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 1-8 have been cancelled.
Claims 9-23 are pending and under current examination.
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 1-23 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.
Claim 9 is indefinite because the claim is internally contradictory. Claim 9 requires a composition that can achieve a mean steady state Cmax, steady state Tmax, or steady state AUC after a single dose; however, mean steady state values are only applicable if multiple doses have been given. These terms refer to the average Cmax, Tmax, or AUC once steady state levels have been reached in a dosing regimen in which rate of elimination from the body is equivalent to the drug is re-introduced into the body (i.e. after a subsequent dose is given). Clarification is requested.
Claim 9 is indefinite because it requires a percentage of water without indicating the type of percentage (e.g. wt/wt or wt/vol). As such, the absolute amount of water permitted in the composition is indefinite.
Claim 17 is indefinite because it requires a percentage of water without indicating the type of percentage (e.g. wt/wt or wt/vol). As such, the absolute amount of water permitted in the composition is indefinite.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefinite concerns outlined above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claim 23 fails to include all the limitations of the claim upon which it depends. Claim 23 depends from claim 21, which, as it is currently worded, limits administration to once daily; however, claim 23 requires twice daily administration and therefore is outside the scope of claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 9-23 are rejected under 35 U.S.C. 103 as being unpatentable over Ajani et al. (WO2009019138; publication date: 10/15/2009; cited in the IDS filed 05/02/2024) in view of Ajani et al. (20050026889; publication date: 02/03/2005; cited in the IDS filed 05/02/2024) and further in view of Ray et al. (US20050008704; publication date: 01/13/2005).
With regard to claim 9, Ajani 138 discloses cortexolone 17a-propionate as an active agent for use in treating, inter alia, androgenetic alopecia and acne (see e.g. claims 18 and 27), wherein the active agent can be formulated into a liquid or semi-liquid formulation for topical administration, such as for example, cream, gel, ointment, emulsion or dispersion (page 11). In the context of describing crystallization of cortexolone 17a-propionate in a pharmaceutical composition, Ajani 138 discloses dissolving the cortexolone 17a-propionate in propylene glycol, polyethylene glycol, or short chain aliphatic alcohols. The dissolved cortexolone 17a-propionate is then combined with water at a specific ratio to crystalize a solvate (page 11). Ajani 138 also describes use of a liquid or semi-liquid formulation for topical administration, such as for example, cream, gel, ointment, emulsion or dispersion containing cortexolone-17α-propionate in the range of 0.1 to 2% by weight, preferably in the range of 0.2 to 1%, in a crystalline form selected from among solvate forms I, II, III or IV, preferably in solvate form IV, both in solution and crystalline dispersion states (page 11).
Thus in view of Ajani one having ordinary skill would have understood that cortexolone-17α-propionate is effective to treat androgenic alopecia or acne and that it can be dissolved in propylene glycol, polyethylene glycol, or short chain aliphatic alcohols; however, Ajani does not disclose a formulation having less than 5 % wt water, the claimed range of 5 – 15 wt % cortexolone-17α-propionate, or the pharmacokinetic functional language recited in instant claim 9.
Ajani 889 discloses compounds of formula II are useful for as antiandrogenic drugs (claim 2; formula II narrowly embraces cortexolone-17α-propionate):
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Ajani 889 teaches that these compounds are effective in doses ranging from 10 to 4000 micrograms (0040).
Ray teaches a composition for enhancing the solubility of hydrophobic pharmaceuticals comprising a drug and polyethylene glycol (abstract).
It would have been prima facie obvious to formulate cortexolone-17α-propionate as an anhydrous pharmaceutical composition having higher concentration of dissolved cortexolone-17α-propionate than expressly recited in Ajani 138. The artisan of ordinary skill would have been motivated to do so as a step in exploring optimal dose of the drug for topical delivery, using the guidance from Ajani 889 regarding effective dosage range for this category of compound. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, 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 also In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). See MPEP 2141.03 and 2144.05(II)(A). In the instant case, the antiandrogenic effect of cortexolone-17α-propionate had been recognized, and the substance was taught for topical delivery in various dosage forms. The solubility of cortexolone-17α-propionate in specific non-aqueous solvents that are also known to be suitable for formulating hydrophobic drugs was taught in the prior art. Arriving at an effective dose in a non-aqueous, pharmaceutically acceptable solvent such as the propylene glycol, polyethylene glycol, or short chain aliphatic alcohols taught as suitable to dissolve cortexolone-17α-propionate by Ajani 138 and, regarding PEG, suitable for dissolving hydrophobic active agents by Ray, would have been merely routine experimentation for the artisan of ordinary skill. The skilled artisan would have had reasonable expectation of success because Ajani 889 provides a dosage range as a starting point, and the solvents noted above were all known to dissolve cortexolone-17α-propionate and to be suitable pharmaceutical solvents. The examiner considers optimizing the dose to achieve the claimed pharmacokinetic parameters recited in instant claim 9 to have been obvious for exactly the same reasons stated above.
With regard to claims 10 and 11, the examiner does not consider the doses recited in these claims to patentably define over the cited prior art for the reasons set forth above regarding the range recited in instant claim 9.
With regard to claim 12-15, as discussed above, Ajani 138 teaches formulations that are liquid or semi-solid, and specifically cream, gel, ointment, emulsion or dispersion.
With regard to claims 17 and 18, optimizing water content is considered obvious exactly as set forth above for instant claim 9. It would have been obvious to select a solvent in which the cortexolone-17α-propionate is soluble in order to increase the concentration of this active agent as a aspect of dose optimization. Moreover, Ajani 138 teaches that cortexolone-17α-propionate precipitates in the presence of water (page 11), thus in order to increase the solubility of this substance in a formulation, the artisan of ordinary skill would have recognized removal of water would have been beneficial.
With regard to claims 19 and 20, as noted above, Ajani 138 teaches cortexolone-17α-propionate to be soluble in propylene glycol, polyethylene glycol, or short chain aliphatic alcohols and it would have been obvious to use these substances in combination (i.e. two or more) because they were taught for the same purpose. See MPEP 2144.06).
With regard to claims 21-23, as discussed above, Ajani 138 teaches topical administration of cortexolone-17α-propionate to treat acne of androgenic alopecia. It would have been a matter of routine for one of ordinary skill to optimize the dose and dosing schedule to achieve this outcome. See MPEP 2144.05.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-25 of U.S. Patent No. 10603327; cited in the IDS filed 05/02/2024;
claims 1-20 of U.S. Patent No. 10980819;
claims 1-16 of U.S. Patent No. 11213531; cited in the IDS filed 05/02/2024; and
claims 1-18 of U.S. Patent No. 11883415.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims render obvious the instant claims.
Inter alia, the claims of the cited patents embrace a method of treating androgenetic alopecia in a subject in need thereof, comprising topically administering once or twice a day to the subject an effective amount of a pharmaceutical formulation comprising about 5 weight percent to about 15 weight percent cortexolone-17α-propionate and a pharmaceutically acceptable amount of one or more pharmaceutically acceptable solvents, wherein the one or more pharmaceutically acceptable solvents comprise a mixture of a C1-C4 alcohol, a polyol ether, and a polyol, further wherein the cortexolone-17α-propionate is fully solubilized in the formulation, and wherein the formulation contains less than about 5 percent water.
With regard to the pharmacokinetic functional language recited in instant claim 1, the examiner considers optimizing the antiandrogenic effect by optimizing dose of the active compound to have been prima facie obvious to one of ordinary skill. See MPEP 2144.05. Moreover, the dose, composition, and dosing schedule in the cited patents appear to be identical to the composition and dosing schedule embraced by the instant claims. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Claims 9-23 rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-29 of U.S. Patent No. 8785427; cited in the IDS filed 05/02/2024;
claims 1-24 of U.S. Patent No. 9433628; cited in the IDS filed 05/02/2024;
claims 1-24 of U.S. Patent No. 9486458; cited in the IDS filed 05/02/2024;
claims 1-20 of U.S. Patent No. 10159682; cited in the IDS filed 05/02/2024;
claims 1-34 of U.S. Patent No. 10166245; cited in the IDS filed 05/02/2024;
claims 1-15 of U.S. Patent No. 10716796;
claims 1-20 of U.S. Patent No. 11207332;
claims 1-21 of U.S. Patent No. 12337002;
in view of Ajani et al. (WO2009019138; publication date: 10/15/2009; cited in the IDS filed 05/02/2024), Ajani et al. (20050026889; publication date: 02/03/2005; cited in the IDS filed 05/02/2024) and Ray et al. (US20050008704; publication date: 01/13/2005).
Inter alia, the claims of the cited patents embrace a pharmaceutical composition comprising cortexolone-17α-propionate, water, and an excipient in the form of a liquid or semi-solid, such as a suspension, emulsion, cream, gel, ointment, or lotion.
The claims of the ‘628, ‘458, ‘682, ‘245, ‘796, ‘332, and ‘002 recite that the excipient is selected from propylene glycol, cetylic alcohol, glyceryl monostearate, liquid paraffin, or a combination of any of the foregoing.
The claims of the cited patents do not recite a limitation that the formulation has less than 5 % wt water, the claimed range of 5 – 15 wt % cortexolone-17α-propionate, or the pharmacokinetic functional language recited in instant claim 9.
Ajani 138 discloses cortexolone 17a-propionate as an active agent for use in treating, inter alia, androgenetic alopecia and acne (see e.g. claims 18 and 27)). In the context of describing crystallization of cortexolone 17a-propionate in a pharmaceutical composition, Ajani 138 discloses dissolving the cortexolone 17a-propionate in propylene glycol, polyethylene glycol, or short chain aliphatic alcohols. The dissolved cortexolone 17a-propionate is the combined with water at a specific ratio to crystalize a solvate (page 11). Thus in view of Ajani one having ordinary skill would have understood that cortexolone-17α-propionate is effective to treat androgenic alopecia or acne and that it can be dissolved in propylene glycol, polyethylene glycol, or short chain aliphatic alcohols.
Ajani 889 discloses compounds of formula II are useful for as antiandrogenic drugs (claim 2; formula II narrowly embraces cortexolone-17α-propionate):
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Ajani 889 teaches that these compounds are effective in doses ranging from 10 to 4000 micrograms (0040).
Ray teaches a composition for enhancing the solubility of hydrophobic pharmaceuticals comprising a drug and polyethylene glycol (abstract).
It would have been prima facie obvious to formulate cortexolone-17α-propionate as an anhydrous pharmaceutical composition having 5-15% by weight dissolved cortexolone-17α-propionate and less than 5% wt water. The artisan of ordinary skill would have been motivated to do so as a step in exploring optimal dose of the drug for topical delivery, using the guidance from Ajani 889 regarding effective dosage range for this category of compound. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, 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 also In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). See MPEP 2141.03 and 2144.05(II)(A). In the instant case, the antiandrogenic effect of cortexolone-17α-propionate had been recognized, and the substance was taught for topical delivery in various dosage forms. The solubility in non-aqueous solvents, known to be suitable for formulating hydrophobic drugs was also taught in the prior art. Arriving at an effective dose in a non-aqueous, pharmaceutically acceptable solvent such as the propylene glycol, polyethylene glycol, or short chain aliphatic alcohols taught as suitable to dissolve cortexolone-17α-propionate by the cited patents and, regarding PEG, suitable for dissolving hydrophobic active agents by Ray, would have been merely routine experimentation for the artisan of ordinary skill. The skilled artisan would have had reasonable expectation of success because Ajani 889 provides a dosage range as a starting point, and the solvents noted above were known both to dissolve cortexolone-17α-propionate and to be suitable pharmaceutical solvents. The examiner considers optimizing the dose to achieve the claimed pharmacokinetic parameters recited in instant claim 9 to have been obvious for exactly the same reasons stated above.
Claims 9-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-69 of copending Application No. 19168605; and
claims 1-21 of copending Application No. 19213049
in view of Ajani et al. (WO2009019138; publication date: 10/15/2009; cited in the IDS filed 05/02/2024), Ajani et al. (20050026889; publication date: 02/03/2005; cited in the IDS filed 05/02/2024) and Ray et al. (US20050008704; publication date: 01/13/2005).
Inter alia, the claims of the cited applications embrace a pharmaceutical composition comprising cortexolone-17α-propionate, water, and propylene glycol, cetylic alcohol, glyceryl monostearate, liquid paraffin in the form of a liquid or semi-solid, such as an emulsion or cream.
The claims of the cited applications do not recite a limitation that the formulation has less than 5 % wt water, the claimed range of 5 – 15 wt % cortexolone-17α-propionate, or the pharmacokinetic functional language recited in instant claim 9.
Ajani 138 discloses cortexolone 17a-propionate as an active agent for use in treating, inter alia, androgenetic alopecia and acne (see e.g. claims 18 and 27). In the context of describing crystallization of cortexolone 17a-propionate in a pharmaceutical composition, Ajani 138 discloses dissolving the cortexolone 17a-propionate in propylene glycol, polyethylene glycol, or short chain aliphatic alcohols. The dissolved cortexolone 17a-propionate is the combined with water at a specific ratio to crystalize a solvate (page 11). Thus in view of Ajani one having ordinary skill would have understood that cortexolone-17α-propionate is effective to treat androgenic alopecia or acne and that it can be dissolved in propylene glycol, polyethylene glycol, or short chain aliphatic alcohols.
Ajani 889 discloses compounds of formula II are useful for as antiandrogenic drugs (claim 2; formula II narrowly embraces cortexolone-17α-propionate):
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Ajani 889 teaches that these compounds are effective in doses ranging from 10 to 4000 micrograms (0040).
Ray teaches a composition for enhancing the solubility of hydrophobic pharmaceuticals comprising a drug and polyethylene glycol (abstract).
It would have been prima facie obvious to formulate cortexolone-17α-propionate as an anhydrous pharmaceutical composition having 5-15% by weight dissolved cortexolone-17α-propionate and less than 5% wt water. The artisan of ordinary skill would have been motivated to do so as a step in exploring optimal dose of the drug for topical delivery, using the guidance from Ajani 889 regarding effective dosage range for this category of compound. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, 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 also In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). See MPEP 2141.03 and 2144.05(II)(A). In the instant case, the antiandrogenic effect of cortexolone-17α-propionate had been recognized, and the substance was taught for topical delivery in various dosage forms. The solubility in non-aqueous solvents, known to be suitable for formulating hydrophobic drugs was also taught in the prior art. Arriving at an effective dose in a non-aqueous, pharmaceutically acceptable solvent such as the propylene glycol, polyethylene glycol, or short chain aliphatic alcohols taught as suitable to dissolve cortexolone-17α-propionate by the cited applications and, regarding PEG, suitable for dissolving hydrophobic active agents by Ray, would have been merely routine experimentation for the artisan of ordinary skill. The skilled artisan would have had reasonable expectation of success because Ajani 889 provides a dosage range as a starting point, and the solvents noted above were known both to dissolve cortexolone-17α-propionate and to be suitable pharmaceutical solvents. The examiner considers optimizing the dose to achieve the claimed pharmacokinetic parameters recited in instant claim 9 to have been obvious for exactly the same reasons stated above.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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