CTNF 18/554,180 CTNF 84005 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Applicant’s election without traverse of SEQ ID No. 24 and HLA-A in the reply filed on 5/18/2026 is acknowledged. Claims 81 and 167-179 are pending. Claims 167-179 are newly added. Claims 81 and 167-179 are currently under examination and the subject matter of the present Office action. Claim Rejections - 35 USC § 112 07-30-01 AIA 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. New Matter: 07-31-01 Claims 81 and 167-179 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. The specification and claims as originally fail to provide adequate written description for the newly added limitations of claim 81 which recites “a composition comprising a peptide from the RNF83 to the subject, wherein the peptide from the RNF43 protein comprises the amino acid sequence of SEQ ID: 24.” Upon review of the instant specification, there seems to be no disclosure these limitations. Applicant has set forth guidance in originally filed claims 8-10, 83, 87 and 89-94. A review of this disclosure does not appear to lend support for the aforementioned limitation. None of the originally recited 166 claims recite the RNF43 protein. While it is recognized that adequate written description of a limitation is not required to be stated in haec verba in the specification or claims as originally filed, adequate written support for all claim limitations must arise from either an explicit or an implicit suggestion by the disclosure to show that such a concept as now claimed was actually in possession of the Applicant before the effective filing date. MPEP §2163 states, “The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.” In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar , 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. The test of sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co., Inc. , 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow , 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983))…Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar , 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991).” Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 U.S.C. 112(a). Scope of enablement: 07-31-03 AIA Claim s 81 and 167-179 are 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 treatment of colorectal cancer , does not reasonably provide enablement for prevention of cancer . 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 use the invention commensurate in scope with these claims. The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands , 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman , 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors: 1) the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention, 5) the state of the prior art, 6) the relative skill of those in the art, 7) the predictability of the art, and 8) the breadth of the claims. These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher , 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons: 1. The nature of the invention, state and predictability of the art, and relative skill of those in the art Claim 81 recites a method of treating or preventing cancer in a subject, the method comprising an effective amount of a composition comprising a peptide from the RNF43 protein to the subject, wherein the peptide from the RNF43 protein comprises the amino acid sequence of SEQ ID No. 24. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience. That factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally considered to be an unpredictable factor. See In re Fisher , 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.), Nationwide Chemical Corporation, et al. v. Wright, et al. , 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances), Ex parte Sudilovsky 21 USPQ2d 1702 (Appellant's invention concerns pharmaceutical activity. In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian recombinant virus vaccine was uncertain). The art of treating and preventing cancer, is inherently unpredictable due to the diverse chromosomal, genetic, and protein changes associated with cancer, as well as a poor understanding of what environmental, genetic, and biological factors are involved in cancer development. 2. The breadth of the claims The claims are extremely broad insofar as they disclose the general treatment and prevention of cancer regardless of the underlying primary cause of such cancer. 3. The amount of direction or guidance provided and the presence or absence of working examples The specification provides no direction or guidance for determining the particular administration regimens ( e.g ., dosages, timing, administration routes, etc.) necessary to prevent cancer particularly in humans. Further, there is no working example whereby animals or humans predisposed to developing cancer are prevented from developing such a cancer simply by administration of the claimed compound. 4. The quantity of experimentation necessary Because of the known unpredictability of the art (as discussed supra ) and in the absence of experimental evidence commensurate in scope with the claims , the skilled artisan would not accept the assertion that the instantly claimed compounds could be predictably used as a treatment or prevention of cancer as inferred in the claims and contemplated by the specification. Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” (42 USPQ 2d 1001, Fed. Circuit 1997). The prevention of cancer is entirely unpredictable due the diverse environmental, genetic, and biological causes of cancer. Further still, there is limited evidence in the prior art that compounds useful in treating cancer are also effective in preventing the same cancer they treat. Determining if any particular claimed compound would prevent cancer would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. This is undue experimentation given the limited guidance and direction provided by Applicants. Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success . Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 169 and 174-177 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 169 states that “the molecule comprises an antibody, a lipid, an adjuvant or a detection moiety” and claims 174-177 recites that the cancer comprises a cancer. For claim 169, it is unclear how a molecule comprises another molecule. Forms of the term “comprise,” are considered open-ended language and therefore it is unclear what the conjugated molecule actually is or which cancer is being treated. The metes and bounds of the claims are unclear and, therefore, are indefinite. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 81, 167-172 and 174-176 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Gerhard et al. (U.S. 2018/0088121) . Gerhard et al. teach a method of treating cancer in a subject, including colon cancer, comprising administration of a neopeptide that is identical to instantly claimed SEQ ID NO. 24: PNG media_image1.png 320 562 media_image1.png Greyscale (claim 52; paragraphs [0131], [0151], SEQID No. 8 pp. 20). This neopeptide can be expressed or derived from a tumor suppressor gene such as MLH1 or MSH2 and can be conjugated to an MHC monomer (claims 8, 30 and 42) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 81 and 167-179 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerhard et al. (U.S. 2018/0088121) in view of Moreira et al. (JAMA, October 17, 2021, Vol. 308, No. 15, 1555-1565) and Scarpa et al. (Oncotarget, Vol. 6, No. 41, 19(41): 43472-43482, 2015) . The teachings of Gerhard et al. are set forth supra . Gerhard et al. are silent on the treatment of Lynch syndrome and the colorectal cancer comprising a mismatch repair deficient colorectal cancer (MMR-d) and/or microsatellite instability (MSI) positive colorectal cancer. Moreira et al. teach that Lynch syndrome is also known as hereditary non-polyposis colorectal cancer, and is the most common form of hereditary colorectal cancer. It is an autosomal dominant disorder caused by germline mutations in DNA mismatch repair (MMR) genes such as MLH1 and MSH2 (page 1555). Scarpa et al. state that MMR deficiency in colorectal cancer does not appear to affect survival rates of patients with Stage 1 or Stage II colorectal cancer compared to those that are not MMR deficient (page 43474, column 2, under Survival Analysis). One of ordinary skill in the art would have found it prima facie obvious before the effective filing date to administer the neopeptide and conjugates thereof to a subject having Lynch syndrome or MMR-deficient cancer. One would have been motivated to do so in because MLH1 and MSH2 are germline mutations that are present in Lynch syndrome subject. Further, one would be motivated to MMR deficient subjects as it is recognized that current colorectal cancer treatments are effective in these subjects. Therefore, one would have a reasonable expectation of success that the neopeptide and conjugates thereof taught in Gerhard would be effective in subjects having Lynch syndrome or MMR-deficient cancer. CONCLUSION No claim is found to be allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA PAGONAKIS whose telephone number is (571)270-3505. The examiner can normally be reached M-F from 8AM to 4PM EST. 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For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. AP (5/27/26) /ANNA PAGONAKIS/Primary Examiner, Art Unit 6221
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