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 .
Applicants' arguments, filed 06/08/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112—New by Amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Matter
Claims 1, 3-4, 6-26, 29-31, 33-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims have been amended to recite “A skin-care composition consisting of an emulsion of beta-glucan, a natural oil, hydrogen peroxide and lactic acid.” The phrase constitutes new matter insofar as it was not disclosed as part of the invention as originally filed. Specifically, the transitional phrase “consisting of” excludes ingredients not specified in the claim. In this case, the claims recite an emulsion without water.
The instant specification defines an emulsion as “a mixture of two or more liquids that are normally immiscible owing to liquid-liquid phase separation . . . In the current context an oil-in-water is formed, in which water is the dispersed phase and oil is the continuous phase” (p. 8 line 30 through line 3 at p. 9; see also p. 3, lines 26-29, “beta-glucan functions as an emulsifier linking and stabilizing the oil and water phases together). Every embodiment in the specification comprises water. Because applicant’s definition of an emulsion includes water, claiming an emulsion without water is considered new matter.
112 4th Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18-24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 18-24 fail to further limit claim 1 insofar as claims 14-24 add ingredients to a closed system. Claim 1, from which claims 18-24 depend, is limited to four (4) ingredients because of the transitional phrase “consisting of”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103—New by Amendment
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.
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, 3-4, 6-10, 18-23, 25-31, 33, 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tate&Lyle (www.tateandlyle.com, published online 2013) in view of He et al., (CN 106963658, cited in IDS) and further in view of Shibuya et al., (CN 104918603).
Tate&Lyle teaches “oat beta glucan under the brand name PromOatTM for use in the food, beverage and supplement markets, and under the brand name AvenacareTM for use in the cosmetics industry” (2nd paragraph). Note: PromOat is the source of processed oat grains and beta glucan for the instant invention (see Specification at p. 10)
Tate&Lyle further teaches, “Beta glucan is a soluble fibre which has widely approved health claims, including EFSA, for lowering cholesterol and reducing post prandial glycaemic response” (3rd paragraph).
Tate&Lyle does not teach an emulsion, a natural oil, hydrogen peroxide, or lactic acid.
He et al. teaches cosmetic compositions comprising Nano platinum (p. 1, para. [0002]), where “cosmetics include but are not limited to lotions, skin lotions, skin creams, facial masks, essences, cleansing creams, facial cleansers, and cleansing gels, cleansing foam, cleansing oil, foundation, powder, lipstick and more” (p. 2, para. [0008]).
The prior art teaches a specific embodiment of a facial mask comprising 9.5g (9.5 w/w %) olive oil (natural oil), 0.45g β-glucan, 3.0g sodium lactate, 0.45g triethanolamine, and ionic water to 100 g (52.86%) (Example 9, paras. [0114]-[0116]). Note: sodium lactate is the sodium salt of lactic acid, which is recognized in the instant specification as a suitable form of lactic acid (see p. 3, lines 11-12).
The prior art formulation suffices as an oil-in-water emulsion, insofar as it comprises oil in a continuous phase of water. The triethanolamine suffices as emulsifier. As a facial mask, the embodiment anticipates administration to a patient in need thereof, as per claim 31.
He does not teach hydrogen peroxide.
Shibuya et al. teaches external anti-aging compositions for skin and methods of producing the same (2nd page, 1st paragraph). Suitable compositions include facial masks (31st page, Example 13).
The compositions may comprise hydrogen peroxide, as an antibacterial agent (14th page, 3rd paragraph) and as a whitening agent (16th page, 5th paragraph); rapeseed oil, as softening agent (9th page, last paragraph); xanthan gum as thickener (18th page, 2nd paragraph), chlorine, as antibacterial agent (14th page, 3rd paragraph); and fragrances such as cinnamaldehyde (13th page, 3rd paragraph), which has antibacterial properties, as per claim 23. The fragrances, preservatives and bactericides may be present from 0.00001% by mass or more (13th page, 2nd paragraph), as per claim 4. Moisturizing ingredients may be in and amount of 0.0001% by mass or more”(17th page, 4th paragraph).
The compositions further comprise “lactic acid” as “cell activator” or transdermal absorption enhancer (18th page, 7-8th paragraph), “keratolytic agent” (19th page, 2nd paragraph); improving skin transformation (6th page, last paragraph), which may be present from 0.00001 mass parts or more (7th page, 2nd paragraph).
The pH of the compositions may fall within the range of 3-11 (20th page, 3rd paragraph), as per claim 30.
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
In this case, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add known cosmetic ingredients to the cosmetic formulations of Tate&Lyle based on their art recognized suitability for their intended use in cosmetic compositions.
Accordingly, adding a natural oil (within the claimed range), lactic acid, hydrogen peroxide, rapeseed oil, xanthan gum, chlorine, fragrances, and a pH in the range of 2-6 to the cosmetics of Tate&Lyle, such that a formulation would have consisted of a combination of consist of a natural oil, hydrogen peroxide, lactic acid, along with the beta glucan would have been reasonable for the person having ordinary skill in the art, in view of He et al. and Shibuya et al.
2) Claim(s) 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tate&Lyle (www.tateandlyle.com, published online 2013) in view of He et al., (CN 106963658, cited in IDS) and further in view of Shibuya et al., (CN 104918603) as applied to claims 1, 3-4, 6-10, 18-23, 25-31, 33, 34 above, and further in view of USDA (Oat Beta Glucan, 2015).
The combination of Tate&Lyle, He et al., and Shibuya et al., which is taught above, differs from claim 11-17, insofar as it does not teach how the beta-glucan is processed nor its nutritional profile.
USDA teaches “PromOat® β-glucan” as a source of beta glucan (p. 3), derived from cell walls of oat cereal kernels (p. 14, 2nd paragraph), as per claim 8-10.
The reference provides many facts concerning PromOat® β-glucan such as “the oat grain is dehulled” and milled to remove flour (starch) and bran (protein)(p. 9), as per claim 11. Below is the nutritional analysis of PromOat:
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(p. 12-13). Note that the nutritional information includes 4% proteins, as per claim 12; fat, carbohydrates, fibers, sugar, protein, as per claim 13.
Table 2 below comprises further analytical results of the PromOat® β-glucan:
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(p. 12). From the chart above, it can be appreciated that the concentration of nutrients is expected to vary from lot to lot. Ingredients such as fats, minerals, sugars, moisture, as per claim 17, are present but variable; See also physical and chemical data below (from the 81st page):
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Note the β-D-glucan content of 33-36%, as per claims 14-15.
It should also be noted here that the nutritional information of claims 8-17 is derived from PromOat® β-glucan (see Specification at p. 10) and is the source of beta glucan.
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing for PromOat® β-glucan of Tate&Lyle to be processed as claimed, and comprise the nutrients claimed insofar as PromOat® β-glucan is taught to be process, as claimed, and comprise nutrients, as claimed in view of the USDA report on PromOat® β-glucan. PromOat® β-glucan is also the described in the specification as the source of beta glucan for use in the instant cosmetic formulations.
Technological Background
The prior art made of record and considered pertinent to applicant's disclosure Zhang et al., (Applied Biochemistry and Biotechnology, 2019). Zhang et al. is pertinent for teaching, “It has been found that lactic acid and hydrogen peroxide (H2O2) displayed co-operatively enhanced killing activity to pathogens. The synergistic effect was investigated with using several microbe species, suggestion that low concentration of lactic acid and H2O2 could kill both Gram-negative and Gram-positive bacteria or even fungal pathogens” (Abstract). The synergistic effect was tested on “Escherichia coli” as indicator bacteria (Id).
Response to Arguments
Applicant’s argument with respect to the art rejections are moot in view of the new grounds of rejection above.
Applicant further argues, “The presently claimed invention provides an unexpected synergistic bactericidal effect when hydrogen peroxide and lactic acid are combined at the claimed concentrations” (p. 9).
However, lactic acid and hydrogen peroxide are known antibacterial agents. Accordingly, their combination is expected to be bactericidal. Solely to rebut applicant’s notion of an “unexpected” effect from the combination of hydrogen peroxide and lactic acid, the Examiner cites Zhang et al., (Applied Biochemistry and Biotechnology, 2019) teaching the synergistic effect of the combination of hydrogen peroxide and lactic acid on gram negative and gram-positive bacteria. Zhang et al. teaches, “It has been found that lactic acid and hydrogen peroxide (H2O2) displayed co-operatively enhanced killing activity to pathogens. The synergistic effect was investigated with using several microbe species, suggestion that low concentration of lactic acid and H2O2 could kill both Gram-negative and Gram-positive bacteria or even fungal pathogens” (Abstract). The synergistic effect was tested on “Escherichia coli” as indicator bacteria (Id). Accordingly, applicant’s data showing bactericidal effects from the combination of hydrogen peroxide and lactic acid is not surprising.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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