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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 10 June 2025, in which claims 1, 8, and 10 are amended to change the scope and breadth of the claim, and claims 5-7 are canceled.
This application is the national stage entry of PCT/CN2020/105728, filed 30 July 2020, and claims benefit of foreign priority document CHINA 201910741989.4, filed 12 Aug 2019; this foreign priority document is not in English.
Claims 1-4 and 8-10 are pending in the current application and are examined on the merits herein.
Objections Withdrawn
Applicant’s amendment, filed 10 June 2025, with respect that claim 1 is objected to because of informalities has been fully considered and is persuasive, as amended claim 1 is in a form having proper grammar.
This objection has been withdrawn.
Rejections Withdrawn
Applicant’s amendment, filed 10 June 2025, with respect that claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter has been fully considered and is persuasive, as amended claim 10 does not recite a “use” claim.
This rejection has been withdrawn.
Applicant’s amendment, filed 10 June 2025, with respect that claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter has been fully considered and is persuasive, as amended claim 10 does not recite a “use” claim.
This rejection has been withdrawn.
The terminal disclaimer, filed 10 June 2025, with respect that claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,679,097 in view of Baron et al. (US 2012/0177730, published 12 July 2012, of record) and Simonson et al. (Diabetes Care, 1997, 20(4), p597-606, of record) has been fully considered and is persuasive, as the terminal disclaimer is recorded.
This rejection has been withdrawn.
The terminal disclaimer, filed 10 June 2025, with respect that claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 17/633,824 in view of Baron et al. (US 2012/0177730, published 12 July 2012, of record) and Simonson et al. (Diabetes Care, 1997, 20(4), p597-606, of record) has been fully considered and is persuasive, as the terminal disclaimer is recorded.
This provisional rejection has been withdrawn.
The terminal disclaimer, filed 10 June 2025, with respect that claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 17/633,850 in view of Baron et al. (US 2012/0177730, published 12 July 2012, of record) and Simonson et al. (Diabetes Care, 1997, 20(4), p597-606, of record) has been fully considered and is persuasive, as the terminal disclaimer is recorded.
This provisional rejection has been withdrawn.
The terminal disclaimer, filed 10 June 2025, with respect that claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 17/633,951 in view of Baron et al. (US 2012/0177730, published 12 July 2012, of record) and Simonson et al. (Diabetes Care, 1997, 20(4), p597-606, of record) has been fully considered and is persuasive, as the terminal disclaimer is recorded.
This provisional rejection has been withdrawn.
The terminal disclaimer, filed 10 June 2025, with respect that claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 17/633,712 in view of van Baar et al. (Diabetes Care, 2018, 41, p1543-1556, of record), Baron et al. (US 2012/0177730, published 12 July 2012, of record) and Simonson et al. (Diabetes Care, 1997, 20(4), p597-606, of record) has been fully considered and is persuasive, as the terminal disclaimer is recorded.
This provisional rejection has been withdrawn.
The following are new or modified grounds of rejection necessitated by Applicant’s amendment, filed 10 June 2025, in which claims 1, 8, and 10 are amended to change the scope and breadth of the claim, and claims 5-7 are canceled.
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.
Amended Claims 1-4 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Baron et al. (US 2012/0177730, published 12 July 2012, of record) in view of Horiba (US 2017/0165310, published 15 June 2017, of record) and Simonson et al. (Diabetes Care, 1997, 20(4), p597-606, of record).
Baron et al. teaches chemosensory receptor ligand compositions, including bitter receptor ligand compositions, for use in treating conditions including diabetes (abstract; page 2, paragraph 8). In one aspect of the invention, the compositions described comprise a bitter receptor ligand such as a limonoid aglycone (page 59, paragraph 400). Exemplary bitter phytonutrients in common plant foods that can be bitter receptor ligands are listed in the table spanning pages 67-69 and include limonoids such as limonin, nomilin, and limonin glucoside (paragraph 521, pages 67-69), addressing limitations of claim 7. The compositions may be co-administered with known therapies for the treatment of any of the conditions described (page 139, paragraph 1204). Co-administration includes simultaneous administration in separate compositions, administration at different times in separate compositions, or administration in a composition in which both agents are present (page 139, paragraph 1205), teaching the form of separate pharmaceutical compositions which can be administered simultaneously or sequentially and addressing limitations of the form of the claims 2-4. Baron et al. teaches the known therapies for diabetes include sulfonylureas such as glipizides and glimepiride used to decrease glucose level (page 140, paragraphs 1210-1211), addressing limitations of claim 7. The compositions can be formulated suitable for oral use, for example, as tablets, troches, lozenges, or suspensions, and including pharmaceutically acceptable excipients (page 142, paragraphs 1227-1228), addressing limitations of claims 8-9. Baron et al. teaches the chemosensory receptor ligands can be administered in amounts ranging from about 0.01 to about 100 mg/kg (page 131, paragraph 1133). The composition is used in methods for treating and preventing disorders of glucose metabolism and their associated conditions including diabetes and symptoms of diabetes, administered in an amount effective to treat the condition (page 133, paragraph 1149-1151; page 134, paragraph 1158).
Baron et al. does not specifically disclose the embodiment of the combination product comprising a limonoid compound and a sulfonylurea compound, the amount of the limonoid compound, and the amount of the sulfonylurea compound (claim 1).
Horiba teaches a citrus seed extract-containing composition to exert a function such as lowering a blood-glucose level (abstract; page 1, paragraph 25). The composition of the present embodiment includes a limonoid aglycone and a limonoid glycoside both derived from a citrus seed extract, and the limonoid aglycone is limonin, nomilin, deacetylnomilin or obacunone (page 3, paragraphs 69-73). The dosage of the composition may be appropriately set depending on a target application, an age and weight of target. For example, a typical dosage of obacunone as a dried material may be in the range of 0.1-2,000 mg/kg, preferably 2-300 mg/kg per day per adult human (page 4, paragraph 94). Horiba teaches the working examples of the composition reducing blood glucose levels (experiments 1-2 at pages 5-6; experiment 5 at page 7, paragraphs 174-182).
Simonson et al. teaches investigation of the efficacy, safety, and dose-response characteristics of an extended-release preparation of glipizide using the gastrointestinal therapeutic system (GITS). In the first trial, once-daily doses of 5, 20, 40, or 60 mg glipizide GITS were compared with placebo in 143 patients. All doses of glipizide GITS produced significant reductions from placebo (page 597, abstract). Simonson et al. teaches sulfonylurea agents partially ameliorate each of the major metabolic defects that characterize the diabetic state (page 597, right column, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Baron et al. in view of Horiba and Simonson et al. in order to select the composition comprising the combination of a limonoid and a sulfonylurea from within the scope of Baron et al., and to select the amount of each active compound based on the guidance of Horiba and Simonson et al. One of ordinary skill in the art would have been motivated to combine Baron et al. in view of Horiba and Simonson et al. with a reasonable expectation of success because Baron et al. broadly teaches the composition comprising the combination of a limonoid and a sulfonylurea and provides examples of limonoid and sulfonylurea compounds for the intended use of reducing glucose levels, Horiba teaches the working example of a limonoid composition used to reduce blood glucose levels and further providing guidance to select the chemosensory receptor ligand of Baron et al. to be a limonoid compound, and Simonson et al. teaches doses of glipizide such as 40 or 60 mg as a starting point for such routine experimentation. See also MPEP 2144.06 at I. providing “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) In this case Baron et al. teaches limonoid and sulfonylurea compounds for the intended use of reducing glucose levels and Horiba teaches limonoid compounds for the same purpose, and Baron et al. teaches formulating a combination of agents for this same purpose. Regarding the amount of the limonoid compound in the composition, Horiba suggests it would have been obvious to select the optimal amount through routine experimentation and provides guidance in the dosage of 2-300 mg/kg per day for an adult human.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 10 June 2025, have been fully considered and not found to be persuasive.
Applicant notes that Baron et al. does not specifically disclose the embodiment of the combination product comprising a limonoid compound and a sulfonylurea compound. As detailed in the rejection of record, Baron et al. teaches limonoid and sulfonylurea compounds for the intended use of reducing glucose levels and Horiba teaches limonoid compounds for the same purpose, and Baron et al. teaches formulating a combination of agents for this same purpose. Further, MPEP 2144.06 citing In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) provides “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…” Therefore the prior art of record makes obvious the combination of agents as claimed.
Applicant asserts that the particular components of the limonoid compound and sulfonylurea brings about unexpected effects. However, the cited prior art teaches the predicted effect of each compound on, for example, reducing blood glucose level. For example, Simonson et al. teaches the reduction in plasma glucose and increase in insulin resulting from administration of glipizide (Simonson et al. page 600, middle column to page 601, left column, paragraph 1; and page 602, figure 4). Horiba teaches the limonoid obacunone reduced blood glucose levels (Horiba experiment 5 at page 7, paragraphs 174-182; figure 11 and 12). The evidence provided in the application in examples 1-5, for example at example 2 showing the combination of obacunone and gliclazide, appears to show an additive effect. One of ordinary skill in the art would understand that these active agents act to reduce elevated blood glucose levels that characterize the diabetic state, meaning that the limiting value for the blood glucose is the value for the normal control group. Therefore the evidence provided in the application shows the additive effect from combining the individual active agents, which results in the limiting value of for the blood glucose approximately the same as the normal control group. Further, regarding claims 1-4 and 8-9, it is unclear how the doses provided in g/kg are commensurate in scope with the recited amounts of the claimed product given that the dose administered will depend on the method of administration, such as administering a specific amount in divided doses over the course of a day. Therefore it is unclear that the claimed invention provides unexpected results commensurate in scope with the claims.
Conclusion
No claim is found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693