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. This is the first action on the merits. Election/Restrictions Applicant’s election of Group (I) in the reply filed on March 15, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Group (I) , drawn to compositions comprising an inhibitor of the P2X4 receptor or an inhibitor of the P2X4 receptor signaling pathway in combination with a cel l death inducing chemotherapeutic drug and/or cell death inducing therapy , embraced by claims 1- 3 and 16 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL . Applicant further elected the following specie s : NC-2600 as a specific inhibitor of the P2X4 receptor, and 5-fluorouracil (5-FU) as a cell death inducing chemotherapeutic drug and/or cell death inducing therapy. The Examiner has determined claims 1-3 read on the elected species. Claims 1- 3 and 8- 18 are pending and claims 1-3 are under consideration. Claim 16 is withdrawn based on the species election and claims 8- 15, 17 and 18 are withdrawn based on the restriction requirement. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. 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 applicant regards as his invention. Claim s 2 and 3 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 pre-AIA the applicant regards as the invention. In claim 2 , the term “Carbamazepine der” is vague. Said term is not defined in the specification. The “der” portion of the term seems out of place. The rejection may be overcome by removing the “der.” Regarding claim 3 , the phrase, “modified versions of these inhibitors” is indefinite. The specification does not define what the modified versions of the inhibitors is and thus, the metes and bounds of the phrase is vague. 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 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. Claim Rejections - 35 USC § 103 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 set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a). Claim s 1-3 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over He et al. (Cells, 2020, 9(11), 2511 , cited on IDS ) in view of Marketscreener (2016, < Nippon Chemiphar : Neuropathic Pain Drug P2X4 Receptor Antagonist NC-2600 Moves into Phase 1 Clinical Trial (pdf, 127KB) | MarketScreener > downloaded on March 30, 2026) and Longley et al . ( Nat Rev Cancer 3 , 330–338 (2003) . The present application claims a composition comprising an inhibitor of the P2X4 receptor or an inhibitor of the P2X4 receptor signaling pathway in combination with a cell death inducing chemotherapeutic drug and/or cell death inducing therapy , wherein the inhibitor of the P2X4 receptor is NC-2600 and the cell death inducing chemotherapeutic drug is 5-fluorouracil (5-FU) . He et al. teach “ Inhibiting the P2X4 Receptor Suppresses Prostate Cancer Growth In Vitro and In Vivo , Suggesting a Potential Clinical Target,” see title of the reference. Marketscreener identifies NC-2600 as a P2X 4 inhibitor, see title , “ Nippon Chemiphar : Neuropathic Pain Drug P2X4 Receptor Antagonist NC-2600 Moves into Phase 1 Clinical Trial . He et al. nor Marketscreener teach a combination of NC-2600 and 5-FU. However, Longley teaches 5-FU is a well-known anti-tumor agent and is used in combination therapies, see page 330, left-hand column, second paragraph, among other citations in the reference . It has been held that combinations of two or more compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. In re Susi , 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett , 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). Therefore, it would have been obvious at the time of filing to combine these anti-cancer agents with the expectation that such a combination would be effective in treating cancer . Thus, combining them flows logically from both having been individually taught in prior art. Thus, said claims are obvious. The rejection may be overcome by submitting unexpected results commensurate in scope with the claimed subject matter. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SUSANNA MOORE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9046 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday, 10:00 am to 7:00 pm . 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, Jeffrey Murray can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-9023 . 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. /SUSANNA MOORE/ Primary Examiner, Art Unit 1624