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
Claims 1-20 are pending and are examined on the merits herein.
Specification
The disclosure is objected to because of the following informalities:
A number of terms are inappropriately capitalized in the application, including in the specification and the abstract. This includes the following terms:
fermented green tea extract, L-theanine, caffeine; ashwagandha extract; black pepper extract; huperzine; fermented alpha gpc/citoline matrix; turmeric root extract; lion's mane extract; Ginkgo biloba powder extract; Panax ginseng extract; Rhodiola extract; cognitive probiotic blend; folic acid; vitamin D3; vitamin C powder; vitamin B12; vitamin B6; pantothenic acid; vitamin B3 crystalline powder; vitamin B2 powder; vitamin B1 HCL; and biotin.
Additionally, it is noted that the disclosure uses the term “lions mane” for a fungus that is commonly known as “lion’s mane”.
Similarly, “Citoline” is not a recognized term in the art, and instead appears to be a typographical error for “citicoline” (e.g. CDP-choline).
Appropriate correction is required.
Claim Objections
Claims 1, 4, 6-8, 10, 13, 15-17 are objected to because of the following informalities:
In the claims, the following terms are capitalized which are not proper nouns or special terms, and thus should not be capitalized. This includes: fermented green tea extract, L-theanine, caffeine; ashwagandha (e.g. Withania somnifera) extract; black pepper extract; huperzine; fermented alpha gpc/citoline matrix; turmeric root extract; lion's mane (e.g. Hericium erinaceus) extract; Ginkgo biloba powder extract; Panax ginseng extract; Rhodiola extract; cognitive probiotic blend; folic acid; vitamin D3; vitamin C powder; vitamin B12; vitamin B6; pantothenic acid; vitamin B3 crystalline powder; vitamin B2 powder; vitamin B1 HCL; and biotin.
The claimed ingredient of: “Fermented Alpha GPC/Citoline Matrix” appears to recite a fermented complex of Alpha-GPC (L-alpha-glycerylphosphorylcholine) and citicoline (CDP-choline). “Citoline” is not a recognized term in the art, and instead appears to be a typographical error for citicoline (e.g. CDP-choline).
Appropriate correction is required.
Claim Interpretation
The following is noted regarding the instant claims: a series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
The claims have been interpreted under the Broadest Reasonable Interpretation (B.R.I.) in light of the specification.
The following terms of the art, described in the specification, are noted:
The claim element of “Fermented Green Tea Extract, L Theanine, and Caffeine” appears to be referring to a fermented green tea extract which contains L-theanine and caffeine and thus provides each of the recited claim elements (see e.g. [0032]). No specific bacteria or treatments are named that carry out the fermentation of the green tea extract.
The claim element “Fermented Alpha GPC/Citoline Matrix” appears to refer to a blend of Alpha-GPC (L-alpha-glycerylphosphorylcholine) and citicoline (CDP-choline). As discussed above, citoline is not a recognized term in the art, and instead appears to be a typographical error for citicoline. In the specification, this element is also named “AlphaDeum” which appears to be a proprietary term and not a recognized element in the art. The specification has not specifically defined these terms. No specific bacteria or treatments are named that carry out the fermentation.
Regarding the Cognitive Probiotic Blend, no special definition is provided for this term in the specification. The specification at [0049] describes that a sufficient amount of a Cognitive Probiotic Blend at 100cfu is between about 15-25mg. The next paragraph, [0050] describes 100 billion cfu. It is presumed that 100 billion cfu (colony forming units) is the actual sufficient amount. This has been applied during examination and searching of the art.
In claim 10, the term “Reactive CE” is recited, which appears to be a term for a particular brand or product for the Green Tea Extract, L-Theanine, and Caffeine, but no specific definition or description has been provided in the disclosure. From searches of the art, it appears that this might have been meant to recite “Reactivate CE”, which appears to be a proprietary blend of herbal extract compounds (see “recomnd Nutrition - Clear Focus, Brain Supplements for Memory and Focus Support, Memory Supplements with Ashwagandha, Lions Mane, Ginkgo Biloba, and More”, Amazon, accessed from amazon.com/recomnd-Clear-Focus-Cognitive-Supplement/dp/B0CYCLCD8Z, cited on the PTO-892 and described in detail below). Thus, “Reactive CE” does not appear to limit claim 10, and instead refers to a specific blend of fermented green tea extract including L-theanine and caffeine.
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.
Claims 1-20 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.
The claims require a “Cognitive Probiotic Blend”, recited in both independent claims 1 and 10, which is not defined by the disclosure. This does not appear to be a term known in the art, and the actual composition cannot be identified. The term is indefinite because the specification does not clearly define the term. There is no definition nor adequate description such that one can determine the meaning of “Cognitive Probiotic Blend”. No specific or exemplary bacteria strains are defined. Because there is no manner to determine the composition of the Cognitive Probiotic Blend, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
All of the claims recite “Fermented Green Tea Extract, L- Theanine, and Caffeine”. This claim element is indefinite because there is no way to determine if this requires three separate components: 1. Fermented Green Tea Extract; 2. L-Theanine; 3. Caffeine, or if this is one entire fermented mixture of Green Tea Extract, L- Theanine, and Caffeine. One cannot determine the metes and bounds of the claimed composition because the mixture that is fermented cannot be determined from the disclosure. Further, there is no description of the fermentation, nor is any bacteria or conditions described that result in the claimed element.
All of the claims recite “Fermented Alpha GPC/Citoline Matrix”. There is no way to determine the meaning of this claim element. Is this a single mixture, i.e. a matrix of Alpha GPC and citicoline (CDP-choline) that is fermented? Or is this a mixture of fermented Alpha-GPC with citicoline (CDP-choline), in a matrix? There is no manner, from the claim language nor the specification, to determine the metes and bounds of the claimed composition because the compounds that are actually fermented cannot be determined from the disclosure. Further, there is no description of the fermentation, including active bacteria or fermenting conditions, described for this claimed element.
Claim 10 also recites “wherein the sufficient amount of Reactive CE”, in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. The claim does not previous recite “a sufficient amount of Reactive CE”. It appears that this term is attempted to be used as a name or brand for the mixture of Fermented Green Tea Extract, L Theanine, and Caffeine. However, such a definition is not defined in the specification and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 3 recites: “wherein an effective dose of the composition is two capsules, and wherein 1-4 capsules per day equals the effective dose.” The claim recites both a specific number of capsules for the effective dose (e.g. a narrower limitation) and a range of one to 4 capsules per day (e.g. the broader limitation). 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. The claims are considered indefinite because there is a question or doubt as to what is the amount required of the claim? Is it the broad range of one to four capsules? Or is the specification amount of two capsules for the effective dose required?
Claims 4, 10, and 13 each recite the relative term “about”. The term “about”, is a relative term used in approximations that renders the instant claims indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Regarding specifically the term “about”, there is no definition provided in the specification such that one can determine the amount of uncertainty allowed in the measurement. Because there is no defined amount of allowable error, in either direction, that still fulfills the claim language, there is no way to determine the metes and bounds of the claimed composition amounts. See MPEP § 2173.05(b).III.A regarding the indefiniteness of the term “about” where there is nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
Claim 14 depends on claim 12, which requires that the effective dose of the composition is two capsules, and also recites “to provide the effective dose upon ingestion of at least one capsule.”. The actual metes and bounds of claim 14 (and all claims 15-20 dependent thereof) is indefinite because both “the effective dose of the composition is two capsules” and “using a capsule to provide the effective dose upon ingestion of at least one capsule” is recited. Because the resulting dependent claim recites a broader limitation and a narrower one in the same claim, the claim is rejected as indefinite, because it becomes unclear what is actually required of the claim protection that is sought.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 112(a) - Written Description
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.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
All of the claims require a “Cognitive Probiotic Blend”, as recited in both independent claims 1 and 10, which is not adequately defined by the disclosure.
This does not appear to be a definition known in the art, such that the actual composition used cannot be identified. The specification does not clearly define what is in the cognitive probiotic blend. No specific or even exemplary bacteria strains are defined.
The dependent claims do not practically limit the encompassed composition of the probiotic blend, which can essentially be any potential beneficial bacteria strains.
According to the B.R.I. of the claim, when viewed in light of the specification, there exists a nearly limitless number of species of probiotic bacteria blends within the claimed scope. There are a huge number of known beneficial probiotic bacteria strains. The specification does not define the probiotic blend by structure or by function, instead only the generic function of “cognitive” is provided. The claims encompass all and every blend of beneficial bacteria, essentially a near indefinite amount of combinations. The specification recites no species that comprise a blend that fulfills the recited limitations.
MPEP § 2163.(II)(A)(3)(a) states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The specification fails to reasonably describe the full genus of the claimed invention by providing identifying characteristics or functional properties of the probiotic blend.
The instant specification does not disclose relevant identifying characteristics, such as key structural or other physical properties, or functional characteristics coupled with a known or disclosed correlation between function and structure, such that the entirety of the claimed genus is encompassed by the description in the disclosure.
The specification states, generally, that “The cognitive blend (i.e., the cognitive matrix) may improve gastrointestinal health (i.e., gut health and gut microbiome health) and thus improve digestive functions. In addition, the gut-brain axis which is important for neurotransmitter replenishment, humoral function and immune response is optimized.” ([0051]). This amounts to a general description of the function of probiotic bacteria, however this does not define the bacteria blend, and no specific species or strains are recited. These are broad functional descriptions yet the claims are directed to a defined composition, and the structural description of all of the components, including the cognitive probiotic blend is necessary.
When turning to the art, it is apparent that there are a great number of possible probiotic bacteria, and a nearly infinite number of combinations of strains that could comprise the blend.
“Cryan” ("Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour." Nature reviews neuroscience 13.10 (2012): 701-712) teaches that it is generally accepted that the adult microbiota consists of more than 1,000 species and more than 7,000 strains (pg. 702, left col). Cryan teaches that major strain and species differences occur in terms of their effects on the gut–brain axis and states that “caution needs to be exercised when generalizing such effects from one bacterial strain to another, and efforts need to be directed at identifying the mechanism by which each strain induces its effects” (Figure 2 legend, and pg 707, right col, last two paragraphs).
Other art teaches the existence and benefits of additional various probiotic bacteria.
Mao et al. (US PGPub No. 20220143113A1) describes compositions of novel Lactobacillus plantarum strains for use in preventing and/or treating mental illness, symptoms affecting mental health and/or conditions associated with chronic stress, in a mammal, characterized, for example, by psychological symptoms of depression, anxiety, perceived stress, deficits in cognitive function and dementia ([0002], Abstract, Title). The treatments taught in Mao are purported to be effective in alleviating symptoms of cognitive and memory disorders, including dementia, and Alzheimer's disease ([0094]). Mao specifies three particular strains of Lactobacillus plantarum bacteria (e.g. LP12151, LP12418, LP12407, or Lpc-37, also known as DGCC4981 or Lbc81), that are taught to provide the purported cognitive benefits when administered ([0033]-[0039]). Mao also describes that the strains LP12151, LP12418, and LP12407 are probiotic bacteria, and defines the term “probiotic bacteria” as covering any non-pathogenic bacteria which, when administered live in adequate amounts to a host, confer a health benefit on that host, wherein the bacteria must survive passage through the upper part of the digestive tract of the host ([0042]).
“van Hemert” (US PGPub No. 20180271919) discloses a probiotic composition comprising: Bifidobacterium bifidum W23, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Bifidobacterium lactis W52, Lactococcus lactis W19, and Lactococcus lactis W58 formulated to treat or prevent depression in a human (Claim 1, Table 2). This also includes alleviating of symptoms related to cognitive function ([0005]; [0075]; [0098]).
Thus it is evident from the art that there are a large number of potential probiotic bacteria and the effects upon administration of different species is not well defined. There is no special or known definition for “Cognitive Probiotic Blend” as used herein. Although this claim element is defined in the specification in terms of the functional properties, there is no accepted correlation between structure and the function known in the art.
The specification provides no examples of the claimed genus and no actual reduction to practice of the full breadth of the vast genus.
For these reasons, the disclosure fails to provide adequate written description to support the entirety of the broad genus claim to any and all cognitive probiotic blends.
Claims 1 and 10 are thus rejected under 35 U.S.C. § 112(a) because the claimed subject matter is not described in the specification in such a way as to reasonably convey to a skilled artisan that the inventor, or a joint inventor, had possession of the claimed invention.
The dependent claims 2-9 and 11-20 are also rejected under 35 U.S.C. § 112(a), because these claims require the cognitive probiotic blend, according to claims 1 or 10, and fail to practically further limit or describe the cognitive probiotic blend.
Claim Rejections - 35 USC § 102
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention, evidenced by “recomnd Nutrition - Clear Focus, Brain Supplements for Memory and Focus Support, Memory Supplements with Ashwagandha, Lions Mane, Ginkgo Biloba, and More” (Amazon Product Page for Clear Focus, accessed from amazon.com/recomnd-Clear-Focus-Cognitive-Supplement/dp/B0CYCLCD8Z on 9/23/26, First available April 7, 2024, see print-out provided with the PTO-892 accompanying this communication).
The product page listing for “recomnd Nutrition - Clear Focus” discloses a commercially available supplement for memory and focus support, e.g. cognitive improvement, as required of claims 1 and 10. This product is being sold by a third party (e.g. Amazon.com) and is branded as “recomnd” (see e.g. Top Highlights and product information). There is no indication on the record that this company is the same as the Applicant/Assignee (“Herbanized Wellness, LLC”).
The reported benefits of the composition include: supporting mental and physical energy levels, gently reduce brain fog, support alertness, improve long-term cognitive wellness, providing a sense of calm and positivity, promoting emotional well-being, and improve mental agility and recall (see section “About this item”, reproduced below).
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The product details describe that the supplement composition was first available at this vendor on April 7, 2024, and were manufactured by “recomnd”. See reproduction below:
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Reviews of the product appear as early as June 2, 2024, before the effective filing date of the instant invention. Thus, it is evident that this product was publicly available and sold prior to the instant filing date.
Regarding the composition, the ingredients label is reproduced below:
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It is noted that the composition includes the following per serving:
Biotin- 15mcg; vitamin B1 (thiamine) - 600mcg; vitamin B2 (riboflavin) - 650mcg; vitamin B3 (niacinamide) – 8mg; vitamin B5 (pantothenic acid) - 2.5mg; vitamin B6 (pyridoxine HCL) - 850mcg; vitamin B12 (methylcobalamin) – 1.2 mcg; vitamin C (ascorbic acid) – 45mg; vitamin D3 (cholecalciferol) – 10mcg; Folate (folic acid, 334 mcg DFE) – 200mcg; “Dr. Beltran Cognitive Matrix” – 1263mg, which is said to contain: Alpha Deum, Reactivate ce, Ashwagandha Extract 8:1, Acto-Pro 10 (Ginseng Extract 10%), Ginkgo Biloba Extract- 24%; Lions Mane Extract 10%; Rhodiola rosea Extract- 3%; rosavins 1%; Turmeric Extract 10%; cognitive probiotic (100 billion) 2 billion cfu/serving; Black Pepper Extract 95%; Huperzine A 1%, as well as 89mg of caffeine per serving.
From the instant specification, the “Alpha Deum” ingredient is described as a Fermented Alpha GPC/Citoline Matrix ([0043]), and this appears to be the same ingredient used in “recomnd Nutrition - Clear Focus” and the “Reactivate ce” ingredient of the product page appears to be the same as “Fermented Green Tea Extract, L-Theanine, and Caffeine” (see e.g. the instant claim 10).
The label also describes that a serving size is 2 capsules, and that other ingredients include rice flour and silica magnesium stearate- common powder additives. Thus, this is evidence that the product is produced as a powder and encapsulated.
Thus, the product described on the product page of “recomnd Nutrition - Clear Focus” appears to be essentially the same as that of the instant claims, and this reference discloses all of the required ingredients of claim 1. Thus, the product description page anticipates the instant claim 1. Further, the additional elements of claims 2, 4-9, 11-12, and 14-20 are all taught either directly by the cited product page, or would have been inherent functional characteristics of the composition. Further, the recited uses in claims 9 and 18-20 amount to intended use and result in no structural difference of the composition, compared to the cited product.
For the amounts of the products described in claim 3, as best understood from the description, the product “recomnd Nutrition - Clear Focus” is deemed to fulfill all of these amounts. Although the exact amount of the “Alpha Deum” ingredient and the “Reactivate ce” mixture are not disclosed, the product appears to be essentially the same as that of the instant claim, and thus, absence any evidence to the contrary. Further, the ingredients that make up the “Dr. Beltran Cognitive Matrix” are stated to be provided at 1263mg in the product description, and the same ingredients as recited in the instant claims 3 and 13 adds up to 1263 mg, thus it appears to be the same mixture as previously sold. The product description is deemed to disclose a composition that is essentially identical to that of claim 3, as well as claims 10 and 13.
MPEP § 2112.01.I. describes that when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent, and that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
It is thus found that a product possessing the same structural composition, purported functional characteristics, and having the same uses as the compositions of claims 1-20 was publicly available and on sale as of April 7, 2024 prior to the instant effective filing date of November 27, 2024. See MPEP §§ 2152.02(c), 2152.02(d), 2152.02(e), and 2133.03(b).
Claims 1-20 are thus rejected as being anticipated by this public disclosure.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“Moaseri”, US PGPub No. 20230079480, discloses various compositions for oral consumption, which can comprise- from among a large list of possible active ingredients- vitamin C, vitamin D, and various vitamin Bs ([0292]-[0294]); molecules with nootropic function including at least alpha-GPC, caffeine, folic acid, hyperzine-A, and L-theanine ([0295]; see also [0603]: alpha-GPC and citicoline) various fungi and plant extracts classified as nootropics (ashwagandha, Ginkgo biloba, Panax ginseng, turmeric, Hericium erinaceus (i.e. lion's mane), and Rhodiola ([0352]; [0375]-[0376]); green tea extract ([0479]); strains, species, or mixtures of bacteria with probiotic properties ([0417]-[0419]); the bioenhancer piperine, an alkaloid isolated from Piper nigrum, black pepper ([0559]); and extracts of green tea leaves, described therein for weight loss ([0618]).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW TERRY MOEHLMAN whose telephone number is (571)270-0990. The examiner can normally be reached M-F 9am-5pm EST.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
