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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention. The claims recite “dissolving the components into purified water according to a ratio.” As no ratio is provided that limits the claim, it’s unclear in what way the components are dissolved into purified water “according to a ratio.”
Claim Rejections - 35 USC § 102
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 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.
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heldreth, Amended Safety Assessment of Acid Violet 43 as Used in Cosmetics, International Journal of Toxicology 2021, Vol. 40(Supplement 2) 5 S–15S. Helreth teaches Violet No. 2 (Acid Violet 43) (a staining agent comprising acid violet 43) (title; abstract; introduction). Regarding the recitation “for gastrointestinal mucosa,” this is an intended use of the staining agent. As Acid Violet 43 recited in the prior art has the same structure as the presently claimed acid violet 43, it must be fully capable of performing the same intended use as recited in the present claims, that is, be for gastrointestinal mucosa. Further an aqueous solution including the staining agent is prepared (Results).
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over by Heldreth, Amended Safety Assessment of Acid Violet 43 as Used in Cosmetics, International Journal of Toxicology 2021, Vol. 40(Supplement 2) in view of Bawazir, Effects of Food Colour Allura Red (No. 129) on some neurotransmitter, Antioxidant Functions and Bioelement Contents of Kidney and Brain Tissues in male albino Rats, Life Science Journal 2016;13(12). The relevant portions of Hedreth are given above.
Hedreth fails to teach incorporation of Allura red and an antioxidant.
Bawazir teaches the incorporation of Allura red in food products, drugs, and cosmetics, and the inclusion of antioxidants to hinder oxidation of colorant such as Allura red (abstract; introduction).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate Allura red and an antioxidant into the composition of Hedreth. The motivation for his would have been to adjust the hue or tone of the product, and the antioxidant would deter oxidation and fading of the dye. It would have been further obvious to optimize the relative concentrations of acid violet 43 and allure red to achieve a specific hue or contrast, and in the course of doing so, the artisan would find the presently recited percentages and weight ratios through routine experimentation. The motivation for this would have been to achieve a specific hue or contrast. “‘[W]here 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)” MPEP § 2144.05, II.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over by Heldreth (Amended Safety Assessment of Acid Violet 43 as Used in Cosmetics, International Journal of Toxicology 2021, Vol. 40(Supplement 2) in view of Bawazir, Effects of Food Colour Allura Red (No. 129) on some neurotransmitter, Antioxidant Functions and Bioelement Contents of Kidney and Brain Tissues in male albino Rats, Life Science Journal 2016;13(12) in further view of Lin (Structural Identification and Bioactivities of Red-Violet Pigments Present in Basella alba Fruits, J. Agric. Food Chem. 2010, 58, 10364–10372).
The relevant portions of Hedreth and Bawazir are given above.
Hedreth and Bawazir fail to teach an antioxidant required by claim 7.
Lin teaches that butylated hydroxytoluene is an effective antioxidant agent to preserve acid violet pigment (abstract; Introduction).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate butylated hydroxytoluene into the composition. The motivation or this would have been to prevent oxidation of the pigment. It would have been further obvious to optimize the amount of antioxidant to prevent oxidation of the pigment, and in this way, the artisan would have found the present range through routine experimentation. “‘[W]here 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)” MPEP § 2144.05, II.
Claims 1 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over by Heldreth (Amended Safety Assessment of Acid Violet 43 as Used in Cosmetics, International Journal of Toxicology 2021, Vol. 40 (Supplement 2) 5 S–15S) in view of Franco (Assessment of semi-permanent hair dyes in wash water from beauty salons by liquid chromatography-tandem mass spectrometry selected reaction monitoring (LC-MS/MS-SRM), Anal. Methods, 2020, 12,5415). The relevant portions of Hedreth are given above. Further in Heldrech, an aqueous solution including the staining agent is prepared by Heldreth ().
Heldreth fails to teach storing the product in a brown bottle.
Franco teaches that dark colored bottles hinder oxidation (Sectoin 2.6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the composition into a brown bottle. The motivation for this would have been to hinder oxidation of the agent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
June 2, 2026
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