Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
The disclosure is objected to because of the following informalities: A SEQ ID NO must be provided for every recited amino acid sequence subject to the sequence disclosure rules. See 37 CFR 1.821(d). Such sequences are present in Schemes 1-4 and 7-10. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 29-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,146,003. Although the claims at issue are not identical, they are not patentably distinct from each other because the more specific product claims of the ‘521 patent clearly anticipate the instant generic claims.
Claims 29-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,834,521. Although the claims at issue are not identical, they are not patentably distinct from each other because the more specific product claims of the ‘521 patent clearly anticipate the instant generic claims.
Claims 29-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,011,637. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘637 patent anticipate instant claim 29. The ‘637 patent claims a purified peptide comprising the amino acid sequence SEQ ID NO:1, and claims a method of purifying the peptide. The purified peptide recited in the claims of the ‘637 patent comprises less than 0.25% alpha-Asp-9-plecanatide. See especially claim 1 of the ‘637 patent. With respect to the limitation “oral formulation”, the limitation does not appear to impart any compositional or structural limitations on the recited purified peptide. Accordingly, the limitation appears to be an intended use limitation, which does not impart patentability to a product claim where the product is otherwise anticipated by the prior art. In any event, the claims of the ‘637 patent recite the same components which are present in instant claims 29-40. Further, peptides are inherently capable of being orally administered, i.e. swallowed. Accordingly, the claimed purified peptide of the ‘637 patent inherently satisfies the limitation “oral formulation”. With respect to instant claims 31-33 and 36-337, the claims of the ‘637 patent do not recite an amount of the purified peptide. It would have been obvious to one of ordinary skill in the art to produce the isolated peptide recited in the claims of the ‘637 patent in any amount, because the scale-up of a chemical synthesis is routine in the art, and because the amount of purified peptide would not have been expected to have any effect on the intrinsic properties of the peptide. See MPEP 2144.04(IV)(A).
With respect to instant claim 34 and 40, the ‘637 patent does not claim an alpha-Asp-9-plecanatide concentration of 0.15% to 0.25% relative to the weight of the purified peptide. It would have been obvious to one of ordinary skill in the art to produce a peptide in accordance with the claims of the ‘637 patent and comprising from 0.15% to 0.25% of alpha-Asp-9-plecanatide, because it is desirable in the peptide arts to minimize the amounts of impurity in a desired product, because optimization of purification procedures is routine in the peptide arts, and because the alpha-Asp-9-plecanatide concentration recited in instant claim 34, 40 is encompassed within the concentration range recited in claim 1 of the ‘637 patent. Any overlap between two ranges is sufficient to establish a prima facie case of obviousness. See MPEP 2144.05(I).
Claims 29-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,011,637 in view of Shailubhai et al (U.S. Patent Application Publication 2010/0221329) or the WO Patent Application 2012/037380. The claims of the ‘637 patent are discussed in the above paragraph. The ‘637 patent does not claim its purified peptide as part of an oral formulation including a pharmaceutically acceptable excipient comprising microcrystalline cellulose and magnesium stearate; and does not claim an amount of the purified peptide. Shailubhai et al teach oral formulations comprising guanylate cyclase-C (GCC) agonist peptides. The peptide preferably comprises SEQ ID NO:1 (which is identical to SEQ ID NO:1 of the instant claims and to SEQ ID NO:1 of the peptide recited in the claims of the ‘637 patent). The formulations can comprise a pellet-forming agent, a filler, a swellable polymer, a disintegrant, a suspending agent, a burst controlling agent, and water insoluble particulate matter, each of which can be microcrystalline cellulose. The formulations can also comprise a lubricant which can be magnesium stearate. See, e.g., paragraphs [0012], [0021], [0062], [0071], [0080], [0089], [0092], [0095], [0105], [0106], [0110], [0114], and [0117]; and claims 3 and 4. The WO Patent Application ‘380 teaches an oral dosage formulation comprising the GCC agonist peptide SP-304, microcrystalline cellulose, and magnesium stearate. SP-304 has an amino acid sequence corresponding to SEQ ID NO:1 as recited in the instant claims, and to SEQ ID NO:1 as recited in the claims of the ‘637 patent. Chromatographic purity of the GCC agonist peptide is preferably no less than 95%, the impurity content of the GCC agonist peptide is preferably no greater than 5%, and the oral dosage formulation is substantially free of inorganic acids and carboxylic acids. Unit dose amounts of the peptide range from 0.1 mg to 10 mg, including 3.0 mg. See, e.g., page 37, first entry of the table; Examples 11 and 12; and claims 2-15 and 21-23. It would have been obvious to one of ordinary skill in the art to formulate the purified peptide recited in the claims of the ‘637 patent as an oral formulation including microcrystalline cellulose and magnesium stearate, because Shailubhai et al and the WO Patent Application ‘380 both teach that the peptide recited in the claims of the ‘637 patent can be usefully formulated as an oral formulation comprising microcrystalline cellulose and magnesium stearate, and because use of the purified peptide recited in the claims of the ‘637 patent in the oral formulations taught and suggested by Shailubhai et al and the WO Patent Application ‘380 would have been expected to have the benefits of using purer pharmaceutical ingredients, e.g., reduced side effects due to impurities. It would further have been obvious to one of ordinary skill in the art to determine all operable and optimal amounts for the peptide claimed in the ‘637 patent when used in the oral formulations taught and suggested by Shailubhai et al and the WO Patent Application ‘380, because the dose of an active agent is an art-recognized result-effective variable which is routinely determined and optimized in the pharmaceutical arts.
Instant claims 29-40 are deemed to be entitled under 35 U.S.C. 119(e) to the benefit of the filing date of provisional application 61/831,402 because the provisional application, under the test of 35 U.S.C. 112(a), discloses the claimed invention.
Claims 29-40 are deemed to be allowable over the prior art of record or any combination thereof. The prior art of record does not teach or renders obvious an oral formulation comprising a peptide comprising Inventors’ SEQ ID NO:1 and comprising the specified amounts of alpha-Asp-9-plecanatide. The prior art of record does not teach that alpha-Asp-9-plecanatide can be present in a synthesized peptide comprising Inventors’ SEQ ID NO:1, does not provide any motivation to reduce the content of alpha-Asp-9-plecanatide present in the synthesized peptide, and does not teach or render obvious methods for reducing the content of alpha-Asp-9-plecanatide in the synthesized peptide. When the evidence in favor of obviousness is weighed against the evidence in favor of nonobviousness, the latter is deemed to preponderate.
Allowable Subject Matter
The WO Patent Application 2012/118972 has been carefully considered; however, in view of the effective filing date of the instant claims (see section 10 above), the WO Patent Application ‘972 is not available as prior art under 35 U.S.C. 102 against the instant claims.
Conclusion
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/RONAK C PATEL/Primary Examiner, Art Unit 1788
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