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  • PTAB · Jun 12, 2025 · DER2023-00006 · APJ John E Schneider · DER · Rehearing

    The Board denied Manitowoc’s rehearing request, declining new evidence and finding no overlooked or misapprehended argument supporting institution of a derivation proceeding.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “As set forth in our rules, a request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and where each matter was previously addressed.” 37 C.F.R. §42.71(d). A request for rehearing may not include new evidence absent a showing of good cause why the evidence was not presented earlier. Huawei Device Co., Ltd. v. Optis Cellular Tech., LLC, Case IPR2018-00816, slip op. at 4 (PTAB Jan. 8, 2019) (Paper 19) (precedential). Such evidence includes declarations, and timely declarations must be filed in the form of an exhibit. 37 C.F.R. § 42.63(a). As Petitioner’s Request does not comply with our rules, we deny the Request.” slip op. at 2

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Turning to the Request, it too is deficient. A Request for Rehearing must include specific identification of matters which the requesting party believes the Board overlooked or misapprehended. 37 C.F.R. § 42.71(d). A Request for Rehearing is not an opportunity to present new arguments. Moreover, Petitioner has not shown that we misapprehended or overlooked any particular matters in the Petition.” slip op. at 3

    None
  • PTAB · Apr 18, 2025 · DER2023-00006 · APJ John E Schneider · DER · Institution

    The Board denied institution of a derivation proceeding because Manitowoc did not show that all elements of amended claim 1 were conceived and communicated to Gate CFV Solutions.

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

      “invention and communicated that invention to Respondent prior to July 22, 2021, the filing date of Respondent’s ’693 application. See Pet. 6–10. Of great importance here, however, are the requirements noted above, that Petitioner must show: (1) that Petitioner has at least one claim that is the same or substantially the same as Respondent’s claimed invention; (2) that Petitioner has at least one claim that is the same or substantially the same as the invention Petitioner disclosed to Respondent; and (3) that the challenged claims are drawn to the same or substantially the same invention as the invention Petitioner disclosed to Respondent. See 37 C.F.R. § 42.405(a)(2), 37 C.F.R. § 42.405(b)(3). For the reasons discussed below, Petitioner has not made the requisite showing in the Petition with respect to at least item (2).” slip op. at 9

    None
  • PTAB · Oct 8, 2021 · IPR2020-00770 · APJ John E Schneider · IPR · Final written decision

    Claims 1–5, 8, and 9 are unpatentable as obvious over Moriarty and Phares; claims 6 and 7 were not shown unpatentable over either asserted ground.

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

      “Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). Here, we do not need to define the outer bounds of the term “pharmaceutical batch” because the parties’ dispute over this term centers on the issue of storage stability.7 Patent Owner argues “the correct construction 6 The parties use the terms “purification” and “isolation” interchangeably in the papers. We use the term “isolation” in this Decision. 7 The parties agree on the “pharmaceutical” aspect of the term. We note the ’901 patent defines “pharmaceutically acceptable” as “being useful in preparing a pharmaceutical composition that is generally safe, non-toxic and neither biologically nor otherwise undesirable and includes being useful for veterinary use as well as human pharmaceutical use.” Ex. 1001, 5:27–31.” slip op. at 19

    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner

      “[A]n invention is construed not only in the light of the claims, but also with reference to the file wrapper or prosecution history in the Patent Office.” Graham, 383 U.S. 1, 33. “The prosecution history of a related patent can be relevant if . . . it addresses a limitation in common with the patent in suit.” Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294, 1305 (Fed. Cir. 2001); see also Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed. Cir. 1999) (“When multiple patents derive from the same initial application, the prosecution history regarding a claim limitation in any patent that has issued applies with equal force to subsequently issued patents that contain the same claim limitation.”). Here, the Specification of the ’901 patent includes the same language “crude treprostinil salts can be stored as raw material at ambient temperature” addressed in the prosecution of the parent ’623 application. Ex. 1001, 17:5–6. More importantly, challenged claim 6 recites the same limitation “preparing a pharmaceutical product . . . after storage” the applicant expressly interpreted there. See Ex. 2028, 193. Because “the same claim limitation is at issue, prosecution disclaimer made on the same limitation in an ancestor application will attach,” the applicant’s interpretation of “storing”/“storage” during the prosecution of the ’623 application applies here. See Omega Eng’g, Inc., v. Raytek Corp., 334 F.3d 1314, 1333 (Fed. Cir. 2003). slip op. at 23

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

      “Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1276 (Fed. Cir. 2013). Here, step (c) of challenged claim 1 requires “contacting the solution comprising treprostinil from step (b) with a base to form a salt of treprostinil.” Ex. 1001, 17:27–29 (emphasis added). The claim language itself, thus, dictates that the solution formed in step (b), and not treprostinil isolated from step (b), is the starting material for forming a salt in step (c). The Specification of the ’901 patent supports our determination. Indeed, the Specification touts that one of the advantages of the disclosed process is that “the treprostinil salts can be synthesized from the solution of treprostinil without isolation,” because “[t]he impurities carried over from intermediate steps (i.e. alkylation of triol and hydrolysis of benzindene nitrile) are removed during the carbon treatment and the salt formation step.” Ex. 1001, 17:1–11. As a result, we agree with the argument presented in the Patent Owner Response that “claim 1 requires the solution in which treprostinil is formed be used directly in the next salt-forming step without isolating treprostinil in between.” See PO Resp. 11.” slip op. at 27

    • Skill levelSkill level board ownOther

      “pharmaceutical manufacturing.” Id. at 23. We find Patent Owner’s definition of the skill level too narrow. Patent Owner relies on the declaration of Dr. Pinal, who testifies that the ’901 patent is “focused on the production of pharmaceutical compositions and products, on a commercial batch-size scale.” Ex. 2002 ¶ 91; see also id. ¶ 92 (opining that organic and medicinal chemists do not have the “requisite skill set for the large-scale manufacture” of drugs); PO Resp. 24 (arguing an ordinarily skilled artisan is aware of “problems encountered in preparing a commercial-scale pharmaceutical product”).” slip op. at 29

    Patent outcomesUS 9,604,901 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,604,901
  • Eis GmbH v. Novoluto GmbHNo claims unpatentable
    PTAB · Sep 23, 2021 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Final written decision

    Claims 1–3, 5, 7, 8, 11, 14, 15, and 17–26 were not shown unpatentable under the Taylor anticipation or Taylor-based obviousness grounds.

    RulingsFinal written decision
    • Expert testimonyPatent owner expert creditedDenied

      “disclosure of a suction cup “sealingly” receiving the vulva occurs when the vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . . and then expands bellows 160’ after member 156 ‘sealingly’ engages the vulva.” Reply 9. The single statement in Taylor on which Petitioner relies states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he first stimulator 154 includes a suction cup member 156 that conformingly and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31. We agree with Dr. Jensen that this does not support Petitioner’s conclusion that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s testimony that reads as follows as consistent with Taylor’s disclosure.” slip op. at 35

    • ExcludeMotion to exclude, deniedDenied

      “5. Conclusion For the reasons set forth above, we deny the portion of Petitioner’s” slip op. at 73

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

      “7 Petitioner presents argument that the term “pressure field generator” should be construed as a means-plus-function term limited to the following structure: at least one first chamber, at least one second chamber, and at least one connection element. Reply 25–26. As we find that it is not necessary to construe this term to resolve the issues before us, we do not address these arguments presented by Petitioner.” slip op. at 17

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

      “disclosure of a suction cup “sealingly” receiving the vulva occurs when the vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . . and then expands bellows 160’ after member 156 ‘sealingly’ engages the vulva.” Reply 9. The single statement in Taylor on which Petitioner relies states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he first stimulator 154 includes a suction cup member 156 that conformingly and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31. We agree with Dr. Jensen that this does not support Petitioner’s conclusion that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s testimony that reads as follows as consistent with Taylor’s disclosure.” slip op. at 35

    Patent outcomesUS 9,849,061 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,849,061
  • PTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing

    The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

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

      “Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable

      “These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5

    • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

      “the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7

    Claim construction§ 112 disclosure
    Patents in suitUS 10,155,039
  • PTAB · Oct 1, 2020 · IPR2018-00295 · APJ John E Schneider · IPR · Rehearing

    The Board denied Patent Owner’s rehearing request and left in place its finding that proposed substitute claims 49–56 were unpatentable over the cited combinations including Randolph.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. LEGAL STANDARD A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). The burden of showing a decision should be modified on a request for rehearing lies with the party challenging the decision. Id.” slip op. at 4

    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

      “We next turn to the guidance the POP provided in Hunting Titan. First, the POP held that “the Board may, in certain rare circumstances, raise a ground of unpatentability that a petitioner did not advance, or insufficiently developed, against substitute claims proposed in a motion to amend.” Id. at 4. The rare circumstances exemplified in the decision include cases where the petitioner has ceased to participate in the proceeding; where the petitioner has not opposed the motion to amend; or “where certain evidence of unpatentability has not been raised by the petitioner, but is readily identifiable and persuasive such that the Board should take it up in the interest of supporting the integrity of the patent system, notwithstanding the adversarial nature of the proceedings.” Id. at 12–13. The POP also held that where the Board intends to raise a new ground of unpatentability in connection with a motion to amend, the patent owner must be given notice and an opportunity to address the proposed new grounds. Id. 15.” slip op. at 6

    • Strike new argumentNew argument consideredDecided for petitioner

      “We next turn to the guidance the POP provided in Hunting Titan. First, the POP held that “the Board may, in certain rare circumstances, raise a ground of unpatentability that a petitioner did not advance, or insufficiently developed, against substitute claims proposed in a motion to amend.” Id. at 4. The rare circumstances exemplified in the decision include cases where the petitioner has ceased to participate in the proceeding; where the petitioner has not opposed the motion to amend; or “where certain evidence of unpatentability has not been raised by the petitioner, but is readily identifiable and persuasive such that the Board should take it up in the interest of supporting the integrity of the patent system, notwithstanding the adversarial nature of the proceedings.” Id. at 12–13. The POP also held that where the Board intends to raise a new ground of unpatentability in connection with a motion to amend, the patent owner must be given notice and an opportunity to address the proposed new grounds. Id. 15.” slip op. at 6

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundTeaching away not foundDecided for petitioner

      “We are not persuaded that our Decision was in error. As Petitioner points out, Dr. Tallon testified about the motivation to combine the various references. Supp. Resp. 7–8. Specifically, Dr. Tallon testified that astaxanthin was a known “potent antioxidant,” and that a person of ordinary skill in the art would have been motivated to combine krill oil of the cited references because of the health benefits associated with, inter alia, see also MTA Opp. 24–25 (Petitioner’s argument as to motivation to combine). With respect to the amount of astaxanthin ester, we are not convinced that Randolph teaches away from the claimed range. While Randolph does teach that the amount of astaxanthin may be 1% or greater, in the same paragraph Randolph states that the amount of astaxanthin is typically from about 0.5 mg to 50 mg. Ex. 1011 ¶ 44. Thus, while Randolph may teach high amounts of astaxanthin, it also teaches lower amounts that yield astaxanthin ester amounts within the range recited in the proposed substitute claims. Similarly, other teachings in the art do not dissuade one skilled in the art from using lower amounts of astaxanthin ester. A reference does not teach away “if it merely expresses a general preference for an alternative invention but [does] not criticize, discredit or otherwise discourage investigation into the claimed invention.” Depuy Spine v. Medtronic Sofmaor, 567 F.3d 1314, 1327 (Fed. Cir. 2009). Patent Owner has not pointed to nor have we discerned any teaching in the art that would dissuade one skilled in the art from using a lower amount of astaxanthin ester. As discussed above, Randolph specifically teaches lower amounts of astaxanthin, which in turn teaches lower amounts of astaxanthin ester. Ex. 1011 ¶ 44; Ex. 1086 ¶¶ 199–202.” slip op. at 18

    § 103 obviousness
    Patents in suitUS 9,320,765
  • Eis GmbH v. Novoluto GmbHRehearing granted
    PTAB · Sep 25, 2020 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Rehearing

    Granted EIS GMBH’s rehearing request and instituted IPR of claims 1–3, 5, 7, 8, 11, 14, 15, 17–21, and 23–26 on all asserted grounds.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

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

      “We conclude from a review of Fang and Taylor that they are not substantially the same art nor is Petitioner making substantially the same argument as was presented the Office during prosecution of the ’061 Patent based on Fang. We find that the way in which Fang and Taylor work appear to be materially different. Fang appears to apply only suction to the skin whereas Taylor, with the sealingly connected suction cup, appears to apply a cyclical vacuum that Dr. Prisco testifies meets the claim limitations requiring generation of a pattern of negative and positive pressures, modulated with respect to a reference pressure. Ex. 1002 ¶¶ 62–64, 75. Thus Taylor appears to teach the claim element Patent Owner argued during prosecution was missing from Fang. Also, in applying factors (b) and (d) of Becton, Dickinson, because of such differences noted above, we find that Taylor is not cumulative of Fang, which was considered and applied by the Office during prosecution of the ’061 Patent. 4. Conclusion Thus, we find that Taylor and Fang are not substantially the same art, nor were substantially the same arguments based on these references presented in the Petition and during prosecution of the ’061 Patent, respectively. As discussed above, because Petitioner primarily relies on Taylor in all four grounds for teaching the modulation of positive and negative pressures with respect to a reference pressure as required by all of the challenged claims, we also find that, overall, the same or substantially the same art was not previously presented to the Office nor were the same or substantially the same arguments previously presented to the Office. Therefore, we do not need to reach the application of the remaining Becton, Dickenson factors relating to whether the Petitioner has demonstrated a material error by the Office. Thus, we decline to exercise our discretion under § 325(d) to deny institution of an inter partes review here.” slip op. at 12

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

      “how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

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

      “We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
    Patents in suitUS 9,849,061
  • Eis GmbH v. Novoluto GmbHRehearing granted
    PTAB · Jun 17, 2020 · IPR2019-01302 · APJ John E Schneider · IPR · Rehearing

    Granted rehearing and instituted inter partes review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Guan, Lee, and Hovland.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs if the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision.” Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015). With this in mind, we address the arguments presented by Petitioner in turn.” slip op. at 3

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

      “Request for Rehearing and conclude there are genuine issues of material fact about the teachings of Guan that warrant institution and resolution at trial.” slip op. at 2

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

      “Patent Owner contends that Guan is non-analogous art in that it is not related to stimulation of the clitoris. Prelim. Resp. 59. Patent Owner also contends that there is no motivation to combine the teachings of Lee and Guan. Id. at 60–63. Patent Owner argues that one skilled in the art would not consider using the indirect stimulator of Guan in the dildo of Lee as it would require a modification of Lee beyond a simple substitution of elements. Id.” slip op. at 5

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

      “Petitioner has also provided a reasonable motivation to combine the teachings of Lee and Guan. Lee comprises a dildo with an extension which directly stimulates the clitoris, a body part. Ex. 1006, Fig. 1; Ex. 1002, ¶¶ 72, 134–137. Guan discloses an apparatus, which indirectly stimulates a body part. Ex. 1007, 3; Ex. 1002 ¶ 137. Given the teaching in the art of the problems with direct stimulation versus indirect stimulation, we agree on this record with Dr. Prisco that one skilled in the art would have had a reason to substitute the indirect stimulation device of Guan for the direct intensive and is best decided on a full record. Cf. Monark Knitting Mach, Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 886 (Fed. Cir. 1998) (determining that issues of fact concerning secondary considerations precluded grant of summary judgment) reasonable expectation of success. Ex. 1002 ¶¶ 132–137.” slip op. at 6

    § 103 obviousness
    Patents in suitUS 9,937,097
  • PTAB · Mar 6, 2020 · IPR2018-01730 · APJ John E Schneider · IPR · Final written decision

    Claims 1–20 are unpatentable across the stated anticipation and obviousness grounds; the contingent motion to amend with substitute claims 21–29 is denied because those claims are obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “At institution, we preliminarily adopted Petitioner’s definition of an ordinarily skilled artisan, and determined that the prior art itself was sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. Inst. Dec. 8. We note that Patent Owner states that it “accepts [Petitioner’s] definition of a POSITA.” PO Resp. 15. Accordingly, for this Decision, we adopt Petitioner’s definition, while maintaining that the prior art demonstrates the appropriate level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art). Moreover, we have reviewed the credentials of Drs. Tallon and Hoem, and consider each of them to be qualified to provide their opinion on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention.” slip op. at 10

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

      “Such broadening usages as ‘about’ must be given reasonable scope; they must be viewed by the decision maker as they would be understood by persons experienced in the field of the invention. Although it is rarely feasible to attach a precise limit to ‘about,’ the usage can usually be understood in light of the technology embodied in the invention.” Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996). After considering the parties’ arguments and reviewing the Specification of the ’765 patent, we conclude that Petitioner’s proposed construction is consistent with the intrinsic evidence. Although the ’765 patent does not explicitly address the issue of “about,” the meaning of the term can be discerned from a careful reading of the Specification. Example 8 of the ’765 patent reports the analysis of phospholipid available Krill product. Ex. 1001, col. 31, l, 46–col. 32, l. 42. Table 22, reproduced above, reports the calculated values for the various phospholipids in values to a tenth of a percent. Id. at col. 32, ll. 18–38. In the discussion of the table, the values are rounded to the nearest whole number, not the nearest tenth. Id. at col. 32, ll. 11–15. This is consistent with the approach advanced by Petitioner. IPR2018-00295, Paper 35, 12.3 Similarly here, we find that although the Specification does not explicitly define the term “about,” its meaning may be discerned from the manner by which the Specification refers to reported values for phospholipid profiles of krill oil. Ex. 1001, 32:18–44 (Table 22). In the discussion of the lipids reported in Table 22, the values are rounded to the nearest whole number, not the nearest tenth. Id. at 32:47–52. This is more consistent with the approach advanced by Petitioner than by Patent Owner. Thus, as determined in that Final Written Decision, and for the reasons set forth therein, “the term ‘greater than about 5% w/w’ shall be construed to mean ‘greater than 4.5% w/w.’” IPR2018-00295, Paper 35, 13.” slip op. at 12

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

      “We have considered the arguments of the parties and the evidence of record and conclude that claims 5 and 6 are not anticipated by Catchpole. While we agree with Petitioner that Catchpole teaches compositions that can Catchpole discloses a krill oil composition having that amount of acylalkyphospholipids. Catchpole teaches a method of separating lipid materials from a feed material. Ex. 1009, 4. The feed material used in Catchpole may be derived from “terrestrial animals, marine animals, terrestrial plants, marine plants, or micro-organisms such as microalgae, yeast and bacteria. Preferably the feed material is derived from sheep, goat, pig, mouse, water buffalo, camel, yak, horse, donkey, llama, bovine or human.” Id. at 7. Catchpole does not specifically disclose a Krill extract that contains greater than 10% acylalkyphospholipids. The only specific disclosure of the acylalkyphospholipid content of krill oil is in Table 16 discussed above, which discloses an acylalkyphospholipid content of 4.8%, less than the 6% and 7% recited in claims 5 and 6. Based on the foregoing we conclude that claims 5 and 6 are not anticipated by Catchpole. E. Ground 2 - Obviousness Based on Catchpole Combined with Sampalis” slip op. at 17

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

      “have been fully and fairly tried in a previous action and adversely resolved against a party-opponent.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013) (citing Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379 (Fed Cir. 1999)). “It is well established that collateral estoppel, also known as issue preclusion, applies in the administrative context.” MaxLinear, Inc. v. CF CRESPE LLC, 880 F.3d 1373, 1376 (Fed. Cir. 2018) (citations omitted); Webpower, Inc. v. WAG (Final Written Decision). The application of collateral estoppel is not limited to patent claims that are identical. Ohio Willow Wood, 735 F.3d at 1342. “Rather, it is the identity of the issues that were litigated that determines whether collateral estoppel should apply. . . . If the differences between the unadjudicated patent claims and the adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Id. As our reviewing court has explained, collateral estoppel precludes a party from relitigating an issue if: (1) prior action presents an identical issue; (2) the prior action actually litigated and adjudged that issue; (3) the judgment in that prior action necessarily required determination of the identical issue; and (4) the prior action featured full representation of the estopped party. VirnetX Inc. v. Apple, Inc., 909 F.3d 1375, 1377 (Fed. Cir. 2018) (quoting Stephen Slesinger, Inc. v. Disney Enters., Inc., 702 F.3d 640, 644 (Fed. Cir. 2012)).” slip op. at 21

    Patent outcomesUS 9,072,752 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 9,072,752
  • PTAB · Jan 13, 2020 · IPR2018-01179 · APJ Erica A Franklin · IPR · Final written decision

    Claims 33–61 are unpatentable as obvious across four grounds; the Board denied Patent Owner’s contingent motion to amend claims 75–84 as those substitute claims were also obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “At institution, we preliminarily adopted Petitioner’s definition of an ordinarily skilled artisan, and determined that the prior art itself was sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. Inst. Dec. 9. We note that Patent Owner states that it “accepts [Petitioner’s] definition of a POSITA.” PO Resp. 16. Accordingly, for this Decision, we adopt Petitioner’s definition, while maintaining that the prior art demonstrates the appropriate level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art). Moreover, we have reviewed the credentials of Drs. Tallon and Hoem, and consider each of them to be qualified to provide their opinion on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention.” slip op. at 11

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

      “As noted by Petitioner, the Board construed the phrase “greater than about 5% w/w” as meaning “greater than 4.5% w/w” in a Final Written Decision addressing similar claims of a related patent. Pet. Reply 12. Specifically, in IPR2018-00295, the Board’s analysis of the claim phrase “greater than about 5% w/w” of krill oil in the Final Written Decision reads as follows: Such broadening usages as ‘about’ must be given reasonable scope; they must be viewed by the decision maker as they would be understood by persons experienced in the field of the invention. Although it is rarely feasible to attach a precise limit to ‘about,’ the usage can usually be understood in light of the technology embodied in the invention.” Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996). After considering the parties’ arguments and reviewing the Specification of the ’765 patent, we conclude that Petitioner’s proposed construction is consistent with the intrinsic evidence. Although the ’765 patent does not explicitly address the issue of “about,” the meaning of the term can be discerned from a careful reading of the Specification. Example 8 of the ’765 patent reports the analysis of phospholipid fractions of a product of the invention and a commercially available Krill product. Ex. 1001, col. 31, l, 46–col. 32, l. 42. Table 22, reproduced above, reports the calculated values for the various phospholipids in values to a tenth of a percent. Id. at col. 32, ll. 18–38. In the discussion of the table, the values are rounded to the nearest whole number, not the nearest tenth. Id. at col. 32, ll. 11–15. This is consistent with the approach advanced by Petitioner. IPR2018-00295, Paper 35, 12.10 Similarly here, we find that although the Specification does not explicitly define the term “about,” its meaning may be discerned from the manner by which the Specification refers to reported values for phospholipid profiles of krill oil. Ex. 1001, 32:55–67 (Table 22). In the discussion of the lipids reported in Table 22, the values are rounded to the nearest whole number, not the nearest tenth. Id. at col. 32:47–52. This is more consistent with the approach advanced by Petitioner than by Patent Owner. Thus, as determined in that Final Written Decision, and for the reasons set forth therein, “the term ‘greater than about 5% w/w’ shall be construed to mean ‘greater than 4.5% w/w.’” IPR2018-00295, Paper 35, 13. Similarly, we construe the recitation in claim 33 requiring “greater than about 3% ether phospholipids” as meaning “greater than 2.5% ether phospholipids,” and we construe the recitation in claim 46 of “greater than 4% ether phospholipids” as meaning “greater than 3.5% phospholipids.” Although Petitioner and Patent Owner propose additional claim constructions, we determine that explicit construction of those additional claim terms is not necessary for purposes of this Decision.” slip op. at 14

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

      “Based upon our review of the arguments, however, it does not appear that those differences between the claims analyzed in IPR2018-00295 and the challenged claims are material to the issue presented by Patent Owner regarding whether a person of ordinary skill in the art would combine ranges for specific lipid components in an extract from references that use different extraction techniques. Indeed, a side-by-side comparison of the argument set forth in Patent Owner’s Response filed in IPR2018-00295 and the Patent Owner’s Response filed here reveals that the same, virtually verbatim, arguments were made in both cases, absent changes in, e.g., citations and referring to Bottino II instead of Frick 1984 as disclosing a “non-selective” Folch extraction of krill. Compare IPR2018-00295, Paper 14, 14–22, with IPR2018-01179, Paper 12, 24–31. In the Final Written Decision, Patent Owner’s arguments, repeated here, were rejected. IPR2018-00295, Paper 35, 34–39. In any event, we do not apply collateral estoppel to this issue, as the parties have not fully briefed their positions in this proceeding. However, we determine that the analysis in the Final Written Decision for IPR2018-00295 regarding whether a skilled artisan would have been motivated to combine ranges for specific lipid components in an extract from references using different, i.e., “selective and non-selective” extraction techniques is applicable here. In particular, for the same reasons discussed in the IPR2018-00295 Final Written Decision, we accord persuasive weight to Dr. Tallon’s testimony that a POSITA would have known that the relative proportions of natural krill and hence the natural krill oil constituents could be varied in predictable ways by applying a single solvent or combination of solvents including super critical fluid extraction to selectively extract specific groups of lipid components based on their different solubility, and by blending these selective extracts in known and predictable ways to produce a desired krill oil composition. Ex. 1006 ¶¶ 104, 106, 110; see IPR2018-00295, Paper 35, 37–39. We note that Dr. Tallon provided similar testimony in IPR2017-00746, Ex. 1006 ¶ 212, which the Board also credited in determining that the claims of the ’877 patent, directed to a method of producing krill oil comprising extracting oil from denatured krill product with a polar solvent, IPR2017- 00746, Paper 23, 47–48, are unpatentable. Indeed, the Federal Circuit affirmed that Final Written Decision and the Board’s finding that “the lipid components of krill oil can be extracted using any number of suitable solvents, that the proportions of the components could be varied in predictable ways, and that the resulting extracts could be blended to produce a final krill oil product.” Aker Biomarine Antarctic, 786 F. App’x at 254. Moreover, as discussed in the IPR2018-00295 Final Written Decision, the ’765 patent, which shares the same Specification as the challenged patent, describes the compositions of the invention as being prepared by “blending the neutral and polar lipid extracts.” IPR2018-00295, Paper 35, 39, Ex. 1001, 12:34–35. As explained there, “[t]he Specification provides no further guidance regarding the blending step but instead relies on the” slip op. at 35

    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

      “Having considered the amended limitations of the substitute claims, and incorporating our analysis and conclusions regarding for the reiterated arguments regarding a motivation to combine and reasonable expectation of success from our discussion of the original claims, we conclude that the preponderance of the evidence demonstrates that substitute claims 75–82 are unpatentable as obvious over the combination of Yoshitomi, Catchpole, Bottino II, Sampalis I, Randolph, Sampalis II, and NKO; substitute claim 83 is unpatentable as obvious over the combination of Yoshitomi, Catchpole, Bottino II, Sampalis I, Fricke, Randolph, Sampalis II, and NKO; and substitute claim 84 is unpatentable as obvious over Yoshitomi, Catchpole, Bottino II, Sampalis I, Sampalis II, Randolph, and NKO. Accordingly, Patent Owner’s contingent Motion to Amend is denied. of this issue here is consistent with what was decided in that Final Written Decision. CONCLUSION For the foregoing reasons, we conclude that Petitioner has established by a preponderance of the evidence that claims 33–38, 40–43, 46–49, 51–52, 55–58, and 60 are unpatentable as obvious over Breivik II, Catchpole, Bottino II, and Sampalis I; claim 39 is unpatentable as obvious over Breivik II, Catchpole, Bottino II, Sampalis I, and Sampalis II; claims 44, 50, 53, and 59 are unpatentable as obvious over Breivik II, Catchpole, Bottino II, Sampalis I, and Fricke; and claims 45, 54, and 61 are unpatentable as obvious over Breivik II, Catchpole, Bottino II, Sampalis I, and Randolph. Additionally, we deny Patent Owner’s contingent Motion to Amend. V. ORDER Accordingly, it is hereby: ORDERED that based on a preponderance of the evidence, claims 33–61 of the ’453 patent are unpatentable; FURTHER ORDERED, Patent Owner’s Motion to Amend is denied;” slip op. at 51

    Patent outcomesUS 9,375,453 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,375,453
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