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 October 17, 2025 has been received and entered.
3. Claims 1-12 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of Group I, claims 1-9, in the reply filed on October 17, 2025 is acknowledged.
5. Claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-9 are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a composition containing Xylaria nigripes extract, Panax notoginseng extract, and Cuscuta chinensis extract, does not reasonably provide enablement for a “synergistic” ratio of these three ingredients. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are drawn to a composition containing Xylaria nigripes extract, Panax notoginseng extract, and Cuscuta chinensis extract in a ratio to provide a “synergistic” effect in increasing GABA content and GABA-related enzymes, and decreasing beta-amyloid protein aggregation. Applicant’s specification asserts that Figures 1-6 show that a combination of Xylaria nigripes extract, Panax notoginseng extract, and Cuscuta chinensis extract produces a synergistic effect in comparison with Xylaria nigripes extract alone and a combination of Xylaria nigripes extract and Panax notoginseng extract. However, it is not clear if these figures show a synergistic result. The combination of the three ingredients do show a better result. However, this is only in comparison with the results for Xylaria nigripes extract alone and the combination of Xylaria nigripes extract and Panax notoginseng extract. The individual results for Panax notoginseng extract and Cuscuta chinensis extract are not demonstrated. Thus, it cannot be clearly determined if the results shown for the combination of three ingredients are actually synergistic rather than an additive effect. Thus, the data presented in the specification is not considered to support the claim limitation that the results are “synergistic.” Given that synergism is unpredictable, in order to determine if the claimed composition is actually synergistic, the artisan would be forced to test all encompassed ratios of the three ingredients in comparison with the individual ingredients in order to determine which concentrations are actually “synergistic.” This clearly a burden of undue experimentation. Thus, the claims are not considered to be enabled for “synergistic” compositions.
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.
Claims 1-9 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.
8. Claims 1 and 2 are indefinite because it is unclear what is meant by the limitation that Xylaria nigripes extract, Panax notoginseng extract, and Cuscuta chinensis extract are the “main active components” in the composition. It is unclear what characteristics the composition must have in order for these ingredients to be the “main active” ingredients. This lack of clarity is especially confusing given that claim 1 states that the composition “consists essentially of” of these three ingredients as “main active components” and claim 2 states that the composition “consisting of” these three ingredients as “main active components”. It is unclear if the compositions can contain other ingredients as long as they are not considered to be “main active components.” For example, if a reference composition contains an additional “active” ingredient but at a lesser amount than Xylaria nigripes extract, Panax notoginseng extract, or Cuscuta chinensis extract, does this reference composition read on the claimed invention because a smaller amount of a fourth ingredient would not be considered a “main” ingredient? Clarification is needed.
9. Claim 1 is indefinite because the metes and bounds of what are considered to be a “mood support” are unclear.
10. Claim 7 is indefinite because the phrase “provides cytoprotective and neuroprotective properties, but an efficacy in decreasing oxidative stress as well as inhibiting AB protein misfolded/aggregation” is unclear. The narrative phrasing of the claim is inconsistent with US claim construction. In addition, the overall language of the limitation is unclear because it is unclear why providing cytoprotective and neuroprotective properties is in contrast to decreasing oxidative stress.
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.
11. Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite Xylaria nigripes extract, Panax notoginseng extract, and Cuscuta chinensis extract. Xylaria nigripes, Panax notoginseng, and Cuscuta chinensis are all naturally occurring. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, extraction of mushrooms and plants only concentrates and portions the naturally occurring compounds in the ingredients which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the ingredients. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the mushroom and plants and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the ingredients. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the mushroom or plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Thus, each of the extracts in turn is a mixture of the naturally occurring compounds found in the particular ingredients. Combining the extracts from the individual plants leads to a combination of the naturally occurring compounds from each of the ingredients. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a mixture of the naturally occurring compounds found in the plant. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. It is noted that the claims state that they are drawn to “synergistic” ratios of the three ingredients. While synergism would demonstrate a marked distinction, the evidence of synergism in the specification is not considered to be persuasive for the reasons discussed above in paragraph 7. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of sleep and mood support, increasing GABA content, increasing GABA-related enzyme activity, decreasing beta-amyloid protein aggregation, and treating insomnia, depression, a neurological condition or Alzheimer’s disease. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the combination of extracts. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended uses are not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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.
12. Claim(s) 1-3 and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “SleepBoost” product description (“SleepBoost™, formulated with Zylaria™. May Support a Sense of Calm Through Natural Neuro Pathways.” https://www.amazon.com/SleepBoostTM-Xylaira-nigripes-supplement-pathways/dp/B076CTZGC6?ref_=ast_sto_dp – 2018).
This reference teaches the “SleepBoost” composition containing Xylaria nigripes mycelium extract, Cuscuta chinensis seed extract, and Panax notoginseng root extract in capsule form (edible carrier). The reference teaches that the product supports better sleep and mood by modulating GABA. The reference composition does not contain any additional active ingredients. Thus, it considered to “consist essentially of” and “consist of” Xylaria nigripes extract, Panax notoginseng extract, and Cuscuta chinensis extract as the active ingredients (see page 1). Page 9 of the product information indicates that the product was first available in 2018. In addition, page 11 contains comments from a customer from 2018.
The reference does not specifically teach that the composition is in “synergistic” ratios. However, as discussed above in paragraph 7, applicant’s support for “synergistic ratios” is not considered to be persuasive.
The reference does not specifically teach that the composition has all of the same effects as claimed by applicant. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
13. Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Zylaria” (https://web.archive.org/web/20210803004824/https://nulivscience.com/ingredients/zylaria/10 - internet archived version from August 3, 2021), Xie (Molecules (2018), vol. 23, no. 940, 18 pages), and Lan (CN 1709100 A – English translation).
Zylaria teaches a Xylaria nigripes mycelium composition that is useful in improving sleep and mood by promoting GABA function. No other active ingredients are required by this reference.
Xie teaches that Panax notoginseng root extract is useful for treating insomnia (see abstract and Introduction section). No other active ingredients are required by this reference.
Lan teaches that dodder (Cuscuta chinensis) seed extract is useful for treating insomnia (see abstract). While Lan also teaches the including medlar in the composition, as discussed above in paragraph 8, the scope of the claims is unclear. In addition, regarding applicant’s claims which use the transitional phrase “consisting essentially of,” MPEP section 2111.03 states:
For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355.
Therefore, “consisting essentially of” will be construed as “comprising” until the above conditions are met.
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that treat insomnia. It is well known that it is prima facie obvious 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. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to treat insomnia, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat insomnia. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, as discussed above in paragraph 7, there is no persuasive evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
The reference does not specifically teach that the composition has all of the same effects as claimed by applicant. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
14. No claims are allowed.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655