DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Preliminary Amendment filed 29 May 2023, Applicant amended claims 1, 3-8, and 12. Additionally, Applicant cancelled claims 2, 9-11, and 13-14. Claims 1, 3-8, and 12 are pending.
Claim Objections
Claim 12 is objected to because of the following informality: The phrase “eczema skin disease” includes a redundancy because eczema is necessarily a skin disease. Appropriate corrected is required. The examiner recommends deleting “skin disease.”
Claim Rejections - 35 U.S.C. 112(a)
The following is a quotation of 35 U.S.C. 112(a):
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.
Claims 1, 3-8, and 12 are rejected under 35 U.S.C. 112(a) for lack of enablement.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronics, 8 USPQ2d 1217 (Fed. Cir. 1988)). MPEP § 2164.01. Whether undue experimentation is needed is not based upon a single factor but rather is a conclusion reached by weighing many factors. MPEP § 2164.01(a). These factors were outlined in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988) and include the following: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of any working examples; and (8) the quantity of experimentation necessary needed to practice the claimed invention based on the content of the disclosure. MPEP § 2164.01(a).
There is no requirement in any of claims 1, 3-8, and 12 that an effective amount of the Syzygium formosum extract is administered to the individual. Applicant’s specification does not reasonably provide enablement for treating or ameliorating skin inflammation by administering a negligible or otherwise ineffective amount of the S. formosum extract. In sum, a person having ordinary skill in the art could not practice the full scope of Applicant’s invention, as recited in claims 1, 3-8 and 12, without first engaging in undue experimentation.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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 1, 3-8, and 12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claims 1 and 3-4, the following limitation is unclear: “a fraction of Syzygium formosum extract.” What is a fraction of an extract? This seems redundant given that an extract, itself, is the product of treating plant material with a solvent to remove soluble substances. Isn’t the word “fraction” merely an (indefinite) placeholder for the solvent selected to perform the extraction?
In further regard to claim 4, what is a fractioning process? Is it the same as an extraction process?
Regarding claims 5-8, the relationship between the limitations recited in each of these claims and the method of claim 1 is unclear. Claims 5-8 each introduce limitations as if the claims were still directed to a composition of matter. How do the limitations of claims 5-8 relate to the method of ameliorating or treating skin inflammation now recited in claim 1? Those limitations must be linked to an active step of the claimed method to clarify the claims.
Regarding claim 12, there is insufficient antecedent basis for the following adjective phrase: “skin inflammatory.” Applicant is referred to MPEP § 2173.05(e) (antecedent basis).
In further regard to claim 12, what is a “weak rash”? Furthermore, the adjective <weak> is a subjective term of degree that renders the claim indefinite. MPEP § 2173.05(b)(I) (“Even if the specification uses the same term of degree as in the claim, a rejection is proper if the scope of the term is not understood when read in light of the specification.”).
In still further regard to claim 12, what is “dry eczema”? This does not appear to be a medically-recognized type of eczema. Perhaps this is the result of an error in translating from Korean to English?
Claim Rejections - 35 U.S.C. 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.
Claims 1, 3-4, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (“Anti-allergic effects of the ethanol extract of Syzygium formosum (Wall.) Masam leaves and its immunoregulatory mechanisms.” Journal of ethnopharmacology 211 (2018): 171-179).
Nguyen is directed to “a scientific basis for the traditional (indigenous) use of the S. formosum leaves extract for the treatment of various allergy symptoms in Vietnam.” Abstract.
Nguyen discloses: “Syzygium formosum (Wall.) Masam, a flowering plant that belongs to the myrtle family, Myrtaceae, is widely found in India, Malaysia, and Vietnam (Soh and Parnell, 2015). Previously it was shown that S. formosum leaves extract (SFLE) has a very high level of antioxidant activity demonstrating the remarkable free radical scavenging activity and the strong inhibition of lipid peroxidation (Phuong et al., 2006). In the Vietnamese folk medicine, SFLE has been traditionally used for treatment of skin allergic and skin inflammation treatment (Do et al., 2004).” (Emphasis added) Page 172, left column. “S. formosum (Wall.) Masam is an evergreen tree naturally growing in the Southeast Asian countries. The hot water extract of its leaves has been traditionally used to treat various atopy-like symptoms (e.g., skin dermatitis, diarrhea) in Vietnam (Do et al., 2004).” (Emphasis added) Page 177, right column. “In addition, hot-water extracts of S. formosum leaves-containing mixed herbal formula have been also used as indigenous herbal recipes for treatment of boils, scabies, skin eruptions, skin allergy and diarrhea (Do et al., 2004).” (Emphasis added) Page 172, left column.
On the basis of the foregoing disclosure, claims 1, 3, and 12 are anticipated by Nguyen.
Regarding claim 4, Nguyen discloses the following extraction process: “The leaves of S. formosum were dried further in dry oven (70 °C overnight) and grounded to the powder. The dried powder was put in sealed bottle and kept at 4 °C before use. The leaf powder (150.0 g) was submerged in ethanol (1.0 L) for 4 h at room temperature with gentle shaking for extraction. The leaf power was recovered and extracted with ethanol (1.0 L) two more times. After extraction, ethanol (3.0 L) was evaporated with a rotary vacuum evaporator at 45 °C to obtain the greenish-brown slurry (23 g).” (Emphasis added) Page 172 at Section 2.3.1. “For in vivo experiment, the SFLE slurry described 2.3.1 was pulverized into powder, and the SFLE powder was mixed with Tween 20-Saline solution to the final concentration 1 mg/mL and 2.5 mg/mL, respectively (Hadziabdic et al., 2015).” Page 172 at Section 2.3.3.
Claims 1, 3-8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi (KR 20130068307 A).
Choi, which published in Korean, is directed to “a composition for inhibiting 15-hydroxyprostaglandin dehydrogenase (15-PGDH) containing a plant extract as an active ingredient.” The examiner obtained an English machine translation of Choi using Google Patents. Unless otherwise indicated, all citations refer to that translation, which accompanies this Office action.
Choi identifies Syzygium formosum extract as a suitable active ingredient for the pharmaceutical composition. Page 7/16 at Example 9; see also page 4/16.
Choi discloses that the pharmaceutical composition can be administered to treat “skin wounds or burns.” Page 2/16 at claims 22-23; see also page 4/16 (“Furthermore, the present invention provides a pharmaceutical composition for treating skin wounds or burns, which contains at least one plant extract selected from the group consisting of the extract as an active ingredient.”). The examiner notes that skin wounds are recited in claim 12 of the present application.
Choi discloses: “The compositions of the present invention may be administered orally or parenterally, for example, as creams, gels, sprays, ointments, warnings, lotions and patch and bone external preparations that may be used in the skin and mucous membranes.” Page 6/16.
Choi discloses that the plant extract can be formulated for external use as a lotion comprising the following three excipients: (i) cetearyl alcohol, which is an emollient commonly known as cetostearyl alcohol; (ii) glycerin, which is a humectant; and (iii) xanthan gum, which is a thickener. Pages 10/16 – 11/16 at Example 2 (“Preparation of Lotion”).
Following a review of Choi, a person having ordinary skill in the art would have readily envisaged (i) formulating Syzygium formosum extract as the lotion of Example 2 and, thereafter, (ii) administering that lotion to treat a skin wound. Therefore, claims 1, 5-8, and 12 are anticipated by Choi. MPEP § 2131.02(III) (“A reference disclosure can anticipate a claim when the reference describes the limitations but ‘d[oes] not expressly spell out’ the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.”), quoting Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015).
Regarding claim 3, Choi discloses: “Wherein the plant extract extracted from the extraction solvent is a mixture of water, alcohol, or their, preferably water, C1 - preferable to use a lower alcohol or a mixture of C4, and one is more preferable to extract with methanol or ethanol It is not limited to this.” Page 4/16; see also id. (disclosing “hot water extraction”).
Regarding claim 4, Choi discloses: “The number of times the extraction of the plant extract is preferably 1-5 times, more preferably three times repeated extraction is not limited thereto.” Page 4/16.
Conclusion
Claims 1, 3-8, and 12 are rejected.
Claim 12 is also objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
19 February 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611