DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/26/2025 has been entered.
AIA Status of the Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, filed 9/26/2025, have been fully considered.
The nonstatutory double patenting rejection over U.S. Patent No. 11,690,845 is WITHDRAWN in view of Applicant’s amendments to the claims. It would not have been obvious to modify the method of the ‘845 Patent to (1) carry out the first administration for a period of at least 12 months; (2) determine the amount of estradiol and norethindrone acetate to administer in the first administration; and (3) carry out a second administration without estradiol and norethindrone acetate, as instantly claimed.
Applicant traverses the nonstatutory double patenting rejection over U.S. Patent No. 11,045,470. As argued by Applicant, “independent claim 45 has been amended to further recite ‘a time period of at least 12 months’ for the first daily oral administration of elagolix” and, as such, claim 45 as amended “is patentably distinct from the reference claims of the ‘470... Patent” (Applicant Arguments, Page 6).
The argument is not found persuasive. As discussed in the previous basis of the rejection:
At the outset, as stated by the ‘470 Specification, “the treatment cycle is 3 months or 6 months of daily administration of Elagolix” (Column 14, Lines 4-5) and, “[a]lternatively, the treatment cycle is 12 months of daily administration of Elagolix” (Column 14, Lines 17-18).
Accordingly, in interpreting the scope of the claimed recitation of “for a period of time as needed to manage the heavy menstrual bleeding associated with uterine fibroids” in light of the ‘470 Specification, it is evident that the treatment would be for a period of time not to exceed 24 months.
Furthermore, as stated by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454 (CCPA): “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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, determining the length of treatment of any condition is clearly a result-effective variable. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal length of time to continue treatment in order to best achieve the desired results.
As such, the claims are MAINTAINED rejected on the grounds of nonstatutory double patenting over U.S. Patent No. 11,045,470.
And since Applicant does not traverse the nonstatutory double patenting rejection over U.S. Patent No. 10,881,650, that rejection is also MAINTAINED.
Allowable Subject Matter
As amended, claims 45, 47-48, 50-58, 63-65 and 68 are drawn to is a method for managing heavy menstrual bleeding associated with uterine fibroids in a premenopausal adult human female, the method comprising administering:
(a) a first daily dosage for a period of at least 12 months (more specifically, at least 18 months (claim 68)) and up to 24 months, comprising:
(i) the orally active, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix;
(ii) 1.0 mg estradiol; and
(iii) 0.5 mg norethindrone acetate; and
(b) a second daily dosage comprising elagolix without estradiol or norethindrone acetate.
The closest prior art is considered to be NCT01441635 (10/05/2011 – provided in Applicant’s IDS submitted 5/20/2021; of record), which discloses a “proof-of-concept study to determine whether elagolix [elagolix sodium] is safe and effective in the treatment of pre-menopausal women, at least 20 years of age, with heavy uterine bleeding associated with uterine fibroids... versus placebo, and in combination with add-back therapy” (Brief Summary), in particular wherein the add-back therapy entails “estradiol/norethindrone actetate” (Arm/Group 6; Intervention 6) and the outcomes include “[t]he mean change from baseline to the last menstrual cycle in uterine blood loss” over three months (Primary Outcome) and “[c]hange from baseline to Month 3 in Number of Bleeding Days” (Secondary Outcome).
However, Federal Circuit and PTAB decisions demonstrate that a clinical trial, in the absence of results, “is insufficient to establish a reasonable expectation of success” (Applicant Arguments, Page 8). As stated in IPR 2015-01136, Paper 23, “[t]here is insufficient evidence to find that one skilled in the art would find that there is a reasonable likelihood of success” that a drug could treat a certain condition based solely on “a proof of concept study” (Pages 13-14). Although evidence which actually demonstrates the efficacy of a specific dose would provide “one having ordinary skill in the art… ample reason to use routine experimentation… to determine the optimum doses for… treatment” (IPR 2015-01993, Paper 63, Pages 25-26), absent such evidence, a proof-of-concept clinical trial represents nothing more than a hope that the tested drug will be useful in the treatment of a condition (in IPR 2015-01136, Paper 23, Page 14). This reasoning is further supported by OSI Pharmaceuticals, LLC v. Apotex, Inc., 939 F.3d 1375 (Fed. Cir. 2019) and Novartis Pharm. Corp. v. West-Ward Phar. Int’l Ltd., 923 F.3d 1051 (Fed. Cir. 2019).
In the instant case, the closest “evidence which actually demonstrates the efficacy” of elagolix in the instantly claimed method is Neurocrine Biosciences (Abbot and Neurcrine Announce Global Agreement to Develop and Commercialize Elagolix for the Treatment of Endometriosis, June 16, 2010) which teaches “[e]lagolix is a novel, first-in-class oral gonadotropin-releasing hormone (GnRH) antagonist” wherein “[e]xtensive preclinical and clinical experience with elagolix suggests this drug could be an important advance for women with… uterine fibroids” (Paragraphs 1-2).
However, Neurocrine Biosciences does not provide any evidence or suggest the “[e]xtensive preclinical and clinical experience with elagolix” could be used for managing heavy menstrual bleeding associated with uterine fibroids, as recited by the instant claims.
For all the foregoing reasons, the claimed method is free of the art and non-obvious.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 45, 47-48, 50-58, 63-65 and 68 are MAINTAINED rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,881,659.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘659 claims are similarly drawn to a method of treating heavy menstrual bleeding associated with uterine fibroids comprising administering elagolix once daily in combination with 1.0 mg estradiol and 0.5 mg norethindrone acetate (and a second daily administration of elagolix without estradiol and norethindrone acetate) for a time period as recited by the instant claims, which would provide the instantly claimed outcomes.
Claims 45, 47-48, 50-58, 63-65 and 68 are MAINTAINED rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,045,470.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘470 claims are similarly drawn to a method of treating heavy menstrual bleeding associated with uterine fibroids comprising administering elagolix once daily in combination with 1.0 mg estradiol and 0.5 mg norethindrone acetate (and a second daily administration of elagolix without estradiol and norethindrone acetate) for a time period as needed to manage the heavy menstrual bleeding associated with uterine fibroids… wherein the method is effective to manage the heavy menstrual bleeding… while limiting bone mineral density loss from baseline in the patient caused by exposure to elagolix to less than 8% following 24 weeks of said once daily oral administration” (claim 1).
As such, the ‘470 claims differ from the instant claims in that the ‘470 claims do not define with specificity that the period of treatment at least 12 months and up to 24 months.
At the outset, as stated by the ‘470 Specification, “the treatment cycle is 3 months or 6 months of daily administration of Elagolix” (Column 14, Lines 4-5) and, “[a]lternatively, the treatment cycle is 12 months of daily administration of Elagolix” (Column 14, Lines 17-18). Elsewhere, the Specification states that “[t]he Elagolix... can be administered to a subject daily (namely, continuously)... for a duration of at least... 12 months, at least 18 months...” (Column 19, Lines 58-62).
Accordingly, in interpreting the scope of the claimed recitation of “for a period of time as needed to manage the heavy menstrual bleeding associated with uterine fibroids” in light of the ‘470 Specification, it is evident that the treatment could be for a period of time of at least 12 months (or, at least 18 months) and not to exceed 24 months.
Furthermore, as stated by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454 (CCPA): “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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, determining the length of treatment of any condition is clearly a result-effective variable. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal length of time to continue treatment in order to best achieve the desired results.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611