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 .
Status of the Claims
Claims 1-16 are pending.
Priority
This application, filed on 12/20/2024, claims priority to KR application No. 10-2024-0000274, filed on 01/02/2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/20/2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, each of the information disclosure statements is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rho et al (hereinafter “Rho”, WO03027055A1, published 04/03/2003).
Independent claim 1 is directed to a method for protecting skin in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof.
The term “an effective amount” is a relative set of measure in that it is not defined by the claim or the specification to any specific dosage or dosage range for any of the recited active ingredient. Accordingly, for the purpose of examination, an amount of 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, that is employed in order to generate the desired therapeutic outcome, is included in the interpretation of “an effective amount”.
Regarding claim 1, Rho (see e.g., compound Example 4, page 13, lines 20-21 and Experimental Example 5, pages 20-21, Table 7), teaches a method for protecting pig skin from damage caused by UVA radiation, comprising administering 2-methyl-5-(methylethyl)phenyl (2E)-3-(3,4,5-trimethoxyphenyl)-2-propanoate:
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(compound Example 4, see page 13, lines 20-21, which is same compound recited on page 4 of the instant specification), to the pig skin.
Regarding claims 2-4 and 7-10, the recitation of the limitation of the method of claim 1 resulting in: i) inhibiting or preventing skin damage (claim 2); ii) improving skin self-regenerating power (claim 3); iii) repairing DNA damage (claim 4); iv) increase expression of DNA repair genes (claims 7-8); and v) inhibiting expression of aging genes (claims9-10), is not given any patentable weight because each of the clause is simply expressing the intended result of a process positively recited. Please see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003). Since Rho teaches a method of claim 1 (see discussions above), the method of Rho, must necessarily produce the same outcomes of recited in claims 2-4 and 7-10, because each of the recited outcome is a natural process that flows from the subject and the administered 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof. Please see MPEP, 2111.04.
Regarding claims 5-6, Rho teaches UVA radiation (see discussions above).
Regarding claim 11, Rho (see page 20), teaches 1 % (10 g/L) of compound Example 4, which is within the claimed range of “0.01-100 g/L”, recited in claim 11. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03.
Regarding claims 12-13 and 15, Rho teaches a skin external application composition (see discussions above).
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 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rho (WO03027055A1), as applied to claims 1-13 and 15 above, and in view of Yeonsu et al (hereinafter “Yeonsu”, U.S. Pub. No. 20220031648, published 03/03/2022).
The limitations of claims 1-13 and 15, as well as the corresponding teachings of Rho are discussed above, and are hereby incorporated into the instant rejections.
The invention of claims 14 and 16 are similar to claim 1, however, claims 14 and 16 differ slightly from claim in that the claims require: i) food composition (claim 14); and ii) 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, in an amount of 0.01-30 mg/kg/day.
Although Rho is not explicit in disclosing the limitations of claims 14 and 16, the claimed inventions would have been obvious over Rho.
This is because at the time of the instant invention, it was known in the art that 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, can be: i) formulated as food composition; and ii) administered in an amount within the claimed 0.01-30 mg/kg/day. For example, similar to Rho (see discussions above), Yeonsu discloses that a composition comprising 5-methyl-2-propan-2-ylphenyl (E)-3-(3,4,5-trimethoxyphenyl)prop-2-enoate (see ¶ 0024), may be a food, cosmetic or pharmaceutical composition (see ¶ 0015), and administration dosage may be 0.37-37 mg/kg/day (see ¶ 0010), which is within the claimed range of “0.01-30 mg/kg/day”, recited in claim 16. A specific example in the prior art which is within a claimed range anticipates the range. Please MPEP § 2131.03.
Yeonsu similarly relates to use of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, for relieving skin itch or skin irritation in a subject in need thereof (see ¶ 0008).
Accordingly, at the time of the instant invention, a person skilled in the art would have envisaged a method comprising administering 5-methyl-2-propan-2-ylphenyl (E)-3-(3,4,5-trimethoxyphenyl)prop-2-enoate, as a food composition and in a dosage range of 0.37-37 mg/kg/day, in the disclosures of Rho and Yeonsu. One of the ordinary skills in the art would have had a reasonable expectation that the administration of the composition, would, for example, protect the skin.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
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(a). 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. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Nonstatutory 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 18/968,486 (‘486 application) in view of: 1) Rho (WO03027055A1); and 2) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Rho and Yeonsu are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘486 application are similarly drawn to 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method for protecting skin in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, whereas, the claims of the ‘486 application (e.g., claim 1), are directed to a method for promoting hair sprouting or hair growth in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof.
Although the ‘486 application is not explicit in claiming a method for protecting skin, the selection of a method for protecting skin from the ‘486 application embodiment would have been obvious in view of Rho and Yeonsu.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 19/177,888 (‘888 application) in view of: 1) Rho (WO03027055A1); and 2) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Rho and Yeonsu are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘888 application are similarly drawn to 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method for protecting skin in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, whereas, the claims of the ‘888 application (e.g., claim 1), are directed to a method for inhibiting sebum secretion in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof.
Although the ‘888 application is not explicit in claiming a method for protecting skin, the selection of a method for protecting skin from the ‘888 application embodiment would have been obvious in view of Rho and Yeonsu.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 18/917,401 (‘401 application) in view of: 1) Rho (WO03027055A1); and 2) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Rho and Yeonsu are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘401 application are similarly drawn to 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method for protecting skin in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, whereas, the claims of the ‘401 application (e.g., claim 1), are directed to a method for preventing or improving skin aging in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof.
Although the ‘401 application is not explicit in claiming a method for protecting skin, the selection of a method for protecting skin from the ‘888 application embodiment would have been obvious in view of Rho and Yeonsu.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 18/829,496 (‘496 application) in view of: 1) Rho (WO03027055A1); and 2) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Rho and Yeonsu are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘496 application are similarly drawn to 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method for protecting skin in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, whereas, the claims of the ‘496 application (e.g., claim 1), are directed to a method for enhancing skin vitality in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof.
Although the ‘496 application is not explicit in claiming a method for protecting skin, the selection of a method for protecting skin from the ‘496 application embodiment would have been obvious in view of Rho and Yeonsu.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 18/968,486 (‘486 application) in view of: 1) Rho (WO03027055A1); and 2) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Rho and Yeonsu are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘486 application are similarly drawn to 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method for protecting skin in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, whereas, the claims of the ‘486 application (e.g., claim 1), are directed to a method for promoting hair sprouting or hair growth in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof.
Although the ‘486 application is not explicit in claiming a method for protecting skin, the selection of a method for protecting skin from the ‘486 application embodiment would have been obvious in view of Rho and Yeonsu.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent No. 11,583,512 (‘512 patent) in view of: 1) Rho (WO03027055A1); and 2) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Rho and Yeonsu are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘512 patent are similarly drawn to 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method for protecting skin in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, whereas, the claims of the ‘512 patent (e.g., claim 1), are directed to a method for relieving skin itch or skin irritation in a subject in need thereof, with an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof.
Although the ‘512 patent is not explicit in claiming a method for protecting skin, the selection of a method for protecting skin from the ‘512 application embodiment would have been obvious in view of Rho and Yeonsu.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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