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 .
DETAILED ACTION
This Final Office action is based on the 18/683627 application originally filed February 14, 2024.
Amended claims 1-12 and 15-21, filed April 27, 2026, are pending and have been fully considered. Claims 13 and 14 have been canceled. Claims 16-21 are new.
The rejection under 35 USC 112 2nd paragraph is withdrawn in light of applicants amendments and remarks.
The rejection under 35 USC 101 is withdrawn in light of applicants amendments and remarks.
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) 1-12 and 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trinh et al. (US 5,540,853) hereinafter “Trinh” in view of Dekany (US 2016/0113952).
Regarding Claims 1-12 and 15-20
Trinh discloses in column 1 lines 14-25, perfume in personal cleansing and cosmetic products provides olfactory aesthetic benefit and/or serves as a signal of cleanliness. These are especially important functions of these personal care products. Personal care products generally include "rinse-off" products, such as soaps, liquid soaps, shampoos, hair conditioners, etc., which are applied to, e.g., skin or hair and then rinsed off from the skin or hair, and "leave-on" products, such as skin moisturizers, sun screen products, deodorants, hair sprays, mousse, etc., which are applied and are normally allowed to remain on, e.g., skin or hair.
Trinh discloses in column 1 lines 47-54, to provide personal cleansing compositions containing enduring perfumes which are effectively retained and remain on the skin or hair for a long lasting aesthetic benefit with minimum amount of material, and not lost and/or wasted in the cleaning and drying steps. It is also an object to provide perfumes that are non-irritating insofar as that is possible.
Trinh discloses in column 2 lines 12-31, personal treatment compositions such as deodorants, perfumes, colognes, suntan lotions, skin softening lotions, etc., which are meant to leave relatively large amounts of material on the skin, are especially improved by use of these enduring perfume compositions, since they minimize the amount of material in contact with the skin.
Trinh discloses in column 6 lines 54-67, numerous examples of other surfactants are disclosed. They include anionic surfactants, nonionic surfactants, cationic surfactants, amphoteric surfactants, zwitterionic surfactants, and mixtures thereof. They include alkyl sulfates, alkylpolyethyleneglycol sulfates, alkyl sulfonates, alkyl glyceryl ether sulfonates, anionic acyl sarcosinates, methyl acyl laurates, N-acyl glutamates, acyl isethionates, alkyl sulfosuccinates, alkyl phosphate esters, ethoxylated alkyl phosphate esters, trideceth sulfates, protein condensates, mixtures of ethoxylated alkyl sulfates and alkyl amine oxides, betaines, sultaines, and mixtures thereof. Included in the alkylpolyethyleneglycol sulfate surfactants are the alkyl ether sulfates with 1 to 12 ethoxy groups, especially ammonium and sodium lauryl ether sulfates.
Trinh discloses in column 14 lines 5-18, personal cleansing compositions that are normally rinsed, like shampoos and personal skin cleansers, comprises from about 0.01% to about 95% of a surfactant system. This surfactant system comprises anionic, nonionic, cationic, and/or zwitterionic type surfactants as described hereinbefore. For non-shampoo surfactant systems the surfactant system typically comprises at least one surfactant selected from the group consisting of soap, acylglutamates, alkyl sarcosinates, alkylpolyethyleneglycol sulfates, alkylglyceryl ether sulfonates, and/or acyl isethionates.
Trinh further discloses in column 14 lines 39-67 and column 15 lines 1-30, soap surfactant systems including compositions can comprise at least about 2% by weight of the surfactant system is soap. Preferably the alkali metal soap is C10 -C22, preferably C12 -C18, more preferably C12 -C14 (cocoate, laurate, PKO) sodium, potassium, ammonium, triethanolammonium, and/or magnesium soap. Preferably these soaps have saturated alkyl chains. These soaps are preferably prepared by the in situ saponification of the corresponding fatty acids, but they can also be introduced as preformed soaps. The addition of C10 -C22 soap also decreases any "slippery feel" caused by any synthetic surfactant that is present. A soap based liquid composition comprises: (A) from about 5% to about 20% by weight of potassium C8 -C22 fatty acid soap (includes stearic acid, lauric acid and myristic acid) ; (B) from about 0.1 to about 7% C8 -C22 free fatty acid; (C) from about 8% to about 35% of a polyol selected from the group consisting of: glycerin, glycerol, propylene glycol, polypropylene glycol, polyethylene glycol, ethyl hexanediol, hexylene glycol, and other aliphatic alcohols; and mixtures thereof; (D) from about 0.5% to about 15% petrolatum preferably having an average particle size of from 45 microns to about 120 microns; and
(E) from about 0.5 to about 5% glycol ester selected from the group consisting of glycol monoesters and diesters of fatty acids with a chain length from about 10 to about 22, and mixtures thereof, typically formulated as a liquid which additionally comprises from about 35% to about 70% water, wherein the ratio of said soap plus any synthetic surfactant, which is optionally added, to said free fatty acids plus glycol ester is preferably from about 1:1 to about 15:1 and more preferably from about 3:1 to about 12:1; wherein said liquid has a viscosity of from about 500 cps to about 60,000 cps at about 26.7° C.; and wherein the fatty acid of (A) and (B) have an Iodine Value of from zero to about 15. The fatty acid matter of the above soap based liquid composition typically has an IV of from zero to about 15, preferably below about 10, more preferably below about 3. The compositions can contain fatty acids derived from essentially saturated hydrocarbon chain lengths of from about 8 to about 22 carbon atoms. These fatty acids can be highly purified individual chain lengths and/or crude mixtures such as those derived from fats and oils. In general, the higher the proportion of longer chain length fatty acids, the poorer the lather, but the greater the pearlescent appearance and mildness of the product. The above soap based liquid composition can contain from about 8% to about 35% of a polyol selected from the group consisting of: glycerin, glycerol, propylene glycol, polypropylene glycol, polyethylene glycol, ethyl hexanediol, hexylene glycol, aliphatic alcohol; and mixtures thereof; and preferably contains 10-30% of said polyol, preferably glycerol.
Trinh discloses in column 15 lines 55-57, the level of water in the above soap based liquid composition is typically from about 35% to about 70%.
Trinh discloses in column 15 lines 64-67, the liquid soap is called a dispersoid because at least some of the fatty matter, at the levels used herein, is insoluble. The above soap based liquid composition is phase stable, even after storage.
Trinh further discloses in column 29 lines 8-20, other ingredients are selected for the various applications. E.g., alcohols, hydrotropes, colorants, and fillers such as talc, clay, calcium carbonate and dextrin can also be used. Cetearyl alcohol is a mixture of cetyl and stearyl alcohols. Preservatives, e.g., trisodium etidronate and sodium ethylenediaminetetraacetate (EDTA), generally at a level of less than 1% of the composition, can be incorporated in the cleansing products to prevent color and odor degradation. Antibacterials can also be incorporated, usually at levels up to 1.5%. Salts, both organic and inorganic, can be incorporated into the compositions of the present invention. Examples include sodium chloride, sodium isethionate, sodium sulfate, and their equivalents.
It is to be noted, Trinh discloses the addition of antibacterials but fails to specifically teach the claimed one or more human milk oligosaccharide selected from the group consisting of 2'-fucosyllactose, 3-fucosyllactose, difucosyllactose, lacto-N-fucopentaose I, lacto-N- neotetraose and lacto-N-tetraose as well as mixtures thereof.
However, it is known in the art to add known human milk oligosaccharides to a shampoo composition for the skin as a microbiota treatment, as taught by Dekany.
Dekany discloses in paragraph 0110, when the mixture of oligosaccharides is added to the pharmaceutically acceptable carriers a dosage in the form of for example, but not limited to tablets, powders, granules, suspensions, emulsions, infusions, capsules, injections, liquids, elixirs, extracts and tincture can be made, which especially useful when the gut microbiota is treated. For skin microbiota treatment, a solution, gel (e.g. water-based), cream, emollient, foam, ointment, lotion, shampoo or spray can be used. The most suitable formulas for the treatment of the oral cavity can be solid formulations such as lozenges, lollipops, troches, dragees, chewable gums, solid candies, granular solids such as powders, chewable tablets or pills, orally dispersible tablets or pills, orally dissolvable tablets, pills or capsules, and the like, as well as liquid or semi-solid formulations such as solutions, suspensions, pastes, creams, lotions, and emulsions. To the above formulas, if needed, probiotics, e.g. lacto bacteria, Bifidobacterium species, prebiotics such as fructooligosaccharides and galactooligosaccharides, proteins from casein, soy-bean, whey or skim milk, carbohydrates such as lactose, saccharose, maltodextrin, starch or mixtures thereof, lipids (e.g. palm olein, sunflower oil, safflower oil) and vitamins and minerals essential in a daily diet can also be further added.
Dekany further discloses in paragraph 0054, these preferred compounds of formula 1 are core milk oligosaccharides that can be found in mammalian or human milk. The human core milk oligosaccharides containing N-acetyl-lactosamine and/or lacto-N-biose are listed in Table 1, including lacto-N-tetraose (LNT) and lacto-N-neotetraose (LNnT).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to add the human milk oligosaccharides of Dekany to the personal care composition of Trinh. The motivation to do so is to use human milk oligosaccharides for the skin as a skin microbiota treatment.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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.
Regarding Claim 21
Trinh discloses in column 16 lines 34-54, suitable suspending agents for use herein include ethylene glycol esters of fatty acids preferably having from about 14 to about 22 carbon atoms, more preferably 16-22 carbon atoms. More preferred are the ethylene glycol stearates, both mono and distearate, but particularly the distearate containing less than about 7% of the mono stearate. Other suspending agents include alkanol amides of fatty acids, preferably having from about 16 to about 22 carbon atoms, more preferably about 16 to 18 carbon atoms. Preferred alkanol amides are stearic monoethanolamide, stearic diethanolamide, stearic monoisopropanolamide and stearic monoethanolamide stearate. Other long chain acyl derivatives include long chain esters of long chain fatty acids (e.g., stearyl stearate, cetyl palmitate); glyceryl esters (e.g., glyceryl distearate) and long chain esters of long chain alkanol amides (e.g., stearamide diethanolamide distearate, stearamide monoethanolamide stearate). Ethylene glycol esters of long chain carboxylic acids, long chain amine oxides, and alkanol amides of long chain carboxylic acids, in addition to the preferred materials listed above, can be used as suspending agents. Trinh further discloses in column 44 lines 17-23, suitable emulsifiers can include, but are not limited to, polyethylene glycol 20 sorbitan monolaurate (Polysorbate 20), polyethylene glycol 5 soya sterol, Steareth-20, Ceteareth-20, PPG-2 methyl glucose ether distearate, Ceteth-10, Polysorbate 80, cetyl phosphate, potassium cetyl phosphate, diethanolamine cetyl phosphate, Polysorbate 60, glyceryl stearate, PEG-100 stearate, and mixtures thereof. The emulsifiers can be used individually or as a mixture of two or more and can comprise from about 0.1% to about 10%, more preferably from about 1% to about 7%, and most preferably from about 1% to about 5% of the composition.
It is to be noted, Trinh discloses the claimed chemical structures and are not mutually exclusive from surfactant properties. “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. There-fore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) MPEP 2112.01.
Response to Arguments
Applicant's arguments filed April 27, 2026 have been fully considered but they are not persuasive.
Applicants argued: “It is noted that there is no reason provided by the Examiner why the skilled person would actually seek to combine Dekany with Trinh. More specifically, there is absolutely no reason provided as to why an ordinarily skilled person reading Trinh would then consider Dekany to be pertinent to the problems confronting the present Applicant, namely the problem of increasing the ability of soaps and surfactants to foam. Dekany relates merely to treating an unbalanced microbiota of a mammal, in particular the gut microbiota (see e.g. [0033]). The only disclosures of treating the skin microbiota is in relation to skin diseases (see paragraph [0086]). These treatments may be in the form of gel (e.g. water-based), cream, emollient, foam, ointment, lotion, shampoo or spray (paragraph [0110]). Many of such treatments do not in fact contain soaps. Furthermore, Dekany lists 28 different HMOs in the table bridging page 9 to 10 as equivalents to one another for such microbiota "treatments". Certainly, there is no motivation for an ordinarily skilled person to even attempt to try HMO as a foam-increasing agent in topical personal care solutions, let alone selecting the specific six (6) claimed HMOs from the 28 HMOs generally disclosed in Dekany. This is particularly true since Dekany is not concerned at all with increasing soap foaming ability but instead is directed toward treatments of unbalanced microbiota of a mammal.”.
Applicants arguments are not deemed persuasive. As stated in the above rejection, both Trinh and Dekany disclose the use of antimicrobial agents used in shampoo compositions. Dekany further discloses the mixture of oligosaccharides are used in shampoo for skin microbiota. It is known in the art that shampoo is made from surfactants. Therefore, it is maintained, it would have been obvious to one of ordinary skill in the art to combine Trinh and Dekany due to both references are directed to shampoo compositions.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LATOSHA D HINES whose telephone number is (571)270-5551. The examiner can normally be reached Monday thru Friday 9:00 AM - 6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Prem Singh can be reached at 571-272-6381. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Latosha Hines/Primary Examiner, Art Unit 1771
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