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 Application
Claims 1-2, 4, 6-7, 9, 15-25, 28-36, 40-42, 66, 80-82, and 91 are pending
Claims 40-42, 66, and 80-82 are withdrawn from examination as being drawn to a nonelected species.
Claims 1-2, 4, 6-7, 9, 15-25, 28-36, and 91 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/04/2022, 10/21/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of Chinese Application No. CN202011506821.4 filed on 12/18/2020, U.S. Provisional Application No. 63/021,630 filed on 05/07/2020 and PCT Application No. PCT/US2021/031168 filed on 05/06/2021.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 10/21/2025 is acknowledged.
Claims 40-42, 66, and 80-82 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/19/2025.
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.
Claims 9, 15-17, and 24-25 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.
Claims 9 and 25 recite the limitation "the lipophilic excipient" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 15-17 recite the limitation "the 2-component solvent system" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "the solubilizing agent" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6-7, 9, 19, and 91 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al. (US 2011/0262502, already of record).
Lee et al. teaches formulations comprising 17-HPC (see abstract). Lee et al. teaches such compositions further comprising surfactants including polysorbate 60, glycerol monooleate, and oleic acid, which reads on the limitations of solubilizing agents and lipophilic agents (paragraph 0076). Lee et al. teaches kits comprising such compositions (paragraph 0003). Lee et al. teaches such compositions in the form of a solution (paragraph 0094).
Therefore, the reference is deemed to anticipate the instant claims above.
Claims 1, 4, 6-7, 9, 18-19, 28, 31, and 34-36 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Giliyar et al. (US 2019/0275060, as disclosed in IDS).
Regarding claims 1 and 18, Giliyar et al. is drawn towards compositions comprising esters of 17-hydroxyprogesterone, including 17-hydroxyprogesterone acetate and 17-alpha hydroxyprogesterone caproate (17-HPC) (see abstract; paragraph 0003; claim 1). Regarding claims 1, 4, 6-7, 9, Giliyar et al. teaches such compositions further comprising a solubilizing agent such as benzyl benzoate and lipophilic additives such as glyceryl monooleate (paragraphs 0009, 0210, 0220). Regarding claims 19, 28, and 31, Giliyar et al. teaches such compositions in the form of a solution or a soft capsule comprising a gelatin shell (paragraph 0225).
Therefore, the reference is deemed to anticipate the instant claims above.
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.
Claims 2, 15-17, 20-25, and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Giliyar et al. (US 2019/0275060, as disclosed in IDS) as applied to claims 1, 4, 6-7, 9, 18-19, 28, 31, and 34-36 above.
The teachings of Giliyar et al. are presented above. Giliyar et al. further teaches 17-HPC present in an amount of about 5% to about 80% (paragraph 0220). Giliyar et al. further teaches the ratio of 17-HPC to benzyl benzoate can be 1:0.01 to about 1:5, which results in a concentration of benzyl benzoate in a range of about 0.5% to about 80% (paragraph 0221). Giliyar et al. further teaches that the lipophilic additive can be present in an amount of 5-95% (see Table A1). Giliyar et al. further teaches the administration of from 100 mg/mL to 500 mg/mL of 17-HPC (paragraph 0270).
Giliyar et al. does not explicitly teach the recited concentrations of 17-HPC, solubilizing agents, and lipophilic agents.
Even though the range for the concentration of components as taught by Giliyar et al. is not the same as the claimed concentrations, Giliyar et al. does teach an overlapping range of concentrations, and it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05(I). Furthermore, the determination of concentrations is well within the purview of those skilled in the art through routine experimentation, and it has been held that “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). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the concentrations of 17-HPC, the solubilizing agents, and lipophilic agents in order to increase the bioavailability and solubility of 17-HPC as taught by Giliyar et al. (paragraph 0009).
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
Conclusion
Claims 1-2, 4, 6-7, 9, 15-25, 28-36, and 91 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691