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 .
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 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.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/14/2026 was filed after the mailing date of the final rejection on 10/07/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of claims
Claims 2-4 and 19-22 have been canceled and claims 18 and 23-43 have been withdrawn. Claims 1, 5-17, and 44-46 are under examination in the instant office action.
Rejections withdrawn
Applicant’s arguments and affidavit filed on 05/12/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are maintained for reasons of record and the following.
The amendment filed 04/22/2022 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: although the group 1 data in table 1 is scientifically impossible (1000 mg of resveratrol and 1000 mg of ELP in 1 g of final product), there is no factual support that the final concentration of resveratrol in the final composition is 500 mg/g in table 1 since components other than resveratrol and ELP can be in the final composition while the instant specification (the clean copy filed on 05/24/2021) supports the final concentration of resveratrol in the final composition being 1000 mg/g in paragraph 367.
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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, 5-17, and 44-46 are rejected under 35 U.S.C. 103(a) as being unpatentable over Berl (US 2012/0088829 A1).
Berl teaches stabilized aqueous formulations comprising
at least 5% by weight (50 mg/mL) of bioactive including ubiquinol ester/diester, resveratrol ester, resveratrol, etc., or mixture and a 2nd lipophilic bioactive molecule such as ubiquinone or ubiquinone ester/diester with the weight ratio between ubiquinol ester/diester or resveratrol ester to 2nd lipophilic bioactive molecule being 50:50, and
a micelle-forming surfactant (also solubilizing agent) including Cremophor RH 40 (PEG-40 hydrogenated castor oil), etc.,
stabilizers including flavonoids such as EGCG and green tea extract
with the bioactive to surfactant being about 1:0.3-20 and ubiquinol ester/diester or resveratrol ester to stabilizer weight ratio of about 1:3; (entire reference, especially abstract, paragraph 19, 43, 44, 47, 59, 61, 63, 90, 123, 136, 141, 142, 145, 151, 152, and 153). Unsaturated fatty acid is not recited as a must have component. The [EGCG] is calculated to be 150 mg/mL based on 5% by weight of resveratrol ester or resveratrol.
Unsaturated fatty acids and triglycerides are not taught by Berl as a must have component while according to the instant specification inclusion of unsaturated fatty acids and triglycerides, as preferred embodiment, i.e., the criticality of micelle not containing unsaturated fatty acids and triglycerides is not established.
Glycerol is not taught by Berl as a must have component (new claim 45) while according to the instant specification glycerol is a suspending agent in a preferred embodiment, i.e., the criticality of micelle not containing glycerol is not established.
With respect to the art rejection above, it is noted that the reference does not teach that the composition can be used in the manner instantly claimed, [for subcutaneous injection and for reducing localized fat]; however, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Berl does not specify the same 1st and 2nd surfactant (PEG-40 hydrogenated castor oil vs the claimed polyoxyl 35 castor oil (PEG-35 hydrogenated castor oil)).
This deficiency is cured by the rationale that chemical compounds having “very close” structural similarities and similar utilities, without more a prima facie case may be made.
It would have been prime facie obvious at the time of the invention to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace PEG-40 hydrogenated castor oil taught by Berl with PEG-35 hydrogenated castor oil. Analogs differing only in the number of repeating units are prima facie obvious, and require no secondary teaching. An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties. The difference between the prior art and the instant application is the presence of PEG-40 versus PEG-35, and both of the compounds are used for the same utility: as surfactant with an HLB>10. Thus, the skilled artisan would reasonably expect success in this substitution. Furthermore, any polyoxyethylene castor oil with HLB>10 was claimed as suitable (dated 04/22/2022) and thus the criticality of the claimed PEG-35 hydrogenated castor oil over PEG-40 hydrogenated castor oil taught by Berl is not established. According to MPEP 2144.09.II:
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Berl does not specify the same resveratrol ester to stabilizer weight ratio.
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed resveratrol to surfactant weight ratio is 1:10-500 and the resveratrol ester to solubilizing agent (surfactant) weight ratio taught in the prior art is about 1:0.3-20, and therefore, overlaps with the claimed range.
Berl does not specify different bioactives in separate micelles, i.e., 1st micelles and 2nd micelles as recited in the instant claim 9.
This deficiency is cured by rearranging old elements is a prima facie case of obviousness when old elements in the prior art perform the same function as the now claimed structures.
Berl exemplified different bioactives being mixed before the formation of micelle, i.e., different bioactives are in the same micelles while the instant claim 9 recites 2nd lipophilic being in 2nd micelles with resveratrol in the 1st micelles; however, whether the bioactives being in the same micelles and different micelles do not change the function of the bioactives, i.e., being bioactives and thus is obvious.
Response to Applicants’ arguments:
Applicant’s arguments based on the affidavit are addressed in the Response to applicants’ 37 CFR 1.132 declaration below.
Response to applicants’ 37 CFR 1.132 declaration:
The affidavit under 37 CFR 1.132 filed 05/12/2026 does provide the missing information for a meaningful analysis of the experimental results in the instant specification. However,
first, the concentration of RES in the final product of groups 1-9 in table 1 in the instant specification is inconsistent with table 1 and 2 in the affidavit and thus the concentrations of RES in the final product in table 1 in the instant specification is incorrect which results in a 112(a) rejection below; and
second, the experimental results in table 1 and 2 in the affidavit are insufficient to overcome the rejection of pending claims as set forth in the last Office action because: RES:ELP ratio is not the only variable in table 2 in the affidavit, rather, the concentrations of RES, ELP, or mixture of RES+ELP relative to the final product and relative to water in groups 1-9 in table 2 in the affidavit are all variables, thus a person or ordinary skill in the art can’t determine whether RES:ELP ratio or any of the concentrations of RES, ELP, or mixture of RES+ELP relative to the final product and relative to water, respectively, is the variable that is a contributing factor for the particle sizes in table 2.
New ground of rejection
The affidavit files on under 37 CFR 1.132 filed 05/12/2026 necessitates the following new ground of rejection.
Claim Rejections - 35 USC § 112
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.
Claims 1, 5-17, and 44-46 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Table 1 in the specification as filed contains incorrect final concentrations of RES in groups 1-9 as evidenced by table 1 in the affidavit filed on 05/12/2026.
New ground of rejection
Upon reconsideration the following new ground of rejection is applied.
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, 8, 13, and 44-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landers et al. (US 2005/0137147 A1).
Landers et al. meet all of the limitations of claims 1. Landers et al. disclose compositions in form of emulsion (including micelles, the instant claim 1) (paragraph 49) for injection (the instant claims 1 and 44) (paragraph 47 and claim 8) and exemplified in paragraph 51 a composition comprising
0.001% by weight of agent stimulating Nrf2 protein nuclear translocation;
0.1% by weight of Cremophor EL (Polyoxyl 35 castor oil, the claimed component a in the instant claim 1);
disodium EDTA (the hydrophilic drug in the instant claim 13); and
water (the instant claim 8);
wherein agent stimulating Nrf2 protein nuclear translocation includes resveratrol the claimed component b the instant claim 1) (paragraph 24 and 26).
No unsaturated fatty acids and triglycerides is included (the instant claim 1).
No glycerol is included (the instant claim 45).
No oil phase excipient is included (the instant claim 46).
The weight ratio between resveratrol and Cremophor EL is calculated to be 1:100 (0.1%:0.001%=100:1) (within the claimed 1:10-500 in the instant claim 1.
With respect to the art rejection above, it is noted that the reference does not teach that the composition can be used in the manner instantly claimed, [for subcutaneous injection and for reducing localized fat in the instant claims 1 and 44]; however, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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