DETAILED ACTION
This action is in response to papers filed on 02/13/2026. Currently, claims 1 and 36 of S.V. Bhagwat. et.al., US 17/689,286 (03/08/2024) are pending examination on the merits: claims 2, 11-22, and 24-35 are canceled, and claim 36 is newly added. Claims 1 and 36 are rejected.
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 .
Priority
This application claims benefit of 63/281,143 (11/19/2021) and claims benefit of 63/158,688 (03/09/2021).
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/13/2026 has been entered.
Withdrawn Rejections
The following is withdrawn:
The rejection of the previous claims as being unpatentable over A. Bastian et.al. WO 2020/014435 A1 (2020) (“Bastian”), Akinpeloye et al. Obstet. Gynecol. Cases Rev., 1-3 (2017) (“Akinpeloye”), E.M. Walsh et.al. 47, Semin Oncol. 187–200(2020) (“Walsh”) and E. Hénin et.al. 156, Breast Cancer Res Treat 331–341 (2016) (“Hénin”), as applied above to claims 1-2, 12-13, 15, 17-18, 25 and 27, in further view of Morice et al., (2016) The Lancet 387, Issue 10023, Pages 1094-1108 (“Morice”) are withdrawn in view of Applicant’s cancellation of the previous claims except for the currently amended claim 1. Applicant Remarks at page 5.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over A. Bastian et.al., WO 2020/014435 A1 (2020) (“Bastian”), in view of:
E.M. Walsh et.al. 47, Semin. Oncol. 187–200(2020) (“Walsh”).
E. Hénin et.al. 156, Breast Cancer Res. Treat. 331–341 (2016) (“Hénin”).
Regarding claims 1 and 36:
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Bastian teaches the instantly claimed compound of claim 1, both the R-enantiomer and the S-enantiomer, as example species, and Bastian claim 4 specifically discloses the R-enantiomer and (per Bastian claim 6) the tosylate salt of the R-enantiomer. 4-methylbenzenesulfonic acid salts is also known as tosylate salts.
Bastian at page 16, lines 14-29.
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Bastian at page 6, Table 1.
Bastian also teaches the compounds of formula (I) as selective estrogen receptor degraders (SERDs), that are useful for treating breast cancer, ovarian cancer, endometrial cancer, prostate cancer, uterine cancer, gastric cancer, or lung cancer, by administering to a patient in need of such treatment, an effective amount of a compound of Formula I or a pharmaceutically acceptable salt thereof (Abstract and at page 1, lines 29-30).
Bastian at page 2, lines 17-25:
The newly invented SERDs that are described herein provide inhibition of ER-mediated transcription that will be useful in treating cancers such as breast cancer, ovarian cancer, endometrial cancer, prostate cancer, uterine cancer, gastric cancer, and lung cancer as well as mutations due to emerging resistance. These SERDs can be used either as single agents or in combination with other classes of drugs including selective estrogen receptor modulators (SERMs), aromatase inhibitors, CDK4 inhibitors, CDK6 inhibitors, PBK inhibitors, and mTOR inhibitors to treat hormone receptor-positive cancers such as breast cancer, gastric cancer, and/or lung cancer.
Bastian further teaches the claimed compound at page 60, lines 10-13: “As a potent degrader and antagonist of ERα, oral SERD such as Example 1B has the potential to be more effective in slowing or halting ESR1 mutant or PIK3CA mutant breast cancers as a single agent or in combination with CDK4/6 inhibitor such as abemaciclib or PI3K/mTOR inhibitor such as Compound A…”.
Bastian also teaches that the cancer may also be ER-positive breast cancer, ER-positive gastric cancer, or ER-positive lung cancer. Bastian at page 9, line 18. As it relates to ER-positive breast cancer, while Bastian does not expressly disclose HER2-negative breast cancer, Walsh teaches that the majority of breast cancers are HER2-negative. Walsh at page 1, line 6-8; and Abstract: “The majority of breast cancers are diagnosed at an early stage and are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative.”. This is important because the prior art establishes that the majority of breast cancers are hormone receptor-positive, for example, ER-positive and HER-2 negative, and a known combination for breast cancer.
Bastian also teaches that the dosages of the compound Formula I or its salt normally fall within the daily range of about 100 mg to about 2000 mg. Bastian at page 10, line 21-24, encompassing the claimed amount of 400 mg. Applicant argues that the 400 mg dose exhibited unexpected results in Table S11 of Jhaveri et al. reference. However, there is not support for this conclusion. In fact, Jhaveri et el., instead noted that “At the 400 mg once daily dose, imlunestrant exhibited a low incidence of GI toxicities (mostly grade 1-2), sustained exposures above the EC80 range … in pretreated patients with ER1/HER2– ABC. These data supported selection of 400 mg once daily as the RP2D…” page 4182 (Discussion). Jhaveri et al, then concludes: “In conclusion, imlunestrant at the RP2D of 400 mg orally once daily had a manageable safety profile with mostly low grade, reversible, GI symptoms, suggesting potential suitability for chronic administration…” at page 4184 (Conclusion).
Key knowledge generated according to Jhaveri et al: “At the recommended phase II dose of 400 mg once daily, imlunestrant had favorable safety, PKs, and encouraging pre liminary antitumor activity in cyclin-dependent kinase 4/6 inhibitor (CDK4/6i)–pretreated patients as monotherapy and in combination with everolimus/alpelisib. In CDK4/6i-naïve patients, imlunestrant + abemaciclib and imlunestrant + abemaciclib + aromatase inhibitor had an 18-month progression-free survival of 60.7% and 73.4%, respectively.”.
The determination of the RP2D is not an unexpected result. This is determined by one of ordinary skill through routine optimization.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, the claim to 400 mg is as a result of a routine optimization to determine the most effective amount over the range disclosed by the prior art, and would have been obvious to determine by one of ordinary skill art, at least for efficacy purposes.
Regarding the limitation of “wherein the patient previously received endocrine therapy”, while Bastian does not expressly teach that the patient previously received endocrine therapy, Bastian does teach that “Due to tumor heterogeneity and acquired resistance to endocrine therapies, combination therapy has become essential in ER-positive and advanced/metastatic breast cancer treatment for effective therapy or to overcome acquired resistance…” at page 56, lines 15-17. Bastian, also at page 56, lines 18-21, goes on further to teach that as a result of this understanding in the art concerning acquired resistance due to endocrine therapy and the positive role combination therapy have in mitigating these effects, “We have tested the combination effect of Example 1B with CDK4/6 inhibitor abemaciclib, mTOR inhibitor everolimus, PIK3CA inhibitor alpelisib and PBK/mTOR inhibitor 8-[5-(l-hydroxy-1-methylethyl)pyridin-3-yl ]-1-[ (2S)-2-methoxypropyl ]-3-methyl-l ,3-dihydro-2H-imidazo[ 4,5-c]quinolin-2-one ("Compound A") in five ER-positive breast cancer cell lines in vitro…”. Table 15, for example, discloses the many example studies teaching the combination of Example 1B with other targeted agents in ER-positive breast cancer cell lines in vitro. In vivo combination studies were also performed, as disclosed on page 60. Bastian at page 60 teaches that “Combination of CDK4/6 inhibitors and fulvestrant has been approved for the treatment of ER-positive metastatic breast cancer but a high percentage of patients develop resistance due to acquired mutations in ESR1 or PIK3CA…”.
However, considering the potency of the claimed compound, “… oral SERD such as Example 1B has the potential to be more effective in slowing or halting ESR1 mutant or PIK3CA mutant breast cancers as a single agent or in combination with CDK4/6 inhibitor such as abemaciclib or PBK/mTOR inhibitor such as Compound A…” at lines 10-13. The compound of Example 1B was then tested in combination with abemaciclib or Compound A in ESR1 wild type and PIK3Ca mutant MCF7 breast cancer at lines 15-17. The teachings clearly suggest that the compound is useful as treatment, inclusive of a population with advanced/metastatic breast cancer who may have received previous endocrine therapy and acquired resistance (c.f., ESR1 mutation) from such treatments.
Consistent with this reasoning, it would have therefore been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bastian’s claim 14 “A method of treating breast cancer, ovarian cancer, endometrial cancer, prostate cancer, uterine cancer, gastric cancer, or lung cancer, comprising administering to a patient in need of such treatment an effective amount of a compound or a pharmaceutically acceptable salt thereof…” (Bastian claim 14), wherein the compound is the instantly claimed compound according to Bastian’s claim 4:
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wherein the patient previously received endocrine therapy, and would thus benefit from using Bastian’s Example 1B, alone or in combination with other therapies because Bastian teaches that due to tumor heterogeneity and acquired resistance to endocrine therapies, “… oral SERD such as Example 1B has the potential to be more effective …as a single agent or in combination …” at page 60, lines 10-13 against cancers that have acquired resistance (i.e., ESR1 or the PIK3Ca mutant MCF7 breast cancer for example) at page 60, lines 3-17; and wherein the cancer is ER-positive and HER2-negative (for example, Bastian’s claims 15-17) in view of Walsh. The motivation for one of ordinary skill in the art is that instantly claimed compound has been shown to treat breast cancer, for example, where combination therapy was tested (for example, Bastian, Tables 15-18) to overcome resistance due to acquired mutation affecting patients treated with endocrine therapies such the currently approved ER-positive metastatic breast cancer treatment combination of CDK4/6 inhibitors and fulvestrant (Bastian at page 60, lines 7-9). This modification would have therefore been obvious to one of ordinary skill in the art, resulting in the claimed method as recited by Bastian, but optimized.
Applicant’s claim to an effective dose of 400 mg of a compound of Formula I falls within Bastian’s disclosed daily range of about 100 mg to about 2000 mg. Bastian at page 10, line 21-24. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, the claim to 400 mg is as a result of a routine optimization to determine the most effective amount over the range disclosed by the prior art, and would have been obvious to determine by one of ordinary skill art, at least for efficacy purposes.
Henin teaches success with changing the dose with time in a related context such that one of ordinary skill in the art would have considered similar dosing optimization and arrive at the claimed dose reduction for the claimed time periods to achieve optimum therapy response. More specifically, Hénin teaches that in a phase I MODEL1 trial, HER2-negative, hormone-resistant metastatic breast cancer patients were treated with escalating doses (85-110 mg) of docetaxel plus epirubicin every 2 weeks for six cycles. See E. Hénin et.al. 156, Breast Cancer Res Treat 331–341 (2016). Dosage/regimen optimization is considered routine in the art.
Therefore, it would have been obvious to one of ordinary skill to routinely optimize the dosage/regimen schedule as it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05, "II. Optimization of Ranges".
Claims 1 and 36 are obvious over Bastian in view of Walsh and Henin.
Applicant’s Arguments
Applicant argues that claim 1 has been amended to recite “advanced breast cancer”, and 400 mg as a critical dose and that the 400 mg dose is administered in the treatment of advanced breast cancer. Applicant refers to Table S11 of Jhaveri et al., in the as filed Applicant’s Remarks dated 03/19/2025.
Applicant argues that the claimed 400 mg dose is critical, non-obvious, and produces unexpected results. Although this does fall within a previously disclosed range, the Applicant cites MPEP 2144.05 and related case law (In re Dreyfus; In re Brandt) to emphasize that a sub-range is only obvious when there is no showing of criticality or unexpected results. Here, the 400 mg dose was identified through in vivo human studies as the Recommended Phase 2 Dose (RP2D) used in clinical trials to assess safety and efficacy of the drug. Data from Jhaveri et al., J. Clin. Oncol. (2024) show that patients receiving 400 mg exhibited better progression-free survival (PFS) and objective response rate (ORR) than those receiving ≥600 mg, despite higher doses yielding greater plasma concentrations. This outcome, the Applicant argues, is surprising and contrary to expectation, demonstrating the 400 mg dose’s critical and optimal profile for safety, efficacy, and PK/PD balance.
Applicant argues that the 400 mg dose afforded better plasma concentration than 600 or 800 mg doses, which Applicant argues is contrary to what one ordinary skill in the art would expect. Applicant’s Remarks filed 03/19/2025 at page 9. For this reason, Applicant believes the rejection is novel and non-obvious over the prior art.
Examiner’s Response
Applicant’s arguments have been fully considered, but are not persuasive. See, § 103 rejection above. Applicant contends that the amended claim reciting a 400 mg dose for treatment of advanced breast cancer using the claimed compound is non-obvious in view of Table S11 of Jhaveri et al., asserting that 400 mg affords better plasma concentration than, for example, 600 or 800 mg and is contrary to what one of ordinary skill in the art would expect.
However, the prior art of Bastian teaches a dosage range that encompasses the claimed 400 mg amount. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Bastian teaches the claimed dose as discussed above. Further, the data relied upon by Applicant in Table S 11 does not demonstrate criticality or unexpected results sufficient to overcome the prima facie case of obviousness. Here, the 400 mg dose was identified through in vivo human studies as the Recommended Phase 2 Dose (RP2D) used in clinical trials to assess safety and efficacy of the drug. Data from Jhaveri et al., J. Clin. Oncol. (2024) show that patients receiving 400 mg exhibited better progression-free survival (PFS) and objective response rate (ORR) than those receiving ≥600 mg, despite higher doses yielding greater plasma concentrations.
This is in line with Jhaveri et al., Fig. 2 plasma concentration profile. Figure 2 indicates that plasma exposure reaches a plateau at approximately 400 mg dose level. Increasing the dose to 800 mg does not meaningfully increase plasma concentration, indicating that systemic exposure is saturated at or around 400 mg. In other words, the pharmacokinetic data demonstrates a maximum plasma concentration (Cmax) plateau begins at 400 mg, with higher doses failing to provide increased exposure.
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To one of ordinary skill in the art, such plateauing behavior is consistent with routine pharmacokinetic principles, as it is well understood in the art that receptor binding, absorption pathways, transport mechanisms, or systemic exposure can become saturated at higher doses. Once saturation is reaches, further dose escalation does not proportionally increase plasma concentration or influence other PK/PD properties. Determining the point at which exposure plateaus constitutes routine optimization. Optimization of a result effective variable, such as dosage, is ordinarily within the level of skill in the art.
It is therefore within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05, "II. Optimization of Ranges". In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Henin as discussed above teaches success with changing the dose with time in a related context such that one of ordinary skill in the art would have considered similar dosing optimization and arrive at the claimed dose reduction for the claimed time periods to achieve optimum therapy response.
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 1 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6-8 and 15-17 of US 10,654,866 B2 (2020) (“’866”) in view of Bastian, Walsh, and Henin.
The instant claims 1 and 36 are directed to methods of treatment of advanced breast cancer, comprising administering a compound of formula I to a patient in a claimed amount.
Claims 6-8 and 15-17 of reference ‘866 are directed to a method of treating cancer including breast cancer, ovarian cancer, and endometrial cancer (claims 16), wherein the breast cancer is ER-positive (claim 17), by administering a pharmaceutical composition, comprising one or more other therapeutic agents (claim 15), and wherein the pharmaceutical composition comprise a compound is (claim 6):
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The pharmaceutically acceptable salt is a benzenesulfonic acid salt (claim 7), wherein the pharmaceutically acceptable salt is a 4-methylbenzenesulfonic acid salt (claim 8).
Conflicting claims 6-8 of ‘866 claim the compound or its tosylate salt, as the same compound of Formula I in instant claim 1.
The instant claims differ from the prior art in that the instant claims, for example instant claim 1, discloses a method of treating an ER-positive and HER2-negative cancers. Claim 6 of ‘866, teaches the same compound, for treating cancer including ER-positive breast cancer and endometrial cancer as disclosed in claim 16 of ‘866.
In a double patenting context, it is proper to look at the conflicting reference’s disclosure regarding a conflicting compound’s utility to determine the overall question of obviousness for examined method of treatment claims that employ that same compound.
It would have been prima facie obvious, for one of ordinary skill in the art, to modify the teachings of ‘866, in view of Bastian, Walsh, and Henin, and arrive at the claimed invention to treat ER-positive and HER2-negative breast cancer, comprising administering a dose of a compound of Formula I at 400 mg to a patient in need of such treatment, with reasonable expectation of success. One of ordinary skill in the art would be motivated to do so because, Bastian teaches the treatment of ER-positive breast cancer, using the claimed compound of Formula I. Bastian specifically teaches the treatment of ER-positive breast cancer with the claimed compound. Therefore, one of ordinary skill practicing the teachings of ‘866, in view of Bastian and Walsh, regarding ER-positive cancer is motivated to treat ER-positive and HER2-negative breast cancer as claimed as discussed above. Henin also teaches success with changing the dose with time in a related context such that one of ordinary skill in the art would have considered similar dosing optimization and arrive at the claimed dose reduction for the claimed time periods to achieve optimum therapy response.
Therefore, the instant claims identified are obvious over ‘866 to one of ordinary skill in the art. It would be obvious to one of ordinary skill in the art to use the claimed compound to treat ER-positive and HER2-negative breast cancer.
Applicant’s Arguments
Applicant argues the same as the above rejections. See Applicant’s Remarks on page 9.
Examiner’s Response
Applicant’s arguments have been fully considered, but are not found to be persuasive in view of the above rejection, and the Examiner’s Response discussed above. The rejection is maintained.
Conclusion
No claims are allowed.
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/C A/Examiner, Art Unit 1622 March 2, 2026
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622