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 .
Status of the Claims
Accordingly, claims 1-11, 13, 14, and 16-22 remain pending in the application.
Withdrawn Rejections and Response to Arguments
All previously issued rejections have been modified as detailed below in view of the claim amendments filed 8/4/2026. Applicant’s arguments filed 8/4/2026 (hereafter, “Remarks”) have been fully considered and are addressed as follows.
Regarding the previously issued rejections of claims 21 and 22 under 35 U.S.C. 112(b), Applicant argues that the claim amendments resolve the problem. In reply, and upon full consideration, Applicant’s argument is not persuasive because the metes and bounds of the claim remain unclear, and limitations are not imported from the specification into the claim. The conditions of the “EN 14476” testing are not described and the term is considered in analogy with the way trademarked names are considered, as potentially variable according to definition and/or a function of time and/or regulation. Moreover, the specification as filed mentions the Europen EN 14476 standard at [00018] and subsequently describes it generally at paragraph [00095] of the specification as filed. However, this standard only references an effect which is an at least 4.0 log reduction in virus titer for poliovirus, adenovirus, and murine norovirus “when tested in accordance the test methdos describe din EN 14476”. As such, the virus titer conditions and/or efficacy condition remain unclear.
Regarding the rejections under 35 U.S.C. 103, Applicant argues that the claimed method achieves an effect distinguishing over Mayhall. In reply, Applicant’s argument has been fully considered but is not persuasive because Applicant’s arguments pertaining to efficacy of the method claimed are not supported by evidence in the record commensurate in scoped with the claim language. It has not been established, for instance that poliovirus, adenovirus, and murine norovirus are representative of the claimed “one or more non-enveloped viruses”. This argument is otherwise addressed in the modified grounds of rejection necessitated by amendment, in view of the newly narrowed range of pH adjuster/carbomer ratio. Further, regarding 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).
Applicant re-iterates his previous argument that Mayhall “teaches away” from the claimed amount of alcohol. In reply, 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.
Maintained Grounds of Rejection, Modified
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 the titer be subject to various conditions which may vary? Appropriate clarification is required.
Modified Grounds of Rejection Necessitated by Amendments of 8/4/2026, 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 to 1.5/1, 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 from 0.6/1 to 1.5/1”, Table 2 has 0.4% by weight of triethanolamine and 0.19% by weight of Carbopol, which is a ratio of 2.1:1, a value outside but similar to the newly narrowed range of 0.6/1 to 1.5/1 (limitations of claims 1, 5, 13,14). 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. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Here, it is the examiner’s position that where Mayhall teaches a pH adjuster in a composition to be used for the very same purpose as well as a carbomer in a composition to be used for the very same purpose, the exemplified embodiment in the prior art which is outside the newly claimed range renders obvious the newly claimed range since the general conditions of the claimed are disclosed in the prior art.
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 as well as claims 21 and 22, the prior art renders obvious the same components in similar 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 or substantially the same components to have the same or substantially 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 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 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 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/
