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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 18, 22, 39, 46, 61-62, 87, 105-106, 108-110, and 184) in the reply filed on 11/04/2025 is acknowledged. The Applicant’s election of species (a)-(h) is also acknowledged. As stated by the Applicant, claims 1-3, 18, 39, 46, 87, 105, 110, and 184 encompass the elected species.
Accordingly, claims 22, 61-62, 106, 108-109, 196-197, 203, 208 are withdrawn as being directed to a non-elected invention or species. Claims 3, 18, 22, 39, 46, 61-62, 87, 105-106, 108-109, 184, 196-197, and 203 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 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 statements (IDS) submitted on 01/29/2024, 05/02/2025, 11/04/2025, and 12/18/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites an oil-in-water emulsion wherein the oil phase comprises a first adduct; optionally a polyol; a polyethyleneimine intermediate; and optionally a third multifunctional crosslinker. The aqueous phase comprises a water-soluble polymer. However, Examples 1-4 and 5-9 of the instant specification disclose water-based coatings of the invention which comprises an “oil phase” and an “aqueous phase”, wherein the polyethyleneimine intermediate is explicitly defined as “water-soluble” ([0413]) and is present in the aqueous phase (Table 2; [0434]). This includes the instantly elected QPEI: HB37478. Additionally, the preparation of Examples 1-9 do not describe if and how a QPEI is incorporated into an oil phase as claimed and as such the specification lacks written description for claims as currently presented, e.g. is the QPEI actually being dissolved in an organic solvent which is immiscible in water prior to forming any mixtures in order to keep it in the oil phase as claimed? Thus, there appears to potentially be some written aspect of the claims missing as to how the polyethyleneimine intermediate is contained in the oil phase as claimed.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites an oil-in-water emulsion wherein the oil phase comprises a first adduct; optionally a polyol; a polyethyleneimine intermediate; and optionally a third multifunctional crosslinker. The aqueous phase comprises a water-soluble polymer. However, Examples 1-4 and 5-9 of the instant specification disclose water-based coatings of the invention which comprises an “oil phase” and an “aqueous phase”, wherein the polyethyleneimine intermediate is explicitly defined as “water-soluble” ([0413]) and is present in the aqueous phase (Table 2; [0434]). This includes the instantly elected QPEI: HB37478. Additionally, the preparation description of Examples 1-9 do not describe if and how a QPEI is incorporated into an oil phase as claimed since it is specifically defined to be water soluble.
It is unclear how the PEI intermediate of the invention resides in an oil phase, as instantly claimed, if it is explicitly defined by the instant specification as water-soluble and there is no solvent required by instant claim 1 which would incorporate QPEI into an oil phase. For the sake of compact prosecution, the polyethyleneimine intermediate will be interpreted as being incorporated into any phase of the solution.
Claim 105 defines the polyethyleneimine intermediate as being selected form a variety of structures which include the following:
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.
The above structures lack antecedent basis because claim 1, from which claim 105 depends, recites wherein nitrogen atoms present in the polyethyleneimine intermediate are at least partially quaternized. The above PEI structures do not provide any quaternized nitrogen atoms and therefore lack antecedent basis.
Claim 110 recites “a random polymerization/crosslinking product”, however, polymerization and crosslinking are known to be different processes in the art. The use of a slash therefore yields the claim indefinite as it is unclear if polymerization and crosslinking are being used interchangeably or if the product is both polymerized and crosslinked or one of the two.
Claims 2-3, 18, 39, 46, 87, and 184 fail to further clarify the above issues and are therefore rejected by virtue of their dependency on claims 1 and 110.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1-3, 18, 39, 46, 110, and 184 are rejected under 35 U.S.C. 103 as being unpatentable over Jin, W., et al. (CN 111849328 A, 10/30/2020, IDS dated 12/18/2025), hereinafter Jin, in view of Wang, S., et al. (US 20110124772 A1, 05/06/2011, PTO-892), hereinafter Wang.
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).
Regarding claim 1: A specific embodiment teaches that 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). The QPEI of Jin reads on the instantly claimed polyethyleneimine intermediate wherein the nitrogen atoms are at least partially quaternized.
In another embodiment, the same procedure as above is provided except hydroxyethyl cellulose (HEC) is dispersed in water with the isocyanate, QPEI, and oxalic acid rather than the polyurethane emulsion (embodiment 3). The HEC reads on the instantly claimed water-soluble polymer.
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 (p. 3, para. 10).
The teachings of Jin differ from that of the instant invention in that Jin does not explicitly teach an oil-in-water emulsion comprising both a first adduct and an water-soluble polymer as recited in claim 1, nor does Jin explicitly teach the first adduct to comprise a multifunctional crosslinker and quaternary ammonium salt as recited in claim 1.
However, given the teachings of Jin, it would have been prima facie obvious to combine embodiments to provide a coating solution comprising both a polyurethane emulsion and HEC since antiviral membrane solutions comprising QPEI with polyurethane and HEC are independently taught by Jin. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One of ordinary skill in the art would have had a reasonable expectation of success in combining the polyurethane emulsion and HEC of Jin in the antiviral coating solution since Jin teaches that the aqueous polymer may comprise a polyurethane emulsion, HEC, or a combination of the two.
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]). Exemplary polyols include polytetramethylene oxide (PTMO) ([0041]). 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):
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, wherein m=1-3, n=7, 11, 15, 17, and X is a chloride or bromide ion ([0064]).
Wang further teaches the preparation of a thermoplastic polyurethane with an antimicrobial agent covalently bonded to the polymer ends having the above QAS structure. Methylene diphenyl diisocyanate (MDI) is reacted with polycarbonate diol followed by the addition of a solution mixture of butane diol and the above hydroxyl functional quaternary ammonium halide ([0076]). The resulting polymer solution reads on the instantly claimed first adduct of a first multifunctional crosslinker (i.e., MDI) and a first quaternary ammonium salt (i.e., hydroxyl quaternary ammonium halide). It further comprises a polyol in the form of polycarbonate diol and/or butane diol.
Solutions comprising the above polymer are cast into films on PET Mylar substrates and dried under heat ([0079]). The membrane of the invention may have any shape resulting from a process utilizing a liquid which is subsequently converted to a solid during or after fabrication, e.g., solutions, dispersions, 100% solids prepolymer liquids, polymer melts, etc. ([0099]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the antimicrobial functionalized polyurethane of Wang in the polyurethane emulsion of Jin since QAS functionalized polyurethanes are known and routine in the art of antimicrobial coatings. The QAS functionalized polyurethanes of Wang provide antimicrobial activity via the QAS moieties that are covalently attached to the polyurethane backbone. One of ordinary skill in the art would have therefore been motivated to use such a polyurethane system in the antiviral coating of Jin since QAS functionalized polyurethanes are known and effective for providing antimicrobial properties to a membrane coating similar to that of Jin. Furthermore, Jin teaches adding polyurethanes into the membrane coating solution, meaning one of ordinary skill in the art could have substituted the polyurethane of Jin for the QAS functionalized polyurethane of Wang to predictably generate the desired membrane coating and film. One of ordinary skill in the art would have had a reasonable expectation of success in using the QAS functionalized polyurethane of Wang in the antiviral coating of Jin since both teach antimicrobial coatings formed with polyurethanes.
The combination of Jin and Wang makes obvious an antimicrobial composition comprising a quaternary polyethyleneimine, a polyurethane emulsion, and hydroxyethyl cellulose dispersed in water (taught by Jin), wherein the polyurethane comprises polyisocyanates, a polyol, and a quaternary ammonium salt (taught by Wang). The QPEI and HEC of Jin read on the instantly claimed polyethyleneimine intermediate and water-soluble polymer, respectively. The polyethyleneimine of Jin comprises nitrogen atoms that are at least partially quaternized, as instantly claimed. The polyisocyanate and quaternary ammonium salt of Wang read on the claimed first multifunctional crosslinker and first quaternary ammonium salt, respectively, wherein the first QAS has a reactive linking group to react with the first multifunctional crosslinker (i.e., hydroxyl group). This combination therefore reads on the instantly claimed first adduct. Wang also teaches the inclusion of polyols in the polyurethane solution, which reads on the optionally present polyol. It is noted that the second adduct, the third multifunctional crosslinker, and the substitution of hydroxyalkylene functionality in the PEI is optional as defined in claim 1.
While neither Jin nor Wang explicitly teach an oil-in-water emulsion, Jin teaches a polyurethane emulsion dispersed in water. A polyurethane emulsion dispersed in water implies that the polyurethane forms a phase which is immiscible with water. Thus, the polyurethane solution is understood to form an “oil phase” dispersed within an “aqueous phase”, thereby reading on the instantly claimed oil-in-water emulsion. The QPEI is present in the solution, which reads on the instant invention as best interpreted given the 112 issues above.
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 Jin and Wang 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 Jin and Wang.
Regarding claim 2: Jin teaches that the aqueous polymer of the invention is crosslinked by 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). The aqueous polymer of Jin is defined as HEC and/or a polyurethane emulsion. It is clear that when both are present, as in the combined composition above, crosslinks will form between the HEC and the polyisocyanate moieties of the PU emulsion via the aqueous isocyanate. Even if crosslink formation is not inherent, it would have been prima facie obvious to one of ordinary skill in the art to crosslink the two together in order to improve stability and maintain long-term moisture permeability as taught by Wang.
Regarding claim 3: The antimicrobial QAS of Wang is a hydroxy functionalized antimicrobial quaternary ammonium halide with the following structure:
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, 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. It would have been prima facie obvious to one of ordinary skill in the art to select such a structure since it is known and effective for providing antimicrobial activity to a polyurethane and both Jin and Wang teach antimicrobial polyurethane compositions. 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.
Regarding Claim 18: As discussed above, the first multifunctional crosslinker is a polyisocyanate as taught by Wang. The second and third multifunctional crosslinkers are optional and are therefore not required.
Regarding Claim 39: Wang teaches that polyols used to make polyurethanes may include polytetramethylene oxide (PTMO). Thus, it would have been prima facie obvious to one of ordinary skill in the art to incorporate a polyol such as polytetramethylene oxide into the polyurethane of Jin and Wang since it is a known and routine polyol in the art of polyurethane coatings. 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. PTMO reads on the instantly elected species of polyol (i.e., polytetramethylene glycol), which is an example of a polyether polyol.
Regarding claim 46: As discussed above, the water-soluble polymer is hydroxyethyl cellulose which reads on the instantly elected species of a water-soluble polymer.
Regarding claims 110 and 184: The final film coating of Jin and Wang is prepared by coating the mixed solution onto a substrate and drying it with heat, a process taught by both Jin and Wang. Jin teaches that isocyanates are added to form crosslinks. Wang teaches that the polyurethanes are a polymerization product of the polyisocyanate, polyol, and hydroxy QAS. Thus, the final film coating of Jin and Wang results in an polymer network comprising a random polymerization/crosslinking product of the reagents present in the mixed solution. The mixed solution as taught by Jin and Wang comprises (i) a first adduct of a first multifunctional crosslinker (i.e., polyisocyanate) and a first quaternary ammonium salt; (ii) a polyol; and (iii) a polyethyleneimine intermediate (i.e., QPEI), as instantly claimed. The film coating formed also reads on a composition comprising the polymer network.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 are rejected under 35 U.S.C. 103 as being unpatentable over Jin and Wang as applied to claim 1-3, 18, 39, 46, 110, and 184 above, and further in view of Herchen, S., et al. (WO 2022203952 A1, 09/29/2022, filed 03/18/2022, IDS dated 05/02/2025), hereinafter Herchen.
The applied reference has a common Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The combined teachings of Jin and Wang are discussed above.
The combined teachings of Jin and Wang differ from that of the instantly claimed invention in that Jin and Wang do not teach the instantly claimed polyethyleneimine intermediate of claims 87 and 105.
Herchen discloses quaternary ammonium polymers with broad spectrum antimicrobial properties that produce fast acting, long lasting, non-toxic and nonallergenic colorless and transparent durable surface coatings that are resistant to water and common solvents (abstract). The antimicrobial surface coatings comprise cross-linked Polyurethane Alkyl Quaternary PEI-B (PUA-Q-PEI-B) formed by crosslinking the hydroxyl alkyl quaternized polyethyleneimine (HA-Q-PEI) below with at least one polyisocyanate ([00019]).
Herchen teaches hydroxyl alkyl quaternized polyethyleneimine polymers with the following structure to have excellent antiviral efficiencies:
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, wherein R1 is methyl; R2 is n-hexyl; and X- is a Bromide (Example 5; [0153]; Table 2). Such a structure reads on the instantly elected polyethyleneimine intermediate of claims 87 and 105.
It would have been prima facie obvious to one of ordinary skill in the art to replace the
polyethylene imine quaternary ammonium salt of Jin in the combined composition above with the QPEI of Herchen since it is a known and effective antimicrobial agent in the art. One of ordinary skill in the art would have been motivated to use the QPEI of Herchen since it possesses desirable antiviral properties and is known for use in polyurethane based coatings such as those of Jin and Wang. One of ordinary skill in the art could have substituted one QPEI for another to predictably generate the instantly claimed invention. There would have been a reasonable expectation of success since both Jin and Herchen teach quaternized polyethyleneimines as antimicrobial compounds in coating compositions.
Claims 1-3, 18, 39, 46, 87, 105, 110, and 184 are rejected under 35 U.S.C. 103 as being unpatentable over Jin and Wang as applied to claim 1-3, 18, 39, 46, 110, and 184 above, and further in view of Gao, B., et al. (2007). J. Biomater. Sci. Polymer Edn. Vol. 18, No. 5, pp. 531-544 (IDS dated 01/29/2024), hereinafter Gao.
The combined teachings of Jin and Wang are discussed above.
The combined teachings of Jin and Wang differ from that of the instantly claimed invention in that Jin and Wang do not teach the instantly claimed polyethyleneimine intermediate of claims 87 and 105.
Gao discloses a quaternerized polyethyleneimine (QPEI) prepared by a tertiary amination reaction and quaterization. Experiments showed the QPEI to possess outstanding antibacterial activity (abstract).
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:
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It would have been prima facie obvious to one of ordinary skill in the art to replace the
polyethylene imine quaternary ammonium salt of Jin in the combined composition above with the QPEI of Gao since it is a known and effective antibacterial agent in the art. One of ordinary skill in the art would have been motivated to use the QPEI of Gao since it possesses desirable antibacterial properties. One of ordinary skill in the art could have substituted one QPEI for another to predictably generate the instantly claimed invention. There would have been a reasonable expectation of success since both Jin and Gao teach quaternized polyethyleneimines as antimicrobial compounds.
While the QPEI of Gao does not read on the instantly elected QPEI (i.e., HB37478) it 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), as defined in (i) of claim 87. The QPEI of Gao further reads on the following structure of claim 105:
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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.
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 8 and 9 of copending Application No. 18/639,636 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending claim 8 recites a topical formulation comprising a polymeric component selected from a group which includes: (2) a polymer, copolymer, interpenetrating polymer network, polyelectrolyte complex, blend or composite comprising: (i) 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; (ii) a polyethyleneimine intermediate, or a second adduct of the polyethyleneimine intermediate and a second multifunctional crosslinker; wherein the polyethyleneimine intermediate comprises optionally substituted hydroxyalkylene functionality that reacts with the first adduct, and nitrogen atoms present in the polyethyleneimine intermediate are at least partially quaternized; (iii) optionally a polyol; (iv) optionally a water-soluble polymer; and (v) optionally a third multifunctional crosslinker. Copending claim 9 further defines that the formulation may be an emulsion. As such the copending claims define every element of the instantly claimed emulsion.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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). 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.
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.
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).
Thus it would have been prima facie obvious to one of ordinary skill in the art to add the QPEI of Jin into the composition of the copending claims since QPEIs are known and routine in the art as taught by Jin. One of ordinary skill in the art would have been motivated to incorporate the PEI of Jin 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 hydroxyethylene 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.
Conclusion
No claims are allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616