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 .
This application is the national stage entry of PCT/JP2023/001625, filed 20 Jan 2023; and claims benefit of foreign priority document JAPAN 2022-015836, filed 03 Feb 2022. This foreign priority document is not in English.
Claims 1-10 are pending in the current application and are examined on the merits herein.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Iriyama et al. (US 2012/0183481, published 19 July 2012, provided by Applicant in IDS filed 03 July 2024) in view of Galey (US 2004/0146474, published 29 July 2004, cited in PTO-892).
Iriyama et al. teaches a heparanase activity inhibitor comprising, as an active ingredient, a cyclic carboxamide derivative represented by formula (I)
PNG
media_image1.png
84
78
media_image1.png
Greyscale
(abstract). In embodiments the compound is 2-imidazolidinone, 1-(2-hydroxyethyl)-2-imidazolidinone, or 1-(2-hydroxyethyl)-2-pyrrolidone (page 1, paragraph 20), addressing limitations of claims 1-3. 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 (paragraph 53 spanning page 3-4), addressing limitations of claims 1 and 8. The term “anti-aging” means preventing and improving wrinkles, sagging and hardening of skin by suppressing alteration of skin caused by heparan sulfate-binding growth factors, and suppressing elastin breakdown, to maintain an elastic, youthful and healthy state of skin (page 3, paragraph 43), addressing limitations of claims 9-10. The heparanase inhibitor of the invention may be applied to skin for utilization in a cosmetic method to prevent large wrinkle formation, and/or to alleviate and eliminate formed wrinkles. 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 (page 4, paragraph 58). 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 (page 4, paragraph 54).
Iriyama et al. does not specifically disclose the composition comprising adenosine, an adenosine derivative, or a salt thereof (claim 1). Iriyama et al. does not specifically disclose the amount of the cyclic carboxamide derivative o (claim 3).
Galey teaches a method for softening lines and/or relaxing the skin, and/or relaxing facial features, comprising topical application to the skin of a composition comprising at least one compound selected from the group consisting of adenosine and analogues of adenosine, in a physiologically acceptable medium. Particular uses of the invention composition include the decreasing of wrinkles (page 1, paragraph 15), addressing limitations of claims 1 and 5-6. The analogues of adenosine include 5'-adenosine monophosphate (page 2, paragraph 25), addressing limitations of claim 5. The quantity of adenosine and/or adenosine analogue for use in accordance with the invention is a function of the desired effect and can thus vary widely. To provide an order of magnitude, the composition of the invention can comprise 0.001% to 10% by weight, preferably 0.01% to 1% by weight of adenosine and/or adenosine analogue with respect to the total composition weight (page 2, paragraph 32), addressing limitations of claim 7. Galey teaches the examples of an aqueous cosmetic composition comprising 0.10% by weight adenosine (page 4, paragraph 68), or approximately 1 mg/mL Adenosine addressing limitations of claim 7.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Iriyama et al. in view of Galey in order to arrive at an anti-wrinkle composition comprising the cyclic carboxamide derivative of Iriyama et al. and the adenosine of Galey, and to select the optimal or workable concentration of the cyclic carboxamide derivative in the composition through routine experimentation. One of ordinary skill in the art would have been motivated to combine Iriyama et al. in view of Galey with a reasonable expectation of success because both Iriyama et al. and Galey are drawn to topical or cosmetic anti-wrinkle or anti-aging compositions, and Iriyama et al. teaches the composition may contain other desired components. See also MPEP 2144.06 at I. providing ““It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)” In this case both Iriyama et al. and Galey each teach active agents for use in a topical or cosmetic anti-wrinkle composition, and it would have been obvious to combine the active agents to give a third topical or cosmetic anti-wrinkle composition comprising the combination of active agents. Regarding claim 4 reciting the concentration of the cyclic carboxamide derivative in the composition, Iriyama et al. teaches the dosage of the cyclic carboxamide derivative may be appropriately established depending on the dosage form or the condition of skin wrinkles to be treated, and Galey teaches the example of an aqueous cosmetic composition and the concentrations of components used in the composition. MPEP 2144.05 at II.A. provides “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” In this case Iriyama et al. suggests it would have been routine experimentation to establish the optimal or workable amount of the cyclic carboxamide derivative in the composition, and Galey teaches examples of concentrations of components in an aqueous cosmetic composition used for the same purpose.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
Prosecution Insights