DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Current Status of 18/597,413
3. This Office Action is responsive to the amended claims of 6 March 2024.
4. Claims 1-20 have been examined on the merits.
Priority
5. The effective filing date is 6 March 2024.
Information Disclosure Statement
6. The information disclosure statements (IDS) submitted on 9 July 2024, 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 § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CLARK (US7838447B2).
CLARK teaches a pre-moistened wiper of nonwoven fabric or web comprising a sanitizing formulation that includes 10.0 wt.% ethanol, 190 ppm (0.019 wt%) benzalkonium chloride, 0.50 wt.% nonionic surfactant and water (Formulation #7, Col 22). The sample also contains 0.30 wt.% EDTA, but it is a well-known preservative and a chelating agent, and so it is not precluded by the claims. The formulation shows a 99.992% (> 4-log) reduction in Staphylococcus aureus (hereinafter, S. aureus) (Table 1, Col 24) with an exposure condition of 30 seconds after a wiping time of 30 seconds. Thus, claim 1 is anticipated by CLARK.
Claim Rejections - 35 USC § 103
8. 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.
9. Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over FRANK (US20230111060 A1, pub. date: 4/13/2023) in view of RUTALA (Rutala et al. “Susceptibility of Candida auris and Candida albicans to 21 germicides used in healthcare facilities” Infection Control & Hospital Epidemiology (2019), 1–3).
Determining the scope and contents of the prior art
FRANK teaches nonwoven substrate pre-dosed wipes and packaged systems that are useful for a sanitizing or disinfecting wipe comprising 0.73 wt% quaternary ammonium compounds (QACs), 0.45 wt.% C1-C4 alcohol, 0.10 wt % fragrance, 0.44 wt.% C12-C14 fatty alcohol alkoxylate (nonionic surfactant) and water, as well as 1.00 wt% glycol ether and 0.01 wt% organic acid and 0.01 wt% builder (Table 2A, p 10). The composition exhibits a 5.06-log reduction (Table 3, p 12) in S. aureus at a 30 second contact time (para [0108], p 11).
RUTALA teaches germicidal activity against Candida auris of 21 germicides, most of which are commercial products. A disinfectant spray comprising 58% ethanol and 0.1% QAC and a wipe comprising 55% isopropyl alcohol and 0.5% QAC show 3.8 and 3.9 log reduction, respectively, against C. auris with a one-minute contact time, while 70% ethanol and 70% isopropyl alcohol exhibit similar activities (Table 1, p 2).
Ascertaining the differences between the prior art and the claims at issue
The instant claims are generally drawn to a pre-loaded cleaning wipe with loaded liquid includes a moderate amount of alcohol, a low amount of a quaternary amine antimicrobial, and a surfactant to help cleaning and antimicrobial performance. In some versions, the liquid also includes a glycol ether solvent, acids, water, and other optional additives such as fragrance or colorant. The application emphasizes that the formulation can sanitize quickly, including achieving at least a 3-log reduction in S. aureus and/or Candida auris (C. auris) within 2 minutes.
FRANK teaches a disinfecting composition with (1). QAC of 0.73 wt%, just outside of the upper range of 0.70 wt% of the instant claim 1; (2). 0.45 wt% C1-C4 alcohol, outside of the lower range of about 10 wt% alcohol recited in claim 1. Thus, FRANK meets all the limitations of instant claims 2, 7 and 8 except the two out-ranges in claim 1. But FRANK doesn’t teach the activity against C. auris.
RUTALA teaches three alcohol-QAC systems (entries 14, 16 and 17 in Table 1) have germicidal activity against C. auris with 3.8 to 4.1 log reduction of C. auris in a one-minute contact time. RUTALA further teaches the activity against C. auris remains relatively constant changing alcohol concentration from 70% ethanol/isopropanol with water to 55%-58% of the alcohol(s) with 0.1%-0.5% QAC showing 3.8 to 4.1 log reduction of C. auris. RUTALA cures the defects of FRANK.
It is noted that the three alcohol-QAC systems (entries 14, 16 and 17 in Table 1) cited are substantially similar with the compositions of instant claim 1, except the concentration of alcohol(s) is 55-58% (with QAC) is above of the upper limit of about or less than 40% in the instant claim 1.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Regarding claim 1, FRANK teaches a disinfecting composition with (1). QAC of 0.73 wt%, just outside of the upper range of 0.70wt% of the instant claim 1; (2). 0.45 wt.% C1-C4 alcohol, outside of the lower range of about 10wt% alcohol recited in claim 1. Taking into consideration of the ranges of “about” defined in Specification of within 10% (para [0033], p 3), 0.45 wt.% C1-C4 alcohol overlaps with about 10 wt% to about 40 wt% of alcohol in claim 1 with respect to alcohol concentration. A builder is an adjuvant (paras [0079]-[0080], p 7), which is not precluded from the claims. Therefore, claims 1 is obvious over FRANK. The limitations of instant claims 2, 7 and 8 are all met by FRANK (see, above ¶10), thereby being obvious over FRANK.
Regarding claims 3-6, a routine optimization of formulation(s) by adding new components, changing concentrations and adjusting pH values of the formulation. There is no indication of such unexpected results from the claims or from the Specification.
MPEP 2144.05(II)(A) provides guidance about the routine optimization of
prior art conditions: "Generally, differences in concentration or temperature will not
support the patentability of subject matter encompassed by the prior art unless
there is evidence indicating such concentration or temperature is critical. "[W]here
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." In re Aller,
220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "The normal desire of scientists
or artisans to improve upon what is already generally known provides the motivation to
determine where in a disclosed set of percentage ranges is the optimum combination of
percentages.” In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
It would be obvious for an artisan to use these routine optimizations in claims 3-6 with great confidence of forming effective composition as a daily practice and taught by the reference. Therefore, claims 3-6 are obvious over FRANK.
Regarding claim 9, the three alcohol-QAC systems (entries 14, 16 and 17 in Table 1) cited in RUTALA are substantially similar with the instant claims, so claim 9 is obvious over FRANK in view of RUTALA.
10. Claims 10-17 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over LESLIE (US 20220087255A1, pub. date: 03/24/2022) in view of RUTALA (presented above) and further in view of the Safety Date Sheet (SDS, 12/16/2014) of wipe 46781-13 (EPA registration number) on Products on EPA’s Registered Antimicrobial Products Effective Against Candida auris [List P] (minimum log reduction >= 5).
LESLIE teaches compositions as shown in Table 7 (p 11). Composition (b), without adding enhancer, with an over 5-log reduction of S. aureus population at pH =
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3.4, falls in all material limitations of the instant claims 10, 12, 14, 15 and 18 (Note: non-ionic surfactants include glycol ethers (papa [0047], p 11)), except the entry (ii) of the Quat in claims 10 (B) and 18 (B). LESLIE further teaches another composition (a) with 0.1-0.4% enhancer also achieves a over 5-log reduction of S. aureus population.
It is well-known that quaternary ammonium compounds (QACs, or Quat) are among the most commonly used disinfectants against bacteria, enveloped viruses, and fungi (Table 2, p 466, GERBA). The artisan would be motivated to add a well-known Quat to modify the LESLIES’ teaching to arrive the instant claims 10 and 18 with a great degree of confidence of successfully forming an effective disinfecting cleanser.
As for the activity against C. auris, RUTALA teaches disinfect compositions against C. auris with 3.8 to 4.1 log reduction in a one-minute contact time of three alcohol-QAC systems (entries 14, 16 and 17 in Table 1), which are substantially the same as the compositions of instant claims 10 and 18.
Claims 10, 12, 14, 15 and 18 are obvious over LESLIE in view of RUTALA.
Claims 11, 13, 17 and 19, directed to a routine optimization of adding a component in a composition per MPEP 2144.05(II)(A) as above (see ¶ 10), are obvious over LESLIE in view of RUTALA.
Regarding claims 16 and 20, the SDS of wipe 46781-13 on the EPA’ Antimicrobial list P discloses its composition comprising 15% IPA, 7.5% ethanol, 0.76% didecyldimethylammonium chloride, 0-5% ethylene glycol monobutyl ether achieves a minimum log reduction >= 5 with a contact time of 1 min. It is noted that the composition of the wipe is substantially same as those in claims 10 and 18, except the un-reported surfactant(s). Thus, claims 16 and 20 are obvious over LESLIE in view of the SDS of wipe 46781-13.
Conclusion
11. No claims are presently allowable as written.
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/B.T./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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