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 1-8 are pending and are examined on the merits in this prosecution.
Claim Interpretation
Claim 4 recites the limitation “a mass ratio of the blending amount of phenylethylresorcinol to the blending amount of the organic acid or the salt thereof is 0.025 to 10.” This limitation is interpreted by the Examiner as a ratio of 0.025:1 to 10:1 for the following reason: the percentage of the organic acid is disclosed as 0.005 to 5 mass% in the instant specification (pg 2, [0005]). As such, the mass percentage of the organic acid cannot exceed 5% in the claim. If this interpretation is not what the claim is intended to convey, applicant must explain the reasoning.
CLAIM REJECTIONS
Indefiniteness Rejection
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 8 is rejected under 35 U.S.C. 112(b) 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.
Claim 8 recites the limitation “wherein a mass ratio of the blending amount of vitamin C or the derivative thereof to the blending amount of organic acid is 1/300 to 1.” It is unclear what ratio applicant has meant to convey by the term “1/300 to 1.” Specifically, it is unclear whether the ratio is 1/300:1 (that is, 0.0033:1) or 1:1 to 1:300. For the purposes of this examination, prior art meeting either value or range is considered sufficient for an obviousness rejection.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Dutta (WO 2019/029922 A1; equivalent of JP-2020-529399 A and US 2021/0085585 A1 cited on IDS dated 4/29/2024).
Dutta teaches a personal care composition comprising a combination of 1-piperidinepropionic acid and pyridinecarboxamide, a composition that provides synergistic skin lightening (Abstract). 1-Piperidinepropionic acid is also known as a wrinkle improving agent (pg 2: 7-10). Dutta further teaches and phenylethyl resorcinol as an additional, preferred agent for skin lightening agents (pg 8: 4-6). This teaching also reads of claim 5.
For claim 2, Dutta teaches “the additional skin lightening agents may be added in an amount from 0.001 to 15 wt%, preferably from 0.01 to 10 wt%, more preferably from 0.1 to 5 wt%, even more preferably from 0.5 to 3 wt%,” (pg 8, 9-11), overlapping the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding claim 3, Dutta teaches amounts of 1-piperidinepropionic acid (1 PP) that overlaps the claimed range (pg 3: 26-30]):
The composition comprises from 0.0001 to 10 wt%, preferably from 0.0005 to 9 wt%, more preferably from 0.001 to 8 wt%, even more preferably from 0.005 to 7 wt%, further more preferably from 0.001 wt to 6 wt%, still more preferably from 0.01 to 5 wt%, yet more preferably from 0.05 to 4 wt% and most preferably from 0.1 to 3 wt%, of 1 PP.
For claim 4, as set forth above, the mass ratio of the amount of pheylethylresorcinol to the amount of the organic acid (1-piperidinepropionic acid) overlaps the claimed range.
For claim 6, Dutta teaches the cosmetic composition can comprise additional skin lightening agents such as vitamin C (pg 7: 18-21).
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Dutta. However, the claimed combination of components, including the phenylethylresorcinol and 1-piperidinepropionic acid, are taught as known and used for administration in a cosmetic formulation for skin lightening. It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer the claimed combination of ingredients, including phenylethylresorcinol and 1-piperidinepropionic acid, to a subject with for the purpose of skin lightening, with a reasonable expectation of success that the treatment would be efficacious, as taught by Dutta. It is noted that the composition of Dutta also comprises pyridinecarboxamide. Since the claim construction recites the transitional phrase “comprising,” an inclusive or open-ended term, the additional element of pyridinecarboxamide is not excluded. See MPEP 2111.03(I).
2) Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Dutta (cited above), In view of Sanadi (“The effect of Vitamin C on melanin pigmentation – A systematic review,” Journal of Oral and Maxillofacial Pathology, Volume 24, Issue 2, May-August 2020, 374-382).
The teachings of Dutta are discussed above.
While Dutta teaches the cosmetic composition can comprise additional skin lightening agents such as vitamin C, Dutta teaches the additional skin lighteners, including phenylethylresorcinol and vitamin C, are present in an aggregate amount from 0.001 to 15 wt% (pg 8, 9-11). However, Dutta does not specifically teach an amount of vitamin C.
Sanadi teaches this missing element of Dutta.
Sanadi teaches vitamin C is effected to relieve depigmentation of hyperpigmented spots on the skin (Abstract). Sanadi teaches topical vitamin C (ascorbic acid) in skin lightening formulations have vitamin C in a concentration range of 1%–20% (pg 380, left column, third paragraph). This amount overlaps the amount recited in claim 7 and the ratio recited in claim 8.
Routine optimization of the amount of vitamin C required in the skin lightening formulation of Dutta would have led to the claimed range of an amount of 0.005% to 1% psi because Sanadi teaches that vitamin C is a skin lightening agent effective in an amount of 1% as the only skin lightening agent in a composition, and one of ordinary skill would have found it obvious to optimize that amount of vitamin C to a level of 1% or less in view of the two other skin lightening agents present in the Dutta composition.
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