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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 26, 2024 and August 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1 – 14 are examined here-in.
Claim Interpretation
Claims 5 – 10 do not further limit the active method steps defined by independent claim 1, which recites “administering or applying to a subject in need thereof an effective amount of a kaempferol saccharide compound”. According to MPEP 2111.04, "a 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim" and "a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited".
In this case, claims 5 – 10 include the term "wherein", rather than "whereby", however, in the instant case it appears that these terms are synonymous, performing the same grammatical function.
The wherein clauses for claims 5 and 6 do not inform the artisan of how the “administering or applying” steps are performed; rather, the wherein clauses merely expresses the intended result of a process step (i.e. for inhibiting or preventing skin damage, for improving skin’s natural regenerative power).
The wherein clauses for claims 7 and 8 do not inform the artisan of how the "administering or applying" steps are performed; rather, the wherein clauses merely characterize the results of those steps (i.e. inhibits expression of a DNA damage gene, DNA damage gene is γH2AX).
The wherein clauses for claims 9 and 10 do not inform the artisan of how the "administering or applying" steps are performed because “wherein the damage is caused by ultraviolet rays” and “wherein the ultraviolet rays are at least one of UVA and UVB” do not change the manipulative steps of “administering or applying”. In other words, the action of “administering or applying” a kaempferol saccharide compound is not meaningfully changed by the recitations of “wherein the damage is caused by ultraviolet rays” and “wherein the ultraviolet rays are at least one of UVA and UVB”.
For the purposes of compact prosecution, although these limitations do not further limit the active method steps defined by independent claim 1, they are still addressed with prior art rejections below.
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.
Claims 5 – 8, 11, 12, and 14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claims 5 – 8, 11, 12, and 14 recite the limitation "the composition". Independent claim 1, from which claims 5 – 8, 11, 12, and 14 depend does not recite a composition. Therefore, there is insufficient antecedent basis for the limitation “the composition” in the claims.
The term “natural” in claim 6 is a relative (and subjective) term which renders the claim indefinite. The term “natural” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
(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 – 8 and 11 – 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ko (EP 3,967,319 A1).
Ko teaches a method for protecting the skin by administering an effective amount of a composition containing kaempferol saccharide (of chemical formulas 1 – 4) to a subject in need thereof (paragraphs 0055, 0083 – 0085).
Ko’s kaempferol saccharide chemical formulas 1 – 4 match the instantly claimed chemical formulas 1 – 4 as shown in instant claim 1. Ko’s teaching for a method for protecting the skin by administering an effective amount of a composition containing kaempferol saccharide (of chemical formulas 1 – 4) to a subject in need thereof (paragraphs 0055, 0083 – 0085) anticipates instant claim 1.
Ko teaches kaempferol saccharide is extracted from Camellia japonica seed cake (paragraphs 0038 – 0041), anticipating instant claim 2.
Ko teaches the concentration of kaempferol saccharide may be 0.01 – 100 µM (paragraph 0042, claim 3), anticipating instant claim 3.
Ko’s teaching that the kaempferol saccharide compound is applied to skin cells (paragraphs 0044 – 0055, examples 1 and 2) anticipates instant claim 4.
Each of the functional limitations recited for claims 5 - 8 (i.e. inhibiting or preventing skin damage (claim 5), improving skin’s natural regenerative power (claim 6), inhibits expression of a DNA damage gene (claim 7), the DNA damage gene is γH2AX (claim 8)) are the result of a method of application for kaempferol saccharides to the skin as taught by Ko since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations (examples 1 and 2 in the instant specification recite the addition of kaempferol saccharides but no other compounds). According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a).
Since the method of applying kaempferol saccharides to the skin as taught by Ko appears to overlap with the claimed method, the skilled artisan would have expected that the method of Ko would have had the same ability to inhibit or prevent skin damage, improve skin’s natural regenerative power, and inhibit expression of a DNA damage gene such as γH2AX as that which is instantly claimed. Something which is old (e.g., the method of Ko) does not become patentable upon the discovery of a new property (e.g., the ability to inhibit expression of a DNA damage gene such as γH2AX ), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I) and 2112(II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990). Therefore, since Ko’s prior art teachings recite the administration of kaempferol saccharides to the skin, the functional limitations of claims 5 – 8 are anticipated.
Ko’s teaching that the composition is a cosmetic composition (paragraph 0065, claim 11) anticipates instant claim 11.
Ko’s teaching that the composition is a pharmaceutical composition (paragraphs 0076 – 0079, claim 5) anticipates instant claim 12.
Ko teaches the dosage of the active ingredient is 0.01 – 100 mg/kg/day (paragraph 0080, claim 6), anticipating instant claim 13.
Ko’s teaching that the composition is a food composition (paragraphs 0081 0082, claim 12) anticipates instant claim 14.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1 – 8 and 11 - 14 are also rejected under 35 U.S.C. 103 below.
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 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 non-obviousness.
Claims 1 – 8 and 11 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ko (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Ko does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1 – 8 and 11 – 14 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Ko thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Ko teaches a method for protecting the skin by administering an effective amount of a composition containing kaempferol saccharide (of chemical formulas 1 – 4) to a subject in need thereof (paragraphs 0055, 0083 – 0085).
Ko teaches kaempferol saccharide is extracted from Camellia japonica seed cake (paragraphs 0038 – 0041).
Ko teaches the concentration of kaempferol saccharide may be 0.01 – 100 µM (paragraph 0042, claim 3) and the dosage of the active ingredient is 0.01 – 100 mg/kg/day (paragraph 0080, claim 6).
Ko teaches the composition may be a cosmetic composition (paragraph 0065, claim 11), a pharmaceutical composition (paragraphs 0076 – 0079, claim 5), or a food composition (paragraphs 0081 0082, claim 12).
As discussed above, for the purposes of this ground of rejection, and purely arguendo, the examiner will take the position that Ko does not teach a specific embodiment having each of the claimed elements, however, claims 1 – 8 and 11 – 14 are rendered prima facie obvious over the teachings of Ko, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., kaempferol saccharides) were known in the prior art (e.g., compositions for application to the skin) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a method for administering or applying a composition with kaempferol saccharides) to one of ordinary skill in the art.
Ko’s kaempferol saccharide chemical formulas 1 – 4 match the instantly claimed chemical formulas 1 – 4 as shown in instant claim 1. Ko’s teaching for a method for protecting the skin by administering an effective amount of a composition containing kaempferol saccharide (of chemical formulas 1 – 4) to a subject in need thereof (paragraphs 0055, 0083 – 0085) reads on instant claim 1.
Ko’s teaching that kaempferol saccharide is extracted from Camellia japonica seed cake (paragraphs 0038 – 0041), reads on instant claim 2.
Ko’s teaching that the concentration of kaempferol saccharide may be 0.01 – 100 µM (paragraph 0042, claim 3), reads on instant claim 3.
Ko’s teaching that the kaempferol saccharide compound is applied to skin cells (paragraphs 0044 – 0055, examples 1 and 2) reads on instant claim 4.
Each of the functional limitations recited for claims 5 - 8 (i.e. inhibiting or preventing skin damage (claim 5), improving skin’s natural regenerative power (claim 6), inhibits expression of a DNA damage gene (claim 7), the DNA damage gene is γH2AX (claim 8)) are the result of a method of application for kaempferol saccharides to the skin as taught by Ko since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations (examples 1 and 2 in the instant specification recite the addition of kaempferol saccharides but no other compounds). According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a).
Since the method of applying kaempferol saccharides to the skin as taught by Ko appears to overlap with the claimed method, the skilled artisan would have expected that the method of Ko would have had the same ability to inhibit or prevent skin damage, improve skin’s natural regenerative power, and inhibit expression of a DNA damage gene such as γH2AX as that which is instantly claimed. Something which is old (e.g., the method of Ko) does not become patentable upon the discovery of a new property (e.g., the ability to inhibit expression of a DNA damage gene such as γH2AX ), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I) and 2112(II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990). Therefore, since Ko’s prior art teachings recite the administration of kaempferol saccharides to the skin, the functional limitations of claims 5 – 8 are obvious.
Ko’s teaching that the composition is a cosmetic composition (paragraph 0065, claim 11) reads on instant claim 11.
Ko’s teaching that the composition is a pharmaceutical composition (paragraphs 0076 – 0079, claim 5) reads on instant claim 12.
Ko’s teaching that the dosage of the active ingredient is 0.01 – 100 mg/kg/day (paragraph 0080, claim 6), reads on instant claim 13.
Ko’s teaching that the composition is a food composition (paragraphs 0081 0082, claim 12) reads on instant claim 14.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ko (as cited above) and further in view of Rosenbloom (US 2003/0118536 A1).
Ko’s teachings are discussed above.
Ko does not teach the damage is caused by ultraviolet rays that are at least one of UVA and UVB.
Rosenbloom teaches the missing elements of Ko.
Rosenbloom teaches compositions and methods for treating the skin after exposure to ionizing radiation (abstract).
Rosenbloom teaches that ionizing radiation, such as ultraviolet radiation, causes DNA mutations, damage, and possible death to cells (paragraph 0015).
Rosenbloom teaches that compounds such as kaempferol have anti-inflammatory effects, which are radioprotective (paragraphs 0021 – 0022, 0025).
The combination of Ko and Rosenbloom’s teachings renders claims 9 and 10 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to utilize Ko’s kaempferol saccharide composition to mitigate cellular DNA damage caused by ultraviolet radiation because Rosenbloom teaches that kaempferol has radioprotective activity against ionizing radiation such as ultraviolet radiation (paragraphs 0015, 0021 – 0022, 0025). Therefore, the combination of Ko and Rosenbloom’s teachings would yield predictable results (i.e. a kaempferol saccharide composition to mitigate cellular DNA damage) which is prima facie obvious according to MPEP 2143(i)(a).
Ko’s teaching for a method for protecting the skin by administering an effective amount of a composition containing kaempferol saccharide (of chemical formulas 1 – 4) to a subject in need thereof (paragraphs 0055, 0083 – 0085) in combination with Rosenbloom’s teaching that kaempferol has radioprotective activity against ionizing radiation such as ultraviolet radiation (paragraphs 0015, 0021 – 0022, 0025) reads on instant claim 9 and 10.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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