- 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
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.