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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
  • 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
  • Apple Inc. v. Alivecor, Inc.Some claims unpatentable
    PTAB · Oct 26, 2023 · IPR2022-00872 · APJ Jeffrey N Fredman · IPR · Final written decision

    Claims 1, 2, 4–8, 10, 12, and 13 are unpatentable as obvious; claims 3, 9, and 11 were not shown unpatentable because the combinations lacked a persuasive reason to record spoken messages simultaneously with ECG …

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for patent owner

      “PO Resp. 9. Patent Owner asserts “a POSA would have understood the plain and ordinary meaning of the term ‘acoustic signal’ [is] a signal that is transmitted as a sound wave through the ambient environment.” Id.; Ex. 2003 ¶ 25. Patent Owner therefore asserts a POSA would have understood the claimed “frequency modulated ECG acoustic signal” is a signal that is transmitted as a sound wave through the ambient environment, [and excludes] signals transmitted by electronic or wireless radio means, because claim 1 requires the acoustic signal to be “received from a built-in microphone of the smartphone.” PO Resp. 9; Ex. 2003 ¶ 26. Petitioner responds by asserting that “a POSITA would have understood that acoustic transmission is a form of wireless transmission.” Pet. Reply 24; Ex. 1021, 46:7–47:5 (citing the Jafari Deposition where Dr. Jafari stated “in the event of an acoustic signal, there is no need to connect a wire”) Having considered the entire record, we do not find there is a substantive dispute over the term “acoustic signal” as both Patent Owner and Petitioner agree that acoustic signals include wireless signals transmitted as a sound wave through the environment. We will apply this understanding in our further analysis.” slip op. at 7

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A person of ordinary skill in the art (“POSITA”) would have had either (1) at least a bachelor of science in electrical engineering, mechanical engineering, or biomedical engineering, or a related discipline, with at least two years of relevant multidisciplinary work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals, or (2) a medical degree and at least five years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals.” slip op. at 5

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for petitioner

      “interference of sound waves was a known phenomenon at the time of the invention does not demonstrate that the ordinary artisan would have had reason to select particular carrier frequencies for the ECG acoustic signals that avoided human voice frequencies in the absence of any disclosure that such frequencies were known to interfere. Rather, we agree with Patent Owner that this is hindsight reasoning because until the ’882 patent pointed out this concern in the context of claim 1, there is no indication the prior art recognized that human voice interference was an issue.” slip op. at 26

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMixed

      “that Vyshedskiy’s disclosure of a list of preferred carrier frequencies represents a permissible “obvious to try” situation. In KSR, the Supreme Court stated that a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421. And simply because the prior art “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). The instant facts represent a situation where, at the time of invention in 2010, it would have been obvious to try the known carrier frequencies of Vyshedskiy for modulation of the acoustic ECG signal of Albert in the claimed frequency range of 6 kHz to 20 kHz because these carrier frequencies would have been obvious alternatives to try to address Vyshedskiy’s disclosed design need for simultaneous measurement of heart sound auscultation and ECG heart cycle. See Pet. 17 (citing Ex. 1005 ¶¶ 13– 15).” slip op. at 27

    Patent outcomesUS 8,509,882 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,509,882
  • PTAB · Oct 23, 2023 · IPR2022-01011 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1–7 and 9–11 are unpatentable over the asserted obviousness grounds; claims 8 and 12–20 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “On the full trial record, we adopt Petitioner’s proposed level of ordinary skill in the art, with Patent Owner’s additions. The additions are consistent with the evidence of record. For example, we find that adding chemistry and biology degrees is appropriate in view of Dr. Miller’s testimony that college-level chemistry and biology courses typically include training on extractive technologies. Ex. 1017 (Miller Tr.), 38:9–39:18. We also agree with Patent Owner that the educational level of the inventors may be considered (see Env’t Designs, Ltd., 713 F.2d at 696), and on this record, we accept Patent Owner and Dr. Miller’s undisputed representation that “named inventor Jason Wasserman had a bachelor’s degree in Agricultural Science and Sustainable Agriculture, a life sciences degree.” Ex. 2008 (Miller Decl.) ¶ 32; PO Resp. 5. Thus, for the reasons above, we define a person of ordinary skill in the art as someone who would have had (1) a bachelor’s degree in chemistry, biology, mechanical engineering, chemical engineering, petroleum engineering, or an equivalent field of physical science, life science, or engineering; and some academic or industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices; or (2) at least four years of industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices.” slip op. at 11

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “Based on this experience, we determine that Dr. Miller qualifies as a person of ordinary skill in the art because by 1992, he had “at least four years of industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices,” as required by the level of ordinary skill we adopt herein. He also avers that he gained additional training and engaged in additional extraction work prior to the effective filing date. Id. Additionally, between 2015 and 2020, Dr. Miller “enter[ed] the cannabis extraction and concentration industry, designing, building, and operating [his] own facility,” further qualifying him as a person of ordinary skill in the art. Ex. 2002 (Miller Decl.) ¶ 10; see also Reply 6 (acknowledging Dr. Miller’s post-2015 “experience and expertise in closed loop extraction systems”). Although this work started in 2015 (two years after the effective filing date of 2013), a person of ordinary skill in the art need not have been one of ordinary skill at the time of a patent’s filing date. See U.S. Endoscopy Group, Inc. v. CDX Diagnostics, Inc., IPR2014-00639, Paper 27, at 18 (Sept. 14, 2015) (“A witness must provide testimony about the level of skill in the art as of the critical date; however, the witness need not have acquired that knowledge as of the critical date.”). For the reasons discussed above, we determine that Dr. Miller is qualified in this proceeding to testify from the perspective of a person of ordinary skill in the art.” slip op. at 14

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

      “We find that Patent Owner has the better argument. Patent Owner’s citations demonstrate that “[t]he ’751 patent consistently describes ‘solvent collection line’ as a line, a pipe, hose, or tube used for the transport of gasses or liquids,” and that this usage is consistent with the way both parties’ declarants use the term “line.” PO Resp. 29–30; Ex. 1001, 9:16–10:41, 14:65–15:10, Figs. 1, 2, 5; Ex. 2002 (Miller Decl.), ¶ 60; Ex. 2003 (Chess Depo. Tr.), 100:6–17, 145:20–146:7, 169:18–171:2. In contrast, Petitioner’s argument is undermined by the same passage it cites. Specifically, “what the ’751 Patent explains in the same paragraph Petitioner cites is that the ‘solvent collection line 190 is configured to pass through condensing system 105 between second pump 102 and solvent collection container 15.’” Sur-reply 14–15 (quoting Ex. 1001, 8:60–63) (emphasis Patent Owner’s). “Figure 5 shows that both ‘solvent collection line 190’ and ‘coolant line 109’ are still ‘lines’ as they pass through ‘first condenser column 107.’” Id. at 15 (citing Ex. 1001, Fig. 5, 9:48–58). Figure 1, in contrast, shows that coolant pump 104 is a component that is distinct from coolant line 109. See id. (citing Ex. 1001, Fig. 1, 9:6–25). For the above reasons, we construe “line” to mean “a pipe, hose, or tube.”” slip op. at 19

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

      “We need not define the exact contours of a “canister interface,” including deciding whether it is “more than a mere connector.” Nor do we need to construe the claim term “support.” It is sufficient to note that a canister interface is not simply the system’s canisters themselves. The plain language of the claims recite that the “canister interface” must be configured to “support” the canisters (thereby distinguishing the canister interface from the canisters themselves). The Specification likewise distinguishes the canister interface and the canisters, indicating that the canister interface “allow[s] canisters to be easily detached and reattached.” Ex. 1001, 11:61– 62. Similarly, Mr. Chess distinguished a “detachable canister interface” from the system’s canisters/containers, characterizing the former as a “fitting of some sort so that you can disconnect or connect the solvent source container to the extraction vessel or canister.” Ex. 2003 (Chess Depo. Tr.), 182:10–16 (emphasis added).” slip op. at 46

    Patent outcomesUS 9,144,751 mixed
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 9,144,751
  • PTAB · Oct 11, 2023 · IPR2022-00878 · APJ Lynne H Browne · IPR · Final written decision

    Claims 55–72, 78–80, 83, and 84 are unpatentable over the instituted grounds; Petitioner did not show claim 85 unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill 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 contends that a person of ordinary skill in the art would have been a mechanical engineer, medical device engineer, or an interventional cardiologist with a working knowledge of stent-based prostheses for use in a patient’s heart or vasculature to replace and/or repair a diseased valve, intravascular delivery systems for the delivery of such prostheses, and methods associated with the delivery and implantation of such prostheses in a patient. Pet. 31 (citing Ex. 1026 ¶ 27). Patent Owner “does not dispute Petitioner[’s] definition of a person of ordinary skill in the art.” PO Resp. 2. 8 The parties have not directed our attention to any objective evidence of obviousness or non-obviousness. reasonable and consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 12

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

      “Terms Defined by the ’400 Patent 1. Both parties discuss claim terms (“substantially conical,” “folds,” “biocompatible membrane [that] does not comprise a treated tissue,” “cusp,” “cuff wall,” “frame,” “mobile leaflet layer” or “mobile leaflet,” “proximal,” “non-transverse”, and “plurality of . . . leaflets”) which are defined by the ’400 patent’s explicit definition of these terms or its explicit definition of a related term (e.g., definition of “folding” also defines claim term “folds”). Pet. 26–28; PO Resp. 26–28. Both parties assert that the definitions in the ’400 patent define these claim terms. Id. We agree. For the claim terms defined by the ’400 patent, Patent Owner has acted as its own lexicographer by setting out the definitions of these claims terms in the specification of the ’400 patent. Thorner v. Sony Comput. Ent. Am., LLC, 669 F.3d 1362, 1365 10 We note that throughout its claim construction arguments, Patent Owner refers to the claim construction of the word “attach;” however, the claim term at issue is “attached.” We understand Patent Owner to be referring to this claim term and treat Patent Owner’s arguments as if they refer to the claim term “attached.” discussed in Sections D–F below, we construe these terms in accordance with their definitions set forth in the ’400 patent.” slip op. at 14

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

      “f) Conclusion Re Claim Construction For “Attached” We begin our analysis by reiterating that under the Phillips standard, claim terms are generally given their ordinary and customary meaning as would be understood by one with ordinary skill in the art in the context of the specification, the prosecution history, other claims, and even extrinsic evidence including expert and inventor testimony, dictionaries, and learned treatises, although extrinsic evidence is less significant than the intrinsic record. Phillips, 415 F.3d at 1312–17. When a patent owner wishes to employ a definition that is different from the ordinary and customary meaning of a claim term, it may do so by acting as its own lexicographer setting out the definition of that claim term in the specification of its patent. Thorner, 669 F.3d at 1365. As discussed in Section II.C.1 above, Patent Owner has acted as its own lexicographer and defined numerous claim terms in the ’400 patent. See Ex. 1001, 11:41–13:18. Thus, it is readily apparent that when Patent Owner intended to employ a definition of a claim term that differed from the the ordinary and customary meaning of that claim term, Patent Owner provided such a definition. A person of ordinary skill in the art would infer accordance with their ordinary and customary meaning. Having considered the full record before us including the evidence, testimony, and argument in support of the parties’ positions, we agree with Petitioner that the claim term “attached” should be construed in accordance with its ordinary and customary meaning, which the parties agree is “fastened, secured, or joined, directly or indirectly.”12 Pet. Reply 1; PO Resp. 15. We do not find that the context of the ’400 patent further narrows this term such that a person of ordinary skill in the art would have understood “attached” to require attachment “at the same location.” Accordingly, we apply the ordinary and customary meaning of the claim term “attached” in considering the challenges set forth in the Petition discussed below.” slip op. at 22

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

      “testimony, and arguments in support of both parties’ positions, we agree with Petitioner that Melsheimer’s cusps are substantially conical as required by independent claim 55. The definition of “substantially conical” set forth in the ’400 patent does not require that every part of the structure in question resemble a cone. Ex. 1001, 12:47–54. Rather, it requires a structure that “resembles a cone or portion thereof at some point in the practical use of the structure” and a “cross-sectional perimeter or area of the structure in the operationally closed position that decreases moving from the level of the leaflet apposition to the proximal end of the valve.” Id. (emphasis added). Melsheimer discloses receptacles 18 that are cone-shaped. Ex. 1003, Fig. 4A. Although, Melsheimer’s leaflet 16 and receptacle 18 pairs are not entirely cone-shaped, they do still resemble a cone. Further, Melsheimer’s receptacles 18 have the required cross-sectional perimeter. See id. Accordingly, we determine that these pairs (i.e., Melsheimer’s cusps) are “substantially conical” in accordance with the definition set forth in the ’400 patent. Conclusion For Grounds 1–3 Having considered the full record before us including the evidence, testimony, and arguments of both parties, we determine that Petitioner shows by a preponderance of the evidence that claims 55, 56, 58, 59–61, 63, 65, and 66 are anticipated by Melsheimer (Ground 1). We further determine that claims 57, 64, 78, and 79 are unpatentable over Melsheimer alone or in combination with Eberhardt (Ground 2) and that claims 62, 83, and 84 are unpatentable over Melsheimer alone or in combination with Pavcnik (Ground 3).” slip op. at 31

    Patent outcomesUS 9,737,400 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,737,400
  • PTAB · Jul 26, 2023 · IPR2022-00625 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1 and 7–17 are unpatentable: claims 1, 7, 9–13 under §102 over Britt; claims 8 and 14 under §103 over Britt and Buese; and claims 15–17 under §103 over Hebert and Britt. Claims 2–6 …

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “On the full trial record, we adopt Petitioner’s proposed level of ordinary skill in the art, as modified by Patent Owner. Patent Owner’s proposed additions to the educational level are consistent with the evidence of record. For example, we find that adding chemistry degrees is appropriate in view of Dr. Miller’s testimony that “extractive technologies are chemistry,” and that college level chemistry typically includes training on extractive technologies. Ex. 1023 (Miller Tr.), 35:9–22, 38:25–39:18. Similarly, adding biology degrees is appropriate because Dr. Miller testified that in training for a biology degree, one is exposed to college-level chemistry and training in extractive technologies. Id. at 38:9–24. We also agree with Patent Owner that the educational level of the inventors may be considered (see Envtl Designs, Ltd., 713 F.2d at 696), and on this record, we accept Patent Owner and Dr. Miller’s undisputed representation that “named inventor Jason Wasserman had a bachelor’s degree in Agricultural Science and Sustainable Agriculture, a life sciences degree.” Ex. 2007 (Miller Decl.) ¶ 37; PO Resp. 4.” slip op. at 10

    • Expert testimonyDecided for patent owner

      “ordinary skill in the art based on education because he holds degrees in geology and earth and environmental sciences, which are not specifically recited in the proposed level of ordinary skill in the art. Reply 3. Petitioner characterizes Dr. Miller’s degrees as “advanced degrees in life sciences” (id. at 3), while Patent Owner characterizes them as “at least an ‘equivalent physical science degree’” (Sur-reply 5). On this record, we determine that we need not resolve whether Dr. Miller’s degrees qualify him as a person of ordinary skill in the art, because we find that he is qualified based on his experience. Dr. Miller has “decades (1988 to present) of direct experience in the use of partial and complete extractions of diverse materials in environmental studies.” Ex. 2007 (Miller Decl.) ¶ 8. He has also “studied, used, and developed thousands of extractions to solubilize and remove oils, wastes, metals, and other toxins from soil, water, plants, and animal tissues for analysis.” Id. He avers that “[e]xtractive chemistry was core to [his] business practice in 1988 and remains so to this day,” and that “[b]y 1992 [he] would have developed ordinary skill in the art having 4 years of experience relevant to the current subject.” Id. ¶ 10. Based on this experience, we determine that Dr. Miller qualifies as a person of ordinary skill in the art because by 1992, he had “at least four years of industry experience working with, designing, or studying methods of extracting solute from a source material or similar devices,” as required by the level of ordinary skill we adopt herein. He also gained additional training and engaged in additional extraction work prior to the effective filing date. Id.” slip op. at 11

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

      “of a source material,” and “[w]ithin the canister, the source material is exposed to a solvent to create an extract mixture.” Pet. 18 (citing Ex. 1001, 2:1–3). We adopt this understanding of the term “canister,” because it is supported by the cited portion of the Specification and is undisputed on this record.” slip op. at 15

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

      “Ex. 1001, 22:1–6. We agree with Petitioner this language does not require control over when the extract mixture formed in step 1(c) is communicated to the extract containers in step 1(d). Reply 7. Dr. Miller conceded that “[e]xtraction is going to start instantaneous[ly],” such that at least some portion of an extract mixture is instantaneously created in step 1(c). Ex. 1023 (Miller Tr.), 67:23–68:7, 120:8–13. Thus, “the next step could occur instantaneously.” Reply 9. We see nothing in the claim language requiring any degree of completion of step 1(c), or any waiting period, before step 1(d) begins. Nor do Patent Owner’s briefs point to any particular aspect of these limitations that allegedly demand such an interpretation. See generally PO Resp. 5; Sur-reply 6–9. Dr. Miller asserts that the plain meaning of steps “does not allow for a passive, automatic, and continuous flow of extract mixture from the canister to one or more extract containers” (Ex. 2007 (Miller Decl.) ¶¶ 30–31), but he too fails to identify what in the language of these terms prohibits this. The claims here “do not exclude a continuous process, in which later steps are initiated as soon as at least some product from the previous step forms, while previous steps are still ongoing.” Kaneka Corp. v. Xiamen Kingdomway Group Co., 790 F.3d 1298, 1306 (Fed. Cir. 2015).” slip op. at 17

    Patent outcomesUS 9,587,203 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
    Patents in suitUS 9,587,203
  • PTAB · Jul 10, 2023 · IPR2022-00605 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1–6, 8–10, and 12–17 are unpatentable over Gravesen and Brister; claims 7, 11, and 18–28 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The person of ordinary skill in the art as of the earliest possible effective filing date (“POSITA”) would have had a Bachelor’s degree in Bioengineering, Mechanical Engineering, Electrical Engineering, or a related subject, and one or more years of experience researching, developing and/or designing insertable medical devices, including, e.g., systems for implanting wearable medical devices such as cannulas, infusion sets, and analyte sensors, or equivalent experience. Less work experience may be compensated by a higher level of education, such as a Master’s Degree, and vice versa. Pet. 14–15 (citing Ex. 1003 (Fletcher Decl.) ¶ 22). Patent Owner does not dispute Petitioner’s proposal. PO Resp. 11 n.1. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision.” slip op. at 8

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

      “Second, turning to the extrinsic evidence of record, Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 (Fletcher Decl.) ¶ 81 (citing Ex. 1025 (dictionary excerpts), 1). In contrast, Dr. Cima provides no evidence corroborating his evidence. The language Patent Owner quotes from the Petition comes from a “Dictionary of Mechanical Engineering.” See Pet. 38 n.9 (quoting Ex. 1024, 328). This contradicts Patent Owner’s argument that Petitioner’s proposed construction “has no basis in mechanical engineering.” PO Resp. 19. view that a rotor must rotate on a central axis. He cites a textbook indicating that “[r]otational motion needs to take place around an appropriate axis,” but he does not explain whether or why the “appropriate axis” must necessarily be a “central axis.” Ex. 2024 (Cima Decl.) ¶ 179 (quoting Ex. 2040 (Rotordynamics) 2 (emphasis added)). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).” slip op. at 11

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

      “On the full trial record, we again find that Patent Owner’s proposed narrowing is unwarranted. First, the intrinsic record does not support Patent Owner’s required “central” axis. Patent Owner argues that the Specification describes two inserter embodiments as having “rotors,” and those rotors have a central axis. PO Resp. 17–18 (citing Ex. 1001, 29:25–28, 29:55–59, Figs. 32, 45). Patent Owner, however, fails to explain why those embodiments should be understood to limit the claims. For example, in Phillips, the Federal Circuit “expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.” Phillips, 415 F.3d at 1323; see also SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“[A] particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.”). Second, turning to the extrinsic evidence of record, Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 (Fletcher Decl.) ¶ 81 (citing Ex. 1025 (dictionary excerpts), 1). In contrast, Dr. Cima provides no evidence corroborating his evidence. The language Patent Owner quotes from the Petition comes from a “Dictionary of Mechanical Engineering.” See Pet. 38 n.9 (quoting Ex. 1024, 328). This contradicts Patent Owner’s argument that Petitioner’s proposed construction “has no basis in mechanical engineering.” PO Resp. 19. view that a rotor must rotate on a central axis. He cites a textbook indicating that “[r]otational motion needs to take place around an appropriate axis,” but he does not explain whether or why the “appropriate axis” must necessarily be a “central axis.” Ex. 2024 (Cima Decl.) ¶ 179 (quoting Ex. 2040 (Rotordynamics) 2 (emphasis added)). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).” slip op. at 11

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Although the Petition does state that a person of ordinary skill in the art “would understand the plain and ordinary meaning of a ‘recess’ to include ‘an indentation in a line or surface (as an alcove in a room),’” the Petition does not specify what else is “include[d]” in this term, nor does it specify that the plain and ordinary meaning of “recess” includes the entire interior of a housing. The Petition also does not invoke the Specification as demonstrating that the plain and ordinary meaning of “recess” includes the entire housing.13 Pet. 64 (emphasis added). Petitioner’s belated proposal also conflicts with the language of the claims themselves. Independent claim 1 recites “a rotor disposed within the inserter housing.” Ex. 1001, 43:42. Dependent claim 7 narrows claim 1 by reciting that “the housing comprises a recess in which the rotor is received.” Id. at 44:11–12. If the interior of the inserter housing and the recess could be one and the same as Petitioner proposes, there would be no need for claim 7, because it would not further limit claim 1. See 35 U.S.C. § 112(d) (“a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed”); see also Nazomi Commc’ns, Inc. v. Arm Holdings, PLC, 403 F.3d 1364, 1370 (Fed. Cir. 2005) (“The concept of claim differentiation ‘normally means that limitations stated in dependent claims are not to be read into the independent claim from which they depend.’”) (quoting Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971–72 (Fed. Cir. 1999)). Accordingly, we decline Petitioner’s belated request to construe “recess” to include “an entire cavity of a housing or a cylinder.” 13 We acknowledge that Petitioner argued that the entire interior of Gravesen’s housing maps to the claimed “recess,” but this was in the context of comparing the prior art to the claim as construed. Indeed, Petitioner asserted that “the space within [Gravesen’s] housing is an alcove.” Pet. 64– 65 (emphasis added). In sum, Petitioner did not timely argue that the plain and ordinary meaning of the term “recess” includes an entire cavity of a housing or a cylinder. We adopt the only construction Petitioner offered and supported in the Petition. In view of the above, we construe “recess” as meaning “an indentation in a line or surface (as an alcove in a room).”” slip op. at 16

    Patent outcomesUS 10,945,649 mixed
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,945,649
  • PTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision

    The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology and cancer biology, which would encompass the blood cancers recited by Patent Owner. 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 find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7

    • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

      “We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16

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

      “The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed

      “We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16

    Patent outcomesUS 10,993,942 mixed
    Claim construction§ 112 disclosure
    Patents in suitUS 10,993,942
  • PTAB · Jan 4, 2022 · IPR2020-01113 · APJ Michael A Valek · IPR · Final written decision

    Claims 1–4 are unpatentable as obvious over Misselbrook, CN ’588, and JP ’902; claims 7–12 were not shown unpatentable because the grounds did not establish motivation to add a disintegrating agent.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “relevant to determining the level of ordinary skill in the art include the type of problems encountered in the art and prior art solutions to those problems. See Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). The prior art itself may also reflect an appropriate level of skill. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner

      “We also adopt the parties’ position that the preamble of claims 1 and 7 is not limiting beyond the term “granule.” Claims 1 and 7 each recite “[a] chemically stable dry flow, low compact, dust free soluble phosphoramidothioate granule consisting of” the set of ingredients recited in body of those claims. Ex. 1001, 7:44–45, 8:19–20. While the wherein clause describing the dimensions of “said granule” relies on “granule” in the preamble for antecedent basis, none of the other preamble language appears to be necessary to breathe life and meaning into the claim, and the claim body recites a structurally complete invention. See Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (explaining that a preamble is limiting if it is “necessary to give live, meaning, and vitality to the claim,” but “is not limiting where a patentee defines a structurally complete invention in the claim body”) (internal quotations omitted). Thus, we agree with the parties, and the district court in the related litigation, that the preamble language other than “granule” is not limiting.” slip op. at 10

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

      “Moreover, we agree that the transitional phrase “consisting of” in claims 1 and 7 creates a “very strong presumption that the claim element is ‘closed’ and therefore exclude[s] any elements, steps, or ingredients not specified in the claim.” Pet. 5; Resp. 12 (both quoting Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016)). Neither party seeks to overcome that presumption, nor do we see any basis for doing so based on the record before us. Accordingly, we construe the challenged claims to be limited to granule compositions containing only those ingredients recited in the claims. There are no other terms that need to be construed to resolve the issues presented in this proceeding. Therefore, we do not construe any additional terms. See, e.g., Nidec Motor Corp. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 11

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

      “demonstrating that the “general conditions” regarding the use of these ingredients in such compositions was known. In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (noting that any overlap between the claimed and disclosed ranges serves to disclose the “general conditions” of the claim). “Such overlap itself provides sufficient motivation to optimize the ranges.” Id. Moreover, we credit Mr. Geigle’s testimony that a POSITA would have understood because the concentration of acephate was increased the concentration of the other ingredients would necessarily decrease and that a POSITA would have been able optimize these amounts using standard techniques and testing. Ex. 1003 ¶¶ 85–113. Thus, Petitioner has demonstrated that these ingredient concentrations are result-effective variables that would have been obvious to optimize through routine experimentation.” slip op. at 24

    Patent outcomesUS 7,473,685 mixed
    Claim construction§ 103 obviousnesscites Graham
    Patents in suitUS 7,473,685

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.