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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/13/2026 has been entered.
Status of the Claims
Claim 12 has been newly canceled, and claim 15 previously was canceled. New claims 21 and 22 were added. Accordingly, claims 1-11, 13, 14, and 16-22 remain pending in the application.
Withdrawn Rejections and Response to Arguments
All rejections of claim 12 are withdrawn in view of Applicant’s cancelation of that claim. All other previously issued rejections are withdrawn in view of the amendments filed 3/13/2026 and modified as detailed below in order to address the new claims and new claim language.
Applicant’s arguments filed 3/13/2026 (hereafter, “Remarks”) have been fully considered and are addressed as follows.
Regarding the previously issued rejections of claims 1-14 and 16-20 under 35 U.S.C. 103 as being unpatentable over Mayhall, Applicant emphasizes that the claimed method achieves the effect of log reduction against one or more non-enveloped viruses of at least 3.0 which is provided by the combination of composition components which are alcohol and pH adjuster: carbomer ratio as specified in the claims. Applicant notes sections of the specification as filed in support of the claim amendments and points out additional claim language of achieving the effect of a 120 second exposure specific scenario results.
Applicant argues that Mayhall does not teach the claimed concentration of alcohol, the claimed weight ratio of pH adjuster/carbomer in a high-alcohol system, any criticality of these variables, or claimed efficacy against non-enveloped viruses.
In reply, regarding Applicant’s argument that Mayhall does not teach the claimed concentration of alcohol and subsequent argument on page 8 of Remarks that Mayhall teaches away from high alcohol, this argument is not persuasive in view of Mayhall as a whole which teaches ethanol or isopropanol can be present in a range from about 25% to about 99% (see [0044]), a range including the instantly claimed range of greater than 75% by weight. Moreover, at paragraph [0044] Mayhall teaches ethanol in particular to be suitable as a solvent in a relatively larger amount, so Applicant’s relatively limited reading of Mayhall is not persuasive.
In reply to Applicant’s argument that Mayhall does not teach the ratio claimed, this argument is not persuasive since Mayhall overlapping elements as these. Mayhall teaches a pH adjuster such that the pH of the composition is in the range of 2 to 11 and further demonstrates 0.4% by weight of pH adjuster triethanolamine and 0.19% by weight Carbopol (see Table 2) in an example having a ratio as claimed and further teaches otherwise overlapping and broader ranges of pH adjuster and Carbopol than those amounts of this aforementioned example.
In reply to Applicant’s argument that Mayhall does not teach criticality and subsequent arguments on pages 8 and 9 to this point, this argument is not persuasive in view of the preponderance of evidence in the record. Moreover, to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show any criticality of the claimed range. Specifically, the evidence that Applicant cites including the Leslie Declaration do not appear to be of practical and statistical significance and commensurate in scope with the claims. It is further noted that the examples only measure efficacy regarding poliovirus nor are the conditions under which this measurement is taken described in claim 1.
On page 10 of Remarks, Applicant characterizes the Office’s position as one of inherency with regard to efficacy claimed and concludes that the office has not met the burden of showing that Mayhall inherently renders obvious a formulation further specified. In reply, Applicant’s argument is not persuasive since the claims under examination are method claims and Applicant’s argument pertains to a composition. Additionally, the Leslie Declaration that Applicant cites appears to be from another application which pertains to composition claims and not the method claims currently under examination.
In reply to Applicant’s argument that Mayhall does not teach the claimed efficacy, MPEP 2112 section I states: “[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 unknown property which is inherently 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).
All previously issued rejections under 35 U.S.C. 103 are withdrawn in order to address the claims as amended. No new reference is cited in the new grounds of rejection necessitated by amendment as presented below.
New Grounds of Rejection Necessitated by Amendments of 3/13/2026
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 21 and 22 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.
Paragraph [00095] in the specification as filed defines EN 14476 as recited in claims 21 and 22 as a European test standard providing minimum requirements for virucidal activity of chemical disinfectants and antiseptic products wherein this standard requires that a chemical disinfectant for hand hygiene achieve at least a 4.0 log reduction in virus titer for poliovirus, adenovirus, and murine norovirus “when tested in accordance the test methods described in EN 14476”. The test methods are not defined or described, and, as a result, the metes and bounds of this standard are unclear. Would an at least 4.0 log reduction of the particular viruses meet the claim or would the titer be subject to various conditions which may vary? Appropriate clarification is required.
Modified Grounds of Rejection Necessitated by Amendments of 3/13/2026, No New Reference Cited
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 1-11, 13, 14, and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Mayhall et al. (US 2006/0205619, hereafter “Mayhall”).
The instant claims are drawn to a method comprising applying a topical sanitizing composition to a skin surface. The topical sanitizing composition comprises at least one pH adjuster, at least one carbomer, and greater than 75 wt% of one or more C1-8 alcohols, wherein the weight ratio of the pH adjuster/carbomer in the composition is at least 0.6/1, wherein the potentiometric pH of the composition is at least 6.1, and wherein the method achieves a log reduction against one or more non-enveloped viruses of at least 3.0 after a 120 second exposure.
Mayhall et al. teaches a thickened rinseless hand sanitizer composition and method of applying to the skin of a human (see abstract, in particular; [0007]). Mayhall et al. teaches that the composition is in the form of a gel (see [0036]) and that is preferably a viscosity from about 100 to about 15,000 centipoise (see [0040]). Mayhall et al. teaches that the composition includes a thickener, and that the preferred thickeners are polyacrylic acid copolymer that are commercially available as Carbopol (i.e. a carbomer, see [0039]), and that the thickener may be present from about 0.001-5% by weight of the composition, dependent on the desired viscosity (see [0040]). Carbopol 1342 is preferred (see [0039])(a cross-linked polyacrylic acid copolymer as in claim 2). Mayhall et al. teaches that the solvent is preferably selected from a group which includes ethanol or isopropanol and can be present from about 25 to about 99% of the composition (see [0044])(“greater than 75 wt% of one or more C1-8 alcohols” as recited in claim 1; limitation of claim 6); suitable alcohols which may include ethanol and propanols may be used in admixture as solvent (see [0041])(limitations of claims 7-9, overlapping ranges). Mayhall et al. teaches that the composition may optionally include a pH adjuster such the pH of the composition is in the range from 2 to 11 (see [0048])(range overlapping range of “wherein the potentiometric pH of the composition is at least 6.1” as in claim 1). Mayhall et al. teaches that the pH adjuster can be triethanolamine (see [0050])(limitations of claims 3 and 4). Mayhall et al. teaches that the composition can include skin conditioners, including aloe and Vitamin E (see [0054]) as well as skin conditioners including for instance propylene glycol and/or glycerine (see [0053], and [0054])(limitations of claims 10). Mayhall et al. teaches that the composition can also include isopropyl myristate and cetyl myristate (see [0054])(limitation of claim 12). These skin conditioners may be included in an amount of up to about 10% by weight (see [0056])(limitation of claim 11). Mayhall et al. teaches examples with isopropanol, 0.4% by weight of triethanolamine (i.e. a pH adjuster) and 0.19% by weight of Carbopol (see Table 2).
Although Mayhall et al. teaches a composition with at least one pH adjuster, 0.001-5% by weight of a thickener such as Carbopol, and about 25 to about 99% of the composition ethanol or isopropanol, the reference does not teach with sufficient specificity to anticipate.
Accordingly, this rejection is made using obviousness rationale. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to arrive at a method comprising applying a topical sanitizing composition to a skin surface, wherein the composition comprises at least one pH adjuster, at least one carbomer, and at least 75% of one or more C1-8 alcohols, all having a pH and component ratios further specified in the claims and overlapping the suggestions of Mayhall. One would have been motivated to do so since Mayhall et al. teaches a composition with at least one pH adjuster (i.e. triethanolamine), at least one carbomer (i.e. Carbopol), and one or more C1-8 alcohols (i.e. isopropanol), teaches that the compositions can include about 0.001-5% by weight of thickener and 25 to about 99% of the solvent, which is taught to include isopropanol, and teaches the pH of the composition is in the range from 2 to 11. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Regarding the limitation of “the weight ratio of the pH adjuster/carbomer in the topical sanitizing composition is at least 0.6/1”, Table 2 has 0.4% by weight of triethanolamine and 0.19% by weight of Carbopol, which is a ratio of 2.1:1, which reads on “at least 0.6/1” (limitations of claims 1, 5, 13,14). Regarding the limitation of “wherein the topical sanitizing composition achieves a log reduction against one or more non-enveloped viruses of at least 3.0” as in claim 1 as amended and “…at least 4.0” as in claims 16 and 20, the prior art renders obvious the same components in the same amounts in a method of application as instantly claimed . A person of ordinary skill in the art would reasonably expect the use of the same composition, with the same components in the same amounts to have the same result.
The limitations of claims 17-20 have been addressed above in regard to claims 1, 4, 9, and 16 in particular.
As to the new language at the end of claims 1 and 17, specifying a log reduction after a 120 second exposure, it is the examiner’s position that the structural components (a method comprising a topical sanitizing composition as claimed) addressed above in the method addressed above taught by Mayhall and its effects (performance of the method step) are inseparable. Moreover, Mayhall’s Table 7 shows an example wherein 3 log microorganism reduction is achieved at both one minute and at five minutes thereby reasonably suggesting that a 2 minute exposure (120 seconds as claimed) may be achieved with Mayhall’s topical application of Mayhall’s compositions. Similarly regarding new claims 21 and 22, Mayhall’s methods reasonably would be expected to achieve the claimed result since a method and its effects are inseparable; it is noted that paragraph [00095] in the specification as filed defines EN 14476 as a standard requiring a chemical disinfectant for hand hygiene achieve at least a 4.0 log reduction in virus titer for poliovirus, adenovirus, and murine norovirus when tested in accordance with the text methods described in EN 14476.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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