DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Per amendment dated 10/23/25, claims 17-34 are currently pending in the application.
Applicant’s election of Group IV invention, encompassing claims 18-25 and 34, in the reply filed on 10/23/25 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Claims 17, 26-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 18-24, 34 are rejected under 35 U.S.C. 103 as being unpatentable over Alard et al. (EP 3473236 A1, coted in IDS dated 6/10/22), alone, or in view of Tranchant et al. (US 20180002493 A1).
Regarding claims 34, 23 and 24, Alard teaches biocompatible microgel particles that are incorporated into skin or hair (Ab., [0092]), comprising in one embodiment, 80 to 90 mol% diethylene glycol methacrylate units, 5 to 15 mol% of oligoethylene glycol methacrylate monomer unit, which may include 4 to10 ethylene glycol moieties, 2 mol% to 8 mol% (meth)acrylic acid units, and 1 to 5 mol% of crosslinking agent, such as N,N-methylenebisacrylamide [0045]-[0050]. It is noted that the disclosed monomer units fall within the scope of the mol fraction of monomers for obtaining the claimed microgel of claim 34.
Alard teaches that oligo(ethylene glycol) methacrylate unloaded microgels have the advantage of self-assembling in one or more layers of particles by simple evaporation of water that is contained in an aqueous dispersion of particles at ambient temperature, that active organic substance may be trapped within the microgel particles, that the microgel dispersions are capable of forming a transparent films, and cohesive and elastic films useful skincare applications, and polymerization by aqueous precipitation method [0067]-[0093].
Disclosed Example 1 is drawn to a bare microgel dispersion formed by polymerizing monomers within the scope of the claimed invention, purified by centrifugation/redispersion cycles. Disclosed Example 2 drawn to films formed from OEGDA-microgel dispersion, wherein a water-soluble polymer is formed as a by-product of microgel particles [0106]-[0143].
Alard is silent on a process wherein the microgel particles and the water-soluble polymer of the claimed composition may be independently obtained, and wherein the content of water-soluble polymer is between 0% and 100% by mass of the sum of microgel particles and water-soluble polymer in dry state.
At the outset, it is noted that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05.
It is noted that per instant specification [0041], the expression “between” excludes the numerical limits that follow it. Additionally, noting that Alard teaches that a water-soluble polymer is formed as a by-product of microgel particles, the recitation “may be obtained” in claim 34 does not mandate that the microgel particles and the water-soluble polymer be independently obtained. Even so, when a product recited in product-by-process format reasonably appears to be the same as or obvious from a product of the prior art, the burden is on applicant to show that the prior art product is in fact different from the claimed product, even though the products may be made by different processes. In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985); MPEP 2113. This principle applies even in the context of a process claim that recites a step of using a product that is defined by the method by which it is produced. The nesting of a product-by-process limitation within a method claim does not change the proper construction of the product-by-process limitation itself.
Furthermore, while teaching purification of the final microgel dispersion by centrifugation/redispersion cycles, Alard is silent on the purity level of microgel particles as being at 100%, or the absence of even one molecule of water-soluble polymer in the final microgel particles. It would have been obvious to one of ordinary skill in the art, as of the effective filing date of the claimed invention, to apply an aqueous microgel dispersion within the scope of Alard on a person’s skin and drying it. A skilled artisan would recognize that during the disclosed centrifugation/redispersion cycles, the water-soluble polymer content in the supernatant aqueous medium and in the water of the microgel would equilibrate, and therefore, reasonably expect Alard’s process to include a composition comprising a microgel to include a minute amount of a water-soluble polymer, absent evidence to the contrary. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
In the alternative, although Alard teaches microgel dispersion that is purified by centrifugation/redispersion cycles, Alard is silent on the process details for the purification. However, in a related field of endeavor, the secondary reference to Tranchant teaches poly(oligo(ethylene glycol) methacrylate microgels for use in cosmetics (Ab..), wherein the microgel particles may be separated from the reaction medium by centrifugation (10 000 rpm, 30 min), the reaction medium is replaced by pure water (of milliQ grade), and the step is repeated five times [0102].
Given the teaching in Tranchant, it would have been obvious to one of ordinary skill in the art, as of the effective filing date of the claimed invention, to apply an aqueous microgel dispersion within the scope of Alard, as separated by Tranchant’s method, on a person’s skin and drying it. Additionally, for reasons stated in paragraph 8 above, a skilled artisan would reasonably expect Alard’s process, as modified by Tranchant, to include a composition comprising a microgel and a minute amount of water-soluble polymer, absent evidence to the contrary.
Regarding claims 18 and 19, Alard teaches loading of active materials in an amount of 500 microgram to 10 mg/g of unloaded microgels [0073], thereby obviating the claimed range of a mixture of microgel particles and the water-soluble polymer or the solid content in the composition.
Regarding claim 20, Alard teaches a film thickness of 10 to 500 microns [0021].
Regarding claims 21 and 22, Alard teaches the water-soluble polymer as a by-product formed from monomers within the scope of the claimed process, and a microgel dispersion formed by substantially the same process as that of the claimed invention. Thus, a skilled artisan would reasonably expect any water-soluble polymer remaining in the microgel particles to have the claimed radius of gyration and molecular weight, absent evidence to the contrary.
Claims 34, 18, 21-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-7, 10, 11 of copending Application No. 17/784,500 (reference application, amdt. dated 8/15/25). Although the claims at issue are not identical, they are not patentably distinct from each other because copending claims 10 and 11 are as follows:
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Additionally, copending claim 1 is drawn to a cosmetic composition, pharmaceutical composition or medical device, each comprising a water-soluble polymer and microgel particles, wherein said water-soluble polymer and microgel particles may be formed from N,N’-methylenebisacrylamide as in the claimed invention. Thus, claim 34 is encompassed by copending claim 11.
Additionally, although copending claim 1 is silent on a process of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the cosmetic or pharmaceutical composition on a person and drying it as in the claimed invention, and reasonably expect the composition comprising water-soluble polymer and microgel particles formed from N,N’- methylenebisacrylamide as a crosslinking to be capable of forming a flexible, cohesive and adhesive film on the basis that the compositions limitations in the process of claim 34 are met (obviates claims 34, 24 and 25). As stated in paragraph 7 above, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Regarding claims 18, 20, 21, 22, 23, copending claims 4, 3, 5, 6 and 7, respectively,
obviate the claimed limitations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Satya Sastri at (571) 272 1112. The examiner can be reached Monday-Friday, 9AM-5.30PM (EST). If attempts to reach the examiner by telephone
are unsuccessful, the examiner's supervisor, Mr. Robert Jones can be reached at (571)-270-
7733. The fax phone number for the organization where this application or proceeding is
assigned is (571) 273 8300.
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/Satya B Sastri/
Primary Examiner, Art Unit 1762