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
Status of claims
The amendment filed on 01/27/2026 is acknowledged. Claims 1-24 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments, arguments, and terminal disclaimer filed on 01/27/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s terminal disclaimer has overcome the nonstatutory obviousness-type double patenting rejections of claims 1-24 over claims 1-25 of U.S. Patent No. 9,987,325 B2, claims 1-20 of U.S. Patent No. 10,226,503 B2, claims 1-33 of U.S. Patent No. 10,537,548 B2, claims 1-13 of U.S. Patent No. 10,537,605 B2, claims 1-23 of U.S. Patent No. 10,716,824 B2, claims 1-25 of U.S. Patent No. 9,987,325 B2, claims 1-21 of U.S. Patent No. 11,433,034 B2, and claims 1-21 of U.S. Patent No. 12,357,588 B2 from the previous Office Action. The approval of Applicant’s terminal disclaimer has overcome the provisional nonstatutory obviousness-type double patenting rejection of claims 1-24 over claims 1, 5-18, and 23-46 (07/02/2025) of copending Application No. 15/754,363 from the previous Office Action. 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 remained for reasons of record and the following. The rejections are modified based on the amendments.
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 1-8 and 18-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kuhrts (US 2011/0281957 A1) as evidenced by Teslenko (US 2011/0159104 A1) and Bruning et al. (US 2006/0182773 A1).
Kuhrts teaches a method of treating obesity (claims 26-29) in human (paragraph 60) (the instant claim 21) by subcutaneous injection to an anatomically secluded site (the claimed local site in the instant claim 1) (paragraph 63 and 77 and claims 1 and 20)
a water-soluble formulation to be formulated with water/propylene glycol solution (aqueous solution in the instant claim 8 and cosolvent in the instant claim 22) (paragraph 45 and 72) as an emulsion (the claimed resveratrol being encapsulated by a non-ionic surfactant in the instant claim 1 and emulsion being the claimed micelle in the instant claim 1 according to Teslenko paragraph 63) comprising
a mixture of 3 g resveratrol (the instant claims 6, 7, and 18) in 50 mL polyoxyl 40 castor oil (macrogolglycerol hydroxystearate → polyoxyl 40 hydrogenated castor oil, the claimed non-ionic surfactant in the instant claims 1-3) (paragraph 10, 11, 64, 72, example 1, and claims 1 and 13) (1.03 g/mL density of polyoxyl 40 castor oil → the resveratrol to surfactant weight ratio is calculated to be 1:17.17: 3 g : (50 mLx1.03 g/mL) = 1:17.17 (the instant claims 4 and 5);
wherein the formulation is transparent that can be clearly seen through with the naked eye with no particles of undissolved resveratrol visible to the naked eye and light may be transmitted through the transparent water-soluble formulations without diffusion or scattering and forms a transparent water-soluble formulation when added to water (paragraph 32, 40, and 45), i.e., particle size of <100 nm according to Bruning et al. paragraph 2.
Curcumin is not taught by Kuhrts as a component in the water-soluble formulation.
Although Kuhrts is silent about reducing local subcutaneous fat, the dosage form taught by Kuhrts is the same as the claimed, the patient population in need of treatment is the same as claimed, and method of administration is the same as claimed; thus it does not appear that the claim limitations result in a manipulative difference in the method steps when compared to the prior art disclosure and the method taught by Kuhrts would have the same effect of reducing local subcutaneous fat as claimed. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001): “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” And “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 16 U.S.P.Q.2d 1934 (Fed. Cir. 1990)
Kuhrts does not specify the claimed dosage amount in the instant claim 19 and the schedule in the instant claim 20.
This deficiency is cured by Kuhrts’s teachings of dosing regimen depending upon patient condition, pharmacokinetics parameters known in the art, single or multiple administrations of resveratrol formulations can be administered depending on the dosage and frequency as required and tolerated by the patient (paragraph 61-63).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to come up with the dosing regimen based on the teachings in Kuhrts. The person of ordinary skill in the art is a health care provider, pharmacist, or medicinal chemist. The skilled artisan is aware that the appropriate dosaging scheme, including amount of drug in each dose, frequency of dosages, total amount of drug per day, and length of treatment, will vary depending on the subject and the condition to be treated. The person of ordinary skill in the art is a person who knows the relevant art at the time of the invention. MPEP 2141. In the case at hand, the artisan is using a drug that is already known in the art. Holding the precise dosages claimed to be obvious is no more than an acknowledgement that the doctor knows how much drug to give the patient, and that the manufacturer of dosage forms makes them with the appropriate amount of a drug. Additionally, or in the alternative, obviousness is based on the notion that "where the general conditions of a claim are disclosed by the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 20 F.2d 454, 456, 10 USPQ 233, 235 (CCPA 1955). Here, the claimed drug is already known in the art. The art also recognizes what conditions are treatable by the claimed drug. The claimed dosage represents no more than a determination of the workable range or amount of drug for achieving the known effect. Determining optimum dosages is routine in the pharmaceutical arts. Thousands of different drugs are sold to the public by prescription or over the counter, and for each of them, the appropriate or optimal dosage has been determined.
Kuhrts does not specify the same claimed diameters in the instant claims 23 and 24.
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 ranges of micelle diameter are 3-250 nm and 5-50 nm and the range of micelle diameter taught in the prior art is <100 nm and therefor, overlaps with the claimed ranges.
Response to Applicants’ arguments:
Applicants argue that according to Harold et al. and Zhang et al. micelle is different from emulsion and thus the emulsion taught by Kuhrts not the same as the claimed micelle.
However, this argument is not deemed persuasive.
As stated by Harold et al. micelle, emulsion, liposome and lipid nanoparticles are often loosely defined and used interchangeably (abstract) while a micelle in water has hydrophobic tails of surfactants binding together within the core (the section under “A) Micelle” and figure 2) and (o/w) emulsion has hydrophobic tails of surfactants binding with oil to trap the oil within the core and thus is a bloated micelle with oil in the core (the section under “B) Emulsion” and figure 3). Thus, the definitions of Harold et al. are: a micelle does not have content in the core besides the hydrophobic tails of surfactants vs (o/w) an emulsion (droplet) has oil content in the micelle core encapsulated by surfactant.
Fact: oil is not miscible with water and resveratrol is hydrophobic and is not miscible with water and thus would act as oil component in an emulsion.
The micelles recited in the instant claims encapsulate (trap) hydrophobic resveratrol (non-water miscible) and the instant specification defines “micelle” and “drug-containing micelles” on page 3 last paragraph and page 4 in 1st paragraph:
“micelle” refers to a microstructure formed by surfactants, wherein each of the surfactants has a hydrophilic end and a hydrophobic (lipophilic) end, and the surfactants are arranged in a way that the hydrophilic ends face outward and the hydrophobic (lipophilic) ends face inward to form the microstructure. In some embodiments, the microstructure is a spherical structure, a spherical-like structure, or other microstructural structures.
In the present disclosure, the term “drug-containing micelles” refer to micelles containing resveratrol; that is, the term “drug-containing micelles” refer to micelles encapsulating or containing resveratrol.
And on page 8, 2nd full paragraph
In some embodiments, the pharmaceutical composition disclosed herein further comprises an oil phase excipient to enhance the stability of the pharmaceutical composition and the solubility of the drug. In some examples, the oil phase excipient may include unsaturated fatty acid, glycerol, triglyceride, and other oil phase excipient, or a combination thereof. In some examples, the unsaturated fatty acid may comprise oleic acid, castor oil, sesame oil, cottonseed oil, soybean oil, safflower oil, corn oil, and other unsaturated fatty acid, or a combination thereof. In some examples, the triglyceride may comprise medium chain triglycerides and other triglyceride, or a combination thereof.
Thus, the claimed micelles comprising resveratrol encapsulated by surfactant micro-structure are not the micelles defined by Harold et al. but actually the emulsion defined by Harold et al. with micelles trap resveratrol (as hydrophobic and non- water miscible component) and oil (the instant claim 22) in the core, and are loosely recited in the instant claims and defined as micelles in the instant specification according to the definitions of Harold et al.
Claims 9-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kuhrts (US 2011/0281957 A1) as evidenced by Teslenko (US 2011/0159104 A1) and Bruning et al. (US 2006/0182773 A1), as applied to claims 1-7 and 18-24, in view of Park et al. (US 2012/00521338 A1) and Kuhrts (US 2015/0182625 A1).
The teachings of Kuhrts (US 2011/0281957 A1) are discussed above and applied in the same manner. Kuhrts (US 2011/0281957 A1) teach the composition comprising other compatible therapeutic agents (paragraph 82). The formulation comprising 1-25 mg of resveratrol (claim 9).
Kuhrts (US 2011/0281957 A1) do not specify the other compatible therapeutic agents being the claimed in the instant claims 9-17.
This deficiency is cured by Park et al. who teach subcutaneous injecting 0.5-1500 mg/kg/day) (the amount of green tea extract for a 100 kg person would be 50-150,000 mg/day) green tea extract (which contains the claimed epigallocatechin gallate and quercetin in the instant claims 9-11, 13, 14) for treating obesity; wherein the green tea extract contains 10-15% by weight of epigallocatechin gallate (EGCG) (abstract and paragraph 24, 33, 37, and 38) and Kuhrts (US 2015/0182625 A1) who teach methods for increasing the water solubility and/or bioavailability of a lipophilic natural compounds including epigallocatechin gallate and quercetin with a non-ionic surfactant including polyoxyl 40 castor oil (macrogolglycerol hydroxystearate, i.e., polyoxyl 40 hydrogenated castor oil) in clear injectable formulations and exemplified in example 5 a composition comprising 3.3% by weight of EGCG (abstract, paragraph 21, 26, 27, 69, and claims 1, 4, 23-25, 28-31, and 34). The ratio between 25 mg of resveratrol taught by Kuhrts (US 2011/0281957 A1) and 50 mg green tea extract is calculated to be 1:2 which is within the claimed 30:1 - 1:20 (1: 0.033-20) in the instant claims 12, 15, and 17. The amount of EGCG in 1 mL composition is calculated to be about 33 mg/mL (the instant claim 16) assuming the density of the composition being about 1 g/mL
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Kuhrts (US 2011/0281957 A1), Park et al., and Kuhrts (US 2015/0182625 A1) to specify the other compatible therapeutic agents in the composition taught by Kuhrts (US 2011/0281957 A1) being the claimed in the instant claims 9-17. Subcutaneous injecting green tea extract for treating obesity and the water solubility and/or bioavailability of green tea extract in clear injectable formulations being increased with polyoxyl 40 hydrogenated castor oil are well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Argument regarding the 103 rejection is basically the same as the above rejection, thus the response discussed above applies here as well and is not persuasive for reason discussed above.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-24 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of copending Application No. 18/317,564, and claims 1-17 of copending Application No. 18/466.003.
Although the copending Applications and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same method.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments:
Applicant states that the provisional obviousness-type double patenting rejections be held in abeyance until the claims have been allowed. Until that time the claims must remain rejected.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG YU/
Primary Examiner, Art Unit 1614
Prosecution Insights