DETAILED ACTION
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 .
Response to Amendment
In the amendment filed on 12/11/2025 Applicant amended claims 1, 3, 4, 7, 10, 21, canceled claims 9, 14, and added the new claim 35. Claims 1, 3-7, 10-13, 15-18, and 21-35 are pending; claims 5, 17-18, and 22-30 remain withdrawn for reasons of record. Claims 1, 3-4, 6-7, 10-13, 15-16, 21 and 31-35 are examined.
Withdrawn claim rejections
Claim Rejections - 35 USC § 112
The rejection of claims 1, 3, 4, 6, 7, 9-16, 21 and 32-35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 3, 6, 7, 9-16, 21 and 31-34 under 35 U.S.C. 103 as being unpatentable over Derouazi et al. in view of Divita et al. is withdrawn in view of the persuasive arguments of Applicant.
Maintained claim rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 4, 6, 7, 10-13, 15-16, 21 and 31-34 remain and claim 35 is rejected
under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
To reiterate,
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the
right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991) (emphasis added).
On pages 15 of the Remarks Applicant argues that: "A comprehensive list of known CPPs can be found online in the publicly-available CPP site 2.0 website, which is an updated version of the database (CPP site) of cell-penetrating peptides." Thus, Applicant concludes that: “The specification therefore provides a "representative number of species" of cationic cell-penetrating peptides that adequately describe the entire genus of cationic cell-penetrating peptides of the present claims.”
Further , Applicant argues that: "Furthermore, as described in Renkvist et al. (2001), there are numerous antigens known in the art. A variety of T cell-defined epitopes encoded by tumor antigens and recognized by T cells ( either cytotoxic CD8+ or helper CD4+) are listed in PCT Int. Pat. Appl. Publ. No. WO 02/064057, which is specifically incorporated herein in its entirety by express reference thereto.") PCT Int. Pat. Appl. Publ. No. WO 02/064057, also published as US20030077289, lists the therapeutic peptides set forth in Table A.) The specification therefore provides for a representative number of antigenic peptides to support the genus of antigenic peptides of the present claims.”
The arguments were carefully considered but not found persuasive because, as shown in the previous Office action, the specification shows actual possession of constructs comprising a cell penetrating peptide (CPP) which is TAT, covalently linked to a therapeutic peptide ligand (NY-ESO-1, TRP2 or CT83) in a mixture with TLR ligands [(CpG and MPLA-CM for short) or (CpG and MPLA and poly (I:C)-CMI for short] (Examples section). The constructs, once mixed in conditions that are conducive to formation of nanoparticles, are used for inducement of strong antitumoral response for breast cancer and melanoma or for eliciting strong immune responses when using CT83 (as a vaccine composition). Just presenting a laundry list of different components of a car for instance does not mean that a skilled artisan would be in possession of a particular vehicle.
Applicant claims possession of (a) a population of nanoparticles, self-assembled at neutral pH, and comprised of a plurality of any cationic cell-penetrating peptides covalently linked to any therapeutic peptide ligand and MPLA; and (b) a pharmaceutically-acceptable buffer, diluent, carrier, or vehicle. Given the breadth of the claim it is considered that Applicant was not in possession of the composition as claimed.
In an effort towards compact prosecution, Examiner opines that incorporating claims 3 and 6 in the independent claim 1 would increase the chances towards an eventual allowance.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647