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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/15/26 has been entered.
The Amendment filed 1/15/26 has been received, entered into the record, and carefully considered. The following information provided in the amendment affects the instant application by:
Claims 6 and 11 have been amended.
Claims 13-17 have been added
Claims 1-5 and 7-8 have been canceled.
Remarks drawn to rejections of Office Action mailed 11/18/25 include:
112 2nd paragraph rejections: which have been overcome by applicant’s amendments and have been withdrawn.
103 rejections: which have been overcome by applicant’s amendments and have been withdrawn. To clarify the record, the examiner previously rejected the claims over US2006/0011858 – however, as applicants noted – the correct reference number should have been US2006/0018858. A new obviousness rejection as it relates to the presently amended claims is set forth below.
An action on the merits of claims 6 and 9-17 is contained herein below. The text of those sections of Title 35, US Code which are not included in this action can be found in a prior Office action.
Claim Objections
Claim 14 is objected to because of the following informalities: there is an unnecessary break in the claim between the words “vasodilation” and “rate” which is written as:
“…vasodilation
rate expressed…”.
The claim should be written “…vasodilation rate expressed…” without the extra line incorporated therein. Appropriate correction is required.
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.
Claim(s) 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over JP2010215520A.
The claims of the present application are drawn to methods of increasing a vasodilation rate in a subject in need thereof comprising orally administering one or my types of α-glucosyl-isoquercitrin or a mixture thereof with isoquercitrin thereby increasing vasodilation rate expressed as flow-mediated vasodilation (FMD) value. Dependent claims limit the amounts to 1-50mg/kg of active agent and that he subject is a middle age subject having at least one risk factor for cardiovascular disease.
JP’520 teaches methods of administering α-glucosyl-isoquercitrin in oral form to treat various diseases and mask the unpleasant taste of the compound. In [0040] ‘520 teaches to formulate the composition into granules or a chewable tablet as it may be difficult for middle-age or elderly people to swallow the tablets – thus rendering obvious methods to be practiced on middle aged subjects. [0020] states that the enzyme treated rutin (α-glucosyl-isoquercitrin) is known to have a vasodilating effect and can be administered in amounts of 1-500mg or 0.015-8.5mg/kg – overlapping with the present dosages (see [0022]). The compositions therein are taught to be administered for various means including blood circulation disorders (see last sentence of [0043]). What was not specifically exemplified is administering the drug to increase the vasodilation rate in a subject in need thereof as required herein.
However, it would have been prima facia obvious to administer the oral α-glucosyl-isoquercitrin compositions to increase vasodilation as ‘520 specifically teaches to do this. They note the drug is used to increase vasodilation, they provide for oral compositions comprising the same active agents in the same amounts, and suggest the use for the same purpose. A skilled artisan would have found the present methods obvious in view of the teaching of the same in ‘520. The oral compositions of ‘520 were shown to be palatable, and were taught to be useful for increasing vasodilation in the same amounts claimed herein. Regarding the limitation of increasing the vasodilation rate expressed as a flow-mediated vasodilation value, this is seen to be a means of measuring the rate and would be an obvious way to measure this in the art. The manner of measuring the vasodilation would not affect the actual vasodilation, and thus the arts teaching od the same activity would not change based on how the activity was measured.
Claim(s) 6 and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over JP2010215520A as applied to claims 14-17 above, and further in view of JP4505707B2.
The claims of the present application are drawn to methods of improving or alleviating dry spots, wrinkles, sagging, swelling, sensitivity to cold, and stiff shoulders comprising orally administering one or my types of α-glucosyl-isoquercitrin or a mixture thereof with isoquercitrin thereby increasing vasodilation rate expressed as flow-mediated vasodilation (FMD) value. Dependent claims limit the amounts to 1-50mg/kg of active agent and that he subject is a middle age subject having at least one risk factor for cardiovascular disease.
JP’520 teaches methods of administering α-glucosyl-isoquercitrin in oral form to treat various diseases and mask the unpleasant taste of the compound. In [0040] ‘520 teaches to formulate the composition into granules or a chewable tablet as it may be difficult for middle-age or elderly people to swallow the tablets – thus rendering obvious methods to be practiced on middle aged subjects. [0020] states that the enzyme treated rutin (α-glucosyl-isoquercitrin) is known to have a vasodilating effect and can be administered in amounts of 1-500mg or 0.015-8.5mg/kg – overlapping with the present dosages (see [0022]). The compositions therein are taught to be administered for various means including blood circulation disorders (see last sentence of [0043]). What was not specifically exemplified is administering the drug to treat dry spots, wrinkles, sagging, swelling, sensitivity to cold, or stiff shoulders in a subject in need thereof as required herein.
However, JP4505707B2 states that vasodilators are effective in treating stiff shoulders and coldness, etc. by promoting blood flow – see English portion of title/description.
As such, it would have been obvious to one of skill in the art to use the oral vasodilator composition of ‘520 to treat stiff shoulders/coldness/etc. as ‘707 teaches that vasodilators are effective in treating these conditions. It is obvious to replace one active agent for another which is taught to have the same activity and one would have a reasonable expectation of success since the oral α-glucosyl-isoquercitrin containing compositions of ‘520 are taught to be effective as vasodilators and would thus have the same activity in treating the vasodilator related diseases as in ‘707.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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TRAVISS C. MCINTOSH III
Primary Examiner
Art Unit 1693
/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693