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
Receipt of Remarks/Amendments filed on 04/22/2026 is acknowledged. Claims 1-2, 18, 105, 108-110, 208 are amended and claims 4-17, 19-21, 23-38, 40-45, 47-60, 63-86, 88-104, 107, 111-183, 185-195, 198-202, 204-207, and 209-218 are canceled. Claims 22, 61-62, 106, 108-109, 196-197, 203, 208 remain withdrawn as being directed to a non-elected invention or species. Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 are examined on the merits herein.
Priority
The instant application filed 09/27/2023, claims priority to Provisional Application No. 63/410,722, filed 09/28/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/22/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Rejections
Claim 1 was rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 were rejected under 35 U.S.C. 112(b) as being indefinite. Applicant’s amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claims 1-3, 18, 39, 46, 110, and 184 were rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Wang. Applicant’s amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 were rejected under 35 U.S.C. 103 as being unpatentable over Jin, Wang, and Herchen. Applicant’s amendments to the claims and statement of common inventorship has overcome the rejection and the rejection is withdrawn.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 were rejected under 35 U.S.C. 103 as being unpatentable over Jin, Wang, and Gao. Applicant’s amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 9 of copending Application No. 18/639,636. Applicant’s cancelation of claims 8 and 9 in the copending application has rendered the rejection moot.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 57 of copending Application No. 18/373,686 in view of Jin. Applicant’s amendments to the claims have overcome the rejection and the rejection is withdrawn.
The following grounds of rejection are new or maintained, with the new ground being necessitated by amendment:
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.
Claims 1-2, 18, 46, 87, and 105 are rejected under 35 U.S.C. 103 as being unpatentable over Qu, X., et al. (US 20070166344 A1, 07/19/2007, PTO-892), hereinafter Qu, in view of Jin, W., et al. (CN 111849328 A, 10/30/2020, IDS dated 12/18/2025), hereinafter Jin, and Gao, B., et al. (2007). J. Biomater. Sci. Polymer Edn. Vol. 18, No. 5, pp. 531-544 (IDS dated 01/29/2024), hereinafter Gao.
Qu discloses surface-active, non-leaching antimicrobial film forming compositions and methods for their application (abstract). The compositions include long chain molecules that chemically bond with a polymeric matrix upon drying or curing of the matrix to provide a non-leaching surface having long lasting antimicrobial efficacy ([0011]).
Regarding claim 1: A curable antimicrobial coating composition of Qu comprises a polyurethane prepolymer; a carrier solvent capable of at least partially dissolving said polyurethane prepolymer; a hydrophilic component; and at least one quaternary ammonium compound having the following formula:
PNG
media_image1.png
200
208
media_image1.png
Greyscale
, wherein L represents a hydrocarbon group which comprises at least one functional group capable of forming a chemical bond with the polyurethane prepolymer ([0024]-[0026]), specifically -OH ([0064]-[0065]). The polyurethane prepolymer comprising at least one functional group capable of forming a chemical bond, preferably a covalent bond, with the functional group of the long chain compound, either directly or through a cross-linker ([0017]), preferably that functional group is an isocyanate ([0028]; [0066]; [0112]; Examples; claim 33-34). As such, the polyurethane prepolymer of Qu reads on a first multifunctional crosslinker and the quaternary ammonium compound reads on a first quaternary ammonium salt (QAS) having a reactive linking group to react with the first multifunctional crosslinker, as recited. Together, the polyurethane prepolymer and QAS read on the instantly claimed first adduct. The composition can further include a crosslinker capable of crosslinking the functional groups of the polyurethane prepolymer and the long chain organic compound ([0022]; claims 38). The crosslinker may be a multifunctional isocyanate ([0032]; claim 38), which reads on the instantly claimed second multifunctional crosslinker. The hydrophilic component comprises PVP ([0024]; [0031]; [0070]-[0072]; Examples; claims 2, 32, and 47), which reads on the instantly claimed water-soluble polymer. Other examples of the hydrophilic polymer include hydroxyethyl cellulose (HEC) ([0024]; [0044]; claims 2, 32, and 47). The coating composition can also include a modifying polymer selected from polyol, polyamine, and more ([0029]; claim 35). It is noted that a polyol and third multifunctional crosslinker are optional as defined in instant claim 1. The carrier solvent is water in several embodiments ([0034]; [0077]; Ex. 3; Ex. 22; claim 42).
The teachings of Qu differ from that of the instantly claimed invention in that Qu does not explicitly teach an emulsion, nor a polyethyleneimine intermediate as recited in claim 1.
Jin teaches a preparation method of antiviral moisture-permeable coatings and films. The antiviral coatings are prepared by first obtaining a polyethyleneimine quaternary ammonium salt (QPEI) and matching said QPEI with oxalic acid in an aqueous polymer (abstract; claim 1). The polyethylene- imine quaternary ammonium salt is multi-chain quaternary ammonium salt; it has very high antiviral, it can kill the virus in a short time (p. 2-3, bridge paragraph). The antiviral moisture-permeable membrane of Jin is prepared by 1) forming a polyethyleneimine quaternary ammonium salt (QPEI) and 2) adding a polyurethane emulsion to water, then adding isocyanate, the above QPEI, and oxalic acid to obtain the antiviral moisture-permeable coating. The antiviral moisture-permeable coating is coated onto PET non-woven fabric and dried with heat to obtain an antiviral moisture-permeable film (embodiments 2 and 5). Jin teaches that the aqueous polymer may be polyurethane emulsion, hydroxyethyl cellulose, or a combination (p. 3, para. 10), and that the aqueous polymer is crosslinked by the aqueous isocyanate. Uncrosslinked aqueous polymer is easily dissolved by water, and isocyanate crosslinking improves the stability of the material, maintaining long-term high moisture permeability (p. 3, para. 10).
Gao discloses a quaternerized polyethyleneimine (QPEI) prepared by a tertiary amination reaction and quaternization. Experiments showed the QPEI to possess outstanding antibacterial activity (abstract). Polyethyleneimine (PEI) is a water-soluble polyamine (p. 532, para. 2). The QPEI was prepared from a polyethyleneimine (Mr = 2 x 104 to 5 x104 ) which underwent a tertiary amination reaction using propylene oxide as the alkylation agent and subsequent quaternization with benzyl chloride:
PNG
media_image2.png
241
286
media_image2.png
Greyscale
. The QPEI of Gao reads on the instantly claimed polyethyleneimine intermediate comprising hydroxyalkylene functionality and partially quaternized nitrogen atoms, as recited in claim 1.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the QPEI of Gao into the antimicrobial coating composition of Qu since the QPEI of Gao possesses excellent antibacterial activity, and QPEIs are known and routine in the art of polyurethane coatings as taught by Jin. First, it would have been obvious to one of ordinary skill in the art to add a QPEI into the polyurethane coating composition of Qu since QPEIs are known and effective antimicrobial components for polyurethane coatings as taught by Jin. Furthermore, a hydroxyl-functionalized QPEI such as that of Gao would have been desired in the composition of Qu, since the hydroxyl groups enable covalent bonding and crosslinking of the QPEI into the polymer matrix of Qu thereby preventing leaching. The entirety of Qu centers around the formation of non-leaching antimicrobial coatings. The preferred method of linking antimicrobials, suitable for a non-leaching anti-microbial mode of action, is the formation of a covalent bond by reacting an available free isocyante group from a polyurethane prepolymer with an amine or hydroxyl group of specific antimicrobial quaternary ammonium compounds ([0063]; [0013] of Qu). Specially, the antimicrobial molecules of Qu comprise a hydroxyl-functional material (ROH) ([0061]; [0066]). Thus, one of ordinary skill in the art would have been motivated to incorporate a antimicrobial QPEI having -OH reactive groups, such as that of Gao, since a hydroxy-functionalized QPEI has the benefit of being able to form covalent bonds with the polymeric matrix of Qu. One of ordinary skill in the art could have combined the elements of Qu, Jin, and Gao according to known methods to predictably yield a non-leaching, antimicrobial coating composition that reads on the antimicrobial composition as claimed.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since Qu and Jin both teach antimicrobial polyurethane coatings and Jin and Gao both teach QPEIs as antimicrobial agents. Moreover, Qu welcomes the addition of polyamines into the coating composition.
Regarding the recitation of an oil-in-water emulsion, Jin teaches a coating composition comprising a polyurethane emulsion dispersed in water which implies that polyurethane forms a phase which is immiscible with water. Thus, a polyurethane emulsion dispersed in water reads on an oil-in-water emulsion wherein the polyurethane is understood to form an “oil phase” and the water forms the “aqueous phase”. It would have prima facie obvious to configure the combined coating composition of Qu, Jin, and Gao in the form of an emulsion since emulsions are known and routine in the art as taught by Jin. One of ordinary skill in the art could have provided the composition of Qu with the emulsion format of Jin simply by dispersing the appropriate components in water to predictably yield the instantly claimed oil-in-water emulsion, wherein each component ends up in the appropriate phase based on its water-solubility. In any case, emulsions are well known in the art for applying coatings, and one of ordinary skill in the art could have adjusted the composition of Qu, Jin, and Gao to form an oil-in-water emulsion according to the instant invention, which is applied to a substrate as a liquid and dried to form a film as taught by both Qu and Jin. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Qu teaches a carrier solvent such as water. Additionally, it is discussed in the instant specification that upon reacting a reactive quaternary ammonium salt with a multifunctional crosslinker (such as a polyisocyanate), the resultant reaction mixture becomes readily emulsifiable in water with excellent emulsion stability, particularly in the presence of a water-soluble polymer as a protective colloid ([0009]). As discussed above, Qu teaches the reaction of a reactive QAS with a multifunctional crosslinker, such as a polyurethane prepolymer and multifunctional isocyanate crosslinkers, as well as a hydrophilic component such as PVP or HEC, and a carrier such as water. Given the emulsion formation discussed in the instant specification, it is believed that the combined solution of Qu, Jin, and Gao will inherently form an oil-in-water emulsion when water is the carrier solvent, since it contains the necessary components as set forth in the instant specification.
Regarding the formation of a random polymer or interpenetrating polymer network as recited in claim 1, the claim itself is drawn to a antimicrobial composition being made up of individual components in solution. Thus, if each of the individual components are present as claimed, it is inherent that a random polymer or polymer network can be produced. Because the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property (i.e., ability to form a polymer or polymer network). It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). Furthermore, based on the teachings of Qu, Jin, and Gao, a composition based on their combination would be used in a method of coating and drying the composition onto a substrate, wherein the individual components of the coating composition would form a polymeric matrix resulting from random polymerization between the functional groups present on the polyurethane prepolymer (i.e., isocyanate group), QAS (hydroxyl group), QPEI (hydroxyl group), and crosslinker (isocyanate group), thereby reading on the polymer network as claimed.
As such the entirety of claim 1 is obvious in view of the teachings of Qu, Jin, and Gao.
Regarding claim 2: Qu teaches a polyurethane prepolymer and a crosslinker, both of which comprises isocyanate functional groups in a specific embodiment ([0028]; [0032]; claims 33-34 and 38). Qu and Jin also teach water-soluble (i.e., hydrophilic/aqueous) polymers. Jin teaches crosslinking the aqueous polymer with isocyanate. According to Jin, uncrosslinked aqueous polymer is easily dissolved by water, and isocyanate crosslinking improves the stability of the material, maintaining long-term high moisture permeability (p. 3, para. 10). It would have therefore been prima facie obvious to one of ordinary skill in the art to crosslink the hydrophilic polymer in the combined composition with the polyurethane prepolymer or additional crosslinkers of Qu, having isocyanate groups, since crosslinking of an aqueous polymer via isocyanates in a coating composition improves the stability of the material while maintaining long-term high moisture permeability as taught by Jin. The use of a known technique (i.e., crosslinking) to improve similar products (i.e., antimicrobial coatings) in the same way (i.e., improved stability), is considered prima facie obvious. See MPEP 2143.
Regarding claim 18: The polyurethane prepolymer of Qu comprises reactive isocyanates ([0028]; claims 33-34). Specifically, linear polyurethane polyisocyanate prepolymers are used in several examples (Ex. 1, 2, 4, 7, 13-15, etc.), therefore reading on a first polyisocyanate. The additional crosslinkers, discussed above, include multifunctional isocyanates ([0032]; claim 38), which read on a second polyisocyanate. The polyisocyanates may be the same or different as defined by the instant claim.
Regarding claim 46: As discussed above, both Qu and Jin disclose hydrophilic/aqueous polymers, which include hydroxyethyl cellulose (HEC). While Qu does not explicitly define an example or the selection of HEC as the hydrophilic component, it would have been prima facie obvious to one of ordinary skill in the art to select hydroxyethyl cellulose as the hydrophilic component in the combined coating composition, since hydroxyethyl cellulose is a known and routine hydrophilic/aqueous component of antimicrobial coating compositions as taught by both Qu and Jin. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. One of ordinary skill in the art would have had a reasonable expectation of success since both Qu and Jin teach HEC as an acceptable hydrophilic polymer to incorporate into polyurethane coating compositions.
Regarding claim 87: The QPEI of Gao, reaction scheme shown above, reads on a reaction product of reagents comprising a polyethyleneimine, a mono-epoxide (i.e., propylene oxide), and an alkylating agent (i.e., propylene oxide or benzyl chloride), wherein the mono-epoxide is substituted with a C1 alkyl, as defined in (i).
Regarding claim 105: While the QPEI of Gao does not read on the instantly elected QPEI (i.e., HB37478), the QPEI of Gao (structure below) reads on the following claimed structure (below):
Gao structure:
PNG
media_image2.png
241
286
media_image2.png
Greyscale
(Scheme 1);
Claimed structure:
PNG
media_image3.png
263
241
media_image3.png
Greyscale
wherein Y2 is hydrogen; n is from 1-3000; R10 is a C1 alkyl; R21 is a C1 alkyl substituted with a C6 aryl; and X- is a halide, as claimed.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 are rejected under 35 U.S.C. 103 as being unpatentable over Qu, Jin, and Gao as applied to claims 1-2, 18, 46, 87, and 105 above, and further in view of Wang, S., et al. (US 20110124772 A1, 05/06/2011, on record), hereinafter Wang.
The combined teachings of Qu, Jin, and Gao are discussed above.
Qu further teaches the quaternary ammonium compound below for providing non-leaching and non-adhering antimicrobial efficacy:
PNG
media_image4.png
261
452
media_image4.png
Greyscale
([0064]-[0065]). At least one of groups R1, R2, or R3 has a length sufficient to penetrate cell walls of microbial organisms ([0063]). Specifically, R1 and R3 independently have chain lengths between 1 and about 4 atoms; and R2 has a chain length between about 12 and about 23 atoms ([0027]). Preferably R4 has a length sufficient so that N is at or protrudes through an organic debris deposited on the surface of the cured composition ([0065]).
The combined teachings of Qu, Jin, and Gao differ from that of the instant invention in that none explicitly teach the quaternary ammonium salt as elected in claim 3, nor the explicit inclusion of a polyol of claim 39.
Wang, in the same field of endeavor, teaches polymers with non-leaching antimicrobial activity and their use as surface coatings or bulk resins for medical devices. The antimicrobial polymers are prepared with antimicrobial moieties covalently bonded to a polymer chain end or to a polymer backbone at a side chain end (abstract). The polymer backbone of the antimicrobial polymer may be a polyurethane made by the reaction of polyisocyanates with polyols ([0040]-[0041]; claim 5). Exemplary polyols/polyethers include polytetramethylene oxide (PTMO) ([0041]; [0045]). The antimicrobially active moiety is a compound such as a quaternary ammonium salt ([0033];[0056]), specifically a hydroxy functionalized quaternary ammonium halide (Examples; claim 3):
PNG
media_image5.png
168
429
media_image5.png
Greyscale
, wherein m=1-3, n=7, 11, 15, 17, and X is a chloride or bromide ion ([0064]). When m is 2, n is 17, and X is bromide, the QAS reads on the instantly elected C18DMDEG structure and the structure of claim 3.
Regarding claim 3: It would have been prima facie obvious to one of ordinary skill in the art to replace the hydroxyl functionalized QAS of Qu in the combined composition above with the C18DMDEG QAS of Wang since it is a known and routine QAS compound in the art as taught by Wang. One of ordinary skill in the art could have replaced the QAS compound of Qu with the QAS of Wang, since it entails no more than the simple substitution of one known component for another to yield predictable results. Additionally, the selection of m, n, and X would have been prima facie obvious since it entails no more than choosing from a finite number of identified, predictable solutions with a reasonable expectation of success. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since the QAS structure of Wang reads on the broader QAS structure of Qu, and both references disclose the use of hydroxyl functionalized quaternary ammonium salts for the formation of non-leaching, antimicrobial polymer coatings.
Regarding Claim 39: Wang teaches that polyether polyols, such as PTMO, can be reacted with isocyanates as part of the polyurethane polymer backbone. Thus, it would have been prima facie obvious to one of ordinary skill in the art to incorporate a polyether polyol into the polymer matrix of the combined composition of Qu, Jin, and Gao since polyols are known and routine in the art of polyurethane coatings. One of ordinary skill in the art could have incorporated a polyether polyol into the combined composition of Qu, Jin, and Gao via known methods to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in adding a polyol since Qu welcomes the addition of modifying polymers such as polyols.
Regarding claims 110 and 184: Qu teaches a curable antimicrobial film forming composition comprising a polymeric matrix which forms a chemical bond with a long chain compound (i.e., the QAS) upon drying or curing of the composition (abstract; claim 1). The polyurethane prepolymer and long chain compound (i.e., a QAS) of Qu reads on the first adduct of a first multifunctional crosslinker and first quaternary ammonium salt of (i). The polyol taught by Qu and Wang, and made obvious above, reads on the polyol of (ii). The QPEI made obvious by Jin and Gao reads on the polyethyleneimine intermediate of (iii). The additional crosslinker of Qu reads on the second multifunctional crosslinker of (iv). The third multifunctional crosslinker of (v) is optional and the hydrophilic polymer of Qu reads on the water-soluble polymer of (vi). Qu and Jin teach methods of applying their respective coating compositions to a substrate and heating or curing the compositions to form a film. Specifically, Qu teaches that non-leaching coatings are achieved by covalent bonds between the polymer matrix, the crosslinker, and the long chain antimicrobial compounds. It would have been prima facie obvious to use the combined composition of Qu, Jin, Gao, and Wang in a method of applying and heating/curing the composition since this is a known and routine use for these compositions in the art as taught by Qu and Jin. Since the individual components of the coating solution comprises reactive groups meant to covalently bond with one another (i.e., isocyanate and hydroxyl groups), such a method would result in a polymer or polymer network comprising a random polymerization and crosslinking product of the reagents present in the mixed solution, thereby reading on the polymer or polymer network as claimed. The film coating formed also reads on a composition comprising the polymer network. One of ordinary skill in the art would have had a reasonable expectation of success in forming such a product with the combined coating composition of Qu, Jin, Gao, and Wang since the individually claimed components are present with reactive groups that which are known in the art to form bonds with one another.
Double Patenting
The nonstatutory 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 nonstatutory 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 nonstatutory 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 nonstatutory 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
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 57 of copending Application No. 18/373,686 in view of Jin et al. (CN 111849328 A) and Gao et al. (2007). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Jin and Gao.
Copending claim 1 recites an antimicrobial composition comprising an oil-in-water emulsion, the oil-in-water emulsion comprising: (i) an oil phase comprising a first adduct of a first multifunctional crosslinker and a first quaternary ammonium salt, wherein the first quaternary ammonium salt has a reactive linking group to react with the first multifunctional crosslinker; a polyol; and optionally a second multifunctional crosslinker; and (ii) an aqueous phase comprising a water-soluble polymer. Copending claim 57 recites a random polymer or an interpenetrating polymer network produced from random polymerization/crosslinking of the first adduct, the polyol, the water-soluble polymer, and, when present, the second multifunctional crosslinker.
The only difference between the copending claims and the instant invention is that the instant invention requires a polyethyleneimine intermediate with hydroxyalkylene functionality.
Jin teaches a preparation method of antiviral moisture-permeable coatings and films. The antiviral coatings are prepared by first obtaining a polyethyleneimine quaternary ammonium salt (QPEI) and matching said QPEI with oxalic acid in an aqueous polymer (abstract; claim 1). The aqueous polymer may be polyurethane emulsion, hydroxyethyl cellulose, or a combination (p. 3, para. 10).
Gao discloses a quaternerized polyethyleneimine (QPEI) prepared by a tertiary amination reaction and quaternization. Experiments showed the QPEI to possess outstanding antibacterial activity (abstract). The QPEI was prepared as follows:
PNG
media_image2.png
241
286
media_image2.png
Greyscale
It would have been prima facie obvious to one of ordinary skill in the art to incorporate the QPEI of Gao into the antimicrobial coating composition of the copending claims since the QPEI of Gao possesses excellent antibacterial activity, and QPEIs are known and routine in the art of polyurethane coatings as taught by Jin. First, it would have been obvious to add a QPEI into the polyurethane coating composition of the copending claims since QPEIs are known and effective antimicrobial components for polyurethane coatings as taught by Jin and the QPEI of Gao could have been selected by one of ordinary skill in the art given its known and effective antimicrobial activity. One of ordinary skill in the art would have been motivated to incorporate the QPEI of Jin and Gao since it has antimicrobial activity which would benefit the antimicrobial composition of the copending claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of copending Application No. 18/371,358 in view of Jin et al. (CN 111849328 A) and Wang, et al. (US 20110124772 A1). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Jin and Wang.
Copending claim 1 recites an antimicrobial composition comprising a polymer, wherein: the polymer comprises a reaction product of a polyethyleneimine oligomer, a multifunctional crosslinker, an alkylating agent, an optional monoisocyanate and an optional catalyst; the polyethyleneimine oligomer comprises optionally substituted hydroxyalkylene functionality that reacts with one of or both of the optional monoisocyanate and the multifunctional crosslinker; and nitrogen atoms present in the polyethyleneimine oligomer are at least partially quaternized by the alkylating agent. Copending claim 11 defines the multifunctional crosslinker as a polyisocyanate.
The copending claims differ from the instant claims in that they do not define an emulsion nor wherein the first multifunctional crosslinker forms an adduct with a first quaternary ammonium salt, nor an aqueous phase comprising a water-soluble polymer.
Jin teaches a preparation method of antiviral moisture-permeable coatings and films. The antiviral coatings are prepared by first obtaining a polyethyleneimine quaternary ammonium salt (QPEI) and matching said QPEI with oxalic acid in an aqueous polymer (abstract; claim 1). The aqueous polymer may be polyurethane emulsion, hydroxyethyl cellulose, or a combination (p. 3, para. 10).
Wang teaches polymers with non-leaching antimicrobial activity and their use as surface coatings or bulk resins for medical devices. The antimicrobial polymers are prepared with antimicrobial moieties covalently bonded to a polymer chain end or to a polymer backbone at a side chain end (abstract). The polymer backbone of the antimicrobial polymer may be a polyurethane ([0040]-[0041]) and the antimicrobially active moiety is a compound such as a quaternary ammonium salt ([0033];[0056]).
It would have been prima facie obvious to formulate the antimicrobial composition of the copending claims as an emulsion as taught by Jin wherein a quaternary ammonium salt is present to react with the multifunctional crosslinker of the copending claims in order to increase antimicrobial activity as taught by Wang. It would have also been obvious to add in a water soluble polymer such as the HEC of Jin since such a polymer is known and routine in antimicrobial compositions also comprising QPEIs as taught by Jin. Generally, the combination of prior art elements according to known methods is considered prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 04/22/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that the polyethyleneimine quaternary ammonium salt (QPEI) of Jin is merely an additive which does not covalently bond to the crosslinked aqueous polymer. Furthermore, since the QPEI does not comprise hydroxyalkylene functionality, now made essential by the instantly amended claims, it could not react with the first adduct.
In response to this argument, the newly applied rejection which is based on Qu in view of Jin and Gao, makes obvious a hydroxyalkylene functionalized QPEI such as that of Gao. Such a QPEI would have been prima facie obvious for the reasons set forth above, specifically because 1) QPEIs are known and routine compounds to incorporate in polyurethane coatings as taught by Jin; 2) the QPEI of Gao has known and effective antimicrobial properties which would benefit the antimicrobial coatings of Qu; and 3) Qu teaches that hydroxyl functionality is desired for quaternary ammonium compounds since such functionality enable covalent boning between the antimicrobial moieties and the polyurethane backbone, which prevents undesired leaching. Thus, Applicants arguments are moot in view of the new rejection which makes obvious a hydroxyalkylene functionalized QPEI.
(2) Applicant argues against the fact that it would be obvious to combine embodiments of Jin to provide a coating solution comprising both a polyurethane emulsion and HEC.
This argument is moot since the above rejections no longer rely on this reasoning. Qu, the instantly applied primary reference, teaches a specific embodiment comprising the instantly claimed first adduct and a hydrophilic polymer in combination.
(3) Applicant argues against Wang stating that Wang fails to teach or suggest the use of quaternary polyethyleneimines as antimicrobial active moieties. Applicant also argues that Wang’s antimicrobially active polymer molecules are block polymerization products prepared in a step-wise fashion which results in polymers which are structurally different from the random polymerization products as claimed. Applicant asserts that selecting any of the block polymer precursors of Wang for modification of Jin’s blends into the instantly claimed compositions would occur only through impermissible hindsight.
In response to this argument it is noted that Wang is not relied on for the teaching of a quaternary polyethyleneimine. As discussed above, Jin and Gao make obvious the addition of a QPEI, specifically a hydroxyl functionalized one, into the compositions of Qu. Secondly, Wang teaches individual components which may be used in polyurethane coatings such as polyols and quaternary ammonium salts. While Wang teaches block polymerization methods, these individual components have the same reactivity regardless of their use in a block polymers or random polymers. One of ordinary skill in the art could have substituted the QAS of Qu with the QAS of Wang regardless of the polymerization method since both QAS compounds have the same reactivity allowing them to react with the isocyanates in the prepolymer or crosslinker. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
(4) Applicant argues that even if one were to replace the polyethyleneimine quaternary ammonium salt (QPEI) of Jin with the QPEI of Gao, there is no teaching in Gao to further modify Jin to have the QPEI react with specific block polymer precursors of Wang especially since Gao does not teach its antibacterial QPEI in a polymerization process.
As discussed in the rejections set forth above, which now rely on the combination of Qu, Jin, and Gao, the obviousness to incorporate the QPEI of Gao into the composition of Qu is multipart: 1) QPEIs are known and routine compounds to incorporate in polyurethane coatings, such as those of Qu, as taught by Jin; 2) the QPEI of Gao has known and effective antimicrobial properties which would benefit the antimicrobial coatings of Qu; and 3) Qu teaches that hydroxyl functionality is desired for quaternary ammonium antimicrobials since such functionality enable covalent bonding between the antimicrobial moieties and the polyurethane backbone, which prevents undesired leaching.
(5) The above responses can also be applied to applicant’s arguments regarding the double patenting rejections.
Allowable Subject Matter
In the Remarks of 04/22/2026, Applicant has provided a statement invoking the 35 USC 102(b)(2)(C) exception, disqualifying Herchen (WO 2022203952 A1) as prior art. As such, the instantly elected QPEI structure (structure below), denoted as QPEI HB37478 in the instant specification and the election response of 11/04/2025, is free of the prior art. However, there is no claim as instantly recited, which specifically defines the structure of QPEI HB37478.
PNG
media_image6.png
187
237
media_image6.png
Greyscale
(QPEI HB37478)
Conclusion
No claims 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
Prosecution Insights