DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed December 5, 2025 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1-12 and 15-20 are pending.
Election/Restrictions
4. In the reply filed on October 2, 2023, applicant elected Group I, claims 1-12 and 15-16, a combination of humulone, xanthohumol, and myrcenol for species A, and a combination of honokiol and magnolol for species B without traverse.
5. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
6. Claims 1-12 and 15-16 are examined on the merits solely in regards to the elected species.
Claim Rejections - 35 USC § 103
7. Claim(s) 1-12 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stogniew (US 2004/0228934), Kuhrts (US 2015/0209307), Yasushi (JP 2006213628 – English translation), Buchwald-Werner (EP 2 060 192), “L-Theanine” article (Alternative Medicine Review (2005), vol. 10, no. 2, pp. 136-138) for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues:
…the Examiner presents no evidence that the claimed composition, comprising at least at
least four active ingredients, namely 1) humulone, xanthohumol, or myrcenol; 2) honokiol or magnolol; 3) rosmarinic acid; and 4) L-Theanine, will have the intended outcome, namely to promote relaxation. In other words, one cannot say, especially in the context of chemical compositions that include a plurality of active ingredients, that the
combination will have the intended effect and not an antagonistic effect. An antagonistic
effect is one where an ingredient interacts with another ingredient to make the
composition have a lesser effect or a completely different effect.
As shown in the article attached as Exhibit A, "Synergy and antagonism in natural
product extracts: when 1 + 1 does not equal 2" (Nat Prod Rep. 2019 June 19; 36(6): 869-
888), many ingredients in food products combine together in an antagonistic manner:
A less-discussed phenomenon, antagonism, in which effects of active constituents are masked by other compounds in a complex mixture, also occurs in natural product mixtures. (Abstract)
Indeed, the authors point out that many natural products consisting of complex
combinations of natural ingredients can suffer from antagonism - that is where one
expects an additive effect and instead finds a subtractive effect (where one active
ingredient cancels out another active ingredient) or where the combination of active
ingredients results in a different and negative result compared to what was expected.
Thus, while the Examiner has pointed out several references where each
ingredient is highlighted for its solo efficacy, there is no further teaching, suggestion or
motivation provided to combine the ingredients together with any expectation of success,
namely that the sum of the parts does not present negatively when combined together. It
cannot be assumed that merely combining ingredients together in a complex combination
will even result in an additive effect. As the authors point out, most studies separate one
ingredient within a natural product and develop that one ingredient into a viable drug. See
p. 2, lines 5-6. Indeed, this is reflective of what the Examiner has shown in the prior art.
However, what is not demonstrated by the prior art is how the combination of ingredients
may interact with each other in negative ways and why one would thus want to combine
the ingredients together with other ingredients. Thus, there would be no teaching,
suggestion, or motivation to combine the specific compounds as defined by independent
claim 1.
However, it is well established that it is prima facie obvious to combine to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. Since the references show that all of the claimed substances are used in compositions to promote sleep and relaxation, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be successful in creating compositions to promote sleep and relaxation (see MPEP section 2144.06).
In addition, as discussed in MPEP section 2143(I-A), in order to be persuasive, an argument based on the art teaching away from a combination needs to be specific to the facts of the particular claimed invention. In this case, there is no specific teaching away in the references that would lead an artisan of ordinary skill in the art to conclude that such a combination of ingredients would not be successful or would be antagonistic as suggested by applicant. The article provided as Exhibit A discusses antagonism in general and for ingredients that are not in applicant’s claimed combination. The article does not discuss the specific ingredients and extracts claimed by applicant. Thus, the Exhibit A article would not lead an artisan to assume that the combination suggested by the combination of the references would not be successful because it does not discuss any of the claimed ingredients or claimed extracts. Therefore, applicant’s arguments are not persuasive.
8. No claims are allowed.
THIS ACTION IS MADE FINAL. 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 Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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