Written Description Support for Claimed Range Requires More than Broad Disclosure

federal circuitGen. Hosp. Corp. v. Sienna Biopharmaceuticals, Inc., No. 2017-1012, 2018  (Fed. Cir. May 4, 2018) (Before Moore, Reyna, and Taranto, J.) (Opinion for the court, Moore, J.)

Appellant General Hospital Corp. (“GHC”) appealed the Board’s dismissal of an interference because the claims of its involved patent application lacked sufficient written description. GHC also appealed the Board’s denial of its contingent motion to add a new claim.

The application was directed to methods of removing hair using nanoparticles to damage hair follicles. The disclosure described formulations by reference to optical density (OD), whereas, the claims in the interference referred to concentration in particles per ml. The parties disputed the proper coefficient to convert OD to concentration. The Board accepted the coefficient offered by Sienna’s expert. Using that coefficient, the Board found that no OD values disclosed in the application, when converted, were within the claimed concentration range. Therefore, the application did not provide written description support for the disputed claims.

On appeal, the Federal Circuit agreed with the Board’s findings that none of the disclosed values in the patent-application-in-suit fell within the claimed ranges. The Court stated that “[t]he disclosure of a broad range of values does not by itself provide written description support for a particular value within that range.” In this case, “concentrations from less than 1 x 1011 particles per ml to some unidentified maximum, does not provide written description support for the claimed concentration of ‘about 6.6 x 1011 particles per ml,’ nor does the disclosure of particular discrete values within that range, none of which are the claimed value.”

The Court reiterated its prior precedent that the disclosed range must particularly identify or single out the claimed range. See Eiselstein v. Frank, 52 F.3d 1035, 1040 (Fed. Cir. 1995) (a 50% overlap was insufficient for written description support). In this case, even generously interpreting the claims in GHC favor, the overlap was less than 50%, and did not indicate the claimed values.

Accordingly, the Board did not err in its analysis, and substantial evidence supported the Board’s finding of a lack of sufficient written description.

GHC also appealed the Board’s denial of its contingent motion to add a new claim. The new claim covered a particular species of the genus claim discussed above. The Court found that the Board was arbitrary and capricious in finding that GHC failed to meet its burden to show that the new claim was patentable. The Board did not engage in a substantive analysis or identify any particular ground on which GHC failed to establish patentability. The Board ignored GHC’s certification that it was not aware of any reason why the new claim was not patentable nor did the Board point to any inconsistency with the prosecution history. The Court reversed the Board’s denial of GHC’s contingent motion to add a new claim and remanded for further proceedings.

Take Away

The disclosure of a wide range with exemplary values does not provide written description support for a narrower claimed range, absent something to indicate the claimed range was considered critical or that inventor was in possession of the specific claimed embodiments. The Board cannot reject a motion to add a new claim to a patent application involved in an interference without explaining its findings.



The Author

Joseph Robinson

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

Joseph Robinson

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

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