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 .
Non-Final Rejection
The Status of Claims:
Claims 1-15 are pending.
Claims 1-15 are rejected.
DETAILED ACTION
1. Claims 1-15 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/US23/14226 03/01/2023 ,PCT/US23/14226, which has a priority of 63333959 04/22/2022 and PCT/US23/14226 ,which has a priority of 63315502 03/01/2022.
Drawings
3. The drawings filed on 8/30/24 are accepted by the examiner.
IDS
4. The IDS filed on 8/30/24 are reviewed by the examiner.
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 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.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 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 the applicant regards as the invention
In claim 1, the phrase” "improving the aspect of inflammatory prone skin" is recited. This expression can be vague and indefinite because there is no clear definition or guideline or standard to measure how much improved akin conditions can be considered as an improved inflammatory skin condition in the claim.
In claims 1 and 9, he terms "sclareol-like" and "sclareolide-like" are recited.
These expressions can be vague and indefinite because it is not known to the skilled reader which structures are intended to be encompassed by these terms. The terms may include analogues/derivatives, e.g. compounds obtained from another compound by a chemical reaction (including compounds which are structurally remote from the starting material), functional derivatives (such as compounds, wherein hetero-atoms are exchanged by alternative atoms), compounds with numerous different types of side groups etc. The examiner recommends to remove therm from the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3 and 11 recite the broad recitation “the growth of Malassezia species”. and the claims also recite “preferably the growth of Malassezia restricta”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The examiner recommends to put that narrowed limitation into their dependent claims.
In the present instance, claim 15 recites the broad recitation” in a form suitable for topical application” and the claim also recites “ preferably in the form of a liquid, a lotion, an aerosol, a cream, a gel or an ointment”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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)(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.
Claim(s) 1, 4-5, 7-9 ,12-13, 15 are rejected under 35 U.S.C. 102(A)(2) as being clearly anticipated by Henkel et al (WO 02/30385 A2).
Henkel et al discloses a method for treatment of the skin and mucous membranes by using diterpenes with a labdane structure, including sclareol or sclareolide in therapeutic and cosmetic preparations, such as psoriasis (see page 4, paragraphs 1-2; see page 8, example 3.1; claims 1, 2, 4, 6). The actives are present in quantities of 0.01- 5 wt.% of the preparations (see claim 5). Oils, lotions, emulsions, creams, gels, powders or aerosols are, for example, suitable as cosmetic supports. Example 3.1 (see page 8) describes a lotion for skin soothing. These are identical with the claims.
Claim(s) 1, 4-5, 7-9 ,12-13, 15 are rejected under 35 U.S.C. 102(A)(2) as being clearly anticipated by Subbiah (WO 99/63978).
Subbiah teaches a method for treating certain types of dermatitis, e. g. perioral dermatitis, or seborrheic dermatitis (see page 4, lines 19-23) or rosacea (see page 6, line 31 to page 7, line 8) by using sclareolide or sclareol or sclareolide- or sclareol-like compounds (see page 5, lines 12-28) in a topical application (see claims 1, 4, 5, 6,12-16). The topical formulations, such as creams, gels or ointments are preferred (see page 9, lines 27-32). The compounds have antifungal and antibacterial properties (examples 1-3). These are identical with the claims.
Claim(s) 1, 2, 4-10 and 12-15 are rejected under 35 U.S.C. 102(A)(2) as being clearly anticipated by Krutmann et al (WO 2016/188988 A1).
Krutmann et al discloses a method for treating acne and dermatitis by using a composition comprising sclareolide by means of reducing or preventing air pollution-induced or air pollution-inducible skin damage, such as skin inflammation ( see page 2, paragraph [0007] to page 3, paragraph [0008]); (see page 35, paragraphs[00147]-[00148]; (see page 41; example 3; claims 1, 2, 6-9). Sclareolide is a cell differentiation enhancer which stimulates the production of lipids from epidermal cells, and concurrently increases the lipid content of the barrier (see page 6, a paragraph [0032]). The composition contains 0.01-1.0% active agent (see page 55, claim 7) and can be in the form of a lotion or cream (see page 55, claim 6). These are identical with the claims.
Claim(s) 1, 4-9 and 12-15 are rejected under 35 U.S.C. 102(A)(2) as being clearly anticipated by Braquet et al (US 5,906,993).
Braquet et al discloses a method of treating diseases associated with excessive proliferation of benign cells, such as psoriasis, and other diseases of the skin (see col.1, lines 31-41; col. 2, lines 23-32; col. 4, lines 19-22; claims 1, 4) by using (+) sclareolide. The composition can be administered parenterally, e.g. by subcutaneous administration, in the form of a sterile aqueous solution (see col. 2, lines 9-22); this is also suitable for topical application (as a liquid). These are inherently identical with the claims.
Claim(s) 1, 2, 4-10 and 13-15 are rejected under 35 U.S.C. 102(A)(2) as being clearly anticipated by Maes et al (WO 01/74327 A1).
Maes et al describes a method for treating or preventing dry skin by using a composition containing a protease inhibitor and a cell differentiation enhancer, which can be sclareolide in a topical application (see pages 13-15, claims 1, 5, 6-9, 17, 18). The composition can be used for treating or preventing dry skin. A composition 0.1 % sclareolide and 0.2% white birch extract; or (2) a composition containing 0.1 % sclareolide and 0.2% boswellic acid; or (3) a composition containing 2% each of phytocohesine, cennamides, boswellic acid, cholesterol, and linoleic acid, and 1 % sclareolide show substantial efficacy in skin barrier repair (see pages 11-12; example 1 ). These are inherently identical with the claims.
Conclusion
Claims 1-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached on 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 6/24/2026
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