DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed August 15, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 11, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1 – 12 and 17 – 30 are pending.
Claims 2 – 11 are withdrawn.
Claims 17 – 30 are newly added.
Claims 1, 12, and 17 – 30 are examined here-in.
Claim Objections
Claims 12 and 23 are objected to because of the following informalities:
In line 10 of page 5, claim 12 reads “at least one at least one centrifugation/redispersion cycle…” One of the “at least one” phrases should be deleted.
In lines 10 and 12 of page 7, claim 23 recites “the microgels” which should be “the microgel particles”.
Appropriate correction is required.
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 and 30 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Alard (EP 3,473,236 A1, of record).
Alard teaches temperature and pH-responsive oligo(ethylene glycol)-based biocompatible microgels for incorporation in cosmetic compositions (abstract). Alard teaches that the microgels are made with poly(ethylene glycol) methyl ether methacrylate crosslinked polymer, which is made up of diethylene glycol methacrylate monomeric units, oligoethylene glycol methacrylate monomeric units, and methacrylic acid monomeric units (paragraphs 0046, 0051, claim 1). Alard teaches that the mean size of particles in the dry state may range from 100 to 1,000 nm (paragraph 0054). Further, Alard teaches that the microgel particles can be suspended in water-soluble polymer (paragraph 0143). These teachings anticipate claims 1 and 30 of the instant application.
Alard’s teachings in example 1 teaches 83.9 mmol of di(ethylene glycol) methacrylate monomer, 9.36 mmol of oligo(ethylene glycol) methacrylate monomer (with an average MW of 475 g/mol), 5 mmol of methacrylic acid monomeric units, and 1.92 mmol of a cross-linker (paragraph 0107) which overlaps on the amounts of 83 mol% to 84 mol% di(ethylene glycol) methyl ether methacrylate, from 9.0 mol% to 9.5 mol% of an oligo(ethylene glycol) methyl ether methacrylate having a number average molecular weight of 475 g/mole, from 4.9 mol% to 5.1 mol% of methacrylic acid as a vinyl monomer comprising a carboxyl group, and from 1.9 mol% to 2.0 mol% of a crosslinking agent, the sum of the four mole fractions being equal to 100 mol% recited in instant claim 1. Teachings of the prior art which are within the claimed range, or overlapping with sufficient specificity are anticipatory according to MPEP 2131.03(I)&(II).
Notably, the instant claims 1 and 30 recite “wherein the microgel particles and water-soluble polymer are obtained by…” and “wherein the water-soluble polymer and microgel particles are obtained by…”. The limitations of obtaining the microgel particles and water-soluble polymer via aqueous phase precipitation polymerization are product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps according to MPEP 2113(I).
Even though product-by-process claims are written as defined by the process, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Alard’s composition with microgel particles and a water-soluble polymer where the particles have an average size of 100 to 1,000 nm in the dry state (paragraphs 0054, 143) anticipates the composition recited in instant claims 1 and 30. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding the process obtaining the microgel particles and water-soluble polymer via aqueous phase precipitation polymerization does not determine patentability of the composition. (MPEP 2113).
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1 and 30 are also rejected under 35 U.S.C. 103 below.
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 non-obviousness.
Claims 1 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Alard (as cited above).
First, regarding claims 1 and 30, for the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Alard does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by the claim without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Alard thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Alard’s teachings are discussed above.
Claims 1 and 30 are rendered prima facie obvious over the teachings of Alard, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results according to MPEP 2143(I)(a). In the instant case, all the claimed elements (e.g., water-soluble polymer, microgel particles) were known in the prior art (e.g., polymer compositions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a microgel particle composition for cosmetic application) to one of ordinary skill in the art.
Alard’s teachings of a cosmetic composition (abstract) with water-soluble polymer and microgel particles with diethylene glycol methacrylate monomeric units, oligoethylene glycol methacrylate monomeric units, and methacrylic acid monomeric units having a dry size of 100 to 1,000 nm paragraphs 0046, 0051, 0054, 0143, claim 1) read on claims 1 and 30 of the instant application, which recite compositions comprising a water-soluble polymer and microgel particles which have a dry size of 100 to 1,000 nm, which may be obtained by polymerization of diethylene glycol methacrylate monomer, oligoethylene glycol methacrylate monomer, and a vinyl monomer having a carboxyl group.
Alard’s teachings in example 1 teaches 83.9 mmol of di(ethylene glycol) methacrylate monomer, 9.36 mmol of oligo(ethylene glycol) methacrylate monomer (with an average MW of 475 g/mol), 5 mmol of methacrylic acid monomeric units, and 1.92 mmol of a cross-linker (paragraph 0107) which overlaps on the amounts of 83 mol% to 84 mol% di(ethylene glycol) methyl ether methacrylate, from 9.0 mol% to 9.5 mol% of an oligo(ethylene glycol) methyl ether methacrylate having a number average molecular weight of 475 g/mole, from 4.9 mol% to 5.1 mol% of methacrylic acid as a vinyl monomer comprising a carboxyl group, and from 1.9 mol% to 2.0 mol% of a crosslinking agent, the sum of the four mole fractions being equal to 100 mol% recited in instant claim 1. Claimed amounts that overlap with teachings of the prior art are prima facie obvious according to MPEP 2143(I)(a).
The recitation of crosslinking agents oligo(ethylene glycol) diacrylate, N,N’-methylenebisacrylamide, or (ethylene glycol) dimethacrylate in instant claim 1 is met by Alard’s teachings that the cross-linking agent can be oligo(ethylene glycol) diacrylate (average MW of 250 g/mol), N,N’-methylenebisacrylamide, or (ethylene glycol) dimethacrylate (paragraph 0107). While Alard does not teach a relationship between the crosslinking agent and the mass ratio of water-soluble polymer and microgel particles, it would be within the capability of a person of ordinary skill in the art to achieve a desired mass ratio of products via routine optimization, which is prima facie obvious according to MPEP 2144.05(II).
Notably, the instant claims 1 and 30 recite “wherein the microgel particles and water-soluble polymer are obtained by…” and “wherein the water-soluble polymer and microgel particles are obtained by…”. The limitations of obtaining the microgel particles and water-soluble polymer via aqueous phase precipitation polymerization are product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps according to MPEP 2113(I).
Even though product-by-process claims are written as defined by the process, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Alard’s composition with microgel particles and a water-soluble polymer (paragraph 0143) reads on the composition recited in instant claims 1 and 30. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding the process obtaining the microgel particles and water-soluble polymer via aqueous phase precipitation polymerization does not determine patentability of the composition. (MPEP 2113).
Examiner’s Reply to Attorney Arguments Dated August 15, 2025
Applicant argues that composition claims 1 and 30, which recite the processes of claims 12 and 24, have unique characteristics determined by the process of making (Remarks page 11). As noted in the body of the rejection above, while product-by-process claims are written as defined by the process, the determination of patentability is based on the product itself, and if the product is substantially identical to the prior art, the burden shifts to the Applicant to show a non-obvious difference (MPEP 2113(II)). In the instant case, the product recited in composition claims 1 and 30 is not patentably distinct from Alard’s composition with microgel particles and a water-soluble polymer (paragraph 0143). Although it appears that Applicant suggests composition claims 1 and 30 have distinct features with regards to the relative amounts of water-soluble polymer and microgel particles or the identity of water-soluble polymer (Remarks page 11), these features are not recited in the rejected claims (MPEP 2145(VI)). Therefore, Alard’s composition with microgel particles and a water-soluble polymer (paragraph 0143) reads on the compositions of claims 1 and 30 and the 102 and 103 rejections are maintained.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Double Patenting over 17/784,507
Claims 1, 12, and 17 - 30 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 27 - 34 of copending Application No. 17/784,507.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claim 1 is drawn to a cosmetic composition, pharmaceutical composition, or medical device comprising a water-soluble polymer and microgel particles (having an average size of 100 to 1,000 nm when dry) where the monomer units are di(ethylene glycol) methyl ether methacrylate, oligo(ethylene glycol) methyl ether methacrylate, and a vinyl monomer with a carboxyl group in claimed mol percentages with oligo(ethylene glycol) diacrylate, N,N’-methylenebisacrylamide, and (ethylene glycol) dimethacrylate as possible cross-linking agents.
Conflicting claim 17 is drawn to a cosmetic composition, pharmaceutical composition, or medical device comprising a water-soluble polymer and microgel particles (having an average size of 100 to 1,000 nm when dry) where the monomer units are di(ethylene glycol) methyl ether methacrylate, oligo(ethylene glycol) methyl ether methacrylate, and a vinyl monomer with a carboxyl group and at least one of two crosslinking agents is N,N’-methylenebisacrylamide.
The instant and conflicting claims differ because conflicting claim 17 does not recite molar ratios of the monomers but does recite that the medical device may optionally include water and that the cosmetic or pharmaceutical composition has a solid content of 1.5 to 100% by mass.
Conflicting claim 17 recites a process for preparing a cosmetic composition, pharmaceutical composition, or medical device by preparing a mixture of microgel particles and a water-soluble polymer with the first step being aqueous phase precipitation polymerization, a purification step, and a mixing step which reads on instant claim 12.
Conflicting claim 28 recites at least one centrifugation/redispersion cycle for the purification step where the microgel particles are in the precipitate reading on instant claim 13.
Conflicting claim 29 recites at least one centrifugation/redispersion cycle for the purification step to collect the water-soluble polymer which reads on instant claim 14.
Conflicting claim 30 recites the microgel particles and water-soluble polymer are produced at the same time and the centrifugation/redispersion is performed to collect the microgel particles, reading on instant claim 15.
Conflicting claim 31 recites the single-step process of claim 30 where the ratio between the mass of water-soluble polymer and microgel particles is between 0 and 100%, reading on instant claim 16.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Reply to Attorney Arguments Dated August 15, 2025
Applicant states that a Terminal Disclaimer submitted over 17/784,507 renders the provisional NSDP rejection moot (Remarks page 12). However, it appears no Terminal Disclaimer has been filed in either the instant application file (17/784,500) or 17/784,507. Therefore, the provisional non-statutory double patenting rejection is maintained.
Potentially Allowable Subject Matter
Claims 12 and 17 – 29 are free of prior art.
With regards to claims 12 and 17 – 23, Alard does not fairly teach or suggest a process for preparing a composition comprising microgel particles having an average particle size of 100 to 1,000 nm in a dry state and a water-soluble polymer which specifically includes the recited steps of centrifugation/redispersion, recovering target components from precipitate and supernatant, and mixing the components in a designated mass ratio, as recited in instant claim 12. Claims 17 – 23 are dependent on potentially allowable claim 12.
With regards to claims 24 – 29, Alard does not fairly teach or suggest a process for preparing a composition comprising microgel particles having an average particle size of 100 to 1,000 nm in a dry state and a water-soluble polymer which specifically includes the recited steps of centrifugation/redispersion, recovering first microgel particles, preparing second microgel particles and water-soluble polymer, centrifugation/redispersion, recovering second water-soluble polymer, and mixing the components in a designated mass ratio as recited in instant claim 24. Claims 25 – 29 are dependent on potentially allowable claim 24.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612