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
Priority and Status of Claims
1. This application is a 371 of PCT/CN2022/126631 10/21/2022, which claims benefit of the foreign application: PCT/CN2021/125895 10/22/2021.
2. Amendment of claims 1, 3-4, 6-20, 23-26, 28-30 and 33, and cancelation of claims 2, 5, 27 and 32 in the amendment filed on 7/21/2026 is acknowledged. Claims 1, 3-4, 6-26, 28-31 and 33 are pending in the application.
Responses to Amendments/Arguments
3. The rejection of claims 1, 3-4, 6-26, 28-31 and 33 under 35 U.S.C. 112 (b) has been overcome in the amendment filed on 7/21/2026. Since claims 2, 5, 27 and 32 have been canceled, therefore the rejection of claims 2, 5, 27 and 32 under 35 U.S.C. 112 (b) has been obviated herein.
4. Since claim 32 has been canceled, therefore the rejection of claim 32 under 35 U.S.C. 112 (a) has been obviated herein.
5. Applicant's arguments regarding the rejection of claim 29 under 35 U.S.C. 112(a) have been fully considered but they are not persuasive.
Applicants state “Claim 29 depends from claim 1. Thus, the thermodynamically stable form of crystals is incorporated into claim 29, rendering claim 29 enabled to produce the thermodynamically stable form of crystals.”, see page 11.
However, applicants fail to disclose the instant type A of the compound in claim 1 still exist and can produce the thermodynamically stable form of crystals. Moreover, applicants do not disclose the instant crystalline, after mixing, grinding, compressing would be not transformed into another thermodynamically stable form(s) (i.e., type C). Therefore the rejection of claim 29 under 35 U.S.C. 112(a) is maintained.
6. Applicant's arguments regarding the rejection of claims 30-31 and 33 under 35 U.S.C. 103 (a) over Zhang et al. ‘859 have been fully considered but they are not persuasive.
Applicants state “claim 30 depends from claim 1, the rejection under 35 U.S.C. 103(a) with regard to claim 1 has likewise been overcome”, see page 11.
However, the instant crystalline type A or C would be dissolved into a free form after administration in a patient, thus it will be no distinct from Zhang et al. ‘859 free form for treating disease or condition. Therefore the rejection of claims 30-31 and 33 under 35 U.S.C. 103(a) over Zhang et al. ‘859 is maintained. The rejection of claims 1, 3, 14, 24 and 29 under 35 U.S.C. 103(a) over Zhang et al. ‘859 has been overcome in the amendment filed on 7/21/2026. Since claims 2 and 32 have been canceled, therefore the rejection of claims 2 and 32 under 35 U.S.C. 103(a) has been obviated herein.
7. Applicant's arguments regarding the rejection of claim 30 under the obviousness-type double patenting over Zhang et al. ‘221 have been fully considered but they are not persuasive.
Applicants state “Zhang et al. ‘221 is a national phase patent of WO'859. As stated above, claims 1-2, 24, and 29-30 are not obvious over WO '859. For the same reasons, these claims are likewise not obvious over the claims of US'221. Withdrawal of the nonstatutory obviousness-type double patenting rejection is respectfully requested.”, see page 12.
However, the instant crystalline type A or C would be dissolved into a free form after administration in a patient, thus it will be no distinct from Zhang et al. ‘221 free form for treating disease or condition. Therefore claim 4 of Zhang et al. ‘221 still renders obvious over the instant invention.
Since a terminal disclaimer against Zhang et al. ‘221 has not been filed to the Office, therefore the rejection of claim 30 under the obviousness-type double patenting
over Zhang et al. ‘221 is maintained. Applicant are requested to file a terminal disclaimer to overcome the rejection.
8. Claims 1, 3-4, 6-26 and 28 are neither anticipated nor rendered obvious over the record, and therefore are allowable.
9. THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
August 25, 2026
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