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 1-2 and 4-21 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/CN2021/143129, filed on 12/30/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections – Withdrawn
The prior rejection of claims 2, 4-9, 11 and 18-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, has been overcome by Applicant’s amendment to claims 2, 4-9 and 11 and is therefore withdrawn. Applicant’s amendment of claims 2, 4, 6, 8 and 11, to remove references to Figures as representations of the physicochemical properties of the claimed compounds, overcomes the prior rejection.
The prior rejection of claims 1, 12 and 14-17 under 35 U.S.C. 103 as being unpatentable over Duan (U.S. Patent No. 12,221,432 B2) in view of Bock (U.S. PG Pub 2019/0337921 A1) and Wermuth (Wermuth, C.G., Stahl, P.H.; Handbook of Pharmaceutical Salts, Eds. Stahl, P.H., Wermuth, C.G., Chapter 11: “Selected Procedures for the Preparation of Pharmaceutically Acceptable Salts,” Wiley-VCH, Weinheim, Germany; 2002) has been overcome by Applicant’s amendment to claims 1, 12 and 14-15 and is therefore withdrawn. Applicant’s amendment of claims 1, 12 and 14-15, to remove from the claim the category of non-crystalline salt forms of a compound of Formula (I) from the genus of claimed compounds, overcomes the prior rejection.
The prior rejection of claims 1-11 and 14-17 under 35 U.S.C. 103 as being unpatentable over Duan in view of Bock and Sharif (Sharif, et al.; Asian Journal of Chemistry, v29, pp1253-1257; 2017) has been overcome by Applicant’s amendment to claims 1-2, 4-11 and 14-15 and cancellation of claim 3 and is therefore withdrawn. Applicant’s amendment of claims 1-2, 4-11 and 14-15 to remove from the claim the category of non-crystalline salt forms of a compound of Formula (I) from the genus of claimed compounds, overcomes the prior rejection.
The prior rejection of claims 1 and 12-17 under 35 U.S.C. 103 as being unpatentable over Duan in view of Bock and Wermuth, and further in view of Hilfiker (Hilfiker, R.; Polymorphism in the Pharmaceutical Industry, Wiley-VCH, Weinheim, Germany; 2006) has been overcome by Applicant’s amendment to claims 1, 12 and 14-15 and is therefore withdrawn. Applicant’s amendment of claims 1, 12 and 14-15, to remove from the claim the category of non-crystalline salt forms of a compound of Formula (I) from the genus of claimed compounds, overcomes the prior rejection.
The prior rejection of claims 1, 12 and 14-17 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-17 and 19-20 of U.S. Patent No. 12,221,432 B2 (hereafter referred to as “Duan”) in view of Bock (U.S. PG Pub 2019/0337921 A1) and Wermuth (Wermuth, C.G., Stahl, P.H.; Handbook of Pharmaceutical Salts, Eds. Stahl, P.H., Wermuth, C.G., Chapter 11: “Selected Procedures for the Preparation of Pharmaceutically Acceptable Salts,” Wiley-VCH, Weinheim, Germany; 2002), has been overcome by Applicant’s amendment to claims 1, 12 and 14-15 and is therefore withdrawn. Applicant’s amendment of claims 1, 12 and 14-15, to remove from the claim the category of non-crystalline salt forms of a compound of Formula (I) from the genus of claimed compounds, overcomes the prior rejection.
The prior rejection of claims 1-11 and 14-17 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-17 and 19-20 of Duan in view of Bock and Sharif (Sharif, et al.; Asian Journal of Chemistry, v29, pp1253-1257; 2017), has been overcome by Applicant’s amendment to claims 1-2, 4-11 and 14-15 and cancellation of claim 3 and is therefore withdrawn. Applicant’s amendment of claims 1-2, 4-11 and 14-15 to remove from the claim the category of non-crystalline salt forms of a compound of Formula (I) from the genus of claimed compounds, overcomes the prior rejection.
Claim Rejections - 35 USC § 112(b) – Maintained
The prior rejection of claim 10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is maintained. Applicant has amended claim 10, without traverse, in the belief that that amendment has addressed the prior rejection; however claim 10 continues to make reference to figures/drawings rather than defining the claimed composition solely by clearly delimiting the physicochemical characteristics of the composition(s). A person of ordinary skill in the art would not understand the metes and bounds of the claim with regard to whether a composition falls within the scope of the claim without precisely matching the experimental conditions that produce the cited Figures, including instrumental parameters that cannot be readily disclosed in the claim. Applicant has provided additional experimental parameters but it remains ambiguous whether a composition intended to fall within the scope of the claims could be analyzed under the claimed conditions to produce figure(s) not deemed “substantially as depicted” in the cited figure(s), due to differences in instrumental calibration, tuning, quantity of averaged scans, or other parameters. Applicant is referred to MPEP § 2173.05(s):
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)”
Claims Free of the Prior Art
Claims 1-2, 4-9 and 11-21 are allowed. The following is an examiner’s statement of reasons for allowance: Prior art does not teach or reasonably suggest, alone or in combination, a crystalline form of a compound of instant formula (I) or a crystalline form of a salt of a compound of formula (I), wherein the crystalline form of the salt of the compound of formula (I) is selected from the group consisting of a crystalline form of the hydrochloride, a crystalline form of the fumarate, a crystalline form of the maleate, a crystalline form of the methanesulfonate, and a crystal form of the hydrobromide, and the structure of formula (I) is as shown below:
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Further, prior art does not teach or reasonably suggest, alone or in combination, a pharmaceutical composition comprising a comprising a therapeutically or prophylactically effective amount of the crystalline form of the compound of formula (I), or the crystalline form of the salt of the compound of formula (I) according to claim 1, or a method for treating or preventing an estrogen receptor (ER) related disease, comprising administering to a subject in need thereof a therapeutically or prophylactically effective amount of the crystalline form of the compound of formula (I), or the crystalline form of the salt of the compound of formula (I) according to claim 1, including wherein the ER-related disease is breast cancer or is ER-positive breast cancer. Prior art does not teach or reasonable suggest, alone or in combination, a method for preparing the crystalline form of formula (I) or the crystalline form of the salt of the compound of formula (I) according to claim 2 or according to claim 8, comprising a step of precipitating the crystalline form of the compound of formula (I) in a solvent of ethyl acetate, or a method for preparing the crystalline form of formula (I) or the crystalline form of the salt of the compound of formula (I) according to claim 6, comprising a step of precipitating the crystalline form of the compound of formula (I) in a solvent of acetone.
Closest Prior Art:
The closest prior art is found in Duan (U.S. Patent No. 12,221,432 B2). Duan discloses a genus of indole compounds of a specific formula as well as isomers thereof and pharmaceutically acceptable salts thereof and the use of the genus of compounds, isomers thereof and salts thereof in preparing a drug for treating estrogen receptor-positive breast cancer (Abstract). Duan discloses the specific compound of instant formula (I), designated as “compound 3” by Duan (Cols. 59-60, lines 1-20), which Duan prepares as the hydrochloride salt (Col. 60, lines 37-39). Duan also discloses a general approach to preparing pharmaceutically acceptable salts of the compound disclosed therein, wherein the free acid or base form of the compound reacting with a stoichiometric amount of the appropriate base or acid in water or an organic solvent or a mixture thereof (Col. 40, lines 6-9). Duan does not disclose any crystalline form of any compound disclosed therein, nor any crystalline form of any salt of any compound disclosed therein.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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 W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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