DETAILED ACTION
Status of Claims
Claims 14-29 are currently pending. Claims 14-28 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claim 29 are withdrawn from consideration. 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 Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 14-28) in the response filed on January 12, 2026 (to the November 14, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claim of Group II (claim 29) is withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group I with traverse.
Accordingly, the November 14, 2025 Requirement for Restriction is made FINAL, and claims 14-28 are examined as follows.
Claim Objections
The following claims are objected to because of the following informalities:
A. Claim 15 is objected to because of the following informalities: the claim should end with a period. See MPEP § 608.01(m).
B. Claim 23 is objected to because the claim should read:
23. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the composition is a composition for topical use which is administered topically to a subject having the cellular senescence-associated disorders in the skin and/or hair follicles or wherein the composition is a nutraceutical composition which is administered orally to a subject having the cellular senescence-associated disorders in the skin and/or hair follicles.
C. Claim 24 is objected to because the claim should read:
24. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 23, wherein the composition is a composition for topical use selected from the group consisting of a solution, a suspension, an emulsion, a cream, a paste, a gel, a lotion, a powder, a soap, a surfactant-containing water, an oil, and a spray.
D. Claim 28 is objected to because the claim should read:
28. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 27, wherein the method is for improving skin elasticity, skin firmness, skin thickness, skin tone, skin radiance, skin barrier, skin moisturizing, skin rejuvenation, or two or more thereof[[,]]; or for counteracting or ameliorating skin sagging, skin hyperpigmentation, skin hypopigmentation, loss of skin elasticity, loss of skin firmness, erythema, poor skin barrier function, DNA-damages, hair-loss, hair-thinning, hair fragility, grey-hair, or two or more thereof.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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 21 and 27-28 are rejected under 35 U.S.C. § 112 (b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or, for pre-AIA , that applicant regards as the invention.
A. Claim 21 is drawn to:
21. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 20, wherein the SASP factors are selected from the group consisting of gamma-H2AX, tumor necrosis factor alpha, inflammatory cytokines such as interleukins (ILs) selected from the group consisting of IL-1α, IL-1β, IL-6, and IL-8, and metalloproteinases such as matrix metalloproteinases (MMPs) selected from the group consisting of MMP-1 and MMP-3.
wherein the use of the phrase “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (i.e.,, “such as interleukins (ILs) selected from the group consisting of IL-1α, IL-1β, IL-6, and IL-8” and “such as matrix metalloproteinases (MMPs) selected from the group consisting of MMP-1 and MMP-3”). See MPEP § 2173.05(d). In this respect, examiner suggests including additional dependent claims from claim 21, each drawn to further limiting the “inflammatory cytokines” and “metalloproteinases” of claim 21.
B. Claim 27 is drawn to:
27. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the method reduces cellular senescence in the cellular senescence-associated disorders in the skin and/or hair follicles by improving the appearance or other properties of skin, hair, or both.
wherein the use of “other properties” recitation, “other properties of skin, hair, or both,” is indefinite for rendering the metes and bounds of claim 27 unclear as to what “other properties of skin, hair, or both” are included or excluded. Subsequent claim 28 depends on claim 27 and is thus, indefinite as well.
Further clarification is required.
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)(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 14-28 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by KIM (KR 20200063855 A, Publ. Jun. 05, 2020; as evidenced by English language translation of KR 20200063855 A; on 01/24/2024 IDS; hereinafter, “Kim”).
Page and paragraph numbers for Kim refer to the English language translation of KR 20200063855 A.
Kim is directed to:
A Composition For Promoting Melanin Synthesis Comprising Flower Extract Of Milk Thistle
Abstract
The present invention relates to a composition for promoting melanin synthesis comprising an extract of milk thistle flowers as an active ingredient. According to the present invention, the composition comprising the extract of milk thistle flowers promotes melanin synthesis and induces melanism to provide effects of preventing, mitigating, or treating vitiligo, gray hair, or hypochromatism. Moreover, the composition does not cause skin irritation, has no cytotoxicity and is effective to promote the melanin synthesis while providing excellent stability to a human body, thereby being safely used as an active ingredient of a cosmetic or pharmaceutical composition first preventing, mitigating, or treating vitiligo, gray hair, or hypochromatism.
Kim, title & abstract. In this regard, Kim teaches an extract of “[t]wo types of milk thistle” from being “mmersed in a 70% ethanol solvent, followed by ultrasonic extraction for 48 hours”:
Example 1: Preparation of extracts by site of two types of milk thistle
Two types of milk thistle (Silybum marianum, Silybum ebumeum) were collected by flower, above-ground leaf stem, and by root. In the case of a flower, it was prepared separately from the seed part. The collected site was washed clean to completely remove foreign substances and impurities, then shaded at 20 to 35°C, and then pulverized to make the particle size less than 1 mm. Thereafter, 1 kg of the powder of the two types of crushed milk thistle was immersed in a 70% ethanol solvent, followed by ultrasonic extraction for 48 hours, and then the obtained extract was filtered using filter paper (Advantes, No. 2). Then, the mixture was concentrated under reduced pressure to prepare extracts for each part of two types of milk thistle.
(Kim, p. 2, par. 9, cont. on p. 3, Ex. 1), and further in this regard, Kim teaches a “nutritional cream containing 0.1%, 0.5% and 1% of the two flower extracts of milk thistle prepared in Example 1”:
Example 3: Safety confirmation test for human skin of two types of flower extract of milk thistle
Skin safety verification experiments were performed to confirm that the two types of milk thistle flower extracts according to the present invention are safe for human skin. To this end, a skin stimulation test was conducted.
A nutritional cream containing 0.1%, 0.5% and 1% of the two flower extracts of milk thistle prepared in Example 1, respectively, was prepared. Specifically, after heating and dissolving purified water, triethanolamine and propylene glycol, which are water phase, at 70°C, beeswax, liquid paraffin, oil component, emulsifier, and preservative were heated to 70°C to emulsify by adding the dissolved solution. After the emulsification was completed, the solution was cooled to 45°C, and 0.1%, 0.5% and 1% of milk thistle flower extract were added and dispersed, respectively, and then cooled to 30°C. As the content of the milk thistle flower extract was increased to 0.1%, 0.5% and 1%, the nutritional cream was prepared by reducing the content of liquid paraffin to 9.91%, 9.51% and 9.01%, respectively.
Using the nutrition cream prepared as described above, a total of nine 24-hour cumulative patches were applied to the upper forearm every other day for 30 healthy adults to determine whether milk thistle flower extract irritates the skin.
Fining chamber (Finn chamber, Epitest Ltd, Finland) was used as the patching method. Each of the external preparations for skin was added dropwise to the chamber by 15 .Math.l and then patched. The degree of reaction on the skin each time was scored using Equation 1 below, and the results are shown in Table 2 below.
(Kim, p. 3, par. 4, to p. 4, par. 2, Ex. 3).
Regarding independent claim 14 and the requirements:
14. ([…]) A method for treating cellular senescence-associated disorders in skin and/or hair follicles by applying, a composition comprising an extract of flowers of Silybum marianum from which seeds have been removed, comprising less than 0.1% by weight of silymarin, based on the total weight of the dry extract, onto the skin and/or the hair follicles having senescence-associated disorders.
Kim clearly teaches an extract of “[t]wo types of milk thistle” (Kim, p. 2, par. 9, cont. on p. 3, Ex. 1), and “nutritional cream” thereof (Kim, p. 3, par. 4, to p. 4, par. 2, Ex. 3) for treating “vitiligo, gray hair, or hypochromatism” (Kim, abstract), WHEREBY it is noted:
an extract of “Silybum marianum” that is “collected by flower, above-ground leaf stem” and “prepared separately from the seed part” (Kim, p. 2, par. 9, cont. on p. 3, Ex. 1) reads on “an extract of flowers of Silybum marianum from which seeds have been removed, comprising less than 0.1% by weight of silymarin, based on the total weight of the dry extract” of claim 14; and
taking a “nutritional cream containing 0.1%, 0.5% and 1% of the two flower extracts of milk thistle prepared in Example 1” (Kim, p. 3, par. 5, cont. on p. 4), wherein “a total of nine 24-hour cumulative patches were applied to the upper forearm every other day for 30 healthy adults” (Kim, p. 4, par. 1) reads on the active “applying” […] onto the skin and/or the hair follicles” step of claim 14 as well as at least “epidermal tissue” and “hair follicle tissue” of clam 26:
26. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the skin and/or hair follicles present in the skin is selected from an epidermal tissue, a subcutaneous tissue, a hair follicle tissue, and a combination of two or more thereof.
wherein “vitiligo, gray hair, or hypochromatism” (Kim, abstract) reads on the patient population of “skin and/or the hair follicles having senescence-associated disorders” of claim 14, as well as claims 25 and 28 for at least “age-related senescent cells” and “grey-hair”:
25. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the cellular senescence occurs from the presence of age-related senescent cells, stress-related senescent cells, or both.
[…]
28. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 27, wherein the method is for improving skin elasticity, skin firmness, skin thickness, skin tone, skin radiance, skin barrier, skin moisturizing, skin rejuvenation, or two or more thereof, or for counteracting or ameliorating skin sagging, skin hyperpigmentation, skin hypopigmentation, loss of skin elasticity and firmness, erythema, poor skin barrier function, DNA-damages, hair-loss, hair-thinning, hair fragility, grey-hair, or two or more thereof.
Further regarding claim 14 and the requirement for “less than 0.1% by weight of silymarin” in “an extract of flowers of Silybum marianum from which seeds have been removed, comprising less than 0.1% by weight of silymarin,” Kim obtains an extract of “Silybum marianum” that is “collected by flower, above-ground leaf stem” and “prepared separately from the seed part” that is processed at “20 to 35°C” and “immersed in a 70% ethanol solvent, followed by ultrasonic extraction for 48 hours” (Kim, p. 2, par. 9, cont. on p. 3, Ex. 1), which relates to the extraction described at par. [0077] of the instant published application, US 2023/0330003 A1:
[0077] In a preferred embodiment, the flower extract of Silybum marianum is a hydroethanolic extract obtained by extraction flowers of Silybum marianum from which seeds have been removed with an ethanol/water mixture containing between 60 and 80% (v/v) ethanol (preferably at ambient temperature, e.g at 15 to 25° C.), wherein said extract comprises less than 0.1 % by weight of silymarin, or less than 0.01 % by weight of silymarin, or less than 0.001 % by weight of silymarin, or 0% by weight of silymarin, based on the total weight of the dry extract.
as well as a “hydroalcoholic” extract of claims 15-16:
15. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the extract of Silybum marianum is a hydroalcoholic or an alcoholic extract[.]
16. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the extract of Silybum marianum is a hydroalcoholic extract.
In this respect, it is noted MPEP § 2112.01 states: “where the claimed and prior art products are identical or substantially identical in structure of composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP § 2112.01. Therefore, it reasonably follows that Kim’s extract would contain “less than 0.1% by weight of silymarin” because Kim’s extract is obtained from a substantially identical extract process.
Thus, Kim anticipates claims 14-16 and 25-26.
Regarding claims 17-21 and 27, it is noted that the requirements:
17. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the extract of Silybum marianum has senolytic activity including specifically inducing or promoting cell death of senescent cells in the skin and/or the hair follicles with senescence-associated disorders.
18. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 19, wherein the extract of Silybum marianum has senolytic activity including specifically inducing or promoting apoptotic cell death of senescent cells in the skin and/or the hair follicles with senescence-associated disorders.
19. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the extract of Silybum marianum has senomorphic activity including suppressing senescence phenotypes in senescent cells in the skin and/or hair follicles, restoring proliferation ability of senescent in the skin and/or hair follicles, restoring metabolic process in the senescent cells in the skin and/or hair follicles, or a combination of two or all thereof.
20. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the extract of Silybum marianum has one or more of the following effects on the senescent cells in the skin and/or hair follicles selected from the group consisting of:
(a) inhibiting release of senescence-associated secretory phenotype (SASP) factors from senescent cells in the skin and/or hair follicles;
(b) regenerating cell proliferation ability of the senescent cells;
(c) counteracting senescence-induced cell deterioration of the senescent cells;
(d) restoring metabolic process in the senescent cells, and
(e) inducing or promoting cell death of senescent cells.
21. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 20, wherein the SASP factors are selected from the group consisting of gamma-H2AX, tumor necrosis factor alpha, inflammatory cytokines such as interleukins (ILs) selected from the group consisting of IL-1α, IL-1β, IL-6, and IL-8, and metalloproteinases such as matrix metalloproteinases (MMPs) selected from the group consisting of MMP-1 and MMP-3.
[…]
27. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the method reduces cellular senescence in the cellular senescence-associated disorders in the skin and/or hair follicles by improving the appearance or other properties of skin, hair, or both.
are functional limitations. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claim 14, which achieve the resulting effects on cellular senescence-associated disorders. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: an intended effect on cellular senescence-associated disorders of a composition that meets the structural requirements of claim 14, as administered by the active step thereof. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claim 14, and administered by the active step thereof, will achieve the intended result of the functional limitations and fall within the boundaries of the claims.
Thus, Kim anticipates claims 17-21 and 27-28.
Regarding claim 22 and the requirements:
22. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the composition comprises 0.0001 to 20% by weight of the extract of Silybum marianum, based on the total weight of the composition.
Kim teaches a “nutritional cream containing 0.1%, 0.5% and 1% of the two flower extracts of milk thistle prepared in Example 1” (Kim, p. 3, par. 4, to p. 4, par. 2, Ex. 3) of an extract of “Silybum marianum” that is “collected by flower, above-ground leaf stem” and “prepared separately from the seed part” that is processed at “20 to 35°C” and “immersed in a 70% ethanol solvent, followed by ultrasonic extraction for 48 hours” (Kim, p. 2, par. 9, cont. on p. 3, Ex. 1). In this regard, it is noted that MPEP § 2131.03 states “[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is 'anticipated' if one of them is in the prior art.” Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)).
Thus, Kim anticipates claim 22.
Regarding claim 23-24 and the requirements:
23. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 14, wherein the composition is a composition for topic use which is administered topically to a subject having the cellular senescence-associated disorders in the skin and/or hair follicles or wherein the composition is a nutraceutical composition which is administered orally to a subject having the cellular senescence-associated disorders in the skin and/or hair follicles.
24. ([…]) The method for treating cellular senescence-associated disorders in the skin and/or hair follicles according to claim 23, wherein the composition is a composition for topic use selected from the group consisting of a solution, a suspension, an emulsion, a cream, a paste, a gel, a lotion, a powder, a soap, a surfactant-containing water, an oil, and a spray.
Kim teaches a “nutritional cream containing 0.1%, 0.5% and 1% of the two flower extracts of milk thistle prepared in Example 1” (Kim, p. 3, par. 4, to p. 4, par. 2, Ex. 3) that is “applied to the upper forearm every other day for 30 healthy adults” (Kim, p. 4, par. 1), which reads on a “cream” of claim 24, and “a composition for topic use which is administered topically to a subject having the cellular senescence-associated disorders in the skin” of claim 23.
Thus, Kim anticipates claim 23-24.
Conclusion
Claims 14-28 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611