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 .
DETAILED ACTION
Claim Status
Claims 110-113 are pending. Claims 110-113 have been added. Claims 1, 3, 5-6, 9, 12, 22, 25-26, 30, 37, 42-43, 47, 50, 52, 100-102, 104-106 and 108-109 have been canceled. Claims 110-113 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I and the following species:
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Claim Objections
Claim 110 is objected to because of the following informalities: The SMILES Strings claimed should be replaced with the corresponding structures. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: The SMILES Strings in Tables 3-4 should be replaced with the corresponding structures. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
This is a new rejection.
Claims 112-113 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 112-113 are drawn to the pharmaceutical composition of claim 111 for inhibiting MDM2, inhibiting MDM2 and MDM4, or for treating various diseases or disorders. The MPEP 2111.02 states that “[I]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999)””. In the instant case, the limitations “for inhibiting MDM2”, “for inhibiting MDM2 and MDM4”, and “for treating a disease or disorder” are intended use of the product and are not given any patentable weight. Therefore, claims 112-113 fail to further limit the subject matter of claim 111. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 3, 5-6, 9, 12, 22, 25-26, 30, 37, 42-43, 47, 50, 52 and 100-101 under 35 U.S.C. 102(a)(1) as being anticipated by Fasan et al. is withdrawn in view of the amendments to the claims.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
This is a new rejection.
Claims 110-113 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fasan et al. (ChemBioChem 2006, 7, 515-526).
With respect to claim 110, Fasan et al. teach the following cyclic peptide (see Fig. 1), which corresponds to the instantly claimed species (i.e. SMILES String No. 1), thus anticipating the claim.
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With respect to claim 111, Fasan et al. teach that “[I]nhibitors of the interaction between the p53 tumor suppressor protein and its natural human inhibitor HDM2 are attractive as potential anticancer agents (page 515, right column, 1st para). One of ordinary skill in the art would have at once envisaged a pharmaceutical composition comprising the cyclic peptide and a pharmaceutical acceptable excipient for administration.
With respect to claims 112-113, as discussed above under 35 U.S.C. 112(d), the claims fail to further limit the subject matter of claim 111, thus are anticipated.
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.
This is a new rejection.
Claims 110-113 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-102 of copending Application No. 18/516155 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the relate to the same cyclic peptide.
With respect to claim 110, ‘155 teaches cyclic peptides of Formulas IIa, IIb, IIIa and IIIb (claims 69-70 and 91-92), which reads on many of the cyclic peptides of instant claim 110.
With respect to claim 111, ‘155 teaches a pharmaceutical composition comprising the cyclic peptide a pharmaceutically acceptable excipient (claim 94).
With respect to claims 112-113, as discussed above under 35 U.S.C. 112(d), the claims fail to further limit the subject matter of claim 111, thus are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658