• CQV Co., Ltd. v. Merck Patent GmbHNo claims unpatentable
  PTAB · Oct 14, 2025 · PGR2021-00054 · APJ Kristina M Kalan · PGR · Remand

  Claims 1–22 were not shown unpatentable because Sample C was not proven publicly available as prior art, and the original decision found the remaining grounds insufficient.

  RulingsRemand decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “We agree with Patent Owner that Petitioner’s evidence in Kuntz (Ex. 1026), the Annual Report (Ex. 1028), Masuko (Ex. 1029), and Pfaff (Ex. 1034) is insufficient to show that Xirallic® Sample C was available to the public before the effective filing date of the ’861 patent. Petitioner has not asserted, nor do we find, that any of these documents refer to or describe the lot of Xirallic® from which Sample C was taken. See Final Dec. 26. Kuntz, the Annual Report, Masuko, and Pfaff may support a finding that the Xirallic® line of products was available to the public, but these documents do not support a finding that the lot of Xirallic® from which Sample C was taken was available to the public. We also agree with Patent Owner that the Technical Data Sheets (Exs. 1005–1010), Certificates of Analysis (Exs. 1011–1017), and Material Safety Data Sheet (Ex. 1025) are insufficient to show that Xirallic® Sample C was available to the public. Petitioner has not asserted, nor do we find, that any of these documents refer to or describe the lot of Xirallic® from which Sample C was taken. See Final Dec. 26–27. Regardless of how the Technical Data Sheets were used in the Opposition against the European counterpart of the ’861 patent (Exs. 1040, 1041) and during the prosecution of the application from which the ’861 patent issued (Ex. 1003, 102–104), the Technical Data Sheets do not refer to or describe the lot of Xirallic® from which Sample C was taken. Moreover, as noted by Patent Owner, the Technical Data Sheets (Exs. 1005–1010) indicate that they are “preliminary” and Petitioner has not provided any evidence that the Technical Data Sheets were ever issued to the public, as opposed to just issued internally. See PO Resp. 18–19. We also find persuasive Patent Owner’s argument that the Technical Data Sheets are preliminary because other, later-dated technical data sheets (Exs. 2012, 2013) lack the “preliminary” label and list characteristics that are different from those in Exhibits 1005–1010. See PO Resp. 19 (comparing, e.g., Ex. 1009 and Ex. 2013; Ex. 1005 and Ex. 2012). The Technical Data Sheets may support a finding that the Xirallic® products they describe existed as of the dates on the documents, but they do not support a finding that the lot of Xirallic® from which Sample C was taken was available to the public.” slip op. at 20

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedOther

    “witnesses. See Elbit Systems of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (citing Trs. of Columbia Univ. v. Illumina, Inc., 620 F. App’x 916, 922 (Fed. Cir. 2015); Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 856 (1982)). We have reviewed the witness testimony in the record and, more particularly, Mr. Choi’s deposition answers regarding Petitioner’s purchase of the lot of Xirallic® from which Sample C came. We find that Mr. Choi’s responses cast doubt on the credibility of his declaration testimony, namely with regard to the public availability of Sample C. Mr. Choi represented that he was involved in the purchase of the lot of Xirallic® from which Sample C was taken. Ex. 2011, 48:1–23. Mr. Choi stated that he instructed Petitioner’s marketing team manager to buy the sample from a distributor of Patent Owner’s products located in Europe. Id. at 48:24–49:4. Mr. Choi stated that he has evidence of the transaction, but refused to reveal the name of the company from which Petitioner purportedly purchased the lot of Xirallic® (id. at 49:5–50:3) and refused to produce an email in his possession that would corroborate his testimony regarding Petitioner’s acquisition of the product (id. at 50:8–16, 51:10–23). Mr. Choi represented that he does not remember how much Petitioner paid for Sample B. Id. at 56:4–5. Mr. Choi admitted that the entity from which Petitioner acquired the lot of Xirallic® from which Sample C was taken is “not currently a Merck distributor” (Ex. 2011, 50:4–7) and was not “a Merck distributor at the time” that “samples B and C were purchased” (id. at 51:25–52:2). According to Mr. Choi, the company is a “former distributor” of Patent Owner’s products. Id. at 52:3–6. Mr. Choi did not know, according to his testimony, when that unnamed entity first obtained the lot of Xirallic® (id. at 52:7–10) and he stated that he did not have personal knowledge of how the entity obtained the lot of Xirallic® (id. at 52:12–19). Instead, Mr. Choi assumed the entity was “able to obtain the sample through the routine course or process” the entity uses “to take samples or get samples.” Id. at 52:12–19. Mr. Choi believed the sample of Xirallic® from which Sample C was taken was sealed when Petitioner received it because samples from dealers are sealed, and he remembered observing that the package was from a dealer. Id. at 52:24– 54:25. However, Mr. Choi admitted that he did not obtain a technical data sheet or certificate of analysis for the lot of Xirallic® from which Samples B and C were taken. Id. at 59:6–11. Mr. Choi also answered questions regarding Petitioner’s purchase of Samples D and H. Ex. 2011, 62:20–66:8, 67:7–9, 73:12–13, 73:17–22. Similar to his testimony regarding Samples B and C, Mr. Choi admitted withholding an email regarding the purchase of the lot of Xirallic® from which Sample D was taken. Id. at 62:20–63:9. Mr. Choi also admitted that he did not know how Akzo USA or Axalta obtained the Xirallic® the companies sold to him, and admitted that Akzo USA was not a distributor of Patent Owner’s products at the time Petitioner purchased the product. Id. at 63:10–66:8, 73:17–22. Mr. Choi also admitted that Petitioner did not pay Akzo USA for the lot of Xirallic® from which Sample D was taken, and did not pay Axalta for the lot of Xirallic® from which Sample H was taken. Id. at 67:7–9, 73:12–13. Although Petitioner presents declaration testimony from Mr. Choi representing that he purchased the lot of Xirallic® from which Samples B and C were taken in October 2011 (Ex. 1004 ¶ 16), Mr. Choi’s declaration testimony lacks corroborating evidence, and his deposition testimony does not support that the product was available to the public, as we found in our Final Written Decision. See Final Dec. 27–28. Notably, Petitioner produced corroborating evidence for Mr. Choi’s acquisition of Samples A, H, and I. See Ex. 1004 ¶¶ 13 (citing Ex. 1047), 18 (citing Exs. 1024, 1025). However, Mr. Choi withheld similar evidence for the Xirallic® lots from which Samples B, C, and D were taken. See Ex. 2011, 50:8–16, 51:10–23, 62:20– 63:9; Final Dec. 28. As Patent Owner argues, there is “no information to determine when a contract was established, that there was consideration for the exchange, that the product was available to be delivered when the alleged transaction took place, or even when the product was delivered. Choi has no memory of what was paid for the product.” Sur-Reply 24–25; see also PO Resp. 13–14; PO Br. Rem. 2–4.” slip op. at 34

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Based on the evidence discussed above, we are not persuaded that Petitioner has shown by a preponderance of the evidence that Sample C was available to the public. Regardless of whether a company avoids wasting shelf life of its products (Ex. 1004 ¶¶ 15–16), there is no persuasive evidence in the record showing that the lot of Xirallic® from which Sample C was taken was released from quality control and then made available to the public by Patent Owner. Mr. Choi’s testimony shows that Petitioner obtained the lot of Xirallic® from which Sample C was taken in an atypical manner (i.e., not from Patent Owner or one of Patent Owner’s current distributors) (Ex. 2011, 49:5–50:7, 50:8–16, 51:10–23, 51:25–52:6, 52:12– 19), and there is no evidence in the record to show that the lot of Xirallic® was intended for sale, rather than for experimental use only or for some other restricted use. Accordingly, we determine Petitioner has not demonstrated by a preponderance of the evidence that Sample C qualifies as prior art against the ’861 patent, and we determine that Petitioner has not shown by a preponderance of the evidence that the ’861 patent is unpatentable over the grounds relying on Sample C.” slip op. at 38

  Patent outcomesUS 10,647,861 not shown unpatentable
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 10,647,861
• Beone Medicines USA, Inc. / Beigene, Ltd. v. Pharmacyclics LLCAll claims unpatentable
  PTAB · May 1, 2025 · PGR2024-00009 · APJ Sheridan K Snedden · PGR · Final written decision

  Claims 1–8, 12, and 20 are unpatentable for lack of written description under § 112(a); the Board did not reach the enablement, anticipation, or obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(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). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting and that the terms “optionally substituted fused heterocyclic ring system” and “irreversible” BTKIs should be construed consistent with the definitions provided in the Specification. Pet. 42–45; see also id. at 42 (citing Ex. 1001, 19:57–20:7 (defining “optionally substituted” or “substituted”), 14:51–52 (defining “fused”), 15:66–16:21 (defining “heterocycle”), 14:36–44 (defining “ring” and “ring system”), 26:23–25 (defining “irreversible Btk inhibitor”); PO Resp. 26.” slip op. at 14

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner

    “used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(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). Moreover, “claim terms need only be construed ‘to the extent necessary to resolve the controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). The parties agree that the preamble of the claims should be limiting” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “To satisfy written description for the claimed genus of iBTKIs, the Specification must describe either a representative number of members of the genus or structural features common to the members of the genus with enough precision that a POSA can visualize or recognize the members of the genus. See Ariad, 598 F.3d at 1350. Patent Owner concedes that the Specification does not describe a representative number of members of the genus, stating “this is a common structural features case.” Tr. 65:25–66:3. We, therefore, focus our analysis on whether the Specification adequately describes common structural features of the genus. We find that it does not.” slip op. at 30

  Patent outcomesUS 11,672,803 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 11,672,803
• Intas Pharmaceuticals Ltd. v. Atossa Therapeutics, Inc.All claims unpatentable
  PTAB · Jan 29, 2025 · PGR2023-00043 · APJ Tina E Hulse · PGR · Final written decision

  Claims 1, 2, 4, 15, and 20–22 are anticipated by Ahmad; claims 3, 5–14, and 16–19 are obvious over the cited prior art.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “As explained in our Institution Decision, we adopted Patent Owner’s definition because we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art—both definitions provide for a highly skilled POSA with experience in formulating drugs. Dec. Inst. 8. Petitioner’s counsel confirmed during the hearing that there was no substantive difference between the parties’ definitions. Tr. 7:25–8:5. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We, therefore, adopt Patent Owner’s definition of a POSA. Moreover, we find that Dr. McConville, Dr. Bihovsky, and Dr. Davies are all qualified to opine from the perspective of a skilled artisan as all are persons of at least ordinary skill in the art, based on either party’s definition.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “When read as a whole, however, we find compelling that the Specification consistently identifies (Z)-endoxifen salts as separate from (Z)- endoxifen. Throughout the Specification—including in the Abstract and the Summary of the Invention—the ’334 Patent refers to “(Z)-endoxifen and salts thereof,” suggesting that references to “(Z)-endoxifen” alone do not include the salt forms unless expressly identified as such. See, e.g., id. at Abstract (“The present disclosure provides . . . methods of making (Z)- endoxifen or a salt thereof”), 2:60–62 (Summary of the Invention stating same); 6:4–6 (Summary of the Invention stating “process for manufacturing (Z)-endoxifen or salts thereof”). Moreover, the Specification states that although endoxifen is available commercially as an (E)/(Z) isomer free base mixture, as well as ≥98% (Z)- endoxifen HCL and (Z)-endoxifen citrate salts, “[t]here remains a need for (Z)-endoxifen free base preparations that are sufficiently stable for preparation of pharmaceutical compositions.” Id. at 82:3–5, 82:37–39. Accordingly, the Specification states, “[p]rovided herein in the present disclosure are preparations of endoxifen free base that are . . . at least 90% (Z)-endoxifen free base.” Id. at 82:43–45. Taking the language of the claims and the Specification as a whole, we determine that the intrinsic evidence supports construing the limitation “the compound of Formula (III) is (Z)-endoxifen” to be limited to the (Z)- endoxifen free base form and excludes the salt and solvate forms.” slip op. at 13

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art”). As such, Apple instructs us that a petitioner need not provide evidence in its petition to show a prior art patent is enabling as part of its burden to prove anticipation. Id. at 449–50 (finding the Board erred in shifting the burden to the petitioner to provide evidence in its petition to show prior art patent publication was enabling). Thus, it is Patent Owner’s burden to establish by a preponderance of the evidence that Ahmad is not enabling. Before we turn to the substantive grounds, we must first resolve the parties’ disputes over several legal issues regarding enablement. First, Patent Owner asserts that “[w]hile the claims of a prior art patent are presumed enabled, . . . [t]here is no presumption that every prophetic example in the specification is enabled, especially where that prophetic example is not explicitly claimed.” PO Resp. 32 (citations omitted). This is an incorrect statement of the law. The Federal Circuit has clearly stated that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354–55 (Fed. Cir. 2003). Patent Owner may rebut that presumption, but that presumption of enablement exists nonetheless for both the claimed and unclaimed disclosures.” slip op. at 17

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “We find Petitioner has the better position. Ahmad itself provides the reason to combine Ahmad’s formulation with Cole’s enteric coating, stating in the stomach” and to “prevent release of medication before it reaches the small intestine.” Ex. 1003, 18:19–24. It was known that endoxifen could be susceptible to degradation in the acidic conditions of the stomach, and a POSA would have been motivated to use an enteric capsule to avoid acidic degradation and improve bioavailability. Ex. 1031 ¶ 6 (citing Ex. 1019, 1353). We credit Dr. McConville’s testimony that applying enteric coatings would have been routine (Ex. 1020 ¶ 71; Ex. 1031 ¶ 5), which is consistent with Ahmad’s disclosure that the enteric coating “can be done as methods known in the art.” Ex. 1003, 18:27–29. Similarly, the ’334 Patent states that “enteric tablets, enteric caplets, or enteric capsules of the present disclosure may be prepared by techniques known in the art.” Ex. 1001, 39:28–30. Moreover, the fact that Cole uses paracetamol as a model drug and not endoxifen is of no concern to our obviousness analysis. We credit the formulation expertise of Dr. McConville, who explains that “[i]n the case of an enteric coated capsule, it is the degradation of the enteric coating and the capsule that will control the release of the drug, not the nature of the drug itself.” Ex. 1031 ¶ 7 (citing Ex. 1008, 84). Thus, a POSA would have understood that the capsule in Cole would have the same benefits for use with other drugs, such as endoxifen. Id. Patent Owner and Dr. Davies identify certain complications that may plague enteric-coated endoxifen formulations and HPMC capsules, such as “potential interactions between enteric coatings and pharmaceutical compositions” and “variations in release profiles.” PO Resp. 63–64; Ex. 2020 ¶¶ 164, 166. But we are not persuaded by that argument, because we agree with Dr. McConville that Patent Owner and Dr. Davies fail to cite any credible evidence of such complications between enteric coatings and interactions. Ex. 1031 ¶¶ 8, 10. Having considered the arguments and evidence presented by the parties, we find that the combination of Ahmad and Cole teaches each limitation of claims 5–8, 16, and 17 and that a POSA would have had a reason to use the enteric coating and HPMC capsules of Cole with the (Z)- endoxifen formulation of Ahmad to reach the claimed invention with a reasonable expectation of success. See Ex. 1020 ¶¶ 84–97; Ex. 1031 ¶¶ 5–16.” slip op. at 34

  Patent outcomesUS 11,572,334 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,572,334
• Samsung Electronics Co., Ltd. / Apple Inc. v. RJ Technology LLCSome claims unpatentable
  PTAB · Jan 17, 2025 · IPR2024-00597 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 2–4 and 6–18 are unpatentable as obvious over Abe and Guyomard, with claims 9–10 also obvious over Iwaizono; claims 1 and 5 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art “would have had a Master’s degree in material science, chemical engineering, chemistry, or similar field with four years of experience designing testing, and building secondary lithium batteries.” Pet. 11 (citing Ex. 1002 ¶ 51). Petitioner further contends that a person of ordinary skill in the art would have been aware of “(1) positive electrode materials, (2) negative electrode materials, (3) separators, (4) electrolytes, (5) charge-discharge parameters, and (6) protection circuits, as well as ‘battery failure modes’ such as plating and the formation of dendrites.” Id. (citing Ex. 1002 ¶¶ 50–51). Patent Owner “does not dispute Petitioner’s level of ordinary skill.” PO Resp. 17. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the person of ordinary skill in the art as it is consistent with the disclosures of the ’641 patent and the prior art of record.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “We also agree with Patent Owner that the charge cut-off voltage is not necessarily the applied voltage during charging. PO Resp. 20. Rather, depending on the charging protocol used and when in the charging cycle the voltage is applied, the applied voltage could be higher than the battery voltage. Ex. 2013; Ex. 2006 ¶ 91. For example, as discussed in more detail below with respect to the Uemura grounds, when fast charging using constant current is used and the charging rate is not slow, the applied voltage will be higher than the battery voltage when the constant current charging phase is stopped. Ex. 2006 ¶ 91; Ex. 2013. Likewise, during constant current/constant voltage charging, the applied voltage approximates the battery voltage only when the battery is nearly completely charged. Ex. 2013; Ex. 2006 ¶ 91. Thus, the applied voltage may be, but is not necessarily, the charge cut-off voltage. In view of the foregoing, we construe “charge cut-off voltage” in claims 1 and 5 as “the maximum value to which the battery is configured to be charged.” PO Resp. 18; Ex. 2008, 217:6–11; Pet. Reply 5. Contrary to Patent Owner’s arguments, however, we do not understand the phrase “configured to be charged” to necessarily represent a single voltage for the battery that is determined based on the structure and chemistry of the battery. Pet. Reply 4–5. Rather, the charge cut-off voltage is a selected potential, or voltage, of the battery or cell at the end of charging that is controlled by a circuit or device, such as a charger or control circuit within the battery. Ex. 1001, 9:50–55; Ex. 1048, 2, 7–8; Ex. 1008, 3:9–13. And, for the reasons discussed herein, the charge cut-off voltage may be, but is not necessarily, the same as the applied voltage during charging. PO Resp. 20.” slip op. at 15

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “charge cut-off voltage “greater than 4.2 V but less than 5.8 V” and calculating a specific or theoretic capacity “with a charge cut-off voltage limited to 4.2” (claim 1) or “with a charge cut-off voltage set at 4.2 V” (claim 5). Ex. 1001, 16:56–61, 17:6–11. Although the parties dispute the precise scope of these claim terms, the parties agree that the first use of “charge cut-off voltage” in claims 1 and 5 refers to the potential of the battery as a whole (between the cathode and the anode), and not a half-cell voltage using lithium metal as a counter electrode.10 Tr. 17:1–3 (agreeing 10 With respect to the phrase “as calculated by a theoretic capacity with a charge cut-off voltage set at 4.2 V,” the parties in fact appear to be in that the first use of “charge cut-off voltage” in claim 5 refers to a full-cell voltage); Sur-reply 5; PO Resp. 22. We need not further construe the claims to resolve the disputes between the parties. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “Given Mr. Juzkow’s unambiguous testimony that Uemura uses constant current charging that would stop when the applied voltage reached 11 The chart is reproduced from SAFT, Charging your lithium-ion batteries: 5 expert tips for a longer lifespan, (https://www.saft.com/energizing-iot/charging-your-lithium-ion-batteries-5-expert-tips-longerlifespan#:~: text=When%20the%20battery%20provides%20current,This%20restore s%20the%20battery's%20capacity). 4.3 V, as well as Dr. Yao’s persuasive testimony that Uemura’s constant charging rate is not slow, we credit the testimony of Dr. Yao that one of ordinary skill in the art would have understood that the internal voltage to which the battery of Uemura was charged is less than 4.3 V. Ex. 2006 ¶ 119. In particular, Dr. Yao persuasively testifies that one of ordinary skill in the art would have believed that the charge cut-off voltage was no more than 4.2 V, and most likely equal to “about 4 V.” Id. ¶¶ 119–122.” slip op. at 21

  Patent outcomesUS 7,749,641 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,749,641
• Samsung Electronics Co., Ltd. / Apple Inc. v. RJ Technology LLCSome claims unpatentable
  PTAB · Jan 17, 2025 · IPR2023-01183 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 2–4 and 6–18 are unpatentable as obvious over Abe and Guyomard, with claims 9 and 10 also obvious over Iwaizono; claims 1 and 5 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art “would have had a Master’s degree in material science, chemical engineering, chemistry, or similar field with four years of experience designing testing, and building secondary lithium batteries.” Pet. 11 (citing Ex. 1002 ¶ 51). Petitioner further contends that a person of ordinary skill in the art would have been aware of “(1) positive electrode materials, (2) negative electrode materials, (3) separators, (4) electrolytes, (5) charge-discharge parameters, and (6) protection circuits, as well as ‘battery failure modes’ such as plating and the formation of dendrites.” Id. (citing Ex. 1002 ¶¶ 50–51). Patent Owner “does not dispute Petitioner’s level of ordinary skill.” PO Resp. 17. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the person of ordinary skill in the art as it is consistent with the disclosures of the ’641 patent and the prior art of record.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “constructions. First, we agree with Petitioner that the ’641 patent indicates that the charge cut-off voltage selected for a particular battery need not be a fixed property of the battery or something that is set by the design and chemistry of the battery. Consistent with this conclusion, the ’641 patent discloses that a “charging device controls the charge cut-off voltage of the single lithium-ion cell within a range from 4.3 V to 5.8 V.” Ex. 1001, 9:50– 55. This strongly suggests that the charge cut-off voltage is controlled by the charger and is not necessarily an inherent property of the battery. Patent Owner contends that this is merely an unclaimed embodiment, but the relevant disclosure states that the charging device for the “present invention” may be any type of device “with the proviso that said charging device controls the charge cut-off voltage.” Id. at 9:50–53.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “charge cut-off voltage “greater than 4.2 V but less than 5.8 V” and calculating a specific or theoretic capacity “with a charge cut-off voltage limited to 4.2” (claim 1) or “with a charge cut-off voltage set at 4.2 V” (claim 5). Ex. 1001, 16:56–61, 17:6–11. Although the parties dispute the precise scope of these claim terms, the parties agree that the first use of “charge cut-off voltage” in claims 1 and 5 refers to the potential of the battery as a whole (between the cathode and the anode), and not a half-cell voltage using lithium metal as a counter electrode.10 Tr. 17:1–3 (agreeing 10 With respect to the phrase “as calculated by a theoretic capacity with a charge cut-off voltage set at 4.2 V,” the parties in fact appear to be in that the first use of “charge cut-off voltage” in claim 5 refers to a full-cell voltage); Sur-reply 5; PO Resp. 22. We need not further construe the claims to resolve the disputes between the parties. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Given Mr. Juzkow’s unambiguous testimony that Uemura uses constant current charging that would stop when the applied voltage reached 11 The chart is reproduced from SAFT, Charging your lithium-ion batteries: 5 expert tips for a longer lifespan, (https://www.saft.com/energizing-iot/charging-your-lithium-ion-batteries-5-expert-tips-longerlifespan#:~: text=When%20the%20battery%20provides%20current,This%20restore s%20the%20battery's%20capacity). 4.3 V, as well as Dr. Yao’s persuasive testimony that Uemura’s constant charging rate is not slow, we credit the testimony of Dr. Yao that one of ordinary skill in the art would have understood that the internal voltage to which the battery of Uemura was charged is less than 4.3 V. Ex. 2006 ¶ 119. In particular, Dr. Yao persuasively testifies that one of ordinary skill in the art would have believed that the charge cut-off voltage was no more than 4.2 V, and most likely equal to “about 4 V.” Id. ¶¶ 119–122. Petitioner argues that because the battery of Uemura is charged “to” a maximum voltage of 4.3 V, Uemura discloses the claimed charge cut-off voltage under either Petitioner’s or Patent Owner’s construction of the term. Pet. Reply 11–12 (citing Ex. 1009 ¶ 81; Ex. 1044 ¶¶ 56–59). This argument is not persuasive because Mr. Juzkow unambiguously testified that charging in Uemura stopped when the applied voltage reached 4.3 V, and Uemura discloses that the battery was charged “at” a voltage ranging from 4.3 V to 2.0 V, not “to” such a voltage. Ex. 1009 ¶ 81; Ex. 2008, 113:2–13; Ex. 2006 ¶ 119 n.64; Sur-reply 9. In view of the foregoing, we determine that Petitioner has not demonstrated by a preponderance of the evidence that Uemura anticipates independent claims 1 and 5 of the ’641 patent.” slip op. at 21

  Patent outcomesUS 7,749,641 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,749,641
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentable
  PTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision

  Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedMixed

    “To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10

  • Strike new argumentOther

    “Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56

  Patent outcomesUS 10,849,908 unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,849,908
• Texas Instruments Incorporated v. Greenthread, LLCInstituted
  PTAB · Oct 11, 2024 · IPR2024-00771 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board instituted IPR on claims 1–6 of the ’195 patent on all asserted grounds and granted Texas Instruments’ motion to join the Cirrus IPR.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “Because the Preliminary Response in the instant case includes arguments pertaining to the sufficiency of the asserted prior art references, which were not raised in the preliminary response in the Cirrus IPR, we briefly address below the patentability of the challenged claims.” slip op. at 6

  • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

    “II. TIMELINESS OF THE PETITION UNDER 35 U.S.C. § 315(B) Pursuant to 35 U.S.C. § 315(b), “[a]n inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.” Patent Owner argues that the Petition is untimely under 35 U.S.C. § 315(b) because Petitioner is in privity with time-barred entities. Prelim. Resp. 10– 30. However, 35 U.S.C. § 315(b) also provides that the one-year time bar “shall not apply to a request for joinder under subsection (c).” See also 37 C.F.R. § 42.122(b). Because the Petition is accompanied by a timely request for joinder (Paper 2) to the instituted proceeding (IPR2024-00017), which we grant as further discussed below, Patent Owner’s argument that the Petition is time-barred under 35 U.S.C. § 315(b) is moot, irrespective of whether Petitioner is in privity with time-barred entities.” slip op. at 5

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “B. Whether to Join Petitioner as a Party to the Cirrus IPR Joinder may be authorized when warranted, but the decision to grant joinder is discretionary. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. A motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See, e.g., Kyocera Corp. v. Softview LLC, IPR2013- 00004, Paper 15 (PTAB April 24, 2013). As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). As an initial matter, we find the Motion for Joinder meets the timing requirements of 37 C.F.R. § 42.122(b) because Petitioner filed it on April 4, 2024, no later than one month after the Cirrus IPR was instituted on May 1, 2024.” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “5. “Aid the Movement of Minority Carriers” Patent Owner argues that the Petition fails to show that the applied prior art references disclose the claim limitations “requiring ‘aid the movement of minority carriers,’” as twice recited in claim 1. Prelim. Resp. 8. Patent Owner summarizes this dispute as follows: The challenged patent discloses and claims a semiconductor device with (among other things) a “drift layer having a graded concentration of dopants . . . [and] further having a first static unidirectional electric drift field to aid the movement of minority carriers.”[] The Petition should not be instituted, because (among other deficiencies) it fails to show that the prior art discloses the “aid the movement of minority carriers” claim limitation. Rather than pointing to anything in the prior art that would teach this claim limitation, the Petition assumes that any “graded concentration of dopants” would necessarily “aid the movement of minority carriers.” The Petition contains no analysis explaining why the “graded concentration of dopants” in the prior art meet the “aid the movement of minority carriers” limitation, apart from the fact that they are “graded concentration of dopants.” In other words, Petitioner reads the “aid the movement of minority carriers” limitation out of the claims completely. Id. at 1–2. Patent Owner includes additional details in support of its view that the asserted prior art fails to establish obviousness of the “aid carrier movement” limitations of claim 1. Prelim. Resp. 1–10.” slip op. at 8

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,421,195
• Nespresso USA, Inc. v. K-Fee System GmbHAll claims unpatentable
  PTAB · Sep 10, 2024 · IPR2023-00502 · APJ Grace Karaffa Obermann · IPR · Final written decision

  Claims 1–16 are unpatentable as obvious over the combined disclosures of Yoakim, Jarisch, and Rapparini.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner

    “To obtain the benefit of the filing date of an earlier application, Patent Owner bears the burden of producing evidence to establish where each limitation of the challenged claims is disclosed in a single priority application. Studiengesellschaft Kohle, 112 F.3d at 1564; NTP, 654 F.3d at 1276. Petitioner identifies limitations of the challenged claims that are missing from each individual German priority application. Pet. 39–42. Patent Owner responds with no evidence or arguments suggesting that the identified limitations are disclosed in a single application. Resp. 10–12. On this record, no challenged claim is entitled to the benefit of the filing date of any of the three German priority applications; therefore, Jarisch qualifies as prior art under at least 35 U.S.C. § 102(e).” slip op. at 19

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In other words, even if we accept that Dr. Howle has some experience designing medical devices and components, and that those experiences represent work designing products similar to mechanical beverage systems, Patent Owner fails to direct the Board to evidence sufficient to establish that this experience, in the aggregate, amounts to “at least five years” or involved “experience with sensors for recognizing identifiers.” Dec. 8 (adopting Patent Owner’s own proposed definition of ordinary skill in the art); see Sur-reply 3 (citing Ex. 1066, 34:16–35:9; Ex. 1067, 101:3–12, 102:30– 104:9; Ex. 2017 ¶¶ 3, 4) (failing to establish adequately, if at all, how Dr. Howle’s qualifications include the requisite minimum five-year period of relevant design experience). Accordingly, we determine that Dr. Howle is not qualified to offer expert testimony from the perspective of a person having ordinary skill in the art in this proceeding.12 Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–78 (Fed. Cir. 2022). The Federal Circuit has made plain that, “[t]o offer expert testimony from the perspective of a skilled artisan in a patent case,” including the issue of patent “validity,” the “witness must at least have ordinary skill in the art.” 12 To be clear, we are not saying that a witness supplying expert opinions must have satisfied the requirements of the level of ordinary skill in the art on or before the priority date of the challenged patent, which Patent Owner seems to understand. See Sur-reply 4–5. Instead, we evaluate whether Dr. Howle had at least the requisite qualifications of a person having ordinary skill in the art by the time he rendered his opinions. Osseo Imaging, LLC v. Planmeca USA, Inc., Appeal No. 2023-1627, slip op. at 7 (Fed. Cir. Sept. 4, 2024) (“[A]n expert can acquire the necessary skill later and develop an understanding of what a person of ordinary skill knew at the time of the invention,” however, where “the expert was not a person of ordinary skill at the time of the invention may well be used during cross-examination to undermine the credibility of the expert.”); see id., slip op. at 5–6 (affirmatively quoting Kyocera). Id. (Board’s emphasis). “Without that skill, the witness’[s] opinions are neither relevant nor reliable.” Id. at 1377. “‘Admitting testimony from a person . . . with no skill in the pertinent art serves only to cause mischief and confuse the factfinder.’” That testimony would ‘amount[ ] to nothing more than advocacy from the witness stand.’” Id. (quoting Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362, 1364–65 (Fed. Cir. 2008)). Alternatively, even if we accept that Dr. Howle possesses “at least five years” of relevant design experience, on this record, we agree with Petitioner that his opinions are entitled to less weight than those of Petitioner’s witness, Mr. Jobin. Reply 27. Unlike Dr. Howle, Mr. Jobin is a designer by profession, with more than 30 years of industry experience. Reply 27 (citing Ex. 1003 ¶¶ 5–30). For example, Mr. Jobin designed a home-based beer dispensing system utilizing cartridge identification technologies. Id. (citing Ex. 1003 ¶ 24). Mr. Jobin also “has substantial experience with sensors for recognizing identifiers.” Id. (citing Ex. 1003 ¶ 19; Ex. 1072, 3712–19, 67:22–70:19). Dr. Howle, by contrast, “has never designed a beverage machine.” Reply 22; see generally Sur-reply (declining to contest that assertion).13” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “In Petitioner’s contrary view, Jarisch teaches how to move a code in a centrifugal brewing system to the bottom of the flange and how to configure a light-conductive material so that the detector’s light source will reach the bottom of the flange. Pet. 45–46; Reply 21–22 (Ex. 1003 ¶¶ 194–195; Ex. 1005 ¶¶ 82–84, Fig. 5). Although Figure 61 of Yoakim discloses a flare in its brewing chamber, bodily incorporation is not required, and we are directed to no persuasive argument or evidence that Yoakim could not be configured with a straight chamber, as depicted in Figure 5 of Jarisch. We credit the testimony of Mr. Jobin that a person of ordinary skill in the art would have sought to place the code at the bottom of the flange and would have had a reasonable expectation of success in so doing. Ex. 1003 ¶ 184. For reasons explained above, we assign little or no weight to Dr. Howle’s conflicting testimony because he has little or no experience designing a mechanical beverage system or similar product. See supra 10– 16. Petitioner lays out persuasive reasons why Dr. Howle’s testimony, on this particular point, is “conclusory” and rests on “bodily incorporation” of the references. Reply 24; see id. at 22–24 (pointing out with particularity fundamental flaws in Dr. Howle’s opinions); In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.”); In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”). In addition, Patent Owner contends that Yoakim requires that the capsule holder be capable of receiving a set of multiple volume capsules and that there is a “snug fit” to avoid “unbalances.” Sur-reply 8 (citing Ex. 1004 ¶¶ 205, 479, 484, 507, 512). According to Patent Owner, Petitioner does not explain adequately how the use of Jarisch’s “straight chamber” with a capsule holder that does not engage with the side wall of the capsule would allow insertion of multiple volume capsules or permit a “snug fit” in the modified device of Yoakim. Id. at 8–9. Patent Owner’s view that Yoakim discloses the use of certain capsules which might not fit into a device with Jarisch’s non-flared structure is ineffective to undercut the sufficiency of Petitioner’s showing on this point. Petitioner is not seeking a bodily incorporation of Yoakim and Jarisch and, in any event, other embodiments of Yoakim do not require the type of flared capsule identified by Patent Owner. Ex. 1004, Fig. 63. Furthermore, we credit the testimony of Mr. Jobin that one of ordinary skill in the art would have understood how to design the chamber of Yoakim to allow reading of a barcode on the underside of the flange. Ex. 1003 ¶¶ 187–195. With respect to the argument that the use of Jarisch’s design would not allow a snug fit, we are directed to no persuasive evidence that Jarisch’s lack of contact between the capsule side wall and the holder would render the device inoperable or less effective. Resp. 39–40; see Reply 22 (citing Ex. 2019, 36:18–37:6). Indeed, as Petitioner points out, Jarisch indicates that its device, including its capsule holding means, allows the capsule to be successfully driven in rotation. Reply 22 (citing Ex. 1005 ¶ 23).” slip op. at 49

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “That argument is not persuasive. A reference need not identify or discuss another prior art patent or application in order for that reference to be deemed relevant or analogous art. Nor do we endeavor to determine why, or why not, a particular reference is discussed in a prior art reference. The analogous art inquiry focuses on reasonable pertinence and involves assessing the similarities between the claimed invention and the prior art, including the problems addressed and the closeness of the subject matter, as viewed by an ordinarily skilled artisan. Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 1360 (Fed. Cir. 2020); see Airbus S.A.S. v. Firepass Corp., 941 F.3d 1374, 1380-81 (Fed. Cir. 2019) (relevant analysis focuses on comparing the disclosed embodiments, function, and structure of the claimed invention to the disclosures of the prior art). Against that backdrop, we reject Patent Owner’s suggestion that the inquiry involves whether the inventors of Jarisch saw a need to discuss Yoakim’s disclosure in Jarisch’s priority document.” slip op. at 45

  Patent outcomesUS 10,994,923 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,994,923
• Chongqing Yanmei Technology Co., Ltd. v. Terves, LLCSome claims unpatentable
  PTAB · Aug 27, 2024 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 19–61, 63–77, and 79 are unpatentable as anticipated by Doud; claims 78, 80, and 81 are not shown unpatentable. The contingent motion to amend is granted in part and denied in part.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art “would have at least a Ph.D. in chemistry, metallurgy, or material science or material engineering” or, in the alternative, “would have a Bachelor of Science or Master of Science degree in one of these disciplines plus experience involving the use and design of dissolvable metal alloys for use in creating tools and other downhole parts for well drilling or completion activities.” Pet. 13–14. Patent Owner does not oppose Petitioner’s contentions regarding the level of ordinary skill in the art. PO Resp. 12 n.4. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan as it is consistent with the prior art of record.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “With respect to claim 19, Petitioner proposes constructions for the terms “in situ precipitate” and “a plurality of particles of said in situ precipitate having a size of no more than 50 µm.” Pet. 11–12. With respect to claims 76–81, Petitioner proposes a construction for the term “wherein said additive material includes one or more metal materials selected from the group consisting of 0.1–35 wt. % copper, 0.1–24.5 wt. % nickel and 0.1–20 wt. % cobalt.” Id. at 13. Patent Owner contends no claims require construction for purposes of this Decision. PO Resp. 12 n.4, 17–18; Mot. 16–17. Upon review of the prior art of record, we determine that no claim terms require express construction for purposes of this Final Written Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed

    “Ex. 2027, 20:25–21:5 (emphasis added). The disclosure that the “magnesium composite” of “[t]he present invention” “includes at least 50 wt% magnesium” is unambiguous and constitutes strong evidence that the inventors were not in possession of a magnesium composite with less than 50 wt. % magnesium, or additive concentrations above 50 wt. %. See SciMed Life Systems, Inc. v. Advanced Cardiovasular Systems, Inc., 242 F.3d 1337, 1343 (Fed. Cir. 2001) (noting that a description of the “present invention” as having a particular structure “is strong evidence that the claims should not be read to encompass the opposite structure”). Consistent with this conclusion, the original claims of the ’295 application all limited the additive material in the composite to 0.05 wt %–45 wt %. Ex. 2027, 26:1– 13, 29:9–15. Likewise, in each example where copper, nickel, or cobalt additives are used in the range recited in the proposed substitute claims, the magnesium composite is “over 50 wt% magnesium,” and any claims that do not require this range of magnesium are limited to an additive range of “about 0.05 wt%–45 wt% of said mixture.”8 Ex. 2027, 6:13–7:4, 7:16–19, 8 Written description support is considered from the view point of the ordinarily skilled artisan. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Patent Owner, bearing the burden to show written description support in any priority application for which it seeks the benefit of its filing date, provides no testimony from an ordinarily skilled artisan regarding written description support in the ’295 application, or any evidence to show what such an artisan would conclude from the express disclosures of the ’295 application. Lectrosonics, Paper 15 at 7; In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (noting that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120”). Where there is any ambiguity in the disclosures of the ’295 application, the absence of supporting testimony tends to cut against 26:2–31:2; see Ex. 1005 ¶¶ 12, 13, 18, 19, 16–21, 26, 28, claims 16–21, 26– 28. In view of the foregoing, we are not persuaded that Patent Owner has demonstrated that the inventors of the priority applications were in possession of a magnesium cast composite that included less than 50 wt. % magnesium, or greater than 50 wt. % additives. As proposed substitute claim 104 encompasses a magnesium cast composite with up to 90 wt. % additives, and therefore as little as 10 wt. % magnesium, Patent Owner has not demonstrated that the full scope of this claim finds written description support in any application prior to the ’915 application, filed on October 12, 2018.” slip op. at 17

  • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed

    “The definiteness requirement of § 112(a) is satisfied when “a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable clarity.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014); see 37 C.F.R. § 42.100(b) (changing the claim construction standard used to review a claim proposed in a motion to amend from the broadest reasonable construction to the “same construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b)”). Proposed substitute claim 104 generically requires “in situ precipitate” and also a specific type of in situ precipitate: “in situ galvanically-active intermetallic precipitate.” Mot. Appendix A. Although this claim would have best been clarified by Patent Owner after seeking preliminary guidance on its Motion to Amend, upon review of the written description, claims, and figures of the ’740 patent, as well as Patent Owner’s clarification in its Reply to the Opposition, we agree with Patent Owner that one of ordinary skill in the art would have understood that the “in situ galvanically-active intermetallic precipitate” is merely a more complete description of the “in situ precipitate” mentioned earlier in the sentence. Mot. Reply 4. As such, we do not find that this part of proposed substitute claim renders claim 104 indefinite.” slip op. at 22

  Patent outcomesUS 10,689,740 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Graham · Nautilus
  Patents in suitUS 10,689,740
• Jeisys Medical Inc. v. Serendia, LLCInstituted
  PTAB · Aug 20, 2024 · IPR2024-00463 · APJ Carl M Defranco · IPR · Institution

  The Board instituted IPR on claims 2–6, 8, 9, 13–16, and 18, finding a reasonable likelihood that at least claims 2, 8, and 13 are anticipated by Mehta.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied

    “Videndum clarified the Board’s application of the General Plastic/Valve framework. For instance, in Ford, the Director explained that “[u]nder existing Office policy and precedent, the Board does not recognize a ‘significant relationship’ between parties [i.e., serial petitioners] having different accused products that merely engage in court-ordered pretrial coordination.” Ford, at 9 (emphasis added). And, in Videndum, the Director further explained that where “the first and second petitioners are neither the same party, nor possess a significant relationship under Valve, General Plastic factor one necessarily outweighs the other General Plastic factors.” Videndum, at 6–7. Thus, per Ford and Videndum, we will not discretionarily deny a later petition in view of an earlier petition where the earlier and later petitioners are neither the same party nor have a significant relationship. After reviewing the record, we find that no significant relationship exists with Cartessa to justify application of the General Plastic/Valve framework. Contrary to Serendia’s assertions about the joint submissions of Jeisys and Cartessa in the parallel ITC proceeding (see Prelim. Resp. 8–10), the relevant facts and circumstances here are akin to those in Ford. More specifically, like the “court-ordered” coordination of the petitioners in Ford, the collaboration of Jeisys and Cartessa as co-respondents in the ITC proceeding was mandated by the rules of the ITC proceeding, and, thus,” slip op. at 8

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “We agree with Jeisys. Mehta is not substantially the same as Mehta ’705. What Mehta ’705 omits, but Mehta includes, is an embodiment comprising “graphical user interface 320” and “tissue characteristic indicator 350” that allows a user to monitor the needle’s “location” in the tissue so as to decide when the needle is placed at a “desired depth.” Ex. 1006, 32:46– 13 US 8,540,705 B2, issued Sep. 24, 2013 (Ex. 1011). 14 Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential). 33:29, Figs 10A–10F. Nowhere do we discern a similar embodiment in Mehta ’705. At best, Mehta ’705 discloses a “display screen” for displaying a “variety of information to the physician . . . such as treatment delivery settings, electrode impedance, electrode temperature, tissue temperature, treatment duration, power delivered, energy delivered, etc.” Ex. 1011 (Mehta ’705), 29:44–58, Figs. 10A, 10B. But, notably lacking from Mehta ’705 is any disclosure of determining the “depth” and “location” of the needle’s placement in the tissue, let alone means for doing so, which Mehta discusses at length and upon which Jeisys relies to meet the “desired distance” limitation. See Ex. 1006, 32:46–33:61; Pet. 27–28. Because Mehta includes disclosure relevant to the disputed “desired distance” limitation that is absent from Mehta ’705, Serendia fails to satisfy the first part of the Advanced Bionics framework. See Wolfspeed, Inc. v. The Tr. of Purdue Univ., IPR2022-00761, Paper 13, at 7–8 (PTAB Mar. 30, 2023) (Vidal, K.) (reference not “substantially the same prior art” when it includes disclosure relevant to unpatentability grounds not present in references previously before the Office). And to the extent Serendia makes a similar argument with respect to the asserted secondary references of Na, Lee, and Livneh, it is of no consequence given Serendia’s failed showing with respect to the primary reference of Mehta.15 Thus, we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d).” slip op. at 11

  • Skill levelSkill level petitioner adoptedOther

    “Jeisys proposes, and Serendia agrees, that we should adopt the level of ordinary skill in the art as defined in the parallel ITC proceeding, that is, (1) 7–10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D. . . . [and] may have worked as part of a multidisciplinary team and drawn upon not only his or her own skills, but also would have taken advantage of certain specialized skills of others on the team when solving a technical problem. Pet. 11 (citing Ex. 1005, at 14); Prelim. Resp. 33 (accepting Jeisys’s definition of the level of skill in the art). For purposes of this proceeding, we see no reason to depart from that definition, as it appears consistent with the level reflected in the asserted prior art.” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We need not formally construe the “desired distance” limitation in order to resolve whether institution is appropriate. That is because, on the current record, the asserted prior art satisfies the “desired distance” limitation regardless of which parties’ proposed construction we adopt. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)). Nonetheless, the parties are free to further explore the appropriate construction of “desired distance” at trial, in particular, whether the plain language of the claims limits their scope to extendable needles (as opposed to fixed needles), and whether construing the “desired distance” limitation as being based on a user’s selection improperly reads a preferred embodiment into the claims.” slip op. at 14

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
  Patents in suitUS 10,869,812

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