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 .
Election/Restrictions
Applicant’s election without traverse of Group III, Claims 23-24 in the reply filed on 2/20/2026 is acknowledged.
Claims 1-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/20/2026.
Claims 23 and 24 are currently under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 23 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon utilizing a natural product without significantly more.
Claim 23 recites a method for activating dorsolateral prefrontal cortex, the method comprising administering 6-methylsulfinylhexyl isothiocyanate to a subject and claim 24 recites that the 6-methylsulfinylhexyl isothiocyanate is incorporated into a food product.
These instantly claimed limitations are drawn to a product of nature, namely naturally occurring 6-methylsulfinylhexyl isothiocyanate found in wasabi. Wasabi, which is a food product, contains 6-methylsulfinylhexyl isothiocyanate. Administration of the 6-methylsulfinylhexyl isothiocyanate to a subject absent amounts and absent any step that would define a patient population as anyone other than a subject whereby the administration of the natural product provides a natural effect on dorsolateral prefrontal cortex is considered to be natural phenomenon. Thus, the method of administering 6-methylsulfinylhexyl isothiocyanate, which affects the dorsolateral prefrontal cortex does not amount to an exception of the judicial exception, because isolation or purification does not result in a product which is ‘markedly different’ from the naturally-occurring component and the administration is through a food product which is also naturally where the 6-methylsulfinylhexyl isothiocyanate is found and the method of administration has the inherent effect of activating dorsolateral prefrontal cortex. Thus, while administering 6-methylsulfinylhexyl isothiocyanate is administration of an isolated natural product it is merely a compound that may or may not be separated from the naturally-occurring wasabi, the result of extraction is still 6-methylsulfinylhexyl isothiocyanate which is naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Further, administration is not having any effect other than what is naturally expected, which is activating dorsolateral prefrontal cortex. Please note that in Myriad, excising DNA to isolate the DNA from its natural source did not constitute a product which was “markedly different” from the naturally occurring DNA even though the excised ends of the DNA were different in structure when compared to native DNA.
Thus, the claims are drawn to a natural phenomenon. Therefore, the claims are drawn to judicial exceptions. There are no structural limitations in claims 23 and 24 in addition to the extract containing naturally occurring ingredients and consumption of the plant itself in claim 24.
Claim Rejections - 35 USC § 102
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 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.
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.
Claims 23 and 24 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Okunishi et al. (U, Japanese Pharmacology and Therapeutics, January 2019; 47(2):275-286).
Okunishi teaches administering wasabi root extract product (which reads on incorporated into a food) rich in 6-(methylsulfinyl) hexyl isothiocyanate named "Wasabi Sulfinyl (WS)" administered to improve attention/processing-related cognitive performance (See e.g. abstract).
Although Okunishi does not expressly teach that the administration activates the dorsolateral prefrontal cortex, activation of the dorsolateral prefrontal cortex is inherent to the administration of 6-methylsulfinylhexyl isothiocyanate as taught by Okunishi because the ingredients and the method of administration to subjects for improving cognitive function (same patient population) is the same as disclosed in the instantly claimed invention of Applicant. Thus, the functional effect of activating the dorsolateral prefrontal cortex is inherent to the method taught by Ichikawa.
Therefore, the reference anticipates the claimed subject matter.
Claims 23 and 24 are rejected under 35 U.S.C. 102(a)(1) as anticipated by ICHIKAWA et al. (N, WO 2010084661 A1, translation provided herein).
Ichikawa teaches administering 6-methylsulfinylhexyl isothiocyanate to a mouse (which reads on subject) as part of a standard diet to promote learning function (See e.g. Example 2). Ichikawa further teaches food material comprising 6-methylsulfinylhexyl isothiocyanate for promoting learning function (See e.g. claims).
Although Ichikawa does not expressly teach that the administration activates the dorsolateral prefrontal cortex, activation of the dorsolateral prefrontal cortex is inherent to the administration of 6-methylsulfinylhexyl isothiocyanate as taught by Ichikawa because the ingredients and the method of administration to subjects for improving cognitive function (same patient population) is the same as disclosed in the instantly claimed invention of Applicant. Thus, the functional effect of activating the dorsolateral prefrontal cortex is inherent to the method taught by Ichikawa.
Therefore, the reference anticipates the claimed subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy L. Clark whose telephone number is (571)272-1310. The examiner can normally be reached M-F 8:00am-5:00pm.
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/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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