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 .
Response to Arguments
Applicant’s amendment filed 12/12/2025 is accepted and entered.
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
The Examiner notes that Applicant indicates on page 5 of the remarks that “the Examiner mistakenly cites “1 to 2 wt. %”” instead of the claimed 0.5 to 5 wt.% - as set forth below and in the Office Action mailed on 08/12/2025, Claims 1 and 9-11 were rejected together. Claim 11 recites the range 1 to 2 wt.%, which is within the range of Claim 1 (0.5 to 5 wt.%), Claim 9 (0.5 to 3 wt.%), and Claim 10 (0.75 to 2.5 wt.%); as any art that reads on Claim 11 would necessarily also read on Claims 1, 9, and 10, the claims were rejected together.
Applicant argues on pages 5-6 that there is a technical advantage associated with using the claimed diester skincare additive (hereinafter referred to as “Diester”) in the claimed amounts, and that there is no suggestion in either Gatto or Zhang that using the claimed amounts of Diester would lead to reduced skin irritation/inflammation and wet friction. Applicant points to Examples 1 and 2 in the specification as basis for this technical advantage.
However, this is not found persuasive. In Example 1, Applicant compared two groups of textiles to determine the skin irritation produced. Sample A was treated with a known skin irritant, and Sample B was treated with the same amount of the same skin irritant but also with Diester (¶ [0072] of published application). Notably, the test of Example 1 does not compare amounts of Diester (¶ [0072]). Similarly, Example 2 compared groups of textiles to determine the skin friction. Fig. 3 and 5 show the friction forces for Samples A and Samples B, where Sample A was treated with a commercially available hygiene finisher and Sample B was treated with the commercially available hygiene finisher and Diester (¶ [0082, 0085, 0087]). Figs. 4 and 6 show the friction forces for Samples A and Samples B, where Sample A was treated with a different commercially available hygiene finisher than for Figs. 3 and 5, and Sample B was treated with this different commercially available hygiene finisher and Diester (¶ [0082, 0084, 0086]).
While Example 2 does test different amounts of Diester (¶ [0089]), all the amounts of Diester tested are within the range claimed within Claim 1. Although the Specification appears to suggest that a Diester treat rate of 2 wt.% is the most desired, it also states specifically that there are still skin care benefits from the other amounts tested (¶ [0089-0092]). Since Applicant does not show any data comparing irritation or skin friction to samples treated with other skin care additives in the same amounts as Diester (for example, testing the irritation of a textile treated with 1% SLS and 2% shea butter instead of 1 % SLS and 2% Diester), or for amounts outside of the claimed range, it is not found persuasive that Applicant’s specification demonstrates a technical advantage to using Diester specifically in the claimed amounts. Applicant’s specification does not show that Diester performs better than other skin care additives or that values of Diester outside of the claimed range perform unexpectedly worse than values within the claimed range.
Applicant also argues on pages 6-7 of the Remarks that one of ordinary skill in the art would have no rationale to combine Gatto and Zhang as they have disparate subject matters. Applicant alleges that Zhang relates to breast/udder pumps and resolving issues specific to breast feeding/pumping such as mastitis – as such Applicant alleges that Zhang is directed to breast health rather than the problem solved by Applicant, allegedly “resolving issues associated with personal hygiene products.” (Remarks, pg. 6).
This is not found persuasive. Applicant cites to ¶ [0005, 0006, 0010]) of Zhang as indication that Zhang is directed to breast health rather than “issues associated with personal hygiene products”. However, ¶ [0010] specifically states that the systems and methods of the invention are for “providing certain substance or substances to breasts to prevent and/or treat causes, symptoms, and conditions of breast and/or udder diseases” (emphasis added). ¶ [0005, 0006] describe various symptoms of various breast infections, many of which are general skin irritation symptoms such as redness, swelling, and itching. Since Zhang indicates that the substances can be used to treat symptoms of breast conditions, and many of those symptoms are also symptoms of general skin irritation, one of ordinary skill in the art would have found it obvious to look to Zhang for improvements that could be made in other areas other than just breast specific issues, such as general skin care issues or specifically personal hygiene / feminine care skin issues.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Since Zhang does indicate Diester is a skin care additive that can be used, the argument that combining Gatto with Zhang is hindsight is not persuasive.
Applicant did not specifically argue the dependent claims.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claim(s) 1, 2, 9-16, 19, and 25-31 are rejected under 35 U.S.C. 103 as being unpatentable over Gatto et al (US 2008/0200894) in view of Zhang (US 2014/0236072).
Regarding Claims 1 and 9-11, Gatto discloses a personal hygiene product (10, Fig. 1; ¶ [0014-0015]) comprising at least a first layer (topsheet 14, Fig. 1) having a top surface and a bottom surface, wherein at least the first layer (14, Fig. 1) comprises a skin care additive comprising a PPG material (¶ [0021-0022, 0027]; the PPG material can be applied neat, such that the lotion consists of the PPG material, or as part of a lotion with other ingredients) and wherein the personal hygiene product is not wetted before application to the skin (¶ [0014-0015]; diapers and sanitary napkins are not known in the art to be wetted prior to wear, and since there is no indication that this article is wetted prior to use, one of ordinary skill would find it clear that the article is not wetted prior to application to the skin), and wherein at least the first layer (14, Fig. 1) is formed from a non-woven textile (¶ [0017-0018])
Gatto is silent whether the skin care additive is a diester which is di-PPG-2 myreth-10 adipate, and whether the diester skin care additive is present in an amount of between 1 weight % and 2 weight % relative to the layer(s) containing the diester skin care additive.
Gatto discloses that the amount of lotion added onto a layer is variable, and can be tailored for specific needs, for example based on the desired fluid handling properties of the specific article (¶ [0024, 0027]). Lotion has various skin care benefits, however lotion can impede acquisition of menstrual fluid through the absorbent article (¶ [0003-0006]). As such, the amount of lotion added onto a layer is disclosed to be a result effective variable in that changing the amount of lotion added changes the level of skin care benefit imparted to the user and the efficacy of menstrual fluid absorption through the layer. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Gatto to have the skin care additive be present in an amount within the claimed range, as it involves only adjusting the amount of an additive that is disclosed by Gatto to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gatto by making the skin care additive be present in the amount of at least 1 weight % and 2 weight % relative to the layer(s) containing the skin care additive as a matter of routine optimization since it has been held that “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).
Zhang teaches a system for maintaining skin health which utilizes skin care ingredients and additives, therefore being within the same problem-solving field of improving skin health, where the skin care additive is a diester which is di-PPG-2 myreth-10 adipate (¶ [0106]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the generic PPG skin care additive of Gatto for the specific diester, di-PPG-2 myreth-10 adipate, of Zhang, as Zhang indicates that di-PPG-2 myreth-10 adipate is a known skin care ingredient (as motivated by Zhang ¶ [0106]).
Regarding Claim 2, Gatto further discloses at least a second layer (secondary topsheet 15, or, in an alternative, backsheet 16, Fig. 1) having a top surface and a bottom surface.
Regarding Claim 12, Gatto further discloses a solvent or diluent (¶ [0044] a carrier can be considered a diluent).
Regarding Claim 13, Gatto further discloses an additional additive (¶ [0043]).
Regarding Claim 14, Gatto further discloses a stabilizer (¶ [0044] a carrier can be considered a stabilizer).
Regarding Claim 15, Gatto further discloses the skin care additive is present on at least the top surface of the first layer (14, Fig. 1; ¶ [0021-0022] although the preferred embodiment has the skin care additive on the bottom surface of the topsheet, Gatto clearly envisions the skin care additive could be on either the bottom or top surface of the topsheet).
Regarding Claim 16, Gatto further discloses the skin care additive is present on at least the top surface of the second layer (15, Fig. 1; ¶ [0023]; the skin care additive can be on either the top or bottom surface of the secondary topsheet).
Regarding Claim 19, Gatto further discloses at least one absorbent layer (18, Fig. 1) interposed between the first layer (14, Fig. 1) and the second layer (16, Fig. 1; ¶ [0020]), such that the personal hygiene product is an absorbent hygiene product (¶ [0015]).
Regarding Claim 25, Gatto further discloses the personal hygiene product is a diaper or pad (¶ [0014-0015]).
Regarding Claims 26 and 27, Gatto/Zhang discloses the claimed invention substantially as claimed as set forth above for Claim 1. The personal care article of Gatto/Zhang, as described above in Claim 1, has a skin care additive that reduces skin care irritation. As such, utilizing the personal care article of Gatto/Zhang would prevent or alleviate dermatitis and/or bed sores, as both dermatitis and bed sores are forms of irritation.
Regarding Claims 28 and 29, Gatto/Zhang discloses the claimed invention substantially as claimed as set forth above for Claim 1. The personal hygiene article of Gatto/Zhang, as described above in Claim 1, would be expected to show a reduction in skin friction and trans-epidermal water loss compared to a personal hygiene product not containing the skin care additive di-PPG-2-myreth-10 adipate. It has been held that when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to inherent (see MPEP 2112.01 I).
Regarding Claim 30, Gatto further discloses the personal hygiene product is in a dry state when applied to the skin (one of ordinary skill would find it obvious that a diaper or sanitary napkin is not wetted prior to wear, as wetting the absorbent article would decrease the total absorbency of the article).
Regarding Claim 31, Gatto further discloses the personal hygiene product is in prolonged contact with the skin (diapers and sanitary napkins are known in the art to be worn for a prolonged period, generally multiple hours before being changed).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gatto et al (US 2008/0200894) in view of Zhang (US 2014/0236072) further in view of Ludwig et al (US 2017/0246052).
Regarding Claim 17, Gatto/Zhang is silent regarding a sealing means having a top surface and a bottom surface, and wherein the sealing means comprises a coating comprising the skin care additive, and the coating is present on at least the top surface of the sealing means.
Ludwig teaches an absorbent article, thus being in the same field of endeavor, which comprises a sealing means (leg cuffs 26, Fig. 4; ¶ [0116]) having a top surface and a bottom surface (as seen in Fig. 4), wherein the sealing means (26, Fig. 4) comprises a coating comprising a skin care additive, wherein the coating is present on at least the top surface of the sealing means (26, Fig. 4; ¶ [0116]). This promotes healthy skin for the user where the article seals against the skin (¶ [0116]).
Therefore, it would have been obvious to modify the personal hygiene article of Gatto/Zhang to include a sealing means comprising a coating comprising the skin care additive of Gatto/Zhang, as taught by Ludwig (¶ [0116]). This promotes healthy skin for the user where the article seals against the skin (as motivated by Ludwig ¶ [0116]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gatto et al (US 2008/0200894) in view of Zhang (US 2014/0236072) further in view of Chmielewski et al (US 2016/0354506).
Regarding Claim 24, Gatto/Zhang is silent whether the second layer is an air permeable waterproof layer.
Chmielewski teaches an absorbent article, thus being in the same field of endeavor, with a second layer that is an air permeable waterproof layer having a top and bottom surface (¶ [0002-0003, 0019]). This air permeable backsheet improves the comfort of the absorbent article (¶ [0002-0003]).
Therefore, it would have been obvious to modify the personal hygiene product of Gatto/Zhang to have a second layer that is an air permeable waterproof layer (¶ [0002-0003, 0019]). The breathability of the backsheet improves the comfort of the absorbent article (as motivated by Chmielewski ¶ [0002-0003]).
Conclusion
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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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781