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 .
Claim Objections
Claim 1 is objected to because of the following informalities: claim limitations under the structures of both (A) and (B) have been written in brackets “(in the formula, . . .)”, in lieu of standard claim practice, wherein claim format uses instead the word “wherein.”
Appropriate correction is required.
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 2-6 recite the limitation "the component (A)" or "the component (B)". There is insufficient antecedent basis for these limitations in the claim.
In the interest of compact prosecution, the Examiner interprets these limitations, to take “the component (A)” as an example, to directed instead to “the cyclic carboxamide derivative represented by Formula (a) or a salt thereof” or to “the derivative of Chemical Formula 1”.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0183481 A1 to Iriyama et al. (“Iriyama”) in view of EA 042490 B1 (“EP ‘490”, in Russian, with English translation made of record).
Iriyama teaches a heparanase activity inhibitor comprising, as an active ingredient, a cyclic carboxamide derivative represented by formula (I)
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(abstract). In embodiments the compound is 2-imidazolidinone, 1-(2-hydroxyethyl)-2-imidazolidinone, or 1-(2-hydroxyethyl)-2-pyrrolidone ([0020]), while also providing a whitening effect ([0001]). The dosage form of the heparanase activity inhibitor of the invention is not restricted, and an external preparation for skin is preferred for use as an anti-aging agent ([0053]).
The term “whitening" means suppressing blackening of skin caused by accumulation of melanosomes in keratinocytes, that occurs with activation of melanocytes accompanying decomposition of heparan sulfate in the basal membrane, thereby improving, e.g., skin spots, freckles, and loss of skin clarity. Unless otherwise specified, the term "whitening method" is used in a cosmetic sense according to the invention, but it may also be used in a medical sense.” ([0045]). Example 3 specifically discloses evaluation of the whitening effect with the heparinase inhibitor. ([0074]-[0077]).
The method and dosage for an external preparation for skin according to the invention used in a beautifying method is not particularly restricted and may be appropriately established depending on the dosage form or the condition of skin wrinkles to be treated, but typically a suitable dose, e.g. from 0.1 ml to 1 ml per cm is rubbed directly onto the skin ([0058]).
The dose is not specifically disclosed in a mg/ml amount, as per Applicant’s claim 4, but is disclosed rather in ml per cm rubbed directly onto the skin. Iriyam further does not disclose that the composition has tyrosinase inhibitory activity, per Applicant’s claim 8. However, since Iriyama discloses that the composition has a whitening effect, as per Applicant’s claims, this necessarily discloses that the effect of the composition is therapeutic, to include through inhibition of tyrosinase activity.
The heparanase activity inhibitor of the invention may also contain one or more other desired components in addition to the cyclic carboxamide derivative of formula (I) or its salt, so long as the inhibiting effect on heparinase activity by the cyclic carboxamide derivative of formula (I) or its salt is not substantially impaired ([0054]).
Iriyama does not specifically disclose the composition comprising an organic acid represented by Formula (b), or a salt thereof (claim 1), to include specifically 1-piperidine propionic acid (claim 5), as well as its amount, whitening cosmetic effect and its tyrosinase inhibitory activity (claims 6-8).
EP ‘490 relates to a personal care composition, in particular for skin lightening. The composition comprises a combination of 1-piperidinepropionic acid and 3-pyridinecarboxamide. The composition provides synergistic skin lightening. Preferably, the composition comprises from 0.0001 to 10% by weight of 1-piperidinepropionic acid and from 0.001 to 10% by weight of 3-pyridinecarboxamide. The invention also relates to a method for lightening human skin, which comprises applying the composition of the invention to the skin and optionally rinsing with water. (Abstract). The disclosed amount of .001 to 10% by weight of 3-pyridinecarboxamide corresponds to 0.01- 100 mg/ml. Applicant’s claimed range falls within this claim range.
EP ‘490 does not explicitly disclose that the composition comprising 1-piperidinepropionic acid has a tyrosinase inhibitory activity. However, since the same compound is used as an external use skin preparation, and with the same amount, then it will necessarily exhibit tyrosine kinase activity.
Accordingly, it would have been obvious to a person of skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Iriyama and EP ‘490 in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so guided by the desire to achieve an improved cosmetic composition for external use, which achieves improved effects by virtue of the combination of two well known in the art cosmetic ingredients, which are both capable of achieving, inter alia, a whitening skin effect. EP ‘490 provides further motivation to do because it shows that a combination of ingredients is capable of achieving synergistic skin lightening.
Other relevant art
The Examiner also notes for the record the following cumulative prior art, which shows the use of 1-piperidine-propionic acid as a single active ingredient in a cosmetic composition.
Shiseido’s new ingredient to protect skin from external stresses - Premium Beauty News, 4 April 2009, available at https://www.premiumbeautynews.com/shiseido-s-new-ingredient-to,776
In the wake of a research that evidenced the role of the protein Serpin b3 as a factor in blocking the skin’s barrier function against external stresses such as dryness and ultraviolet rays, Shiseido has developed an ingredient for inhibiting production of this substance.
The amount of Serpin b3 varies greatly according to each person; its concentration is markedly increased in the epidermis of rough skin and biochemical analysis has shown that increased Serpin b3 significantly disturbs stratum corneum formation. By analyzing the epidermis of approximately 2,000 people all around the world, Shiseido found that there is a strong correlation between the amount of Serpin b3 and the skin’s sensitivity to external stresses.
The Japanese cosmetics giant subsequently evidenced the capacity of 1-piperidine-propionic acid, an alanine derivative, to inhibit the production of Serpin b3.
“On human skin, 1-piperidine-propionic acid suppresses the production of Serpin b3 and results in improvement of the barrier function, moisture retention ability and skin texture and smoothness. These results have proven that application of 1-piperidine-propionic acid leads to improve skin quality,” the company explains in a release.
Based on these discoveries, Shiseido believes it would be possible to develop completely new skin care products for “fundamental improvement of skin quality”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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