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After rejecting Cochlear's remaining challenges, the majority addressed Oticon's cross appeal regarding claims 7-10, and affirmed the PTAB's decision except as to claim 10. Id. at 16-17. In the IPR, the PTAB found that claims 7-10 recite means-plus-function limitations, but the specification fails to provide any corresponding structures for such limitations, which leaves the limitations wholly undefined and without any discernible meaning, and prevents comparison to prior art. Id. On these facts, the PTAB concluded that claims 7-10 had not been proved unpatentable. Id. at 16-17. On cross appeal, the majority affirmed the PTAB's decision as to claims 7-9, but found that the PTAB erred as to claim 10. Id. at 17. Claim 10 recites a "directivity means comprising at least one directivity dependent microphone and/or signal processing means in the electronic circuitry." Id. at 18. Focusing on the use of "and/or," the majority construed the term to cover three independent alternatives including directivity dependent microphone only, which recites a structure with a discernible meaning and can be compared to prior art. Id. at 18-19. Therefore, the majority vacated and remanded for further proceedings as to claim 10. Id. at 20.

The majority commented that while a claim is indefinite if it recites a means-plus-function limitation in the absence of any corresponding structure in the specification, the PTAB lacks statutory authority to make such determination in an IPR. Id. at 17. The majority further noted that under Federal Circuit precedent, Oticon would not be estopped by 35 U.S.C. §315(e) from challenging such a claim under §102 or 103 in other proceedings. Id. at 18.

While concurring in the majority's decision as to claims 7-10, Judge Newman dissented as to the first set of claims. Id. at 1 (Newman, J., dissenting). In her view, the preamble phrase should have been found limiting because it defines what the inventors actually invented and intended to encompass by the claims, i.e., an effective treatment for unilateral (one-sided) hearing loss, not general improvements in hearing aids. Id. at 3-4 (Newman, J., dissenting). Judge Newman found that the majority's treatment of the preamble phrase caused major changes in the relation of the claimed invention to the prior art, including opening the claims to prior art that is distinct from the claimed invention, and mooting the important analysis as to whether there is motivation to combine certain prior art references. Id. at 3-4 (Newman, J., dissenting). Treating the preamble as limiting and for additional reasons specific to certain dependent claims, Judge Newman found that no prior art taught or suggested the claimed invention, and the first set of claims should have been held to be not unpatentable. Id. at 5-6 (Newman, J., dissenting).

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Federal Circuit Finds That District Court Correctly Applied the Disclosure-Dedication Doctrine In Granting a Motion for Judgment of Non-Infringement on the Pleadings

On May 8, 2020, a Federal Circuit panel consisting of Judges O'Malley, Reyna and Chen issued a unanimous opinion, authored by Judge Reyna, in Eagle Pharm. Inc. v. Slayback Pharma LLC, 958 F.3d 1171 (Fed. Cir. 2020). Eagle appealed from the United States District Court for the District of Delaware's judgment of non-infringement on the pleadings. Because the district court did not err in its application of the disclosure-dedication doctrine and there is no material dispute of fact to resolve, the panel affirmed.

Eagle sued Slayback for infringement of four patents under the doctrine of equivalents, asserting claims directed to liquid pharmaceutical compositions for treating chronic lymphocytic leukemia and non-Hodgkin lymphoma. Slip Op. at 2. The asserted claims of the patents recite a "composition comprising … a pharmaceutically acceptable fluid comprising a mixture of polyethylene glycol and propylene glycol … and a stabilizing amount of an antioxidant …." Id. at 3. Slayback conceded to the presence of all claim limitations in the accused product except for the "pharmaceutically acceptable fluid" limitation. Id. at 3. Eagle asserted that ethanol in the accused product is insubstantially different from propylene glycol (PG) in the claimed composition. Id. at 3. In granting Slayback's motion for judgment of non-infringement on the pleadings under Rule 12(c), the district court concluded that the disclosure-dedication doctrine bars Eagle's claims for infringement under the doctrine of equivalents. Id. at 5.

The panel first addressed whether the district court properly applied the disclosure-dedication doctrine on the merits, and concluded that it did. The specification discloses three distinct formulations: 1) chloride salt formulations; 2) antioxidant formulations; and 3) dimethyl sulfoxide formulations. Id. at 7. Eagle argued that a skilled artisan would not consider ethanol as an alternative to PG for the claimed antioxidant formulations because the specification only discloses ethanol as an alternative to PG for the unclaimed chloride salt formulations, but does not do so while discussing the claimed antioxidant formulations. Id. at 7. Citing Federal Circuit precedent, the panel rejected this embodiment-level approach to the disclosure-dedication doctrine, and reiterated that the correct disclosure test is whether the specification discloses the unclaimed matter as an alternative to the relevant claim limitation. Id. at 7-8. The panel found that the patents at issue pass this test because they disclose ethanol as an alternative to PG in the "pharmaceutically acceptable fluid" claim limitation. Id. at 8. As the asserted patents dedicated ethanol to the public by disclosing without claiming it as an alternative to PG in the claim limitation, the panel affirmed the district court's decision on the merits. Id. at 9.

The panel then turned to Slayback's challenge to the district court's application of the disclosure-dedication doctrine on procedural grounds, and found no procedural defects. According to Eagle, the district court erred by resolving a factual dispute at the pleadings stage without drawing all reasonable inferences in Eagle's favor. Id. at 9. Specifically, Eagle argued that the district court was required to infer that a skilled artisan would not have considered ethanol as an alternative to PG in the claimed antioxidant formulations, because a similar opinion in Eagle's expert declaration was the best and only evidence of a skilled artisan's understanding of the disclosure. Id. at 4, 9-10. The panel found that the district court did not abuse its discretion when it set aside the expert's declaration, because the patents provide sufficient context to decide the issue at hand and expert testimony is not always required for a district court to determine how a skilled artisan would understand a patent's disclosure. Id. at 10-11. The panel concluded that the district court's factual finding on the issue of disclosure is the only reasonable inference that can be made from the patent disclosures. Id. at 11. Finding no material issue of fact to resolve, the panel rejected Slayback's procedural challenge. Id. at 11.

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Jeff Ginsberg is a Partner at Patterson Belknap Webb & Tyler LLP and Assistant Editor of The Intellectual Property Strategist. Zhiqiang Liu is an associate at the firm.