DETAILED ACTION
This office action is in response to applicant’s filing dated July 6, 2026.
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 .
Notice of Change of Examiner
Please note that the Examiner prosecuting this application has been changed to Examiner Rayna B. Rodriguez of Art Unit 1628. Please address all future correspondences to Examiner Rodriguez.
Status of the Claims
Claims 26-40 and 42-45 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed July 6, 2026. Acknowledgement is made of Applicant's amendment of claims 42 and 44; cancelation of claim 41. Claims 1-25 were previously canceled.
Applicants elected with traverse Group I, drawn to a crystalline product and composition comprising said product as the elected invention and SGLT-2 inhibitors as the active ingredient species in the reply filed on February 27, 2026. The requirement is still deemed proper. Claims 35-39 and 42-45 remain withdrawn.
Claims 26-34 and 40 are presently under examination as they relate to the crystalline form I of the compound of formula (I) and compositions thereof and the elected species SGLT-2 inhibitors.
Priority
The present application is a 371 of PCT/CN2022/083323 filed on March 28, 2022, which claims benefit of foreign priority to CHINA 202110339125.7 filed on March 30, 2021.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Drawings
Acknowledgement is made of the drawings received on July 6, 2026. These drawings are accepted.
Withdrawn Objections and/or Rejections
Claim Rejections - 35 USC § 112(a)
Written Description
The rejection of claim 41 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 has been rendered moot in view of the cancelation of claim 41. Thus, the rejection has been withdrawn.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 112(d)
Failure to Further Limit
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.
Claims 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 26 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 peaks expressed in degrees 2-theta at approximately 14.45, 17.04, 19.35, 22.51, and 24.78. Claims 27-31 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.
Response to Arguments
Applicant argues;
Each of the claims are narrower in scope than claim 26, from which they depend. Claim 26 is not limited to all possible diffraction peak positions of the claimed crystalline form I of the compound having Formula (I). While claims 27 and 31 explicitly add diffraction peak positions to those already listed in claim 26 but list them in these claims, they are still narrower than claim 26 because claim 26 is not required to have these added diffraction peak positions. Claims 28-30, on the other hand, do not list the diffraction peak positions already listed in claim 26 but accomplish the same type of result as claims 27 and 31l by using the term "also has diffraction peaks."
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Crystalline forms are defined by their unique three-dimensional arrangement often described utilizing x-ray powder diffraction. X-ray diffraction pattern is an inherent property of the crystalline form of which it describes. As set forth above, claims 27-31 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. Thus, claims 27-34 simply express additional inherent properties of the identical compound and thus do not further limit the limitations of claim 26.
Allowable Subject Matter
Claims 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
Claims 27-34 are rejected. Claims 26 and 40 are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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, Amy L Clark can be reached at 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.
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
Prosecution Insights