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
Claims 1-13 are pending in the instant application. Applicant’s election without traverse of Group I, Claims 1-7 and 12 in the reply filed on 19 September 2025 is acknowledged. Claims 8-11 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 19 September 2025.
Claims 1-7 and 12 are being examined on the merits.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 7, the phrase “further comprising one or more of a ginkgolide compound, vitamin A; vitamin E; vitamin D; vitamin C; and one or more adenine derivative compounds” is indefinite because as written, it is unclear whether the composition comprises one or more ginkgolide and Vitamin A, Vitamin E, Vitamin D, or Vitamin C, and one or more adenine derivative compound or one or more of a compound selected from the group consisting of a ginkgolide, Vitamin A, Vitamin E, Vitamin D, Vitamin C, and one or more adenine derivative compound, or another combination thereof.
Clarification is required, however for the purposes of compact prosecution, the broadest reasonable interpretation of the claim is being interpreted as the nutraceutical composition of claim 1, further comprising one or more of a compound selected from the group consisting of ginkgolide, Vitamin A, Vitamin E, Vitamin D, or Vitamin C, and one or more adenine derivative compound.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112(b) for the reasons set forth above.
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.
(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.
Claims 1, 4, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raz et al. (WO 2020/136593 A1).
The instant claims are as of record, drawn to a nutraceutical composition comprising at least 20 weight% levomenol (α-bisabolol) and at least 20 weight% of a ginseng extract.
Raz et al., however, anticipate the claims by teaching a therapeutic product comprising at least one cannabinoid and at least one herbal preparation (nutraceutical composition; extract) including Panax ginseng (ginseng extract) and further comprising a primary terpene including bisabolol (levomenol; Raz et al., [0054], page 15-16; as required for instant Claim 1). The primary terpene comprises at least 20-80 weight% of the total terpenes in the product and the terpenes form at least 0.5-70 weight% of the product, which means that the primary terpene may comprise at least 0.1-56 weight% of bisabolol (Raz et al., [00140], pages 33-34 and [00148], page 36; as required for instant Claims 1 and 4). The herbal preparation (e.g., ginseng extract) comprises 0.5-70 weight% of the product (Raz et al., [00289], page 72; as required for instant Claims 1 and 5).
Claim Rejections - 35 USC § 103
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 1-7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. (WO 2020/136593 A1) as applied to Claims 1, 4, and 5 above, and further in view of Yucel et al. (US 2020/0246404 A1).
The instant claims and teachings of Raz et al. are as of record.
Raz et al. do not teach wherein the composition further comprises a zinc compound, Vitamin D, ginsenoside compounds, ginkgolide compounds, Vitamins A, E, or C, or one or more adenine derivative compounds.
Yucel et al. teach compositions comprising one or more active ingredient. The active ingredient can include one terpene including alpha-bisabolol (levomenol), which may be present in an amount from 0-50 weight% (encompasses the ranges of at least 20 weight% and at least 40-50 weight%; Yucel et al., [0238]-[0239], page 25; as required for instant Claims 1 and 4). The active ingredients can additionally be selected from or more of any of the following nutraceuticals (nutraceutical composition) ginseng, ginsenoside C, ginsenoside Rb1, ginsenoside Rg1 (ginseng extracts; ginsenoside compounds); Vitamins A, C, D, and E; ginkgolides A, B, C, J, and M; adenine, adenosine monophosphate, and NADH (Yucel et al., [0087], page 5; as required for instant Claims 1, 3, 6, 7, and 12); and zinc (Yucel et al., [0089], page 5; as required for instant Claim 2). The composition may also comprise an amount of active ingredients ranging from 0.5-12.5 weight% (as required for instant Claims 2 and 3).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Raz et al. and Yucel et al. to arrive at the instantly claimed invention because of the beneficial effects of the additional ingredients including effects on CNS and brain function, energy, weight loss, male libido, and female libido, providing essential vitamins and minerals, and antioxidant properties (Yucel et al., [0092]-[0105], pages 5-6). A skilled artisan could therefore incorporate these additional ingredients into the composition of Raz et al. with a reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Prior Art Made of Record but not Relied Upon
Im et al. (J Ginseng Res, 2016, 309-314) teach that Korean Red Ginseng, the processed root of Panax ginseng, comprises ginsenosides and has broad antiviral capabilities via inhibition of attachment, membrane penetration, and replication in addition to enhancing host immunity.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655