CTNF 18/459,107 CTNF 97184 DETAILED ACTION Notice of Pre-AIA or AIA Status 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. Status of the Claims Claims 1-6 are examined herein. Claim Objections Claims 1-2 are objected to because: Claim 1 recites detecting autoantibody in a subject … in a sample from a test subject. The terminology should be consistent: a subject or a test subject. Claim 2 recites antibody while referring to the anti-deoxyhypusine synthase autoantibody. The terminology should be consistent. Appropriate correction is required. 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. 07-31-01 Claims 1-6 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. Claim 1 is directed to a method for detecting anti-deoxyhypusine synthase autoantibody in a subject with a digestive system cancer. Claim 6 recites esophageal cancer or colorectal cancer. Prior art is silent on method for detecting anti-deoxyhypusine synthase autoantibody in a subject with a digestive system cancer. The level of predictability in the art of cancer detection is low. Level of one of ordinary skill is high with an ordinary practitioner possessing a PhD and related post-doctoral research experience. Amount of direction and examples provided by the inventor – the specification discloses data only for two cancers: esophageal and colorectal. Other cancers listed in [0038] are not supported by data. The data related to esophageal and colorectal cancers are presented in Fig. 9-10. All other figures in the specification are related to arteriosclerosis not claimed in instant invention. The data presented in Fig. 9-10 have a serious problem because samples for the cancer patient group were pooled, assayed, and plotted together “serum specimens of esophageal cancer patients (61 cases) and colorectal cancer patients (19 cases)” ([0135]). The specification fails to provide results for esophageal cancer separately from the results for colorectal cancer, and separate results cannot be extracted from this one experiment. The pooled samples make it impossible to make a conclusion that both esophageal cancer samples and colorectal cancer samples indeed performed in this assay as expected. The ROC curve of Fig. 10 is not very close to the theoretical curve of an ideal assay, and the specification fails to provide any data that the autoantibody assay method was validated for both esophageal cancer and colorectal cancer samples. Therefore, there is a possibility that one of the groups of the cancer samples (esophageal or colorectal) may have failed to perform in this assay. As such, the combined data provided in the specification fail to separate contributions of the esophageal cancer samples from contributions of the colorectal cancer samples to the assay of Fig. 9 and the ROC curve of Fig. 10. Based on the above findings, one of ordinary skill in the art would conclude that Applicant did not have possession of the claimed invention for both the broad category of digestive system cancers in claim 1 and for individual esophageal and colorectal cancers. 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 Claim 2 is 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 2 recites said test sample. There is insufficient antecedent basis for this limitation in the claim, because claim 1 does not recite any test sample. Subject Matter Free of the Prior Art Claims 1-6 are free of the prior art. Please, see 112(a) rejection above for details. The prior art does not teach a method for detecting anti-deoxyhypusine synthase autoantibody in human subjects with or without any cancer condition. The closest prior art: Brissette et al . (PGPub 20040014064) teach a method for identifying a candidate therapeutic for an erythropoietic disorder, said method comprising: contacting a compound with a panel comprising SEQ ID NO:1 listed in a table in Fig. 3, but fail to teach detection of anti-deoxyhypusine synthase autoantibody using the SEQ ID NO:1. Wu et al . (PGPub 20070224201) teach an isolated antibody that binds to a polypeptide having the amino acid sequence shown in any one of FIGS. 1-6355 - SEQ ID NO:1 is listed in the specification, but fail to teach detection of anti-deoxyhypusine synthase autoantibody using the SEQ ID NO:1. McClelland et al . (PGPub 20110236903) teach autoantibodies specific to prostate cancer ([0382]), but fail to teach detection of anti-deoxyhypusine synthase autoantibody using the SEQ ID NO:1. Chan et al . (PGPub 20130084582) teach detecting induced autoantibody of PLSCR1, STOML2 or SEC61 protein to diagnose colorectal cancer (Abstract), but fail to teach detection of anti-deoxyhypusine synthase autoantibody. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677 /REBECCA M GIERE/Primary Examiner, Art Unit 1677 Application/Control Number: 18/459,107 Page 2 Art Unit: 1677 Application/Control Number: 18/459,107 Page 3 Art Unit: 1677 Application/Control Number: 18/459,107 Page 4 Art Unit: 1677 Application/Control Number: 18/459,107 Page 5 Art Unit: 1677