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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 May 2026 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 27 May 2026 in response to the final rejection mailed 28 January 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 27 May 2026 replaces all prior versions and listings of the claims.
Claims 21-30 are pending. Claim 27 remains withdrawn. Claim 21 is amended. Claims 21-26 and 28-30 are being examined on the merits.
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 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. Additionally, a skilled artisan could reasonably substitute and make changes to preservative combinations which are useful for the same purpose (e.g., in wet wipes) and therefore would have a reasonable expectation of success at providing both sodium benzoate and benzoic acid as the preservatives of the composition, particularly since they are known to be used in combination in the art of wet wipes (Roden, Table 7, pg. 34).
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. A skilled artisan would also be motivated to maintain an acidic pH because organic acids such as benzoic acid requires an acidic pH for the liquid phase to ensure activity of the preservative (Roden, Organic acids, alcohols, and glycols, pg. 34).
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).
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 22-26 and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-6 and 8-10 of U.S. Patent No. 11,376,293 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because while the instant ‘624 claims do not include an aloe based emollient of Claim 1 of the ‘293 patent, instant Claim 21 is a broad comprising claim which does not exclude said aloe based emollient, and in addition, the composition Example 1 (instant specification, pg. 12-13) includes aloe vera gel and the composition may include a suitable emollient such as aloe vera (instant specification, pg. 9, ln. 6-8).
Instant Claims 22, 23, 24, 25, 26, 28, 29, and 30 are identical to ‘293 Claims 2, 3, 4, 5, 6, 8, 9, and 10, respectively.
Consequently, practicing at least one of the instant or conflicting reference claimed invention would have at least rendered obvious the other invention as claimed.
Response to Arguments
Applicant's arguments filed 27 May 2026 have been fully considered but they are not persuasive.
Applicant argues that because Roden says that preservation of wet wipes presents challenges and thus requires a unique solution incorporating a combination of preservatives, that routine selection of different preservatives would therefore materially affect the basic and novel characteristics of the claimed composition. Applicant goes on to argue that while Roden discloses preservatives and preservative combinations, they do not teach or suggest a preservative consisting essentially of benzyl alcohol and sodium benzoate.
Firstly, it is noted that Roden discloses a combination of phenoxyethanol, sodium benzoate, dehydroacetic acid, and benzoic acid (Table 7, pg. 34). The transitional phrase "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 characteristic(s)" of the claimed invention (see MPEP § 2111.03.III). It is also noted that the specification states that suitable preservatives are “well known to those skilled in the art” and include parabens, sodium hydroxymethyl glycinate, benzoic acid, malic acid, DMDM hydantoin, methylparaben, propylparaben, diazolidinyl urea (instant Specification, pg. 8, ln. 4-15). The exemplary composition of Example 1 (pg. 12-13) also includes additional preservatives outside of benzyl alcohol and sodium benzoate, as does original Claim 12 (Claims dated 4/12/2022). Without evidence to the contrary, the inclusion of phenoxyethanol, and dehydroacetic acid does not materially affect the basic and novel characteristics of the claimed composition, and a skilled artisan could reasonably swap out different preservatives or provide different preservative combinations with a reasonable expectation of success.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 5:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
