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 .
Notice of Priority
This applications claims priority for Korean application KR10-2023-0121927 filed 13 September 2023.
DETAILED ACTION
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 10 September 2024 has been considered by the Examiner.
Claim Status
Claim(s) 1-13 are examined on the merits herein.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim(s) 1 and its dependents, citing reference to “enhancing skin vitality” is interpreted inasmuch as it pertains to not worsening skin vitality, given the term enhancement is relative to a baseline not defined in the specification. Furthermore, “skin vitality” is interpreted as a perceived “brightening” effect as a proxy for skin health, as the term is not defined in the specification.
Claim 3, citing reference to “hydrocortisone” is interpreted inasmuch as it refers to cortisol, as defined by Clegg (Clegg B, Cortisol & Hydrocortisone, 15 June 2015, URL: https://www.chemistryworld.com/podcasts/cortisol-and-hydrocortisone/8647.article)
Claim Rejections - 35 USC § 112
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.
Claim(s) 7-9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 details the composition to be applied to a subject whose mitochondrial activity is decreased. However, the scope of the claim is unclear as the metes and bounds of the “mitochondrial activity is decreased” are unclear. For example, it is uncertain which mitochondrial activity is decreased (ATP production, mitophagy, metabolite production, etc.), as decreases in certain activity (i.e. ATP production) may be observed as increases in other activity (i.e. mitophagy). Claim(s) 8 and 9 are similarly unclear. It also uncertain where in the subject the mentioned processes are decreased, as these processes are uniquely cellular and the subject is composed of multiple cells and in a variate matrix of the human body. Furthermore, “decreased” is a directional term, implying reference to an established baseline that is left undefined in the specification.
Therefore, Claim(s) 7-9 are rejected under 35 U.S.C. 112(b).
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 non-obviousness.
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.
Claim(s) 1-6 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rho et al (Published: 27 July 2006; US 2006/0167093 Al; henceforth Rho), in view of Butani (Published: 22 July 2023; Butani A, The Connection Between Stress & Hyperpigmentation, Anjali MD Skincare, BRIGHTBLOG) and Jeong et al (Filed: 29 July 2021; US 2022/0031648 Al; henceforth Jeong).
Rho teaches method of synthesis and application of trimethoxy cinnamate thymol ester compositions to whiten skin. In doing so, Rho addresses several limitations of the mentioned claims. Claim 1 details a method for enhancing skin vitality, comprising administration of 3,4,5-trimethoxycinnamate thymol ester, and Claim 5 details the compositional fraction of the compound to be within 0.0005 to 1 wt%. In regards to the mentioned claims, and given that “enhancing skin vitality” is interpreted as achieving a “brightening” effect of the skin, Rho meets this limitation by first teaching the Instantly disclosed compound, below:
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where R1 is -CH=CH- and R2 is thymyl [pg. 3; [0031]]. Furthermore, Rho teaches the application of these compounds to human skin and measurement of an “increase of brightness of skin” thereafter by means of depigmentation of UV-induced spots [pg. 6; Experimental Example 2; [0081]]. Further still, Rho teaches an embodiment where the compound is used at 0.01-20.0 wt% [pg. 4; [0043]], and claims these facets in their invention [Cl. 1, Cl. 6], where Cl. 6 details a cosmetic composition as required by Claim 12. Additionally, in teaching Experimental Example 2, Rho also meets the limitation of external application of the composition, as required by Claim 10. Furthermore, in regards to ranges, it is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). However, Rho does not make the connection between skin vitality and various causative factors, such as mitochondrial activity, mitophagy activity, ATP production, or stress hormone activity, nor does Rho teach the use-case formatting of the composition (i.e. food, pharmaceutical) and efficacious dosages.
Butani teaches the effects of stress on skin, with hyperpigmentation being a possible outcome. Claim 2 details the skin vitality enhancement pertaining to, at least, inhibition of stress hormone activity, with Claim 3 further limiting the stress hormone to be cortisol; Claim 6 details the composition to be applied to a subject whose skin vitality is reduced by stress. In regards to Claim 2-3 and 6, Butani teaches that hyperpigmentation can be caused by stress, mechanistically through the release of cortisol, which triggers a series of events that lead to an increase in melanin production, and eventually hyperpigmentation. Additionally, Butani teaches that stress can cause inflammation in the body, which can also contribute to the development of dark spots and uneven skin tone (i.e. decreased skin vitality) [How Stress Can Cause Hyperpigmentation; par. 2].
Jeong teaches similar trimethoxy cinnamate thymol compounds for use in relieving skin irritation, and in doing so, address several further limitation of the Instant invention. Claim 4 details the dosage of the compound to be within 0.001 - 1000 mg/kg. In regards to Claim 4, Jeong meets this limitation by teaching a daily dosage of the compound within 0.37-37 mg/kg [pg. 1; [0010]], and further claims this facet in their invention (Cl. 3). Furthermore, in regards to ranges, it is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Jeong teaches preferred embodiments where the composition is either a food composition or a pharmaceutical composition [pg. 1; [0015]], as required by Claim(s) 11 and 13.
A prima facie case of obviousness can be made for one of ordinary skill in the art to apply the compounds and methods of Rho in treating hyperpigmentation caused by the stress factors taught by Butani, to administer the compounds in dosages and forms taught by Jeong, to arrive at the disclosed invention before the priority date of the Instant application. One of ordinary skill in the art would be motivated to do so provided the mechanistic rationale for hyperpigmentation taught by Butani and ample experimental evidence for both the depigmentation of human skin taught by Rho, and efficacious dosages for skin treatment taught by Jeong. In doing so, one of ordinary skill in the art would be met with a high expectation of success for “enhancing skin vitality” when applying these teachings.
Therefore, Claim(s) 1-6 and 10-13 are rejected under 35 U.S.C. 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 § 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.
Claim(s) 1, 4-5, and 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following reference claim(s) of the following U.S. Patent Applications and Patents:
A. Claim(s) 1 and 5-9 of U.S. Patent Applications No. 19/177888; henceforth ‘888
B. Claim(s) 1-2 and 12-16 of U.S. Patent Applications No. 18/990489; henceforth ‘489
C. Claim(s) 1 and 7-11 of U.S. Patent Applications No. 18/917401; henceforth ‘401
D. Claim(s) 1, 3-4, and 7-10 of U.S. Patent No. US 11,583,512 B2; henceforth ‘512
Claim 1 details a method for enhancing skin vitality via administration of 3,4,5-trimethoxycinnamate thymol ester. In regards to Claim 1, References A-D teach methods of improving skin health, whether through inhibiting sebum secretion [‘888; Claim 1], or protecting skin by inhibiting damage [‘489; Claim(s) 1-2], or preventing/improving skin aging [‘401; Claim 1], or relieving skin itch [‘512; Claim 1] – all via application of a trimethoxycinnamate thymol ester; in the case of ‘512 a reported trimethoxy cinnamate compound. Although the claims at issue are not identical, they are not patentably distinct from each other because the universal treatment of separate deleterious symptoms by nature of applying the compound (i.e. trimethoxycinnamate thymol ester) will, even in its separate parts, contribute to enhancing skin vitality.
Claim 4 details an effective compositional constituency range of 0.001 – 1000 mg/kg for performing the method of Claim 1. In regards to Claim 4, References A-D teach ranges that overlap with the Instantly claimed range, from 0.01 – 10 mg/kg [‘888; Claim 9] to 0.01 – 30 mg/kg [‘489; Claim 16] to 0.37 – 37 mg/kg [‘512; Claim 3] to 0.1 – 1000 mg/kg [‘401; Claim 7]. Although the claims at issue are not identical, they are not patentably distinct from each other given the overlapping ranges.
Claim 5 details an effective dosage range for 3,4,5-trimethoxycinnamate thymol ester to be 0.0005 - 1 wt%. In regards to Claim 5, References A and C-D teach ranges that overlap with the Instantly claimed range, such as 0.001-20 wt % [‘512; Claim 4], 0.1 – 10 wt% [‘401; Claim 8], and 0.01 - 5 wt% [‘888; Claim 5]. Although the claims at issue are not identical, they are not patentably distinct from each other given the overlapping ranges.
Claim 10 details the composition of the method to be purposed for external application. In regards to Claim 10, References A-D each claim this same limitation, for example, as does ‘888 [Claim 6], ‘489 [Claim 12], ‘401 [Claim 10], and ‘512 [Claim 7].
Claim 11 details the composition to be a food composition. In regards to Claim 11, References B-D each claim this same limitation for methods, for example, as does ‘489 [Claim 14], ‘401 [Claim 11], and ‘512 [Claim 8].
Claim 12 details the composition to be a cosmetic composition. In regards to Claim 12, References A-D claim this same limitation for their methods as well, for example, as does ‘888 [Claim7], ‘489 [Claim 13], ‘401 [Claim 9], and ‘512 [Claim 9].
Claim 13 details the composition to be a pharmaceutical composition. In regards to Claim 13, References A-B, and D claim this same limitation for their methods, for example, as does ‘888 [Claim 8], ‘489 [Claim 15], and ‘512 [Claim 10].
The Instant invention, as it pertains to the mentioned claims, is thus found to be patentably indistinct from the mentioned co-pending applications and patents, as each disclosed method describes a similar operation of applying 3,4,5-trimethoxycinnamate thymol ester to a subject in need thereof, for the treatment of perceptibly unhealthy skin.
Therefore, Claim(s) 1, 4-5, and 10-13 are rejected as double patenting.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STANLEY BRAM whose telephone number is (571)272-8779. The examiner can normally be reached 7:30 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee R Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STANLEY BRAM/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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