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
The listing of claims filed 30 October 2025 has been examined.
Claims 83-100 are pending.
Claims 83-100 are newly added.
Claims 1-82 are cancelled.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 05 September 2024 and 13 October 2025 are acknowledged and have been considered.
Priority
The instant application was received 06 June 2024; it is a national stage application of PCT/IB2022/054955, filed 26 May 2022, and claims foreign priority to IN202121056647, filed 06 December 2021. Acknowledgment is made of Applicant’s claim for foreign priority and certified copies of the priority documents have been received.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains phrases which can be implied, specifically the phrase, “The present disclosure also relates to…” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 103
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.
Claims 83-100 are rejected under 35 U.S.C. 103 as being unpatentable over Purohit (WO 2021/100029 A2; IDS dated 13 October 2025, Cite No. 2) in view of Reed (US 8,207,152 B2; IDS dated 05 September 2024, Cite No. 1).
Regarding claims 83-85, Purohit teaches the compound (7R,8R,9S,13S,14S,17S)-17-hydroxy-13-methyl-7-(9-((4,4,5,5,5-pentafluoropentyl)sulfinyl)nonyl)-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta [a]phenanthren-3-yl 4-(pyrrolidin-1-yl)piperidine-1-carboxylate (p. 33; p. 81, Claim 23):
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Additionally, Purohit discloses a method by which the above compound can be synthesized from Fulvestrant (p. 50, Example-09).
Purohit does not explicitly teach the instantly claimed compound, which contains a carbonyl group instead of a hydroxyl group.
Reed teaches compounds having the same steroidal fused ring system as the instantly claimed compound and Fulvestrant (Sheet 1 of 16, Fig. 1):
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In the compounds disclosed by Reed, the group located in the same position as the hydroxyl group in the instantly claimed compound may be either a hydroxyl or a carbonyl group. Reed reports experimental data obtained using the compounds shown above. For example, Reed compares the effect of 2-methoxyoestradiol (Compound 1; 2-MeOE2) and 4,2-methoxyoestrone (Compound 4; 2-MeOE1) on cell growth in various cell lines (Sheet 14 of 16, Fig. 14; Col. 26, Lines 1-20; Col. 17, Lines 4-9). Note, the only difference between Compounds 1 and 4 is a hydroxyl or carbonyl group, with Compound 1 having a hydroxyl group and Compound 4 having a carbonyl group. Compounds 1 and 4 each have a similar effect, with Compound 4 appearing to be slightly more effective in inhibiting cell growth in some cell lines, like MCF7 and ZR-75-1 (Sheet 14 of 16, Fig. 14).
Reed does not explicitly teach the instantly claimed compound.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Purohit would have found it prima facie obvious to prepare the instantly claimed compound based on the teachings of Reed because Reed indicates a carbonyl group is tolerated in the same position as the hydroxyl group in the compound disclosed by Purohit. Furthermore, Reed’s experimental data suggests the carbonyl and hydroxyl groups have a similar effect on cells in vitro and the carbonyl may confer additional benefit over the hydroxyl group in some cell types. Thus, a PHOSITA would have been motivated to try substituting the hydroxyl group in the compound disclosed by Purohit with a carbonyl group as taught by Reed. A PHOSITA would have had a reasonable expectation of success in modifying the compound disclosed by Purohit based on the teachings of Reed because structurally similar compounds generally have similar activity when the instantly claimed substitution (i.e., -OH changed to =O, or vice versa) is made, so a PHOSITA would have been motivated to make said substitution in search of analogs having similar activity.
Regarding claims 86-88, Purohit in view of Reed teaches all of the claimed elements as stated above. Furthermore, Purohit indicates Fulvestrant derivatives can be included in pharmaceutical compositions (p. 1, Lines 1-5; p. 84, Claim 30) and the compound in such compositions can include enantiomers, diastereomers, racemates, pharmaceutically acceptable salts and solvates thereof as well as pharmaceutically acceptable excipients (p. 6, Lines 23-25).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Purohit would have found it prima facie obvious to prepare pharmaceutical compositions comprising enantiomers, diastereomers, racemates, pharmaceutically acceptable salts or solvates of the instantly claimed compound as well as excipients based on the teachings of Reed because Purohit suggests such components may be included in the composition and a skilled artisan would recognize such components may result in the composition having preferred pharmaceutical characteristics, such as improved bioavailability. Furthermore, a PHOSITA would have had a reasonable expectation of success in using enantiomers, diastereomers, racemates, or pharmaceutically acceptable salts or solvates of the instantly claimed compound because a PHOSITA would have recognized enantiomers, diastereomers, racemates, or pharmaceutically acceptable salts or solvates of pharmaceutical compounds typically have similar pharmaceutical activity.
Regarding claims 89-100, Purohit in view of Reed teaches all of the claimed elements as stated above. Furthermore, Purohit’s compounds can be used in treating, “…a benign or malignant disease of the breast or reproductive tract, preferably treating breast cancer.” (p. 7, Lines 5-9; p. 84, Claim 31).
Additionally, Reed’s compositions may be used in treating cancers, specifically breast cancer (Col. 2, Lines 65-67).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Purohit would have found it prima facie obvious to use the instantly claimed compound or compositions comprising the instantly claimed compound in treating diseases such as breast cancer based on the teachings of Reed because both Purohit and Reed suggest their compounds are useful in treating cancers, specifically breast cancer. Furthermore, the compounds disclosed by Purohit are Fulvestrant derivatives (p. 1, Lines 7-12) and a skilled artisan would recognize Fulvestrant has been used in treating breast cancer for over 20 years. Thus, a PHOSITA would have been able to predict additional Fulvestrant derivatives, like the instantly claimed compound, would also be useful in treating breast cancer. Phrased differently, A PHOSITA would have had a reasonable expectation of success in using Fulvestrant derivatives in treating the same diseases Fulvestrant has been used in treating because similar compounds would be expected to be useful in treating the same diseases, like breast cancer or diseases of the reproductive tract, owing to the compounds’ similar structures.
The applied reference has common joint inventors (PUROHIT, Parva Yogeshchandra and GOSWAMI, Vishalgiri Gunvantgiri) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 83-100 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14, 18-19, and 22-23 of copending Application No. 17/779,015 and claims 3-6 and 20-21 of copending Application No. 17/058,390 in view of Purohit (WO 2021/100029 A2; IDS dated 13 October 2025, Cite No. 2) and Reed (US 8,207,152 B2; IDS dated 05 September 2024, Cite No. 1).
Application ‘015 claims Fulvestrant-derivative compounds which share the same steroidal fused ring system and core structure as the instantly claimed compounds, except the ‘015 compounds have a hydroxyl group in place of the carbonyl on the ring system in the instantly claimed compounds (Claim 23).
Application ‘015 does not explicitly claim the instantly claimed compound.
Application ‘390 claims Fulvestrant-derivative compounds which share the same steroidal fused ring system and core structure as the instantly claimed compounds, except the ‘390 compounds have a hydroxyl group in place of the carbonyl on the ring system in the instantly claimed compounds.
Application ‘390 does not explicitly claim the instantly claimed compound.
Purohit teaches the compound (7R,8R,9S,13S,14S,17S)-17-hydroxy-13-methyl-7-(9-((4,4,5,5,5-pentafluoropentyl)sulfinyl)nonyl)-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta [a]phenanthren-3-yl 4-(pyrrolidin-1-yl)piperidine-1-carboxylate. Additionally, Purohit discloses a method by which the above compound can be synthesized from Fulvestrant (p. 50, Example-09).
Purohit indicates Fulvestrant derivatives can be included in pharmaceutical compositions (p. 1, Lines 1-5; p. 84, Claim 30) and the compound in such compositions can include enantiomers, diastereomers, racemates, pharmaceutically acceptable salts and solvates thereof as well as pharmaceutically acceptable excipients (p. 6, Lines 23-25).
Purohit’s compounds can be used in treating, “…a benign or malignant disease of the breast or reproductive tract, preferably treating breast cancer.” (p. 7, Lines 5-9; p. 84, Claim 31).
Purohit does not explicitly teach the instantly claimed compound.
Reed teaches compounds having the same steroidal fused ring system as the instantly claimed compound and Fulvestrant (Sheet 1 of 16, Fig. 1). In the compounds disclosed by Reed, the group located in the same position as the hydroxyl group in the instantly claimed compound may be either a hydroxyl or a carbonyl group. Reed reports experimental data obtained using the compounds shown above. For example, Reed compares the effect of 2-methoxyoestradiol (Compound 1; 2-MeOE2) and 4,2-methoxyoestrone (Compound 4; 2-MeOE1) on cell growth in various cell lines (Sheet 14 of 16, Fig. 14; Col. 26, Lines 1-20; Col. 17, Lines 4-9). Note, the only difference between Compounds 1 and 4 is a hydroxyl or carbonyl group, with Compound 1 having a hydroxyl group and Compound 4 having a carbonyl group. Compounds 1 and 4 each have a similar effect, with Compound 4 appearing to be slightly more effective in inhibiting cell growth in some cell lines, like MCF7 and ZR-75-1 (Sheet 14 of 16, Fig. 14).
Additionally, Reed’s compositions may be used in treating cancers, specifically breast cancer (Col. 2, Lines 65-67).
Reed does not explicitly teach the instantly claimed compound.
A person having ordinary skill in the art (PHOSITA) following the teachings of Purohit and Reed would have found it prima facie obvious to prepare the instantly claimed compound based on the teachings of Reed because Reed indicates a carbonyl group is tolerated in the same position as the hydroxyl group in the compound disclosed by Purohit. Furthermore, Reed’s experimental data suggests the carbonyl and hydroxyl groups have a similar effect on cells in vitro and the carbonyl may confer additional benefit over the hydroxyl group in some cell types. Thus, a PHOSITA would have been motivated to try substituting the hydroxyl group in the compound disclosed by Purohit with a carbonyl group as taught by Reed.
Because claims 83-100 in the instant application would have been obvious over claims 13-14, 18-19, and 22-23 of copending Application No. 17/779,015 and claims 3-6 and 20-21 of copending Application No. 17/058,390 in view of Purohit and Reed, claims 83-100 in the instant application are not patentably distinct from claims 13-14, 18-19, and 22-23 of copending Application No. 17/779,015 and claims 3-6 and 20-21 of copending Application No. 17/058,390.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ADAM C MILLIGAN can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.L.B./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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