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 .
Priority
The instant application is a continuation application of US application 17/743,778 of US application 17/727,255, US application 17/327,458 of US application 16/705,042 of US application 16/408,653 of US application 16/116,323 of US application 15/374,882 of US Provisional application 62/266,233 filed 12/11/2015. The instant application will be examined with an effective filing date of 12/11/2015.
Status of the Claims/Application
Claims 1-20 are pending and are herein under examination on the merits.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 05/25/2023 and 08/27/2024 are acknowledged and are in compliance with the provisions of 37 CFR 1.97. They have been considered by the examiner.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11433124B2 in view of WO 2009/138236 herein referred to as US’124 and Stevanovic respectively.
US’124 teaches a method of eliciting an immune response in a cancer patient, comprising administering to said patient a composition comprising a population of activated T cells that express a peptide, wherein said peptide consists of the amino acid sequence of SEQ ID NO: 32 (which is the same as applicant's SEQ ID NO. 32), wherein the peptide is in a complex with an MHC molecule. The method claims also use the peptide in a composition with adjuvants (including those listed in applicant's claims 8-13).
The only difference between the patent claims and the instant application is the formulation of the peptide as pharmaceutically acceptable salts (chloride salt, acetate sale), the compositions comprising buffer, adjuvants (as listed in applicant's claims 9-13) and water, saline, Ringer's solution, dextrose solution, sustained release preparations, and the peptide being pegylated.
Stevanovic discloses methods of treating a patient who has cancer or a methods of eliciting an immune response in a cancer patient, comprising administering to said patient a composition comprising a population of activated T cells that selectively recognize cells in the patient that aberrantly express a peptide wherein the peptide is in a complex with MHC (see summary, page 56 and entire reference). The reference also discloses that the peptides can be modified by making acids or base salts of the peptide and these salts include acetate salts and chloride salts (page 24-25). The reference also discloses that the peptides can be pegylated to extend circulatory half-life. The peptides can be also be in compositions containing, buffers and water (page 59), saline, Ringer's solution, dextrose solution, sustained release preparations (page 36-39) and adjuvants, including those listed in applicant's claims 9-13 (pages 56-58).
Therefore, it would have been obvious for a skilled artisan to modify the teachings of US’124 in view of Stevanovic with a reasonable degree of predictable success since both the patent claims and the reference disclose a method of eliciting an immune response in a cancer patient, comprising administering to said patient a composition comprising a population of activated T cells that express a peptide wherein the peptide is in a complex with MHC and since the peptides in the reference can be in pharmaceutically acceptable salt forms such as acetate salts, chloride salts, and in buffers, adjuvants and water, saline, Ringer's solution, dextrose solution, sustained release preparations and since the peptide can be pegylated to extend circulatory half-life, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the peptide in the salts and formulations as disclosed in the reference.
Furthermore, with respect to claim 19, this is a product-by-process claim. MPEP 2113(I) states "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Thus, claim 19 is being examined as a product claim.
Claims 1-13 and 19-20 and provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-32 of copending US Application No. 18314878. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding the instant claims, the copending application recites all the limitations of the instant claims including the claimed amino acid sequence SEQ ID NO: 32 which is the same as one of the amino acid sequences claimed in the copending application (SEQ ID NO: 514).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 and provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending US Application No. 19511603. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding the instant claims, the copending application recites all the limitations of the instant claims including the claimed amino acid sequence SEQ ID NO: 32 which is the same as one of the amino acid sequences claimed in the copending application (SEQ ID NO: 56).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No Claims Allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL LED YOUTCHOM PENDIE whose telephone number is (571)272-6313. The examiner can normally be reached Mon - Fri: 8AM - 5PM CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanna Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL LED YOUTCHOM PENDIE/ Examiner, Art Unit 1647
/JOANNE HAMA/ Supervisory Patent Examiner, Art Unit 1647
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