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 .
Information Disclosure Statement
The IDSs filed 3/23/23 and 1/24/23 have been considered and initialed copies of the PTO-1449s are enclosed.
Claim Rejections - 35 USC § 101
There is no rejection under 35 USC 101 for the instant set of claims because the specification on page 212 defines the term “pharmaceutically acceptable salt” as “a derivative of the disclosed peptides wherein the peptide is modified by making acid or base salts of the agent.” Thus, this specific definition makes the claimed peptide different from the natural peptide and, thus, the claimed peptide is NOT directed to a natural product.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,738,094 in view of Stevanovic et al WO 2009/138236.
The patent claims a method for producing activated antigen-specific CD8+ CTL that selectively recognize SEQ ID NO. 512 (which is the same as applicant’s SEQ ID NO: 512). The method comprises isolating the CD8+ CTL, contacting them with APC displaying SEQ ID NO. 512 in HLA-A*02 complex. Thus, the patent claims methods of using SEQ ID NO. 512 to produce activated antigen-specific CD8+ CTL. The method of using the instantly claimed peptide, makes obvious the instantly claimed peptide.
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 8-13) and water, saline, Ringer’s solution, dextrose solution, sustained release preparations, and the peptide being pegylated.
Stevanovic et al discloses in vitro methods for producing CTL comprising contacting CTL with APC loaded with peptides (see summary, pages 54-55 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).
Thus, since both the patent claims and the reference disclose a method for producing CTL comprising contacting CTL with APC loaded with peptides 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.
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.
Free from Art
The closest priori art is Parenteau et al US 2016/0161486. SEQ ID NO. 24 in Table 1 is the same as applicant’s SEQ ID NO. 512. Because the peptide in the reference is not modified as acid or base salts, the reference is not an anticipatory reference. A rejection under 35 USC 103 could not be made because SEQ ID NO. 24 is merely listed in a table with 20 other peptides and there is no guidance in the reference to specifically pick and choose SEQ ID NO. 24 over the other peptides. Thus, an obviousness rejection would not be made. Thus, the reference is not prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEELA J HUFF whose telephone number is (571)272-0834. The examiner can normally be reached M-Th 6:30am to 4pm Eastern Time.
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/Sheela J. Huff/Primary Examiner, Art Unit 1643