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 .
Claim Status
Applicant’s remarks and amendments, filed 4 December 2025 in response to the non-final rejection mailed 4 June 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 4 December 2025 replaces all prior versions and listings of the claims.
Claims 21-30 are pending. Claim 27 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 21-26 and 28-30 are being examined on the merits.
Claim Rejections - 35 USC § 103
(maintained)
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 21, 25, 26, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Preparation H Medicated Wipes (National Library of Medicine, 2004) and Roden (The preservation of wet wipes, 2012).
Preparation H teaches topical medicated wipes (wet wipe for cleansing skin; Preparation H, pages 1 and 4) cloth (pad, page 1) comprising water (aqueous-based formulation), anhydrous citric acid (at least one chelating agent), sodium citrate (citrate based buffer), glycerin, and propylene glycol (Preparation H, Inactive Ingredients, page 4; as required for instant Claim 21). The medicated wipes also comprise 50% witch hazel (Preparation H, Active ingredient, page 1; as required for instant Claims 21 and 28).
Preparation H does not teach wherein the pad consists of a woven or nonwoven material comprising cellulosic fibers or the formulation comprising at least one preservative consisting essentially of benzyl alcohol and sodium benzoate.
Roden, however, teaches that most wet wipes utilize nonwoven fabrics due to cost (Roden, pages 31-32; as required for instant Claims 21 and 29) and that natural substances such as cellulose (cellulosic fibers; Roden, page 32; as required for Claim 30) may be used. Additionally, Roden teaches use of preservatives to protect against bacterial and fungal contamination (Roden, page 6), including sodium benzoate and benzoic acid (Roden, Table 6, page 33; as required for instant Claim 21), which have good efficacy against bacteria (Roden, DMDMH and Bronopol, page 6).
Preparation H is relied upon for the reasons discussed above. If not expressly taught by the prior, based upon the overall beneficial teaching provided by this reference with respect to a medicated wet wipe composition, the adjustments of particular conventional working conditions (e.g., determining one or more suitable weight percent of glycerin (Claim 25) or witch hazel (Claim 26) in which provide such a composition) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the application to combine the teachings of Preparation H and Roden to arrive at the claimed invention. Utilizing the cheaper nonwoven fabric saves money on production and use of preservatives helps prevent contamination of the claimed wet wipes with bacteria. This is important because the wipe are being used around a sensitive region of the body and in order to increase longevity of the product. A skilled artisan could therefore provide nonwoven fabric for the claimed invention with a reasonable expectation of success.
Claims 21-26 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Preparation H Medicated Wipes (National Library of Medicine, 2004) and Roden (The preservation of wet wipes, 2012) as applied to Claims 21, 25, 26, and 28-30 above, and further in view of Sirovatka et al. (US 2008/0146484 A1).
The claims and teachings of Preparation H and Roden are as of record.
Preparation H and Roden do not teach wherein the wet wipe comprises about 10 to about 90 weight percent formulation or 4:1 formulation to pad, nor do they teach wherein the pH ranges from about 5 to about 7.
Sirovatka et al., however, teach wherein the wetting composition (aqueous-based formulation) may be in the range of from about 1 gram per gram of dry base sheet (pad) to about 4 grams. This is an about 1:1 to about 4:1 ratio of wetting composition to dry fabric (Sirovatka et al., [0158], page 17; as required for Claims 22 and 23). If, for example, the composition comprised 1 gram of wetting composition per gram of dry base sheet, the total weight would be 2 grams and the weight percent of wetting composition would thus be 50%. Finally, Sirovatka et al. also teach wherein the wet wipe composition has a pH ranging from about 3.5 to about 6.5 (Sirovatka et al., [0094], page 11; as required for Claim 24).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the application to combine the teachings of Preparation H and Roden with those of Sirovatka et al. to arrive at the claimed invention. The wetting composition concentration can be optimized for a given application (Sirovatka et al., [0157], page 17) and the pH ranges of Sirovatka et al. are such that skin irritation is minimized (Sirovatka et al., [0094], page 1), thus a skilled artisan could incorporate these teachings with a reasonable expectation of success at arriving at the claimed invention.
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 was 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.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 4 December 2025 have been fully considered but they are not persuasive.
Applicant argues that the office action fails to take into account that Preparation H Medicated Wipes contain the preservative diazolidinyl urea and that there is no reasoning as to why at least one preservative consisting essentially of benzyl alcohol and sodium benzoate would be included in the claimed composition.
While the claims indicate that the composition comprises at least one preservative consisting essentially of benzyl alcohol and sodium benzoate, the broad “comprising” composition does not exclude the presence of other components within the composition. Additionally, “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristics of the claimed invention (See MPEP § 2111.03). In the instant case, based upon the presented disclosure, routine selection of different preservatives does not materially affect the basic and novel characteristics of the claimed composition. According to the disclosure, suitable preservatives are well known in the art and may include a specific preservative composition comprising methylparaben, propylparaben, and diazolidinyl urea (page 8, lines 4-15). Additionally, the example composition on pages 12-13 comprises diazolidinyl urea, again demonstrating that different preservatives do not materially affect the basic and novel characteristics and that selection of preservatives which have the property of protecting against bacterial and fungal contamination, including sodium benzoate and benzoic acid, which have good efficacy against bacteria (Roden, DMDMH and Bronopol, page 33).
Accordingly, from the teachings of the references and absence any evidence of criticality regarding preservative selection, 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 was 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.
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 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.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655