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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 October 2025 has been entered.
Priority
The application was filed 30 April 2021 and is the continuation of 15/938,314 filed 28 March 2018. The Applicant claims priority to provisional application 62/477,881 filed 28 March 2017. Therefore, the effective filing date of the instant application is 28 March 2017.
Examiner’s Note
The Applicant's amendments and arguments filed 18 September 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 18 September 2025, it is noted that claims 1, 17, and 19 have been amended, claims 4-6, 18, and 20 have been canceled, and no new claims have been added. Support for the amendment can be found in para. 38 of the instant specification. No new matter has been added.
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.
Claim(s) 1, 17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitra et al. (US 2002/0183233 A1) and Liebeskind (US 6632805 B1), as evidenced by Chessa et al. (Staphylococcus aureus and Staphylococcus epidermidis Virulence Stains as Causitive Agents of Persistent Infections in Breast Implants, 2016).
Mitra et al. teach a woven or nonwoven material (entire teaching, para. 10) for antimicrobial purposes (para. 15) that may comprise 0.05-0.5% of triethanolamine (para. 24), 3-(trimethoxysilyl)propyloctadecyldimethyl ammonium chloride as an anion to a quaternary ammonium salt (para. 19), and water (para. 26) in an amount of at least 80% (para. 26), addressing claim 19. One embodiment is a dry wipe made from polyester (para. 10), addressing the limitation in claims 1 and 17. The quaternary ammonium salt may be in an amount of 0.05-5% but may exceed 5% in some cases (para. 19). The formulation (Clorox) shows a 99.9% reduction of S. aureus after 4 minutes (Table 5), which is >3 log reduction (instant specification, para. 53), partially addressing claims 1 and 17. The material may be a cellulose wipe (para. 12, abs), polyester woven material (para. 10), or cotton fibers (para. 10). Polyester and cotton fiber materials that are nonwoven or woven are interpreted as polyester and cotton gauze.
The limitation of an adduct or hydrogen bond forming between triethanolamine and 3-aminopropyltriethoxysilane in claims 1 and 19 is interpreted as an inherent property that would necessarily occur when the compounds are in the presence of one another, presumably by the hydroxyl and amine groups present in the compounds. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unquantified property which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Futhermore, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Mitra does not specifically teach 3-aminopropyltriethoxysilane in their composition or a reduction in specifically S. epidermidis.
Liebeskind et al. teach antimicrobial compositions and methods (abs) for treating a woven or nonwoven textile material (col. 34, lns. 44-47) or surgical dressing (col. 33, ln. 18). The material may comprise 0.001-15% (col. 23, lns. 29-30) or an organosilane, such as 3-aminopropyltrimethoxysilane (col. 20, lns. 48-49), 3-chloropropyltrimethoxysilane (col. 20, ln. 3), or 3-(trimethoxysilyl)propyldimethyloctadecyl ammonium chloride) (col. 19, lns. 66-67), and water (claim 3).
In regards to selecting a combination of 3-aminopropyltriethoxysilane, octadecylaminodimethyltrihydroxysilylpropyl ammonium chloride, 3-chloropropyltrimethoxysilane, triethanolamine, and water, “[w]hen a patent simply arranges
old elements with each performing the same function it had been known to perform and yields no
more than one would expect from such an arrangement, the combination is obvious.” KSR v.
Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)).
“When the question is whether a patent claiming the combination of elements of prior art is
obvious,” the relevant question is “whether the improvement is more than the predictable use of
prior art elements according to their established functions.” (Id.). Addressing the issue of
obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out
precise teachings directed to the specific subject matter of the challenged claim, for a court can
take account of the inferences and creative steps that a person of ordinary skill in the art would
employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of
ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Since Mitra teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Mitra does not specifically teach 3-aminopropyltrimethoxysilane in their composition for claims 1 and 17, or octadecyldimethyl-(3-trimethoxysilylpropyl) ammonium chloride or 3-chlorotrimethoxysilane in claims 18 and 20, one of ordinary skill in the art would have been motivated to combine the composition taught by Liebeskind. Both Mitra and Liebeskind teach a woven or nonwoven antimicrobial material, where Liebeskind teaches that organosilanes have antimicrobial activity (col. 11, ln. 55) and quaternary ammonium chloride compounds are known in the art as antimicrobial agents for a wide variety of substrates and applications (col. 4, lns. 29-36). Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
In regards to the amounts of compounds in claim 1, Liebeskind teaches 0.001-15% of an organosilane compound and Mitra teaches 0.05-0.5% of triethanolamine and at least 80% of water. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I).
In regards to the limitation of a reduction in S. epidermidis in claims 1 and 17, Mitra teaches a 99.9% reduction of S. aureus after about 4 minutes. S. aureus and S. epidermidis are interpreted as having similar function and structure as Gram positive bacteria, where S. aureus is considered more virulent in the context of medical devices (Chessa, pg. 2). Therefore, it is obvious to one of ordinary skill in the art that the composition taught by Mitra and Liebeskin would have similar results of antimicrobial efficacy between S. aureus or S. epidermidis.
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 1-6, 17-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11020278 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because Grossman ‘278 teaches an aqueous antimicrobial coating composition comprising 0.75 wt. % octadecyldimethyl-(3-trimethoxysilylpropyl) ammonium chloride, 3-aminopropyltriethoxysilane or 3-chloropropyltrimethoxysilane, triethanolamine, and water, and is effective against S. aureus (col. 3, ln. 14-19; col. 3, ln. 1-9; col. 3, ln. 42-48), which corresponds to composition claims 1-6 and 17-20 of the instant application.
Response to Arguments
Applicant's arguments filed 18 September 2025 have been fully considered but they are not persuasive.
The Applicant argues that US Patent No. 11,020,278 does not include 3-aminopropyltriethoxysilane and the double patenting rejection should be withdrawn (Remarks, pg. 7).
Applicant’s argument is not found persuasive. Although the claims at issue are not identical, they are not patentably distinct from each other because Grossman ‘278 teaches an aqueous antimicrobial coating composition comprising 0.75 wt. % octadecyldimethyl-(3-trimethoxysilylpropyl) ammonium chloride, 3-aminopropyltriethoxysilane or 3-chloropropyltrimethoxysilane, triethanolamine, and water, and is effective against S. aureus (col. 3, ln. 14-19; col. 3, ln. 1-9; col. 3, ln. 42-48), which corresponds to composition claims 1-6 and 17-20 of the instant application. The composition in ‘278 may include 3-aminopropyltriethoxysilane and cites a favorable reaction between the compounds (col. 16, ln. 60-col. 17, ln. 9).
Response to Arguments
Applicant's arguments filed 18 September 2025 have been fully considered but they are not persuasive.
The Applicant argues that the prior art cited do not teach all of the individual components of the claimed invention (Remarks, pgs .5-6).
Applicant’s argument is not found persuasive. Since Mitra does not specifically teach 3-aminopropyltrimethoxysilane in their composition for claims 1 and 17, or octadecyldimethyl-(3-trimethoxysilylpropyl) ammonium chloride or 3-chlorotrimethoxysilane in claims 18 and 20, one of ordinary skill in the art would have been motivated to combine the composition taught by Liebeskind. Both Mitra and Liebeskind teach a woven or nonwoven antimicrobial material, where Liebeskind teaches that organosilanes have antimicrobial activity (col. 11, ln. 55) and quaternary ammonium chloride compounds are known in the art as antimicrobial agents for a wide variety of substrates and applications (col. 4, lns. 29-36). Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant argues that the prior art teachings do not teach the new limitation and that the bond formation is surprising (Remarks, pgs. 6-7).
Applicant’s argument is not found persuasive. The limitation of an adduct or hydrogen bond forming between triethanolamine, water, and 3-aminopropyltriethoxysilane in claims 1 and 19 is interpreted as an inherent property that would necessarily occur when the compounds are in the presence of one another, presumably by the hydroxyl and amine groups present in the compounds. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unquantified property which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Futhermore, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613