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. Status of Claims The claim set submitted on 22 SEPTEMBER 2023 is acknowledged and considered. In the claim set, Claims 1-19 are presented and are considered on the merits below. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) submitted on 30 JUNE 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification The disclosure is objected to because of the following informalities: The Equation 1 and Equation 2 are extremely blurry and unable to read on page 3, [6] – [9]; page 4, [12]-[15]. Appropriate correction is required. Drawings The drawings are objected to because in each of the figure, the figure numbers include the Korean character. The Korean character should be deleted in all instances. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections Claims 1 and 12 are objected to because of the following informalities: The Equation 1 , Equation 2 , and Equation 3 are extremely blurry and unable to read. Appropriate correction is required. Claim 1 objected to because of the following informalities: In step (c ); ‘predicting clinical response’, should be ‘predicting a clinical response’. Appropriate correction is required. Claim Rejections - 35 USC § 112 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 appl icant regards as his invention. Claim s 1 , 2 and 19 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. It is unclear to the Examiner what a ‘housekeeping control’ is. This is not a term the Examiner is familiar with and it is not well known in the art. Clarification is requested. It is unclear to the Examiner what ‘its’ is referring to. In step (a) ; it is unclear to the Examiner the language ‘a patient using triple …’; how is a patient using the mass spectrometry technique. Is the patient using these techniques on him/her self? It is unclear to the Examiner what the equations are in the claim. Claim 1 was objected above and it also rejected as being indefinite as it is unclear what is being claimed based on the illegible equations. Claim 1 recites the limitation "the targeting agent ". There is insufficient antecedent basis for this limitation in the claim. Is this the same as the ‘cancer-targeting agent’ in the preamble? It is unclear the Examiner if (ratio tumor/normal ) is supposed to be ‘relative expression level’ in step (b) or ‘corrected relative expression level’ in step (c ). Claim 2 recites ‘the sample’. It is unclear the Examiner if ‘the sample’ is referring to ‘pre-treatment cancer tissue sample’ or ‘adjacent normal tissue sample’. Clarification is requested. While not a lack of antecedent basis issue, it is unclear which sample Claim 2 is referring back to. Claim 19 recites ‘Equation 4’; however, Equation 4 is not presented in the claim. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Note: The 101 rejection below is based off the fact that the equations in each of the claims is illegible. Claims 1 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract without significantly more. The claim(s) recite(s) in Claims 1 and 12, respectively: This judicial exception is not integrated into a practical application because once step (a) is performed in Claims 1 and 12 , steps (b) and (c ) are correcting/correlating and predicting step; then nothing else is done. While steps (b) include mathematical formulas or equations; these are abstract ideas. The equations require a series of data gathering steps that collect a necessary input for the equation, the data gathering steps to be insignificant extra-solution activity ; therefore the judicial exception is not integrated into a practical application . The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the elements (a-c) are known it art for prediction of how effective a treatment is. Regarding Claim 2, at step of isolation is well known in the art of assaying samples Regarding Claims 3 and 18, the listed target peptides are known in art and the list is non-specific to gastric cancer. Regarding Claims 10 and 11, the type of cancer is a matter of design choice when performing the method. Claim Rejections - 35 USC § 103 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. 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 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. Claims 12, 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over KIM, KR-10-2020-107731-A, submitted on the Information Disclosure Statement . An English Machine Translation was obtained from Google Patents and is used for the basis of the rejection below. Applicant’s invention is directed towards a method. Regarding Claim 12 , the reference KIM discloses a method of predicting response to a cancer- targeting agent, comprising:(a) performing multiple reaction monitoring (MRM) mass spectrometry on a target peptide and a housekeeping control peptide in a breast cancer tissue sample isolated from a patient using triple quadrupole mass spectrometry and nano- liquid chromatography , Claims 1, 3, 4 ; (b) obtaining a Z normalized tissue amount value by correcting an expression level of the target peptide measured in the multiple reaction monitoring (MRM) with the housekeeping control peptide using Equation 1 and Equation 3 below and substituting a corrected value into a database: Examiner’s Note: the equations are illegible. Examiner is unable to decipher what the equations are to properly rejection this portion of the claims. See claim objection above , Claims 6-10; and (c ) predicting clinical response to the target agent by determining a level of overexpression of the target peptide based on a Z normalized tissue amount result, Claims 14-16. KIM teaches the claimed invention, but is silent in regards to wherein the tissue sample is from a gastric cancer tissue sample. KIM teaches the sample is from breast cancer tissue sample, abstract. However, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the source of the tissue sample to be from a gastric cancer tissue sample instead of from a breast cancer tissue sample as a matter of design choic e as the method itself is not particular to a gastric cancer tissue sample and the method is merely directed at characterizing parameters. Additional Disclosures Included are: Claim 13 : wherein the method according to claim 12, wherein: the target peptide comprises at least one selected from the group consisting of epidermal growth factor receptor (EGFR), MET proto-oncogene receptor tyrosine kinase (MET), 73 fibroblast growth factor receptor 2 (FGFR2), erb-b2 receptor tyrosine kinase 2 (ERBB2), PD-L1 (CD274), TAP2 (TAP2),I2301 (IDO1), SYWC (WARS1), and UB2L6 (UBE2L6), and the housekeeping control peptide is mitogen-activated protein kinase 1 (MAPK1), cyclophilin B (PPIB), and beta-actin (3- actin, ACTB) , [0108], Table 4. ; and Claim 17 : wherein the method according to claim 13, wherein the target peptide comprises ERBB2, and when a median Z normal i zed tissue amount value of ERBB2 is greater than 1.96, clinical response to a HER2 (ERBB2)-targeting agent when used alone or in combination in the patient is predicted to be high , [049-0150], In addition, in addition to the detailed HER2 scoring when the present invention is applied to clinical practice …require Herceptin (trazumab)… Allowable Subject Matter Claims 2-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The instant claims are allowable over the prior art with the exclusion of the claim objections and 112(b) rejections above. The closest prior art of records it to KIM above, which was used in the rejection of Claim 12 above. The KIM reference discloses method for accurately quantifying HER2 protein in breast cancer tissue samples using mass spectrometry, and a method for scoring HER2 based on the same. The method according to the present invention can perform measurement accurately and reproducibly compared to conventional methods, and if the customized treatment according to the same becomes possible, not only the lifespan of the patient can be extended but also the socio-economic cost can be significantly lowered cross-nationally , abstract, Claims. However, the KIM reference fails to teach or suggest step (b) which includes the ‘correcting an expression level’ step. This correction step is non-obvious to one having ordinary skill in the art. Claims 14-16 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Instant Claims 14-16 and 18 include peptides EGFR, MET , FGFR2 and PD-L1 which are not a matter of fact of a choice of peptide as part of the design of the method. There is no teaching or suggestion of choosing these particular peptides in gastric cancer patients. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT CHRISTINE T MUI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571) 270-3243 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-Th 5:30 -15:30 EST . 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) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT LYLE ALEXANDER can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-1254 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. 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. CTM /CHRISTINE T MUI/ Primary Examiner, Art Unit 1797