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
Status of 17/633,479
Claims 398 and 401-414 are currently pending.
Priority
Instant application 17/633,479, filed 2/7/2022, claims priority as follows:
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Provisional application 62/884,426 provides support for the instant claims, and thus, the instant claims are granted the effective filing date of 8/8/2019.
Information Disclosure Statement
All references from the IDS’s submitted on 2/27/2024 and 1/27/2026 have been considered unless marked with a strikethrough.
Response to Arguments/Amendments
The amendment filed 1/27/2026 has been entered. Applicant has amended claims 398 and 401, and cancelled claims 399-400 and 415-417.
Claims 398-417 were rejected under 35 U.S.C. 103 in the Non-Final dated 8/28/2025. In response, Applicant has cancelled claims 399-400 and 415-417, and amended claims 398 and 401. Further, Applicant argues that though the compound of the instant claims shares the same underlying mechanism of action with elagolix, one would have no reason to expect dosing parameters that are applicable to elagolix to be similarly applicable to the presently claimed compounds. The argument has been considered, but is not persuasive because regardless of the structure and the mass of the elagolix and formula (VI) of the instant claims, they do still have the same target and are GnRH antagonists. The reference Abbvie is not used for determining the mass of the dose administered to a patient, where the structure and mass would be relevant, but for the general administration schedule.
Additionally, Applicant’s arguments regarding the inventors’ surprising discovery that treatment with the instantly claims compound can be temporarily paused while preserving near term therapeutic efficacy have been considered, but are not persuasive because the patient population of Figure 2 of the instant disclosure is a patient population with endometriosis, not uterine fibroids (page 112, lines 16-17). The instant disclosure describes uterine fibroids as the most common benign tumors in women (page 1, lines 15-16), and endometriosis as the presence of endometrial-like tissue outside the uterus (page 1, lines 20-21), thus differentiating the two disorders. Thus, though there is a surprising result for methods of treating endometriosis with the compound of the instant claim, the surprising result cannot be translated to methods of treating uterine fibroids because the two are different disorders, as Applicant states in the instant disclosure. Thus, the rejection is maintained and has been updated to reflect the claim amendments and cancellations.
Election/Restriction
Applicant’s election of compound (VI):
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as the species of Formula (Ia), 200 mg as the species of administration amount, at least four weeks as the species of treatment duration, oral administration as the species of route of administration, and add-back therapy comprising 1.0 mg/day β17-estradiol and 0.5 mg/day norethindrone acetate as the species of add-back therapy, without traverse, in the reply filed 7/14/2025 is acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 103 rejection below. During the search, additional art was found that expands the species to the choline salt of the elected compound, additional administration amounts, and additional treatment durations. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 398 and 401-414 read on the elected and expanded species.
Claim Interpretation
Claims 404-408, 411, and 413-414 recite the term, “about”, to describe a dosage imitation or a range of treatment limitation. The term is currently being interpreted to mean within 10% above or below the value being described, as described on page 96, lines 5-6 of the instant specification.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 398 and 401-414 are rejected under 35 U.S.C. 103 as being unpatentable over Obseva S.A. (WO 2018/224497 A1, cited in the IDS of 12/02/2022, herein after “Obseva”), as evidenced by Cohen (Cohen, A. et. al. J. Clin. Endocrinol. Metab. 2009, 94(11), 4351-4360.) and further in view of Abbvie Inc. (WO 2020/028630 A1, herein after “Abbvie”). Though the Abbvie reference was published after the effective filing date granted to the instant application above, it was filed before the effective filing date listed above and thus qualifies under 35 U.S.C. 102(a)(2). This rejection applies to the elected and expanded species.
Determining the scope and contents of the prior art
The reference Obseva teaches methods of reducing the volume of menstrual blood loss in patients, a symptom to measure treatment of uterine fibroids, with gonadotropin-releasing hormone (GnRH) antagonists (abstract). Obseva teaches the elected species, also known as instant Formula (VI) as compound (I) and the choline salt thereof as compound (II):
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Obseva teaches methods of reducing menstrual blood loss using the choline salt of compound (I), deemed compound (II) (page 89, Table 3), and teaches the administration of compound (II) during a treatment period, the monitoring of bone mineral density loss at the end of the first treatment period with compound (II), and determination of the loss of bone mineral density at the end of treatment (page 88, lines 19-24). The Examiner notes that the reduction of blood loss in human patients is concurrent with the definition of “treat” or “treatment” relative to uterine fibroids on page 108, lines 33-37 of the instant disclosure:
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Additionally, Obseva explicitly teaches methods of treating a human patient suffering from uterine fibroids as to exhibit reduced menstrual blood loss with compound (I) or a pharmaceutically acceptable salt thereof (page 89, lines 18-19 and line 22).
With respect to claim 402, the compound can be administered orally in a single unit dosage of either 200 mgs or 100 mgs (page 59, lines 25-30), and further delineate
Regarding claims 403-407, Obseva teaches compound (I) or compound (II) can be can be dosed at 100 mg/day or 200 mg/day for a treatment period lasting four weeks up to 48 weeks or more (page 77, lines 14-19), which satisfies the limitations of both the elected and expanded species.
With respect to claims 409-413, the add-back therapy of Obseva is 1.0 mg/day β17-estradiol and 0.5 mg/day norethindrone acetate (page 86, Table 1 Entry 5 and page 90, lines 3-4), administered during the treatment period.
Regarding claim 414, Obseva teaches the patient population of “premenopausal female human patient” (page 2, line 23), and the age range of 18-48 is evidenced by Cohen, which lists premenopausal women as aged 18-48 years (page 4352, “Patient Population”).
The reference Abbvie Inc. (WO 2020/028630 A1, herein after “Abbvie”) teaches a second administration period of a GnRH inhibitor to treat uterine fibroids (page 28, claim 1 and claim 4) that can be separated by a non-treatment period in which the compound is not administered (page 10, para [0047]). With respect to claims 415 and 416, Abbvie teaches that the second dosing schedule can comprise a lower dose and/or less frequent administration than the first dosing schedule (page 11, para [0051] and claim 1) and finally, regarding claim 417, Abbvie teaches the administration of elagolix in the first treatment period, which is not a compound of instant formula (Ia).
Ascertaining the differences between the prior art and the claims at issue
Obseva fails to teach a distinct second administration period and hence the lesser amount of the second administration period, whereas Abbvie fails to teach the elected species of formula (Ia) and the treatment parameters of the instant claims.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of treating uterine fibroids and estrogen-dependent diseases. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of treating uterine fibroids and estrogen-dependent diseases and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to combine the compounds and treatment parameters of Obseva with the additional second administration period of Abbvie because both teach methods of treating uterine fibroids by the GnRH antagonism mechanism. One of ordinary skill in the art would have been motivated before the effective filing date to combine the teachings of Obseva and Abbvie in order to develop additional methods of treating uterine fibroids and symptoms thereof, and would have readily predicted that an additional administration period would improve known uterine fibroid treatments.
With respect to claim 408, the reference Abbvie teaches a non-treatment period in between the first and second treatment period, but does not explicitly teach the two-week period recited in the instant claim. However, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the non-treatment period of two weeks recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the non-treatment period of the administration schedule to provide optimal uterine fibroid treatment methods. The length of the non-treatment period of the administration schedule in the uterine fibroid treatment method is a result effective parameter that will affect the treatment efficacy of the methods herein. The length of the non-treatment period of the administration schedule in the uterine fibroid methods of treatment is clearly a result effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the reference Abbvie provides a starting point of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal non-treatment period length to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the methods of uterine fibroid treatment and the criticality of the claimed length of non-treatment period, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
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 398 and 401-414 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 220, 223-225, and 228 of copending Application No. 17/291,192 (reference application, herein after the ‘192 Application) in further view of Obseva S.A. (WO 2018/224497 A1, cited in the IDS of 12/02/2022, herein after “Obseva”), as evidenced by Cohen (Cohen, A. et. al. J. Clin. Endocrinol. Metab. 2009, 94(110), 4351-4360.) and further in view of Abbvie Inc. (WO 2020/028630 A1, herein after “Abbvie”). This rejection applies to the expanded species.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘192 Application teaches methods of treating uterine fibroids in a pre-menopausal female about 18-48 years of age with the choline salt of compound (VI):
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And an add-back therapy of β17-estradiol and norethindrone acetate. Though the ‘192 Application does not teach the monitoring of the patient’s bone density, first and second treatment periods, and the non-treatment period in between the first and second treatment periods, Obseva and Abbvie teach as disclosed above and at least those teachings are incorporated herein. The reference Obseva teaches the monitoring of the patient’s bone density and Abbvie teaches a first treatment period, non-treatment period in between a first and second treatment period, and a second treatment period, as stated in the 103 rejection above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 398 and 401-413 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-15 of copending Application No. 18/244,773 (reference application, herein after the ‘773 Application) in further view of Obseva S.A. (WO 2018/224497 A1, cited in the IDS of 12/02/2022, herein after “Obseva”) and further in view of Abbvie Inc. (WO 2020/028630 A1, herein after “Abbvie”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘773 Application teaches methods of treating uterine fibroids in a female patient with the free base or choline salt of instant compound (VI):
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In an amount of about 100 mg to 200 mg per day. Though the ‘773 Application does not teach the monitoring of the patient’s bone density, first and second treatment periods, the non-treatment period in between the first and second treatment periods, or the add-back therapy, Obseva and Abbvie teach as disclosed above and at least those teachings are incorporated herein. The reference Obseva teaches the monitoring of the patient’s bone density and Abbvie teaches a first treatment period, non-treatment period in between a first and second treatment period, and a second treatment period, as stated in the 103 rejection above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 398 and 401-413 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 10-15 of U.S. Patent No. 11,759,464 (herein after the ‘464 patent) in further view of Obseva S.A. (WO 2018/224497 A1, cited in the IDS of 12/02/2022, herein after “Obseva”) and Abbvie Inc. (WO 2020/028630 A1, herein after “Abbvie”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘464 patent teach methods of treating uterine fibroids in a female human patient with the compound of instant formula (IV) in a dosage of about 100-200 mgs per day with an add back therapy of β17-estradiol and norethindrone acetate. Though the ‘464 patent does not teach the monitoring of the patient’s bone density, first and second treatment periods, and the non-treatment period in between the first and second treatment periods, Obseva and Abbvie teach as disclosed above and at least those teachings are incorporated herein. The reference Obseva teaches the monitoring of the patient’s bone density and Abbvie teaches a first treatment period, non-treatment period in between a first and second treatment period, and a second treatment period, as stated in the 103 rejection above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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