DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending and are under examination.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/192,752 (reference application), in view of WO 2009/138236 (Stevanovioc, of record). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘752 application claims a method of treating cancer comprising administering a population of T cells that kill cancer cells that present a peptide consisting of EEQYIAQF (SEQ ID NO: 432), wherein the T cells are produced by contacting T cells with APC presenting said peptide in MHC-I complex. The ‘752 publication also claims the use of adjuvants identical to the adjuvants recited in the present claims.
Although the ‘752 application does not explicitly claim a formulation of the peptide in a pharmaceutically acceptable salt, or a pegylated peptide, it would be obvious to provide the peptide claimed in the ‘752 application as a salt or pegylated peptide based on the teachings of Stevanovic.
Stevanovioc et al 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 use of the peptides to stimulate T cells, wherein the peptides can be in formulations containing acetate salts, chloride salts (page 25). Stevanovioc also teaches said peptides in a composition with an adjuvant including IL-2, IL-7, IL-12, IL-15, or IL-21 (see page 57-59). 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).
Thus, 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 formulations containing acetate salts, chloride salts, buffers and water, adjuvants, 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 formulations and as modified as in the reference.
With respect to claim 19, this is a product-by-process claim. MPEP 2113(I) states ““[E]ven 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It is noted that the claimed peptide constitutes a fragment of naturally occurring protein. However, the claimed limitation that the peptide is in the form of a pharmaceutically acceptable salt, or is pegylated, distinguishes the claimed peptides from those occurring in nature since it provides a markedly different characteristic (see parent application 17/465,426 and the declaration of Dr. Stern, attached herein).
The closes prior art is US 2009/0285843, which teaches a 9 amino acid peptide consisting of KEEQYIAQF (SEQ ID NO: 369) that binds to HLA-A26, HLA-B2705, or HLA-B4402 (See page 46). The ‘843 publication teaches HLA epitopes can range in size from 8-11 amino acids, and that variants can be made including by substitution , deletion, or addition, but that it is generally preferable to maintain anchor positions which are responsible for MHC binding. Furthermore, the ‘843 publication teaches that important MHC anchor residues are generally located near the ends of the epitope, that P1 of an epitope is very often a TCR contact residue, and that MHC anchor residues are highly sequence dependent (See paragraphs 109-111). See also Sarkizova and which teaches that although 8-mers can sometimes bind to some types of HLA, 8-mers do not readily bind to HLA-A26, HLA-B27, and HLA-B44, and instead 9-mers exhibit dominant binding (See Fig. 3a, in particular). The prior art does not teach or suggest the claimed 8 amino acid peptide consisting of EEQYIAQF (SEQ ID NO: 432).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker, can be reached at telephone number 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644