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
Pursuant to the amendment dated 07/14/2026, claims 10 and 14-16 have been cancelled and new claims 24-33 have been added. Claims 1-8 have been cancelled in a previous communication.
Claims 9, 11-13, and 17-33 are pending and under current examination.
All rejections not reiterated have been withdrawn.
A terminal disclaimer is on file for US Patent Nos. 10603327, 10980819, 11213531, and 11883415.
Applicant’s arguments, see pages 15-16 and 18, were found persuasive regarding the claims embracing a solid (i.e. not in solution) form of cortexolone-17α-propionate in US Patent Nos 8785427, 9433628, 9486458, 10159682, 10166245, 10716796, 11207332, and 12337002; and US Serial No. 19213049, therefore the nonstatutory double patenting rejections are hereby withdrawn.
Claim Objections
Claim 9 is objected to because of the following informalities: Part of the unit “(ng*h)/ml” appears to have been accidentally deleted at the end of the claim. Appropriate correction is required.
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 25 and 27 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 25 does not recite a unit following the values for Cmax and AUC. As such the values of these parameters are 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 § 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, 11-13, and 17-33 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 claims 9, 24, and 25, 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 claims 9, 24, and 25 to have been obvious for exactly the same reasons stated above.
With regard to claims 11 and 26, 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, 13, 27, and 28, 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, 18, 29, and 30, 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, 20, 31, and 32, 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 and 33, 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.
Response to Arguments
Applicant's arguments as well as the declaration, both filed 07/14/2026, have been fully considered but they are not persuasive.
Response to declaration filed in the instant case but apparently a copy of a declaration addressing a rejection in US16529214, an application that is not part of the instant continuity chain:
A copy of a declaration filed in US Application No. 16529214 has been filed in the instant application. Insomuch as it is relevant to the current rejection, it is addressed as follows; however, this application is not part of the instant continuity chain.
On page 2, Declarant points out that cortexolone-17a-propionate is difficult to formulate due to its poor solubility, and that it is only sparingly soluble in aqueous buffer and is soluble at 10 mg/mL in DMSO, or approximately 0.9 % by weight; whereas the instant claims require a concentration of 5 to 15% by weight. On page 3, Declarant points out that cortexolone-17a-propionate is soluble at 20 mg/mL in ethanol or DMF. On page 3, Applicant points out that acetone has been used to generate a 1% wt cortexolone-17a-propionate solution but acetone is not a pharmaceutically acceptable solvent at concentrations above 12.69 %. On pages 3-4, Declarant discusses Jackson, which has not been cited in the instant case. On page 5, Declarant points out that the present formulation fully solubilizes the active. On page 6, Declarant argues that the prior art provided no guidance on how to solubilize cortexolone-17a-propionate. Declarant cites another document not cited in the current obviousness rejection, Winlevi. On pages 6-7, Declarant argues that they have surprisingly discovered that by maintaining the concentration below about 5% water they can inhibit a degradation reaction of cortexolone-17a-propionate to an unexpected degree.
These arguments are not persuasive because they don’t appear to address the reasoning underlying the current obviousness rejection. Solubility of cortexolone-17a-propionate in solvents other than those disclosed in the cited prior art (DMSO, acetone, DMF) are not relevant because the prior art teaches completely solubilizing cortexolone-17a-propionate in propylene glycol, polyethylene glycol, or short chain aliphatic alcohols. Applicant’s results do not appear unexpected because propylene glycol, polyethylene glycol, or short chain aliphatic alcohols, the claimed solvents, are also used in the cited prior art to dissolve cortexolone-17a-propionate. Discussion of teachings found within references not cited in the rejection by the examiner are also not relevant to the patentability of the instant claims. Nothing pointed to by declarant contradicts the disclosures relied upon by the examiner in the rejection under 35 USC 103.
Response to Arguments:
On pages 9-10, Applicant argues that in example 9 of WO ‘138, the concentration of cortexolone-17a-propionate is 3.8% wt, which Applicant argues is not what is claimed. Applicant argues further that the solution in example 9 is not a “pharmaceutical formulation” and is subsequently further processed, and that the final product contains cortexolone-17a-propionate at 1% wt as a dispersed phase.
With regard to the argument that the example discloses 3.8% cortexolone-17a-propionate, the examiner points out that the range recited in the claims begins at “about 5%”, thus, arguably the concentration is within the claimed range; however, the obviousness conclusion was based upon the fact that the artisan of ordinary skill would have recognized propylene glycol, polyethylene glycol, and short chain aliphatic alcohols can dissolve cortexolone-17a-propionate. Applicant’s attention is drawn to MPEP 2123(II): Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). One having ordinary skill in the art, a highly intelligent and well-educated individual with e.g. a Ph.D. in formulations science would have recognized that the teachings of Ajani 138 were not strictly limited to the exact concentration of cortexolone-17a-propionate present in a single example that would ultimately be formulated into a dispersed phase in an aqueous vehicle, but rather that these solvents could dissolve this otherwise difficult to dissolve substance at much higher concentrations than some other known pharmaceutical solvents. "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).
With regard to the assertion that the solutions disclosed by Ajani 138 are not a “pharmaceutical formulation”, the examiner respectfully disagrees with Applicant’s interpretation of the scope of this term. There would be nothing preventing use of cortexolone-17a-propionate dissolved in propylene glycol, polyethylene glycol, and/or short chain aliphatic alcohols as a pharmaceutical formulation as these substances are compatible with pharmaceutical use. Moreover, Ray, cited in the rejection, provides evidence that polyethylene glycol was suitable for pharmaceutical use.
On page 10, Applicant argues that while WO [Ajani] 138 discloses that certain solvents can dissolve cortexolone-17a-propionate, a person of ordinary skill would have understood that Ajani 138 related to methods of crystalizing cortexolone-17a-propionate.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the examiner recognizes that the final objective of Ajani 138 is to crystalize the cortexolone-17a-propionate; however, the fact remains that the artisan of ordinary skill would have been aware of the cortexolone-17a-propionate solubility in propylene glycol, polyethylene glycol, and short chain aliphatic alcohols. The motivation to use these solvents to formulate cortexolone-17a-propionate as a non-aqueous composition is derived from secondary references. Regarding the range in ratio of cortexolone-17a-propionate recited in the instant claims, the fact that a concentration of 3.8% dissolved was reached in one example using propylene glycol as a solvent would have given the artisan of ordinary skill a reasonable expectation of success that at least “about 5%” as claimed, could have been reached.
On page 10, Applicant argues that the present application achieves solubilization of cortexolone-17a-propionate without increasing systemic exposure, thereby minimizing or avoiding antiandrogenic side effects.
As noted in the rejection supra, the prior art teaches the solvents that dissolve cortexolone-17a-propionate in the claimed amounts, therefore the solution to the cited problem was already known. It would have been merely routine for one of ordinary skill to test for optimal solubility and concentration to achieve efficacy while minimizing side effects.
On pages 11-13, Applicant summarizes the declaration filed on 07/14/2026. Please refer to the examiner’s response to declaration section above.
On page 14, Applicant asserts that nothing in the cited art teaches or suggests preparing a formulation comprising less than about 5% water.
This assertion is not persuasive because it does not address the reasoning set forth in the rejection.
On page 14, Applicant argues that the importance of formulating Applicant’s high concentration of cortexolone-17a-propionate with less than 5% water was unexpected.
The examiner respectfully disagrees in this case that the result was unexpected as the claimed solvents and those described in the instant specification had been previously taught to solubilize cortexolone-17a-propionate at concentrations of least 3.8%. This is sufficiently close to the claimed about 5% wt that the artisan of ordinary skill would not have been surprised to see about 5% by weight solubility achieved. Please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims. In the instant case, it appears no unexpected result has been made of record.
On page 14, Applicant describes benefits in terms of storage stability; however removal of water typically improves the chemical stability of water-catalyzed chemical reactions, therefore the examiner does not find this to have been an unexpected result.
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, 11-13, and 17-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-69 of copending Application No. 19168605
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.
Response to Arguments
Applicant's arguments filed 07/14/2026 have been fully considered but they are not persuasive. Oon pages 17-18, Applicant points out that the ‘605 application is later filed and therefore the provisional nonstatutory double patenting rejection should be withdrawn.
In response, Applicant’s attention is directed to MPEP 804(I)(B)(1)(b)(iii): If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection. In the instant case, the nonstatutory double patenting rejection is not the only remaining rejection, and is therefore maintained. Moreover, Applicant is reminded that a double patenting rejection also serves public policy interests by preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
