DETAILED CORRESPONDENCE
This office action is in response to applicant’s filing dated August 27, 2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 17-38 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed August 27, 2025. Claims 1-16 were previously canceled.
Applicants elected without traverse Group I, drawn to a pharmaceutical composition comprising 3-beta-hydroxy-5-alpha-pregnan-20-one, a sterol or an ester thereof, a mixture of acylglycerols, and wherein at room temperature the composition is a liquid oil composition as the elected invention and a formulation comprising a sterol or ester, cholesterol, and mixture of acylglycerols, medium-chain triacylglycerol as the elected formulation species in the reply filed on October 25, 2024. The requirement is still deemed proper. Claims 36-38 remain withdrawn.
Claims 17-35 are presently under examination as they relate to the elected species: cholesterol and medium chain acylglycerol and expanded species, sesame oil.
Priority
The present application is a continuation of US Application No. 15/601,214 filed on May 22, 2017, which is a continuation of US Application No. 14/626,490 filed on February 19, 2015, which is a divisional application of US Application No. 13/522,081 filed on August 17, 2012, which is a national stage entry of PCT/SE2011/050036 filed on January 14, 2011 which claims benefit of US Provisional Application No. 61/295,027 filed on January 14, 2010. The effective filing date of the instant application is January 14, 2010.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Withdrawn Objections and/or Rejections
Double Patenting
The terminal disclaimers filed on August 12, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 9,687,496 and 11,534,446 have been reviewed and are accepted. The terminal disclaimers have been recorded. Thus, the rejections of claims 17-35 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,687,496 and over claims 1-19 of U.S. Patent No. 11,534,446 B2 have been withdrawn.
Maintained Objections and/or Rejections
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 17-19, and 24-35 are is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murphy et al (US 6,855,721 B1, cited in the IDS filed November 17, 2022) in view of Benita (US 5,364,632, cited in the IDS filed November 17, 2022) and Angeles Uribe et al (US 5,643,604, cited in the IDS filed November 17, 2022).
With regard to instant claims 17, 24, 27, 28, and 30-35, Murphy teaches a pharmaceutical composition comprising at least one GABAA receptor modulator and a pharmaceutically acceptable carrier (col 4, lines 15-21). Murphy teaches suitable agents active at GABAA receptors include epiallopregnanolone (col 5, lines 35-45). Epiallopregnanolone can be construed to be the same as 3-beta-hydroxy5-alpha-pregnan-20-one, as evidenced by Backstrom et al (US 6,455,516 B1). Backstrom teaches epiallopregnanolone is generic nomenclature for 3-beta-hydroxy-5-alpha-pregnan-20-one (Table 1). Murphy teaches pharmaceutically acceptable carriers for systemic administration, which may be incorporated in the composition of the invention include vegetable oils (col 9, lines 16-19); formulations for parenteral administration may contain as common excipients, oils of vegetable origin (col 11, lines 59-63). Murphy et al teach liquid carriers include sesame oil (col 12, lines 49-50).
Murphy et al do not explicitly teach a composition comprising 3-beta-hydroxy-5-alpha-pregnan-20-one, cholesterol, and a mixture of acylglycerols including the elected medium chain triacylglycerols.
However, Murphy does teach depending on the particular route of administration, a variety of pharmaceutically acceptable carriers well known in the art are used (col 9, lines 9-10), and include vegetable oils (col 9, lines 16-19) and cholesterol (col 9, lines 27-32).
Moreover, Benita teaches a pharmaceutical carrier consisting essentially of a hydrophobic drug and a carrier, wherein said carrier is an oil in water type emulsion wherein about 3.5% (w/v) of an oily carrier consists of a medium chain triglyceride (MCT) oil and up to 50% of a vegetable oil, including sesame oil (claim 2), wherein the carrier is suitable for parenteral administration (claim 3); wherein the hydrophobic drugs include hydrophobic steroids (claim 15) including progesterone (claim 16). A medium chain triglyceride oil reads on a medium chain acylglycerol. Benita et al teach MCT oil has many advantages over vegetable oil, amongst which are the following: lower susceptibility to oxidation; having a specific density of 0.94-0.95 which is higher than that of vegetable oil and which is close to that of water thus facilitating the obtaining of a stable emulsion; being less hydrophobic than vegetable oil and therefore enables achieving higher concentrations of the drug dissolved therein; having a lower viscosity which again enables obtaining a higher concentration of the oily phase in the composition without substantially increasing its viscosity (col 2, lines 41-51). Benita et al further teach on the other hand, vegetable oil has the advantage over MCT oil in its lower price (col 2, lines 55-56). Thus, it was well known at the time of the instant invention that MCT oil (or medium chain acylglycerol) and sesame oil are useful as a co-solvent for lipophilic compounds such as hydrophobic steroid compounds such as progesterone.
3-beta-hydroxy-5-alpha-pregnan-20-one has the structure:
PNG
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390
528
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Progesterone has the structure:
PNG
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424
573
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Thus, progesterone and 3-beta-hydroxy-5-alpha-pregnan-20-one are structurally similar.
Furthermore, Angeles Uribe teaches a process for improving the control of the pharmacokinetic and pharmacological properties of an injectable pharmaceutically active substance which is adaptable for parenteral administration by injection (col 1, liens 7-11); among the preferred carrier substances, there may be mentioned by way of inactive substances which can constitute the structure of the microspheres (col 5, lines 29-31); cholesterol, of melting point 148-149° C., principal sterol in mammals, present in practically all the tissues of the human organism, and its esters (col 5, lines 36-38); it may appear surprising to inject suspensions of cholesterol particles to a human being, considering the part which is attributed to this substance in several cardiovascular diseases; but, compared to the 8-10 gms naturally present in the free state in the physiological medium, the 50-200 mg of an injection are of a small entity; moreover its relatively slow metabolism leads to consider this substance as pharmacodynamically inactive at these injected doses; on the other hand its physical properties are excellent for a carrier substance, in the frame of the present invention (col 5, lines 39-48). Moreover, Angeles Uribe teaches a pharmaceutical formulation suitable for parenteral administration comprising cholesterol as a carrier substance and a pharmaceutically active substance homogenously disbursed within said cholesterol carrier substance (claim 1) wherein the pharmaceutically active substance comprises a steroidal sexual hormone (claim 7), wherein the sexual hormone is progesterone.
It would have been prima facie obvious to one of ordinary skill in the art before the invention to select an oily carrier comprising sesame oil and MCT and a surfactant, cholesterol as the carrier for the composition comprising 3-beta-hydroxy-5-alpha-pregnan-20-one taught by Murphy. The motivation to include a mixture of MCT oil and vegetable oil, sesame oil, would have been the establishment by Benita that MCT oil provides advantages over vegetable oil including achieving higher concentration of the hydrophobic drug in the composition and improved storage stability, while vegetable oil is less expensive and would decrease the overall cost of producing the composition. The skilled artisan would have been further motivated to select MCT and sesame oil as the oily carrier in view of the cited art, since it was known in the art that MCT oil (or medium chain acylglycerol) and sesame oil are useful as a co-solvent for lipophilic compounds such as structurally similar hydrophobic steroid compounds such as progesterone. Moreover, the skilled artisan would have been motivated to select cholesterol as a surfactant since it is a known inactive carrier substance for use in compositions comprising a structurally similar steroid compound.
Regarding the limitation wherein at room temperature the composition is a liquid oil composition, the prior art does not explicitly teach the composition is a liquid oil composition at room temperature. However, the above chemical properties depend, among other things, from the specific components, relative amounts, type of formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation of epiallopregnanolone, cholesterol, and a mixture of acylglycerols wherein the mixture of glyceryl tricaprylate/caprate that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Taken together, all this would result in the composition of claims 17, 24, 27, 28, and 33-35 with a reasonable expectation of success.
Regarding instant claims 18 and 19, the cited references do not explicitly teach the claimed concentrations. However, Murphy teaches the disclosed composition can have a GABAA receptor modulator dosage where a total dosage of about 0.01 to about 1000 mg (col 10, lines 19-21). At the time of the invention, it would have been prima facie obvious to one of ordinary skill in the art to utilize the dosage amounts of GABAA receptor modulator taught by Murphy as a starting point for optimizing the concentration epiallopregnanolone in the composition to obtain a composition with the desired dosage amount.
Taken together, all this would result in the composition of claims 18 and 19 with a reasonable expectation of success.
Regarding instant claim 25, an amount of no more than 30 mg/ml is equivalent to an amount of no more than 3%. Murphy teaches representative carriers include cholesterol and suitable ranges vary from about 1% to about 50% by weight of the total composition. MPEP 2144.05 states: 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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
With regard to instant claims 26 and 29, Benita et al teach a suitable MCT oil is TCM (trade name) being a mixture of triglycerides wherein about 95% (w/v) of the fatty acid chains have either 8 or 10 carbon atoms (col 3, lines 49-52).
Taken together, all this would result in the composition of claims 25, 26, and 29 with a reasonable expectation of success.
Claims 20-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murphy et al (US 6,855,721 B1, cited in the IDS filed November 17, 2022) in view of Benita (US 5,364,632, cited in the IDS filed November 17, 2022) and Angeles Uribe et al (US 5,643,604, cited in the IDS filed November 17, 2022) as applied to claims 17-19 and 24-35 above, and further in view of Blaha et al (Biology of Reproduction, 1978; 18:441-447, cited in the IDS filed November 17, 2022).
Regarding instant claims 20-23, Murphy, Benita, and Angeles Uribe teach a composition comprising 3-beta-hydroxy5-alpha-pregnan-20-one, cholesterol, MCT oil, and sesame oil. The cited art does not explicitly teach the claimed ratios. However, Blaha teaches cholesterol is a useful excipient for a pregnane compound. Blaha teaches a higher concentration of 5-α-pregnane-3,20-dione (DHP) was made in a more oily formula containing 3 parts cholesterol, 11 parts sesame oil, 2 parts beeswax and 12% DHP (page 442, 1st column, 1st paragraph). Assuming DHP is 12% wt of the whole formula, cholesterol, sesame oil, and beeswax would make up 88% of the formula. 3 parts cholesterol, 11 parts sesame oil, 2 parts beeswax is about 16 parts of the 88%. Thus, cholesterol would make 3/16 of the 88%, which is equivalent to 16.5%, which results in a ratio of cholesterol to pregnane compound of 12:16.5 or 1:1.375. At the time of the invention, it would have been prima facie obvious to utilize a ratio of pregnane compound to cholesterol taught by Blaha as a starting point for optimizing the amount of cholesterol and 3-beta-hydroxy5-alpha-pregnan-20-one to formulate a composition comprising epiallopregnanolone, cholesterol, and a mixture of acylglycerols wherein the mixture of acylglycerols is MCT oil and sesame oil since the prior art teaches these amounts and ratios for a composition comprising a structurally similar compound, cholesterol, and sesame oil and because amounts and ratios are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed ratio range, the determination of the optimum or workable amounts and ratios given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the composition of claims 20-23 with a reasonable expectation of success.
Response to Arguments
Murphy/Benita/Angeles Uribe
Applicant argues:
Applicant disagrees with the Examiner's conclusion that epiallopregnanolone can be construed to be the same as 3-beta-hydroxy-5-alpha- pregnan-20-one. In particular, Applicant submits that the term "epiallopregnanolone" (as used in Murphy) refers to 3-alpha-hydroxy-5-alpha-pregnan-20-one, not 3-beta- hydroxy-5-alpha-pregnan-20-one (as recited in present independent claim 1). Applicant does note that the Examiner also points to Backstrom (EP 1063999B1) as evidence that epiallopregnanolone is 3-beta-hydroxy, 5-alpha-pregnan- 20-one - stating that Table 1 of Blackstrom establishes that epiallopregnanolone is generic nomenclature for 3-beta-hydroxy, 5-alpha-pregnan-20-one.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, Backstrom (US 6,455,516 B1, published by one of the instant inventors) explicitly teaches epiallopregnanolone is generic nomenclature for 3-beta-hydroxy-5-alpha-pregnan-20-one (Table 1). This is further supported by MacKenzie et al (Neuroactive Steroids in Brain Function. Springer 2008, Chapter 21 pp 435-447, cited in the IDS filed November 17, 2022) and Wang et al (Biochimie, 2007; 89:182-191, cited in the IDS filed November 17, 2022). MacKenzie teaches epiallopregnanolone is 3β-hydroxy-5α-pregnan-20-one (page 435, Abbreviations). Wang also teaches epiallopregnanolone is 3β-hydroxy-5α-pregnan-20-one (or 5α-P-3β-ol-20-one) (page 184, 2nd column, 1st paragraph). Thus, epiallopregnanolone can be construed to be the same as 3-beta-hydroxy-5-alpha-pregnan-20-one.
Applicant argues:
Benita also does not teach 3-beta-hydroxy-5-alpha-pregnan-20-one. Applicant submits that these different types of (but structurally similar) molecules (such as progesterone and 3-beta-hydroxy-5-alpha-pregnan-20-one) should not be considered interchangeable such that the teachings would be considered combinable. The cited prior art documents do not disclose 3-beta-hydroxy-5-alpha-pregnan-20-one. Rather, the cited documents relate to different compounds, e.g. steroid hormones. In relation to this, Applicant asserts that it is relevant to note that these compounds, e.g. steroid hormones, should not generally be presumed to possess similar characteristics, such as solubility or permeability. the issue at hand is whether the person of ordinary skill in the art, presented with a prior art formulation which includes one compound, would reasonably combine those teachings with that of a second publication (and possibly third publication), each of which describe formulations with different compounds with different solubilities and other physical properties. The differences in these properties are not slight; indeed, the entire reason that the prior art describes compositions with different ingredients is because the compounds described therein have meaningfully different solubilities and other physical properties, compelling different solutions for preparing compositions useful to administer those agents.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicants are reminded that it must be remembered that the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references, which make up the state of the art with regard to the claimed invention. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference and it is not that the claimed invention must be expressly suggested in any one or all of the references; but rather the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As set forth above, Murphy teaches a pharmaceutical composition comprising at least one GABAA receptor modulator, including epiallopregnanolone, which is known to be an alternative name for 3-beta-hydroxy5-alpha-pregnan-20-one and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carriers for parenteral administration include vegetable oils including sesame oil. As set forth above, Benita establishes that it was known in the art that MCT oil provides advantages over vegetable oil including achieving higher concentration of the hydrophobic drug in the composition and improved storage stability, while vegetable oil is less expensive and would decrease the overall cost of producing the composition. As set forth above, it would have been prima facie obvious to one of ordinary skill in the art before the invention to select an oily carrier comprising sesame oil and MCT and a surfactant, cholesterol as the carrier for the composition comprising 3-beta-hydroxy-5-alpha-pregnan-20-one taught by Murphy. The motivation to include a mixture of MCT oil and vegetable oil, sesame oil, would have been the establishment by Benita that MCT oil provides advantages over vegetable oil including achieving higher concentration of the hydrophobic drug in the composition and improved storage stability, while vegetable oil is less expensive and would decrease the overall cost of producing the composition. The skilled artisan would have been further motivated to select MCT and sesame oil as the oily carrier in view of the cited art, since it was known in the art that MCT oil (or medium chain acylglycerol) and sesame oil are useful as a co-solvent for lipophilic compounds such as structurally similar hydrophobic steroid compounds such as progesterone. Moreover, the skilled artisan would have been motivated to select cholesterol as a surfactant since it is a known inactive carrier substance for use in compositions comprising a structurally similar steroid compound.
Applicant argues:
The Examiner's expectation that sufficiently close structural similarity would lead to the compounds in question possessing similar properties, particularly in terms of solubility and permeability, is not supported by the prior art cited by the Examiner. For example, the Examiner cites Blaha who presents data which shows exactly the opposite - that despite close structural similarity, compounds in the steroid family can have dramatic differences in, e.g., solubility and permeability. The experiments described in Blaha employ three different steroids along with the 3-beta-hydroxy-5-alpha-pregnan-20-one of the present claims. These compounds are at least as similar to each other as they are to the 3-beta-hydroxy-5-alpha-pregnan-20-one of the present claims. Yet Blaha states that differences in solubility were notable, with progesterone being quite soluble in its wax-oil mix, DOC and DHP being less so.
In view of Blaha's clear statements of significant differences in solubility and bioavailability between closely-related steroid compounds, Applicant disagrees with the Examiner's the presumed expectation that compounds with sufficiently close structural similarity would possess similar properties particularly in terms of solubility and permeability.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The Examiner notes that Blaha provides no data to support that alleged differences in solubility. Thus, the differences in solubility cannot be ascertained from the disclosure of Blaha. One of ordinary skill in the art would reasonably expect that structurally similar compounds would possess similar solubilities in certain solvents and would have been motivated to utilize solvents that are taught as suitable solvents for progesterone to produce compositions with the structurally similar compound 3-beta-hydroxy-5-alpha-pregnan-20-one of the instant claims. While the compounds are not identical, they are sufficiently close in structure that one of skill in the art would expect such compounds to possess similar properties, thus it would be obvious to one of ordinary skill in the art to look to compositions comprising structurally similar compounds for solvents that would be useful for formulating parenteral compositions.
Applicant argues:
No composition comprising 3-beta- hydroxy-5-alpha-pregnan-20-one is taught by Angeles Uribe. In fact, Angeles Uribe discloses a formulation which incorporates solid cholesterol microspheres which comprise a pharmaceutically active substance; as the cholesterol is metabolized, the active substance is released into the bloodstream. One of ordinary skill in the art, reviewing the disclosure of Angeles Uribe, would not be led to apply the teachings of Angeles Uribe to the system of Murphy. The cholesterol microspheres of Angeles Uribe do not "solubilize" the active pharmaceutical agent. In this context, Applicant notes that the presently claimed invention arises out of the inventors' surprising discovery that the addition of a sterol surprisingly increases the solubility of 3-beta-hydroxy-5-alpha-pregnan-20-one in acylglycerols, and improves the bioavailability of the compound. In contrast, the purpose of the system of Angeles Uribe is to provide delayed release formulations (col. 2, lines 38-41) of active ingredients which are already soluble in biological fluids (col. 5, lines 50-52). The active agents which are suitable for use in the system of Angeles Uribe do not need to be solubilized. Accordingly, Applicant submits that Angeles Uribe does not provide any relevant teachings as to the use of a sterol to improve solubility or bioavailability of any active pharmaceutically active substance (since it concerns delayed release formulations not improved solubility), let alone 3-beta-hydroxy-5-alpha-pregnan-20-one.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Angeles Uribe teaches a process for improving the control of the pharmacokinetic and pharmacological properties of an injectable pharmaceutically active substance which is adaptable for parenteral administration by injection; among the preferred carrier substances, there may be mentioned by way of inactive substances which can constitute the structure of the microspheres; cholesterol, of melting point 148-149° C., principal sterol in mammals, present in practically all the tissues of the human organism, and its esters. Moreover, Angeles Uribe teaches a pharmaceutical formulation suitable for parenteral administration comprising cholesterol as a carrier substance and a pharmaceutically active substance homogenously disbursed within said cholesterol carrier substance (claim 1) wherein the pharmaceutically active substance comprises a steroidal sexual hormone (claim 7), wherein the sexual hormone is progesterone.
As set forth above, it would have been prima facie obvious to one of ordinary skill in the art before the invention to select an oily carrier comprising sesame oil and MCT and a surfactant, cholesterol as the carrier for the composition comprising 3-beta-hydroxy-5-alpha-pregnan-20-one taught by Murphy. The motivation to include a mixture of MCT oil and vegetable oil, sesame oil, would have been the establishment by Benita that MCT oil provides advantages over vegetable oil including achieving higher concentration of the hydrophobic drug in the composition and improved storage stability, while vegetable oil is less expensive and would decrease the overall cost of producing the composition. The skilled artisan would have been further motivated to select MCT and sesame oil as the oily carrier in view of the cited art, since it was known in the art that MCT oil (or medium chain acylglycerol) and sesame oil are useful as a co-solvent for lipophilic compounds such as structurally similar hydrophobic steroid compounds such as progesterone. Moreover, the skilled artisan would have been motivated to select cholesterol as a surfactant since it is a known inactive carrier substance for use in compositions comprising a structurally similar steroid compound.
Murphy/Benita/Angeles Uribe/Blaha
Applicant argues:
Murphy, Benita, and Angeles Uribe are discussed above, and those same comments should be considered incorporated here for the discussion of the rejections of claims 20-23 over Murphy in view of Benita, Angeles Uribe, and Blaha.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicant has not independently argued the merits of this rejection. Arguments regarding Murphy, Benita, and Angeles Uribe have been addressed above. Therefore, the rejection is maintained for the reasons set forth on the record and for those set forth in the response to the arguments above.
Conclusion
Claims 17-35 are rejected.
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628