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 .
DETAILED ACTION
Status of the Claims
Claims 1-5 are presented for examination on the merits for patentability.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/25/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities: p. 29 appears to have a misspelling, wherein “protectin D1” is misspelled as “Protein D1”. Appropriate correction is required. Please review Specification throughout for grammar and spelling.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because: Fig. 1 contains grammatical errors and misspellings. Furthermore, Figs. 1, 6,7 are blurry including the legend and axis, making them illegible. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 3 is objected to because of the following informalities: “Sacharomyces” is misspelled in Claim 3, and should be spelled as Saccharomyces.
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 1-5 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 are generally narrative and indefinite, failing to conform with current U.S. practice. The claims are replete with grammatical errors, including run-on sentences, and are highly repetitive, making it difficult to ascertain the scope being claimed. For example, Claim 1 recites “A comprehensive nutritional support system suitable for a human being comprising nutrition, metabolic support and neurological remodeling support stages characterized in that it comprises the administration of a nutraceutical composition and/or dietary composition and/or food supplement and/or food complement and/or therapeutic composition…”. First, it is unclear what is considered “comprehensive”. Claim 1 repeats the requirement for “at least one protein of animal and/or plant (or vegetable) origin”, and the Examiner cannot ascertain whether Applicant is referring to another protein or not. As such, the metes and bounds of the claims are unclear, and the claims are rejected.
Claim 1 is indefinite because it recites a comprehensive nutritional support “system”, which could be either a product or an apparatus; however the claims describes steps of administration that would seem to indicate a method is being claimed. Therefore, it is unclear what statutory class the claim is being claimed under. For the purpose of compact prosecution, the claim will be examined as a product claim, however, clarification is required. The examiner notes that a statement by applicant that system is intended to mean product/apparatus would be sufficient to overcome this rejection.
Claim 1 is further rejected for reciting “one tree and/or tree bark and/or tree stem and/or tree leaves and/or tree roots” and “at least one plant and/or plant stem and/or plant leaves and/or plant roots”. It is unclear what is encompassed by “tree” and what is encompassed by “plant”. As such, the metes and bounds of the claim is unclear, and the claims are rejected. All dependent claims are also rejected.
Claim 1 recites “SARS (SARS-CoV-1 and SARS-CoV-1)”. It is unclear what the Applicant mean with the use of parentheses, i.e. whether Applicant is limiting the SARS virus or not to only SARS-CoV-1 and SARS-CoV-1. Thus, the metes and bounds of the claims cannot be determined, and the claim are rejected. Should Applicant be attempting to narrow the “SARS” limitation, then Claim 1 is also rejected because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation in the same claim is 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). The claim is 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. Similarly, Claim 3 is indefinite for reciting “brewer’s yeast”, which is a broad recitation, and “Saccharomyces cerevisiae”, which is the narrow limitation falling within the broad limitation.
Claim 2 requires “at least two smoothies per day” and “where smoothie A is administered at breakfast alone or in combination with smoothie B, and smoothie A is administered at dinner”. Based on the phrasing, smoothie B appears to be optional, i.e. it is unclear whether smoothie B is required. Clarification is required.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-2 and 5 are rejected under 35 U.S.C. 103 as obvious over Brooks et al. (US 2010/0297295 A1), hereinafter Brooks.
Brooks discloses novel beverages and raw materials containing microalgae with varying components and formulated for (Abstract).
Regarding Claim 1 Brooks teaches foodstuffs, and specific embodiments wherein the beverage is a milk, a juice, a smoothie, a nutritional beverage, an eggnog, and a meal replacement beverage for human or animal nutrition, which necessarily means that the system is administered orally ([0003], [0012], [0051]). Brooks teaches fruit, vegetables, proteins, carbohydrate and fats, which reads on the lipid, grains such as oats, which reads on cereal, fatty acid, vitamin, mineral, probiotic, artichoke, potato and taro flour, which reads on the tuber ([0045], [0174], [0219], [0245]). Because Brooks teaches protein, and teaches algal biomass, which comprises amino acids, Brooks therefore teaches amino acid (Examples 7 and 17-18; [0285]; Tables 20-22). Brooks teaches Chlorella, Spirulina etc. which reads on the cyanobacteria ([0006], [0097]). Brooks also teaches polyunsaturated fatty acids (PUFA), including docosahexanoic acid (DHA), which is an omega-3 fatty acid, reading on the at least one n-3 PUFA ([0007], [0197]). Brooks teaches obtaining oils from seeds such as pumpkin seed, mustard seed, etc. [0068]. Brooks teaches dried stalks and leaves of a crop, reading on plant/tree stems and leaves ([0081], [0113]. Finally, Brooks teaches different types of milk including algal milk, soy milk, rice milk, and almond milk ([0343], Claim 33).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the components taught by Brooks to make a nutritional beverage. This is a situation where elements of references are combined in a predictable manner so that the elements retain their function. All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding Claim 2, Brooks expressly claims the beverage is a smoothie, and teaches wherein the microalgal biomass is first combined with a second edible liquid to form a slurry and the slurry is then combined with the edible liquid to form the beverage, which reads on the smoothies (Claim 13). The nutritional or dietary supplements containing algal biomass can be taken on a daily basis e.g., 1-4 capsules or tablets per day; and be presented in sachets as a ready-to-mix material e.g., with water, juice, milk or other liquids [0238]. Books teaches a weight management smoothie containing intact high oil comprising distilled water (815 .365 g), stabilizer (4.5 g), apple juice concentrate (58 g), orange juice concentrate (46.3 7 6 g), lemon juice concentrate (1.913 g), mango puree concentrate (42.5 g), banana puree (40.656 g), passionfruit juice concentrate (8.4 g), ascorbic acid (0.320 g), algal flakes (46.41 g), orange flavor extract (1 g), pineapple flavor (0.4 g) and mango flavor (0.16 g) [0278]. Brooks teaches the following claimed components for smoothie A: grape seed oil [0024]; amaranth [0325]; oatmeal [0277]; avocado [0068]; egg whites [0336]; cinnamon [0277]; and almond milk (Claim 13); triglyceride oil , which reads on the lipids (Claims 1 and 19); the algal biomass comprises at least 40% protein (Claim 1); and 25-40% carbohydrates (Claim 20).
One skilled in the art would know to drink the smoothie once or more daily according to their desire or nutritional need, and would adjust the amounts of the components according to their desire or need, and achieve the optimal consistency, viscosity, flavoring etc. See In re Levin. Id.
Regarding the recitation of the intended uses in Claims 1, 2, and 5: “suitable for a human being…”, “comprises the administration of a nutraceutical composition…”, “and for the treatment of gastrointestinal diseases, mental motor diseases such as cerebral palsy and virus immune diseases…” in Claim 1; “administered…at least two smoothies per day” and “where smoothie A is administered at breakfast alone or in combination with smoothie B, and smoothie A is administered at dinner” in Claim 2; and “because the condition to be treated is cerebral palsy and COVID-19” in Claim 5, nothing precludes the use of the compound/composition of the prior art Brooks as instantly claimed (see MPEP 2112.02(II), nor does the recitation impart any structural characteristic that would distinguish it from the prior art compound/composition. "It is not invention to perceive that the product which others had discovered had qualities they failed to detect". See 67 USPQ 155, 326 US 242, 249 (1945). The intended use of the claimed composition does not patentably distinguish the composition per se, because such undisclosed use is inherent in the reference composition.
Claims 3-4 are rejected under 35 U.S.C. 103 as obvious over Brooks, as applied to Claim 1, and in view of Wang et al. ("Resveratrol and Spirulina: Nutraceuticals that Potentially Improve Cardiovascular Disease." Journal of Cardiovascular Development and Disease 7.2 (2020): 138-145.), hereinafter Wang, and Mottet, R. (The Effects of Prebiotic Fiber Inulin on Satiety and Gastrointestinal Tolerance and Prebiotic Properties of a Yeast Fermentate In Vitro. Diss. University of Minnesota, Aug 2020.), hereinafter Mottet, and Durante, W. ("The emerging role of L-glutamine in cardiovascular health and disease." Nutrients 11.9 (2019): 2092.), hereinafter Durante.
Regarding Claim 3, Brooks relates that the algal biomass may contain antioxidant or preservative to maximize shelf life, such as ascorbic acid, and has expressly taught a smoothie with ascorbic acid, which reads on vitamin C ([0243], [0273]). Brooks also teaches essential minerals including zinc, magnesium, and selenium ([0086], [0201]). The algal biomass also contains arginine (Example 7). Brooks further teaches inulin soluble fiber in a cardio/metabolic health bar comprising the algal biomass and oats (Example 9). Brooks does not expressly recite folic acid, which is Vitamin B9, but teaches B-complex vitamins which encompasses folic acid [0126]. Brooks also teaches niacin, which is the same as nicotinic acid [0126]. The algal milk of Brooks comprises heart healthy lipids, essential amino acids, and vitamin D, which encompasses cholecalciferol [0285]-[0286].
Brooks does not teach Spirulina Maxima, resveratrol, glutamine, and Saccharomyces Boulardii.
Wang also teaches nutraceutical systems comprising two dietary supplements - resveratrol and spirulina, which and widely popular in the nutraceutical market, with both having cardioprotective effects (pp. 138 and 141; Figs. 2 and 3). Wang describes how Spirulina maxima and plantesis have been widely cultivated for its massive nutritional value, consisting of 70% vitamins (including B12 and provitamin A), minerals, and fatty acids (p. 139, L. Col.). Wang relates that resveratrol exerts effects on multiple anti-inflammatory targets (p. 140).
Mottet comprehends the prevalence of cardiovascular disease (CVD), type 2 diabetes, obesity, hypertension, and associated inflammatory conditions, and discloses the promotion of healthy bodyweight through enhanced satiety using prebiotics (Abstract). Mottet discloses the effect of incorporating inulin from artichokes into breakfast smoothie (p. iv). Mottet also relates identifying new prebiotics, specifically measuring the prebiotic properties of a yeast fermentate (p. v). Mottet teaches the most well-known yeast in health and nutrition being Saccharomyces cerevisae, also known as brewer’s yeast and baker’s yeast, and relates studies on Saccharomyces boulardii or Saccharomyces cerevisiae as a potential bio-therapeutic agent (probiotic) for the treatment of microbes associated with diarrhea and colitis by antimicrobial and contribution of micronutrients, antioxidants, amino acids, and other bioactive compounds (p. 26).
Durante relates that amino acids play a fundamental role in the cardiovascular system, as an important energy source, with glutamine the metabolism and function affects cardiovascular physiology and pathology (pp. 1-2, 7-8). Durante teaches oral administration of Gln improves glucose tolerance in subjects with or without diabetes, while chronic dietary supplementation of Gln reduces systolic blood pressure, fasting blood glucose, and improves body composition in patients with type 2 diabetes (p. 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine resveratrol and Spirulina maxima taught by Wang, glutamine of Durante, and the Saccharomyces Boulardii taught by Mottet in the smoothie or nutrient systems of Brooks to obtain their additional beneficial effects as supplements and add-on therapies, such as beneficial for the cardiovascular system. Further, as a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached on M-F, 10-6 EST.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792