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 .
Preliminary amendments were filed 09/12/204 and 05/01/2025.
Information Disclosure Statement
Information disclosure statements were filed on 11/18/2024, 09/30/205, 01/26/2026.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3 and 12 in the reply filed on 08/07/2026 is acknowledged.
Claims 8-11 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2026.
Claim Interpretation
As this Examiner understands the invention, the claimed treatment of EAPP is intended to be a biphasic administration of wherein the first phase has a higher daily amount of drospirenone than the second phase. However, despite claim language setting out “a lower daily amount” for the second phase, applicant sets out a higher dosage of 2.5 mg, as opposed to 2.0 as the lowest part of the range of the second phase. The claims are therefore not interpreted as “biphasic” since the dosages are not consistent with the term. The rejections that follow are made until a correction is made to the claimed subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As explained above, while applicant intends to set out a biphasic administration where the second administration sets out a lower dose, the dosage amounts are not consistent with the claim language. In particular, the lower end of the of each phase shows the opposite. Specifically. The lower end of the first phase is lower than the lower end of second phase (2.0 mg vs 2.5 mg). The claims are therefore unclear with respect to USC 112, first paragraph. Clarification is requested.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
While applicant intends to set out a biphasic administration where the second administration sets out a lower dose, the dosage amounts are not consistent with the claim language. In particular, the lower end of the of each phase shows the opposite. Specifically. The lower end of the first phase is lower than the lower end of second phase (2.0 mg vs 2.5 mg). The claims are therefore indefinite under 35 USC 112, second paragraph. Clarification is requested.
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) 1-3 AND 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palacios et al 1, in view XP021282442 (Palacios et al 2).
Palacios et al 1 discloses a method of treating dysmenorrhea comprising of a dose of 4mg of drospirenone alone in a 24/4 regime (4 mgs is administered for 24 days), with the last 24 days no dose of drospirenone are administered as a placebo. This essentially describes a biphasic treatment with the second phase dose lower than that of the first phase dose (see Methods and Conclusions)
Palacios et al 2 discloses a method of an estrogen -free contraceptive method of a dose of 4mg of drospirenone alone in a 24/4 regime (4 mgs is administered for 24 days), with the last 24 days no dose of drospirenone are administered as a placebo (See Abstract). This essentially describes a biphasic treatment with the second phase dose lower than that of the first phase dose.
Both methods of treating dysmenorrhea and contraception put forth by Palacios et al (1 and 2) set method wherein the treatment is biphasic with the second phase dosage is lower than that of the first phase. The two teachings show that treatment of dysmenorrhea and contraception can be accomplished by the same methods and dosage regimens. The instant method as its use as a contraceptive would have been obvious to those ordinary skill in the art at the time of filing given the teachings of Palacios 1 and 2.
Conclusion
No claims are allowed. Correction of the dosages to coincide with the claim language will overcome the rejections of record.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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