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 February 17, 2026 has been received and entered.
3. Claims 1-25 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of Zea mays for species A, leaves for species B, 6-MBOA for species C, and Cannabis sativa oil or CBD/THC for species D (by virtue of the amendment as stated by applicant) in the reply filed on February 17, 2026 is acknowledged.
5. Claims 1-25 are examined on the merits.
Information Disclosure Statement
6. The information disclosure statement filed March 16, 2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Applicant did not provide a copy of Foreign Patent Documents Numbers 1 and 2 or Non-Patent Literature Documents Numbers 2 and 3. Thus, these documents could not be considered and their citations have been lined through.
Claim Objections
7. Claim 6 is objected to because of the following informalities: “propanol” is misspelled as “propenol”. Appropriate correction is required.
8. Claim 11 is objected to because of the following informalities: “pool” is misspelled as “poor”. Appropriate correction is required.
9. Claim 13 is objected to because of the following informalities: “tryptophan” is misspelled as “tryptophane”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3-4, 6-9, 11-18, 23, and 25 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.
10. Claim 3 is indefinite because the phrase “selected from the group comprising” is improper Markush language. The use of “comprising” in a Markush group indicates that their can be other members of the group without specifying their identity. “Comprising” should be changed to “consisting of”. Furthermore, claim 3 only contains one member, i.e. Zea mays. Thus, there is no selection required and the use of Markush language is not needed.
11. Claim 4 is indefinite because the phrase “selected from the group comprising” is improper Markush language. The use of “comprising” in a Markush group indicates that their can be other members of the group without specifying their identity. “Comprising” should be changed to “consisting of”.
12. Claim 6 is rendered indefinite due to the phrase “any suitable solvent.” It is unclear what characteristics a solvent must have in order to be considered “suitable.”
13. Claim 7 is indefinite because the overall phrasing of the claim is unclear. At line 2, “and” or “or” should be inserted after “biotransformed” to indicate if one or all of these methods are required. In addition, it is unclear what sizes are carbon units are considered small and what sizes of bacteria are considered “microbacteria”. “Transgenic microbial” is also unclear. At line 4, “and” or “or” should be inserted between “enzymes” and “by”.
14. Claim 8 is indefinite because the overall phrasing of the claim is unclear. In addition, the phrase “enriched individually or in combination” is confusing because it is unclear if this phrase is referring to benzoxazinoids. In addition, “and” or “or” should be inserted between “digestion” and “column” at line 3.
Claim 8 contains the trademarks/trade names “XAD,” “HP20,” “LH20,” and “CG161”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a material and, accordingly, the identification/description is indefinite.
15. Claim 9 is indefinite because it is unclear if the percentage of 6-MBOA is by weight or volume.
16. Claim 11 is indefinite because it is unclear what is meant by “cultured to process.”
17. Claim 12 is indefinite because there is a lack of antecedent basis for the limitation “the Chlorella powder.”
18. Claim 13 is indefinite because it is unclear if the percentage of protein is by weight or volume.
19. Claim 14 is indefinite because it is unclear what is meant by “blending ratio” and what concentrations of the ingredients must be present in order to meet these ratios.
20. Claim 15 is indefinite because it is unclear what characteristics a compound must have in order to be considered an “active.” In addition, at lines 3-4, the phrase “the pharmaceutical or nutraceutical formulation” should read “the pharmaceutical or nutraceutical or food formulation” to be consistent with line 2 of the claim. Claim 15 is also indefinite because there is a lack of antecedent basis for the limitation “the enriched one or more benzoxazinoids”.
21. Claim 16 is indefinite because it is unclear what characteristics a compound must have in order to be considered an “active.” In addition, it is unclear if the “/” in “CBD/THC” means “and” or “or.”
22. Regarding claim 17, the phrase "or like form" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). In addition, it is unclear what is meant by “aerial spread.”
23. Claim 18 is indefinite because there is a lack of antecedent basis for “the administration”. In addition, claim 18 is indefinite because the phrase “selected from the group comprising” is improper Markush language. The use of “comprising” in a Markush group indicates that their can be other members of the group without specifying their identity. “Comprising” should be changed to “consisting of”.
24. Regarding claim 23, the phrases "gastrointestinal upset like" and “reproductive issues like” render the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
25. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 24 recites the broad recitation “human, companion animals, farm and wild animals” and the claim also recites “including cats, dogs, swine, cattle, sheep, goats, horses, and rabbits” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
26. Claims 1-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products 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 a plant extract, specifically Zea mays (corn), standardized with an amount of a benzoxazinoid, specifically 6-MBOA, in combination with Chlorella. Corn, 6-MBOA, and Chlorella 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 plants only concentrates and portions the naturally occurring compounds in the plants 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 plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant 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 plant. 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 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 6-MBOA is not inventive or “man-made.”
There is no indication that mixing the specified 6-MBOA corn extract together with Chlorella as commensurate in scope with the stated claims changes the structure, function, or other properties of the ingredients in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. The closest naturally occurring counterpart for the Chlorella is the Chlorella itself. Each ingredient in the 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 or creating the products using the claimed product-by-process limitations produces any sort of marked distinction. 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 treating sleep related disorders and cortisol related disorders. 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 the ingredients. 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.
27. Claim(s) 1-9 and 15-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yimam (US 2022/0387366).
This reference claims an extract from corn (Zea mays) immature leaf, mature, leaf or shoots which is enriched for and standardized for a benzoxazinoid (see claims 1-5), specifically at least 0.2% 6-MBOA (see paragraph 27). The extract is combined with additional ingredients including Chlorella and Cannabis sativa oil or CBD/THC (see claim 13). The extract is made in the same manner as claimed by applicant in claims 6-8 (see claims 9-11). The composition is formulated/administered in the same forms as claimed by applicant in claims 15-18 (see claims 12, 14, and 15). The composition has the same effects on sleep disorders and cortisol claimed by applicant (see claims 17-19). The composition is administered in the same dosages claimed by applicant (see claim 2).
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.
28. Claim(s) 1-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yimam (US 2022/0387366) in view of Himuro (Food and Chemical Toxicology (2017), vol. 106, pp. 1-7) and Lee (KR 100995204 – English translation).
The teachings of Yimam are discussed above. Yimam teaches including vitamin B2 and tryptophan in the composition (see claim 13). The reference does not specifically teach that the Chlorella is CK-22 or that it contains vitamins B2, protein, tryptophan, and iron. However, Himuro teaches that the CK-22 strain of Chlorella is known strain of Chlorella appropriate to use in dietary supplements and it demonstrates low levels of toxicity (see abstract and Conclusion sections). In addition, Lee teaches that Chlorella naturally contains high levels of proteins, iron, tryptophan, and vitamin B2 (see page 3 of the translation).
Thus, an artisan of ordinary skill would reasonably expect that Chlorella CK-22 could be beneficially used as the Chlorella ingredient taught by Yimam given its positive characteristics as taught by Himuro. In addition, the artisan would be motivated to modify the Chlorella to include the optimal amounts of nutritionally important ingredients, e.g. vitamins B2, protein, tryptophan, and iron, as taught by Lee in order to best formulate the composition comprising Chlorella as taught by Yimam. This reasonable expectation of success would have motivated the artisan to modify Yimam to include the use of Chlorella strain CK-22 and to optimize the concentration of vitamins B2, protein, tryptophan, and iron in the composition.
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, there is no 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 references do not specifically teach that the Chlorella is made using the processing parameters claimed by applicant in claims 10-12. However, these are known techniques for processing algae and would be obvious to employ during the cultivation and powdering of the Chlorella as taught by the reference. In addition, regarding product-by-process claims, note that MPEP § 2113 states that:
[w]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 35 U.S.C. 102 or 35 U.S.C. 103 of the statute is appropriate…A lesser burden of proof is required to make out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Brown, 59 CCPA 1063, 173 USPQ 685 (1972) ; In re Fessmann, 180 USPQ 324 (CCPA1974)… Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Thus, claims 10-12 are considered to be properly taught by the references.
29. No claims are allowed.
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.
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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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