DETAILED ACTION
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 .
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.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kan et al. (J. Funct. Foods, vol. 72, 2020, pp. 12 pages - see PTO-892).
The claims of the present application are drawn to methods of controlling blood sugar comprising administering an effective amount of gallocatechin gallate (GCG) and isoquercitrin (IQC). Dependent claims provide for various ratios, and the various activities the subject being treated needs, such as the subject needs to decrease glucogenesis in liver cells; reduce expression of glucogenesis-related genes, etc., and also wherein the method is for preventing or treating diabetes, diabetic complications, or sugar metabolism diseases.
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 about 1:3. (Table 1) which reads on the present compositions being administered. 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)
Kan does not exemplify a method of lowering blood sugar and/or treating the claimed conditions.
However, 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 controlling blood sugar and in turn treating diabetes and related sugar metabolism diseases because Kan suggests that the regulation of lipid metabolism exemplified by the same composition claimed herein 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.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zhang et al. (RSC Advances, vol. 27(8), April 19, 2018, pp. 14967-14974) and Wu et al. (Journal of Functional Foods, vol. 48, 2018, pp 200-209).
The claims of the present application are drawn to methods of controlling blood sugar comprising administering an effective amount of gallocatechin gallate (GCG) and isoquercitrin (IQC). Dependent claims provide for various ratios, and the various activities the subject being treated needs, such as the subject needs to decrease glucogenesis in liver cells; reduce expression of glucogenesis-related genes, etc., and also wherein the method is for preventing or treating diabetes, diabetic complications, or sugar metabolism diseases.
Zhang teach methods of inhibiting DPP-4 and increasing GLP-1 and insulin, and reducing fasting glucose and glucose excursions in a diabetic mouse model with IQC. The results showed that IQC significantly inhibited postprandial blood glucose changes in a dose-dependent manner and that IQC has hypoglycemic effects (see abstract and discussion). What is not taught is to add GCG into the compositions herein.
Wu teaches that that GCG has inhibitory activity on α-amylase and α-glucosidase and is useful to efficiently control postprandial glucose levels and has potential as a dietary supplement for the treatment of diabetes (see conclusions and abstract).
It would have been obvious to one of skill in the art at the time of the invention to combine IQC of Zhang and GCG of WU in a new composition to control blood sugar and treat diabetes with these references before them. 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. The 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). (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Regarding claims 3-8 herein which limit various subjects herein, these would all be obvious as the art teaches the individual drugs are effective in controlling and lowering blood sugar levels, thus this combination would be obvious in all of the populations claimed since the activity occurring would be expected to occur in the different sub-populations.
With respect to the weight ratios, these would be seen to be well within the purview of a skilled artisan, differences in concentration 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.
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.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-20 of copending Application No. 18/663,736 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are drawn to substantially overlapping and obvious subject matter. ‘736 is drawn to treating various diseases such as improving or treating metabolic diseases, which the present claims are drawn to (see claim 9 herein) with the same compositions. As such, a skilled artisan would see they are substantially overlapping.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
