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
Claims 1-9 are pending.
Claims 1-9 are being examined.
Priority
The application claims priority to the foreign application KOREA 10-2022-0149570, filed on 11/10/2022.
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.
Drawings
The drawings are objected to because some of the text on the draws are not legible and are blurry. For examples, Figures 8, 10-12. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objection(s) / Rejection(s) Withdrawn
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 1/20/26) that are not repeated and/or maintained in the instant Office action are withdrawn.
New and Maintained Claim Objection(s) / Rejection(s)
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 § 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.
YUN
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Yun, Jang Su (KR 102221750B1; 3/2/2021; Machine translation is relied upon for the following rejection). This rejection is new.
Yun, throughout the reference, teaches Nypa fruticans extract containing cosmetic composition (e.g. Abstract).
For Claims 1, 8 and 9, Yun teaches composition comprising Nipa fruticans or Nipaya or Nippaja (i.e. Nypa fruticans) (e.g. Title, Abstract, Claims) that are used as “a skin care cosmetic preparation” (e.g. [0039] and applying the active ingredient for “preventing, ameliorating” skin condition (e.g. [0041]), which reads on the topical application with an effective dose and method of administration to a subject in need thereof. The Yun reference also teaches “Nippaja extract… exhibits an excellent whitening effect by inhibiting the activity of tyrosinase…” (e.g. para [0032]; [0100]+).
For Claim 2, Yun teaches using ethanol to extract Nipaya (e.g. claim 1+; [0021]; [0110]).
For Claims 3-7, Yun teaches Nipaja extract has higher tyrosinase inhibition activity, which “interfering with the formation of melanin pigment.” (e.g. [0119]), which reads on the inherent property of the “melanin reduction”, inhibition of TYR, increase expression of p-ERK etc, enhances whitening effect of Nypa fruticans extracts (also as evidenced by the instant specification).
KIM
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.), as evidenced by Yun, Jang Su (KR 102221750B1; 3/2/2021; 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).
The Kim reference also teaches the inherent property of the “whitening”, “melanin reduction”, inhibition of TYR, increase expression of p-ERK etc, enhances whitening effect of Nypa fruticans extracts, as evidenced by the instant specification as well as by Yun, as discussed supra.
Response to Arguments
Applicant's arguments filed on 4/20/2026 have been fully considered but they are not persuasive.
Applicants argue that the instant claimed method is similar to the Example 3 for the subject matter eligibility determination analysis, and thus the instant claimed method is eligible.
Contrary to applicant’s assertion, the fact pattern of the instant claimed is different from the Amazonic acid Example. As stated by applicants, the Amazonic acid method claim recites specific patient population and dosage/duration for administration. However, the instant method only recites “topically applying composition containing a Nypa fruticans extract in an effective dose to a skin of a subject.” The patient population is not specified. The dosage and duration of administration are also not specified.
See MPEP 2106.04(d)(2):
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
In this case, the recitation of “whitening skill” is “merely an intended use of the claimed invention or a field of use limitation.” The instant claim recites the step of “applying… to … a subject,” which 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.
Thus, the instant claims are not eligible subject matter, and the rejection under 35 USC 101 is maintained.
Applicants argue that the Kim reference “does not disclose or suggest skin whitening or the regulation of melanin production,” and the reference does not inherently teach “reduction of melanin production.”
Applicant’s argument is not found persuasive because the Kim reference anticipates the instant claimed invention as discussed supra. As discussed previously, the ability of the ethanol extract of Nypa fruticans to “whitening” skin, to inhibit melanin production or related pathway, are inherent property of the Nypa fruticans extract itself, which is evidenced by the instant specification, and claims. In addition, as discussed supra, the rejection over Kim reference has been supplemented with the Yun reference to provide evidence of inherent property of Nypa fruticans. Applicants are respectively directed to the above rejection for detailed discussion.
Conclusion and Correspondence
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUE LIU whose telephone number is (571)272-5539. The examiner can normally be reached M-F 9-5.
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/SUE X LIU/
Supervisory Patent Examiner, Art Unit 1616
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