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 .
Status of Claims/Application
Claims 1-9 for the application are pending. Claims 1-9 for the application are being examined.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/07/2023 and 07/11/2025 have been considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., law of nature, natural phenomenon, or product of nature) without significantly more. The inventor discloses and claims naturally occurring skin whitening effects. The judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims are evaluated below with the “Subject Matter Eligibility Test for Products and Processes” flow chart as shown in the MPEP § 2106 III.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, claims 1 and 8 recite "A method for whitening skin…”and “The skin whitening method...”. Thus, the claimed invention is directed to a process, machine, manufacturer or composition of matter.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, claims 1-8 recite methods of utilizing Nypa fruticans extract which is a natural phenomenon (product of nature) since Nypa fruticans is a naturally occurring plant.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No. Claims 1-8 as a whole does not integrate the exception (i.e. the Nypa fruticans) in into a practical application because the recited method step of “applying… Nypa fruticans extract… to a skin of a subject” is not a “particular” treatment. That is the step of “applying to… a subject” is merely apply the exception in a “generic way.” Thus, the additional element does not integrate the natural product (Nypa Fruticans extract) into a practical application. See MPEP 2106.04(d)(2).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claims 1-8 do NOT recite any additional elements that are sufficient to amount to significantly more than the judicial exception, because the recited steps of “applying… Nypa fruticans extract… to… a subject” is generic to any subject and is “well-understood, routine, conventional activities previously known to the industry.” See MPEP 2106.05(d). In this case, it is routine or well-understood to apply Nypa fruticans to a subject’s skin. For example, Kim (Myung K. Kim. KR 20200000461 A; Published 06/23/2020) teaches such a method as discussed below.
Claim 2 recites the “Nypa fruticans extract” is by ethanol extraction , which also does not amount to an inventive concept because making ethanol-based plant extracts (as well as applying the extract to the skin) are routine and well-known in the art. Claims 3-7 recite inherent property of the Nypa fruticans, and thus do not recite any additional elements that amount to significantly more than the exception, i.e. the Nypa fruticians extract itself.
Claim Rejections - 35 USC § 112
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.
Scope of Enablement Rejection
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating dermatitis using Nypa fruticans extract, does not reasonably provide enablement for treating other skin diseases including melanoma using Nypa fruticans. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. §112, first paragraph, have been described In re Wands, 8 USPQ2d 1400(1988). They are:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The predictability or lack thereof in the art
5. The level of skill in the art;
6. The amount of direction or guidance present;
7. The presence or absence of working examples;
8. The quantity of experimentation needed.
The breadth of the claims / The nature of the invention
The breadth of the claim 9 seems to encompass treatment of all skin diseases caused by excessive melanin production. Claim 9 reads on the method of administering a composition containing any Nypa Fruticans extract as an active ingredient to a subject in need of treatment for the skin diseases caused by excessive melanin production.
The nature of the invention in claim 9 is a treatment of skin diseases caused by excessive melanin production, comprising administering a composition containing a Nypa Fruticans as an active ingredient to a subject in need of treatment for the skin diseases caused by excessive melanin production.
The state of the prior art / The predictability or lack thereof in the art
Treating various skin diseases including melanoma using plant extract (such as Nypa fruticans) is highly complicated and unpredictable. For example, Han (Experimental and therapeutic Medicine. Vol 24(6): 754; 2022) teaches Nypa fruticans is “found to regulate melanogenesis, inhibit cancer, and alleviate inflammation” (Pg. 8, Column Left, Line 29) and “the potential seen possibility that natural resources can be used academically and industrially as materials for anti-melanogenesis agents, cosmetics, food, and pharmaceuticals” (Pg. 8, Column Left, Line 51), which indicates that using Nypa fruticans to treat any skin condition is not yet routinely or predictably done.
Additionally, An et al (Plants. Vol 14(6): 951; 2025) provide a review of using natural products for melanoma therapy and as alternative treatment solutions for chemotherapy. The reference teaches natural products are “utilized in studies investigating early-stage melanoma progression and genetic variations” (Pg. 15, Paragraph 2, Line 5) and “additional in-depth mechanistic research in order to better understand the impacts of natural products on melanoma” (Pg. 17, Paragraph 1, Line 8). So, while treating skin diseases such as melanoma using plant extract is promising, there is still a lack of predictability in the art because more research is needed for it to be understood.
The level of one of ordinary skill
The level of skill would be high, most likely at the Ph.D. level.
The amount of direction or guidance present / The presence or absence of working examples
The only guidance present in the instant specification is directed to preparing the Nypa fruticans extract along with analyzing and the evaluation of the skin whitening effects. The presence of working examples in the instant specification is the tests and results shown of the Melanogenesis inhibitory effect by using cell culture in example 3 (Instant Specification Page 18, Paragraph 79+). No example of using Nypa fruticans to treat any skin diseases in any subject include human was provided in the instant disclosure.
The quantity of experimentation needed
Due to the unpredictabilities that natural products have on melanoma such as lacking and understanding the impacts they have, undue experimentation would be required. Because the instant specification only provides guidance for two for one example of Melanogenesis inhibitory effect using RT-PCR and Western blot, undue experimentation would be required to practice claimed method of treating skin diseases caused by excessive melanin production.
Conclusion
Therefore, based on the evidences as a whole regarding each of the above factors (e.g. factors 1-8), the specification, at the time the application was filed, does not satisfy the enablement requirement for the instant claimed method.
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.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
A rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
Claim(s) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Kim, Myung K. (KR 20200000461 A; Published 06/23/2020; The machine translation is relied upon for the following rejection.).
Kim Myung K. throughout the reference, teaches making and using Nypa fruticans extract.
Regarding claim 1 Kim Myung K. teaches that Nypa fruticans extract effective dosage of 1-10 wt % based on 100 wt % of the cosmetic composition was applied to affected areas of adult subject twice per day. (e.g. Paragraph 0109)
Regarding claim 2 Kim Myung K. teaches that Nypa fruticans extract is extracted by ethanol used as an extraction solvent. (e.g. Paragraph 0036)
Regarding claim 3, it is inherent property for Nypa Fruitcan extract to reduce melanin content after administered to a subject as evidenced by the instant specification stating “the Nypa fruticans extract of the present disclosure reduced the melanin content.” (Instant Specification Page 22, Paragraph 97)
Regarding claim 4, it is inherent property that Nypa Fruitcan extract inhibits melanogenesis as evidenced by the instant specification stating “In the experiment, phosphorylated CREB was evaluated as a transcription factor and melanogenesis-related genes such as tyrosinase, TYRP-1, TYRP-2, MITF, and MC1R in mouse melanocytes (Melan-a) to confirm a melanogenesis inhibitory effect.” (Instant Specification Page 19, Paragraph 84)
Regarding claim 5, it is inherent property for Nypa Fruitcan extract to reduce expressions of TYR, TYRP-1, TYRP-2, and MITF as evidenced by the instant specification stating “In the experiment, phosphorylated CREB was evaluated as a transcription factor and melanogenesis-related genes such as tyrosinase, TYRP-1, TYRP-2, MITF, and MC1R in mouse melanocytes (Melan-a) to confirm a melanogenesis inhibitory effect.” (Instant Specification Page 19, Paragraph 84)
Regarding claim 6, it is inherent property for Nypa Fruitcan extract to increase expressions of p-ERK, p-JNK, and p-p38 as evidenced by the instant specification stating “As shown in FIG. 5, the Nypa fruticans extract of the present disclosure activated p-ERK, p-JNK, and p-p38.” (Instant Specification Page 21, Paragraph 91)
Regarding claim 7, it is inherent property that Nypa Fruitcan extract enhances a whitening effect by activating autophagy as evidenced in the instant specification stating “that the induction of autophagy activity and treatment with the Nypa fruticans extract of the present disclosure effectively increased LC3B protein expression, thereby exhibiting a melanogenesis inhibitory effect.” (Instant Specification Page 21, Paragraph 95)
Regarding claim 8 Kim Myung K. teaches that Nypa fruticans extract effective dosage of 1-10 wt % based on 100 wt % of the cosmetic composition was applied was applied to affected areas twice per day. (e.g. Paragraph 0109)
Regarding claim 9 Kim Myung K. teaches that Nypa fruticans extract can be utilized to treat dermatitis (e.g. Paragraph 0109)
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRANT THOMAS KINSEY whose telephone number is (703)756-1236. The examiner can normally be reached Monday – Thursday 730am-5pm.
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/GRANT THOMAS KINSEY/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616