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 .
Election/Restrictions
Applicant's election with traverse of Claims 17, 21, 25-26, and 29-30 drawn to nucleic acid sequences encoding the amino acid sequences of all SEQ ID NO: 17-22 in the reply filed on 8/10/2026 is acknowledged. The traversal is on the ground(s) that SEQ ID NosL 17-22 corresponds to the six CDR amino acid sequences of the “4141 IVS” TCR, polypeptide encoded by the nucleic acid and in view of claim amendments of 8/10/2026, claims 1-3, 10-15, and 31 may examined along with claims 17, 21, 25-26 and 29-20. This is found persuasive in view of sequence search results and therefore, the restriction requirement between Groups 1-375 as set forth in the office action of 6/8/2026 is withdrawn.
Therefore, the provisions of 35 USC 121 are no longer applicable. See In re Ziegler, 443F.2d 1211,1215, 170, 131-32 (CCPA1971). See also MPEP§ 804.1.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-3, 10-15, 17, 21, 25-26, 29-32 and 40-41 are pending and under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 11/6/2023, 5/21/2024 and 12/12/2024 have been considered. The crossed out reference B2 on the IDS of 5/21/2024 does not have publication year.
Priority
The instant application is a 371 of PCT/US 2022/028066 filed on 5/6/2022 which claims priority to US Provisional 63/185,805 filed on 5/7/2021.
Claim Objections
Claim 15 is objected to because of the following informalities: the examiner suggests that syntax of claim 15 can be improved by inserting “encoding the first and the second polypeptide chains” after the term “The nucleic acid of claim 13”. Appropriate correction is required.
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.
Claim 41 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating cancer having a p53 R175H mutation in a mammal comprising administering a administering to the mammal a population of host cell comprising the nucleic acid of claim 1, does not reasonably provide enablement for a method of treating or preventing any cancer in a mammal not having a p53 R175H mutation comprising administering a administering to the mammal a population of host cell comprising the nucleic acid of claim 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
The instant claims are broadly drawn to a method of treating or preventing any cancer in a mammal not having a p53 R175H mutation comprising administering a administering to the mammal a population of host cell comprising the nucleic acid of claim 1.
The state of the prior art and the predictability or lack thereof in the art:
With regards to the preventing any cancer in mammal or treating any cancer not having p53 R175H mutation, the specification does not disclose sufficient guidance or objective evidence that such polypeptide or a nucleic acid encoding said polypeptide would predictably treat or prevent any cancer. Wu et al. (IDS, JBC Res. Article 298(3) 101684 (2022) teach that specific peptide having p53R175H have been isolated from a number of patients and a p53R175H-specific TCR (6-11) bound to the p53R175H peptide and HLA*A*02:01. They found that TCR 6-11 makes no contact to R175H mutation, yet is nevertheless able to distinguish mutant from wild time p53 (page, 2, left col.). They identified three other peptides (12-6, 38-10, and 1a2) that recognize p53R175H but makes no contact with the R175H mutation. Therefore, a multiple way of recognizing R175H do exist. But they do not reach teach that these peptide can treat or prevent any cancer. Therefore, it is unpredictable and would require a large amount of experimentation to prevent any cancer, wherein the patient has R175H mutation or even treat any cancer wherein the patient does not have R175H comprising administering a nucleic acid encoding the polypeptide that binds to p53 TCR not have R175H.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent. The specification of pages 48-49 disclose that a peptide of SEQ ID NO: 92 comprising R195H present in patient 4141 was recognized by said peptide. But the specification does not disclose that a TCR comprising mutation R175H can prevent any cancer or even treat a cancer patient not having R175H mutation. Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to prevent a cancer or in a patient having R175H mutation or even treat a patient who does not have R175H mutation in p53 comprising administering a nucleic acid sequence of claim 1 in subject need thereof, the lack of direction/guidance presented in the specification regarding the same, the state of the prior art which establishes the unpredictability about preventing or treating any cancer comprising a nucleic acid of claim 1, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Conclusion
Claims 1-3, 10-15, 17, 21, 25-26, 29-32 and 40 are allowable.
Claim 41 is rejected.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
