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 1-8 are pending.
Priority
This application, filed on 12/04/2024, claims priority to KR application No. 10-2023-0174413, filed on 12/05/2023. 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 § 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 1-2, 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ko et al (hereinafter “Ko”, J. Dermatological Science, 2022, 106, 12-20) in view of: 1) Won et al (hereinafter “Won”, J. Invest. Dermatology, 2012, 132, 2849-2851); and 2) Park et al (hereinafter “Park”, Int. J. Molecular Sciences, 2019, 20, 1859, 1-10).
Independent claim 1 is 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.
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 claims 1-2, 4-5 and 7, Ko discloses that 3,4,5-Trimethoxycinnamate thymol ester (TCTE):
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(applicants’ compound recited on page 4 of the instant specification), an anti-melanogenic cosmetic agent prescribed currently, promotes adiponectin synthesis (see e.g., abstract and Figure 1).
Although Ko is not explicit in disclosing a method for promoting hair sprouting or hair growth, the claimed inventions would have been obvious over Ko.
This is because at the time of the instant invention, it was known in the art that adiponectin is an established therapeutic target for promoting hair growth. For example:
1) Won teaches hair growth-promoting effects of adiponectin (see e.g., abstract, Figures 1-2 and discussions therein).
2) Park teaches a method for increasing adiponectin expression and corresponding adiponectin-induced hair growth factors in human dermal papilla cells, comprising administering 3,4,5-Trimethoxycinnamate esters such as KCED-1:
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(see e.g., abstract, Figures 1-6 and discussions therein).
Accordingly, at the time of the instant invention, a person skilled in the art would have envisaged a method for promoting hair sprouting or hair growth in a subject in need thereof, with TCTE, in the disclosures of Ko, Won and Park. One of the ordinary skills in the art would have had a reasonable expectation that the administration of the composition comprising TCTE to a subject in need of hair sprouting or hair growth, would, for example, hair growth in the subject.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ko (J. Dermatological Science, 2022) in view of: 1) Won (J. Invest. Dermatology, 2012); and 2) Park (Int. J. Molecular Sciences, 2019), as applied to claims 1-2, 4-5 and 7 above and further in view of Yeonsu et al (hereinafter “Yeonsu”, U.S. Pub. No. 20220031648, published 03/03/2022).
The limitations of claims 1-2, 4-5 and 7, as well as the corresponding teachings of Ko and Won are discussed above and are hereby incorporated into the instant rejections.
The invention of claims 3, 6 and 8 are similar to claim 1, however, claims 3, 6 and 8 differ slightly from claim in that the claims require: i) 3,4,5-trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof, in an amount of 0.1-100 g/L (claim 3) or 0.01-10 mg/kg/day (claim 8); and ii) food composition (claim 6).
Although Ko and Won do not combine to explicitly disclose the limitations of claims 3, 6 and 8, the claimed inventions would have been obvious over Ko and Won.
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 0.1-100 g/L or 0.01-10 mg/kg/day. For example, similar to Ko and Won (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). In an exemplary embodiment, a content of the thymol trimethoxycinnamate or a stereoisomer, salt, hydrate or solvate thereof may be 0.001-20 wt % (0.01-200 g/L), based on the total weight of the composition (see ¶ 0032).
The claimed 0.1-100 g/L or 0.01-10 mg/kg/day (claims 3 and 8), overlap or lie inside ranges disclosed by the prior art (see discussions above).
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP § 2144.05).
In the instant case, because the claimed 0.1-100 g/L or 0.01-10 mg/kg/day, overlaps or lies inside ranges disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
In the instant case, it is noted that no criticality (emphasis added) has been demonstrated in the specification regarding the claimed 0.1-100 g/L or 0.01-10 mg/kg/day (claims 3 and 8).
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 0.01-200 g/L or 0.37-37 mg/kg/day, in the disclosures of Ko, Won 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, increase adiponectin expression and stimulate hair growth.
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 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 18/990,489 (‘489 application) in view of: 1) Ko (J. Dermatological Science, 2022); 2) Won (J. Invest. Dermatology, 2012); 3) Park (Int. J. Molecular Sciences, 2019); and 4) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Ko, Won, Park 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 ‘489 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 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, whereas, the claims of the ‘486 application (e.g., claim 1), are 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.
Although the ‘489 application is not explicit in claiming a method for promoting hair sprouting or hair growth, the selection of a method for promoting hair sprouting or hair growth from the ‘489 application embodiment would have been obvious in view of Ko, Won, Park 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 1-8 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) Ko (J. Dermatological Science, 2022); 2) Won (J. Invest. Dermatology, 2012); 3) Park (Int. J. Molecular Sciences, 2019); and 4) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Ko, Won, Park 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 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, 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 promoting hair sprouting or hair growth, the selection of a method for promoting hair sprouting or hair growth from the ‘888 application embodiment would have been obvious in view of Ko, Won, Park 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 1-8 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) Ko (J. Dermatological Science, 2022); 2) Won (J. Invest. Dermatology, 2012); 3) Park (Int. J. Molecular Sciences, 2019); and 4) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Ko, Won, Park 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 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, 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 promoting hair sprouting or hair growth, the selection of a method for promoting hair sprouting or hair growth from the ‘888 application embodiment would have been obvious in view of Ko, Won, Park 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 1-8 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) Ko (J. Dermatological Science, 2022); 2) Won (J. Invest. Dermatology, 2012); 3) Park (Int. J. Molecular Sciences, 2019); and 4) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Ko, Won, Park 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 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, 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 promoting hair sprouting or hair growth, the selection of a method for promoting hair sprouting or hair growth from the ‘496 application embodiment would have been obvious in view of Ko, Won, Park 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 1-8 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) Ko (J. Dermatological Science, 2022); 2) Won (J. Invest. Dermatology, 2012); 3) Park (Int. J. Molecular Sciences, 2019); and 4) Yeonsu (U.S. Pub. No. 20220031648).
The corresponding teachings of Ko, Won, Park 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 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, 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 promoting hair sprouting or hair growth, the selection of a method for promoting hair sprouting or hair growth from the ‘512 application embodiment would have been obvious in view of Ko, Won, Park 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.
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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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