 1002 ¶¶ 113, 115. While “inherency may supply a missing claim limitation in an obviousness analysis,” this doctrine “must be carefully circumscribed in the context of obviousness.” PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 1194–1195 (Fed. Cir. 2014). As the Federal Circuit has explained: The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. Id. at 1195 (quoting In re Oelrich, 666 F.2d, 578, 581 (C.C.P.A. 1981). Here, Petitioner and Dr. Sankar have not explained or demonstrated why or how the natural result of administering the dosages in During according to the method disclosed in NCT03350035 would produce and maintain a ganaxolone plasma concentration of about 500 to 1000 ng/ml for about 8 to 12 hours. This deficit is more pronounced in view of the Specification disclosure of a Phase 2 Open-Label Dose Range Study that exemplifies how some ganaxolone dosages that suppressed SE did not produce and maintain ganaxolone plasma concentrations ≥ 500 ng/ml for about 8 to 12 hours. See Ex. 1001, Fig 15; see also Ex. 1001, 55:13–56:30. Thus, because Petitioner relies on inherency for the plasma concentration limitation without providing evidence that such inherency exists, Petitioner has failed to establish sufficiently for institution that During and NCT03350035 teach or suggest each limitation of the claim 1.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,110,100 - Resmed Corp. v. Cleveland Medical Devices, Inc.Institution deniedPTAB · Jun 24, 2024 · PGR2024-00012 · APJ Ulrike W Jenks · PGR · Institution
The Board denied institution of PGR on claims 1–20 because Petitioner did not show the patent was PGR-eligible, having failed to show inadequate written-description support or lack of enablement in the pre-AIA priority applications.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Petitioner has the burden of establishing eligibility for post-grant review. See Mylan Pharms. Inc. v. Yeda Res. & Dev. Co., PGR2016-00010, Paper 9 at 10 (PTAB Aug. 15, 2016). To show that the ’284 patent is eligible for post-grant review, Petitioner bears the burden of proving that the challenged claims lack the priority benefit of the filing date of an earlier 7 The ’284 patent issued from a transition application. A “transition application” is a patent application filed on or after March 16, 2013 (the effective date of the AIA), but which claims priority to an application that was filed prior to the effective date of the AIA. See, e.g., MPEP § 2159.04. challenged claims, or a claim pending during examination of the ’266 application, “was not disclosed in compliance with the written description and enablement requirements of § 112(a) in the earlier application for which the benefit of an earlier filing date prior to March 16, 2013 was sought.” Inguran, LLC v. Premium Genetics (UK) Ltd., PGR2015-00017, Paper 8 at 11 (PTAB Dec. 22, 2015).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“Thus, the ’284 patent specification explains that the system can adjust the positive airway pressure supplied to the subject without human intervention. The system gathers information from the sensors and uses it to “monitor the condition of the subject” and “determine a level of severity of the subject’s sleeping disorder.” Ex. 1001, 23:20–41. Based on this the subject,” for example by adjusting the positive airway pressure provided to the subject. See id. at 19:3–17, 3:37–55. In this way, the ’284 patent specification discloses generating “an index of treatment efficacy” where “the index [is] based in part on data of severity of sleep disorder symptoms of the subject and data of usage of the PAP device by the subject,” because the system uses data collected from the sensors to evaluate the severity of the subject’s sleeping disorder and efficacy of the current treatment, and can adjust the treatment without human intervention as needed. Accordingly, Petitioner has not demonstrated that it is more likely than not that the ’284 patent claims lack written description support in the pre-AIA priority applications for “an index of treatment efficacy” claim term.” slip op. at 13
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“’284 patent claims are not enabled. Prelim. Resp. 24–30. We find that Petitioner has failed to demonstrate, more likely than not, that any experimentation would have been undue in view of the Wands factors. Prelim. Resp. 25 (citing Wands, 858 F.2d at 737). On this record, Petitioner has not demonstrated that the claimed subject matter is unpredictable or would require undue experimentation. Petitioner argues that “the challenged claims are not enabled regarding the ‘index of treatment efficacy’ claim elements.” Pet. 24. But as Patent Owner establishes, Petitioner acknowledges that determining treatment efficacies was merely applying a known technique. See Prelim. Resp. 26 (citing Pet. 36 (determining treatment efficacy “would amount to merely applying a known technique (i.e., determining treatment efficacy based on multiple factors) to a known device ready for improvement (e.g., CPAP treatment system comprising multiple devices) to yield predictable results (i.e., improve operation of CPAP treatment to better treat the patient and its disorder)”). On this record, Patent Owner further demonstrates that “it was well- known in the art [] how to determine indices of treatment efficacy based on breathing metric data over a period of time.” Prelim. Resp. 26; Ex. 2001 at 175 (“Efficacy, in the context of [obstructive sleep apnea] OSA, reflects the ability of treatment to prevent the occurrence of obstructive breathing events during periods when the treatment is being physically applied.”); Ex. 2002 at 1–2 (based on the apnea-hypopnea index (AHI) the severity of obstructive sleep apnea (OSA) can be calculated); Ex. 2003 at 1 (“ResLink presents this efficacy information along with integrated oximetry data for simultaneous onscreen viewing and analysis.”)). index of treatment efficacy on a cell phone or transmitting it to a remote internet site.” Pet. 25. Petitioner, however, has not demonstrated, more likely than not, that it would take undue experimentation to carry out such display or transmission. The Petition merely suggests that the specification lacks enablement of these claim limitations, but fails to provide any analysis of pertinent factors, such as the state of the prior art, the level of ordinary skill, or the level of predictability in the art with regard to displaying and transmitting data on a cell phone at the time of the invention. In sum, we conclude that Petitioner has failed to show that it is more likely than not that the challenged claims are not enabled.” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In this post-grant review, we construe the claims of the ’284 patent “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b).” 37 C.F.R. § 42.200(b) (2019). Under that standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that “[n]o claim term needs formal construction for purposes of evaluating the prior art in this Petition.” Pet. 16. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms requires an explicit construction to determine whether to institute post-grant review. See 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))).” slip op. at 8
Claim construction§ 112 disclosurePatents in suitUS 11,602,284 - Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Institution deniedPTAB · May 17, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable over Perkins or the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Accordingly, we deny institution of post-grant review.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for patent owner
“Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that Perkins is prior art to the ’366 patent only to the extent that the subject matter disclosed in Perkins is likewise described in the Perkins Provisional. Accordingly, we do not consider Petitioner’s arguments that rely on subject matter unsupported by the Perkins Provisional. For example, support for Petitioner’s argument that Perkins discloses “mutant VSV-G envelope protein containing only four mutations at N180, I182, T352, and E353” is not found in the Perkins Provisional and is therefore not considered. Pet. 73 (quoted with Petitioner’s emphasis). Thus, insofar as Petitioner is suggesting that Perkins describes a list of mutations that is narrowed to four positions including a mutation at I182, rather than a listing of thirteen potential positions for mutations (and various combinations thereof with hypothetical mutations at a variety positions), we find no such narrower listing in the Perkins Provisional. Compare Ex. 1005, 22:2–5, with Ex. 1006, 17–18.” slip op. at 19
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“genus even if the species are not themselves recited.” Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001); see also, Atofina, 441 F.3d at 999 (“[A] very small genus can be a disclosure of each species within the genus.” (citing In re Petering, 301 F.2d at 682)). In Petering, for example, the prior art disclosed a small genus of only 20 compounds that included the claimed species. In re Petering, 301 F.2d at 682. In its discussion concluding that a small genus may anticipate a species of that genus, the Court of Customs and Patent Appeals explained that “it is not the mere number of compounds in this limited class which is significant here, but rather, the total circumstances involved, including such factors as the limited number of variations for R, only two alternatives for Y and Z, no alternatives for the other ring positions, and a large unchanging parent structural nucleus.” Id. at 681–682. Having considered the parties’ positions and evidence of record, summarized above, we do not find that Perkins discloses a limited class as exemplified in Petering. To begin, while it is undisputed that Perkins discloses a class of mutant VSV-G envelope proteins that encompasses the recited I182E or I182D mutations, it is also undisputed that Perkins does not disclose the I182E or I182D mutations. Prelim. Resp. 22. Furthermore, and by contrast to the limited class of compounds at issue in Petering, Perkins discloses a class of mutant VSV-G envelope proteins defined as proteins containing one or more of 20 possible mutations or alterations, a class that includes at least 254 proteins. Ex. 1006, 17–18; Prelim. Resp. 26–27. Furthermore, as Patent Owner correctly points out, “[t]he Perkins Provisional does not include any disclosure of the specific mutations to be made at any of these locations. That is, the Perkins Provisional does not indicate the other amino acid(s) to be substituted at the listed locations.” Prelim. Resp. 26. Thus, Perkins fails to provide a POSA with a “‘pattern of preferences’ that serves to narrow the genus.” See, e.g., Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006) (“there is no such clear ‘pattern of preferences’ [as found in Petering] that serves to narrow the genus in claim 2 to a narrow class that includes clopidogrel bisulfate”).” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Obviousness is a question of law based on underlying findings of fact.” In re Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009). A conclusion of obviousness is appropriate where the prior art “contain[s] detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” In re O’Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988); see also, In re Kubin, 561 F.3d at 1359 (KSR “actually resurrects [the Federal Circuit]’s own wisdom in In re O’Farrell”). However, to render a claim obvious, prior art cannot be “vague” and must collectively, although not explicitly, guide an artisan of ordinary skill towards a particular solution. Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009). That is, when a field is “unreduced by direction of the prior art,” and when prior art gives “no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful,” an invention is not obvious. Bayer Schering, 575 F.3d at 1347 (citing In re O’Farrell, 853 F.2d at 903). Having considered the parties’ positions and evidence of record, summarized above, we are not persuaded that Perkins discloses a finite set or limited class of 19 mutations. Pet. 66. Rather, we agree with Patent Owner that Perkins discloses a large genus of mutant VSV-G polypeptides containing at least 254 species—“Perkins Provisional discloses mutations at I182 among a group of 20 other possible locations for modifications[,] . . . [13] of these 20 positions are specific amino acids that . . . can be changed to any of the 19 other natural amino acids” —each species combinable to create a vast number of species. Prelim. Resp. 32. Perkins does not indicate any preference among the 13 disclosed mutations, does not indicate any preference among the 19 other amino acids, and does not indicate any preference as to which mutations should be combined to successful effect. Ex. 1006, 17–18. Thus, while Perkins discloses that one or more mutations “inhibit the envelope protein’s ability to bind its native target, while preserving the envelope protein’s fusogenic properties,” beyond that, a POSA would have no direction for selecting the route to create the I182E or I182D mutations specified by the challenged claims among the various unpredictable alternatives suggested by Perkins. Ex. 1006 at 16; Ex. 1002 ¶ 193. We do not find this to be the easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness. KSR, 550 U.S. at 402. slip op. at 34
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 11,767,366 - Zimvie, Inc. / Zimmer Biomet Spine, Inc. v. Roger P. JacksonInstitution deniedPTAB · Apr 1, 2024 · IPR2023-01433 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable, chiefly because the cited art did not disclose the claimed curved leading faces.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of inter partes review.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“and consistent with the plain meaning, a POSA would have understood that a ‘start structure’ is the beginning of a thread and the ‘leading face’ is the forward most surface of the thread in the direction the thread is to be rotated.” Pet. 15–16 (citing Ex. 1001, 9:38–42, Fig. 5; Ex. 1003 ¶¶ 158, 159). Petitioner further asserts that the concave portion is “inwardly curving,” and the convex portion is “outwardly curving.” Id. at 16 (citing Ex. 1003 ¶ 161). Patent Owner does not propose any claim construction for these terms. See Prelim. Resp. 7. Instead, Patent Owner asserts that “there are no express constructions for the Board to consider or the Patent Owner to address.” Id. We disagree with Patent Owner’s allegation because Petitioner sufficiently explains the plain meaning of the terms “start structure,” “leading face,” “concave surface portion,” and “convex surface portion.” Pet. 15–16. On this record, and for purposes of this Decision, we adopt Petitioner’s proposed constructions of these terms. 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 address the construction of any other claim term. slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“As Patent Owner correctly points out, the ’477 publication does not describe, or even identify, the line in Figure 10 that Petitioner relies on as the leading face. Prelim. Resp. 20. Thus, the only evidence purportedly supports Petitioner’s argument that the unidentified and undescribed line is the leading surface is Dr. McMillin’s testimony. See Ex. 1003 ¶¶ 186, 234. In paragraph 186, Dr. McMillin’s testimony merely repeats, nearly verbatim, Petitioner’s argument, without any explanation or other evidentiary support. See id. ¶ 186. As a result, we accord limited weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). In paragraph 234, Dr. McMillin testifies that an ordinarily skilled artisan would have recognized the unidentified and undescribed line of Figure 10 “as the leading face of the thread, at least because it is the only feature shown that matches with leading face shown in Fig. 8.” Ex. 1003 ¶ 234. We find this testimony inconsistent with the disclosures in Figures 7 and 8.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“For the foregoing reasons, Petitioner does not persuade us that the unidentified and undescribed line in Figure 10 of the ’477 publication represents a leading surface having a partially concave surface and a partially convex surface as required in claim 1.7 For this reason alone, on this record, Petitioner has not established a reasonable likelihood that it would prevail in its challenge of claim 1 based on the ’477 publication. Each of claims 2 and 4–9 depends from claim 1. For the same reasons as explained above, Petitioner has not established a reasonable likelihood that it would prevail in its obviousness challenge of these claims either. b. Substantially Equal Radius of Curvature Claim 1 requires “the partial concave and partial convex surfaces each defined by a radius of curvature that is substantially equal with respect to 7 We also express doubt on whether Petitioner adequately shows the line in Figure 10 is partially concave and partially convex, as required in the disputed limitation. Petitioner’s argument on this point is predicated on an enlarged section of a small drawing, showing a single unidentified and undescribed line that was not apparently intended to demonstrate the direction of any curvature. Ultimately, we do not need to address this issue, because Petitioner does not sufficiently persuade us that the line depicts the leading face recited in the disputed limitation.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 11,129,646 - Advance Medical Designs, Inc. v. Corbin Clinical Resources, LLCInstitution deniedPTAB · Jan 23, 2024 · PGR2023-00041 · APJ Jamie T Wisz · PGR · Institution
The Board denied institution of PGR on claims 1, 4–6, 11–13, 16–18, 23, 24, 28, and 29 under § 325(d), finding substantially the same art was previously presented and no material Office error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Section 325(d), the Board uses the following two-part framework: (1) determining 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, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“are defined by the claims themselves. For example, claim 1 recites “coupling the access needle to one of the plurality of needle receiving ports of the displacement member of the transperineal biopsy guide such that a position and angle of the access needle relative to the displacement member is retained.” Ex. 1001, 36:1–5 (emphasis added). Similarly, claim 13 recites “securing the access needle to the displacement member such that a position and angle of the access needle relative to the displacement member is maintained.” Id. at 36:59–61 (emphasis added).” slip op. at 13
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Further, although Petitioner contends that BK Medical’s needle guide “maintains and stabilizes” the needle position, they provide no explanation as to how it does so and do not appear to account for forces that would move the position of the needle during insertion. Petitioner cites to testimony from their declarant, Dr. Yun, to provide support for this argument; however, Dr. Yun’s testimony is essentially a verbatim repetition of Petitioner’s argument without a discussion of how BK Medical’s needle guide provides such stability. Compare Pet. 59–60 with Ex. 1003 ¶ 107. Thus, we accord little weight to Dr. Yun’s testimony on this topic. 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); see also Xerox Corp. et al., v. Bytemark, IPR2022-00624, Paper No. 9 at 15 (PTAB Aug. 24, 2022) (precedential) (“Conclusory expert testimony “is particularly problematic in cases where, like here, expert testimony is offered not simply to provide a motivation to combine prior-art teachings, but rather to supply a limitation missing from the prior art.”).” slip op. at 31
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“V. 35 U.S.C. § 324(a) Patent Owner also contends that the Board should discretionarily deny institution of the post-grant review under 35 U.S.C. § 314(a) in view of the co-pending Maryland District Court litigation, pursuant to Fintiv. Prelim. Resp. 21–32; see Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB 20 Although we do not specifically discuss the “securing” limitation of claims 13 and 24, the same analysis would apply. 21 We also do not find the testimony of Dr. Záťura or Ex. 1009 to be relevant to the question of whether the Examiner materially erred in finding that the prior art does not teach the “coupling” limitation. Mar. 20, 2020) (precedential). Because we deny the petition under 35 U.S.C. § 325(d), this argument is moot. Further, we note that Petitioner has filed a stipulation under Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 at 19 (PTAB Dec. 1, 2020) (precedential as to § II.A). Pet. 112. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Director’s Memorandum”).22 Pursuant to the Director’s Memorandum, we “will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Director’s Memorandum, 7.” slip op. at 38
Claim constructionDiscretionary denialPatents in suitUS 11,547,436
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.