DETAILED ACTION
The receipt is acknowledged of applicant’s IDS filed 08/03/2023; response to election/restriction requirement filed 01/05/2026; and supplemental response to election/restriction requirement filed 02/25/2026.
Claims 21-39 are pending.
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 .
Election/Restrictions
Applicant’s election of invention II, and species (b), claims 27 and 28, in the supplemental reply filed on 02/25/2026 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)).
Claims 21-26, 29-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election treated as was made without traverse in the reply filed on 02/25/2026.
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 27-28 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. The term is indefinite because it is not clear if acne agent used to cause acne, or acne agent is meant to be acne treatment or antiacne agent as described in the specification. The examiner suggests to change the term to either “acne treatment agent” or “antiacne agent” as described in the specification.
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 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Gueret (US 2005/0191337, IDS filed 08/03/2023), and either Shefer et al. (US 2003/0175333, IDS filed 08/03/2023) or Wise et al. (WO 2011/156217, currently cited on PTO 892, and copy is attached to this office action).
Applicant Claims
Claim 27 is directed to a method of making an anhydrous hydrocolloid matrix premix, the method comprising:
(a) mixing together to form a mixture:
i. encapsulating agents comprising viscosity modifiers and hydrocarbon emollients, and
ii. at least one or more therapeutic agents selected from: an acne agent; a skin conditioning agent; and combinations thereof; and
(b) high shear mixing the mixture to form the premix;
wherein the premix comprises the at least one or more therapeutic agents homogenously distributed therein.
Claim 28 recites the method of claim 27, wherein the therapeutic agent is selected from: salicylic acid; sulfur; resorcinol; resorcinol monoacetate; and combinations thereof.
The term premix as claimed is interpreted as a composition or matrix comprising the claimed ingredients, i.e. composition comprising encapsulating viscosity enhancer, hydrocarbon emollient and therapeutic agent.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Gueret teaches patch for application on the skin comprising polymer matrix
comprising at least one active agent (abstract; ¶¶ 0037-0041). The polymer matrix is anhydrous. The polymer matrix is hydrocolloid, e.g. cellulose derivatives, gums, pectin, etc. (¶¶ 0012, 0030, 0035, 0036, 0067, 0075; claim 1), and applicants used these elements as viscosity modifiers. The active agent includes anti-acne agents including salicylic acid, and skin conditioning agents (¶¶ 0019-0021, 0027; claims 9, 13, 15). The active agent can be present in oil droplets, e.g. paraffin, hydrocarbon based oil, sunflower oil, safflower oil, jojoba oil, and the oil droplets are dispersed in the polymer matrix (¶ 0022), and applicants used these elements as hydrocarbon emollients. The reference teaches a method of making the matrix including the step of homogenizing the ingredients (¶ 0086).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Gueret teaches including active agent in oil droplets, the reference does not teach explicitly teach encapsulating the ingredients as claimed by claim 27. While the reference teaches homogenizing the ingredients forming the matrix, the reference does not teach the step of high shear mixing as claimed by claim 27.
Sheffer teaches cosmetic patch for topical delivery of effective level of
cosmetically active agent to the skin (abstract). Example of active agents is salicylic
acid for treating acne (¶¶ 0067, 0075), skin conditioning agents (¶ 0080), and emollients
(¶ 0053). The reference teaches encapsulation of the active agents in a hydrophobic
nanospheres. The reference teaches that nanospheres are encapsulated in microspheres and distributed in polymer matrix. The nanospheres are made of hydrophobic polymer, lipid or wax that are used by applicants as hydrocarbon emollients. The microspheres are made of water sensitive synthetic material, e.g. polymers, and natural polymers, e.g. gums, starches, cellulose derivatives, that are claimed by applicants as viscosity modifiers. The reference teaches method of making the encapsulated active ingredients by are homogeneously dispersing the active agent in the polymeric matrix by high shear homogenization. On contact with skin moisture, the encapsulated active ingredients are released, thereby promoting the controlled delivery or the enhanced bioavailability of active ingredients and minimizing the interaction of active ingredients with the other compounds present in the patch (¶¶ 0083-0098; 0116, claims 34-39).
Wise teaches method of preparing a non-aqueous premix for a personal care composition by using high shearing device wherein the premix more easily dispersed in the personal care composition with greater formulation flexibility and stability. The personal care composition comprises viscosity modifiers and oils, e.g. palm oil (abstract; page 2, 2nd full paragraph; page 4,1st full paragraph; page 5, 1st full paragraph; page 6, last paragraph; page 7, 1st paragraph; page 9, last paragraph; page12-page 14).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention prepare hydrocolloid composition comprising salicylic acid to treat acne as taught by Gueret, and encapsulate salicylic acid in the microspheres and nanospheres taught by Shefer. One would have been motivated to do so because Shefer teaches that on contact with skin moisture, the encapsulated active ingredients are released, thereby promoting controlled delivery and enhanced bioavailability of active ingredients and minimizing the interaction of active ingredients with the other compounds present in the patch. One would reasonably expect formulating skin patch comprising hydrocolloid matrix comprising encapsulated salicylic acid that is released upon contact with skin moisture while being protected in the patch from interacting with other ingredients in the patch, thereby promoting the controlled delivery and enhanced bioavailability of active agents.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to prepare anhydrous hydrocolloid composition comprising viscosity modifier, hydrocarbon emollient and salicylic acid by homogenizing the ingredients as taught by Gueret, and use high shear taught by any of Shefer or Wise to mix these ingredients. One would have been motivated to do so because Shefer teaches that such a method encapsulates salicylic, thereby promoting controlled delivery and enhanced bioavailability of active ingredients and minimizing the interaction of active ingredients with the other compounds present in the patch; and because Wise teaches that high shear mixing renders the premix more easily dispersed in the personal care composition with greater formulation flexibility and stability. One would reasonably expect making anhydrous premix comprising viscosity enhancer and hydrocarbon emollient, and salicylic acid that promotes controlled delivery and enhanced bioavailability of salicylic acid while maintain flexibility and stability of the composition.
Regarding the step of mixing as claimed by claim 27, it is taught by all cited references.
Regarding the high shear mixing as taught by claim 27 is taught by both Shefer and Wise.
Regarding viscosity modifiers as claimed by claim 27, Gueret and Shefer teach cellulose derivatives, gums, pectin, that applicants used as viscosity modifier to practice the present invention. Wise teaches generic viscosity modifiers.
Regarding hydrocarbon emollients as claimed by claim 27, Gueret teaches paraffin, hydrocarbon based oil, sunflower oil, safflower oil, jojoba oil that applicants used as hydrocarbon emollients. Shefer teaches wax and lipid. Wise teaches palm oil that is used by applicants as hydrocarbon emollient.
Regarding acne agent claimed by claim 27 and specific therapeutic agents claimed by claim 28, both Gueret and Sheffer teach the claimed salicylic acid.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Isis A Ghali/Primary Examiner, Art Unit 1611 /I.G./