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 .
DETAILED ACTION
This action is in response to papers filed August 13, 2026. Applicant’s reply to the restriction/election requirement of June 18, 2026 has been entered. Claims 1, 3, 5, 10, 13, 14, and 18-20 have been amended; and claims 2, 6, 7, 11, 12, 21-24, 26, 27, 29, and 32 have been canceled. Claims 1, 3-5, 8-10, 13-20, 25, 28, 30, 31, 33, and 34 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/US2022/052704, filed December 13, 2022 under 35 U.S.C. 365(c), which claims the benefit of prior-filed U.S. Provisional Patent Application No. 63/289,965, filed December 15, 2021 under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3-5, 8-10, and 13-20, is acknowledged. Applicant’s elections of i) “dispersing agent” as the species of additional requisite constituent, ii) “polysorbate 80” as the species of wetting agent, iii) “sorbitan monopalmitate” as the species of dispersing agent, iv) the combination of “buffer, thickening agent, and preservative” as the species of further constituent, v) “sodium carboxymethylcellulose” as the species of thickening agent, vi) “phosphate buffer” as the species of buffer, and vii) “benzyl compound” as the species of preservative are all also acknowledged. The Examiner has determined that claims 1, 3-5, 8-10, 13-16, and 18-20 read on the elected subject matter.
Accordingly, claims 17, 25, 28, 30, 31, 33, and 34 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 13, 2026. Claims 1, 3-5, 8-10, 13-16, and 18-20 are currently under examination in the application.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract introduces in a rather abstract manner the notion that key requisite features of the invention are the levonorgestrel butanoate particle size and concentration being administered, but never actually informs the reader what the requisite particle size is and what requisite concentration is being administered. Hence, the abstract does not adequately inform the reader what the key technical aspects of the product itself actually are.
3. The abstract should not refer to purported merits or speculative applications of the invention, and should not compare the invention with the prior art. However, this is primarily what the abstract does. Applicant is advised that the abstract is not intended to be a promotional advertisement for their product, and certainly not for promoting their product over competitive products that are already known and on the market.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 5, 13-15, 18, and 20 are objected to because of the following:
i) In claim 1, there is an extraneous comma between “formulation” and “comprising”; and there should be a semicolon between “100 mg/ml” and “and provided that”.
ii) In claim 5, the expression “the formulation is formulated” is awkward and in rough-hewn English grammatical form.
iii) In claims 13-15 and 20, the phrase “wherein the levonorgestrel butanoate particles having a median particle size” is in improper English grammatical form. Applicant is advised to amend the phrase to “wherein the levonorgestrel butanoate particles have a median particle size”.
iv) In claim 18, there is an extraneous comma between “formulation” and “comprising”; there should be a semicolon rather than a comma between “a preservative” and “wherein”; and there should be a semicolon between “100 mg/ml” and “and provided that”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 3-5, 8-10, 13-16, and 18-20 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 1, 4, and 18 stipulate that “if the pharmaceutical formulation comprises a wetting agent and a dispersing agent, then the wetting agent and the dispersing agent are present at a ratio” as specified. However, one of ordinary skill in the art cannot definitively ascertain whether the specified ratio is a weight ratio, a molar ratio, a volume ratio, or what. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 5, which depends from claim 1, stipulates in a wherein clause that “the formulation is formulated” for the purposes of “administer a dose of levonorgestrel butanoate that ranges from 30 mg to 90 mg” and “provide a contraceptive effect”, which renders the claim indefinite for the following reasons:
1. One of ordinary skill in the art cannot definitively ascertain whether claim 5 is merely a statement of intended use, or envisioned use, for the claimed product of claim 1, or rather whether claim 5 intends to impose a requisite active step of using the claimed formulation. In the latter case, claim 5 is a mixed claim type, which is improper.
2. One of ordinary skill in the art cannot definitively ascertain how, if at all, claim 5 further limits the actual composition of claim 1. Indeed, claim 1 already provides that the claimed composition comprises levonorgestrel butanoate at a concentration from greater than 20 mg/ml to 100 mg/ml. Claim 5 stipulates that the “formulation is formulated” to administer a dose of 30 mg to 90 mg levonorgestrel butanote. Yet, the formulation of claim 1, with a concentration of greater than 20 mg/ml to 100 mg/ml meets this criterion already, and the dose can be achieved merely by adjusting the volume of the formulation administered. Hence, one of ordinary skill in the art cannot make heads or tails out of how claim 5 is supposed to further limit claim 1, if at all.
Claim 10 recites at least one broader limitation (e.g. an aromatic compound) and at least one narrower limitation (e.g. a benzyl compound, paraben) that falls within the purview of the broader limitation, in the alternative in the same claim, which it indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3-5, 8-10, 13-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over McCormick et al. (U.S. Patent Application Pub. No. 2019/0328749).
Applicant Claims
Applicant’s elected subject matter is directed to a pharmaceutical formulation comprising levonorgestrel butanoate particles with particle size of 13.7 µm, or 7-20 µm; polysorbate 80; sorbitan monopalmitate; sodium carboxymethylcellulose; sodium phiosphate dibasic; sodium dihydrogen phosphate dihydrate; and benzyl alcohol; wherein the levonorgestrel butanoate is present at a concentration of greater than 20 mg/ml to 100 mg/ml, and wherein the polysorbate 80 to sorbitan monopalmitate ratio is 3:0.1 to 5:0.1.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
McCormick et al. disclose a pharmaceutical formulation comprising levonorgestrel butanoate particles with particle size of e.g. 13 µm, or about 10-30 µm; polysorbate 80; sorbitan monopalmitate; sodium carboxymethylcellulose; sodium phosphate dibasic; sodium phosphate dihydrate; and benzyl alcohol; wherein the levonorgestrel butanoate is present at a concentration of up to 50 mg/ml (abstract; paragraphs 0003, 0011, 0013, 0016-0021, 0023, 0026-0028, 0032, 0048, 0055, 0060, 0061).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
McCormick et al. do not explicitly disclose that the polysorbate 80 to sorbitan monopalmitate ratio is 3:0.1 to 5:0.1. This deficiency is cured by the teachings of McCormick et al. and the knowledge of one of ordinary skill in the art.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of McCormick et al. with the general knowledge of one of ordinary skill in the art to devise Applicant’s presently claimed composition.
McCormick et al. disclose a pharmaceutical formulation comprising levonorgestrel butanoate particles with particle size of e.g. 13 µm, or about 10-30 µm; polysorbate 80; sorbitan monopalmitate; sodium carboxymethylcellulose; sodium phosphate dibasic; sodium phosphate dihydrate; and benzyl alcohol; wherein the levonorgestrel butanoate is present at a concentration of up to 50 mg/ml, wherein the levonorgestrel butanoate particles do not agglomerate, and wherein the formulation, when administered to a subject, facilitates contraception. Since McCormick et al. disclose that a wetting agent such as polysorbate 80 is present in the amount of 0.05-2 wt%, and that a dispersing agent such as sorbitan monopalmitate is present in the amount of 0.05-2 wt%; since one of ordinary skill in the art would readily understand that polysorbate 80 and sorbitan monopalmitate for a surfactant system, and that polysorbate 80 is a hydrophilic surfactant, while sorbitan monopalmitate is a lipophilic surfactant, and the relative amount of these two surfactants can be optimized to prevent the levonorgestrel butanoate particles from agglomerating; and since McCormick et al. disclose that the combination of levonorgestrel butanoate particles with polysorbate 80 and sorbitan monopalmitate exhibited the most acceptable physical stability with respect to appearance, particle size distribution, resuspendability, and syringability of the micronized drug, one of ordinary skill in the art would thus be motivated to optimize the relative amounts of the polysorbate 80 and the sorbitan monopalmitate to thus arrive at a polysorbate 80 to sorbitan monopalmitate weight ratio of about 3:0.1 to 5:0.1.
For example, a polysorbate 80 amount of 2 wt% and a sorbitan monopalmitate amount of 0.05 wt% results in a polysorbate 80 to sorbitan monopalmitate weight ratio of about 4:0.1, squarely within the claimed range.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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