Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application
The Remarks and Amendments filed on 11/06/25 are acknowledged.
Claims 1-19 were previously cancelled, and claim 23 was cancelled on 11/06/25.
Claims 20, 22, 24, and 35 were amended.
Claims 20-22 and 24-39 are pending.
Claims 32-29 were previously withdrawn from consideration.
Claims 20-22 and 24-31 are included in the prosecution.
Maintained - Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 20-22 and 24-31 are again rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McGeechan et al. (US 2012/0157540 A1 – “McGeechan”).
Instant claim 20 is drawn to a sanitizing/disinfecting composition comprising:
a quaternary ammonium compound having the general formula:
PNG
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310
474
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a polyalkylenebiguanide; and
a non-ionic surfactant,
wherein the quaternary ammonium compound is present in an amount of about 50 ppm up to about 400 ppm and the polyalkylenebiguanide is present in an amount of about 50 ppm up to about 550 ppm.
McGeechan teaches disinfectant formulations (Abstract). The formulation comprises a combination of (a) an antimicrobial active agent (e.g. a biguanide; preferably polyhexamethylene biguanide (PHMB)); (b) a dialkyldimethyl ammonium salt; and (c) an alkyldimethylbenzyl ammonium salt ([0007]). In one embodiment, the formulation comprises PHMB, DDAC (didecyldimethyl ammonium chloride), and ADBAC (alkyldimethylbenzyl ammonium chloride) (Example 2 - [0072]). The formulation may comprise Tween 20 (polyoxyethylene (20) sorbitan monolaurate) at a concentration of 3% to produce a stable mixture see Table 1 ([0071]). The antimicrobial components may be diluted with water ([0065]). In one embodiment, the combined amount of (i) an antimicrobial active (e.g. biguanide) and (ii) dialkyldimethyl ammonium salt) is from 500 to 1000 ppm, wherein component (i) and (ii) are present in a range of weight ratios between about 1:1 and about 1:10 ([0009]). The disinfectant formulations may comprise a non-ionic surfactant ([0054]). The disinfectant formulations comprise alcohol ethoxylate ([0080]). Citric acid is disclosed as an optional ingredient ([0064]). The organic solvent ethanol is disclosed ([0064]).
McGeechan discloses that : “The Association of Official Analytical Chemists (AOAC) Germicidal and Detergent Sanitizers Method is a method required to generate data to support the efficacy data requirements for sanitizing rinses (for previously cleaned food-contact surfaces). When claims for the effectiveness of the product in hard water are made, all required data must be developed at the hard water tolerance claimed. Acceptable results must demonstrate a 99.999% reduction in the number of microorganisms within 30 seconds against both Escherichia coli ATCC and Staphylococcus aureus ATCC 6538” ([0074]).
McGeechan does not expressly teach that the quaternary ammonium compound is present in an amount of about 50 ppm up to about 400 ppm and the polybiguanide is present in an amount of about 50 ppm up to about 550 ppm, as recited in instant claim 20.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to prepare a disinfectant formulation comprising a combination of quaternary ammonium compounds which are the dialkyldimethyl ammonium salt DDAC and the alkyldimethylbenzyl ammonium salt ADBAC; the polyalkylene biguanide PHMB; the organic solvent ethanol; and the ethoxylated ester surfactant Tween 20 (polyoxyethylene (20) sorbitan monolaurate), as taught by McGeechan, in view of the combined amount of (i) an antimicrobial active (e.g. biguanide) and (ii) dialkyldimethyl ammonium salt which is from 500 to 1000 ppm, wherein component (i) and (ii) are present in a range of weight ratios between about 1:1 and about 1:10, also as taught by McGeechan, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the combined amount of (i) an antimicrobial active (e.g. biguanide) and (ii) dialkyldimethyl ammonium salt which is from 500 to 1000 ppm, wherein component (i) and (ii) are present in a range of weight ratios between about 1:1 and about 1:10, as taught by McGeechan ([0009]) overlaps and renders obvious the claimed ranges recited in instant claim 20. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 20, the limitation of a sanitizing/disinfecting composition would have been obvious over the disinfectant formulation taught by McGeechan (Abstract, Example 2 – [0072]).
Regarding instant claims 20, 25, and 28, the limitations of the quaternary ammonium compound would have been obvious over the quaternary ammonium compounds which are the dialkyldimethyl ammonium salt DDAC and the alkyldimethylbenzyl ammonium salt ADBAC, as taught by McGeechan ([0007] and Example 2 – [0072]).
Regarding instant claims 20 and 24, the limitations of the polyalkylene biguanide would have been obvious over the PHMB, as taught by McGeechan ([0007] and Example 2 – [0072]).
Regarding instant claims 29 and 30, the limitations of the solvent comprising an organic solvent would have been obvious over the organic solvent ethanol, as taught by McGeechan ([0064]).
Regarding instant claim 20, the limitation of at least one non-ionic surfactant would have been obvious over the Tween 20 (polyoxyethylene (20) sorbitan monolaurate), as taught by McGeechan (Table 1 - [0071]).
Regarding instant claims 20 and 22, the limitations of the quaternary ammonium compound present in an amount of about 50 ppm up to about 400 ppm and the polybiguanide in an amount of about 50 ppm up to about 550 ppm would have been obvious over the combined amount of (i) an antimicrobial active (e.g. biguanide) and (ii) dialkyldimethyl ammonium salt which is from 500 to 1000 ppm, wherein component (i) and (ii) are present in a range of weight ratios between about 1:1 and about 1:10, as taught by McGeechan ([0009]). Please see MPEP 2144.05.
Regarding instant claim 21, the limitation of a linear alcohol ethoxylate would have been obvious over the alcohol ethoxylate, as taught by McGeechan ([0080]).
Regarding instant claims 26 and 27, the limitations of halides and chloride would have been obvious over the DDAC (didecyldimethyl ammonium chloride), and ADBAC (alkyldimethylbenzyl ammonium chloride) (Example 2 - [0072]), as taught by McGeechan.
Regarding instant claim 31, the limitation of builder salts would have been obvious over the carbonate salt, bicarbonate salt or combinations thereof ([0053]), as taught by McGeechan.
Response to Arguments
Applicant’s arguments (Pages 5-7, filed 11/06/25) with respect to the rejection of claims 20-31 under 35 USC § 103(a) as being unpatentable over McGeechan have been fully considered but are not persuasive.
Applicant points to paragraph [0005] of McGeechan, which refers to the upper limit for ADBAC at 200 ppm active ingredient and DDAC at 240 ppm active ingredient, and at such low levels, these quaternary ammonium compounds are normally not effective for its intended purposes. Applicant argues that “… a skilled artisan, a skilled artisan, when starting with McGeechan, would have no motivation to prepare a disinfectant formulation with low levels of quaternary ammonium compounds, given that they are ineffective at those levels and have limited flexibility of use. Said another way, one having skill in the art would have no expectation of arriving at the claimed composition absent hindsight reliance upon the pending claims, which is not permitted under KSR.”
This is not persuasive because paragraph [0005] of McGeechan discloses the background art and information regarding the use of quaternary ammonium compounds and the maximum permissible levels. The objective of McGeechan’s invention is to prepare alternative disinfectant formulations ([0006]). McGeechan’s formulation contains an overlapping combined amount of (i) an antimicrobial active (e.g. biguanide) and (ii) dialkyldimethyl ammonium salt which is from 500 to 1000 ppm, wherein component (i) and (ii) are present in a range of weight ratios between about 1:1 and about 1:10 ([0009]), which renders obvious the ppm ranges recited in instant claim 20.
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). In the instant case, McGeechan’s formulation contains an overlapping combined amount of (i) an antimicrobial active (e.g. biguanide) and (ii) dialkyldimethyl ammonium salt which is from 500 to 1000 ppm, wherein component (i) and (ii) are present in a range of weight ratios between about 1:1 and about 1:10 ([0009]), which renders obvious the ppm ranges recited in instant claim 20.
Applicant argues that “… as acknowledged in the Office Action, McGeechan fails to disclose or suggest, "the quaternary ammonium compound is present in an amount of about 50 ppm up to about 400 ppm and the polyalkylenebiguanide is present in an amount of about 50 ppm up to about 550 ppm," as set forth in amended independent claim 20.”
This is not persuasive because although McGeechan does not expressly teach that the quaternary ammonium compound is present in an amount of about 50 ppm up to about 400 ppm and the polybiguanide is present in an amount of about 50 ppm up to about 550 ppm, as recited in instant claim 20, one of ordinary skill in the art would have found the recited ppm ranges obvious over the overlapping combined amount of (i) an antimicrobial active (e.g. biguanide) and (ii) dialkyldimethyl ammonium salt which is from 500 to 1000 ppm, wherein component (i) and (ii) are present in a range of weight ratios between about 1:1 and about 1:10, which is also taught by McGeechan ([0009]). According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Applicant argues that “… the combination of all the claimed features, including a quaternary ammonium compound present in an amount of about 50 ppm to about 400 ppm, is non-trivial as shown in the Examples and reflected in the present specification … it is the inclusion of the quaternary ammonium compound and the polyalkylenebiguanide, in combination with the other claimed features, that can lead to desirable outcomes.”
The Examples in the instant Specification have been fully considered but Applicants’ arguments are not persuasive because the non-trivial combinations are based on specific components and concentrations, which are not recited in the instant claims. For instance, tetrasodium ethylenediaminetetraacetate and its corresponding concentration from Example 1 are not recited in the instant claims. Also, the alkyl polyglucoside in Formulae 4a-4c and the corresponding concentrations are not recited in the instant claims. Furthermore, MPEP 716.02(d) states: “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.””
Therefore, the rejection of 08/07/25 is maintained.
Maintained - Double Patenting Rejection
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 20-22 and 24-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,766,041 B2 (the ‘041 Patent).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a sanitizing/disinfecting composition comprising (a) a quaternary ammonium compound; (b) a polyalkylenebiguanide; and (c) a non-ionic surfactant, and therefore, contain coextensive subject matter.
The difference is that claim 1 of the ‘041 Patent recites a list of monovalent anions whereas instant claim 20 is silent with respect to these anions.
However, instant claim 25 recites chloride anions associated with the quaternary ammonium compounds, thereby rendering this limitation obvious.
Another difference is that component (c) in the ‘041 Patent is a solvent whereas instant claim 20 does not recite this limitation.
However, instant claims 29 and 30 are drawn to a solvent, thereby rendering this limitation obvious.
The surfactant comprising an ethoxylated ester recited in claim 1 of the ‘041 Patent is rendered obvious by the non-ionic surfactant recited in instant claim 20 and the ethoxylate ester recited in instant claim 21.
The amount of the quaternary ammonium compound, the polyalkylenebiguanide, and surfactant recited in claim 1 of the ‘041 Patent would have been obvious over the amounts recited in instant claim 20 and based on modifications made by one of ordinary skill in the art based on desired sanitizing/disinfecting attributes.
The limitation regarding the Log10 kill value recited in claim 1 of the ‘041 Patent would have been an obvious effect after using the sanitizing/disinfecting composition recited in instant claims.
The alkyl polyglucoside recited in claim 1 of the ‘041 Patent would have been obvious since instant claim 20 recites the transitional phrase “comprising,” which is considered open language and allows the inclusion of additional components.
Therefore, instant claims are obvious over claims of the ‘041 Patent and they are not patentably distinct over each other.
Response to Arguments
Applicant’s arguments (Page 7, filed 11/06/25) with respect to the rejection of claims 20-31 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,766,041 B2 (the ‘041 Patent) have been fully considered but are not persuasive.
Applicant states that they will consider filing a terminal disclaimer (TD) to obviate such rejection when Applicant receives an indication that the pending claims are otherwise in condition for allowance, if filing such TD would help expedite prosecution at that time.
Applicant’s statement is acknowledged. There is still an obviousness rejection in this application and allowable subject matter has not been identified. Until such time that a TD is filed over the ‘041 Patent, the double patenting rejection over the ‘041 Patent is maintained for the reasons explained above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615