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 the composition of Claims 1-16 and 19-21 in the reply filed on 10 July 2026 is acknowledged.
Status of the Claims
Claims 1-23 are pending.
Claims 17, 18, 22, and 23 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-16 and 19-21 are presented for examination and rejected as set forth in greater detail below.
Priority
The instant application is a National Stage entry of International application PCT/EP2023/055377 filed 2 March 2023, which claims the benefit of Provisional U.S. application 63/316,373 filed 3 March 2022.
Claim Interpretation
Applicants claims are directed to compositions which combine a quaternary ammonium antimicrobial compound with a synthetic polymer incorporating at least one cationic monomer, an organic acid, a defined quantity of an organic polar solvent, and either or each of a cationic or amphoteric surfactant, where the composition has a basic pH and is free of nonionic surfactants. Dependent Claims 2-4 and 13 describe the manner in which the compositions of Claim 1 may be used. Applicants are reminded that it has long been held that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). An inventor of a structure (machine or article of manufacture) is entitled to benefit from all of its uses, even those not described, Roberts v. Ryer, 91 U.S. 150, 157 (1875), and conversely, patentability of the structure cannot turn on the use or function of the structure. In re Michlin, 256 F.2d 317, 320 (CCPA 1958). This language therefore does not limit the identity of the composition set forth by these claims. Claim 5 narrows the identity of the antimicrobial component, and each of Claims 6-8 the identity of a monomer required to be present in the polymer of Claim 1. Claim 9 narrows the identity of the acid present, with Claims 10 and 11 narrowing the identity of the surfactant. Claim 12 requires the inclusion of a generic polar solvent, and Claims 14 and 16 requiring the inclusion of at least one base. Claim 15 mirrors the components required by Claim 1, narrowing the required concentrations of each of the elements recited. Claims 19-21 narrow the quantity and identity of the organic polar solvent required by the claims.
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 1-14, 16, and 19-21 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 1 indicates the polar solvent is to be present in at least 20% by weight, preferably at least 30%, Claims 14 and 16 requires at least one base preferably a hydroxide of an alkali or alkaline earth metal, Claim 19 describes polar organic solvent concentration ranges of between 20-65%, preferably 35-60% of the weight of the composition, and Claim 20 requires the polar organic solvent be an aliphatic alcohol, preferably a C2-6 aliphatic alcohol. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-16 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen (WO2015/148063), in view of Hayward (U.S. PGPub. 2021/0029999) and Futterer (WO2008/154617).
Pedersen describes antimicrobial compositions which combine a cationic active ingredient, a foam boosting surfactant, a foam boosting copolymer, a foam stabilizer, and a chelating agent. (Abs.). Pedersen indicates that these cationic actives may be included in concentrations of about 0.1-10% by weight, a range overlapping that of Claim 15, and may be selected from, among others, alkyl dimethyl benzyl ammonium chloride, dialkyl dimethyl ammonium chloride, and benzethonium chloride, addressing limitations of Claim 5. (Pg.7-8), See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Pedersen indicates that the foam-boosting surfactant may be included in concentrations of between about 0.1-40% by weight addressing the limitations of Claim 15, and may be a cationic surfactant, (Pg.9), or an amphoteric surfactant such as a betaine derivative. (Pg.10). Dimethyl amine oxide of Claim 10 is identified as just such a surfactant, used in concentrations of between 0.2-36% by weight. Pedersen indicates that these compositions may contain adjuvants in concentrations of about 1-30% by weight of the composition. (Pg.12). The foam-boosting polymer of Pedersen is to be included in concentrations of about 0.05-18% by weight, and comprises cationic monomers as at least one of the structural units, which Pedersen indicates includes dialkyl diallyl ammonium halides and more specifically diallyl dimethyl ammonium chloride specifically, addressing monomer Ab of Claims 1 and 6. (Pg.15-17). The second structural unit is either an acrylamide or methacrylamide applicants recite as a monomer Ca of Claim 8. (Pg.17). Chelating agents, including a variety of organic acids, are recited by Pedersen as usefully included in these compositions. (Pg.18-19). Pedersen indicates that carriers to be used to solubilize the antimicrobial compositions include a variety of polar solvents, including water, alcohols, or mixtures thereof, and should be buffered to a pH of between about 5-8, overlapping the ranges of the instant claims. (Pg.19). pH adjusting compounds of Pedersen include the sodium, potassium, and lithium hydroxides as well as the citric and lactic acids of the instant claims, and should be included in concentrations of between 0.05-3.5% by weight, a range overlapping and therefore rendering obvious the limitations of Claims 9 and 14-16. (Pg.22), see Peterson, supra.
Despite teaching disinfecting compositions combining alkyl dimethyl benzyl ammonium chloride and dialkyl dimethyl ammonium chloride as disinfectants, polymers containing diallyl dimethyl ammonium chloride polymerized with either acrylamide or methacrylamide monomeric units, organic acids such as citric acid, cationic or amphoteric surfactants including amine oxides, bases such as hydroxides of alkali or alkaline earth metals, and polar solvents including water and alcohols, Pedersen does not identify the amount of polar organic solvent to be included, nor are polymers bearing the Ba monomeric units recited, nor are the use of sultaines or taurates as amphoteric surfactants identified.
However, Hayward, also directed to disinfectant cleaning compositions, indicates that polymers which combine cationic monomers such as the diallyldimethylammonium chloride of both the instant claims as well as the Pedersen reference, neutral monomers including the DMAEMA of Claim 8, and each of the acrylic and methacrylic acid monomers of Claim 7 may be employed to provide a disinfectant composition polymer, in concentrations of between about 0.0005-5% of the composition. [0030-35]. Surfactants for use in disinfectant compositions in concentrations between 0.1-5% of the composition include cationic amine oxides as well as sultaines. [0059; 0082; 0088-89]. Water, as a carrier, may be present in amounts of up to 99% of the composition. [0106].
Futterer also describes compositions for use as disinfectants. (Abs.). Surfactants and biocides compatible with the disinfectants of Futterer include the dialkyldimethylammonium chloride of Pedersen as well as the instant claims. (Pg.43, 47). Futterer indicates that liquid carriers useful in such disinfecting compositions include each of water and monohydric alcohols including ethanol and isopropanol, present in concentrations of between 80-99% by weight of the composition. (Pg.35).
It would have been prima facie obvious to one having ordinary skill in the art to employ the diallyldimethylammonium chloride/DMAEMA/acrylic/methacrylic acid polymer of Hayward in concentrations of between about 0.0005-5% of the composition as the diallyldimethyl ammonium chloride/acrylic/methacrylic acid containing polymer of Pedersen, owing to the known similarity of utility each possess in terms of compatibility and benefits associated with their use in disinfecting compositions. In a similar manner, it would have been obvious to have utilized the sultaines described by Hayward as an amphoteric surfactant in the compositions suggested by Pedersen owing to the art-recognized utility of sultaines as amphoteric surfactants in disinfectant compositions. Finally, it would have been prima facie obvious to have used a combination of water and ethanol or isopropanol taught by Futterer as suitable liquid carriers for disinfectant compositions as the carrier liquid of the disinfectants of Pedersen. This is because Pedersen indicates that water and alkanols may serve as carriers for the compositions suggested therein, and Futterer establishes their known utility as such disinfectant liquid carriers. While not particularly specifying that the alcohol, as an organic polar solvent, need to represent any particular portion of the overall 80-99% of the composition described as being carrier liquid, by teaching that each of alcohols and water may be present in concentrations of between 80-99% of the composition, the skilled artisan would have found it prima facie obvious to employ various concentrations of water and alcohol falling within the overall range Futterer describes. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
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.
At least Claims 1, 2, 5-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,980,230. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘230 patent require the inclusion of a quaternary ammonium compound, synthetic polymer, organic acid, and cationic surfactants, and in later dependent claims add the polar solvent of instant claim 1.
At least Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,877,575. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘575 patent describe a wipe which incorporates a quaternary ammonium compound, synthetic polymer, organic acid, and cationic surfactants, and in later dependent claims add the polar solvent of instant claim 1.
At least Claims 15, 16, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,497,210. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘210 patent describe a composition encompassing overlapping concentration ranges of the quaternary ammonium antimicrobial, cationic polymer, organic acid, and surfactant of the instant claims.
At least Claims 1, 2, 5-9, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9, and 10 of copending Application No. 18/700,248 (reference application) n view of Pedersen, discussed above. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘248 claims recite a disinfectant composition containing each of the synthetic polymer, organic acid, polar solvent and amphoteric surfactant of the instant claims, while not specifically requiring the disinfectant quaternary ammonium compound which Pedersen establishes may be combined with polymers such as those of the ‘248 application to provide disinfectant compositions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
