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 .
DETAILED ACTION
Claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims foreign priority to KR 10-2023-00068217 filed on 5/26/2023. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 6/12/2024.
Information Disclosure Statement
The information disclosure statements (IDS) dated 5/14/2024 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kan et al. (J. Funct. Foods, 2020, PTO-892).
Kan discloses a composition, derived from peach peel extracts (PPE), comprising quercetin-3-glucoside (a.k.a. isoquercitrin, IQC) and gallocatechin gallate (GCG), with a IQC:GCG weight ratio of 1:3. (Table 1) Kan also discloses that the PPE was formulated as a pharmaceutical or food composition. (Sec. 2.1-2.4) Kan further discloses that the PPE extract is effective to regulate lipid metabolism, which in turn is expected to be effective for treating metabolic disorders such as obesity, steatosis, non-alcoholic fatty liver disease (NAFLD), cardiovascular diseases, insulin resistance, hypertension and atherosclerosis. (Sec. 1, Sec. 4)
With respect to claims 4-9, it is noted that the combined prior art does not teach administration of the composition to a subject in need of the claimed modulations, or the claimed administered dosages. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed 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.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 4-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (Separations, 2022, PTO-892).
Song discloses a composition, derived from Camellia japonica extracts (CJE), comprising isoquercitrin (IQC) and gallocatechin gallate (GCG), with a GCG:IQC weight ratio range of 1:2 to 1:25. (Table 3)
With respect to claims 4-9, it is noted that the combined prior art does not teach administration of the composition to a subject in need of the claimed modulations, or the claimed administered dosages. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed 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.
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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 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.
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 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 11, 12, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kan et al. (J. Funct. Foods, 2020, PTO-892).
The disclosure of Kan is referenced as discussed above. Kan does not teach a IQC:GCG ratio of 1:2.2 to 1:2.8 and does not exemplify a method of treating the claimed conditions.
With respect to claim 12, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Kan would be effectively used in treating obesity or other metabolic disorders because Kan suggests that the regulation of lipid metabolism exemplified by the PPE extract would be expected to be effective for treating metabolic disorders such as obesity, steatosis, non-alcoholic fatty liver disease (NAFLD), cardiovascular diseases, insulin resistance, hypertension and atherosclerosis.
With respect to claim 11 and 20, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the ratio of 1:3 exemplified by Kan is close enough to 1:2.8 to have a reasonable expectation of equivalent results. The disclosure of Kan, while not explicitly overlapping the instant ratio, is considered sufficiently close to the instantly claimed ratio such that absent evidence to the contrary, one of ordinary skill in the art would reasonably expect the composition of Kan to have similar properties to the instant composition. It is held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (MPEP § 2144.05)
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 1-12 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Orikoshi et al. (US 2022/0079967A1, March 2022, PTO-892), in view of Kim et al. (US 11,266,706 B2; pub 2019, PTO-892).
Orikoshi et al. discloses a composition comprising isoquercitrin, where the composition is used in a method of improving vascular endothelial function by administering the isoquercitrin composition at a dose of 1.0-50 mg/kg. (Claims 6-10) Orikoshi discloses that the vascular endothelial function improvement composition can specifically be used to treat diabetes, hypertension, dyslipidemia, metabolic syndrome, obesity, insulin resistance, impaired glucose tolerance, diabetic peripheral neuropathy, diabetic nephropathy, diabetic retinopathy, diabetic macroangiopathy, cardiovascular disease, atherosclerosis, heart failure, myocardial infarction, coronary artery disease, and cerebrovascular disease. (¶0107) Orikoshi also discloses that the composition may be formulated as a pharmaceutical composition or a food. (¶0022, 0060)
Orikoshi does not teach a composition comprising isoquercitrin and gallocatechin gallate.
Kim et al. discloses a green tea extract composition comprising 1-5 wt% of gallocatechin gallate (GCG) based on the total weight of the composition. (Example 1 and 5; Col. 2; Claim 1) Kim teaches methods for prevention or alleviation of lipid metabolism disorders including obesity, hyperlipidemia, and fatty liver, comprising administering a green tea extract (Claim 8). Kim exemplifies an extract dosage of 150 mg/kg, which equates to 15-75 mg/kg GCG per dose. (Col. 12)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Orikoshi and Kim and formulate a composition comprising isoquercitrin and gallocatechin gallate, used in a method of treating conditions including obesity, metabolic disorders or reducing body fat. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see also MPEP § 2144.06(I))
With respect to claims 4-9, it is noted that the combined prior art does not teach administration of the composition to a subject in need of the claimed modulations, or the claimed administered dosages. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed 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.
With respect to claim 12, it is obvious that the composition of Orikoshi/Kim would be effectively used in treating obesity or other metabolic disorders because Orikoshi and Kim independently teach that isoquercitrin and GCG are effective for treating metabolic disorders such as obesity, hyperlipidemia, and fatty liver.
With respect to claims 1, 8-11 and 17-20, the dosages and weight ratios overlap or lie inside the ranges disclosed or suggested by Orikoshi/Kim. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kan et al. (J. Funct. Foods, 2020, PTO-892), or in the alternative, over Orikoshi et al. (US 2022/0079967A1, March 2022, PTO-892), in view of Kim et al. (US 11,266,706 B2; pub 2019, PTO-892), further in view of Choe et al. (US 2016/0257728A1, PTO-892).
The disclosure of Kan or Orikoshi/Kim is referenced as discussed above. The cited prior art does not teach treating a subject in need of modulation of the claimed genes, increasing mitochondria in adipocytes or increasing brown fat.
Choe et al. discloses that obesity or obesity related disorders (e.g. dyslipidemia, liver disease) are correlated with decreased amount of brown fat, where brown fat is characterized by increased numbers of mitochondria, as well as modulation of expression of the genes FAS and UCP1. (¶0009, 0066-0069)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the obese subjects of Kan or Orikoshi/Kim would be subject in need of modulation of FAS and/or UCP1 or increasing the amount of brown fat, which would in turn increase the number of mitochondria in adipocytes, due to brown fat inherently having greater number of mitochondria. The obviousness of the needs of the obese subject population is demonstrated by the disclosure of Choe.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior 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 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.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
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 12-20 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of copending application 18/823345. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The method steps described in the instant application are directed to treating metabolic disorders, where the method of treating a liver disease claimed in ‘345, is an obvious variant by falling within the genus of metabolic disorders.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 12-20 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of copending application 18/883178. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The method steps described in the instant application are directed to treating metabolic disorders, where the method of controlling blood sugar claimed in ‘178, is an obvious variant due to diabetes being directly linked to blood sugar control and diabetes falling within the genus of metabolic disorders.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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