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 .
Applicant’s preliminary amendments filed 9/9/2024 have been entered.
Claims 201-220 are pending.
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.
Claim(s) 201-220 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 9,040,693 (‘693) in view of Franke et al., Fertility and Sterility, 2000, 74(3): 534-539. ‘693 and Franke et al. are reference of record.
‘693 teaches a genus of GnRH antagonists including the herein claimed compound, compound 233, as effective in treating endometriosis (see claim 30, col. 7, line 26 for example). . ‘693 teaches the effective amount of using the GnRH antagonists as 0.1-1,000 mg via oral administration (see col. 18, lines 60-63). ‘693 teaches additional agents can be used with the GnRH antagonist compounds; the secondary agents include estrogenic and progestins (see col. 19, lines 14-16).
‘693 does not expressly teach the herein claimed dosage of 100mg. ‘693 does not expressly teach the use of add back therapy as herein claimed.
Franke et al. teaches an add back therapy being used in a GnRH analogue to treat endometriosis-associated pain (see the abstract). Franke et al. teaches that Add back therapy is used in order to combat the adverse effect of hypoestrogenism caused by the GnRH analogue therapy (see page 535, col. 1, third paragraph). Franke et al. teaches the dosage of 2mg of 17β-estradiol and 1mg of norethindrone acetate (see page 535, col. 2, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time of filing to use the herein claimed dosage in the method of treating endometriosis and endometriosis-associated pain. It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the add back therapy into the method of treating pain associated with endometriosis.
One of ordinary skill in the art would have been motivated to incorporate the estradiol and norethindrone, in the herein claimed dosage of the actives, in the method of treating endometriosis and endometriosis-associated pain. The optimization of result effect parameters (e.g., dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The dosage of the Linzagolix taught in the cited prior art encompasses that recited in the claims. Therefore, case of obviousness exists. As for estradiol and norethindrone acetate, the dosage of the agents depends on the how much the level of estrogen being suppressed in the patient who receives GnRH blockage (such as Linzagolix) treatment. Adjusting the dosage of 17β-estradiol and norethindrone acetate to counter the hypoestrogenism caused by Linzagolix would be reasonably expected to be effective and thus, 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 § 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 201-220 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,980,621 (‘621). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘621 teaches the exact same method of treating endometriosis-associated pain and the composition of the compound of formula (II). However, ‘621 does not expressly teach the dosage of the active used in the method/composition as 100mg.
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the dosage of compound of formula (II) to 100mg.
One of ordinary skill in the art would have been motivated to adjust the dosage of compound of formula (II) to 100mg. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since ‘621 teaches the dosage of 200mg, reducing it to 100mg in order to minimize the severe side effects the patients would be seen as obvious.
Claims 217-220 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-20 of copending Application No. 18/244,773 (‘773) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘773 teaches a composition comprising 100mg of compound of formula (II) (see claims 17, 19 for example).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 217-220 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 220, 223-225, 228, 235-236 of copending Application No. 17/291, 192 (‘192) (reference application) in view of Franke et al.. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘192 teaches a method of treating endometriosis comprising 100mg of compound of formula (II) (see claims 220 for example). ‘192 teaches the add-back therapy (see claim 228).
‘192 does not expressly teach the specific add-back agents.
Franke et al. teaches an add back therapy being used in a GnRH analogue to treat endometriosis-associated pain (see the abstract). Franke et al. teaches that Add back therapy is used in order to combat the adverse effect of hypoestrogenism caused by the GnRH analogue therapy (see page 535, col. 1, third paragraph). Franke et al. teaches the dosage of 2mg of 17β-estradiol and 1mg of norethindrone acetate (see page 535, col. 2, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the estradiol and norethindrone, in the herein claimed dosage of the actives, in the method of treating endometriosis and endometriosis-associated pain.
One of ordinary skill in the art would have been motivated to incorporate the estradiol and norethindrone, in the herein claimed dosage of the actives, in the method of treating endometriosis and endometriosis-associated pain. Combining the known add-back therapy agents, such as estradiol and norethindrone acetate, into the method would be reasonably expected to be effective with GnRH antagonist therapy for endometriosis. As for estradiol and norethindrone acetate, the dosage of the agents depends on the how much the level of estrogen being suppressed in the patient who receives GnRH blockage (such as Linzagolix) treatment. Adjusting the dosage of 17β-estradiol and norethindrone acetate to counter the hypoestrogenism caused by Linzagolix would be reasonably expected to be effective and thus, obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 201-220 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 398, 401-414 of copending Application No. 17/633,479 (‘479) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘479 teaches the method of treating endometriosis using the herein claimed compound in a dosage of 100mg, with optional add-back therapy including estradiol and norethindrone acetate (see claim 398, 404, 410-412).
‘479 does not expressly teach the composition comprising the herein claimed compound.
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the herein claimed composition.
One of ordinary skill in the art would have been motivated to formulate the herein claimed composition. As it is known for the herein claimed compound being administered to treat endometriosis, therefore, it would be reasonably expected to be successful to formulate the composition of 100mg of the herein claimed compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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