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 .
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 Status
Claims 1-10 and 18 are pending and are examined on the merits in this prosecution.
Claim Objections
Claim 18 is objected to because of the following informalities: the claim recites the limitation “according to any one among claim 1 to a subject.” Appropriate correction is required.
CLAIM REJECTIONS
Obviousness Rejection
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1) Claims 1-5, 9-10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon (KR 20170114317 (A), cited in IDS dated 12/18/2023; citations below are from the English translation provided by the applicant).
Kwon teaches a composition for preventing hair loss and stimulating hair growth comprising phytosphingosine and a yeast extract as active ingredients (pg 1, [0001]). Kwon further teaches minoxidil as active ingredient for hair growth (pg 2, [0004]). These teachings read on claims 1-5.
For claim 9, Kwon teaches a liquid composition (pgs 13-14, [0066]).
For claims 10 and 18, one of ordinary skill would reasonably conclude that Kwon teaches a composition for baldness of the head. See MPEP 2144.01.
The skilled artisan would have expected success in adding minoxidil to the Kwon's composition for preventing hair loss and stimulating hair growth comprising phytosphingosine and a yeast extract because Kwon teaches that minoxidil is useful for preventing hair loss and stimulating hair growth and, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
2) Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon (cited above), in view of Vañó-Galván (“Safety of low-dose oral minoxidil for hair loss: A multicenter study of 1404 patients,” J Am Acad Dermatol, 2021; 84: 1644-51).
The teachings of Kwon are discussed above.
Kwon does not teach an improvement of maximum hair length or an increase in hair shaft diameter.
Vañó-Galván teaches the missing elements of Kwon.
Vañó-Galván teaches oral minoxidil shortens the telogen phase of the hair growth cycle, causing premature transition to anagen (the active growth phase of hair follicles), and prolongs anagen, resulting in increased hair length and diameter (pg 1645, left column).
The skilled artisan would have expected success in utilizing the composition of Kwon to increase hair length and hair shaft diameter since Vañó-Galván teaches minoxidil shortens the telogen phase of the hair growth cycle, causing premature transition to anagen, and prolongs anagen, resulting in increased hair length and diameter.
3) Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kwon (cited above), in view of Price (“Changes in hair weight and hair count in men with androgenetic alopecia, after application of 5% and 2% topical minoxidil, placebo, or no treatment,” J Am Acad Dermatol, 1999, 41: 717-721).
The teachings of Kwon are discussed above.
Kwon does not teach an increase in the number of hairs.
Price teaches the missing element of Kwon.
Price teaches the quantity of hair and the amount of hair growth increased during a 96 week clinical trial, using either 2% or 5% minoxidil solution, or vehicle. The fourth group, unblinded, received no treatment (Abstract).
The skilled artisan would have expected success in utilizing the composition of Kwon to increase the number of hairs since Price teaches minoxidil causes an increase in the quantity of hair and the amount of hair growth.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612