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 .
Status of the Claims
Claims 1-15 are pending. Claim 15 is withdrawn. Claims 1-14 are rejected.
Information Disclosure Statement
The Information Disclosure Statements (IDS’s) submitted on 12/23/2025 and 1/15/2026 were considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of levonorgestrel for species (A) and meloxicam for species (B) in the reply filed on 1/15/2026 is acknowledged.
Claims 1-14 embrace Applicants elected species and are therefore under examination. The elected species is not allowable and has been rejected below.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
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.
Claim 13 is 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.
Claim 13 currently depends from claim 11 recites the limitation " the polymer(s)" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends changing dependency of claim 13 to claim 12. In the interest of compact prosecution and prior art analysis, Examiner is examining claim 13 as though it depends from claim 12.
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.
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.
Claim(s) 1-11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindenthal et al. (US20160000805).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Lindenthal discloses a pharmaceutical composition containing levonorgestrel (LNG; a progesterone receptor agonist) and a COX (cyclooxygenase) inhibitor for on-demand contraception (see title). In claim 16, Lindenthal further discloses a two-dose (identical) regimen of female contraception with both a COX inhibitor and levonorgestrel. The first dose is taken 0-24 hours prior to expected sexual intercourse and in a period of 0-48 hours after sexual intercourse, the female takes a second dose. Additionally, Lindenthal discloses a slow-release tablet formulation in Example 4 (see para. [0072]).
Lindenthal further teaches a kit for contraception containing 2 pharmaceutical preparations to be administered orally, wherein meloxicam is a suitable COX inhibitor (see para. [0033]). A suitable range for meloxicam dosing is 5-60 mg/day (see para. [0052]). In claim 17, Lindenthal teaches dosing ranges of 50-500 ug (0.05 mg- 0.5 mg; first dose) and 500-1500 ug (0.5 mg to 1.5 mg; second dose) of levonorgestrel.
Additionally, claim 18 discloses the invention as a vaginal ring that is used in a period of 0-24 hours prior to expected sexual intercourse and is worn up to 148 hours after sexual intercourse.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art fails to disclose the first dose being taken at any time post the first act of sexual intercourse. Additional dependent limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1-3 and 6-7, a skilled artisan would have been motivated to provide a two-dose contraception regimen to a female subject at risk of initiating an unwanted pregnancy, which includes both levonorgestrel (a progesterone receptor agonist) and meloxicam (cooxygenase-2 inhibitor) with a reasonable expectation of success. Two doses, pre and post sexual intercourse, of a combination of levonorgestrel and meloxicam would have been predicable at preventing an unwanted pregnancy and acting as female contraception (this includes if a second act of sexual intercourse was performed, as indicated in claim 2). Specifically, regarding claim 7, a skilled artisan would have expected a range of sexual activity in a subject at risk of initiating an unwanted pregnancy.
Additionally, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). It would have been obvious to a PHOSITA to administer the instantly claimed regimen within the specified time frames of (1) within about 24 hours (or within about 12 hours) before the first act of sexual intercourse and (2) between 36 hours and about 60 hours after the first dose with a reasonable expectation of success. The prior art time frames embrace the instantly claimed time frames.
Regarding instant claim 4, a skilled artisan would have been motivated to allow for the first dose to be taken within 24 hours after the first act of sexual intercourse with a reasonable expectation of success because the act of sexual intercourse may have been unpredictable to the female subject. Lindenthal teaches that sperm may live in the cervix for up to 5 days after sexual intercourse (see para. [0023]); timing the administration of the first dose over a range of 24 hours after the first act of sexual intercourse would have been obvious to a skilled artisan as a result of routine optimization. A PHOSITA would have a reasonable expectation of success in providing the first dose within the first 24 hours post sexual intercourse because there is variation in female hormone cycles and the sperm can live in the cervix for up to 5 days.
Regarding instant claim 5, it would have been obvious to a skilled artisan to provide an additional dose of said combination because there are variations in female hormone cycles and sperm may live in the cervix for up to 5 days. Preventing an unwanted pregnancy is a balance between the female hormones and the sperm survival. Adding an additional dose of treatment would have been obvious due to routine optimization in exploring treatment effectiveness.
Regarding instant claim 8, the prior art ranges of both levonorgestrel and meloxicam overlap with the instantly claimed 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.” MPEP 2144.05(I). It would have been obvious to a skilled artisan to optimize the prior art ranges to optimize treatment effectiveness with a reasonable expectation of success.
Regarding instant claims 9-11, it would have been obvious to a skilled artisan to provide a slow-release oral tablet, wherein the two doses/tablets are identical, with a reasonable expectation of success, as such conditions had been previously applied effectively with obvious formulations. Regarding instant claim 14, the prior art also discloses a vaginal administration path of an identical combination (progesterone receptor agonist-levonorgestrel and a COX inhibitor).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindenthal et al. (US20160000805), in view of Huang et al. (Journal of Pharmaceutical Sciences, Vol. 83, No. 6, 1994, 795-797).
The 103 rejection of claims 1-11 and 14 over Lindenthal supra is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Linenthal fails to disclose a wax formulation of the slow-release oral tablet.
Huang discloses an effective prolonged oral release, which incorporates waxes and polymers. “A drug can be incorporated into a matrix consisting of hydrophilic gums, a melt of fats and waxes, or a polymer in which the solubility of the polymer is pH dependent. The release of the drug from these systems may be controlled by diffusion or slow dissolution/erosion of the matrix or a combination of both processes” (see p. 795, left column).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of levonorgestrel and meloxicam in a slow-release tablet with waxes and/or polymers specifically.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 12, it would have been obvious to a PHOSITA to incorporate waxes into a slow-release formulation, as this has been extensively and previously demonstrated to be routine and operative. A skilled artisan would have had a reasonable expectation of success in a wax formulation to control release of a drug in a slow-release formulation. Regarding instant claim 13, which was rejected supra under 112(b), polymers were not specifically required by claim 12; thus, the further limitations of claim 13 are also not required to be taught by the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626