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
Claims 1-22 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-14 and 22 and the species of caproic acid, glycyrrihza glabra extract and zinc carnosine in the reply filed on 5/2/2024 is acknowledged. The traversal is on the ground that there is no serious burden on the Patent Office to examine all of the present claims because the subject matter of Groups I and II is sufficiently related that a search of the subject matter of Group II would encompass a search of the subject matter of Group I. This is not found persuasive because Groups I and Group II are drawn to different statutory categories of invention and examination of Group I is likely to raise serious examination issues under 35 U.S.C. 101. The subject matter eligibility issues for Group I are not relevant to the invention of Group II. See MPEP 808.02.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/2/2024.
Claims 1-14 and 22 are examined herein.
Specification
The use of the terms TRULICITY, BYETTA, VICTOZA, SAXENDA, ADLYXIN, WEGOVY, OZEMPIC, and RYBELSUS (see [0003]), which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 6, 9, and 14 are objected to because of the following informalities:
In claims 1 and 14, “anti-emetic” should be replaced with antiemetic.
In claims 6 and 9, Bacillus Coagulans is a scientific Latin name and should be written as Bacillus coagulans.
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 4-12 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.
Claim 4 recites “The composition of claim 1, comprising: at least one potassium compound, at least on magnesium compound…at least one probiotic…” It is unclear whether the composition is further comprising these additional components or whether claim 4 is further limiting the components already recited in claim 1 (amino acid source, dietary fiber, or the agent treating the additional side effect).
Claim 5 is indefinite for the at least one amino acid source comprises 12-28 grams per 6 oz (117.4 ml) serving of at least one protein. It is unclear whether the serving refers to the amino acid source or the composition as a whole. It is further unclear whether the claim scope is 12-28 grams per 6 oz, as ounces are both mass and volume measurements, or whether the claim scope is limited to the volume measurement since 117.4 ml is listed in parentheses.
Claims 5-8 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
Claim 9 is indefinite for Min (g) >0.000000 for flaxseed, leucine, Glycyrrhiza Glabra Extract, Zinc Carnosine, Amylase, etc. It is unclear whether the requirement is greater than zero, which is a range not a definitive number, or whether the minimum amount is zero.
Claims 10-12 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
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.
Claims 1-5, 13-14 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claim 1 is drawn to a composition comprising at least one amino acid source, at least one dietary fiber, and at least one bioactive agent selected from an anti-emetic agent, an anti-bloating agent, an anti-diarrheal agent, and an anti-constipation agent.
Claim 1 is drawn to a composition of matter, which is one of the four statutory categories of invention (Step 1: Yes). However, the composition of matter is also a product of nature judicial exception (Step 2A Prong One: Yes) because each of the claim limitations is met by a composition comprising Bacillus coagulans MTCC 5856 (anti-emetic, anti-bloating, and anti-diarrheal), oatmeal (dietary fiber and anti-constipation agent, see Johns Hopkins, page 2, Soluble Fiber paragraph), and soy protein (amino acid source) Bacillus coagulans MTCC 5856 is a naturally-occurring bacteria isolated from green malt (Australian Government; 2022 website; Definition of the ingredient, page 1). The bacteria is an anti-diarrheal as evidenced by Majeed et al. (J Clin Toxicol 6.283 (2016): 2161-0495; page 2, left column, paragraph 2) and also decreases bloating and vomiting (Majeed page 8, left column, paragraph 1). There is no evidence of record to support that the composition as a whole has markedly different characteristics than a product of nature.
The judicial exception is not integrated into a practical application (Step 2A Prong Two: No). The claim recites that the composition is “for consumption by an individual who is being treated with a GLP-1 agonist” but this is merely an intended use of the composition. The claim also recites that the composition is a premix or ready-to-drink supplement effective to alleviate at least one additional side effect of being treated with the GLP-1 agonist, said at least one additional side effect being selected from the group consisting of nausea, bloating, vomiting, diarrhea, and constipation. Formulation as a premix or ready-to-drink supplement is well-understood, routine, and conventional. For example, Ensure is a ready-to-drink supplement as evidenced by Ensure (2022, website, see “Ensure® Original Shake” on page 1). The properties of being able to treat additional side effects such as nausea, bloating, vomiting, diarrhea, and constipation are intrinsic properties of the products of nature.
Claim 2 recites the composition further comprises vitamins, minerals, and at least one probiotic. Vitamins, minerals, and probiotics are products of nature. Claim 3 recites the composition further comprises at least one alpha-linoleic acid (ALA) source, at least one medium chain triglyceride having a chain length of 6-12 carbons, leucine, glycyrrhiza glabra, at least one zinc compound, amylase, protease, lactase, cellulase, and lipase. Each of these components is a product of nature. For example, flaxseed is an ALA source (see dependent claim 8), medium chain triglycerides are present in whole milk fat as evidenced by ATP (page 1, “Where are these MCFAs found?”), leucine is a naturally occurring amino acid, glycyrrhiza glabra is a synonym for licorice, which is a plant, zinc is a naturally-occurring element, and the enzymes amylase, protease, lactase, cellulase, and lipase are all naturally occurring.
Claim 4 is also drawn to a product of nature judicial exception: each of the compounds are naturally occurring in minerals or other compounds. For example, choline is naturally present in eggs as evidenced by USDA (page 2, bottom 3 bullet points).
Claim 5 recites the amount per serving of the at least one protein but this is merely limiting the amount of the judicial exception and does not confer markedly different characteristics to the product of nature judicial exception, nor does the claim integrate the judicial exception into a practical application (Step 2A Prong One: Yes, Step 2A Prong Two: No). The claim does not present additional elements that amount to significantly more than the judicial exception (Step 2B: No).
Claims 13 and 22 are also drawn to the product of nature judicial exception, since naturally occurring Bacillus coagulans MTCC 5856 in combination oatmeal (dietary fiber) and soy protein (source of amino acids) meets each of the claim limitations. Dietary fiber decreases constipation and B. coagulans MTCC 5856 decreases bloating, diarrhea, and vomiting (Majeed, page 2, left column, paragraph 2; page 8, left column, paragraph 1).
Regarding claim 14, digestive enzymes, dietary fiber, probiotics, and glycyrrhiza glabra extract are all products of nature. The process of extraction is merely purification of a natural product and is insufficient to confer subject matter eligibility. Thus, claim 14 is also ineligible (Step 1: Yes, Step 2A Prong One: Yes; Step 2A Prong Two: No, Step 2B: No).
Examiner’s Comment
Claim 6 and its dependents are eligible under 35 U.S.C. 101 because, although some components of the composition are products of nature (e.g. biotin and lipase), the composition additionally contains multiple components that are not products of nature: digestion-resistant maltodextrin, dipotassium phosphate, magnesium bisglycinate dihydrate, copper gluconate, chromium polynicotinate, molybdenum glycinate chelate, choline bitartrate are all synthetic compounds. Claim 9 further comprises the synthetic compound zinc carnosine. Thus, claims 6-12 are eligible under 35 U.S.C. 101.
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.
Claims 1-2, 4, 13, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ensure (2022, website) in view of Majeed et al. (J Clin Toxicol 6.283 (2016): 2161-0495).
Regarding claims 1-2 and 4, Ensure teaches a shake (“ready to drink supplement”) comprising milk protein concentrate (“amino acid source,” see Ingredients on page 2), dietary fiber (Nutrition Information, page 2), vitamin B12, choline, potassium, magnesium, iron, manganese, copper, chromium, molybdenum, iodine, selenium, and chloride (Nutrition Information table pages 2-3). The intended use of the Ensure shake is to benefit patients experiencing involuntary weight loss by serving as a sole source of nutrition (paragraph 1 on page 1), thus the Ensure shake is capable of meeting the intended use alleviating loss of lean body mass, which is a side effect of being treated with a GLP-1 agonist.
Ensure does not teach that the shake further comprises a probiotic (anti-diarrheal agent).
Majeed teaches that Bacillus coagulans MTCC 5856 is a probiotic that produces the beneficial form of lactic acid in the intestines and inhibits the growth of pathogenic bacteria (page 2, left column, paragraph 2). Spores of Bacillus coagulans MTCC 5856 are able to withstand high temperature and are stable during processing and storage of various functional foods (page 2, left column, paragraph 2). Majeed teaches that Bacillus coagulans MTCC 5856 exhibits anti-diarrheal activity (page 2, left column, paragraph 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add Bacillus coagulans MTCC 5856 to the Ensure shake in order to improve the health benefits of the shake by inhibiting the growth of pathogenic bacteria in the gut. The person of ordinary skill in the art would have been motivated to use Bacillus coagulans MTCC 5856 in particular as a probiotic because of the strain’s stability in spore form. The person of ordinary skill in the art would have had a reasonable expectation of success in adding Bacillus coagulans MTCC 5856 to the shake in order to inhibit the growth of pathogenic bacteria in the gut.
Regarding claim 4, the modified shake is safe for human consumption because Ensure is already on the market for human consumption and Majeed teaches that Bacillus coagulans MTCC 5856 is safe for human consumption (Abstract Results).
Regarding claims 13 and 22, the shake of Ensure modified by Majeed comprises Bacillus coagulans MTCC 5856, which is an anti-diarrheal (Majeed page 2, left column, paragraph 2), and dietary fiber (Ensure nutrition information on page 2), which is an anti-constipation agent. Bacillus coagulans MTCC 5856 also decreases bloating and vomiting (page 8, left column, paragraph 1). The shake necessarily alleviates nausea because it decreases vomiting. The shake is effective to alleviate body mass because the shake comprises protein (Ensure, nutrition information on page 2).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ensure (2022, website) in view of Majeed et al. (J Clin Toxicol 6.283 (2016): 2161-0495), as applied to claims 1-2, 4, 13, and 22 above, further in view of Belldegrun et al. (US 2019/0388518 A1), Fallon et al. (US 2013/0323223 A1), Lactaid (2019, website), and Ortega et al. (EP 3 028 695 A2), and evidenced by Mohsen et al. (International Journal of Food Science and Technology 44.9 (2009): 1705-1712).
See discussion of the Ensure and Majeed above, which is incorporated into this rejection as well.
Ensure teaches the shake comprises a source of alpha-linoleic acid (page 1, Features, bullet point 3).
Ensure teaches that the shake comprises zinc sulfate (page 2, Ingredients).
Ensure teaches that the shake comprises soy protein isolate, which necessarily includes the amino acid leucine as evidenced by Mohsen (Table 1 on page 1706).
Although Ensure teaches the shake comprises omega-3 fatty acids (page 1, Features, bullet point 3), Ensure does not teach that the composition comprises medium-chain fatty acids such as caproic acid, caprylic acid, capric acid, or lauric acid.
Belldegrun teaches a nutritional supplement for dietary support comprising caproic acid, caprylic acid, capric acid and lauric acid (Abstract and Table 15 on page 21).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the fatty acids of Belldegrun with the Ensure modified by Majeed in order to further enhance the nutritional value of the supplement. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Ensure does not teach that the shake comprises amylase, protease, cellulase and lipase.
Fallon teaches a composition comprises amylase, protease, and lipase for the treatment of celiac disease (Fallon claim 1 and Abstract). Fallon teaches that symptoms of celiac disease include poor weight gain as well as deficiencies in vitamin B12 and other vitamins ([0014]). Fallon teaches the composition further comprises cellulase ([0091]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add the digestive enzymes amylase, lipase, protease, and cellulase to the composition of Ensure modified by Majeed and Belldegrun in order to further improve the digestibility of the composition for patients with celiacs disease. The person of ordinary skill in the art would have been motivated by the teaching of Fallon, who suggests that these enzymes are beneficial for these patients. The person of ordinary skill in the art would have had a reasonable expectation of success in the modified composition of Ensure.
Ensure does not teach that the digestive enzymes further comprise lactase. However, Ensure teaches that the shake comprises nonfat milk (page 2, Ingredients), which necessarily contains lactose.
Lactaid teaches a nonfat milk comprising lactase that decreases discomfort caused by lactose (page 1, summary, and page 2, “Lactase enzymes”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace the nonfat milk in Ensure with the lactase-containing milk of Lactaid in order to improve digestibility of the nonfit milk within the shake. The person of ordinary skill in the art would have had a reasonable expectation of success in replacing the nonfat milk in Ensure with Lactaid containing lactase.
Ensure teaches that the shake comprises natural and artificial flavors (page 3, Ingredients), but Ensure does not teach that the shake further comprises glycyrrhiza glabra extract.
Ortega teaches an antacid formulation for the prevention of acid reflux and/or other gastrointestinal maladies comprising deglycyrrhizinated licorice ([0005]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add Ortega’s deglycyrrhizinated licorice (“glycyrrhiza glabra extract”) to the shake in order to tailor the shake for subjects in need of nutrition but also suffering from gastrointestinal complaints, such as celiac patients. The person of ordinary skill in the art would have had a reasonable expectation of success in the addition of deglycyrrhizinated licorice (“glycyrrhiza glabra extract”) to the Ensure shake.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ensure (2022, website) in view of Majeed et al. (J Clin Toxicol 6.283 (2016): 2161-0495) as evidenced by Fiber Facts (2017, website).
See discussion of Ensure and Majeed above, which is incorporated into this rejection as well.
Regarding claim 5, Ensure teaches that the shake comprises 9 g protein per 8 ounce serving or 18% of daily value (page 2, Nutrition information) as well as corn maltodextrin (page 2, Ingredients). Corn maltodextrin is a dietary fiber and a prebiotic as evidenced by Fiber Facts (page 1, “Soluble Corn Fiber (Resistant Maltodextrin); “How is it processed in the body?”).
9 g protein per 8 oz is slightly below the claimed range of 12-28 grams per 6 oz.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to increase the amount of protein per serving such that the consumer would have ingested closer to the daily value of protein. The person of ordinary skill in the art would have had a reasonable expectation of success in increasing the amount of protein in the shake.
Claim 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ensure (2022, website) in view of Majeed et al. (J Clin Toxicol 6.283 (2016): 2161-0495), as applied to claims 1-2, 4, 13, and 22 above, further in view of Belldegrun et al. (US 2019/0388518 A1), Slaga et al. (WO 91/11117), Szajnar et al. (Journal of Elementology 22.2 (2017): 559-568.), and Kansakar et al. (Frontiers in endocrinology 14 (2023): 1148166; published 07 March 2023) and, and as evidenced by Fiber Facts (2017, website).
See discussion of Ensure and Majeed above, which is incorporated into this rejection as well.
Ensure taches the shake includes milk (page 2, Ingredients), so the shake necessarily contains milk calcium complex (complex of minerals naturally occurring in milk).
Ensure teaches that the shake comprises corn maltodextrin, ascorbic acid, alpha tocopherol acetate, niacinamide, pyridoxine hydrochloride, vitamin A palmitate, riboflavin, folic acid, phytonadione, vitamin D3 (cholecalciferol), vitamin B12 (cyanocobalamin), ferrous sulfate, manganese sulfate, potassium iodide (page 2, Ingredients).
Corn maltodextrin is digestion-resistant as evidenced by Fiber Facts (see Title on page 1).
Ensure does not teach that the shake comprises menaquinone 7.
Belldegrun teaches a dietary formulation comprising vitamins and minerals (Abstract) including menaquinone 7 ([0191]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add menaquinone-7 to the shake of Ensure modified by Majeed in order to further enhance the nutritional benefits of the shake. The person of ordinary skill in the art would have had a reasonable expectation of success in adding menaquinone-7 to the shake.
Ensure does not teach that the shake includes thiamin mononitrate, dipotassium phosphate, copper gluconate, or molybdenum glycinate chelate. Although Ensure teaches that the shake comprises selenium (page 3, Nutrition information table), Ensure does not teach that the supplement shake comprises L-Selenomethionine. Although Ensure teaches that the shake comprises chromium (page 3, Nutrition information table), Ensure does not teach that the supplement shake comprises chromium polynicotinate.
Slaga teaches a dietary supplement including thiamine mononitrate (Abstract and (lines 42-43 on page 22), dipotassium phosphate (line 13 on page 27), copper gluconate (line 4 on page 19), molybdenum glycinate (line 14 on page 29), which is necessarily a chelate. Slaga also teaches that the dietary supplement contains selenomethionine: see line 15 on page 20. Both D- and L-enantiomers are encompassed by the generic term “selenomethionine.” Slaga teaches that the dietary supplement comprises chromium polynicotinate (line 37 on page 28).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add dipotassium phosphate, thiamin mononitrate, copper gluconate, and molybdenum glycinate to the shake of Ensure modified by Majeed in order to further enhance the nutritional benefits of the shake. The person of ordinary skill in the art would have had a reasonable expectation of success in adding thiamin mononitrate, dipotassium phosphate, copper gluconate, and molybdenum glycinate to the shake.
Ensure does not teach that the shake comprises whey protein concentrate and whey protein isolate. Rather, Ensure teaches that the shake includes soy protein isolate (page 2, Ingredients).
Slaga teaches the supplement includes whey protein hydrolysate ([0007]). Hydrolysate is both a concentrate and an isolate.
It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace the soy protein isolate with when protein hydrolysate (“concentrate and isolate”) in order to design a shake suitable for individuals with soy allergies. The person of ordinary skill in the art would have had a reasonable expectation of success in replacing soy protein isolate with whey protein isolate.
Although Ensure teaches that the shake comprises magnesium (page 3, Nutrition information table), Ensure does not teach that the supplement shake comprises magnesium bisglycinate dihydrate or magnesium lactate.
Szajnar teaches fortifying milk with several different magnesium compounds during the yogurt fermentation process, including both magnesium lactate and magnesium bisglycinate (Fig. 2). Szajnar teaches hydrates of different metal salts used in milk fortification (page 565, paragraph 3).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add any of the magnesium salts taught by Szajnar, including magnesium bisglycinate and magnesium lactate, or any hydrate of the magnesium salts (e.g. dihydrate) as the source of magnesium in the shake of Ensure modified by Majeed and others. The person of ordinary skill in the art would have been motivated by the teaching of Szajnar, who suggests both magnesium lactate and magnesium bisglycinate are suitable for supplementation. The person of ordinary skill in the art would have had a reasonable expectation of success in adding these magnesium salts to the shake.
Although Ensure teaches that the shake comprises choline (page 3, Nutrition information table), Ensure does not teach that the supplement shake comprises choline bitartrate.
Kansakar teaches that choline bitartrate is readily soluble in water and widely used for choline supplementation (page 5, left column, paragraphs 1-2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to specifically use choline bitartrate; as the source of choline in the shake of Ensure modified by Majeed and others because it is widely commercially used as a choline supplement and water soluble. The person of ordinary skill in the art would have had a reasonable expectation of success in using choline bitartrate; in the shake.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ensure (2022, website) in view of Majeed et al. (J Clin Toxicol 6.283 (2016): 2161-0495), Belldegrun et al. (US 2019/0388518 A1), Slaga et al. (WO 91/11117), Szajnar et al. (Journal of Elementology 22.2 (2017): 559-568.), and Kansakar et al. (Frontiers in endocrinology 14 (2023): 1148166) as evidenced by Fiber Facts (2017, website), as applied to claim 6 above, further in view of Fallon et al. (US 2013/0323223 A1), Ortega et al. (EP 3 028 695 A2), and Lactaid (2019, website) and evidenced by Mohsen et al. (International Journal of Food Science and Technology 44.9 (2009): 1705-1712).
See discussion of the cited references above, which is incorporated into this rejection as well.
Ensure teaches the shake comprises a source of alpha-linoleic acid (page 1, Features, bullet point 3).
Ensure teaches that the shake comprises zinc sulfate (page 2, Ingredients).
Ensure teaches that the shake comprises soy protein isolate, which necessarily includes the amino acid leucine as evidenced by Mohsen (Table 1 on page 1706).
Although Ensure teaches the shake comprises omega-3 fatty acids (page 1, Features, bullet point 3), Ensure does not teach that the composition comprises medium-chain fatty acids such as caproic acid, caprylic acid, capric acid, or lauric acid.
Belldegrun teaches a nutritional supplement for dietary support comprising caproic acid, caprylic acid, capric acid and lauric acid (Abstract and Table 15 on page 21).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the fatty acids of Belldegrun with the composition of Ensure modified by Majeed and others in order to further enhance the nutritional value of the supplement. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Ensure does not teach that the shake comprises amylase, protease, cellulase and lipase.
Fallon teaches a composition comprises amylase, protease, and lipase (Fallon claim 1) for the treatment of celiac disease. Fallon teaches that symptoms of celiac disease include poor weight gain as well as deficiencies in vitamin B12 and other vitamins ([0014]). Fallon teaches the composition further comprises cellulase ([0091]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add the digestive enzymes amylase, lipase, protease, and cellulase to the composition of Ensure modified by Majeed and others in order to further improve the digestibility of the composition for patients with celiacs disease. The person of ordinary skill in the art would have been motivated by the teaching of Fallon, who suggests that these enzymes are beneficial for these patients. The person of ordinary skill in the art would have had a reasonable expectation of success in this modification.
Ensure does not teach that the digestive enzymes further comprise lactase. However, Ensure teaches that the shake comprises nonfat milk (page 2, Ingredients), which necessarily contains lactose.
Lactaid teaches a nonfat milk comprising lactase that decreases discomfort caused by lactose (page 1, summary, and page 2, “Lactase enzymes”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace the nonfat milk in Ensure with Lactaid containing lactase enzyme in order to improve digestibility of the nonfit milk within the shake. The person of ordinary skill in the art would have had a reasonable expectation of success in replacing the nonfat milk in Ensure with Lactaid containing lactase.
Ensure teaches that the shake comprises natural and artificial flavors (page 3, Ingredients), but Ensure does not teach that the shake further comprises glycyrrhiza glabra extract or zinc carnosine.
Ortega teaches an antacid formulation for the prevention of acid reflux and/or other gastrointestinal maladies comprising deglycyrrhizinated licorice and zinc L-carnosine ([0005]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add Ortega’s deglycyrrhizinated licorice (“glycyrrhiza glabra extract”) and zinc carnosine to the shake in order to tailor the shake for subjects in need of nutrition but also suffering from gastrointestinal complaints. The person of ordinary skill in the art would have had a reasonable expectation of success in the addition of deglycyrrhizinated licorice and zinc carnosine to the Ensure shake.
Regarding claim 8, Ensure teaches that the shake comprises zinc sulfate (page 2, Ingredients).
Ensure teaches that the composition comprises alpha linoleic acid (page 1, Features, bullet point 3). However, Ensure does not teach that the source of AHA is flaxseed. Ensure teaches that the ingredients comprise a blend of vegetable oils including canola and corn (Ingredients, page 2). Ensure teaches that the shake contains 6 g of fat per serving, which is 8% of DV (page 2, Nutrition Information).
Belldegrun teaches that the nutritional supplement for dietary support comprises flaxseed oil ([0171]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Belldegrun’s flaxseed oil with the shake of Ensure modified by Majeed and others in order to increase the increase the fat content of the shake, thus increasing the percentage of the recommended daily value per serving. The person of ordinary skill in the art would have had a reasonable expectation of success in adding flaxseed oil to the Ensure shake modified by Majeed and others.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ensure (2022, website) in view of Majeed et al. (J Clin Toxicol 6.283 (2016): 2161-0495), as applied to claims 1-2, 4, 13, and 22 above, further in view of Lactaid (2019, website).
See discussion of Ensure and Majeed above, which is incorporated into this rejection as well.
The shake of Ensure modified by Majeed comprises Bacillus coagulans MTCC 5856, which is an anti-diarrheal (Majeed page 2, left column, paragraph 2), dietary fiber (Ensure, page 2, Nutrition Information), which is an “anti-constipation agent.” Bacillus coagulans MTCC 5856 also decreases bloating and vomiting (page 8, left column, paragraph 1).
Ensure does not teach that the shake comprises at least one digestive enzyme that is an antiemetic agent.
Lactaid teaches a nonfat milk comprising lactase that decreases discomfort caused by lactose (page 1, summary, and page 2, “Lactase enzymes”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace the nonfat milk in Ensure with Lactaid containing lactase enzyme in order to improve digestibility of the nonfit milk within the shake. The person of ordinary skill in the art would have had a reasonable expectation of success in replacing the nonfat milk in Ensure with Lactaid containing lactase. The presence of lactase necessarily acts as an antiemetic (prevents vomiting) for people with lactose intolerance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657