NON-FINAL REJECTION
This application, filed Oct. 16, 2024, claims benefit of foreign priority to KR 10-2023-0141153, filed Oct. 20, 2023.
Claims 1-11 are pending.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Oct. 16, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Specification
1. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see p. 9, line 13). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. References to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
2. The use of the term MELASOLV, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 U.S.C. § 112(b) – Indefiniteness
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.
1. Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As recognized by MPEP § 2173.05(c)(III), the common phrase "an effective amount" may or may not be indefinite. The proper test is whether or not one skilled in the art could determine specific values for the amount based on the disclosure. See In re Mattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975).
Here, independent claim 1 is drawn to a method for preventing or improving skin aging, comprising administering “an effective amount" of a composition comprising 3,4,5-trimethoxy-cinnamate thymol ester or a stereoisomer, salt, hydrate, or solvate thereof to a subject in need thereof.
However, the specification fails to define or quantify the "effective amount" of the claimed compound that prevents or improves skin aging when administered to a subject in need thereof, as recited by claim 1;
that reduces a cellular senescence biomarker of melanocytes, as recited by claim 2;
wherein the cellular senescence biomarker is β-galactosidase, as recited by claim 3; or that reduces the RNA age of melanocytes, as recited by claim 6.
The specification fails to provide any objective criteria, blood-level targets, minimum efficacy thresholds, or other boundaries that would allow a skilled artisan to determine what amounts or concentrations fall within or outside the claim scope.
Test Examples 2, 3, and 4 present only in vitro data only. Moreover, Test Examples 3 and 4 fail to disclose any amount or concentration of the claimed compound which reduces changes in skin cell morphology caused by UVB, or reduces β-galactosidase in UVB-irradiated melanocytes, respectively. Only Test Example 2 quantifies the amount of the claimed compound which reduces the RNA age of melanocytes in vitro: 10 ppm of MELASOLV.
Thus, the specification provides no accompanying dose-response data or other guidance for determining dosage amounts which produce the claimed cellular effects in vivo. This is insufficient to clearly quantify the dosage range that constitutes an "effective amount."
Because the specification fails to define or quantify the amount of 3,4,5-trimethoxy-cinnamate thymol ester effective to improve skin aging or to achieve the claimed cellular effects, one of ordinary skill in the art would be unable to clearly determine specific effective amount(s). Accordingly, the term "effective amount" renders the metes and bounds of the claims indefinite.
In addition, as recognized by MPEP § 2173.05(g), when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.
MPEP § 2111.04 recognizes that claim scope is not limited by claim language that does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. Giving the claims the broadest reasonable interpretation in light of the specification, the active method step to be carried out is administering an amount of 3,4,5-trimethoxy-cinnamate thymol ester to a subject in need thereof, which in turn may achieve the recited results or effects. Thus, the “wherein” clauses of claims 1-3 and 6 reciting cellular effects simply describe what the active step of administering the claimed compound is supposed to accomplish, and thus fail to further limit the scope of the claims.
"A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited." Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005).
Thus, for examination purposes, the claimed results and/or effects of administering 3,4,5-trimethoxycinnamate thymol ester are construed as intended use limitations and are given no patentable weight.
2. Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Specifically, the claims recite methods of preventing or improving skin aging. However, the specification fails to define the term “skin aging,” or what constitutes an improvement in skin aging. The disclosure provides no objective criteria or clear distinction between signs or symptoms which amount to skin aging, versus features which are not the result of skin aging.
Furthermore, “skin aging” has no unambiguous, broadly accepted definition in the art. As evidenced by, e.g., Wong et al. (cited on PTO-892), “a formally agreed definition of skin aging and its signs is still lacking. There is a rough consensus that skin aging encompasses several phenotypes such as, but not limited to, wrinkling, pigmentation and telangiectasis” (p. 1, ¶ 1).
Given the absence of a definition of “skin aging” in the specification, and the lack of an unambiguous, art-recognized definition of skin aging, infringing activity cannot be clearly distinguished from non-infringing activity, such that the term “skin aging” renders the metes and bounds of the claims indefinite.
For examination purposes, the terms “skin aging” and “improving skin aging” will be given their broadest reasonable interpretation consistent with the specification.
3. Claims 4-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Specifically, claim 4 recites methods of administering the claimed compound to a patient population encompassing subjects “in which melanocytes are flattened or enlarged.” Similarly, claim 5 recites methods of administering the claimed compound to a patient population encompassing subjects “in which β-galactosidase of a melanocyte is activated.”
While it is implicit in Test Examples 3 and 4 that the claimed patient populations encompass subjects who have been exposed to UV-B radiation, e.g., sunlight, the specification provides no objective criteria or guidance as to how to distinguish subjects included by the claims versus those which are excluded. These terms also have no commonly understood and accepted meaning in the art.
Thus, the specification fails to define the claimed subjects so as to clearly circumscribe the patient population encompassed. Because infringing activity cannot be clearly distinguished from non-infringing activity, the metes and bounds of the claims are indefinite.
Claim Rejections - 35 U.S.C. § 112(a) – Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for improving skin aging, does not reasonably provide enablement for preventing skin aging. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with the claims.
MPEP § 2164.01(a), citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), sets out the factors to consider whether experimentation is undue, which are addressed below.
(A) The breadth of the claims. The specification fails to define the term “preventing,” which is given its broadest reasonable interpretation to include any measure taken prior to the development of a condition which precludes its coming into existence, which cannot be predicted or measured with any certainty. “Prevent” connotes an ordered sequence of events in which the intervention is carried out prior to the existence of the condition it is intended to address.
(B) The nature of the invention. The claims are broadly drawn to methods of preventing or improving skin aging. However, all skin has experienced some degree of aging at the time the claimed method is initiated, and thus cannot be prevented.
(C) The level of predictability in the art. The term “prevention” encompasses the complete and absolute absence of the claimed condition(s) which cannot reasonably be achieved with regard to skin aging, or in medicine generally. “Preventing” is tantamount to “curing,” which is unsupported by the disclosure.
(D) The amount of direction provided by the inventor. The specification discloses Test Examples 1-4, which demonstrate that:
(1) the transcriptome patterns of CD-1530, Sirolimus, and Vorinostat, known to have excellent anti-aging effects, were similar to those of MELASOLV (a composition comprising the claimed compound);
(2) the RNA-age of melanocytes treated with MELASOLV decreased by about 4 years;
(3) MELASOLV reduces changes in skin cell morphology caused by UVB irradiation; and
(4) β-galactosidase, an aging indicator, was reduced to a statistically significant degree in melanocytes treated with MELASOLV following UVB irradiation.
However, the specification provides no specific embodiments or working examples in which skin aging is prevented.
(E) The quantity of experimentation needed to make or use the invention. Because "preventing" a condition by the administration of a therapeutic agent cannot be objectively predicted, measured, or achieved with any certainty, coupled with a lack of guidance and direction provided by the instant disclosure, a skilled artisan could not practice the invention commensurate with the full scope of the claims without undue experimentation.
Claim Rejections - 35 USC § 102
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 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.
1. Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (J Cosmet Dermatol. 20: 2851–2859 (2021), cited on PTO-892).
Kim et al. disclose that MELASOLV is a lotion comprising 3,4,5-trimethoxycinnamate thymol ester (TCTE) as the active ingredient, at a concentration of 0.1 wt% (p. 2852, Sec. 2.3). Kim et al. disclose that MELASOLV shows potent depigmenting effect and has been used as a brightening agent in cosmetics for decades (abstract).
Kim et al. disclose that twice-daily application of MELASOLV for 12 weeks to facial skin led to a significant improvement in size, color intensity, and skin brightness in pigmented spot regions. Kim et al. conclude that MELASOLV improves the skin color in pigmented areas with several brightening mechanisms (p. 2858, left col.).
Giving the claims their broadest reasonable interpretation consistent with the specification, “improving skin aging” is construed to encompass skin brightening and/or reduction of pigmentation.
Thus, Kim et al. disclose a method of improving skin aging comprising administering an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester as an active ingredient to a subject in need thereof, as recited by claim 1.
Kim et al. do not explicitly disclose that the administration of MELASOLV reduces cellular senescence of melanocytes, as recited by claim 1; reduces a cellular senescence biomarker of melanocytes, specifically β-galactosidase, as recited by claims 2-3; or reduces the RNA age of melanocytes, as recited by claim 6.
However, by disclosing the administration of an effective amount of 3,4,5-trimethoxy-cinnamate thymol ester to a patient in need thereof to brighten facial skin, the concomitant results, as recited by claims 1-3, are intrinsic in the methods of Kim et al., even if these results was not known or appreciated. As evidenced by, e.g., the instant specification (Test Examples 2-4), carrying out the method of Kim et al. produces the claimed results.
All the molecular and cellular mechanisms by which a compound exerts its therapeutic effects are intrinsic in the methods of Kim et al., and occur each time 3,4,5-trimethoxy-cinnamate thymol ester is administered, regardless of whether those molecular and cellular mechanisms were recognized.
Further, as evidenced by the instant specification (Test Examples 3-4), exposure to UV-B radiation, found in sunlight, causes flattened or enlarged melanocytes, as recited by claim 4, and activates melanocyte β-galactosidase, as recited by claim 5.
As noted above, Kim et al. disclose that MELASOLV is a composition comprising 3,4,5-trimethoxycinnamate thymol ester at a concentration of 0.1 wt%, which reads on the lower endpoint of the range recited by claim 8.
Because this formulation of 3,4,5-trimethoxycinnamate thymol ester was applied to the facial skin of the test subjects twice per day, in an amount effective to achieve a clinical response, it is implicit that the dosage falls within the very broad range of 0.1 to 2000 mg/kg/day, as recited by claim 7.
As noted above, Kim et al. disclose MELASOLV as a cosmetic composition, as recited by claim 9; and for skin external application, as recited by claim 10.
For the foregoing reasons, Kim et al. anticipates claims 1-10.
2. Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rho et al. (WO 2003/027055, cited on PTO-892).
Rho et al. disclose 3,4,5-trimethoxycinnamate thymol ester as the compound of Example 3 (p. 13), formulated as a cream with carriers and excipients (Formulation 3, p. 18, Table 3).
Rho et al. exemplify the administration of the claimed compound in an amount effective to have a whitening effect on human skin (Experimental Example 2, pp. 16-17): twelve human volunteers were irradiated with UVB to induce pigmentation, followed by topical application of a 1% solution of the claimed compound for ten (10) weeks. Results showed excellent whitening effects (Table 2; p. 17, lines 5-8).
Giving the claims their broadest reasonable interpretation consistent with the specification, “improving skin aging” is construed to encompass skin whitening and/or reduction of pigmentation.
Thus, Rho et al. disclose a method of improving skin aging comprising administering an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester as an active ingredient to a subject in need thereof, as recited by claim 1.
Rho et al. do not explicitly disclose that the administration of 3,4,5-trimethoxycinnamate thymol ester reduces cellular senescence of melanocytes, as recited by claim 1; reduces a cellular senescence biomarker of melanocytes, specifically β-galactosidase, as recited by claims 2-3; or reduces the RNA age of melanocytes, as recited by claim 6.
However, by disclosing the administration of an effective amount of 3,4,5-trimethoxy-cinnamate thymol ester to a patient in need thereof to whiten skin, the concomitant results, as recited by claims 1-3, are intrinsic in the methods of Rho et al., even if these results was not known or appreciated. As evidenced by, e.g., the instant specification (Test Examples 2-4), carrying out the method of Rho et al. produces the claimed results.
All the molecular and cellular mechanisms by which a compound exerts its therapeutic effects are intrinsic in the methods of Rho et al., and occur each time 3,4,5-trimethoxy-cinnamate thymol ester is administered, regardless of whether those molecular and cellular mechanisms were recognized.
Further, as evidenced by the instant specification (Test Examples 3-4), exposure to UV-B radiation, found in sunlight, causes flattened or enlarged melanocytes, as recited by claim 4, and activates melanocyte β-galactosidase, as recited by claim 5.
As noted above, Rho et al. disclose a composition comprising 3,4,5-trimethoxycinnamate thymol ester at a concentration of 1%, which falls within the range recited by claim 8.
Because this formulation of 3,4,5-trimethoxycinnamate thymol ester was applied to the skin of the test subjects in an amount effective to achieve a clinical response, it is implicit that the dosage falls within the very broad range of 0.1 to 2000 mg/kg/day, as recited by claim 7.
As noted above, the compositions of Rho et al. are disclosed as cosmetic compositions, as recited by claim 9; and for skin external application, as recited by claim 10.
For the foregoing reasons, Rho et al. anticipates claims 1-10.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (J Cosmet Dermatol. 20: 2851–2859 (2021)) in view of Jeong et al. (US 2022/0031648) (both cited on PTO-892).
Kim et al. disclose that MELASOLV is a lotion comprising 3,4,5-trimethoxycinnamate thymol ester (TCTE) as the active ingredient, at a concentration of 0.1 wt% (p. 2852, Sec. 2.3). Kim et al. disclose that MELASOLV shows potent depigmenting effect and has been used as a brightening agent in cosmetics for decades (abstract).
Kim et al. disclose that twice-daily application of MELASOLV for 12 weeks to facial skin led to a significant improvement in size, color intensity, and skin brightness in pigmented spot regions. Kim et al. conclude that MELASOLV improves the skin color in pigmented areas with several brightening mechanisms (p. 2858, left col.).
Giving the claims their broadest reasonable interpretation consistent with the specification, “improving skin aging” is construed to encompass skin brightening and/or reduction of pigmentation.
Thus, Kim et al. disclose a method of improving skin aging comprising administering an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester as an active ingredient to a subject in need thereof, as recited by claim 1.
Kim et al. do not explicitly disclose that the administration of MELASOLV reduces cellular senescence of melanocytes, as recited by claim 1; reduces a cellular senescence biomarker of melanocytes, specifically β-galactosidase, as recited by claims 2-3; or reduces the RNA age of melanocytes, as recited by claim 6.
However, by disclosing the administration of an effective amount of 3,4,5-trimethoxy-cinnamate thymol ester to a patient in need thereof to brighten facial skin, the concomitant results, as recited by claims 1-3, are intrinsic in the methods of Kim et al., even if these results was not known or appreciated. As evidenced by, e.g., the instant specification (Test Examples 2-4), carrying out the method of Kim et al. produces the claimed results.
All the molecular and cellular mechanisms by which a compound exerts its therapeutic effects are intrinsic in the methods of Kim et al., and occur each time 3,4,5-trimethoxy-cinnamate thymol ester is administered, regardless of whether those molecular and cellular mechanisms were recognized.
Further, as evidenced by the instant specification (Test Examples 3-4), exposure to UV-B radiation, found in sunlight, causes flattened or enlarged melanocytes, as recited by claim 4, and activates melanocyte β-galactosidase, as recited by claim 5.
As noted above, Kim et al. disclose that MELASOLV is a composition comprising 3,4,5-trimethoxycinnamate thymol ester at a concentration of 0.1 wt%, which reads on the lower endpoint of the range recited by claim 8.
Because this formulation of 3,4,5-trimethoxycinnamate thymol ester was applied to the facial skin of the test subjects twice per day, in an amount effective to achieve a clinical response, it is implicit that the dosage falls within the very broad range of 0.1 to 2000 mg/kg/day, as recited by claim 7.
As noted above, Kim et al. disclose MELASOLV as a cosmetic composition, as recited by claim 9; and for skin external application, as recited by claim 10.
Kim et al. differs from the claims in that 3,4,5-trimethoxy-cinnamate thymol ester is not disclosed to be formulated as a food composition, as recited by claim 11.
Jeong et al. disclose and claim methods for relieving skin conditions comprising administering an effective amount of a composition comprising thymol trimethoxycinnamate or a stereoisomer, salt, hydrate or solvate thereof to a subject in need thereof (claim 1).
The structural formulae of the compounds disclosed by Jeong et al. and Kim et al. are shown below, which differ by only one atom:
Jeong et al.
thymol trimethoxycinnamate
Kim et al. (claimed compound)
3,4,5-trimethoxycinnamate thymol ester
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The compositions of Jeong et al. are disclosed as cosmetic compositions, pharmaceutical compositions, for external application to skin, and as a food composition (claims 7-10), as recited by claim 11.
Jeong et al. disclose that the food composition may be formulated into, for example, a tablet, a granule, a pill, a powder, a liquid such as a drink, a caramel, a gel, a bar, a tea bag, etc. Each formulation may contain ingredients commonly used in the art that may be selected by those skilled in the art without difficulty depending on the type of the formulation, purpose of use, etc. in addition to the active ingredient (para. [0041]).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to modify the compositions of Kim et al. by formulating 3,4,5-trimethoxycinnamate thymol ester as a food composition as taught by Jeong et al. with a reasonable expectation of success, because Jeong et al. disclose and claim a compound of very close structural similarity that would be expected to have similar properties and functions, formulated as either a topical composition for external application to skin, or as a food composition, with ingredients and by methods well known and routinely employed by those of ordinary skill in the art.
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.
1. Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/990,489 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims and the examined claims share the identical active step of administering an effective amount of 3,4,5-trimethoxycinnamate thymol ester to treat a skin condition.
The reference claims are drawn to methods for protecting skin, comprising administering to a subject in need thereof an effective amount of a composition including 3,4,5-trimethoxy-cinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof as an active ingredient,
wherein the protecting skin comprises inhibiting or preventing skin damage; improving skin self-regenerative power; repairing DNA damage; increasing the expression of DNA repair genes, including at least one of APEX1, XPA, and RPA1; inhibiting the expression of aging genes, including one or more of P21 and P16;
wherein the damage is caused by at least one of oxidative stress, alkali, drugs, aging, and ultraviolet rays, which are at least one of UVA and UVB;
wherein the composition is a skin external application composition; a cosmetic composition; a food composition, or a pharmaceutical composition;
wherein the 3,4,5-trimethoxycinnamate thymol ester, the stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof is administered at a dosage of 0.01 to 30 mg/kg/day.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 19/177,888 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims and the examined claims share the identical active step of administering an effective amount of 3,4,5-trimethoxycinnamate thymol ester to treat a skin condition.
The reference claims are drawn to methods for inhibiting sebum secretion, comprising
administering to a subject in need thereof an effective amount of a composition including 3,4,5-
trimethoxycinnamate thymol ester, a stereoisomer, pharmaceutically acceptable salt, hydrate,
or solvate thereof as an active ingredient,
wherein the composition is for preventing or improving seborrheic dermatitis, seborrheic scalp dermatitis, folliculitis, acne, or seborrheic eczema; caring for oily skin or an oily scalp; for tightening pores;
wherein the composition is a skin external application composition; a cosmetic
composition; or a pharmaceutical composition;
wherein a daily application amount of the active ingredient is 0.01 to 10 mg/kg.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/968,486 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims and the examined claims share the identical active step of administering an effective amount of 3,4,5-trimethoxycinnamate thymol ester to treat a skin condition.
The reference claims are drawn to methods for promoting hair sprouting or hair growth, comprising administering an effective amount of a composition comprising 3,4,5-trimethoxy-cinnamate thymol ester or a stereoisomer, pharmaceutically acceptable salt, hydrate, or solvate thereof as an active ingredient to a subject in need thereof,
wherein the method promotes the growth of hair length;
wherein the composition is a cosmetic composition; a skin external application composition; a food composition; or a pharmaceutical composition;
wherein the 3.4.5-trimethoxycinnamate thymol ester or the stereoisomer, salt, hydrate, or solvate thereof is administered at a dosage of 0.01 to 10 mg/kg/day.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4. Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/829,496 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims and the examined claims share the identical active step of administering an effective amount of 3,4,5-trimethoxycinnamate thymol ester to treat a skin condition.
The reference claims are drawn to methods for enhancing skin vitality, comprising administering an effective amount of a composition comprising 3,4,5-trimethoxycinnamate thymol ester or a stereoisomer, salt, hydrate, or solvate thereof as an active ingredient to a subject in need thereof,
wherein the skin vitality enhancement comprises at least one of mitochondrial activity enhancement, mitophagy activity enhancement, ATP production enhancement, and stress hormone activity inhibition, wherein the stress hormone is hydrocortisone;
wherein the 3,4,5-trimethoxycinnamate thymol ester or the stereoisomer, salt, hydrate, or solvate thereof is administered at a dosage of 1 μg/kg to 1000 mg/kg;
wherein the concentration of the 3,4,5-trimethoxycinnamate thymol ester or the stereoisomer, salt, hydrate, or solvate thereof is 0.0005 to 1 wt % based on the total weight of the composition;
wherein the composition is applied to a subject whose skin vitality is reduced by stress; whose mitochondrial activity is decreased; whose mitophagy activity is decreased; whose ATP production is decreased;
wherein the composition is a composition for skin external application; a food composition; a cosmetic composition; or a pharmaceutical composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
US Pub. 2019/0041383; Cho. et al. Front. Mol. Biosci. 10:1228640 (Jan. 4, 2024) (both cited on PTO-892).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 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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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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