PTAB
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  • PTAB · Mar 23, 2026 · IPR2024-01473 · APJ Michael A Valek · IPR · Final written decision

    Claims 1, 4, 6, 17, 22, and 25 are unpatentable as anticipated by and obvious over Cai; claims 2, 3, 7, 23, and 24 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We disagree with Patent Owner and again find Petitioner’s description of the level of ordinary skill in the art sufficient for the reasons explained in the Decision on institution. See Dec. 8–10. As explained before, the formal training required by Petitioner’s description of a POSA includes understanding of both proteins and analytical techniques for studying them. See Dec. 9. Neither Patent Owner, nor its declarant, Dr. Cimas, clearly articulates a competing POSA description at trial, but both suggest more formal training, e.g., a graduate degree, is required. See Resp. 65–66; Ex. 2023 ¶ 8 (agreeing with our observation that the educational backgrounds of the inventors and authors of Cai, Zaccaria, and Hu “suggests that a graduate degree is more typical for a POSA”) (quoting Dec. 9, n. 5). Even if we were to accept that modification, it would not change our findings herein. Nor does it suggest that Dr. Vargas, who holds a Ph.D. in chemistry from Stanford University and has substantial experience with mass spectrometry and other analytical techniques, is unqualified to testify from the perspective of one of ordinary skill in the art. See Ex. 1004 (Vargas CV). Accordingly, our findings and conclusions would be the same, even assuming the perspective of a POSA possessing the higher level of formal training and specific proteomics experience that Patent Owner suggests is appropriate here.5” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

      “Ex. 1001, 20:33–39. As Petitioner points out, the first sentence in this passage does not define the term “biological sample,” but rather the term “sample.” Id. According to that sentence, the term “sample” refers to either “a biological sample or a complex biological sample obtained from a subject.” Id. (emphasis added). Patent Owner’s argument assumes, without explanation, that the phrase “obtained from a subject” modifies both instances of “biological sample” in the first sentence. Id. But it need not be read that way. Indeed, that sentence is more naturally read to define “sample” as one of two things––either a “biological sample” or a “complex biological sample” with only the latter being “obtained from a subject.” Id. In addition, the second sentence in the passage above supports Petitioner’s view that the term “biological sample” is not limited to a sample obtained directly from a subject. It provides a broad, non-exhaustive list of “[s]uitable biological samples” that specifically includes the types of biological samples, i.e., “cell lysates,” “systemic blood,” “plasma,” assayed in Petitioner’s cited references. Ex. 1001, 20:36–39. It also lists as an example “processed tissue samples,” which would include samples that have been modified (i.e., “processed”) from the form in which they were originally obtained. Id.; see also Ex. 1001, 20:52–57 (describing tissue processing). Given this broad description, we agree with Petitioner that there is no basis in the cited intrinsic evidence for reading in the “negative limitations” Patent Owner seeks to try to distinguish the particular biological samples assayed in Cai, Hu, and Zaccaria. See Reply 3–4.” slip op. at 12

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

      “We agree with Petitioner. Step 1(a) recites forming coronas around a plurality of particles of “different particle types.” Ex. 1001, 86:53–60. Step 1(b) recites separating a “subset of the plurality of the particles comprising the coronas.” Id. at 86:61–65. As Petitioner correctly observes, as a matter of ordinary English parlance, “there is no requirement whatsoever that the ‘subset’ have all of the same characteristics as the set from which it is separated.” Reply 10. By way of analogy, consider a jar containing a plurality of coins of different coin types, e.g., nickels and dimes. One can separate out a “subset” of that plurality of coins (plural) by removing any two coins from the jar—this is true even if the two coins are both nickels or both dimes. In the same way, nothing in the ordinary meaning of the claim language requires the subset in step 1(b) to include particles with coronas representative of each of the different particle types in step 1(a). Nor has Patent Owner identified any other evidence that supports its attempt to read such a requirement into the claims. See Resp. 16, 18 (citing expert testimony that is not inconsistent with the broader, ordinary meaning of the claim language and, even if it was, would not be a proper basis for limiting the same). For these reasons, we reject Patent Owner’s interpretation of “a subset of the plurality of particles comprising the coronas” in step 1(b) as limited to a subset of each type of particle comprising the coronas formed in step 1(a).” slip op. at 15

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

      “We credit Petitioner’s showing above and agree that Cai discloses a method comprising all of the steps in claim 1. Beginning with step 1(a), Cai discloses contacting two different particle types, i.e., MWCNT and CB, with HeLa cell lysate (i.e., a biological sample) to form protein coronas around those particles. Ex. 1003 ¶¶ 199–206; Ex. 1005, Abstr. (describing MWCNT and CB as distinct “forms of carbon nanoparticles” that bind “vastly different sets of proteins”). Cai’s results show the coronas formed around the MWCNT and CB particles comprise overlapping and distinct proteins as recited in step 1(a). Ex. 1003 ¶¶ 216–222; Ex. 1005, 587 (“a small number of CB-binding proteins also bind to MWCNTs”). A subset of the proteins from the coronas on these particles is then prepared by eluting the bound proteins and analyzing them with SDS-PAGE in a MWCNT and CB “pull-down,” which reads on step 1(b). Ex. 1005, 586 (Fig. 1A–B depicting scheme for “pull-down experiment” and describing other “pull-down experiments” used with SILAC media in Fig. 3), 588 (Fig. 3). Regarding step 1(c), Cai discloses assaying the proteins in those subsets using LC-MS/MS with SILAC encoding to characterize and quantify the relative abundance of the proteins that bind to each type of particle.11 Ex. 1003 ¶¶ 225–229; Ex. 1005, 586–587 (describing “systemic characterization of carbon nanoparticle-protein corona”), 588 (Fig. 3). Cai’s results show “the relative abundance of the MWCNT-binding proteins spread over 8 orders of magnitude” and that “some of the proteins with the highest binding efficiencies” are actually “low abundance proteins” in the lysate, meaning that that Cai’s method selectively enriches such proteins for detection. Ex. 1005, 587. We credit Dr. Vargas’s testimony that these results demonstrate that Cai’s method achieves the “dynamic range” recited in step 1(c). Ex. 1003 ¶¶ 225–229.” slip op. at 23

    Patent outcomesUS 11,435,360 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,435,360
  • PTAB · Nov 25, 2025 · PGR2024-00030 · APJ Linda E Horner · PGR · Final written decision

    Claims 17 and 18 are unpatentable under §112(d) for improper dependent form; claims 1–10 and 12–16 were not shown unpatentable on the asserted obviousness grounds.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

      “We do not credit Dr. Anthony’s testimony, which is based on the arbitrary shading in Figure 7 (see Ex. 1002 ¶ 174), that Schröder teaches or suggests limitation 1[d] because it (1) is inconsistent with Petitioner’s reasoning for limitation 1[c], and (2) it is based on an admitted misreading of the embodiment of Schröder’s Figure 5 (see Ex. 1002 ¶ 175). As to the first item, Dr. Anthony states that “a POSITA would have been motivated to place a battery in a part of the cavity that is far from a PCB holding other electrical components because that configuration allows for better thermal management.” Ex. 1002, para. 175. The problem with this statement is that Petitioner relies on Schröder’s teaching that inlay 12, i.e., the alleged PCB, could include “other electrical components,” such as a battery to support its position that Schröder suggests placing a battery between the ring halves. See, e.g., Pet. Reply 2 (pointing to Dr. Mercier’s depo testimony that inlay 12 with “other components” is inserted between ring halves); id. at 3 (relying on Schröder’s teaching about placing components in depressions on inlay 12). So, Petitioner earlier asserts for the battery limitation 1[c] that Schröder teaches or suggests putting a battery on inlay 12 inside the ring halves, but then for limitation 1[d], Dr. Anthony testifies that a POSITA would place the battery “far” away from the inlay 12 (i.e., the alleged PCB). These positions are inconsistent.” slip op. at 25

    • Skill levelSkill level board ownOther

      “at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. Pet. 8 (citing Ex. 1002 ¶¶ 18–22). Petitioner also contends that a person of ordinary skill would have been “familiar with, for example, sensor system design and signal processing” and that “[a] higher level of education or skill might make up for less experience, and vice versa.” Id. Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. Resp. 26. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’178 patent and the references cited in the Petition.” slip op. at 10

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

      “Patent Owner indicates that in the related ITC proceeding involving the ’178 patent, the Administrative Law Judge (ALJ) adopted three constructions agreed-upon by the parties in that proceeding8 and also construed two disputed terms.9 Resp. 26–27 (citing Ex. 2016, 5, 6, 14). Patent Owner agrees with Petitioner, however, that no terms need to be construed to decide the issues raised in the Petition. Id. at 27. We reviewed the constructions adopted by the ITC. Ex. 2016, 5, 6, 14. 8 In the ITC proceeding, the ALJ adopted the parties’ agreed-upon constructions that: (1) the preamble of claim 1 [a finger-worn wearable ring device] is limiting; (2) [positioned/configured to fit] within a “cavity” is [positioned/configured to fit] within a “hollow space”; and (3) [the internal housing component] “coupled with” [the external housing component] is [the internal housing component] “connected with” [the external housing component]. Ex. 2016, 5. 9 In the ITC proceeding, the ALJ construed the claims such that: (1) the internal and external housing components of claims 1, 12, and 17 enclose space and do not necessarily exclude potting material; and (2) “circumferential,” as recited in claims 1, 17, and 18, does not require a closed shape. Ex. 2016, 14, 17. These constructions are not germane to the issues we need to decide to resolve this proceeding. Thus, we agree that no explicit claim construction is necessary for this decision. To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context in which they are raised in our analysis below.” slip op. at 11

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

      “The record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor, and “Mestas’s batteries, layout, and other components . . . would have to be scaled down 5 to 10 times to be appropriately sized for a finger worn ring.” Resp. 64 (internal quotation marks omitted) (citing Dr. Anthony’s cross-examination testimony at Ex. 2021, 313:12). Moreover, we do not credit Dr. Anthony’s testimony that miniaturization of the battery would have been “trivial to implement.” Ex. 1002 ¶ 242. Dr. Anthony admitted on cross-examination that it would not have been within the level of skill of a person having ordinary skill in the art to design a smaller version of Mestas’s battery, and that such a person would need to procure a battery of the appropriate size and specifications for implementation in a finger-ring from a battery manufacturer. Ex. 2021, 315:9–318:9. Yet Dr. Anthony had not ascertained, for purposes of his testimony, whether there was a battery available in 2013 that was appropriate to fit within the inlay space of the modified version of Schröder’s finger-ring that he and Petitioner allege would have been obvious to one of skill in the art at that time. Id. at 321:5–10. Further, we credit Dr. Mercier’s testimony that Dr. Anthony’s testimony fails to consider the differences in power requirements between Mestas and Schröder or to account for the constraints of such a substantially smaller form factor in Schröder’s finger-ring as compared to Mestas’s wrist device. Ex. 2018 ¶¶ 159–160. Although large curved batteries suitable for use in a wrist band or other larger wearable device, such as shown in Mestas, were known at the time of the ’178 patent, we also have evidence that prior art “finger ring wearables up to the ’178 patent had used ‘coin’ type batteries.” Id. at 66 (citing Ex. 2018 ¶ 161). We credit Dr. Mercier’s testimony that a person having ordinary skill in the art would look to a coin type battery for the necessary power requirements of Schröder’s device. Ex. 2018 ¶ 161. Indeed, this testimony is consistent with the other art of record that consistently shows the use of flat batteries in finger-ring devices, often stacked above and protruding from the general ring shape of the device. See, e.g., Ex. 1005 (Niwa), Figs. 22, 28; Ex. 2025 (Asada ’701 patent), Fig. 4; Ex. 1035 (Rhee), Figs. 7-1, 8-1, 8-2; Ex. 1037 (Asada article), Fig. 9; Ex. 1034 (Asada ’199 patent), Fig. 2; Ex. 1028 (Kimura), Fig. 24; Ex. 2018 ¶¶ 61–70. In fact, Oura’s first-generation ring design, released in 2015, used a Superbowl ring-type design, with the battery and other components mounted on top of the ring. Ex. 2034; Ex. 2018 ¶ 71. Based on these findings, Petitioner has not met its burden to show by a preponderance of the evidence that a person having ordinary skill in the art would have been led to modify Schröder’s finger-ring to place a curved battery between the internal and external housing components in light of the teachings in Mestas. Thus, Petitioner has not met its burden to show by a preponderance of the evidence that dependent claim 3 of the ’178 patent is unpatentable over Schröder and Mestas.” slip op. at 38

    Patent outcomesUS 11,868,178 mixed
    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 11,868,178
  • Apple Inc. v. RJ Technology LLCSome claims unpatentable
    PTAB · Feb 18, 2025 · IPR2023-01350 · APJ Jon B Tornquist · IPR · Final written decision

    Claims 5–10 are unpatentable as obvious; claims 11–14 were not shown unpatentable because the evidence did not establish the claimed capacity retention after 400 cycles.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends a person of ordinary skill in the art “would have held a Bachelor’s degree in chemistry or chemical engineering, with at least 4 years of experience in cell design, electrochemical techniques, and battery materials development.” Pet. 4. Petitioner further contends that a “Master’s Degree can substitute[] for some of the relevant experience,” and “[e]quivalent training with battery specific experience can accommodate other degreed fields.” Id. 9 The parties here do not address objective evidence of nonobviousness. Patent Owner does not dispute Petitioner’s definition of the ordinarily skilled artisan. PO Resp. 20. We adopt Petitioner’s unopposed definition of the person of ordinary skill in the art as it is consistent with the ’641 patent, the prior art of record, and the parties’ arguments.” slip op. at 6

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

      “The parties agree that the term “charge cut-off voltage” is “the maximum voltage to which the battery is configured to be charged.” PO Resp 21–22; Pet. Reply 1. The parties dispute, however, whether the “charge cut-off voltage” is a “battery property” or “the voltage applied to the battery during charging.” PO Resp. 21–24; Pet. Reply 1–6. We need not resolve the precise meaning of “charge cut-off voltage” because there is no dispute that Yamaki discloses this limitation under either party’s interpretation of the claim term. Upon review of the prior art and the parties’ arguments, we determine that no terms of the ’641 patent require express construction. 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))); Pet. Reply 1 (asserting that the challenged claims are unpatentable under either parties’ construction of “charge cut-off voltage”).” slip op. at 7

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

      “Patent Owner’s arguments do not persuasively undermine Petitioner’s position. Sakamoto expressly discloses setting the ratio of negative to positive electrode active material in the range of 1.05 to 1.30. Ex. 1005 ¶ 8. Sakamoto also explains why this range is preferable, i.e., if the ratio is roughly equal “the charge-discharge cycle performance is insufficient due to significant deterioration from charging and discharging,” and if the ratio is 10 Citations to the prosecution history of Yamaki are to the page numbers added to the lower right corner of the document. too high “too much of the compound does not participate in charging and discharging.” Id. ¶¶ 6, 8. These disclosures are sufficient to explain why one of ordinary skill in the art would have found it obvious to select the ratios disclosed in Sakamoto in Yamaki. Id. ¶ 8 (providing a secondary battery with a capacity ratio between 1.05 and 1.30 and noting that by setting the ratio within this range the resulting secondary lithium battery is “safe due to low risk of heat being generated and an explosion occurring”). We also disagree that Sakamoto teaches away from elevated voltages or from increasing the amount of lithium in circulation. See PO Resp. 29. Contrary to Patent Owner’s arguments, Sakamoto provides no general teaching against using a charge cut-off voltage above 4.2 V, or against increasing the level of lithium in circulation. Nor does Sakamoto “criticize, discredit, or otherwise discourage” the claimed invention. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Rather, Sakamoto warns against setting the reversible capacities of the positive and negative electrode substantially equal as this may result in excess lithium plating on the surface of the electrode. Ex. 1005 ¶¶ 6, 8. We agree with Petitioner that this disclosure would lead one of ordinary skill in the art to design a battery with a higher capacity in the negative electrode active material than the positive electrode active material. Pet. 11–12.” slip op. at 14

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “We also disagree that Sakamoto teaches away from elevated voltages or from increasing the amount of lithium in circulation. See PO Resp. 29. Contrary to Patent Owner’s arguments, Sakamoto provides no general teaching against using a charge cut-off voltage above 4.2 V, or against increasing the level of lithium in circulation. Nor does Sakamoto “criticize, discredit, or otherwise discourage” the claimed invention. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Rather, Sakamoto warns against setting the reversible capacities of the positive and negative electrode substantially equal as this may result in excess lithium plating on the surface of the electrode. Ex. 1005 ¶¶ 6, 8. We agree with Petitioner that this disclosure would lead one of ordinary skill in the art to design a battery with a higher capacity in the negative electrode active material than the positive electrode active material. Pet. 11–12.” slip op. at 15

    Patent outcomesUS 7,749,641 mixed
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,749,641
  • 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
  • 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
  • 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
  • PTAB · Mar 20, 2024 · IPR2022-01434 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1–9 and 15 are unpatentable over Chung and Olmos-based obviousness grounds; claims 10–14 were not shown unpatentable because the asserted references did not teach the claimed complementary relationship.

    RulingsFinal written decision
    • Expert testimonyOther

      “improperly incorporates-by-reference 12 pages of expert testimony via a single sentence.” PO Sur-reply 16 n.2 (citing Pet. Reply 17, which in turn cites Ex. 1026 (Hatch Decl.) ¶¶ 49–66). We find that many of the paragraphs within the cited range (i.e., Hatch Declaration paragraphs 49–66) appear to have a tenuous connection to the proposition for which Petitioner cites these paragraphs. See Pet. Reply 17. That said, we find that paragraphs 53–55 directly relate to Petitioner’s proposition in the Reply, i.e., that “Petitioner’s experts explain why a [person of ordinary skill in the art] would rely on a cross-sectional view over a perspective view for making the determination in question, because only the cross-sections provide the needed side view directly orthogonal to the positions of the yellow expansion portion and the end of the dovetail.” Id. Accordingly, we find that paragraphs 53–55—the only paragraphs we cite from Petitioner’s range in reaching our conclusion—are not improperly incorporated by reference into Petitioner’s Reply.” slip op. at 66

    • Strike new argumentNew argument consideredDenied

      “provide Petitioner an opportunity to respond under the new construction, and decline to strike Petitioner’s relevant argument and evidence. Cf. Axonics, 75 F.4th at 1383 (“[W]hen the Board adopts a new claim construction following institution, an IPR petitioner must have adequate notice and an opportunity to respond under the new construction.”). Like in Axonics, in its new arguments on Reply, Petitioner here relies on the same embodiment from the same prior art reference that it relies on in the Petition to support the same legal argument, i.e., that Olmos’s Figure 16 embodiment discloses the “complementary with one another” limitation of challenged claims 10– 14. See Axonics, 75 F.4th at 1384; see also Apple Inc. v. Andrea Elecs. Corp., 949 F.3d 697, 706 (Fed. Cir. 2020) (permitting petitioner to elaborate in reply on an unpatentability theory presented in the petition). Moreover, we permitted Patent Owner to file (and it indeed did file) a sur-reply brief and expert declaration that addressed Petitioner’s new obviousness theories. Accordingly, both parties had adequate notice of our preliminary construction and an opportunity to respond under that new construction. For these reasons, we deny Patent Owner’s motion to strike.” slip op. at 124

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

      “from the expansion portion. We agree with Patent Owner that the wording of this limitation as a whole requires that the “extension necessarily must protrude beyond a longitudinal end of the expansion portion.” Id. at 11. We also agree with Patent Owner that “[u]nder Petitioner’s tenuous theory, an extension in any direction except 90 or 180 degrees would satisfy the claim language since any such direction has a so-called ‘longitudinal component.’” Id. at 13. For these reasons, we disagree with Petitioner’s argument that the purported “longitudinal component” of Chung’s extension satisfies limitation 1[h].” slip op. at 55

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

      “would have been motivated to add an extension to the Figure 16 embodiment because “an integrally-formed extension advantageously requires fewer parts, which facilitates both manufacturing and use.” Pet. 118. We agree with Patent Owner that this argument is unavailing. PO Resp. 50. Petitioner’s combination entails adding an extension (from Figure 8) to an embodiment lacking one (Figure 16). We agree with Patent Owner that adding a new component (whether separately or integrally) can in some instances complicate manufacturing/assembly and increase costs. See id. (citing Ex. 2013 (Culbert Decl.) ¶ 115). Petitioner has not sufficiently demonstrated that the proposed combination in this instance would reduce complexity or facilitate the manufacturing process. Accordingly, we do not rely on this argument offered by Petitioner.” slip op. at 106

    Patent outcomesUS 8,845,731 mixed
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,845,731
  • PTAB · May 18, 2023 · IPR2022-00044 · APJ Ulrike W Jenks · IPR · Final written decision

    Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the 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); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner

      “Petitioner contends that based on Patent Owner’s implicit construction in the district court litigation “that the term ‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 15 (citing Ex. 1020 ¶¶ 41, 50, 58, 62, 74, 87).” slip op. at 13

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

      “knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that [s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995).” slip op. at 37

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “Neither claim 1 nor claim 14 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG. Petitioner’s articulated rationale is that there was an expectation that the composition binds antibodies, including monoclonal antibodies, and therefore, would be useful in a process of for isolating antibodies. Petitioner contends that: A POSA would have also reasonably expected such a combination to achieve a process for isolating one or more target compounds using the recited affinity chromatography matrix given the well-known fact that each individual SPA domain, including the C domain, has affinity for antibodies (Ex. 1004, [1]) as well as Abrahmsén’s confirmation that a G29A mutation on SPA “would not interfere with folding [of SPA] or binding to [antibodies]” (Ex. 1005, 5:13-16). (Ex. 1002 ¶131.) Pet. 25; Reply 8 (“‘A POSA would not have been motivated only by Fab-binding ability, as even Dr. Bracewell agreed that ‘a POSA would have understood that it was desirable to purify monoclonal antibodies for therapeutic use in 2006.’(Ex. 1057, 75:17-76:4, 113:23-114:11, 157:24- 158:9; Ex. 1061 ¶29)”). The law does not require that the teachings of the reference be combined for the reason or advantage contemplated by the inventor, as long as some suggestion to combine the elements is provided by the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976); see In re Kemps, 97 F.3d 1427, 1430” slip op. at 44

    Patent outcomesUS 10,343,142 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,343,142
  • PTAB · May 18, 2023 · IPR2022-00041 · APJ Ulrike W Jenks · IPR · Final written decision

    Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 13

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

      “According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two Domain C units, or a functional fragments or variants thereof.” Ex. 1001, 7:27–30. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. 7: 44–45. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’142 patent’s express construction of the term, and because Patent Owner agrees with Petitioner’s construction, we apply it here.” slip op. at 14

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

      “knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 37

    • Obviousness (§103) › KSR rationalesUnpatentable

      “Here, the teachings of Linhult, Abrahmsén, and Hober suggest mutating the glycine at position 29 for an alanine in any one of the IgG binding domains of E, D, A, B, or C of SPA in order to avoid protein degradation. Ex. 1004, 2; Ex. 1005, 5:4–9. We, therefore, agree with Petitioner that the art expressly suggests that the glycine codon can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). Attaching any one of SPA mutated IgG binding domains E D A B or C to a matrix using “known ligand-construction methods to yield a predictable result[] (e.g., the claimed affinity chromatography matrix)” would have been obvious. Pet. 25 (citing Ex. 1002 ¶ 130). As the Federal Circuit has explained, “[w]here a skilled artisan merely pursues ‘known options’ from ‘a finite number of identified, predictable solutions,’ the resulting invention is obvious under Section 103.” In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1070 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). Accordingly, we agree with Petitioner that the combination of Linhult Abrahmsén, and Hober expressly suggests mutating the glycine codon for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). We also agree that the cited art teaches using these mutant SPA domains in column chromatography for the isolation of antibodies.” slip op. at 36

    Patent outcomesUS 10,343,142 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,343,142
  • PTAB · May 18, 2023 · IPR2022-00045 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–10, 12–14, 16–28, 30–32, and 34–37 are unpatentable as obvious; claims 11 and 29 were not shown unpatentable because the art did not establish expected Fab binding.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here. C.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

      “support, the ligand capable of binding the one or more target compound(s) and comprising at least two polypeptides.” Ex. 1001, 15:46–49; 17:28–31. Petitioner argues that “‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 19–20 (citing Ex. 1002 ¶¶ 43–45). Petitioner argues that this construction is consistent with Patent Owner’s implicit construction in the Delaware litigation between the parties. Id. Patent Owner does not challenge Petitioner’s claim construction. See generally PO Resp. According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two domain C units, or a functional fragments [sic] or variants thereof.” Ex. 1001, 7:35–38. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. at 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. at 7:52–53. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’007 patent’s express construction of the term, we apply that construction for the purposes of this decision.” slip op. at 13

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

      “Petitioner’s articulated obviousness ground is premised on the knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, or C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number – five (5) – SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 38

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “(c) No Teaching Away We are also not persuaded by Patent Owner’s contention that the art teaches away from the G29A substitution because it interferes with Fab binding. See PO Resp. 39–42; Sur-reply 9; Ex. 2009 at 2; Ex. 2010 at 25; Ex. 2012 at 25–26; Ex. 2029 at 7. None of claims 1, 2, or 20 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG.” slip op. at 44

    Patent outcomesUS 10,875,007 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,875,007
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