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 Status
Applicant’s remarks and amendments, filed 29 April 2026 in response to the non-final rejection mailed 4 November 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 29 April 2026 replaces all prior versions and listings of the claims.
Claims 1-15 are pending. Claims 8-11 and 13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 14 and 15 are newly added. Claims 7, 8, and 11 are amended. Claims 1-7, 12, 14, and 15 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on page 4 of the reply filed 29 April 2026 with respect to the rejection of Claims 7 and 12 (as dependent on Claim 7, mistyped as Claim 8) under 35 USC § 112(b) have been fully considered. The rejections of Claims 7 and 12 are withdrawn due to amendment of Claim 7.
Claim Rejections - 35 USC § 102
(maintained)
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
(grounds modified as necessitated by amendment)
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, 12, 14, and 15 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 one 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, 12, and 15); 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, 3, and 15).
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.
Response to Arguments
Applicant's arguments filed 29 April 2026 have been fully considered but they are not persuasive.
Applicant argues that Raz et al. cannot anticipate the claims because the composition of Raz et al. has therapeutic properties related to those of a cannabinoid comprised within the composition. Applicant also argues that because Raz et al. does not provide a specific example comprising levomenol and ginseng, it cannot anticipate the instant claims.
These arguments are not persuasive, however, because MPEP §2123(I) states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). In the instant case, the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. The composition of Raz et al. could therefore include all of the ingredients listed in the Markush groupings pointed out by the applicant and still reasonably encompass the composition of the instant claims. See MPEP § 2111.03.
Applicant goes on to argue that Yucel et al. do not rectify the deficiencies of Raz et al. because it is cited for the disclosure of additional ingredients and because there is not an articulated reason with a rational underpinning to support the proposed combination. Applicant states that the conclusions rest on impermissible hindsight and that there is no teaching of a benefit, synergy, of reason to pair the specific components for the stated condition.
Firstly, it is noted that the claims are not drawn to a stated condition or use and that there is not a recitation of synergy. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Secondly, as stated in the rejection above, a skilled artisan would be motivated to include the additional ingredients of Yucel et al. in the composition of Raz et al. because of their benefits, 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).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Since both Raz et al. and Yucel et al. were known in the art prior to the effective filing date of the instant application, the knowledge of these comprising compositions, including amounts and benefits of various ingredients, this knowledge was within the level of a skilled artisan.
Conclusion
No claims are currently allowed.
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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
Prosecution Insights