DETAILED ACTION
Applicants’ arguments, filed 6 August 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
As a function of the claim amendments, claim 1 recites items (a), (b), (c), (d), and (f) but skips (e). Claim 22 has similar claim limitations. This appears to be a function of how the claims were amended and is not grounds for a rejection.
Claim Rejections - 35 USC § 103 – Obviousness
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9, 11-13, 15-19, 21-22 and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Betlach (US Patent 5,374,661) in view of Grenier et al. (US 2015/0297507 A1).
Betlach is drawn to a composition for transdermal delivery of diclofenac, as of Betlach, title and abstract. Betlach teaches the following composition, as of column 6, reproduced below.
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As to claim 1, the above-reproduced composition appears to be a hydroalcoholic gel. The above-reproduced gel appears to be monophasic as there is no evidence of emulsion formation.
As to claim 1(a), the claim requires diclofenac in a particular concentration. The 1% diclofenac of Betlach meets the claim requirements for the amount of diclofenac.
As to claim 1(b), the claim requires a monoalcohol. The ethanol of Betlach meets this claimed requirement.
As to claim 1(c), the claim requires a polyalcohol. The propylene glycol of Betlach meets this claimed requirement.
As to claims 1(b) and 1(c), Betlach teaches amounts of ethanol and propylene glycol that exceed the claimed amount. Nevertheless, generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of the criticality of the ethanol and/or propylene glycol concentration appears to have been provided. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a diclofenac gel are taught by Betlach; as such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of various excipients via routine experimentation.
As to claim 1(d), the claim requires a gelling agent. The carbomer of Betlach meets this claimed requirement.
As to claim 1(e), the claim requires an optional pH adjusting agent. The triethanolamine of Betlach meets this claimed requirement.
As to claim 1(f), the claim requires water. Betlach teaches this in the above-reproduced table.
As to claim 1, the claim requires a particular pH range. Betlach teaches a pH of 5.5 to 7.5 as of column 5 lines 33-42. This overlaps with the claimed pH range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Betlach differs from the claimed invention because Betlach teaches a sodium salt of diclofenac, rather than the claimed diethylammonium or epolamine salt of diclofenac.
Grenier et al. (hereafter referred to as Grenier) is drawn to diclofenac gel formulations, as of Grenier, title and abstract. On embodiment of such a formulation appears to be as of page 6, Table 6, reproduced below.
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Grenier teaches diclofenaic epolamine or diclofenac diethylammonium in paragraph 0050.
Grenier does not teach the required pH; the examiner notes that the teaching of paragraph 0093 of Grenier refers to the pH of a composition used for testing, not to the pH of the actually administered composition.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the epolamine or diethylammonium counter-ion, as of Grenier, in place of the sodium counter-ion of diclofenac in the composition of Betlach. Betlach is drawn to a composition for delivery of diclofenac, wherein diclofenac is the active agent, and wherein the cationic counter-ion to balance the charge of the diclofenac is sodium. Grenier teaches that epolamine and/or diethylammonium can be used in place of sodium to balance the charge of the negatively charged diclofenac. As such, the skilled artisan would have been motivated to have substituted epolamine and/or diethylammonium in place of sodium in order to have predictably balanced the charge of diclofenac with a reasonable expectation of success. The simple substitution of one known ingredient (e.g. epolamine and/or diethylammonium) in place of another (sodium) in order to achieve predictable results (as a cationic counter-ion to balance the charge of diclofenac) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
As to claim 1, the claim requires that the composition is substantially free from permeation enhancers. As best understood by the examiner, the composition of Betlach, column 6, Table I does not contain a permeation enhancer.
As to claim 2, while the examples of Grenier use ethanol, Grenier teaches isopropanol to be used in place of ethanol in paragraph 0055.
As to claim 3, Betlach teaches propylene glycol in the above-reproduced table.
As to claims 4-5, the total concentrations of propylene glycol and ethanol in Betlach appear to exceed the required 25% maximum of claim 4 or the required 20% maximum of claim 5. Nevertheless, generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of the criticality of the sum of the ethanol and propylene glycol concentration appears to have been provided. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a diclofenac gel are taught by Betlach; as such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of various excipients via routine experimentation.
As to claim 6, Betlach teaches 17.1% ethanol (b) and 10% propylene glycol (c). This is a 1.71:1 or a 3.42:2 ratio of (b) to (c). This ratio appears to be within the claim scope.
As to claims 7-8, the optimization rationale applied by the examiner to claims 4-5 would appear to also be applicable to claims 7-8.
As to claim 9, Betlach teaches carbomer in the above-reproduced table; this reads on the required polyacrylic acid.
As to claim 11, Grenier teaches the diethylamine salt of diclofenac, as of paragraph 0050. This reads on the required diclofenac diethylammonium because the term “diethylammonium” refers to a protonated form of “diethylamine.”
As to claim 12, the 68.6% water in Betlach, above-reproduced table, reads on the required “about 70%” water.
As to claim 13, the amount of carbomer used in Betlach exceeds the required amount. However, Betlach teaches amounts as low as 0.5% as of column 4, bottom paragraph. These amounts appear to overlap with the claimed amounts. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claims 15-16, the composition of Betlach as exemplified above appears to lack emulsifying agents, and humectants.
As to claim 17, the composition of Betlach exemplified above appears to lack a lipophilic phase.
As to claim 18, Betlach appears to be silent regarding the viscosity. Grenier teaches an optimal viscosity of 10,000 cP in paragraph 0143. The examiner understands this to be equivalent to 10 Pa.S. This exceeds the recited “about 5 Pa.S.” Nevertheless, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of a diclofenac alcohol gel have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable viscosity via routine experimentation.
As to claim 19, Betlach appears to be silent regarding drying rate. Grenier teaches a quick-drying formulation in paragraph 0075. As such, there would have been a reasonable expectation that the composition of Grenier would have dried on the skin in the recited time frame. Something which is old (e.g. the composition of Betlach and/or Grenier) does not become patentable upon the discovery of a new property (e.g. the drying time), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II).
As to claim 21, Grenier teaches a transparent formulation, as of paragraphs 0075-0076.
As to claim 22, Betlach teaches diclofenac, propylene glycol, and carbomer, and Grenier teaches diclofenac, propylene glycol, carbomer, and isopropanol, as explained above. The concentration of these ingredients differs in Betlach and Grenier as compared with the instantly claimed invention. Nevertheless, generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Additionally, where 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 this case, the general conditions of an alcoholic gel comprising diclofenac has been taught by Betlach and Grenier; as such, it would not have been inventive for the skilled artisan to have determined the optimum or workable concentrations via routine experimentation. See MPEP 2144.05(II)(A).
As to claim 24, the skilled artisan would have expected the composition of Betlach and/or Grenier to have provided a cooling sensation due to evaporation of the alcohols in the composition. Also see paragraph 0075 of Grenier, which teaches a cool to the touch formulation. As such, the skilled artisan would have been motivated to have applied the composition of Betlach in view of Grenier to have provided a cool to the touch formulation.
As to claims 25-26, Grenier teaches treatment of osteoarthritis, as of Grenier, paragraphs 0080-0081. As such, the skilled artisan would have been motivated to have administered the composition of Betlach in view of Grenier to a patient suffering from osteoarthritis in order to have treated said osteoarthritis.
As to claim 26, the skilled artisan would have expected the composition of Grenier to have been administrable to the upper or lower extremities.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Betlach (US Patent 5,374,661) in view of Grenier et al. (US 2015/0297507 A1), the combination further in view of Smith et al. (US Patent 5,368,581).
Betlach and Grenier are drawn to a single phase hydroalcoholic gel for topical delivery of diclofenac. See the rejection above over Betlach in view of Grenier by themselves.
None of the above references teach an applicator pack.
Smith et al. (hereafter referred to as Smith) is drawn to applicator pads for topical drug delivery, as of Smith, title and abstract. Smith teaches applicator packs as of Smith, column 15 lines 14-20.
Smith does not teach diclofenac.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the composition of Betlach as modified by Grenier to have been delivered using the applicators of Smith. Smith is drawn to applicators for topical delivery of drugs. The compositions of Betlach and Grenier are compositions intended for topical drug delivery. As such, the skilled artisan would have been motivated to have used the applicators of Smith to have predictably topically delivered the diclofenac in the formulations of Betlach as modified by Grenier with a reasonable expectation of success.
The examiner notes here that Smith appears to be drawn to delivery of a different class of drugs as compared with the diclofenac of Betlach and Grenier. Namely, Smith appears to be drawn to delivery of drugs for treating acne, whereas Betlach and Grenier are drawn to delivery of diclofenac, which is a pain treatment drug. Nevertheless, the skilled artisan would have been motivated to have used the applicators of Smith to have predictably delivered the topical preparations of Grenier topically to the skin with a reasonable expectation of success.
Response to Arguments
Applicant has provided arguments in applicant’s response on 6 August 2026 (hereafter referred to as applicant’s response). These arguments are addressed below.
As an initial matter, various arguments presented by applicant, including those related to the Callett-Bois reference and to indefiniteness rejections, appear to be moot in view of the withdrawal of these rejections. As such, arguments related to these references will not be addressed substantively.
In applicant’s response, paragraph bridging pages 2-3, applicant argues that the examiner’s reliance on the basic gel of Betlach, column 6, Table I is misplaced because the relevant basic gel is actually a comparative example. See applicant’s response, page 3, top paragraph, relevant text reproduced below.
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Even if, purely en arguendo, the above-reproduced paragraph’s denoting that Betlach teaches that the basic gel of Betlach is an inferior composition is accurate, this argument is not persuasive to overcome the applied rejection. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use. See MPEP 2123(II) and 2145(X)(D)(1), first paragraph in section. As such, even if, purely en arguendo, Betlach teaches that a composition containing a permeation enhancer is better than a composition lacking a permeation enhancer, that is not understood to teach away from a composition that lacks a permeation enhancer.
On page 3, second paragraph, applicant argues that excluding the permeation enhancers of Betlach would have resulted in a composition unsuitable for the intended purpose of Betlach. The examiner disagrees. In contrast, the examiner admits that excluding the permeation enhancers of Betlach may have resulted in a composition that is not as good for its intended purpose of transdermal administration as a composition having permeation enhancers; however, this is not sufficient to teach away from providing a composition that lacks a permeation enhancer.
Applicant then makes the following argument as of the bottom paragraph of page 3, relevant text reproduced below.
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This is not persuasive as the permeation profile is not recited by the instant claims. As such, applicant appears to be arguing subject matter that was not actually recited by the claims. This argument is not persuasive. See MPEP 2145(VI).
Applicant then makes the following argument, as of the paragraph bridging pages 3-4 of applicant’s response, relevant text reproduced below.
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As best understood by the examiner, the citation to paragraph [0125] refers to the paragraph in the pre-grant publication of the instant application, which is US 2025/0090458 A1. This paragraph appears to be the same as the following paragraph from page 13 of the instant specification as filed.
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The above-reproduced text appears to disclose that the claimed invention achieves permeation characteristics similar to those of the existing Voltaren products, but does not provide data to support this position.
If applicant or declarant was to present data showing superior permeation characteristics in the substantial absence of a permeation enhancer, this could potentially be probative of non-obviousness in theory. Omission of an element with retention of the element’s function is an indicium of non-obviousness. See MPEP 2144.04(II)(B). In this case, omission of the permeation enhancer but retention of the ability of the diclofenac to permeate the skin could potentially be probative of non-obviousness.
With that being said, applicant does not appear to have actually presented data showing that omission of the permeation enhancer but retention of the ability of the diclofenac to permeate the skin actually occurs. The burden is on applicant to establish that results are unexpected and significant. See MPEP 716.02(b)(I). Applicant’s citation of the paragraph in the instant specification on page 13 lines 17-26 is not understood to meet the burden of establishing that the results are unexpected and significant. This is because the above-indicated paragraph merely states that similar permeation characteristics to the comparative example have been achieved, but does not provide graphs, charts, or other indications that the claimed invention achieves the desired permeation characteristics. Applicant has the burden of explaining proffered data; see MPEP 716.02(b)(II). This burden clearly has not been met because applicant has not actually proffered data supporting the idea that the claimed invention has beneficial permeation characteristics that are superior to those of the prior art. Given that applicant has not actually proffered relevant data, applicant has not met the burden of explaining proffered data.
As such, there does not appear to be evidence on the record in the form of secondary considerations such as unexpected results to successfully overcome the applied prima facie case of obviousness.
Applicant then argues that Grenier teaches that higher diclofenac concentrations than what is required by the instant claims are needed to achieve the desired permeation of diclofenac, as of applicant’s response, second half of page 4 and onto page 5. Applicant points to paragraphs 0005-0008 of Grenier which allegedly indicate that the Voltaren 1% gel, which is diclofenac in a concentration of 1%, is not satisfactory from the patient’s perspective. See paragraph 0005 of Grenier, which has been reproduced below.
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As such, applicant’s arguments not persuasive. As best understood by the examiner from reading the above-reproduced text, Voltaren Gel 1% was commercially available at the time of the publication of the Grenier reference and was therefore commercially available at the time of the effective filing date of the instant application. While the above-reproduced paragraph of Grenier indicates that some patients have found Voltaren Gel 1% to be unsatisfactory, this is not understood to teach away from Voltaren Gel 1% because said gel appears to have been commercially available at the time of filing. A known or obvious composition (e.g. 1% diclofenac, which occurs with Voltaren Gel 1%) does not become patentable simply because it has been described as somewhat inferior to some other product (e.g. a higher concentration of diclofenac in a gel) for the same use. See MPEP 2145(X)(D)(1).
Conclusion
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 ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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