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 .
Election/Restrictions
Applicant's election with traverse of Group II and the species of SEQ ID NO:27 in the reply filed on 03-26-26 is acknowledged. The traversal is on the ground(s) that the examiner has not cited evidence showing that the present claims have achieved a separate status in the art or would require a different field of search. This is not found persuasive. MPEP 802.01 provides that restriction is proper between inventions which are independent or distinct. Here, the inventions of the two groups are distinct for the reasons set forth in the action mailed 01-27-2026 (paragraphs 5-6).
As to the question of burden of search, the inventions are classified differently, necessitating different searches in a variety of databases. Further, classification of subject matter is merely one indication of the burdensome nature of the search involved. The literature search, particularly relevant in this art, is not coextensive and is much more important in evaluating the burden of search. Different searches and issues are involved in the examination of each group.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-32, and 37-40 were cancelled. New claims 41-56 were added. Claims 33-36, and 41-56 are pending and under consideration.
Information Disclosure Statement
The IDSs filed 08/17/2023, 02/08/2024, and 03/26/2026 were all considered. See attached. However, some of the references (those lined through) did not appear to have been submitted so they could not be considered. Further, some references only contained an abstract and were annotated as such.
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 34 and 47 are 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 34 and 47 are broadly drawn to transducing and expanding T cells with a T cell receptor (TCR) that binds SEQ ID NO:27 in complex with an MHC class I molecule on the surface of cancer cells. However, the written description does not show possession of any particular TCRs that bind SEQ ID NO:27. For example, there is no identification of common TCR structures such as particular alpha and beta chains that would predictably bind SEQ ID NO:27 or the nucleic acids that would predictably encode TCRs that bind MHC and the peptide of SEQ ID NO:27.
The specification teaches [216] that the peptides of the present invention have been shown to be capable of stimulating T cell responses and/or are over-presented and thus can be used for the production of antibodies and/or TCRs, such as soluble TCRs, according to the present invention. The specification further teaches [0218] that the term “T-cell receptor” (abbreviated TCR) refers to a heterodimeric molecule comprising an alpha polypeptide chain (alpha chain) and a beta polypeptide chain (beta chain), wherein the heterodimeric receptor is capable of binding to a peptide antigen presented by an HLA molecule. The term also includes so-called gamma/delta TCRs.
Other than in-vitro priming of autologous T-cells [0402], the specification does not demonstrate possession of the large genus of other possible T-cell receptor proteins that could be transduced and have binding specificity for SEQ ID NO:27. For example, those skilled in the art recognize that unlike antibodies, which can bind to free-floating antigens, TCRs do not recognize the antigen in isolation. They recognize a complex formed by a small peptide fragment of the antigen nestled within a major histocompatibility complex (MHC) molecule on the surface of another cell (e.g., an antigen-presenting cell). Rossjohn et al. (Annu. Rev. Immunol. 2015. 33:169–200) teach (last para, page 176) that classical MHC-I alleles, which can differ by up to 30 amino acids, and more closely related, polymorphic alleles that differ by just 1–2 amino acids can profoundly affect the repertoire of bound peptides, pMHC-I structure, and, consequently, TCR recognition. As the TCR-pMHC structural database grows it is evident that the rules underlying evolutionarily based interactions are not straightforward. For instance, the same TCR that binds different peptides presented by the same MHC can have considerably different binding footprints, an observation characterized as peptide editing. In addition, the CDR3 composition and structure can override codon interactions, a process termed CDR3 editing (page 183). Hence, due to the many factors affecting TCR binding with cognate antigen, one of skill in the art would reasonably conclude that applicants were not in possession of a genus of TCR-encoding genes that have specificity for SEQ ID NO:27.
A description of a genus of may be achieved by means of a recitation of a representative number of species, defined by structure, falling within the scope of the genus. However, the instant specification fails to provide sufficient descriptive information, such as definitive structural or functional features of the claimed genus of TCRs. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the claiming to a genus of TCRs specific for a peptide (SEQ ID NO:27) is insufficient to describe the large genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe and enable the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the genus of T-cell receptors that would predictably bind to SEQ ID NO:27, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
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.
Claims 33, 35-36, 41-46, 48-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10478480. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to similar and overlapping methods against the same peptide. For example, Claim 1 of the patent is drawn to:
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Compared to current claim 33:
A method of treating a patient who has cancer, comprising administering to the patient a population of T cells that selectively recognize cells which present a peptide consisting of the amino acid sequence selected from GYLQGLVSF (SEQ ID NO: 27) wherein said cancer is selected from prostate cancer, benign prostate hyperplasia, lung cancer, small cell lung cancer, melanoma, liver cancer, breast cancer, uterine cancer, Merkel cell carcinoma, pancreatic cancer, gallbladder cancer, bile duct cancer, colon or rectum cancer (CRC), urinary bladder cancer, non-small cell lung cancer, kidney cancer, acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), ovarian cancer, esophageal cancer, brain cancer, and gastric (stomach) cancer.
“Eliciting an immune response” in a patient with cancer encompasses the current examined methods of treating a patient with cancer. Also, both sets of dependent claims are inclusive of the same adjuvants (e.g., IL-1, IL-4, IL-12, etc.) and both sets of claims are drawn to wherein the T-cells are obtained from healthy donors, or tumor infiltrating lymphocytes or peripheral blood mononuclear cells.
Claims 33, 35-36, 41-46, and 48-56 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12097249. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are specifically drawn to a peptide consisting of SEQ ID NO:27 in the form of a pharmaceutically acceptable salt (Claims 1, 3-4) and a pharmaceutically acceptable carrier (Claims 5-7). Further, the patented peptide “has the ability to bind to an MHC class-I molecule, and wherein said peptide, when bound to said MHC, is capable of being recognized by CD8 T cells”. It would be obvious to one of ordinary skill to look to the specification of the patented claims to understand the scope of the claimed pharmaceutical compositions. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.
No claim is currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
Prosecution Insights