- Manitowoc Foodservice Companies, LLC v. Newton CFV, LLCRehearing deniedPTAB · 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 - Manitowoc Foodservice Companies, LLC v. Gate CFV Solutions, IncInstitution deniedPTAB · 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 - Thorne Research, Inc v. Trustees Of Dartmouth CollegeNo claims unpatentablePTAB · Aug 10, 2022 · IPR2021-00491 · APJ John E Schneider · IPR · Final written decision
Claims 1–3 were not shown unpatentable because the relied-upon portions of the Cell Article and PCT Publication were not shown to be the work of another and thus were not prior art.
RulingsFinal written decision- BurdenDecided for patent owner
“Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 (2018). As discussed above, the ’807 patent meets all four criteria set forth above for each application in the priority chain of the PCT application listed on the face of the ’807 patent. Since the claim of priority arises under Section 120, the provisions of the Paris Convention and PCT do not apply.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artNot shown unpatentable
“Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We are not persuaded by Petitioner’s arguments. Although the laboratory techniques and starting materials used by Drs. Brenner and Bieganowski may have been known in the art, that is not the claimed invention. The invention as recited in claim 1 is directed a composition comprising isolated NR combined with one or more of tryptophan, nicotinic acid, or nicotinamide and one of the recited carriers, wherein the composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration. See Ex. 1001, col. 53. That the certain individual elements of the claimed composition may have been known elsewhere in the prior art does not lead to a conclusion that the relied-upon portions of the Cell Article are “by another.”” slip op. at 30
Patent outcomesUS 8,197,807 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,197,807 - Thorne Research, Inc. v. Trustees Of Dartmouth CollegeAll claims unpatentablePTAB · May 31, 2022 · IPR2021-00268 · APJ John E Schneider · IPR · Final written decision
Claim 2 is unpatentable as anticipated by Stamler and, alternatively, obvious over Stamler.
RulingsFinal written decision- BurdenDecided for petitioner
“2. Anticipation2 “Under 35 U.S.C. § 102, every limitation of a claim must identically appear in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997). “[U]nless a reference discloses within the four corners of the document not only all of the 2 As noted above, the pre-AIA provisions of 35 U.S.C. apply to the ’086 patent. the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateDecided for patent owner
“Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 . As discussed above and in our Decision to Institute, the ’086 patent meets this criterion. While we agree with Petitioner that the face of the ’086 patent does not include a citation of the ‘701 application, the specification does contain a clear claim of priority back to the ’701 application. Ex. 1001, col. 1. ll. 7–13; Ex. 1004 1.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“the art offered by Patent Owner in the ’1795 IPR, which, as noted above, also involved the ’086 patent, should apply to this proceeding, namely “someone with a Ph.D. in biochemistry or similar field in the pharmaceutical sciences, with familiarity and experience with pharmacokinetics.” Pet. 33. Patent Owner does not dispute Petitioner’s definition and, indeed, Patent Owner’s expert, Dr. Amiji, used the same definition in his analysis. Ex. 2014 ¶ 21. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention and supports Petitioner’s definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We have considered the arguments presented by the parties, and find that our initial construction is proper for the reasons set forth in the ’1795 proceeding. Ex. 1018 12–14. We decline to adopt Patent Owner’s construction that calls for an isolation step separate from the process used to manufacture synthetic NR.” slip op. at 16
Patent outcomesUS 8,383,086 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,383,086 - Liquidia Technologies, Inc. v. United Therapeutics CorporationSome claims unpatentablePTAB · 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 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,604,901 - Eis GmbH v. Novoluto GmbHNo claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,849,061 - Ty Inc. v. Softbelly’S, Inc.All claims unpatentablePTAB · Sep 10, 2021 · IPR2020-00689 · APJ John E Schneider · IPR · Final written decision
Claims 15 and 16 are unpatentable: claim 15 as anticipated by Ogawa and obvious over Ogawa and Masahiro; claim 16 as obvious over Ogawa with Cherk, and with Masahiro and Cherk.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We have considered the arguments presented by the parties and the evidence of record and are not persuaded that our original definition of a person of ordinary skill in the art was in error. While the claims at issue refer to an optical grade fabric, we note that the fabric is not the invention. Rather, as stated in the Specification, the field of the invention is “cleaning tools for electronic display screens, and more specifically to cleaning tools for computer display screens and the like.” Ex. 1001, col. 1, ll. 4–6. The claims further narrow the field of the invention to cleaning tools in the form of a doll-like structure. Id. at col. 6, l. 37. Based on the forgoing, we continue to apply the same definition of a person of ordinary skill in the art we used in our Decision on Institution. However, the findings and conclusions set forth below would have been the same had we instead adopted Patent Owner’s proposed definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“We have considered the arguments presented by the parties and the evidence of record and conclude that Petitioner has the better position. The term “display screen,” as used in the challenged claims, refers to an intended use of the cleaning tool. As such, it does limit the scope of the claims. We begin by noting that the challenged claims are directed to a device or apparatus. Ex. 1002, col. 2, ll. 8–13. As such, the claims “cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (1990). The preamble of both claims 6 and 11 read in part: “doll-like figure for cleaning or wiping the surface of a display screen.” Ex. 1001, col. 6, ll. 37–38; col. 7, ll. 1–2. Both claims end with the clause “providing a pliant cleaning tool for wiping a display screen.” Id. at col. 6, ll. 50–51; col. 7, ll. 13–14. These phrases are crafted in terms of a device for performing a specific function or use. This type of phrase has been found to recite an intended use and not a physical limitation. See Marrin v. Griffin, 599 F.3d 1290, 1294–96 (Fed. Cir. 2010). The recitation of the intended use in the body of the claim does not affect our analysis. The term for wiping a display screen still recites a use of the device that does not impart a structural limitation.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We have considered the testimony of both experts and the evidence of record and find Mrs. Ryan’s testimony to be more persuasive. Therefore, we agree with Petitioner that Ogawa discloses a wiping tool which has an inner chamber formed by a strip of optical grade fabric — the wipe portion — and a non-optical grade fabric — the gripping body. We give more weight to Mrs. Ryan’s testimony based on her extensive experience in designing plush toys. Ex. 1005 ¶¶ 3–5. Mrs. Ryan has worked in the area of plush toy design for over twenty-six years and has taught classes relating to plush toy design. Id. ¶¶ 3–4; page 40. In addition, Mrs. Ryan’s testimony regarding how one skilled in the art would envision the wiping tool of Ogawa is consistent with the evidence of record. For example, King4 teaches that teddy bears are formed by joining pieces of fabric creating an inner pocket into which stuffing is inserted. Ex. 1026, 7–12. Cockrill5 also teaches that teddy bears are traditionally made by cutting out the material, sewing the pieces together, and then stuffing the bears. Ex. 1025, 67.” slip op. at 17
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“We have considered the testimony of both experts and the evidence of record and find Mrs. Ryan’s testimony to be more persuasive. Therefore, we agree with Petitioner that Ogawa discloses a wiping tool which has an inner chamber formed by a strip of optical grade fabric — the wipe portion — and a non-optical grade fabric — the gripping body. We give more weight to Mrs. Ryan’s testimony based on her extensive experience in designing plush toys. Ex. 1005 ¶¶ 3–5. Mrs. Ryan has worked in the area of plush toy design for over twenty-six years and has taught classes relating to plush toy design. Id. ¶¶ 3–4; page 40. In addition, Mrs. Ryan’s testimony regarding how one skilled in the art would envision the wiping tool of Ogawa is consistent with the evidence of record. For example, King4 teaches that teddy bears are formed by joining pieces of fabric creating an inner pocket into which stuffing is inserted. Ex. 1026, 7–12. Cockrill5 also teaches that teddy bears are traditionally made by cutting out the material, sewing the pieces together, and then stuffing the bears. Ex. 1025, 67. Dr. Adanur’s experience and expertise appears to be primarily focused on textiles. Ex. 2005 ¶¶ 8–24. While Dr. Adanur testified that he has some experience in the area of plush toys, that experience appears to be limited to selection of fabric that could be used to manufacture plush toys and making several puppets at home to earn extra money. Ex. 1027, 52, 57–59, 78–79. In addition, Dr. Adanur does not cite to any evidence other than Ogawa to support his opinions as to what one skilled in the art would envision upon reading Ogawa. See Ex. 2005 ¶¶ 84–87. Patent Owner, however, contends that Ogawa is silent as to whether the tool has an inner chamber made from a piece of optical grade fabric and a piece of non-optical grade fabric. PO Resp. 1, 22. 4 King, Make Your Own Teddy Bears, 1985 (Ex. 1026) (“King”). 5 Cockrill, The Teddy Bear Encyclopedia, 1993 (Ex. 1025) (“Cockrill”).” slip op. at 17
Patent outcomesUS 6,195,831 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,195,831 - Fresenius Kabi USA, LLC / Fresenius Kabi Swissbiosim GmbH v. Coherus Biosciences, Inc.Rehearing deniedPTAB · 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 disclosurePatents in suitUS 10,155,039 - Rimfrost As v. Aker Biomarine AsRehearing deniedPTAB · 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 obviousnessPatents in suitUS 9,320,765 - Eis GmbH v. Novoluto GmbHRehearing grantedPTAB · 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 denialPatents in suitUS 9,849,061
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.