DETAILED ACTION
Status of the Claims
Claims 1-7 are pending in the instant application and are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant Application is 371 of PCT/JP2022/042810 filed 11/18/2022 and claims priority to JP-2021-196461 filed 12/02/2021.
The U.S. effective filing date has been determined to be 11/18/2022, the filing date of the PCT/JP2022/042810. Applicant's claim for a foreign priority date of, 12/02/2021, the filing date of document JP-2021-196461, is acknowledged, however no English translation of the foreign priority document such that the examiner can confirm written description (112(a)) support therein.
Information Disclosure Statement
The information disclosure statement(s) submitted on 05/02/2024 and 06/26/2024 were filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The abstract of the disclosure is objected to because the abstract includes “[Problem]” and “[Solution]” and is too short. Correction is required. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim includes the text “[Chem. 1]” (line 5)which is extraneous. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over MAKOTO (WO-2012/057123-A11; published 05/03/2012; English Language machine translation relied on herein) in view of IRIYAMA (US-2012/0183481-A1; published July 2012; with priority to PCT/JP2010/066998 published as WO-2011/040496-A12).
Applicants Claims
Applicant claims a cosmetic composition comprising: (A) a Thuja orientalis seed extract; (B) a cyclic carboxamide derivative or salt of the cyclic carboxamide derivative represented by Formula (1)[see claim], and (C) water (instant claim 1). Applicant further claims the component (B) is 1-(2-hydroxyethyl)2-imidazolidinone (instant claim 3). Applicant claims the component (A) is hydrolyzed Thuja orientalis seed extract (instant claim 5). Applicant claims the amount of component (B) is 0.01 to 8 mass% with respect to the total amount of the cosmetic composition (instant claim 4), and the amount of component (A) is 0.01 to 3 mass% with respect to the total amount of the cometic composition (instant claim 6). Applicant further claims the inclusion of a water-soluble thickener (instant claim 7).
Determination of the scope
and content of the prior art (MPEP 2141.01)
MAKOTO teaches that: “Provided in the present invention is a material which is produced by processing a material extracted from a plant seed using an organic solvent, and which is highly effective in promoting collagen production, promoting hyaluronan production, and diminishing the appearance of wrinkles. The collagen production promoter related to the present invention is characterized by being obtained through a process in which: an extracted material containing an oil component is extracted from a seed of a plant belonging to the family Cupressaceae and the genus Platycadus by using an organic solvent; part or all of the solvent is removed from the extracted material by distillation; an aqueous alkali solution having a concentration of 0.5-15 N is added and mixed; acid treatment is performed; and the resultant material is subsequently washed with water.” [emphasis added](abstract, see whole document). And that: “The seed of the plant used in the present invention is a seed of a plant belonging to the genus Konotegasiwa. Of these, it is preferable to use seeds of Platycladus orientalis.” (p. 3, §Description-of-Embodiments, 2nd paragraph)(instant claim 1, item (A)). The examiner notes that Platycaladus orientalis is synonymous with Thuja orientalis which is also known as Konotegasiwa or Hakushinin the latter being known from Chinese Medicine (p. 3, §Description-of-Embodiments, paragraphs 2-4). The examiner further notes that MAKOTO teaches alkali treatment of the seed extract (p. 4, paragraphs 2-4) which results in a hydrolyzed product (instant Specification, p. 4, 2nd paragraph)(instant claim 5).
MAKOTO teaches the seed extract is included in topical cosmetics as an anti-wrinkle agent, and “When preparing a composition for external use on the skin, it is preferable to add 0.0001 to 20% by mass, particularly 0.001 to 2% by mass, as a liquid component, of an accelerator or an anti-wrinkle agent as an active ingredient. preferable.” (p. 4, last three paragraphs). MAKOTO teaches the inclusion of thickener, specifically carboxyvinyl polymer and Acrylic acid alkyl methacrylate polymer (p. 8, bottom §(Table 3), lines 4-5). MAKOTO teaches the inclusion of water (p. 5, 3rd paragraph)(instant claim 1, item C).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of MAKOTO is that MAKOTO does not expressly teach (B) a cyclic carboxamide derivative, and particularly 1-(2-hydroxyethyl)2-imidazolidinone (instant claims 1-3, item B).
IRIYAMA teaches heparanase activity inhibitors comprising, as an active ingredient, a cyclic carboxamide derivative of Formula (I)(title, abstract, see whole document). And particularly that: “The present invention relates to an external preparation for skin containing a cyclic carboxamide derivative of formula (I) as an active ingredient, and particularly to a heparanase inhibitor that, when used as a cosmetic, inhibits activation of heparanase in the skin, inhibits skin alteration occurring with failure of control of growth factors, by supporting heparan sulfate, and allows the condition of youthful skin to be maintained, while also exhibiting a whitening effect.” ([0001]).
IRIYAMA teaches that: “(3) A heparanase activity inhibitor of (1), wherein the cyclic carboxamide derivative is one or more selected from the group consisting of 2-imidazolidinone, 1-(2-hydroxyethyl)-2-imidazolidinone and 1-(2-hydroxyethyl)-2-pyrrolidone.” ([0020])(instant claims 1-3, item B).
IRIYAMA teaches that: “Since the heparanase activity inhibitor of the invention can efficiently inhibit heparanase activity, it can be used as an active ingredient in a wrinkle improving agent, for example, to prevent or suppress formation of wrinkles (particularly large wrinkles), and may also be suitably used as a skin whitener that is effective for preventing or suppressing pigmentation including skin spots, freckles and loss of skin clarity.” ([0021]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a cosmetic composition comprising a Platycaladus orientalis (syn. Thuja orientalis) seed extract including water and a thickener, as suggested by MAKOTO, and further to include a cyclic carboxamide derivative such as 1-(2-hydroxyethyl)-2-imidazolidinone for promotion of youthful and healthy looking skin, as suggested by IRIYAMA ([0043]). One skilled in the art would have been motivated to combine the cyclic carboxamide derivative with the composition of MAKOTO because it is generally considered to be prima facie obvious to combine compounds, each of which is taught by the prior art to be useful for the same purpose, in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from the being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the combination of conventional components of topical skin cosmetic compositions. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Kerkhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required on more than an ordinary level of skill to combine a cyclic carboxamide derivative such as 1-(2-hydroxyethyl)-2-imidazolidinone with the cosmetic compositions of MAKOTO. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application Nos. 18/036,755 (claims 1-10, hereafter ‘755); 18/686,007 (claims 1-10, hereafter ‘007); 18/693,158 (claims 1-11, hereafter ‘158); 18/695,084 (claims 1-8, hereafter ‘084); 18/699,486 (claims 1-6, hereafter ‘486); 18/705,975 (claims 1-11, hereafter ‘975); 18/706,991 (claims 11-15, hereafter ‘991); 18/711,955 (claims 1-11, hereafter ‘955); 18/719,582 (claims 1-6, hereafter ‘582); 18/726,477 (claims 1-8, hereafter ‘477); 18/726,502 (claims 1-11, hereafter ‘502); and 18/726,524 (claims 1-10, hereafter ‘524) in view of MAKOTO (WO-2012/057123-A1; published 05/03/2012; English Language machine translation relied on herein).
The instant claims are discussed above.
Each of copending application nos. ‘755, ‘007, ‘158, ‘084, ‘486, ‘975, ‘991, ‘955, ‘582, ‘477, ‘502 and ‘524 claim compositions for topical (external) use comprising a cyclic carboxamide derivative, and particularly 1-(2-hydroxyethyl)2-imidazolidinone (instant claims 1-3, item B).
The difference between the instantly rejected claims and the claims of copending ‘755 is that the claim of copending ‘755 do not expressly claim the inclusion of items (A) a Thuja orientalis seed extract or (C) water, or the amount of 1-(2-hydroxyethyl)2-imidazolidinone.
The difference between the instantly rejected claims and the claims of copending ‘007 is that the claim of copending ‘007 do not expressly claim item (A) a Thuja orientalis seed extract, or the amount of 1-(2-hydroxyethyl)2-imidazolidinone.
The difference between the instantly rejected claims and the claims of copending ‘158 is that the claim of copending ‘158 do not expressly claim item (A) a Thuja orientalis seed extract.
The difference between the instantly rejected claims and the claims of copending ‘084 is that the claim of copending ‘084 do not expressly claim item (A) a Thuja orientalis seed extract.
The difference between the instantly rejected claims and the claims of copending ‘975 is that the claim of copending ‘975 do not expressly claim item (A) a Thuja orientalis seed extract.
The difference between the instantly rejected claims and the claims of copending ‘991 is that the claim of copending ‘991 do not expressly claim the inclusion of items (A) a Thuja orientalis seed extract or (C) water, or the amount of 1-(2-hydroxyethyl)2-imidazolidinone.
The difference between the instantly rejected claims and the claims of copending ‘955 is that the claim of copending ‘955 do not expressly claim item (A) a Thuja orientalis seed extract.
The difference between the instantly rejected claims and the claims of copending ‘582 is that the claim of copending ‘582 do not expressly claim the inclusion of items (A) a Thuja orientalis seed extract or (C) water, or the amount of 1-(2-hydroxyethyl)2-imidazolidinone.
The difference between the instantly rejected claims and the claims of copending ‘477 is that the claim of copending ‘477 do not expressly claim the inclusion of items (A) a Thuja orientalis seed extract or (C) water, or the amount of 1-(2-hydroxyethyl)2-imidazolidinone in mass%.
The difference between the instantly rejected claims and the claims of copending ‘502 is that the claim of copending ‘502 do not expressly claim the inclusion of items (A) a Thuja orientalis seed extract or (C) water, or the amount of 1-(2-hydroxyethyl)2-imidazolidinone in mass%..
The difference between the instantly rejected claims and the claims of copending ‘524 is that the claim of copending ‘524 do not expressly claim the inclusion of items (A) a Thuja orientalis seed extract or (C) water, or the amount of 1-(2-hydroxyethyl)2-imidazolidinone in mass%.
MAKOTO teaches a cosmetic compositions comprising a Platycaladus orientalis (syn. Thuja orientalis) seed extract including water and a thickener, as discussed above and incorporated herein by reference.
Regarding the amount of the cyclic carboxamide derivative such as 1-(2-hydroxyethyl)2-imidazolidinone in the copending claims that do not expressly include the same, it would have been prima facie obvious to optimize the amount in an external (topical) skin cosmetic (MPEP §2144.05-II).
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of copending application nos. ‘755, ‘007, ‘158, ‘084, ‘486, ‘975, ‘991, ‘955, ‘582, ‘477, ‘502 and ‘524 because the each claim compositions for topical (external) use comprising a cyclic carboxamide derivative, and particularly 1-(2-hydroxyethyl)2-imidazolidinone (instant claims 1-3, item B), and it would have been prima facie obvious to include A) a Thuja orientalis seed extract (and (C) water), as suggested by MATOKO for skin effect of improving wrinkles. The skilled artisan would have been motivated to modify the claims of copending application nos. ‘755, ‘007, ‘158, ‘084, ‘486, ‘975, ‘991, ‘955, ‘582, ‘477, ‘502 and ‘524 and produce the instantly rejected claim because in order to produce an improved topical cosmetic skin cosmetic composition. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill to combine the seed extract of MATOKO (and water) with the copending claims to produce a topical cosmetic skin cosmetic composition.
This is a provisional obviousness-type double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. JP-2005-179226-A (inventors Masahiro Ota & Noritoshi Maeda) is cited as teaching methods for extracting a skin-whitening ingredient from Hakushinin (Thuja Orientalis seed); and DE-2746650-A1 (Hinrich Möller) is cited as teaching cosmetics including imidazolidin-2-ones as skin moisturizers. Lee et al. (“Isolation and Purification of Tyrosinase Inhibitors from the Seeds of Thuja orientalis L.,” 2000, Korean J. Postharvest Sci. Technol., Vol. 7, No. 4, pp. 409-413) is cited as teaching methods of extracting chemicals from seeds of Thuja orientalis.
Claims 1-7 are pending and have been examined on the merits. Claims 1-7 are rejected under 35 U.S.C. 103; and claims are provisionally rejected based on obvious-type double patenting over claims of copending Application Nos. 18/036,755; 18/686,00; 18/693,158; 18/695,084; 18/699,486; 18/705,975; 18/706,991; 18/711,955; 18/719,582; 18/726,477; 18/726,502 and 18/726,524. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
1 Of record as cited by Applicant in IDS dated 05/02/2024, citation No. A7.
2 Of record as cited by Applicant in IDS dated 05/02/2024, citation No. A6.