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 .
Current Status
This action is responsive to the amended claims of 06/02/2026. Claims 1-22 are pending. Claims 13-14 are withdrawn. Claims 1-12 and 15-22 have been examined on the merits.
Election/Restrictions
Applicant’s election of oleic acid, no poloxamer, and hydroxypropyl cellulose in the reply filed on 06/02/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Note, while Applicant initially states poloxamer 188 as a species of poloxamer, Applicant has elected wherein the composition comprises no poloxamer (0 wt%).
A search for the elected species has retrieved prior art (see SEARCH 6 of the attached search notes). Thus, per Markush search practice, the search will not be extended unnecessarily to additional species in this Office Action.
The election reads on claims 1-12 and 15-22.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/02/2026.
Priority
The effective filing date is 05/05/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/03/2023, 02/28/2024, 03/04/2024, and 02/19/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1-12 and 15-22 are objected to because of the following informalities: claim 1 uses quotation marks around acronyms and alternative names for formulation ingredients, e.g., “TPGS”, “DMSO”. The quotation marks are unnecessary, please remove. The dependent claims are similarly objected since they do not fix the issue. 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 1-12 and 15-22 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 “α-tocopherol polyethylene glycol succinate (“TPGS” or “Vitamin E TPGS”)”. TPGS is understood as an acronym for the aforementioned compound; however, the phrase “or “Vitamin E TPGS”” is unclear. Since this phrase is within parentheses, it is unclear if “Vitamin E TPGS” is a required limitation or is merely exemplary. Further, it is unclear if “Vitamin E TPGS” is meant as just another name for the aforementioned compound or if this is a broader genus of said TPGS. Vitamin E comprises 8 compounds including a beta, gamma, and delta form in addition to the alpha form. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 2-12 and 15-22 are similarly rejected since they do not rectify the issue.
To overcome: amend as “α-tocopherol polyethylene glycol succinate (TPGS)”. Parentheses should only be used within chemical names and around acronyms.
Claims 2-3 recite the limitation "between 0 and about 50 wt% Poloxamer 188". There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites the formulation comprises “between 0 and about 5.0 wt% of a poloxamer;” the full range of 0-50 wt% is not supported by the parent claim. Therefore, the metes and bounds of the claims are undefined rendering the claims indefinite.
Claim 18 recites formulations comprising "Propylene glycol or CAPMUL PG PG Monolaurate". There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites the formulation comprises propylene glycol. In the embodiment of claim 18 wherein CAPMUL PG or PG Monolaurate is chosen, not propylene glycol, the formulation does not comprise propylene glycol. Instead, the formulation will comprise propylene glycol monolaurate. Since propylene glycol and propylene glycol monolaurate have different chemical structures, the second embodiment of claim 18 does not fall within the scope of parent claim 1. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 19-21 are similarly rejected since they do not rectify the issue.
Claim 18 recites formulations 29-30, 33-34, 37-38, and 41-42 which all contain 0 wt% of 2-(2-ethoxyethoxy)ethanol. Parent claim 1 requires the formulation to comprise 2-(2-ethoxyethoxy)ethanol. No wt% or range of wt% are recited in claim 1. Since claim 1 does not explicitly say the 2-(2-ethoxyethoxy)ethanol may be absent (e.g., 0 wt%), the 2-(2-ethoxyethoxy)ethanol is required. Thus, it is unclear how the formulations 29-30, 33-34, 37-38, and 41-42 may contain 0 wt% 2-(2-ethoxyethoxy)ethanol. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 19-21 are similarly rejected since they do not rectify the issue.
Claim 18 contains the trademark/trade name “CAPMUL PG”:
PNG
media_image1.png
52
120
media_image1.png
Greyscale
. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a compound of propylene glycol mono/di-ester and, accordingly, the identification/description is indefinite. Note, since “CAPMUL PG” and “PG Monolaurate” are on separate lines in the table, it is unclear if PG Monolaurate is a part of the CAPMUL PG name. In the interpretation where the two are separate names, the CAPMUL PG has no chemical names associated with it. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 19-21 are similarly rejected since they do not rectify the issue.
To overcome: please strike “CAPMUL PG” from the claims. Please only use generic chemical names within claims.
Claim 18 lacks a period at the end of the claim. It is unclear if the claim is complete. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 19-21 are similarly rejected since they do not rectify the issue.
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.
Claims 2-3 and 18-21 are 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. 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.
Claims 2-3 recite "between 0 and about 50 wt% Poloxamer 188". Parent claim 1 recites the formulation comprises “between 0 and about 5.0 wt% of a poloxamer;” the range of 6.0-50 wt% is outside of the scope of claim 1. Therefore, claims 2-3 do not further limit claim 1.
Claim 18 recites formulations comprising "Propylene glycol or CAPMUL PG PG Monolaurate". In the embodiment where CAPMUL PG is chosen, not propylene glycol, the formulation does not comprise propylene glycol. Since propylene glycol is required by parent claim 1, this embodiment is outside of the scope of claim 1. Therefore, claim 18 does not further limit claim 1. Dependent claims 19-21 are similarly rejected since they do not rectify the issue.
Claim 18 recites formulations 29-30, 33-34, 37-38, and 41-42 which all contain 0 wt% of 2-(2-ethoxyethoxy)ethanol. Parent claim 1 requires the formulation to comprise 2-(2-ethoxyethoxy)ethanol. No wt% or range of wt% are recited in claim 1. Since claim 1 does not explicitly say the 2-(2-ethoxyethoxy)ethanol may be absent (e.g., 0 wt%), the 2-(2-ethoxyethoxy)ethanol is required. Thus, formulations 29-30, 33-34, 37-38, and 41-42 are outside of the scope of claim 1. Therefore, claim 18 does not further limit claim 1. Dependent claims 19-21 are similarly rejected since they do not rectify the issue.
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.
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.
Claims 1-12 and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over HNAT (US 2019/0046438; pub. 02/14/2019; cited IDS of 11/03/2023) in view of:
OSMALEK (Osamlek, T. et al., Pharmaceutical Developent and Technology, 2017, 22(4), 521-536; provided IDS of 03/04/2024),
HADDLETON (US 2021/0085623; pub. 03/25/2021; effectively filed 11/01/2019), and
PMC (PMC Isochem, “Vitamin E TPGS,” pub. June 2020, retrieved from www.pharmaexcipients.com/wp-content/uploads/2020/07/TPGS-ISODEL-June-2020.pdf on 07/02/2026).
Note, HADDLETON qualifies as art under 102(a)(1) and (a)(2) date provision; the effectively filed date is the date of filing of the underlying application.
Determining the Scope and Contents of the Prior Art:
HNAT teaches formulations for topical application of active ingredients (Pg. 1 ¶1) comprising a) at least one active agent, b) an oil and optional thickener thereof, c) an organic solvent and thickener thereof, and d) and oil/solvent soluble skin penetrant enhancer (Pg. 1 ¶6-10). The preferred formulation ranges are a) 10-25 wt%, b) 30-40 wt%, c) 20-40 wt% and 6-12 wt% (Pg. 1 Table 1). Exemplary formulations are provided in Tables 2-5 on Pg. 9-13 comprising varying amounts of naproxen, DMSO, ethanol, propylene glycol, and an oil phase of long chain monounsaturated fatty acids, fatty alcohols, and terpenes: e.g., Formulation 2A comprising 15 wt% naproxen, 35 wt% DMSO, 0 wt% water, 10 wt% ethanol, and 26% oil phase; Formulation 3C comprising 15 wt% naproxen, 5 wt% lidocaine, 44 wt% DMSO, 0 wt% water, 12 wt% propylene glycol (1,2-propanediol), and 7 wt% oleic acid. The thickener for the solvent phase is hydroxypropyl cellulose (Pg. 5 ¶90). HNAT further teaches stabilizers including tocopherols can be used to minimize oxidative degradation (Pg. 1 ¶5). When cooled, the formulation is transparent (Pg. 8 ¶195). HNAT also teaches a method for topical delivery of such formulation comprising applying the formulation to a subject in need (Pg. 8 ¶183) to treat pain at a location on the human subject’s body (Pg. 13 Example 5).
OSMALEK teaches known over-the-counter, topical hydrogels of naproxen; e.g., Opokan Actigel comprising 10% naproxen sodium salt, ethanol, propylene glycol, DMSO, and hydroxypropyl cellulose (Pg. 522 Table 1). OSMALEK also teaches organogel formulations comprising 1.2-10 wt% naproxen, 10-11 wt% ethanol, and 37-41 wt% trancutol (2-(2-ethoxyethoxy)ethanol) (Pg. 523 Table 2). The oranogels are transparent with ~99.6 % transmittance (i.e., refractive index of 1-2) (Pg. 525 Table 3). Inclusion of transcutol in the formulation significantly increased drug flux values (i.e., higher bioavailability/penetration of the active) (Pg. 534 Left col. ¶1).
HADDLETON teaches formulations for transdermal delivery of drugs including naproxen (Pg. 1 ¶6-8). The most efficient formulations comprise 2-(2-ethoxyethoxy)ethanol and propylene glycol or 2-(2-ethoxyethoxy)ethanol and DMSO (Pg. 8 ¶117).
PMC teaches Vitamin E TPGS is a pharmaceutical excipient (Pg. 1 ¶1) which enhances drug permeability and stabilizes amorphous drug dispersions (Pg. 3 Properties) while having no effect of skin irritation (Pg. 4 Toxicology Data) and good stability (Pg. 5 Stability).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
HNAT does not teach the solvent comprising 2-(2-ethoxyethoxy)ethanol or the exact wt% of each component in claim 18.
OSMALKE does not teach the full solvent mixture of claim 1 or oleic acid.
HADDLETON does not teach the full solvent mixture of claim 1.
PMC does not teach a formulation of naproxen.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of topical naproxen formulations useful for treating pain and possesses the technical knowledge necessary to make adjustments to the formulation to optimize/enhance drug flux. Said artisan has also reviewed the problems in the art regarding topical naproxen gels and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references HNAT in view of each of: OSMALEK, HADDLETON, and PMC.
The artisan would be motivated to add ethanol and 2-(2-ethoxyethoxy)ethanol to the Formulation 3C of HNAT in order to increase naproxen drug flux, as recognized by OSMALEK (Pg. 534 Left col. ¶1). Since OSMALEK (Pg. 523 Table 2) and HADDLETON (Pg. 8 ¶117) teach 2-(2-ethoxyethoxy)ethanol is compatible with each of the other solvents ethanol, propylene glycol, and DMSO, the artisan would have an expectation of success in creating a viable gel. Further, since HNAT teaches inclusion of a permeation enhancer (Pg. 1 ¶6-10), the artisan would have an expectation of success.
The artisan would be motivated to use hydroxypropyl cellulose in the Formula 3C of HNAT in order to adjust solvent thickness, as recognized by HNAT (Pg. 1 ¶6-10, Table 1 & Pg. 5 ¶90). The artisan would have an expectation of success since the combination of ethanol, propylene glycol, DMSO, and hydroxypropyl cellulose is known to work in commercial naproxen gels (OSMALEK Pg. 522 Table 1).
The artisan would be motivated to use tocopherols such as TPGS in the Formula 3C of HNAT in order to minimize oxidative degradation, as recognized by HNAT (Pg. 1 ¶5). The artisan would be motivated to choose TPGS in particular in view of the positive properties recognized by PMC (above), including stability, no skin irritation, and permeation enhancement. HNAT’s inclusion of a permeation enhancer (Pg. 1 ¶6-10) provides further motivation and expectation of success to the artisan.
Regarding the wt% ranges in claims 1-5, 10-12, and 15-18, the ranges of naproxen (1.2-15 wt%), oleic acid (7 wt%), ethanol (10-11 wt%), propylene glycol (12 wt%), 2-(2-ethoxyethoxy)ethanol (37-41 wt%), and DMSO (35-44 wt%), above, provide a starting point for the artisan to optimize.
MPEP 2144.05(II)(A) provides guidance about the routine optimization of prior art conditions: "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). "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.").”
Furthermore, MPEP 2144.05(I) provides guidance about overlapping ranges: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists…Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
The above wt% ranges overlap and/or approach the ranges in the instant claims for naproxen, oleic acid, ethanol, propylene glycol, 2-(2-ethoxyethoxy)ethanol, and DMSO. Since wt% is calculated out of 100% the remaining ingredients, hydroxypropyl cellulose and TPGS, can be calculated by simple subtraction. Further, HNAT provides a preferred wt% range for hydroxypropyl cellulose: 6-12 wt% (Pg. 1 Table 1) – this approaches the instant wt%. The wt% of each ingredient is the concentration of the ingredient in the formulation. As stated in the MPEP, concentration is a results effective variable recognized for variation and may be optimized by routine experimentation. Absent any evidence demonstrating the contrary, the determination of the optimum or workable concentrations of the formulation ingredients would have been well within the practice of the artisan given the guidance of the prior art.
Further regarding claim 18, formulations 1-60 would be recognized by the artisan as obvious variants of each other and could be reached by the same routine optimization discussed above. For the formulation also comprising lidocaine, HNAT teaches 5 wt% lidocaine (Pg. 11 Table 4 Formulation 3C) – this overlaps with the instant range of claim 2-3 and approaches the wt% in claim 18. By the same logic above, the artisan could routinely optimize the wt% lidocaine in the formulations.
Note, claim 1-3 and 18 recite some ingredients (cannabidiol, vitamin D3, poloxamer) are at 0 wt%; i.e., not present. Thus, the formulation described above meets these limitations.
Regarding claims 6-7 and 19, since the many formulations of HNAT, including Formulation 3C, contain 0 wt% water, the instant claims are met.
Regarding claims 8-9 and 20-21, since HNAT (Pg. 8 ¶195) and OSMALEK (Pg. 525 Table 3) teach transparent formulation, the artisan would have a reasonable expectation of success in formulation a transparent formulation with a refractive index of 1-2. Note, the instrument used to measure the refractive index does not modify the fact that the refractive index is a physical/chemical property of the formulation; the property is inherent to the formulation no matter how the property is measured.
Regarding claim 22, since HNAT teaches treatment of pain by application of topical naproxen formulations on a human subject’s body (Pg. 8 ¶183 & Pg. 13 Example 5), the artisan would be motivated, with an expectation of success, to utilize the formulation made obvious by the combined references for the same purpose.
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 1-12 and 15-22 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/224,835 (reference claims) in view of:
HNAT (US 2019/0046438; pub. 02/14/2019; cited IDS of 11/03/2023),
OSMALEK (Osamlek, T. et al., Pharmaceutical Development and Technology, 2017, 22(4), 521-536; provided IDS of 03/04/2024),
HADDLETON (US 2021/0085623; pub. 03/25/2021; effectively filed 11/01/2019), and
PMC (PMC Isochem, “Vitamin E TPGS,” pub. June 2020, retrieved from www.pharmaexcipients.com/wp-content/uploads/2020/07/TPGS-ISODEL-June-2020.pdf on 07/02/2026).
Determining the Scope and Contents of the Prior Art:
App. No. ‘835 claims are drawn to a topical COX inhibitor formulation comprising 2 wt% diclofenac (the COX inhibitor); ~1-15 wt% long chain monounsaturated fatty acids/alcohols, terpenes, or combination thereof; 0-5 wt% poloxamer; 0-5 wt% cellulosic excipient; and a solvent mixture of ethanol, propylene glycol, 2-(2-ethoxyethoxy)ethanol, and DMSO; wherein the formulation is 5 wt% of less water (ref. claim 1). The long chain monounsaturated fatty acids/alcohols, terpenes, or combination thereof is oleic acid, oleyl alcohol, or a mixture (ref. claims 2-3); oleyl alcohol present at 1 wt% (ref. claim 4). The cellulosic excipient is hydroxypropyl cellulose and the poloxamer is absent (ref. claims 5, 9, 13). The combined solvent mixture is 70-95 wt% wherein ~25-50 wt% is ethanol, ~2-12.5 wt% is propylene glycol, and ~15-25 wt% is DMSO (ref. claims 6-8, 10-12, 14-16). Reference claims 17-20 are drawn to a method of topically treating a pain episode by topically applying the formulation to a location on the human body.
HNAT, OSMALEK, HADDLETON, and PMC teach the instant formulation of instant claims 1-12 and 15-22 as laid out in ¶27, above. Please see above for the teachings thereof.
Further, OSMALEK teaches naproxen is a COX inhibitor (Pg. 521 Left col. ¶1).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
The reference claims do not teach the COX inhibitor is naproxen, the excipient TPGS, or the exact wt% ranges of claims 2-5, 10-12, and 16-21. The claims are silent as to the transparency and refractive index of the formulation.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a topical formulation useful for pain treatment by COX inhibition and possesses the technical knowledge necessary to make adjustments to the composition to optimize/enhance the formulation. Said artisan has also reviewed the problems in the art regarding COX inhibitors and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Application No. 19/224,835 in view of: HNAT, OSMALEK, HADDLETON, and PMC.
The artisan would be motivated to replace the diclofenac of App. No. ‘835’s formulation with naproxen since both are taught as COX inhibitors (‘835 claim 1; OSMALEK Pg. 521 Left col. ¶1). The artisan would have a reasonable expectation of success that naproxen would be compatible with the other formulation ingredients taught by ‘835 since the prior art references HNAT, OSMALEK, and HADDLETON each teach naproxen formulated in similar compositions containing the same ingredients (see all teachings above).
Using the same logic applied above, ¶27, the artisan would be motivated with an expectation of success to add TPGS and/or lidocaine to the naproxen-modified formulation of ‘835.
The claims of App. No. ‘835 teach wt% ranges that are within the ranges of instant claims 1, 6-9, 15, and 22. While the claims of ‘835 do not teach the exact ranges of claims 2-5, 10-12, and 16-21, the wt% is a results effective variable that may be optimized by routine experimentation, as recognized by MPEP 2144.05(I)-(II) cited above, ¶27. By the same logic applied above, the ranges given in ‘835, supplemented by those taught in the prior art, provide guidance for the artisan to optimize the wt% and arrive at the instantly claimed ranges.
Regarding instant claims 8-9 and 20-21, the properties of transparency and refractive index would be expected by the same logic applied in ¶27 above. The naproxen-modified formulation of ‘835 is analogous to that taught in the prior art references HNAT and OSMALEK, so the same motivation and expectation of success applies.
Finally, since App. No. ‘835 (claims 17-20) and HNAT (Pg. 8 ¶183; Pg. 13 Example 5) each teach topical treatment of pain at a location on the human body by application of the formulation, the instant claim 22 is taught. Further, the reference method claims are also applied against the instant composition claims; to practice the method the practitioner must be in possession of the composition.
This is a provisional nonstatutory double patenting rejection.
Claims 1-12 and 15-22 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US 11,872,199 (reference claims) in view of:
HNAT (US 2019/0046438; pub. 02/14/2019; cited IDS of 11/03/2023),
OSMALEK (Osamlek, T. et al., Pharmaceutical Developent and Technology, 2017, 22(4), 521-536; provided IDS of 03/04/2024),
HADDLETON (US 2021/0085623; pub. 03/25/2021; effectively filed 11/01/2019), and
PMC (PMC Isochem, “Vitamin E TPGS,” pub. June 2020, retrieved from www.pharmaexcipients.com/wp-content/uploads/2020/07/TPGS-ISODEL-June-2020.pdf on 07/02/2026).
Determining the Scope and Contents of the Prior Art:
Patent No. ‘199 claims are drawn to a topical, anhydrous formulation comprising 1.8-2.2 wt% diclofenac; 7.2-8.8 wt% oleic acid, oleyl alcohol, or mixture thereof; 2.7-3.3 wt% hydroxypropyl cellulose; 28.35-34.65 wt% ethanol, 9.9-12.1 wt% propylene glycol, 22.05-26.95 wt% 2-(2-ethoxyethoxy)ethanol, and 18-22 wt% DMSO (ref. claims 1-4). Reference claims 5-8 are drawn to a method of topically treating a pain episode by topically applying the formulation to a location on the human body.
HNAT, OSMALEK, HADDLETON, and PMC teach the instant formulation of instant claims 1-12 and 15-22 as laid out in ¶27, above. Please see above for the teachings thereof.
Further, HNAT teaches naproxen and diclofenac as alternative NSAIDs for use as active agents in the formulation taught therein (Pg. 2 ¶19).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
The reference claims do not teach the active ingredient is naproxen, the excipient TPGS, or the exact wt% ranges of claims 2-5, 10-12, and 16-21. The claims are silent as to the transparency and refractive index of the formulation.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a topical formulation useful for pain treatment by COX inhibition and possesses the technical knowledge necessary to make adjustments to the composition to optimize/enhance the formulation. Said artisan has also reviewed the problems in the art regarding COX inhibitors and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Patent No. US 11,872,199 in view of: HNAT, OSMALEK, HADDLETON, and PMC.
The artisan would be motivated to replace the diclofenac of Patent No. ‘199’s formulation with naproxen since both are taught as alternative NSAIDs for use as active agents in a topical pain-treating formulation (Pg. 2 ¶19). The artisan would have a reasonable expectation of success that naproxen would be compatible with the other formulation ingredients taught by ‘199 since the prior art references HNAT, OSMALEK, and HADDLETON each teach naproxen formulated in similar compositions containing the same ingredients (see all teachings above).
Using the same logic applied above, ¶27, the artisan would be motivated with an expectation of success to add TPGS and/or lidocaine to the naproxen-modified formulation of ‘199.
Claims 1-4 of Patent No. ‘199 teach wt% ranges that fall within the ranges of instant claims 1, 6-9, 15, and 22. While the claims of ‘199 do not teach the exact ranges of claims 2-5, 10-12, and 16-21, the wt% is a results effective variable that may be optimized by routine experimentation, as recognized by MPEP 2144.05(I)-(II) cited above, ¶27. By the same logic applied above, the ranges given in ‘199, supplemented by those taught in the prior art, provide guidance for the artisan to optimize the wt% and arrive at the instantly claimed ranges.
Regarding instant claims 8-9 and 20-21, the properties of transparency and refractive index would be expected by the same logic applied in ¶27 above. The naproxen-modified formulation of ‘199 is analogous to that taught in the prior art references HNAT and OSMALEK, so the same motivation and expectation of success applies.
Finally, since Patent No. ‘199 (claims 5-8) and HNAT (Pg. 8 ¶183; Pg. 13 Example 5) each teach topical treatment of pain at a location on the human body by application of the formulation, the instant claim 22 is taught. Further, the reference method claims are also applied against the instant composition claims; to practice the method the practitioner must be in possession of the composition.
Conclusion
Claims 1-12 and 15-22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights