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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/30/23 was filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 9, 13 and 35 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Marsh et al (EP 3 524 224 A1 hereafter Marsh).
Marsh discloses a wet wipe formulation comprising a skin cleansing product that does not comprise any antimicrobial agents for killing microorganism (0016); from 98.5-99% water, a nan-woven fabric (0022) and a pH-regulating present from 0.05-1% (0018), meeting the limitations of claim 1. The skin cleansing product comprises organic acids like lactic acid (0018) meeting the limitation of claim 3. The skin-cleansing product comprises at least one conjugate pair such as sodium citrate-citric acid (0027) meeting the limitations of claim 5. The pH regulators are present in sufficient quantity to bring the pH 4.2 (0027, Examples), meeting the limitations of claim 9. The skin-cleansing product comprises cotton mixed with polyester (041, 0045) meeting the limitation of claims 13. The skin cleansing product is in the form of a wet wipe (Examples, claims), meeting the limitations of claim 35.
Regarding the “sterile” limitation of claim 1, the reference teaches sterile wipes, see para. [0087]. Additionally, it is the position of the Examiner that this limitation is merely in the preamble and is not a limited limitation, especially since the claim is functionally complete. Marsh discloses a wet wp formulation with the same concentration of water, pH components, weak acids and conjugate compounds. The wipes are even used for the same purpose of cleansing infant skin. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). For these reasons, these disclosures render the claims anticipated.
Claim(s) 22, 23, 30 and 34 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Yu et al (CN 103800229 A hereafter Yu).
The Yu patent disclosing a obtaining a sterile skin-cleansing product where the materials for the skin-cleansing product are sterilized before packaging (0008) meeting the limitations of claim 22. The method further comprises sterilizing water by heating/boiling, adding the non-woven materials to the boiling water, soaking the non-woven material in the water, packing the product in sterile packing materials after ultraviolet sterilization/disinfecting (0008, claims], meeting the limitations of claim 23 and 34. After boiling and soaking the materials are air cooled, meaning dry air is used in the sterilization process meeting the limitation of claim 30.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3, 5, 7-9, 13, 18, 20 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Marsh et al (EP 2 524 224 A1 hereafter Marsh) in view of Fu et al (CN 10676482 A hereafter Fu).
As discussed above, Marsh discloses a wet wipe formulation comprising water, pH adjusting compounds and non-woven substrate materials. While Marsh discloses a skin cleansing wet wipe comprising water, no antimicrobial agents for killing bacteria and a pH regulating including conjugate combinations, the reference does not disclose the specific combination or ratios of claim 7 and 8. These elements would be obvious inclusion in a wet wipe formulation as seen in the 482 patent as they are of a similar structure and solve the same problem.
Fu patent discloses a skin cleansing wet wipe formulation comprising up to 99 parts water [014]. The formulation further comprises an organic acid and a pH adjusting compound where the organic acid can be sodium lactate and the pH adjuster can be lactic acid [0015]. The organic acid is present in a concentration from 0.3-1 part while the pH adjuster is present in a concentration from 0.1-3 parts, forming a ratio of 0.3-1:0.1-3 [007-0015]. This ratio of these compound to one another would at least meet the limitations of claim 7 and 8. The wet wipe further comprises nonwoven cotton fibers along with sodium citrate (Example 1). It would have been obvious to include these similar conjugate compounds to the formulation of Marsh as they accomplish the same goal of cleansing the skin while maintaining the pH without harsh antibacterial compounds.
Regarding the ratios and concentrations of claims 18 and 20, it is the position of the Examiner that such limitations do not distinguish over the prior art since the general conditions of the claims have been met by 482. Specifically 482 discloses a wet wipe formulation comprising 99 parts water, sodium citrate and citric acid or sodium lactate and lactic acid in workable ratios of 0.3-1:0.1-3 to one another. 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. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind it would have been obvious to combine the prior art in order to produce a stable and wipe formulation useful in cleansing the skin while avoiding harsh antibacterial compounds that would harm sensitive skin. It would have been obvious to combine the similar conjugate compounds of 482 into the formulation of Marsh as they solve the same problem and have a similar structure. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a sterile wet wipe product useful in cleansing the skin or surface.
Claim(s) 22, 23 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Yu et al (CN 103800229 A hereafter Yu) in view of Tyan et al (The study of the sterilization effect of gamma ray irradiation of immobilized collagen polypropylene nonwoven fabric surfaces, J Biomedical Materials Res, Wiley Periodicals, 2003).
As discussed above, the Yu patent discloses a method for obtaining a sterile wipe formulation comprising ultraviolet radiation. The reference is silent to the specific radiation level of the method. The irradiation level for non-woven biomedical materials for sterilization is known in the art as seen in the Tyan study.
Tyan discloses the optimized range for ionizing radiation for sterilization of nonwoven materials for biomedical purposes (abstract). Radiation of 7.5 kGy provides ideal sterilization conditions for the materials, inhibiting bacterial growth while being non-toxic (1042) meeting the limitation of claim 34. It would have been obvious to irradiate the materials of the 229 patent as seen in the Tyan as this radiation would optimize the non-woven materials for use.
It would have been obvious to combine the prior art with an expected result of a method for making a sterile wipe. It would have been obvious to irradiate the non-woven materials of 229 as it would have eliminated bacterial growth. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable wipe formulation that is sterile for packing and storage.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618