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. DETAILED ACTION This office action is in response to applicant’s reply filed on December 29, 2025. Restrictions/Elections. Applicant’s election of Group II (Claims 7-12) in the reply filed on December 29, 2025, 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). Status of Claims Claims 1-20 are currently pending and are the subject of this office action. Claim s 1-6 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 29, 2025. Claims 7-12 are under examination . Priority The present application claims priority to provisional application No. 63/380,404 filed on 10/21/2022. 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. 1) Claim(s) 7-8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Correa et. al. (Frontiers in Pharmacology (2017) 8:1-12) and Haghighatseir et. al. (Biointerface Research in Applied Chemistry (2020) 10:5792-5796) CLAIM INTERPRETATION : the subjects in need of “decreasing A-beta level and hyperphosphorylated Tau” are considered subjects suffering from Alzheimer’s Disease (AD). For claim 7, Correa teaches that histamine H4 receptor antagonists are effective in treating Alzheimer’s Disease (AD) (see title and abstract). Correa does not teach the treatment of AD with a composition comprising a glucocorticoid. However, Haghighatseir teaches a method of treating AD comprising the administration of a composition comprising the glucocorticoid dexamethasone (see title and entire document). Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat AD combining two compositions (histamine H4 antagonists and a glucocorticoid) each of which is taught by prior art to be useful for the same purpose (treating AD), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven , 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A. 1966). The prior art is silent regarding “ decreasing A-beta level and hyperphosphorylated Tau ”. However, as evidenced by the specification (see [0003]) patients that suffer from AD have A-beta deposition and hyperphosphorylated Tau. Further: “ decreasing A-beta level and hyperphosphorylated Tau ” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compounds (histamine H4 receptor antagonists and glucocorticoids) are being administered to the same subjects (subjects suffering from AD). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. In other words, even though the prior art is silent regarding “ decreasing A-beta level and hyperphosphorylated Tau ”, by practicing the method made obvious by the prior art: “ the administration of a composition comprising a histamine H4 receptor antagonist and a glucocorticoid to patients suffering from AD ", one will also be “ decreasing A-beta level and hyperphosphorylated Tau ” , even though the prior art was not aware of it. Apparently, Applicant has discovered a new property or advantage (" decreasing A-beta level and hyperphosphorylated Tau ”) of the method made obvious by the prior art (“ the administration of a composition comprising a histamine H4 receptor antagonist and a glucocorticoid to patients suffering from AD "). MPEP 2145 II states: “The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious”. Ex parte Obiaya , 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)). All this would result in the practice of claim 7 with a reasonable expectation of success. For claim 8, the prior art is silent regarding: “ wherein the A-beta level both in the hippocampus and cortex are reduced ”. However, the above statements do not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “ a method of treating AD comprising the administration of a composition comprising a histamine H4 receptor antagonist and a glucocorticoid ". MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are: (A) “ adapted to ” or “adapted for ” clauses; (B) “ wherein ” clauses; and (C) “ whereby ” clauses. The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp ., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited .” (Emphasis added). In the instant case “ wherein the A-beta level both in the hippocampus and cortex are reduced ” appears to be the result of the process made obvious by the prior art: “ a method of treating AD comprising the administration of a composition comprising a histamine H4 receptor antagonist and a glucocorticoid ", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight. For claims 10-12, the prior art does not teach the exact dose regimen disclosed. However, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. As such, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to determine the optimal dose regimen to achieve the best result for a particular patient, thus resulting in the practice of claims 10-12 with a reasonable expectation of success. 2) Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Correa et. al. (Frontiers in Pharmacology (2017) 8:1-12) and Haghighatseir et. al. (Biointerface Research in Applied Chemistry (2020) 10:5792-5796) as applied to claims 7-8 and 10-12 above, further in view of Terzioglu et. al. (Bioorganic and Medicinal Chemistry Letters (2004) 14:5251-5256). Correa and Haghighatseir teach all the limitations of claim 9, except for the histamine H4 receptors of Formula I and Formula II. However, Terzioglu teaches that the compounds labeled as 12 and 1 (see Table 1 on page 5254), which correspond to the instantly claimed compounds of Formula I and II respectively, are histamine H4 receptor antagonists. Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any histamine H4 antagonist) for another (compound 12 and/or compound 1) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claim 9, with a reasonable expectation of success. Conclusion No claims are allowed. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MARCOS L SZNAIDMAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3498 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Flexing M-F 7 AM-7 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, FILLIN "SPE Name?" \* MERGEFORMAT Amy L. Clark can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 571 272-1310 . 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. /MARCOS L SZNAIDMAN/ Primary Examiner, Art Unit 1628 January 15, 2026.