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 .
Election/Restrictions
Applicant's election with traverse of Group I (drawn to a stable pharmaceutical composition comprising a capsule dosage form), in the reply filed on 07/16/2026 is acknowledged.
Claims 25-43 are pending of which claims 40-42 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 25-39 and 43 have been examined on the merits.
Please note, for clarity of the record, on 06/02/2026, Applicant elected the following species:
long-chain oil: Glyceryl monolinoleate (referred as "Maisine(RTM) CC"),
surfactant: Capryolcaproyl polyoxyl-8-glycerides (referred as "Labrasof(RTM) 90");
co-surfactant: Propylene glycol monocaprylate (referred as "Capryof(RTM) 90 ").
The co-solvent, Applicant elects Ethanol
Response to argument
Applicant's election with traverse of Group I in the reply filed on 07/16/2026 is acknowledged. The traversal is on the ground(s) that the restriction requirement is improper because the cited prior art does not disclose the three components of the claimed self-emulsifying system. Applicant’s argument has been fully considered but is not persuasive. The combined prior art cited in the 103 rejection below discloses the three components of the self-emulsifying system: long-chain oil, surfactant and co-surfactant, which demonstrate that the common structural feature is known in the art. Therefore, the requirement is still deemed proper but is NOT made FINAL.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office
action.
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 non-obviousness.
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 25-29, 35-36 and 39 is rejected under 35 U.S.C. 103 as being unpatentable over Prattipati et al., US 2021/0121480, in view of Williams et al., US 2020/0316093, Bernick et al., US 2019/0008968.
Regarding claim 25, 35-36, and 39, Prattipati (page 19, claim 1) teaches the following:
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196
436
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Regarding long chain oil, Prattipati ([0158]) teaches:
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398
434
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Regarding surfactant, Prattipati ([0168]) teaches:
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444
430
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Regarding co-solvent, Prattipati ([0060]) teaches: “co-solvents selected from the group consisting of diethylene glycol monoethyl ether (TRANSCUTOL® HP & TRANSCUTOL® P), ethanol, glycerine, polypropylene glycol, polyethylene glycol.”
Regarding dosage form, Prattipati ([0085]) teaches:
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100
438
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Regarding progesterone and estradiol, Prattipati ([0212, Table 3]) teaches that formulation comprises micronized progesterone, estradiol hemihydrate.
However, Prattipati does not explicitly teach co-surfactant as part of the composition.
Bernick (abstract; [0021]; page 13, claim 1) teaches pharmaceutical composition comprising: a progesterone and estradiol; a medium chain oil; and a non-ionic surfactant to improve solubility and bioavailability of the active ingredients. Bernick ([0105]) teaches commercially available formulations of progesterone are poorly or inconsistently absorbed. Bernick ([0063]) teaches that a medium-chain lipid vehicle and a nonionic surfactant can be used in varying relative proportion, i.e., 99:1 to 2:1, to suspend and/or solubilize progesterone. Bernick ([0065], [0067], [0062]) teaches oils used to suspend, partially solubilize, or fully solubilize progesterone include “medium-chain fatty-acid esters of propylene glycol including CAPMUL PG-8 NF (Propylene Glycol Monocaprylate), CAPMUL PG-12 EP/NF (Propylene Glycol Monolaurate) and CAPRYOL (Propylene glycol monocaprylate.)” Therefore, it would have been obvious to a person of ordinary skill in the art (POSITA) to modify Prattipati’s composition by incorporating propylene glycol monocaprylate or propylene glycol monolaurate, as co-surfactant, for example in the Composition 17-19 in Table 7 (Prattipati, [0226]). This would provide a three-component self-emulsifying system comprising Long-chain oil, surfactant, and co-surfactant. Therefore, a POSITA would have made such modification to improve or optimize suspension, solubility, and dispersion of the poorly water-soluble progesterone and estradiol active ingredient.
Regarding claims 26-29, as applied to claim 25 above, Prattipati ([0226], Table 7; [0229], Table 8) discloses procedures for preparing capsules comprising formulations in which the amount of each individual compound is reported in mg, as shown, for example, in Compositions 17, 19, and 22 in Table 7 and 8. The Table below presents those compositions on weight-percent basis, calculated from the mg amount disclosed by Prattipati.
Prattipati’s
Composition
Total Active ingredient (wt%)
Log-chain oil
+ surfactant
(wt%)
Etahnol co-solvent
(wt%)
Composition 17
33.67
65.66
0.67
Composition 19
33.67
64.33
2.0
Composition 22
33.67
62.88
3.33
As discussed previously, Bernick ([0065], [0067], [0062]) teaches the use of glycol monocaprylate or propylene glycol monolaurate useful for suspending and/or solubilizing progesterone, as an example. Therefore, a POSITA would be motivated to incorporate either component into the oil/surfactant portion of Composition 17, 19, or 22 as the claimed co-surfactant. Moreover, Williams ([0047]-[0051]) further discloses such lipid formulation were conventionally formulated by varying the respective contribution of the lipids components. For instance, Williams ([0047]-[0051]) discloses a glycerol fatty acid esters, i.e., glycerol monolinoleate, in amount of 10 to 60 wt %; propylene glycol fatty acid ester and/or a polyoxylglyceride, i.e., propylene glycol monocaprylate and Labrafil ® M2125CS, in an amount of 20 to 60 wt %; a surfactant, i.e., polyoxyl 40 hydrogenated castor oil, in an amount of from 15 to 60 wt %. It is also important to note that Prattipati ([0264]) further teaches that the formulation may be practiced “within a wide equivalent range of parameters.” Herein, Williams teaches that the relative amount of oil, surfactant, and co-surfactant may be varied within substantial ranges in a capsule-compatible lipid matrix. Therefore, a POSITA would have been motivated to select and adjust the relative amount of the long-chain oil, surfactant, and co-surfactant when formulating the self-emulsifying system of the progesterone/estradiol capsule composition as disclosed by Prattipati in view of Bernick. Furthermore, such adjustment would have involved selection of amount from known formulation ranges to optimize the formulation, to obtain a desired dispersion, suspension, and solubilization properties for the poorly-water soluble active ingredient, thereby improving the bioavailability. Therefore, a POSITA would have been motivated to modify Composition 17, 19, and 22 to include propylene glycol monocaprylate as a co-surfactant and then select the relative amount of the oil, co-surfactant, and surfactant within the composition optimization parameters to provide a suitable self-emulsifying capsule file.
Subject Matter Free of the Art of Record
The subject matter of claims 30-34, 37-28 and 43 is free of the art of record. The closest prior art are the Prattatini et al., US 2021/0121480, in view of Williams et al., US 2020/0316093, Bernick et al., US 2019/0008968. While the combined teachings of Prattatini, Williams and Bernick teach a stable pharmaceutical composition suitable for oral administration to a subject in need thereof, however, the prior art does not teach or suggest selecting a surfactant for the self-emulsifying system on whether the surfactant is either solid or liquid at room temperature. Furthermore, the prior art does not disclose a comparable method of preparing the claimed oral capsule formulation. Therefore, there is no motivation for a POSITA to modify the teaching of Prattatini to arrive at the claimed invention. These claims are not allowable until the 103 rejection is overcome.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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