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 .
Election/Restrictions
Applicants’ election, without traverse, of Group I in the reply filed on 08 March 2026 is acknowledged. Group I currently corresponds to claims 1, 3-14, 16 and 18.
Regarding the election of species requirement, Applicants elected, without traverse, the following species for examination:
Group A: hyperpigmented spots;
Group B: health functional food composition; and
Group C: not applicable, because the “cosmetic composition” from
Species Group B was not elected.
The examiner has extended the search of Species Group A to include the species of melasma, which is characterized by hyperpigmentation, including hyperpigmented spots.
In reply to the election of species requirement, Applicants identified claims 1, 3-14 and 18 as encompassing the elected a species. However, because claim 14 is drawn to a genus that is subgeneric to a non-elected species, namely a “cosmetic composition” from Species Group B, claim 14 has been withdrawn from consideration.
Accordingly, claims 14 and 16 have been withdrawn from consideration as being drawn to non-elected species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following elected claims are generic with respect to the elected species: claim 1. However, no generic claim has been found allowable. See rejections below.
Priority
The instant application claims priority as follows:
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Information Disclosure Statement
An information disclosure statement (IDS) has not been submitted.
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.
First Rejection under 35 USC § 102
Claims 1 and 7-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lourith et al. (Annales Pharmaceutiques Françaises (2020) 78, 142-149) as evidenced by Sarni-Manchado et al. (J. Agric. Food Chem. 2000, 48, 5995-6002), Ibrahim et al. (Journal of Ethnopharmacology 174(2015) 492-513) and Yang et al. (Phytother. Res. 25: 1166–1173 (2011)). The evidentiary references are being used to provide evidence for inherency.
Regarding claim 1, Lourith et al. teach a method for skin whitening, or treating or alleviating skin pigmentation, comprising: administering a composition, namely a composition prepared from Litchi chinensis extract, comprising procyanidin A2 and quercetin as active ingredients to a subject in need thereof. Lourith et al. teach that they prepared their extract from the fruit’s pericarp. And as evidenced by Sarni-Manchado et al., a Litchi chinensis extract prepared from the fruit’s pericarp comprises procyanidin A2 and quercetin as active ingredients. See Figure 2 of Sarni-Manchado et al.
Regarding claim 7, because the composition used in the claimed invention and that taught by Lourith et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition inhibits tyrosinase activity, would be expected for the composition taught by Lourith et al. Indeed, as evidenced by Ibrahim et al., a Litchi chinensis extract prepared from the fruit’s pericarp demonstrated an anti-tyrosinase effect (IC50 197.860 μg/mL). See page 501, right column, of Ibrahim et al.
Regarding claim 8, because the composition used in the claimed invention and that taught by Lourith et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition inhibits melanin production, would be expected for the composition taught by Lourith et al. Indeed, as evidenced by Yang et al., quercetin at 20 μM reduced the level of melanin produced by α‐MSH‐stimulated NHEM cells. See page 1070, right column, of Yang et al.
Regarding claim 9, because the composition used in the claimed invention and that taught by Lourith et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition decreases expression of one or more melanin synthesis-related genes, would be expected for the composition taught by Lourith et al. Indeed, as evidenced by Yang et al., quercetin at 50 μM decreased of one or more melanin synthesis-related genes, namely TRP-1 expression and TRP-2 expression, in B16F10 cells. See page 1068, left column, of Yang et al.
Regarding claim 10, because the composition used in the claimed invention and that taught by Lourith et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition increases the expression of at least one gene of (a) LC3-II, ATG5, and Beclin-1 and decreases in the expression of at least one gene of (b) p62, and LC3-I, would be expected for the composition taught by Lourith et al.
Regarding claim 11, because the composition used in the claimed invention and that taught by Lourith et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition inhibits an autophagy inhibitor, would be expected for the composition taught by Lourith et al.
Regarding claim 12, because the composition used in the claimed invention and that taught by Lourith et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition inhibits an autophagy inhibitor, the autophagy inhibitor selected from the group consisting of wortmannin, bafilomycin, and 3-Methyladenine (3-MA), would be expected for the composition taught by Lourith et al.
Regarding claim 13, the extract created from the Litchi chinensis fruit by Lourith et al. is a health functional food composition.
Regarding claims 1 and 7-13 that are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lourith et al., when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). Similarly, where there has been use of an article or where the method of its manufacture is known, more than a new advantage of the product must be discovered in order to claim invention. See General Electric Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945), citing De Forest Radio Co. v. General Electric Co., 283 U.S. 664, 682 (1931). Here, the examiner has provided a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art. Once the examiner has presented evidence or reasoning to show inherency, the burden shifts to applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See MPEP 2112.
Second Rejection under 35 USC § 102
Claims 1, 7-13 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamakoshi et al. (Phytother. Res. 18, 895–899 (2004)) as evidenced by Sochorova et al. (Molecules 2021, 26, 2099), and Yang et al. (Phytother. Res. 25: 1166–1173 (2011)). The evidentiary references provide evidence for inherency.
Regarding claim 1, Yamakoshi et al. teach a method for skin whitening, or treating or alleviating skin pigmentation, comprising: administering a composition, namely a composition prepared from grape seed extract, comprising procyanidin A2 and quercetin as active ingredients to a subject in need thereof. Yamakoshi et al. teach that they prepared their extract from grape seed. And as evidenced by Sochorova et al., a grape seed extract comprises procyanidin A2 and quercetin as active ingredients. See Table 2 of Sochorova et al.
Regarding claim 7, because the composition used in the claimed invention and that taught by Yamakoshi et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition inhibits tyrosinase activity, would be expected for the composition taught by Yamakoshi et al.
Regarding claim 8, because the composition used in the claimed invention and that taught by Yamakoshi et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition inhibits melanin production, would be expected for the composition taught by Yamakoshi et al. Indeed, as evidenced by Yang et al., quercetin at 20 μM reduced the level of melanin produced by α‐MSH‐stimulated NHEM cells. See page 1070, right column, of Yang et al.
Regarding claim 9, because the composition used in the claimed invention and that taught by Yamakoshi et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition decreases expression of one or more melanin synthesis-related genes, would be expected for the composition taught by Yamakoshi et al. Indeed, as evidenced by Yang et al., quercetin at 50 μM reduced decrease of one or more melanin synthesis-related genes, namely TRP-1 expression and TRP-2 expression, in B16F10 cells. See page 1068, left column, of Yang et al.
Regarding claim 10, because the composition used in the claimed invention and that taught by Yamakoshi et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition increases the expression of at least one gene of (a) LC3-II, ATG5, and Beclin-1 and decreases in the expression of at least one gene of (b) p62, and LC3-I, would be expected for the composition taught by Yamakoshi et al.
Regarding claim 11, because the composition used in the claimed invention and that taught by Yamakoshi et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition inhibits an autophagy inhibitor, would be expected for the composition taught by Yamakoshi et al.
Regarding claim 12, because the composition used in the claimed invention and that taught by Yamakoshi et al. both comprise procyanidin A2 and quercetin as active ingredients, the recited property of the claimed composition, namely that the recited composition inhibits an autophagy inhibitor, the autophagy inhibitor selected from the group consisting of wortmannin, bafilomycin, and 3-Methyladenine (3-MA), would be expected for the composition taught by Yamakoshi et al.
Regarding claim 13, the extract created from grape seed by Yamakoshi et al. is a health functional food composition.
Regarding Claim 18, Yamakoshi et al. teach administering the disclosed composition to a subject suffering from chloasma (melasma), which is characterized by hyperpigmentation, including hyperpigmented spots.
Regarding claims 1, 7-13 and 18 that are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamakoshi et al., when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). Similarly, where there has been use of an article or where the method of its manufacture is known, more than a new advantage of the product must be discovered in order to claim invention. See General Electric Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945), citing De Forest Radio Co. v. General Electric Co., 283 U.S. 664, 682 (1931). Here, the examiner has provided a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art. Once the examiner has presented evidence or reasoning to show inherency, the burden shifts to applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See MPEP 2112.
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 framework for the objective analysis for determining obviousness under 35 U.S.C. 103 is stated in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Obviousness is a question of law based on underlying factual inquiries. The factual inquiries enunciated by the Supreme Court in Graham are summarized as follows:
(A) Determining the scope and content of the prior art;
(B) Ascertaining the differences between the claimed invention and the prior art; and
(C) Resolving the level of ordinary skill in the pertinent art.
Objective evidence relevant to the issue of obviousness must be evaluated by Office personnel. Id. at 17-18, 148 USPQ at 467. The evidence may be included in the specification as filed, accompany the application on filing, or be provided in a timely manner at some other point during the prosecution. The weight to be given any objective evidence is determined on a case-by-case basis. The mere fact that an applicant has presented evidence does not mean that the evidence is dispositive of the issue of obviousness.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation (TSM) in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
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 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Lourith et al. (Annales Pharmaceutiques Françaises (2020) 78, 142-149), Yamakoshi et al. (Phytother. Res. 18, 895–899 (2004)), Sarni-Manchado et al. (J. Agric. Food Chem. 2000, 48, 5995-6002), Sochorova et al. (Molecules 2021, 26, 2099), Yang et al. (Phytother. Res. 25: 1166–1173 (2011)), Handog et al. (International Journal of Dermatology 2009, 48, 896-901), Zhu et al. (Journal of Investigative Dermatology Symposium Proceedings (2008), Volume 13), and Cook et al. (Molecular Oncology 9 (215) 997-1007).
As previously discussed, Yamakoshi et al. and Lourith et al. each teach a method for skin whitening, or treating or alleviating skin pigmentation, comprising: administering a composition comprising procyanidin A2 and quercetin as active ingredients to a subject in need thereof. In the case of Yamakoshi et al., the composition was prepared from either Litchi chinensis extract, and in the case of Lourith et al., the composition was prepared from grape seed extract. Similarly, Handog et al. al. teach oral procyanidin for treatment of melasma.
Sochorova et al. teach that a grape seed extract prepared from grape seeds comprises procyanidin A2 and quercetin as active ingredients. See Table 2 of Sochorova et al.
Sarni-Manchado et al. teach that a Litchi chinensis extract prepared from the fruit’s pericarp comprises procyanidin A2 and quercetin as active ingredients. See Figure 2 of Sarni-Manchado et al.
Zhu et al. (Journal of Investigative Dermatology Symposium Proceedings (2008), Volume 13) identify procyanidins and quercetin for use in the treatments for hyperpigmentation disorders.
Yang et al., teach that quercetin at 20 μM reduced the level of melanin produced by α‐MSH‐stimulated NHEM cells. See page 1070, right column, of Yang et al.
Cook et al. reviews strategies for optimizing dosing.
Neither Yamakoshi et al. nor Lourith et al. disclose the ratio of the procyanidin A2 to quercetin, as recited in claim 3, and neither Yamakoshi et al. nor Lourith et al. disclose the concentration ranges, as recited in claims 4-6.
At the time that the claimed invention was filed, procyanidin A2 and quercetin were known for use in the treatments for hyperpigmentation disorders and were known to be active ingredients in certain plant extracts used for treatment of hyperpigmentation disorders. See, for example, Lourith et al., Yamakoshi et al., Yang et al., Handog et al., Zhu et al., Sarni-Manchado et al., and Sochorova et al. At the time that the claimed invention was filed, it would have been obvious to optimize the ratio and concentrations using well know principles. See, for example, Cook et al. The desire to enhance efficacy provides the motivation to optimize the ratio of the procyanidin A2 to quercetin, as recited in claim 3, and optimize the concentration ranges, as recited in claims 4-6. Furthermore, one of ordinary skill would have had a reasonable expectation for successfully optimizing the ratio of procyanidin A2 and quercetin, as recited in claim 3, and optimizing the concentrations, recited in claims 4-4, to enhance efficacy, thereby rendering claims 3-6 obvious.
Conclusion
Claims 1, 3-13 and 18 are rejected. Claims 14 and 16 have been withdrawn from consideration as being drawn to non-elected species. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY S MAYHEW whose telephone number is 571-272-8428. The examiner can normally be reached Mon-Fri, 11:00 AM-7:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BSM/Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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