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 .
Response to Amendments
Applicant’s new claim 13 filed on June 22, 2026, in response to the Office Action of April 24, 2026, is acknowledged by the examiner.
Response to Arguments
The examiner withdraws the Double Patenting rejection in view of the filing and approval of a Terminal Disclaimer on June 22, 2026. The Objection to the Specification is withdrawn in view of Applicant’s submissions. The Objection to the drawings is similarly withdrawn.
Suggestion for Allowance: The examiner notes that if the claims were directed to administering the claimed composition in a method claim for treating erectile dysfunction in a subject in need thereof wherein no additional APIs for treating ED were included in the composition, such claim language would narrow the subject population enough to obviate the prior art.
Applicant argues that the instant claims do not include any agent that can treat ED. The examiner notes that unexpected results have not been shown in this application through a comparison to the embodiments of the closest prior art. Without such show the examiner is merely determining if a prima facie showing is set forth in view of the cited prior art. Additionally, it is not clear that the embodiments taught by the prior art would not also have properties of the claimed compositions- even if those properties were not recognized. The instant claims do not include nor require a subject population. Further, excluding APIs for treating erectile dysfunction does not exclude analgesics, although it does exclude vasodilators. Amlodipine is a vasodilator. Claim 13 excludes testosterone, but it does not exclude analgesics nor synthetic androgens, such as danazol. It also does not exclude similar derivatives or metabolites or other agents. This is important because the APIs used in each of the cited prior art references appear to include agents not used for treating ED nor included in the listing of excluded classes of agents in new claim 13 with the exception of amlodipine.
Applicant argues that the compositions taught by the prior art do not remotely describe a composition having the particular components and ranges without including an API for treating ED.
The examiner highlights below the similarities of the prior art below with respect to teaching the claimed composition.
Wisnieski teaches water is used in examples in an amount of about 28-38%. See Example II-V, col.’s 5-6. Propylene glycol is shown at 10%, water at 37.9%, alcohol at 43.9%, each of which fall within claimed ranges in Example V. Ritter explains that a carbomer can be used as a gelling agent and Ultrez 10 is used in a concentration of 1% in Table 1. Wisnieski also teaches using a gelling agent to include a Carbopol. Ritter also teaches a carrier is taught to comprise: ethanol, water, propylene glycol, and glycerin.
The combination of Ritter and Wisniesky teaches a POSA that a topical composition for pain relief in the urogenital region can include lower and slightly higher amounts of ethanol.
Applicant argues that Ritter and Wisnieski each teach using different amounts of ethanol that the claimed amount.
The examiner notes that Ritter and Wisnieski teach using amounts lower and higher than the claimed amount in compositions for topical pain relief. As such a POSA would understand that a range that falls between two efficacious concentrations would be similarly usable. Further, the distinction has not yet been shown to be critical.
The examiner notes that amlodipine is a vasodilator and therefore Ritter and Wisnieski are not applied to new claim 13.
Davis teaches a composition comprising ethanol, water, propylene glycol, and glycerol. See prior art claims 1, 3, and 5. Further, Carbopol Ultrez 10 is contemplated as a gelling agent, which is an example of a Carbopol. See par. 8. Examples use Carbopol Ultrez 10. See Tables 6 and 8, e.g. Water can be used in a concentration of 20%, propylene glycol can be used in a concentration of 15%, ethanol can be used in a concentration of 32%-40% (Table 5), and glycerol can be used in a concentration of 9.25%. See Table 4 and claims. In some instances the Carbopol Ultrez 10 is used in a concentration of 0.75% and 1%. See Tables 4 and 5. Thus, the combination of non-volatile solvent pair is almost identical to that claimed.
The sole difference here appears to be using lower amounts of glycerol. However, if glycerol is used in a concentration of 9.25% and propylene glycol is used at up to 35% (See par. 4), the claimed concentration of glycerol and propylene glycol is 26-48% and that taught by the prior art is (9.25+15) 24.2% up to 44.25% (9.25+25).
Similarly, Masini-Eteve claims a composition with 10-90% ethanol, 0-10% propylene glycol, 0-5% gelling agent 0-30% glycerin, and remainder water. If the examiner took the middle 50% of these ranges claimed by the prior art, such composition would comprise: 45% ethanol, 5% propylene glycol, 2.5% gelling agent which can include Ultrez as an example, 15% glycerin, and 32.5% water. The middle 50% of the ranges taught by Masini-Eteve is similar to the claimed composition.
In view of the Wisnieski and Ritter, a POSA would understand that the claimed composition would be usable to treat pain through topical administration. In view of Masini-Eteve, a POSA would understand that the composition taught therein and claimed claim 2 would be usable to treat pain when applied topically.
Similarly, Davis teaches a composition for topical administration that provides menthol sensation for topical pain relief. Topical analgesics are contemplated. The composition comprises ethanol, water, propylene glycol, and glycerol. See prior art claims 1, 3, and 5. Further, Carbopol Ultrez 10 is contemplated as a gelling agent, which is an example of a Carbopol. See par. 8. Examples use Carbopol Ultrez 10. See Tables 6 and 8, e.g. Water can be used in a concentration of 20%, propylene glycol can be used in a concentration of 15%, ethanol can be used in a concentration of 32%-40% (Table 5), and glycerol can be used in a concentration of 9.25%. See Table 4 and claims. In some instances the Carbopol Ultrez 10 is used in a concentration of 0.75% and 1%. See Tables 4 and 5. Thus, the combination of non-volatile solvent pair is almost identical.
As such, without a showing of unexpected results and/or without excluding the classes of agents of APIs taught by the prior art, e.g., a prima facie showing is established by the prior art with known result effective variables.
Status of the Claims
Claims 1-13 are pending and examined.
Claim Rejections - 35 USC § 103
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ritter et al., (US2019/0365732), in view of Wisniewski et al., (U.S. Pat. No. 5,093,133).
Claims 1-12 do not exclude all forms of APIs. The claims are only drafted to exclude APIs traditionally known for use in treating erectile dysfunction. Further, it is not clear that a POSA would not understand that teachings of the references as a whole allow for any API to be dissolved ethanol or the other solvents taught by the prior art for incorporation into a topical gel formulation as described by both Ritter and Wisniewski.
The phrase “which may be” in the claims is being interpreted as optionally, rather than an example.
Ritter teaches a topical pain-relief gel composition for treating anorectal diseases. The composition can include 0.1-10% of a gelling agent, 10-40% water, 5-75% glycerin, 5-75% propylene glycol, and 1-20% ethanol. See par.’s 32, 33, 38-40 and 43-47. Further, a carrier is taught to comprise: ethanol, water, propylene glycol, and glycerin. See par. 84. Ritter explains that a carbomer can be used as a gelling agent and Ultrez 10 is used in a concentration of 1% in Table 1. The topical gel can be used for pain relief, and can be used to treat genital and anal warts. The pH of the compositions was neutral ranging from 5-7. See Tables 1-4.
Ritter teaches using a lower concentration of ethanol (20% compared to a claimed concentration of 30-35%).
Wisniewski teaches a pain relief hydroalcoholic gel comprising 40-60% ethanol, e.g., 0-20% propylene glycol, a gelling agent. Water can be used in a concentration of up to 100%, a pH can range from 3.5 to 6, and Carbopol can be used as a gelling agent. A viscosity can be in the range within or about 150,000 to 400,000 cps, but broader ranges are also possible and accepted. Further, pH is most preferably 4.7-5.7. Water is used in examples in an amount of about 28-38%. See Example II-V, col.’s 5-6. Propylene glycol is shown at 10%, water at 37.9%, alcohol at 43.9%, each of which fall within claimed ranges in Example V. Glycerin is taught as a suitable substitute for propylene glycol. See col. 4, line 33.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed compositions in view of the cited prior art. One would be motivated to do so because the difference between the use of any known gelling agent would be obvious. Further, each of the claimed components are known result-effective variables and can be optimized through nothing more than routine experimentation. As such, there is a reasonable and predictable expectation of success in arriving at the claimed compositions in view of the prior art. In this case, Ritter teaches each of the claimed components other than a higher concentration of ethanol. However, Wisniewski teaches using higher concentrations of ethanol as well as the claimed viscosity. Both Ritter and Wisniewski teach compositions that can be used to treat pain anorectal diseases. 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); and a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Masini-Eteve (US2011/0118226).
Masini-Eteve teaches gels for topical application to a subject to treat diseases and conditions of the breast. There is no API for treating ED. Claim 2 of the prior art recites:
2. A pharmaceutical composition according to claim 1 wherein said composition comprises: (i) 0.01 to 10% (w/w) of danazol, (ii) 10 to 90% (w/w) of at least one monoalcohol, e.g., ethanol or isopropanol, (iii) 0 to 10% (w/w) of at least one penetration enhancer, e.g., isopropyl myristate or propylene glycol, (iv) 0 to 5% (w/w) of at least one gelling agent, e.g., polyacrylic acids, cellulosics, or mixtures thereof, (v) 0 to 30% (w/w) of at least one moisturizer, e.g., glycerine, (vi) q.s 100% (w/w) water.
Each of these components overlaps a claimed component. Further, the gelling agent can include a Carbopol polymer including Ultrez. See par. 88. The inclusion of a buffering agent is also contemplated. See par. 102.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed compositions in view of the cited prior art. One would be motivated to do so because the difference the prior art teaches and claims a composition comprising the same components with a slightly broader concentration range. However, each component is a result effective variable and can be optimized through routine experimentation to achieve a desired result. Further, each of the claimed components are known result-effective variables and can be optimized through nothing more than routine experimentation. As such, there is a reasonable and predictable expectation of success in arriving at the instant claims in view of Masini-Eteve. 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).
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US2017/0020898), in view of Shanler et al., (US2015/0328259), and in view of Wisniewski et al., (U.S. Pat. No. 5,093,133).
Davis teaches a composition for topical administration that provides menthol sensation for topical pain relief. Topical analgesics are contemplated. The composition comprises ethanol, water, propylene glycol, and glycerol. See prior art claims 1, 3, and 5. Further, Carbopol Ultrez 10 is contemplated as a gelling agent, which is an example of a Carbopol. See par. 8. Examples use Carbopol Ultrez 10. See Tables 6 and 8, e.g. Water can be used in a concentration of 20%, propylene glycol can be used in a concentration of 15%, ethanol can be used in a concentration of 32%-40% (Table 5), and glycerol can be used in a concentration of 9.25%. See Table 4 and claims. In some instances the Carbopol Ultrez 10 is used in a concentration of 0.75% and 1%. See Tables 4 and 5. Thus, the combination of non-volatile solvent pair is almost identical.
The sole difference here appears to be using lower amounts of glycerol. However, if glycerol is used in a concentration of 9.25% and propylene glycol is used at up to 35% (See par. 4), the claimed concentration of glycerol and propylene glycol claimed is 26-48% and that taught by the prior art is (9.25+15) 24.2% up to 44.25% (9.25+25).
Carbopol Ultrez 10 is known as a thickening agent and gelling agent; the lower alcohol, water, and propylene glycol are known as a non-volatile solvent system; and glycerol is known as a higher hydrophilic non-solvent.
Shanler teaches a composition for topical application to the angiogenital region including the penis. See par. 61. The composition can include propylene glycol, ethanol as an alcohol. See par. 76 and 81. Examples were provided in Carbopol Ultrez 10 was used to maintain stabilized gel formulations, both physically and chemically stable.
Wisniewski teaches a pain relief hydroalcoholic gel comprising 40-60% ethanol, e.g., 0-20% propylene glycol, a gelling agent. Water can be used in a concentration of up to 100%, a pH can range from 3.5 to 6, and Carbopol can be used as a gelling agent. A viscosity can be in the range within or about 150,000 to 400,000 cps, but broader ranges are also possible and accepted. Further, pH is most preferably 4.7-5.7. Water is used in examples in an amount of about 28-38%. See Example II-V, col.’s 5-6. Propylene glycol is shown at 10%, water at 37.9%, alcohol at 43.9%, each of which fall within claimed ranges in Example V. Glycerin is taught as a suitable substitute for propylene glycol. See col. 4, line 33.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed compositions in view of the cited prior art. One would be motivated to do so because the difference between the use of any known gelling agent would be obvious. Further, each of the claimed components are known result-effective variables and can be optimized through nothing more than routine experimentation. As such, there is a reasonable and predictable expectation of success in arriving at the claimed compositions in view of the prior art. The body of prior art as a whole would be interpreted to show that the claimed agents are known for use in combination and the claimed concentrations and viscosities are acceptable and known result-effective variables that can be optimized through nothing more than routine experimentation.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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