DETAILED ACTION
Requirement for Restriction/Election was mailed 27 January 2026.
Applicant’s Response to Requirement for Restriction/Election was received 27 March 2026.
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
The listing of claims filed 27 March 2026 has been examined.
Claims 1-24 are pending.
Claims 12-24 are withdrawn.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 03 November 2023 is acknowledged and has been considered.
Benefit of Earlier Filing Date
The instant application, filed 03 November 2023, claims the benefit of an earlier filing date to U.S. Provisional Patent Application Serial No. 63/422,217, filed 03 November 2022. Acknowledgment is made of Applicant’s claim.
Restriction/Election
Applicant’s election without traverse of Group I (Claims 1-11) in the Response filed 27 March 2026 is acknowledged. The claims in Group II (Claims 12-24) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 March 2026.
Specification
The use of the terms PCCA Lipoderm®, Lipoderm ActiveMaxTM, and Lipoderm High Molecular WeightTM, which are a trade name or a mark used in commerce, has been noted in this application (Paragraph [0037]). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b)
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, 3-9, and 11 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 1 recites “an anthranilic acid derivative”. The specification provides some guidance on the definition of “derivative”, stating, “Fenamic acid is a derivative of anthranilic acid that is a nitrogen isostere of salicylic acid. Several compounds derived from fenamic acid or anthranilic acid, referred to herein as “anthranilic acid derivatives,” are used as non-steroidal anti-inflammatory drugs, including, for example, mefenamic acid, tolfenamic acid, flufenamic acid, and meclofenamic acid. The compositions and methods of embodiments can include any one or various combinations of these anthranilic acid derivatives.” (Paragraphs [0024-0025]). However, it is unclear whether “derivative” is limited to structural and/or functional analogs, and it is unclear what degree of structural or functional similarity must be present in order to be encompassed by the term “anthranilic acid derivative”. Accordingly, the metes and bounds of the terms are unclear and the claims are therefore indefinite.
Claims 3-9 and 11, which depend on claim 1, inherit the 112(b) issue present in claim 1 while failing to resolve the issue.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nitta (JP2003026575).
Regarding claims 1 and 8, Nitta teaches a 1000 g ointment comprising 5 g Tranilast, 10 g anhydrous caffeine, 100 g glycyrrhizinic acid, 100 g stearyl alcohol, 1 g polyoxyethylene hydrogenated castor oil, 1g glyceryl stearyl acid [glyceryl stearate], 400 g white vaseline, and purified water (p. 12, Paragraph [0068], Example 12 (Ointment)). Tranilast, also known as N-(3,4-dimethoxycinnamoyl) anthranilic acid, is an anthranilic acid derivative (p. 3, Paragraph [0003]). The instant specification states, “In certain embodiments, the compositions may include a base such as… an ointment base (e.g., petrolatum, etc.)…” (Paragraph [0037]). A skilled artisan would recognize vaseline is another well-known term for petrolatum and that they are therefore equivalent. Thus, Nitta discloses an ointment containing an anthranilic acid derivative and petrolatum, specifically white petrolatum.
Regarding claims 3-5, Nitta teaches all of the claimed elements as stated above. Furthermore, the instant application states, “For example, in some embodiments, the solvent and/or penetration enhancer may be… hydrogenated castor oil… In some embodiments, the solvent and/or penetration enhancer may be a fatty alcohol such as… stearyl alcohol…” (Paragraph [0028]). Nitta’s 1000 g composition contains 100 g stearyl alcohol, or 10% (w/w) of the total composition, and 5 g Tranilast, or 0.5% (w/w) of the total composition. Stearyl alcohol can be considered a solvent and/or penetration enhancer of claim 3, and the amounts taught are within those of claims 4-5.
Regarding claim 9, Nitta teaches all of the claimed elements as stated above. Furthermore, the instant specification states, “In some embodiments, the composition may include an emulsifying agent, or emulsifier, including, for example,… monoglycerides, diglycerides, triglycerides, and blends thereof…” (Paragraph [0040]). Nitta’s composition contains glyceryl stearyl acid [glyceryl stearate], which a skilled artisan would recognize is a glyceride which can be considered an emulsifying agent of claim 9.
Claims 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato (EP 0200615 A1).
Sato teaches an exemplary emulsion formulation containing 1.0 g 2-furanmethyl-N-(2,3-xylyl)anthranilate, which is an anthranilic acid derivative, as well as 2.5 g stearic acid, 1.5 g cetyl alcohol, 5.0 g vaseline, 10.0 g liquid paraffin, 2.0 g polyoxyethylene monooleate, 3.0 g polyethylene glycol 1500, 0.3 g potassium hydroxide, and purified water wherein the total amount is 100.00 g ( p. 15, “Formulation example 6 (Emulsion)”). Sato discloses the polyethylene glycol 1500 and potassium hydroxide are added to purified water, which altogether comprises the aqueous phase (Col. 29, Lines1-3). The oil phase, comprising the remaining ingredients, is added to the aqueous phase prior to uniform emulsification in a homomixer (Col. 29, Lines 8-12). Furthermore, Sato indicates anthranilic acid derivatives, like mefenamic acid, are used as anti-inflammatory and analgesic agents (Col. 1, Lines 26-43) and are appropriate for use in external skin treatment compositions (Col. 4, Lines, 14-23). A skilled artisan would understand the exemplary emulsion formulation described by Sato to be an oil-in-water emulsion as it contains immiscible aqueous and oil phases wherein the oil phase is added to the aqueous phase.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nitta (JP2003026575).
Regarding claim 2, Nitta teaches all of the claimed elements as stated above. Furthermore, Nitta discloses Formula II, which represents anthranilic acid derivatives (Paragraph [0002]), including Tranilast, mefenamic acid, flufenamic acid, and meclofenamic acid (Paragraph [0026]).
Nitta does not explicitly teach a singular, exemplary composition containing a cream or ointment base and mefenamic acid.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Nitta would have found it prima facie obvious to produce a composition containing a cream or ointment base and mefenamic acid. Nitta discloses anthranilic derivatives such as Tranilast and mefenamic acid, and indicates such anthranilic acid derivatives are useful as anti-inflammatory analgesic agents (Paragraph [0002]). Additionally, Nitta discloses an exemplary ointment composition comprising Tranilast. Thus, a PHOSITA would have been motivated to substitute an alternative anthranilic acid derivative, like mefenamic acid, for Tranilast in the ointment disclosed by Nitta (MPEP 2143(I)(B)).
Claims 6 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nitta (JP2003026575) in view of Mjalli (WO 2021/236782 A1).
Regarding claims 6 and 10-11, Nitta teaches all of the claimed elements as stated above. Furthermore, Nitta teaches antimicrobial ingredients, like benzyl alcohol, may be included in the pharmaceutical composition (Paragraph [0047]) as well as polyhydric alcohols, such as polyethylene glycol (Paragraph [0051]), as tonicity agents (Paragraph [0049]).
Nitta does not explicitly teach a singular, exemplary composition containing a cream or ointment base, anthranilic acid, and an additional compound which is dimethyl sulphoxide (DMSO), ethyl alcohol, diethylene glycol monoethyl ether, polyethylene glycol (PEG), benzyl alcohol, or hydrogenated castor oil nor a composition containing either about 1-3% (w/w) mefenamic acid or about 5-10% (w/w) DMSO.
Mjalli teaches an exemplary formulation containing a gel base and analgesic blend active ingredients comprising 2.5% DMSO, 2% methyl salicylate, and 1% diclofenac (p. 18, Table 17). Mjalli indicates analgesic active ingredients include nonsteroidal anti-inflammatory drugs (NSAIDs) like methyl salicylate, diclofenac, flufenamic acid, meclofenamate, and mefenamic acid (p. 6-7, Paragraph [0031]). Additionally, Mjalli teaches DMSO has been utilized in the treatment of inflammatory conditions and is an effective ingredient in topical compositions due to its abilities to penetrate the skin and aid in the dermal penetration of other therapeutics (Paragraph [0037]). Furthermore, Mjalli suggests the topical composition may comprise about 1-10% (w/w) DMSO (Paragraph [0037]).
Mjalli does not explicitly teach an exemplary composition containing a cream or ointment base and an anthranilic acid derivative nor including 1-3% (w/w) mefenamic acid in the aforementioned composition.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Nitta would have found it prima facie obvious to prepare a composition comprising benzyl alcohol, polyethylene glycol, or 5-10% (w/w) DMSO as well as 1-3% (w/w) mefenamic acid based on the teachings of Mjalli. Nitta suggests additional ingredients such as benzyl alcohol and polyethylene glycol may confer additional benefit to the composition due to their activity as antimicrobial and tonicity agents, respectively. Additionally, Mjalli identifies DMSO as both a solvent and a penetration enhancer, and suggests including about 1-10% DMSO (Paragraph [0037]). Thus, a PHOSITA would have been motivated to include additional compounds which provide added therapeutic benefit, such as benzyl alcohol or DMSO, to the topical composition since Nitta and Mjalli suggest doing so confers advantageous properties to the composition. Regarding including about 1-3% (w/w) mefenamic acid in the topical composition, since Nitta and Mjalli indicate anthranilic acid derivatives are useful therapeutic agents, specifically anti-inflammatory analgesic agents, a skilled artisan would have been motivated to optimize the amount of mefenamic acid in the composition in order to achieve the desired anti-inflammatory effect (MPEP 2144.05(II)(A)). Furthermore, Nitta presents an exemplary ointment composition containing 0.5% (w/w) Tranilast (p. 12, Paragraph [0068], Example 12 (Ointment)) and Mjalli presents an exemplary gel formulation containing 5.5% (w/w) analgesic blend active ingredients comprising DMSO, methyl salicylate, and diclofenac (p. 11, Paragraph [0052]; p. 18, Table 17). Because Nitta and Mjalli also disclose mefenamic acid as an analgesic ingredient, a skilled artisan would have been motivated to substitute mefenamic acid for the other analgesic ingredients in the exemplary compositions taught by Nitta or Mjalli.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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/B.L.B./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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