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  • PTAB · Jun 12, 2024 · IPR2023-00206 · APJ Donna M Praiss · IPR · Final written decision

    Claims 1–12 and 14–24 are unpatentable as obvious over Giacino, Proulx, and Conrad, with Perret or MacLeod for certain dependent claims; the Board did not reach other grounds.

    RulingsFinal written decision
    • Prior constructionPrior construction adoptedDecided for petitioner

      “The District Court’s claim construction for the term “compound” is shown below. Ex. 2016, 8–11. Claim Term District Court Construction The “sulfur compound” limitation must be satisfied by a compound that is present compound10 separately from a protein; “compound” will not be construed as being limited to compounds used as flavor precursors The District Court’s claim construction order cites to U.S. Patent 11,013,250 (the ’250 patent”) as representative of the ’096 patent and other related patents involved in the District Court litigation. See Ex. 2016, 7 (“Claim 1 of the ʼ250 patent claims is generally representative for purposes of the parties’ dispute.”). The District Court determined that plant proteins 10 Ex. 2016, 9, 11 (citing Ex. 1001, 15:26–27).” slip op. at 11

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

      “24. Pet. 20–26. Focusing on independent claim 1’s limitation “a compound selected from cysteine, cystine, thiamin, methionine, and mixtures of two or more thereof,” Petitioner asserts Brown’s disclosure of “pea flour” meets this limitation because “pea flour contains cystine, thiamine, and methionine.” Id. at 22–23 (citing Ex. 1012 (Brown) ¶ 364; Ex. 1003 (Tarte) ¶¶ 121–125; Ex. 1050/Ex. 1059 (Jahreis), 39, 41, 86; Ex. 1106, 3, 6–7). Petitioner qualifies that its mapping of “pea flour” to this claim limitation is based on the interpretation of “compound” as “not . . . limited to free compounds.” Id. at 22 n.7. Specifically, Petitioner states that the mapping is based on Brown’s “pea flour, which contains proteins having the claimed sugar and sulfur compounds.” Id. at 12; see Ex. 1003 ¶ 105 (reiterating this statement). Brown states, in pertinent part, “[a] muscle replica comprising pea flour, sunflower oil, and glucose.” Ex. 1012 ¶ 364. Dr. Tarté states in his declaration that a person of ordinary skill “would have understood that pea flour includes cystine, methionine, and thiamine.” Ex. 1003 ¶¶ 121–125. On cross-examination, Dr. Tarté stated that this mapping to the claim is based on an understanding that Brown’s proteins satisfy the sulfur compound limitation. Ex. 2032, 33:19–34:12; 98:11–99.9 (“[I]n as much as . . . Patent Owner considers proteins to satisfy the sulfur compound claim, then . . . the pea protein flour of Brown also satisfies the [sulfur] compound claim.”), 117:9–118:8. Patent Owner asserts that the Petition’s anticipation ground must fail if the claimed compound limitation does not extend to proteins. PO Resp. 13. Because we adopt the District Court’s construction of the claim term “compound,” Petitioner’s contention that Brown anticipates the ’096 patent necessarily fails. See Verdegaal Bros., 814 F.2d at 631 (“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.”). Petitioner concedes that the viability of this ground depends on construing the term “compound” to include whole proteins, and has failed to present evidence in this proceeding that Brown discloses a sulfur compound that is separate from a protein. Tr. 50:21–52:13 (Petitioner’s counsel conceding that the anticipation ground is not viable under the District Court’s claim construction for “compound”). Thus, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable as anticipated by Brown.” slip op. at 19

    • Obviousness (§103) › Analogous artNon analogous artDecided for patent owner

      “The analogous-art test requires a showing that a reference is either in the field of endeavor of the challenged patent or is reasonably pertinent to the problem with which the inventor was concerned in order to rely on that reference as a basis for unpatentability. In re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992). Patent Owner argues that Petitioner fails to establish Crane as analogous art under this legal framework. PO Resp. 36–40; PO Sur-Reply 1–2. First, Patent Owner asserts Crane is not “from the same field of endeavor” as the ’096 patent. Id. at 37 (citing Ex. 2030 (Qian Decl.) ¶ 86). Based on this record, the ’096 patent is directed to food products while Crane, on the other hand, relates to “methods for producing recombinant functional heme-binding proteins.” Ex. 1001, 1:22–25; Ex. 1014, code (57). As Patent Owner points out, Crane does not even mention food products or any flavor functionality of heme-binding proteins. PO Resp. 37. Petitioner does not address Crane’s field of endeavor in its Petition or Reply. See Pet. 36–50; Pet. Reply 1 (“Petitioner . . . relies on the arguments made in the Petition for Ground 1 and 3A-3D”). We agree with Patent Owner that Crane is not from the same field of endeavor as the ’096 patent. Next, Patent Owner asserts the Petition fails to explain how Crane’s recombinant heme-binding protein is pertinent to the problem addressed by the ’096 patent inventors. According to Patent Owner, the problem solved by the inventors was “to provide meat-like-food products that overcome the limitations of prior-art meat substitutes.” PO Resp. 38. Crane, however, is directed to producing recombinant heme-binding proteins with complete heme incorporation. Ex. 1014 ¶¶ 3–5; Ex. 2030 ¶ 87. Neither Crane nor the Petition addresses how this is relevant to improving meat-associated flavors or aromas in food flavor additives. See generally, Ex. 1014; Pet. 36–50. The Petition asserts that Crane’s recombinant heme-binding protein, if used in place of Conrad’s blood/hemoglobin, which is added to improve taste, “would have produced the proteins with a high degree of purity.” Pet. 47–48. The Petition asserts that the benefit of high purity is greater control over the amount added and consistency in the end product. Id. at 48.” slip op. at 21

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

      “argument at trial, we do not agree with Patent Owner that Petitioner’s basis for improving the nutritional content of the food product of Giacino is unsupported by the record. Proulx identifies iron deficiency as “a major nutritional problem, affecting over 2 billion people[.]” Ex. 1019, 1518; Ex. 1003 ¶ 93; see also Pet. Reply 25. Based on the evidence in this record, Giacino’s compositions lack a significant source of iron. Ex. 1003 ¶¶ 387, 407. Furthermore, like Proulx, Giacino’s composition is intended to be an additive to food products. Specifically, Giacino’s composition is intended to be added to synthetic meat fibers, that may benefit from a source of iron, by mimicking not only the “meaty flavor” or aroma of meat, but the nutritional profile of conventionally sourced beef as well. Ex. 1003 ¶ 410; Ex. 1015, 7:22–26. This reasoning is supported by Petitioner’s expert, Dr. Tarté. Ex. 1003 ¶ 410. Patent Owner acknowledges the nutritive aspect of the addition is a “bonus” to the flavor impact. PO Sur-Reply 25–26. Proulx explicitly teaches adding leghemoglobin as an additive to food (“food fortificant”), therefore a POSITA would have had a reasonable expectation of success in doing so. Ex. 1019, Abs.; see id. at 1521 (“added with tortillas”). Even if the addition of Proulx’s leghemoglobin were to produce autooxidation and impact Giacino’s meaty flavor, the benefit of Proulx’s leghemoglobin as an additive to a food composition is not disputed and supports the combination. “The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.” Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000). Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”). Moreover, the evidence of record regarding the asserted negative effect on aroma and flavor due to heme proteins is that this negative impact is merely a possibility. Ex. 2030 ¶ 76 (Dr. Qian states that heme proteins have an “unpredictable effect” and refers to statements made in related patent prosecution that “fortification [with] iron has a potential negative effect on organoleptic quality of maize products, in that soluble forms of iron can cause oxidative rancidity,” quoting Ex. 1148, 2715). Based on the evidence of record, the benefit of adding heme protein taught by Proulx outweighs the potential negative effect that it may have on Giacino’s flavoring additive. Thus, the preponderance of the evidence in this record supports Petitioner’s assertion that a POSITA would have been motivated to nutritionally fortify Giacino’s meat flavoring composition by adding Proulx’s soy leghemoglobin.” slip op. at 31

    Patent outcomesUS 9,943,096 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,943,096
  • PTAB · Jun 11, 2024 · IPR2024-00251 · APJ Kevin C Trock · IPR · Institution

    The Board instituted IPR on claims 1–9 and all asserted grounds, finding a reasonable likelihood that claims 1–3 and 5–9 are obvious over Neibauer and Cheng.

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

      “Based upon the present record, we determine that Petitioner has made a sufficient showing that one of ordinary skill in the art would have had a reason to combine the asserted art in the manner described by Petitioner. We, therefore, find that Petitioner has shown sufficiently for purposes of institution that a person of ordinary skill in the art at the time of the claimed invention would have had reason to combine the teachings Neibauer and Cheng in the manner described in the Petition, and would have had a reasonable expectation of success in so doing.” slip op. at 31

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “Cheng is sparse. Neibauer and Cheng were among dozens of other references identified on information disclosure sheets submitted during prosecution, and there is no clear evidence of record that Neibauer and Cheng were ever discussed substantively. See generally Ex. 1022. Petitioner argues that “the Examiner erred by overlooking [Neibauer and Cheng] and the compelling grounds of unpatentability they provided.” Prelim. Reply 1. “Neibauer and Cheng were stronger prior art because they disclosed the limitations the Examiner thought were missing from Chow, including the “uploading,” “reformatting,” and “automatically generating” limitations that he highlighted in the Notice of Allowance.” Id. In light of this sparse record, Petitioner’s showing on the merits with respect to Neibauer and Cheng is sufficient to demonstrate that the Office erred with respect to its consideration of these references during prosecution of the ’427 patent. To the extent the Office substantively considered Neibauer and Cheng and concluded that their combination does not teach claim 1, this was material error. It is also notable that the Office cited and relied on both Neibauer and Cheng in the reexamination of U.S. Patent No. 8,135,801 B2, a parent in the same family as the ’427 patent, which resulted in cancellation of all claims of that patent. For the reasons discussed below with respect to the merits, the asserted combination of Neibauer and Cheng sufficiently teaches claim 1. Given the Petition’s detailed analysis, including the supporting testimony of Dr. Madisetti, and the sparse record developed by the Office addressing Neibauer and Cheng during prosecution of the ’427 patent, Petitioner has shown sufficiently that the Office materially erred when it found that the prior art does not teach claim 1.” slip op. at 18

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner states “[f]or purposes of this Response, [Patent Owner] applies Petitioner’s characterization of a POSITA.” Prelim. Resp. 17. Petitioner’s description of a person of ordinary skill in the art is consistent with the ’427 patent and the prior art before us and is supported by the testimonial evidence. Therefore, for the purpose of this Decision, we adopt Petitioner’s description. C. Claim Construction” slip op. at 8

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

      “Given this preliminary record, we do not see a basis for adopting Patent Owner’s proposed meaning of “uploading” as “data sent from a client to a server.” We do not discern a rationale in the claims or the intrinsic record to include the term “client” within the meaning of “uploading.” Rather, given the current record, we preliminarily determine that the ordinary and customary meaning of the term “uploading” as it is used in the ’427 patent and would have been understood by someone of ordinary skill in the art at the time of the claimed invention is “transferring data from an external data source to a set of servers.” This preliminary determination does not preclude the parties from proposing, presenting evidence, or arguing a different meaning for the term “uploading” during trial. To the extent the parties disagree with this preliminary determination, the parties should present their evidence and arguments as permitted by our rules.4 A final determination as to the ordinary and customary meaning of the term “uploading” as it is used in the ’427 patent will be made after the close of all the evidence and after any oral hearing in this matter.” slip op. at 13

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 10,839,427
  • PTAB · Jun 11, 2024 · IPR2024-00249 · APJ Christopher M Kaiser · IPR · Institution

    The Board instituted IPR on claims 1–19, 21, and 22 on all asserted grounds after finding a reasonable likelihood that claim 1 was obvious over Neibauer, Ausems, Cheng, and Squibbs.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

      “relying on are the same or substantially the same as references that were before the Office. In particular, there is no dispute that neither Harvey nor Ausems was considered by the Office, nor that Harvey is not substantially the same as any reference that was before the Office. Prelim. Resp. 9–10; Prelim. Reply 3. Further, we do not agree with Patent Owner that Ausems is substantially the same as Rensin. Specifically, Petitioner relies on Ausems to teach the incorporation of a camera into a mobile device, permitting the recording, storage, and transmission of digital images. Pet. 23; Prelim. Reply 3. We have reviewed the section of Rensin to which Patent Owner directs us (Ex. 2003, 2:2–21), and we do not see substantially the same functionality. Although Rensin teaches that “PDA expansion slots may be used to enhance the PDA capabilities with a digital camera,” Patent Owner does not explain, and it is not clear from our review of Rensin, that Rensin discloses the use of the mobile device to transmit the images recorded by the camera. Ex. 2003, 2:2–21. Accordingly, we are not persuaded that Rensin is substantially the same as Ausems. 3. Conclusion Based on our consideration of Becton Dickinson factors (a), (b), and (d), we find that the same or substantially the same art or arguments were not previously presented to the Office. Thus, our analysis ends at this point, and we need not proceed to part two of the Advanced Bionics framework. See Advanced Bionics, IPR2019-01469, Paper 6 at 8. We therefore decline to exercise our discretion to deny institution based on 35 U.S.C. § 325(d).” slip op. at 14

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

      “Based on the current record, a person of ordinary skill in the art would have combined the teachings of Ausems with those of Neibauer in the manner described above. See Ex. 1002 ¶¶ 114–117. Specifically, a person having ordinary skill in the art would have combined Ausems’s ability to share photos captured by a mobile device with Neibauer’s Yahoo! club in order to “dramatically expand[] the universe of image data that the club based on the current record, a person of ordinary skill in the art would have had a reasonable expectation of success. Id. ¶ 117. Accordingly, on the present record, the combination of Neibauer and Ausems teaches limitation 1a.” slip op. at 22

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “to “a bachelor’s degree in electrical engineering, computer science, or similar field, with two years of experience in developing and implementing network-based computer systems that interact with mobile devices, such as systems for storing and retrieving information over the Internet or communicating using the Web using wireless mobile devices.” Pet. 5–6 (citing Ex. 1002 ¶¶ 14–18). At this stage, Patent Owner “applies Petitioner’s characterization of a person of ordinary skill in the art.” See Prelim. Resp. 15. For purposes of this Decision, we adopt Petitioner’s proposed level of skill, as articulated above. We are satisfied that Petitioner’s proposed and implement the teachings of the ’578 patent and the asserted prior art. This definition is also supported by the testimony of Dr. Madisetti. See Ex. 1002 ¶¶ 14–18.8” slip op. at 9

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

      “Petitioner does not believe express claim construction is necessary at this time.” Pet. 8. Petitioner also discusses various claim construction arguments made in the district court proceeding. See id. at 25–27, 65–66. At this stage, Patent Owner agrees with Petitioner that “no express constructions are required.” Prelim. Resp. 16. 8 If Patent Owner disagrees with this formulation of the level of skill in the art, it must raise that disagreement in its Response. If a different level of skill would affect the outcome in this case, the parties must brief that issue as well. The failure of Patent Owner to describe how a different level of skill in the art is determinative will be a forfeiture of that argument. If there is a dispute regarding the level of ordinary skill in the art, then the parties are also encouraged to submit evidence, other than conclusory expert testimony, that supports their position. claim terms.9 See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 10

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 9,619,578
  • PTAB · Jun 11, 2024 · IPR2024-00246 · APJ Scott B Howard · IPR · Institution

    The Board instituted IPR on claims 1, 6–11, 13–18, and 20–27, finding a reasonable likelihood that claim 1 is obvious over Neibauer, Miller, and Cheng.

    RulingsInstitution decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Dr. Madisetti argues that a person having ordinary skill in the art would have had “a bachelor’s degree in electrical engineering, computer science, or similar field, with two years of experience in developing and implementing network-based computer systems that interact with mobile devices, such as systems for storing and retrieving information over the Internet or communicating using the Web using wireless mobile devices.” Pet. 6 (citing Ex. 1002 ¶¶ 14–18). At this stage of the proceeding, Patent Owner “applies Petitioner’s characterization of a [person having ordinary skill in the art].” Prelim. Resp. 19 (citing Ex. 2001 ¶¶ 42–44). For purposes of this Decision, we adopt Petitioner’s formulation of a person having ordinary skill in the art, which is consistent with the invention claimed in the ’336 patent.10” slip op. at 10

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

      “Petitioner does not believe express claim construction is necessary at this time.” Pet. 8. Petitioner also discusses various claim construction arguments made in the district court proceeding. See id. at 28–29, 65. At this stage, Patent Owner agrees with Petitioner that “no express constructions are required,” and further agrees “that the ordinary and customary meanings of the claim terms apply.” Prelim. Resp. 19. For the purposes of this Decision, we need not expressly construe any claim terms.11 See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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

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

      “considered by the Office. See Prelim. Resp. 6–13; Ex. 1001, code (56). Further, we do not agree with Patent Owner that Miller is substantially the same as Agboatwalla. Specifically, Petitioner relies on Miller for being able to select different types of communication tools for a group: Miller discloses a number of web-based forms that allow the user to (among other things) specify a name and description for the environment (Fig. 13B) identify the members of the environment (Fig. 13C, 14A-C), and select the various communication features (e.g. bulletin board, etc.) that will be available for members (Fig. 16). (Miller, 0045:12-0046:27.) With respect to the selection of communications features, Miller discloses a user interface for allowing the user to select (from a list) the particular features that will be included in the collaborative environment. (Miller, Fig. 16, 0047:31-0048:9, 0042:29-32 (“The group creator selects from among these functions, preferably by way of an easy-to-use web browser interface, and these choices are stored in a database and associated with the group members.”).) These selections are then used in creating the environment or group. (Miller, 0043:3-6 (“In step 1104, the environment is created… to permit the group members to activate the functions selected for the group.”); EX1002, ¶104.) Pet. 19 (emphasis added).13 We have reviewed the section of Agboatwalla to which Patent Owner directs us (Ex. 2003, 2:32–50) and do not see substantially the same functionality. Although Agboatwalla describes a user being able to select what content may be viewed (see id.), Patent Owner does not direct us to, and we do not see, Miller’s teaching of selecting different types of communication pathways that may be selected for a group. Accordingly, Miller is not substantially the same as Agboatwalla. 13 References to Miller are to Petitioner’s pagination in the exhibit, for consistency with the Petition. Based on our consideration of Becton Dickinson factors (a), (b), and (d), we find that the same or substantially the same art or arguments were not previously presented to the Office. Thus, our analysis ends at this point, and we need not proceed to part two of the Advanced Bionics framework. See Advanced Bionics, IPR2019-01469, Paper 6 at 8. We therefore decline to exercise our discretion to deny institution based on 35 U.S.C. § 325(d).” slip op. at 15

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

      “Based on the current record, a person having ordinary skill in the art would have combined those teachings in the manner described above. See Ex. 1002 ¶¶ 105–108. Specifically, a person having ordinary skill in the art would have combined Miller’s ability to select communication channels with Neibauer’s Yahoo! Club in order “to enhance the flexibility and customizability of clubs in Neibauer.” Id. ¶ 107. This would allow the founder to eliminate certain features that “may not have been particularly useful or desirable for some clubs.” Id. Additionally, a person having ordinary skill in the art would have had a reasonable expectation of success. See id. ¶ 108.” slip op. at 26

    Claim constructionDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 8,793,336
  • PTAB · May 24, 2024 · IPR2023-00861 · APJ Christopher M Kaiser · IPR · Remand

    The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under any asserted ground.

    RulingsRemand decision
    • RemandOther

      “Accordingly, the Director instructed us to “determine whether Petitioner has demonstrated that Figure 1 of Godefroy ‘is clear on its face’ or would have reasonably suggested the placement of Godefroy’s sacrificial anode ‘within 10 inches’ of the hot liquid inlet.” Id. at 9. “In making this determination,” the Director instructed us to “consider whether the expert testimony provides sufficient ‘technical detail, explanation, or statements supporting why the expert determines that the feature in question was required or would have been obvious based on the prior art disclosure.’” Id. In addition, although the Director’s decision “is limited to [our] application of Hockerson to the grounds in the Petition involving Godefroy,” the Director instructed us also to “consider what effect, if any, this decision has on the other asserted grounds.” Id. Finally, the Director instructed us to “set forth [our] interpretation” of “the limitation ‘within 10 inches of a hot liquid inlet to the radiator.’” Id. at 8 n.4.” slip op. at 4

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

      “original decision, the Director’s decision, and the evidence currently of record, we determine that Petitioner has not shown a reasonable likelihood that it will prevail in showing that at least one of the challenged claims is unpatentable. Accordingly, we do not institute an inter partes review of any challenged claim based on any ground asserted in the Petition. IV. ORDER For the reasons given, it is: ORDERED that, pursuant to 35 U.S.C. § 314, the Petition is denied, and no inter partes review is instituted.” slip op. at 19

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

      “evidence. The challenged claims require that a sacrificial anode be placed within a certain distance—10 inches—of the hot liquid inlet, and, because the inlet has some non-zero size, it might be possible for an anode to be within that distance from some parts, but not from all parts, of the inlet. Accordingly, specifying the center axis of the inlet as the point from which to measure the distance to the anode improves on the plain words of the claim in terms of achieving the claim’s objective of placing the anode within a specified distance of the inlet. Moreover, when discussing the distance from the inlet to the anode, the specification of the ’494 patent uses the language “within 10 inches in any direction of the center axis of the inlet connection.” Ex. 1001, 7:61–64. Thus, the intrinsic evidence supports adopting Petitioner’s claim construction. Petitioner’s declarant, Dr. Medlin, relies on Petitioner’s proposed construction. See, e.g., Ex. 1004 ¶¶ 20 (noting that the construction “within 10 inches of the center axis of [a] hot liquid inlet” “ha[s] been adopted by Petitioner”), 96 (“the sacrificial anodes contained in each of the turbulators 2 would be placed within 10 inches of a center axis of a hot liquid inlet to the radiator of Tomosada”), 144 (“A POSITA would understand from Figure 1 that the sacrificial anode 14 is within 10 inches of a center axis of a hot liquid inlet”), 267 (“These teachings would further motivate a POSITA to located the sacrificial anode 12 within 10 inches of a center axis of the hot liquid inlet.”). This support for Petitioner’s proposed construction provides further reason for us to adopt it. Because it is supported by the intrinsic evidence of record, because Patent Owner proposes no alternative construction, and because Petitioner’s expert supports it, we adopt the construction of “within 10 inches of a hot liquid inlet to the radiator” that Petitioner proposes. Thus, we construe this term as “within 10 inches of the center axis of a hot liquid inlet to the radiator.” In other words, when discussing the distance between a hot liquid inlet and a sacrificial anode, we interpret “hot liquid inlet” as “center axis of the hot liquid inlet.”” slip op. at 5

    • BurdenNot shown unpatentable

      “Inherency may be relied upon in arguing either anticipation or obviousness. Schering, 339 F.3d at 1377 (applying inherency in an anticipation context); Par Pharma. Inc. v. TWI Pharma., Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014) (applying inherency in an obviousness context). In both cases, however, “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010). Instead, “the limitation at issue necessarily must be present, or the natural result of the combination of elements expressly disclosed by the prior art.” Par Pharma., 773 F.3d at 1195–96. Here, Petitioner has not shown sufficiently that, in Godefroy, the sacrificial anode necessarily is placed within 10 inches of the center axis of the hot liquid inlet. Dr. Medlin testifies that Figure 1 of Godefroy shows that “an entirety . . . or at least a significant portion of the sacrificial anode 14, is within 10 inches of a center axis of the inlet.” Ex. 1004 ¶ 144. But we cannot say that Figure 1 of Godefroy is clear on its face, or reasonably suggests, that this is necessarily the case. There are no dimensions shown on Figure 1, so it is unclear from the figure what the diameter of pipe 12 is. If that diameter is larger than 20 inches, then it simply is untrue that “sacrificial anode 14 is . . . necessarily placed within 10 inches of a center axis of a hot liquid inlet to the radiator,” as Dr. Medlin testifies. Id. ¶ 361. As noted above, neither Petitioner nor Dr. Medlin relies on the hot liquid inlet of Godefroy having any particular diameter, and Godefroy is silent as to the diameter of its inlet. Pet. 69–70; Ex. 1004 ¶¶ 144, 359–361, 381–382, 406–408; Ex. 1008, 1–15. Moreover, as Patent Owner notes, there is a wide range of sizes of radiators, including automobile radiators, available. Prelim. Resp. 3–5; Exs. 2001–2003. In the absence of any testimony or other evidence that tends to show that radiator inlet pipes necessarily have diameters less than 20 inches, Petitioner has not shown sufficiently that the diameter of Godefroy’s inlet pipe is small enough to ensure that any portion of the anode necessarily is within 10 inches of the center axis of the inlet.” slip op. at 11

    Claim constructioncites Phillips
  • PTAB · Mar 26, 2024 · IPR2023-01424 · APJ Donna M Praiss · IPR · Institution

    The Board instituted IPR on claims 1–16 and 18–20, finding a reasonable likelihood of prevailing on the asserted grounds, including anticipation by Ueda and obviousness over Plante and Cho.

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

      “unless the information presented in the petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any argument not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at 1 Petitioner identifies itself as the real party in interest. Pet. 1. In addition, Petitioner notes that Spectrum Holdco LLC is its parent company and that Spectrum Holdco LLC and Spectrum Intermediate LLC “have a financial interest in, or could be substantially affected by the outcome of, this proceeding.” Id. 2 Patent Owner identifies itself as the real party in interest and notes that it is a wholly owned subsidiary of OraSure Technologies, Inc. Paper 4, 2. least one claim. We hereby institute an inter partes review as to claims 1–16 and 18–20 of the ’632 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “We decline to exercise our discretion here. As pointed out by Petitioner, the same or substantially the same art or arguments were not previously presented with respect to the ’632 patent. Pet. 123–24. Petitioner challenges the ’632 patent on grounds that were not asserted against the ’646 patent, namely the grounds based on Ueda. Id. at 71–123. In addition, we found Petitioner’s arguments based on Plante sufficiently persuasive and determined that the challenged ’646 patent claims are unpatentable. IPR2022-01347, Paper 43 (Feb. 7, 2024). For these reasons, we do not exercise our discretion to deny institution.” slip op. at 16

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(POSITA) “would have had at least a bachelor’s degree in mechanical engineering, biomedical engineering, or similar technical degree and at least 3 years of experience in the medical device industry, including experience with containers and valves used in disposable medical devices.” Pet. 8 (citing Ex. 1002 ¶¶ 51–52). Petitioner further asserts that such a person would have collaborated with a team member with training and experience in the biological aspects of the invention and education and experience relating to the collection of biological samples. Id. (citing Ex. 1002 ¶¶ 51– 52). Patent Owner does not offer an alternative definition of a person of ordinary skill in the art at this time. See generally Prelim. Resp. Accordingly, for the purposes of this Decision, we adopt Petitioner’s proposal regarding the level of one of ordinary skill in the art.” slip op. at 10

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

      “We determine that it is not necessary for us to construe “biological sample” or “annular valve” at this stage of the proceeding because neither party contends that construing either term is material to deciding whether to institute a trial on the asserted grounds in the Petition. See 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

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,536,632
  • PTAB · Mar 13, 2024 · IPR2023-01206 · APJ Elizabeth M Roesel · IPR · Institution

    The Board instituted IPR on claims 1, 2, and 4–23 based on three obviousness challenges involving Fugitt and the listed papermaking references.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “We agree with Patent Owner that Papermaking is cumulative to Mohan. Petitioner relies on Papermaking to teach claim 1’s recitation that “a contact surface of said thermo-roller is heated to an elevated temperature of at least 250°F.” Pet. 32–34. Mohan discloses hot hard calendering of paper and paperboard to improve smoothness, where calender rolls have “a roll surface temperature of 250–400°F. during calendering of the web.” Ex. 2002, 1:7–10, 4:46–57.” slip op. at 14

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

      “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2023). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Institution of inter partes review is discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). For the reasons discussed below, the facts do not warrant exercise of discretion to deny institution, and the reasonable likelihood standard is met. We, therefore, grant institution of an inter partes review.” slip op. at 2

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed petitioner constructionDecided for petitioner

      “Patent Owner is correct that the ’142 Patent does not mention heating a counter-roller of a hot-hard calender, and the surface temperature of the counter-roller is not discussed. Prelim. Resp. 12. But nowhere does the ’142 Patent suggest that the counter-roller should not be heated to an elevated temperature. Under the applicable legal standard, the’142 Patent’s silence about whether the counter-roller is heated is not enough to justify reading a negative limitation into the claim. “negative limitation.” Ethicon LLC v. Intuitive Surgical, Inc., 847 Fed. App’x 901, 907 (Fed. Cir. Mar. 15, 2021). “[S]uch exclusions must find support either in ‘the words of the claim’ or through an ‘express disclaimer or independent lexicography in the written description that would justify adding that negative limitation.’” Id. (citing Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366–67 (Fed. Cir. 2002)). “The standards for finding lexicography and disavowal are exacting.” GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1309 (Fed. Cir. 2014). “To act as its own lexicographer, a patentee must ‘clearly set forth a definition of the disputed claim term,’ and ‘clearly express an intent to define the term.’” Id. (citing Thorner, 669 F.3d at 1365). Similarly, disclaimer or disavowal requires that the specification or prosecution history demonstrate that the invention does not include a particular feature. Id. Here, Patent Owner does not point to any claim language, lexicography, or disclaimer in the ’142 Patent or its file history that would support defining a “hot-hard calender” as requiring that only one of the two rollers be heated to an elevated temperature.” slip op. at 20

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

      “As we understand it, one theory of obviousness advanced by Petitioner is combining Fugitt’s teaching that “[t]he rolls of the calender may be steam heated” with Papermaking’s teaching about the surface temperature that can be obtained when using steam to heat the rolls. Pet. 32–33; temperature of Fugitt’s steam-heated rollers in order to achieve a contact surface temperature of at least 250°F, as recited in claim 1. Instead, we understand Petitioner to be relying on Papermaking to teach the temperature of the unmodified rollers of Fugitt. Under this theory, it was not necessary for Petitioner to show that the paperboard substrate properties disclosed in Fugitt would still be achieved after increasing the temperature. Nevertheless, the Petition also relies on Papermaking’s teaching of temperatures that exceed the upper limit for steam-heated rolls, e.g., “[h]igh thermo roll temperatures (in some cases over 200°C [392°F]” or oil-heated rollers having surface that “can reach over 220°C [428°F].” Pet. 33 (citing Ex. 1005, 82; Ex. 1010, 98). Patent Owner is correct that Petitioner relies on Fugitt’s disclosure of paperboard properties (smoothness and basis weight Y2 as a function of caliper thickness) obtained without modifying the roller surface temperature. Pet. 35–36; Prelim. Resp. 44. There is a factual issue as to whether a person of ordinary skill in the art would have expected to achieve the paperboard properties disclosed in Fugitt and recited in claim 1, if the roller temperature were increased above the level achievable by steamheated rolls. There is also a factual issue as to whether Patent Owner’s evidence of increased energy cost would outweigh Petitioner’s asserted benefits of increased temperature. These issues are best resolved after the parties have had to the opportunity to develop the record and cross-examine the opposing experts. See Arctic Cat Inc. v. Polaris Indus., Inc., 795 F. App’x 827, 833 (Fed. Cir. 2019) (“The Board must weigh the benefits and drawbacks of the modification against each other, to determine whether there would be a motivation to combine.”).” slip op. at 25

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,293,142
  • PTAB · Mar 12, 2024 · IPR2023-01349 · APJ Christopher M Kaiser · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable on the asserted obviousness grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2023). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons set forth below, we determine the information presented in the Petition does not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. Accordingly, we do not institute an inter partes review of any claim on any ground asserted in the Petition.” slip op. at 2

    • BurdenDenied

      “Given this, to show that Blangero’s disclosure of MgO or LiF in its coating teaches or suggests a rock-salt crystal structure, Petitioner needs to explain why a person of ordinary skill in the art either would have understood the compounds to have a rock-salt crystal structure when manufactured according to the disclosure of Blangero or would have chosen to use MgO or LiF in a rock-salt crystal structure rather than in another available form. On the first point, Petitioner argues that “‘the stable phase at room temperature and pressure conditions’ of MgO is ‘a rocksalt cubic structure of NaCl (space group Fm-3m).’” Pet. 28 (quoting Ex. 1030, 16; citing Ex. 1003 ¶ 142). But, as Petitioner’s declarant, Dr. Hayes, points out, Blangero does not teach forming MgO in a room-temperature process. Ex. 1003 ¶ 142 (Blangero’s “second firing step” occurs at “925 °C for 12 hours”); see Ex. 1005 ¶ 110 (teaching the firing step to which Dr. Hayes refers). Thus, the significance of rock-salt-type MgO being “the stable phase at room temperature and pressure conditions” is unclear. To the extent that Dr. Hayes explains why MgO, which “is well known to crystallize even at substantially lower temperatures,” such as “room temperature and pressure conditions,” would “do so more readily at [a higher temperature of] 925 °C,” this argument is not discussed, nor even cited, in the Petition. Ex. 1003 ¶¶ 90–94; see Pet. 28. Accordingly, any reliance on this argument by Petitioner constitutes improper incorporation by reference. 37 C.F.R. § 42.6(a)(3). Thus, Petitioner does not show sufficiently that a person of ordinary skill in the art either would have understood MgO to have a rock-salt crystal structure when manufactured according to the disclosure of Blangero or would have chosen to use MgO in a rock-salt crystal structure rather than in another available form. Similarly, with respect to LiF, neither Petitioner nor Dr. Hayes sufficiently explains the choice of rock-salt-type material over other options. Pet. 29 (arguing only that Ex. 1013 shows that “LiF has rock salt structure”); Ex. 1003 ¶ 143 (same). Thus, Petitioner does not show sufficiently that Blangero teaches or suggests a rock-salt crystal structure by virtue of its teaching that either MgO or LiF is present.” slip op. at 12

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not found

      “The 2012 study on which Petitioner relies did not find “superior structural stability” over other lithium-titanium-oxygen compounds, as Petitioner argues. Instead, the study noted that the structure of “LiTiO2 prepared by high-temperature sintering TiO2 with lithium salt . . . impl[ies] LiTiO2 has superior structural stability in organic electrolyte as compared to other Li-Ti-O oxides.” Ex. 1029, 1. Thus, the structural stability was implied from the chemical structure of the material rather than found through study of the material. Moreover, the implied structural stability was only for LiTiO2 that was prepared in a particular way, by high-temperature sintering of TiO2 with lithium salt, and Petitioner does not allege that a person of ordinary skill in the art would have prepared the LiTiO2 they substituted for Blangero’s Li2TiO3 using this method. As for Petitioner’s argument that the study found that LiTiO2 outperformed Li2TiO3, we are not persuaded. The study compared particles with an LiTiO2 coating to uncoated particles, not to particles coated with Li2TiO3. Ex. 1029, 4, Figs. 4(c), 4(d). Although the study notes that particles coated with “[m]onoclinic Li2TiO3 and spinel Li4Ti5O12” exhibit “a noticeable capacity decay . . . when charged at high operating voltage and cycled above room temperature,” it concludes only that particles coated with LiTiO2 “exhibited inspiring high-voltage cycling capability as well as thermal stability than the pristine counterpart.” Id. at 1, 4. In addition, the pristine particles used in the study were made from “Li[NixCoyMnz]O2 (0≤x,y,z<1) (called as LNCM),” and the particles in Blangero do not contain either nickel or manganese in their cores. Ex. 1005 ¶¶ 9–40 (particles contain lithium, oxygen, cobalt, and metals chosen from the group consisting of aluminum, gallium, boron, magnesium, titanium, iron, copper, calcium, barium, yttrium, tin, antimony, sodium, zinc, zirconium, silicon); Ex. 1029, 1. Petitioner does not explain why a person of ordinary skill in the art would expect the study’s results to extend to Blangero’s particles made from a different material. Pet. 29–30. Because Petitioner has not shown sufficiently that Blangero teaches or suggests a second region comprising a rock-salt crystal structure or that a person of ordinary skill in the art would have had a reason to substitute rocksalt-type LiTiO2 for the materials disclosed in Blangero, Petitioner has not shown a reasonable likelihood that it would prevail on claim 1 on its Blangero-based grounds.” slip op. at 15

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner, “[i]ndividuals with different education and additional experience could still [have been] of ordinary skill in the art if that additional experience compensate[d] for a deficit in their education and experience.” Id. On the present record, Patent Owner does not contest Petitioner’s definition of a person of ordinary skill in the art. Prelim. Resp. 19. In light of the record before us, and for purposes of this Decision, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’660 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’660 patent and the prior art. 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)).” slip op. at 8

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,043,660
  • PTAB · Feb 23, 2024 · IPR2023-01350 · APJ Jon B Tornquist · IPR · Institution

    The Board instituted inter partes review of claims 5–14 on all four asserted obviousness grounds, finding a reasonable likelihood that Apple would prevail on at least one challenged claim.

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

      “An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that the information presented in the Petition demonstrates a reasonable likelihood that Petitioner would prevail on at least one of the challenged claims of the ’641 patent. Accordingly, we institute an inter partes review as to all the challenged claims of the ’641 patent on all the grounds of unpatentability set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends a person of ordinary skill in the art, as of the earliest possible priority date for the ’641 patent, “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. Patent Owner does not dispute Petitioner’s definition, “except noting that other majors may provide equivalent education and experience designing, testing, and building lithium-ion batteries.” Prelim. Resp. 14. 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 for purposes of this Decision. The parties may further address at trial whether “other majors” should be added to this definition, and whether such a modification would have any impact on the unpatentability analysis in this case.” slip op. at 6

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

      “Neither party contends any terms of the ’641 patent require express construction. Pet. 4–5; Prelim. Resp. 13–14. And, for purposes of this decision, we agree that no claim terms require express construction. 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 7

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

      “This argument is not persuasive. Contrary to Patent Owner’s arguments, the Federal Circuit has held that “generic” reasons to combine are not inherently suspect, and may reasonably include a desire to make a device “stronger, cheaper, cleaner, faster, lighter, smaller, more durable or more efficient.” See Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021) (quoting DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006)). Regardless, Petitioner’s asserted reasons to combine are specific (improved safety and less deterioration after repeated charging and discharging cycles), as is the proposed combination (implementing Sakamoto’s range of ratios for the positive and negative electrode materials in Yamaki’s lithium ion battery). Pet. 9–12. Identification of specific benefits that are tied to specific elements of specific prior art references is sufficient to support an obviousness ground. See Intel, 21 F.4th at 797.” slip op. at 11

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 7,749,641
  • PTAB · Feb 7, 2024 · IPR2022-01347 · APJ Donna M Praiss · IPR · Final written decision

    Claims 1, 3–8, 11, and 12 are unpatentable as obvious over each of four grounds: Plante and Cho, with or without Maples, and Plante and Patterson, with or without Maples.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(POSITA or POSA) “would have had at least a Bachelor’s degree in mechanical engineering, biomedical engineering, or similar technical degree and at least 3 years of experience in the medical device industry, including experience with containers and valves used in disposable medical devices.” Pet. 16 (citing Ex. 1002 ¶ 49). Petitioner further asserts that such a person would have collaborated with a team member with training and experience in the chemical/biological aspects of the invention, having a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline and “at least two years of post-graduate experience in the area of biological sample preservation and nucleic acid extraction, preservation, and analysis.” Id. at 16–17 (citing Ex. 1011 ¶¶ 24–26). Patent Owner does not dispute using Petitioner’s proposed definition. PO Resp. 6.8 We apply Petitioner’s proposed definition because it is consistent with the problems addressed in the ’646 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings on 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, 162 (Fed. Cir. 1985))).” slip op. at 9

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

      “Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). “In general, a preamble limits the invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Id. (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). “Conversely, a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). The court in Catalina noted that although no litmus test exists for determining whether to treat a preamble as a limitation, several “guideposts” have emerged from the case law in this area. Id. In particular, guideposts tending to show that the preamble is a claim limitation include: Jepson claiming, dependence on a particular disputed preamble phrase for antecedent basis, when the preamble is essential to understand limitations or terms in the claim body, and when the preamble recites additional structure or steps underscored as important by the specification. Id. On the other hand, the preamble might not constitute a claim limitation when the claim body describes such a structurally complete invention that deleting the preamble phrase does not affect the structure or steps of the claimed invention. Id. at 809. Also, “preambles describing the use of an invention generally do not limit claims because the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of the structure.” Id.” slip op. at 13

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

      “the claim must be given their plain meaning unless the plain meaning is inconsistent with the Specification. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). Additionally, ordinary, simple English words whose meaning is clear and unquestionable are to be construed to mean exactly what they say–– absent, of course, any indication that their use in a particular context changes their meaning. Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1372 (Fed. Cir. 2004). The abstract of the ’646 patent describes isolating and preserving cells from bodily fluids “for cellular analysis” and “genomic studies.” Ex. 1001, code (57). In the field of the disclosure portion of the ’646 patent, cells isolated from bodily fluids are preserved “for studies in any of: functional genomic and epigenetic studies, and biomarker discovery.” Id. at 1:25–29. In the background section, the ’646 patent describes the interest in “large-scale epigenetic research” for the purpose of “understanding the mechanisms of gene-environment interactions” suggesting that “epigenetic mechanisms may provide a molecular memory of environmental experiences.” Id. at 1:60–67. The background section further describes the challenges of collecting bodily fluids, such as saliva, is that it is a digestive fluid that can be rich in proteases and that existing solutions used to stabilize cells from blood, which is a transporter fluid, “will not protect cells from proteases found in some bodily fluids, such as saliva.” Id. at 3:24–36, 4:43–47. The detailed description section of the ’646 patent discloses “a solution for preserving cells in one or more bodily fluids, such as saliva and urine” that “may be beneficial for further separation into cell types and downstream molecular analysis” and “allows for storage of cells in the bodily fluid to retain their antigenicity and cellular architecture.” Id. at 16:9–15. The Specification describes some embodiments of solutions for preserving cells in one or more bodily fluids where the solutions contain a chemical fixing agent, a protease inhibitor, an antimicrobial agent, serum proteins, and are buffered to preferred pH ranges. Id. at 16:15–22. Thus, the plain meaning of “preserving a biological sample,” consistent with the ’646 patent disclosure focused on maintaining the architecture of cells contained in a bodily fluid that may include digestive proteases for further study downstream, is “preserving the integrity of a cell contained in a bodily fluid sample.”” slip op. at 15

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

      “We agree that it is not necessary for us to construe these claim terms because neither party asserts that they are material to the asserted grounds in the Petition. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 18

    Patent outcomesUS 11,002,646 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,002,646

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.