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 the Claims Claims 26-45 are pending in the instant application. Election/Restrictions Applicant's election with traverse of FILLIN "Enter claim indentification information" \* MERGEFORMAT Group I, claims 26-34 and 40-41 , drawn to a crystalline form I of the compound having Formula (I) and compo sitions thereof, in the reply filed on FILLIN "Enter mail date of the reply." \* MERGEFORMAT February 27, 2026 is acknowledged. The traversal is on the ground(s) that a priori unity of invention exists between the groups . This is not found persuasive because FILLIN "Enter claim indentification information" \* MERGEFORMAT under 37 C. F.R §1.475 (b), unity of invention is present if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. In the instant applica tion, Groups III and IV are drawn to separate methods of use. Group III is drawn to a method of treating, preventing, or alleviating disease in patients, while claim 45 is drawn to a method of antagonizing mineralcorticoid receptors. None of the combinations recited in 37 C. F.R §1.475 contain more than one method of use. T hus , a priori unity of invention does not exist. The requirement is still deemed proper and is therefore made FINAL. Applicant's election with traverse of FILLIN "Enter claim indentification information" \* MERGEFORMAT SGLT-2 inhibitors as the active ingredient in claim 41 in the reply filed on FILLIN "Enter mail date of the reply." \* MERGEFORMAT February 27, 2026 is acknowledged. The traversal is on the ground(s) that FILLIN "Enter claim indentification information" \* MERGEFORMAT the generic claims are not s o broad as to place an undue burden on the Patent Office to search and examine the full scope of the claims . This is not found persuasive . Firstly, Applicant is reminded that the instant requirement is a Lack of Unity. There are no provisions for serious burden under 37 C.F.R. 1.475 and MPEP 1800. Further, the requirement for restriction between inventions or groups of inventions and/or species fail to relate to a single general inventive concept because they lack the same or corresponding technical feature. See PCT Rules 13.1 and 13.2. These reasons have already been provided to Applicant. The requirement is still deemed proper and is therefore made FINAL. Claims 35-39 and 42-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 27, 2026 . Claims 26-34 and 40-41 are presently under examination as they relate to the crystalline form I of the compound of formula (I ) and compositions thereof. Priority This application claims priority to CN202110339125.7 , filed 03/30/2021 and is a 371 of PCT/CN2022/083323 , filed 03/28/2022 . Drawings The drawings are objected to because all FILLIN "Enter appropriate reason" \* MERGEFORMAT the figures are blurry and hard to read . Fig 1: t he peaks are pixelated and blurry. The vertical axis label and the numbers on both ax e s are blurry and illegible. Fig 2: The axis labels are blurry and difficult to read. Figure 3 the axis labels are blurry and difficult to read. It is also unclear if there is more than one curve. Fig. 4: The figure legend is blurry and difficult to read. Fig 5: The vertical axis label and the numbers on both ax e s are blurry and illegible. Fig 6: The axis labels on both ax e s are blurry and illegible. The figure legend is blurry and difficult to read. 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 Rejections - 35 USC § 112 112(a) – Written Description 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. Claim 41 is 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 . The Written Description Guidelines for examination of patent applications indicates, "the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show applicant was in possession of the claimed genus." (Federal register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 column 3) and (see MPEP 2164). Claim 41 is directed to a pharmaceutical composition comprising a compound having the crystalline form I of the compound of Formula (I) and an SGLT-2 inhibitor. Thus, the claims encompass a composition comprising a compound of formula (I) and a genus of compounds which function as a n SGLT-2 inhibitor. Thus, the claims encompass a genus of compounds which function as a n SGLT-2 inhibitor with no other defining structural components of the compound. SGLT-2 inhibitors can be a small molecule, polypeptide, peptide, glycoprotein, peptide-mimetic, an antigen binding protein (ABP), a DNA, an RNA, RNAi, siRNA, shRNA, a peptide nuclei acid (PNA), a genetic construct for targeting gene editing, a CRI S PR/Cas9 construct, a guide nucleic acid and tracrRNA. Thus, the claims encompass a genus of molecules which function as a n SGLT-2 inhibitor with no other defined structural components to produce a composition combined with a compound of formula (I) . In a review of the instant specification, the specification does not appear to provide guidance as to what structural components are critical to the desired function (see below). The specification does not disclose any specific compounds useful as SGLT-2 inhibitors nor the use of any SGLT-2 inhibitors or other active ingredients in combination with a compound of formula (I) . Because there are an innumerably large number of bio-molecules/compounds within the scope of the generic claims, it would require extensive manpower to make and test each compound to determine which compound would possess the recited properties (i.e., function as an SGLT-2 inhibitor ) and be useful in the instantly claimed compositions. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: "To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co. , 43 USPQ2d 1398. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim . In Regents of the University of California v. Eli Lilly & Co . the court stated: "A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers , 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe , 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli , the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli , 872, F.2d at 1012, 10 USPQ2d at 1618. In the instant case, the claims are drawn to a pharmaceutical composition comprising a compound of formula (I) and a second active ingredient, which is a n SGLT-2 inhibitor. Thus, the claims encompass a genus of molecules which function as a n SGLT-2 inhibitor with no other defined structural components to produce a composition combined with a compound of formula (I) . The claims are generic, broadly reciting a genus of “ an SGLT-2 inhibitor. ” As stated supra , the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim 41 is broad and generic, with respect to all possible compounds encompassed by the claims. Applicant has failed to show that they were in possession of all the diverse compounds encompassed by an SGLT-2 inhibitor . Applicant has not provided any examples of any SGLT-2 inhibitors suitable for use in combination with the claimed crystalline compound . The possible variation s of any molecule that functions as an SGLT-2 inhibitor within the scope of claim 41 are limitless and would encompass compounds that function as an SGLT-2 inhibitor not yet discovered. In a review of the specification, the specification does not disclose any specific compounds as SGLT-2 inhibitors, nor the effectiveness of any compositions with a specific active ingredient in combination with a compound of formula (I) . Because there are an innumerably large number of bio-molecules/compounds within the scope of the generic claims, it would require extensive manpower to make and test each compound to determine which compound would possess the recited properties (i.e., function as an SGLT-2 inhibitor) and be useful in the instantly claimed compositions. The Examiner notes that the same issue would apply to the non-elected species: sGC activators, sGC stimulators, ACE inhibitors, renin inhibitors, angiotensin II receptor antagonists, β -blockers, acetylsalicylic acid, diuretics, calcium antagonists agents, statins, digitalis derivatives, calcium sensitizers, nitrates and antithrombotics. Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize all the compounds claimed to be useful in the compositions of claim 41 . 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim FILLIN "Pluralize \“Claim\” if necessary, insert \“is\” or \“are\” as appropriate, and insert the claim number(s) which are under rejection." s 27-34 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 6 is directed to a crystalline, anhydrate polymorph of the compound having formula (I), designated the form I polymorph , that exhibits an X-ray powder diffraction pattern having characteristic peak s expressed in degrees 2-theta at approximately 14.45, 17.04, 19.35, 22.51, and 24.78 . Claims 2 7-31 describe X-ray powder diffraction pattern peaks of the identical compound cited in claim 26 . Claim 32 is directed to a figure depicting the X-ray diffraction pattern of the identical compound cited in claim 26 . Claim 33 is directed to differential scanning calorimetry properties of the identical compound cited in claim 26 . Claim 34 is directed to a figure depicting the differential scanning calorimetry diagram of the identical compound cited in claim 26. Therefore, claims 27-34 are directed to inherent properties of the identical compound cited in claim 26 . Thus, claims 27-34 do not further limit the limitations of claim 26. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Allowable Subject Matter Claim s FILLIN "Enter claim identification information" \* MERGEFORMAT 26 and 40 are allowable. A review of the prior art reveals that although the compound of formula (I) is known , the crystalline form I is not known. Wang ( US 2022/0211665 A1 , cited in the IDS filed 10/16/2023) teaches a compound of formula (I) (claim 5), but does not teach any X-ray powder diffraction data. Because the crystalline form I of the compound having formula (I) is novel, a pharmaceutical composition comprising the crystalline form I would be novel as well. Conclusion Claim s 26 and 40 are allowable. Claims 27- 34 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT OLIVER D. HEES whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9840 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:00 am - 5:00 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, FILLIN "SPE Name?" \* MERGEFORMAT AMY L. CLARK can be reached at 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. /OLIVER D HEES/ Examiner, Art Unit 1628 /Rayna Rodriguez/ Primary Examiner, Art Unit 1628