In Re: Institut Pasteur
Docket No. 2022-1896 (https://cafc.uscourts.gov/opinions-orders/22-1896.OPINION.12-13-2023_2237277.pdf) (Non-Precedential)
LOURIE, DYK, TARANTO
December 13, 2023
Brief Summary: USPTO PTAB decision supporting examiner’s obviousness-type double patenting rejection affirmed.
Summary: Pasteur appealed PTAB decision examiner’s obviousness-type double patenting rejection of its claims to a method for treating pain using peptides derived from Basic Proline-rich Lacrimal Protein having particular amino acid sequences (Gln-Arg-Phe-Ser-Arg (SEQ ID NO: 2) and Glp-Arg-Phe-Ser-Arg (SEQ ID NO: 55)) at a specified dose (“10-300 mg/day”). The claims were rejected “on the ground of obviousness-type double patenting over “claims 1, 3, 5, 6, 8, 10, 11 and 14 of U.S. Patent No. 9,403,871”, of which claims 1 and 6 are directed to a method for treating pain using “Gln-Arg-Phe-Ser-Arg (SEQ ID NO: 3) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO: 7)” (claim 1) at a dose of “10-100 mg” (claim 6). “In the rejection…the examiner explained that it would have been “obvious for one of ordinary skill in the art to treat chronic pain by the methods of claims 1, 3, 5, 6, 8, 10, 11 and 14 of U.S. Patent No. 9,403,871, which would require treatment for several days, 7 included.” The PTAB agreed with the examiner that “the ’871 patent’s claim term ‘pain’ . . . includes at least ‘acute pain’ and ‘chronic inflammatory pain such as arthritis or inflammatory bowel disease” and the “claim term ‘effective amount of an isolated peptide’ includes within its scope . . . a therapeutic mixture including about 0.0001 to 100 milligrams of the peptide, or, most preferably, 10–100 milligrams per dose, and that ‘[m]ultiple doses can be administered.’” The Board also concluded that “one of ordinary skill in the art would have found it obvious to treat such pain for 7 days (and more) because of its persistent nature” and “‘[i]t is reasonable to interpret that treatment ‘administering a dose of 10-100 mg of the peptide’ occurs at intervals necessary to alleviate pain, starting with daily administration’ and if pain persists, chronically, to a second day, treatment should likewise extend to the second day, and so on to the claimed 7 days (or beyond).” In an RCE, Pasteur proposed amending its pending claim to further limit the dose and to recite “without inducing pharmacodependence or tolerance in the patient”, but the amended claims were rejected (e.g., “[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” (quoting Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (PTAB also cited In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002); declaration and proposed secondary considerations not persuasive (e.g., “reasonably expected to produce identical effect”)). The FC panel found no error with the PTAB’s decision (e.g., “It is settled that inherency may supply a missing claim limitation in an obviousness analysis.” Hospira, FC 2020; analysis of unexpectedness (Honeywell, FC 2017; In re Couvaras, FC 2023 (“unexpected properties may cause what may appear to be an obvious composition to be nonobvious”)). The PTAB decision was therefore affirmed.