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
Claims 1-19 and 22-30 are pending. Claims 27-30 are withdrawn. Claims 1-19 and 22-26 are rejected.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 3/11/2026 was considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group I and the species:
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in the reply filed on 11/6/2025 is acknowledged.
Claims 1-19 and 22-26 embrace the elected species and are therefore under examination. Because the method claims, 27-30 are withdrawn, Examiner no longer required the elected species of a specific condition, rosacea. The compound elected supra is not allowable.
Claims 27-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Amendments/Arguments
Applicant’s amendments and arguments, filed 3/11/2026, with respect to objections, 112b rejections, and double patenting rejections have been fully considered and are persuasive; these objections and rejections have been withdrawn.
Applicant’s amendments and arguments, filed 3/11/2026, with respect to the rejection(s) of claim(s) 1-26 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration and as necessitated by amendments, a new ground(s) of rejection is made in view of US20230125380. Consequently, because a novel 103 is made and previous 103 is withdrawn, Applicant’s arguments regarding the previous 103 will not be addressed. As described under the restriction/election section supra, search has been focused on the elected species.
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.
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) 1-18 and 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harden et al. (US20230125380; eligible as art under 102(a)(2)).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Harden discloses the following in claim 1:
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(compound same as first compound of instant claim 1 and Applicant’s elected species), wherein the excipient may be PEG 400, butylated hydroxytoluene (BHT) (may also be an antioxidant), benzyl alcohol (7 carbon atoms, may also be a preservative and/or additional excipient), water (may also be a nonsolvent), and/or diethylene glycol monoethyl ether (see para. [1301]). Additionally, the topical composition may have antioxidants in the preferred concentration range of about 0.001 wt% to about 0.1 wt % (see para. [1309]).
Harden additionally discloses the possible inclusion of a gelling agent used to increase the viscosity of the final composition; “Preferred concentration range of a viscosity increasing agent can be from about 0.01 wt % to about 20 wt. %....” (see para. [1308]). See the following examples from para. [1308]:
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(note the prior art “acrylate crosspolymer” embraces the instant claims “crosslinked polyacrylic acid”, embraces both gelling agent and viscosity enhancing agent) .
In para. [1307], Harden discloses that the “topical compositions described herein may also contain one or more ‘humectant(s)’ used to provide a moistening effect”, which may include silicone oil. The composition may additionally comprise triglycerides (which can act as an emollient) and sodium lauryl sulfate (surfactant) (see para. [1304]).
Claim 2 of the prior art recites the following:
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and claim 11 teaches treating mammalian skin.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not disclose the exact claimed amounts of all of the ingredients in the instant topical composition.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1-18 and 22, it would have been obvious to a skilled artisan to arrive at the instantly claimed topical composition in the form of a gel, cream, or ointment for mammalian skin, particularly the instantly claimed amounts of various ingredients with a reasonable expectation of success as a result of routine experimentation. All of the specific components and ingredients in the instant claim were disclosed for a topical composition of the prior art. “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 MPEP 2144.05(IIA). Additionally, some of the ingredients listed do have overlapping ranges with the prior art. “In the case where the claimed ranges ’overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). A skilled artisan would have been motivated to explore the optimum working ranges of the instantly claimed ingredients with a reasonable expectation of success in arriving at an effective topical composition.
Regarding instant claims 23 and 24, the prior art gel embraces both an aqueous or non-aqueous gel wherein the instant amounts/ratios of PEG400 and diethylene glycol monoethyl ether would have been discovered as a result of routine optimization. Regarding instant claims 25 and 26, the prior art teaches both an ointment and a cream, wherein the instant amounts/ratios of PEG400 and diethylene glycol monoethyl ether would have been discovered as a result of routine optimization.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harden et al. (US20230125380; eligible as art under 102(a)(2)), in view of Osborne et al. (AAPS PharmSciTech, Vol. 19, No. 8, 2018, 3512-3533).
The 103 rejection of claims 1-18 and 22-26 supra over Harden (US20230125380) is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Harden fails to disclose the pH of the topical composition.
Osborne teaches skin penetration and permeation properties of Transcutol® (see title). “A vehicle that has emerged over the years as a safe solubilizer and enhancer for a broad range of drug actives is the highly purified NF/EP grade of diethylene glycol monoethyl ether (DEGEE) commercially known as Transuctol®” (see abstract). Additionally, “Transcutol is chemically stable in neutral and alkali pH, with optimal formulation range of pH 4 to 9” (see p. 3514, left column).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of the claimed pH ranges of the topical composition in the prior art.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 19, a skilled artisan would have been motivated to explore the usefulness of Transcutol in a topical composition, particularly because of its utility as a solubilizer and drug active enhancer within the instantly claimed pH range of “about 4 to about 7”. It would have been obvious to a skilled artisan to explore the use of a solubilizer to enhance the miscibility and activity of the various ingredients of the instant claims with a reasonable expectation of success in arriving at the instantly claimed pH of an effective IRAK4 inhibitor.
Conclusion
Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action. Accordingly, 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 extension fee 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 MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 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, 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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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626