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 Claims
Amendment filed on 03/20/2025 is acknowledged.
Claim 1 is amended. Claims 5-9 remain canceled.
Claims 1-4 and 10-13 are pending and being examined on merits herein.
Priority
This instant claim 18030178, filed on 04/04/2023, is a 371 of PCT/EP2021/077967, filed on 10/08/2021, claims foreign priority to European Patent Office (EPO) 20200917.1, filed on 10/08/2020.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 12/22/2025) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 03/20/2026.
Claim Objection
Claims 2, 4 and 13 are objected to for the following informalities:
Claim 2 part b) recites “at least one initiator”, part c) recites “at least one anti-microbial agent”, part d) recites “at least one solvent”. In order to address proper antecedent basis to claim 1, a word “the” in front of each of these terms is required.
Claim 4 recites “for example benzalkonium chloride”. It is recommended to rewrite this example into a dependent claim as a specific compound for the QACs.
Claim 13 recites “wherein one or more of non-polymerizable water soluble material, at least one coinitiator, and at least one antioxidant, …at least one anti-microbial agent and at least one solvent”, for proper antecedent basis, in front of each of these ingredients, word “the” is required.
Appropriate correction is required.
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.
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.
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.
Claims 1-4 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US20160280827, 03/23/2016), as evidenced by Balzarini et al. (EP2484360, 08/08/2012, in record of 07/01/2025), in view of Wuest et al. (US20180111893, 04/26/2018).
Anderson throughout the reference directs to polymeric hydrogels and the preparation methods of producing polymers by free radical polymerization and self-assembly (e.g., Abstract; [0148]), comprising polymerizing boronic-acid containing monomers, amine-containing, aliphatic monomers (e.g., Abstract; [0007]; [0149]).
Regarding instant claim 1, Anderson teaches that the polymers can be prepared using free-radical polymerization involving light (photoinitiator) to form free radicals that initiate the polymerization (e.g., [0150]; [0152]), and the polymer can retain polymerized antimicrobial agents and antiviral agents (e.g., [0018], [0344]; [0347]) useful for personal hygiene or disinfecting surfaces and other purposes (e.g., [0381]).
Regarding instant claim 1 a), Anderson specifies that the polymers used for free radical polymerization comprise a plurality of sides chains and a polyethylene backbone [0143], e.g., hydrophilic polymer PEG, or a PEG-containing material [0311]. In example 1, Anderson shows preparation of the polyethylene-containing polymer comprising radically polymerizable end groups from the photopolymerizable monomers such as acrylamide [0401], an active agent being integrated into the polymer material is (acrylamino)phenylboronic acid (containing radical end group acrylamide) in example 1 [0403]. Even though Anderson does not expressly define the polymerizable material is water soluble and each comprises one or more radically polymerizable end groups, they are inherent properties of the instantly claimed polymeric material, and therefore, they are taught by Anderson. MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Regarding instant claim 1 b), Anderson teaches that photoinitiators are designed to work using UV light (200-400 nm), long UV rays, short UV rays, visible light ( 400-800 nm), blue light (420-500 nm), or IR light (800-2500 nm) [0152], exemplary photoinitiators including AIBN (2,2'-azobisisobuty-ronitrile), anisoin, anthraquinone, benzoin, benzoyl peroxide, and many others [0152]. In example 1, free radical polymerization involves AIBN as a photoinitiator to form free radicals to initiate the polymerization reaction [0401-0403]. The phrase after the polymerizable material “to form a polymerized anti-microbial agent retaining material” is “process of using” or “intended use” of the polymerizable material because it does not contribute to the structural limitation of the polymerizable material. Since prior art teaches initiator for radical polymerization of the polymerizable material, the “process of using” or “intended use” would necessarily be present or capable of being achieved.
Regarding instant claim 1 c), Anderson teaches antimicrobial agents, such as benzalkonium chloride [0347], an quaternary ammonium compound, (corresponding to element C in Formula (V)) are suitable to be added to the formulation.
Regarding instant claim 1 d), Anderson teaches in example 1 during the preparation MeOH is implemented as solvent [0403]. Anderson teaches in general the polymers are formed in the presence of aqueous media (e.g., water based media) or other solvents (e.g., methanol or ethanol) (e.g., [0145]), and other solubilizing agents and emulsifiers (e.g., [0356]), suitable diluents and suspending agents (e.g., [0357]).
Regarding instant claim 2, Anderson specifies that the polymers are capable of self-assembling into hydrogels in aqueous solution (e.g., water), with about 2-10% w/w polymer, or about 5% w/w polymer, or about 10-20% w/w polymer, or about 20-30 w/w polymer in the aqueous solution to form hydrogels [0154] (overlapping with polymerizable material 3-50% in instant claim 2a). In a general procedure of polymer synthesis, 12.5% of 2,2’-azobis(2-methylpropionitrile) is used as initiator [0403] (corresponding to 0.001-5% of initiator amount in instant claim 2b). Anderson teaches from about 1% to about 10% w/w active ingredient (e.g., antimicrobial ingredient) can be added in the topically administrable formulation like hydrogel [0366] (overlapping to 0.001-10% of antimicrobial agent in instant claim 2c). In example 1, during the process 3.5 ml MeOH and 200 ml Et2O solvent was used, while by calculation of total 100% subtracting maximum amount of 30% polymer, 12.5% initiator and 10% active ingredient, resulting in 47.5% solvent in the formulation [0403] (overlapping to 10-90% of one solvent in instant claim 1d).
Regarding instant claims 3 and 4, Anderson exemplifies antimicrobial preservatives suitable for the polymeric material include benzalkonium chloride, benzethonium chloride, benzyl alcohol, bronopol, cetrimide, cetylpyridinium chloride, chlorhexidine, chlorobutanol, chlorocresol, chloroxylenol, cresol, ethyl alcohol, glycerin, hexetidine, phenol, phenoxy-ethanol, phenylethyl alcohol, phenylmercuric nitrate, propylene glycol, thimerosal, and mixtures thereof (e.g., [0342]; [0347]). As evidenced by instant claim 4, benzalkonium chloride is an amphiphilic ionic antimicrobial compound, with the structure containing phenol ring as hydrophobic and charged ammonium as hydrophilic.
Regarding instant claims 10 and 11, As discussed above regarding instant claim 1, Anderson teaches the formulations are useful for personal hygiene and surface disinfection (e.g., [0381]), and therefore they are photopolymerized anti-microbial agent retaining material formed by polymerization of a polymerizable sanitizing formulation. Anderson teaches in Example 1 the polymers are able to self-assemble to injectable hydrogels (e.g., [0401]; [0155]; Fig. 1).
Regarding instant claim 12, Anderson specifies that the polymers used for free radical polymerization comprise a plurality of sides chains and a polyethylene backbone [0143], e.g., hydrophilic polymer PEG, or a PEG-containing material [0311]. In example 1, Anderson shows preparation of the polyethylene-containing polymer comprising radically polymerizable end groups from the photopolymerizable monomers such as acrylamide [0401]. In example 1, free radical polymerization involves MeOH implemented as solvent [0403] and AIBN as an photoinitiator to form free radicals to initiate the polymerization reaction [0401-0403], which are designed to work using UV light (200-400 nm), long UV rays, short UV rays, visible light ( 400-800 nm), blue light (420-500 nm), or IR light (800-2500 nm) [0152].
Anderson teaches in example 1 active agent being integrated into the polymer material is antimicrobial (acrylamino)phenylboronic acid, as evidenced by Balzarini, phenylboronic acid compounds constitute antiviral activities and the compounds or boronic-containing polymers can be used as antiviral agents (Title, Abstract; Pg. 14, (c)phenylboronic acid comprising compounds or polymers) (corresponding to antimicrobial agent).
In summary, Anderson’s preparation of the composition results in the method of producing the formulation, comprising a polymerizable water-soluble material selected from at least PEG- containing radically polymerizable end groups such as acrylamide, obtaining one initiator selected from common UV, violet, or visible light active photoinitiators such as AIBN, obtaining one solvent such as MeOH, mixing the polymerizable water soluble material, with at least one anti-microbial agent such as phenylboronic acid, and at least one initiator to provide a polymerizable sanitizing formulation.
Regarding instant claim 13, Anderson further teaches that any photoinitiator may be used in the polymerization and a combination of photoinitiators can be used [0152], preservatives include antioxidants, chelating agents, antimicrobial preservatives [0344], some non-polymerizable water soluble acidic preservative materials, e.g., vitamin A, vitamin C, citric acid, acetic acid [0350], alcohol solvents as preservatives such as ethanol, phenol, bisphenol [0349], and many other preservatives or disinfectants can be included in the formulation [0351].
Instant claims 12-13 are product-by-process claims, the patentability is based on the product itself. If the product is the same as a product from the prior art, the claim is unpatentable. MPEP 2113 indicates that the process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences’ distinguishing the claimed produce from the prior art”. See MPEP 2113:"[E]ven though product-by-process claims are limited by and defined by the process, 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 re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "In determining validity of a product-by-process claim, the focus is on the product and not the process of making it." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009).
Anderson does not explicitly teach the anti-microbial agent constitutes the formula A-B-C (V) and the polymerizable group A in formula (V) as methacrylate or C as the specific nitrogen-containing salt as recited in instant claim 1.
Wuest throughout the reference teaches antimicrobial compositions comprising novel polycationic amphiphilic compounds as antimicrobial agents that can be used in aqueous emulsions such as personal care products, soaps and detergents, disinfectants, cleaners, and sanitizers (e.g., [0265]; Abstract).
Wuest teaches an antimicrobial polymer comprising at least one monomer of formula XVIII, PM-L-PA (e.g., Claim 50; [0032]; [0221]), wherein PM is polymerizable moiety attached to a polycationic amphiphile (PA) via a linker L (e.g., Claim 50; [0034]; [0222]) (PM corresponding to polymerizable group A, L corresponding to linker B, PA corresponding to C as recited in formula A-B-C formula (V) in instant claim 1), wherein the polymerizable moiety PM can include methacrylate, acrylamide, and many others (e.g., Claim 52; [0223]) (corresponding to polymerizable group A as methacrylate in instant claim 1 formula (V)), the polycationic amphiphile PA may be any compound comprising at least one tetrasubstituted nitrogen atom (a QAC) [0224] with antimicrobial activity (e.g., [0316-0318]), such as benzalkonium chloride (e.g., [0318]; Table 1) (corresponding to C nitrogen containing salt in instant claim 1 formula (V)). Wuest indicates that the linker may be any suitable linker, as would be understood by one of ordinary skill the art, including an alkyl group, a poly(alkylether), and many others [0219], such as C1-C25 alkyl group wherein alkyl group can be substituted (e.g., Claim 56) (corresponding to linker B with overlapping carbon numbers as C2 to C50 alkyl chains in instant claim 1 formula (V)).
It would have been prima facie obvious for a person with ordinary skills in art prior to filing date to incorporate Wuest’s teaching of antimicrobial polymers’ specific structure formula into the photopolymerizable formulation and polymerization process of Anderson to arrive at current invention. Because Anderson teaches that quaternary ammonium salt such as benzalkonium chloride is suitable antimicrobial agent for the formulation and already teaches antimicrobial formulation resulted from photopolymerizable polymers containing polymerizable group (e.g., acrylamide) which can integrate and retain antimicrobial agents, while Wuest confirms and demonstrates that polymer PM-L-PA with polymerizable group such as acrylamide and methacrylate linked to tetrasubstituted nitrogen containing QAC can result in novel antimicrobial polymers, it would have motivated artisans in the field to incorporate Wuest’s teaching into Anderson to achieve antimicrobial polymers without additional antimicrobial agents. It would have provided reasonable expectation of success because prior art demonstrates multi-functional antimicrobial properties of the polymers as sanitizers. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D). Moreover, It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the weight amounts of ingredients and alkyl chain carbon numbers in the photopolymerizable sanitizing formulation overlap with those taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Response to Arguments
Applicant’s remarks/arguments filed on 03/20/2026 have been fully considered.
Applicant asserts that “add/swap stearalkonium chloride” rational does not result in the claimed structure, because antimicrobial agent as defined in claim 1 having formula (V) A-B-C, and Mahimwalla does not provide proper structural mapping of formula (V). The combination of prior art is based upon hindsight reconstruction and lacks sufficiently articulated reason to combine.
In light of applicant’s remarks and claim amendment filed on 03/20/2026, Anderson no longer reads into the formula A-B-C, and new prior art reference Wuest teaching the antimicrobial polymer with formula A-B-C, as presented above in this office action is combined with Anderson and Balzarini to address the specificity of A as methacrylate, B as the specific linker, and C as a nitrogen-containing salt as recited in claim 1. Previous prior art Mahimwalla is removed from the obviousness rejection in this office action. Therefore, the argument against add/swap stearalkonium chloride with Anderson’s phenylboronic acid in the polymer structure, and Mahimwalla does not have proper structural mapping of formula (V) therefore are moot. Consequently, the hindsight combination of prior art is also moot because the new ground of rejections have changed the previous reasoning.
Please refer to the entire office action as a complete response to the arguments.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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