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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 10/29/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: the 35 U.S.C. 112(d) rejections of claims 24, 52, and 80 have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-84
Withdrawn claims: None
Previously canceled claims: None
Newly canceled claims: 24, 52, and 80
Amended claims: 1, 29, 57, and 82
New claims: 85 and 86
Claims currently under consideration: 1-23, 25-51, 53-79, and 81-86
Currently rejected claims: 1-23, 25-51, 53-79, and 81-86
Allowed claims: None
Claim Rejections - 35 USC § 103
NOTE: The claims are addressed separately in three groups that are roughly equivalent: 1-28 and 85; 29-56; and 57-84 and 86. Thus, even though claim rejections from corresponding claims may rely on the same combination of prior art references, the claim rejections do not group any claims from the three separate groups together (e.g., claims 1 and 29) in order to maintain clarity. The rejections of the corresponding claims in each group are essentially substantively identical.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 11-23, 25, 26, and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1).
Regarding claim 1, Bhagat discloses a diet package system that may be provided in various discrete packages ([0012], where the packages may be indicated for use “three times daily”), and where the individual packages may comprise “drinks, snacks, meals, desserts, cereals, salad, side dish, sauces, desserts, spreads, etc.” ([0015], [0017]) in the form of “legume, grain, vegetable, fruit, meat, seafood, herb, spice, nut, seeds, oil, or butter” ([0039]-[0040]), and where the package may recite printed instructions specifying consumption of the meal portions during a single-day fasting interval within 12-24 hours ([0012], where the packages may be marked to provide frequency of consumption, including three times daily or once daily).
Though Bhagat does not explicitly disclose a diet package providing breakfast, lunch, and dinner meal portions for a one-day fast that comprises three meal portions comprising the claimed components, the claimed diet package would be obvious in view of the disclosure of Bhagat for the following combination of reasons.
First, the claim is merely directed to a composite package comprising individually-packaged food elements that are all known food components, as will be established subsequently herein. Bhagat is so broad that it renders the inclusion of any known food components into packages in order to form a composite food package obvious, since the reference discloses that the food components may comprise “legume, grain, vegetable, fruit, meat, seafood, herb, spice, nut, seeds, oil, or butter” ([0039]-[0040]) and sweeteners ([0044]) that may variously constitute “drinks, snacks, meals, desserts, cereals, salad, side dish, sauces, desserts, spreads, etc.” ([0015], [0017]).
The descriptions of the package as being a “fasting mimicking diet package providing breakfast, lunch, and dinner meal portions for a one-day fast” constitute statements of intended use and/or designations that do not materially limit the claimed composite food package. MPEP 2111.02.
Regarding a composition claim that is merely directed to a combination of food ingredients, please note In re Levin, 84 USPQ 232, and the cases cited therein, which are pertinent to such a claim. The court in Levin states:
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. Levin at 234.
The present claim does not require any coaction or cooperative relationship between any of the selected ingredients, especially one that produces a new/unexpected/useful function, and also does not require a minimum amount of any of the claimed components or the exclusion of any additional ingredients. The package merely is required to contain some “meal portion” that contains at least some minimal amount of the noted food components.
Given the determination that the general disclosure of Bhagat renders obvious the incorporation of essentially any food component into a diet package, the individually-claimed components are considered and shown to be known as food components as follows.
Bhagat discloses the food components as including:
a nut-containing ([0143]) nutrition bar ([0015]);
a micronutritional vegetable ([0141]) powder ([0142]) including vitamin and mineral supplements ([0082]-[0083]);
an oil composition ([0143]);
a soup composition ([0123], where a combination of vegetables, legumes, meat, herbs, and milks that may be in the form of a liquid or semi-liquid would be fairly deemed a “soup”);
a kale cracker composition ([0141], kale; [0123], “a bakery food product such as a bread”), and
an olive-containing composition ([0013]).
Duplication of any of the components, including the nut-containing composition and the soup composition, would be obvious. MPEP 2144.04 VI B (“mere duplication of parts has no patentable significance unless a new and unexpected result is produced”).
Raney et al. discloses algal oil in particular as being suited for use in food products ([0006], [0119]) as a source DHA ([0074]). A skilled practitioner would find the incorporation of algal oil into the package as taught by Bhagat to be obvious, since Bhagat teaches generally that the package may include an edible oil ([0143]) and indicates a preference for the inclusion of DHA ([0013]) and Raney et al. teaches algal oil as being suited as a source of DHA for use in food products.
As for claim 2, Bhagat discloses the inclusion of tea that may include lemon ([0180], Table 5, “Spices” and “Beverages”).
As for claim 3, Bhagat discloses the nut bar as containing almonds, macadamia, and pecan ([0143]). Raney et al. discloses the algal oil composition as including DHA ([0074]) and an Aurantiochytrium algal oil ([0069]).
As for claim 4, Bhagat discloses the inclusion of inulin ([0084]-[0086]), almonds ([0143]), almond butter ([0143], [0011]), crispy brown rice ([0141]), cocoa powder ([0141]-[0142]), flaxseed oil ([0143], [0119], Table 3, Lignans), rice dextrin ([0086], [0141]), grape juice ([0141], where grapes would comprise grape juice), and salt ([0082], where supplementation with sodium and chloride is considered to constitute salt). Bhagat further discloses the inclusion of chocolate (p. 7, Table 1, Flavonoids/Thearubigins; [0040]-[0041]). MPEP 2144.04 IV A/B indicates that changes in size/shape are insufficient to patentably distinguish a claimed product from the prior art, such that the disclosure in Bhagat of the use of chocolate is adequate to deem the use of chocolate chips obvious. Bhagat also discloses the inclusion of oats ([0141]), which renders the inclusion of any type of oats obvious, including rolled oats. Inclusion of these components in a second nut bar is within the scope of the disclosure of Bhagat in terms of the types of food components the ingredients may be contained in, as detailed previously in relation to claim 1.
As for claim 5, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious, such that any relative sizes between the first and second nut bars would be obvious. Bhagat further discloses the compositions as comprising almonds, macadamias, pecans ([0143]), honey ([0144]), flaxseed ([0143]), coconut flour ([0143]), and rosemary extract ([0141]).
As for claim 6, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious, such that any relative sizes between the first and second nut bars would be obvious. Bhagat further discloses the compositions as comprising almonds, macadamias, pecans ([0143]), honey ([0144]), flaxseed ([0143]), coconut flour ([0143]), and rosemary extract ([0141]).
As for claim 7, Bhagat discloses the compositions as comprising almonds, macadamias, pecans ([0143]), and blueberries ([0141]).
As for claim 11, Bhagat discloses the compositions as comprising almonds ([0143]), kale ([0141]), sesame seeds ([0143]), and tapioca flour ([0031], [0142], where a dry powder is considered to be a flour).
As for claim 12, Bhagat discloses the compositions as comprising almonds ([0143]), kale ([0141]), sesame seeds ([0143]), tapioca flour ([0031], [0142], where a dry powder is considered to be a flour), chia seeds ([0066]), flax seeds ([0143]), sunflower oil ([0026]), salt ([0082], where supplementation with sodium and chloride is considered to constitute salt), coconut sugar ([0143]), vinegar, chili pepper, black pepper, garlic, cumin seed, oregano (p. 23, Table 5, Spices), onion ([0141]), tocopherols ([0083]), and citric acid ([0141], as part of lemon or lime).
As for claim 13, Bhagat discloses the compositions as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), and yeast extract ([0144], [0142]).
As for claim 14, Bhagat discloses the compositions as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), yeast extract ([0144], [0142]), and tomato ([0141]).
As for claim 15, Bhagat discloses the composition as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), yeast extract ([0144], [0142]), tomato, basil, parsley, and whole grain brown rice ([0141]).
As for claims 16-18, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious. Claim 1 does not require any amount of any component, which thus may be in any size. A package size that provides 75% or less (claim 16), 50% or less (claim 17), or 25% or less (claim 18) of a daily recommended caloric intake for a subject would thus be obvious, since an especially small package would be presumed to fall well below the claimed threshold values.
As for claims 19-23, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious. Claim 1 does not require any amount or relative amount of any component, which thus may be in any size and provide any amount of each individual type of nutrient. Thus, providing a package wherein the combination of all components falls within the claimed ranges for fat, sugar, and protein, would be obvious to a skilled practitioner.
As for claims 25 and 26, Bhagat discloses administering the diet to a subject in need of inducing differential effects on disease factors and markers associated with aging (claim 25), including cholesterol (hypercholesterolemia) and triglycerides (weight gain, obesity) (claim 26) ([0014]).
As for claim 85, Bhagat discloses administering the diet daily ([0012]). The presently-claimed method occurs for only one day and does not require anything beyond that day; the method is considered complete upon the administration of one day’s worth of the diet. Following the completion of the method, a person would be free to consume whatever he may chose, including a second-day regimen of the diet, resumption of a regular diet, or fasting.
Claims 8, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 1 above, and further in view of Longo et al. (U.S. 2015/0004280 A1).
Regarding claim 8, Bhagat discloses the compositions as comprising vitamins A, E, K, B12, Ca, Fe, Cu, Mg, Mn, Se, and Zn ([0082]), vitamin C ([0074]), vitamin B6 ([0090]), vitamin B9 ([0083]).
Bhagat does not disclose the compositions as comprising D3, B1, B2, B3, B5, B7, iodine, chromium, or molybdenum.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include vitamins D3, B1, B2, B3, B5, and B7, as well as iodine (potassium iodide), chromium (chromium picolinate), and molybdenum (sodium molybdate) ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Regarding claims 27 and 28, Bhagat and Raney et al. disclose the composition of claim 1.
The cited prior art does not specifically disclose a method for promoting and inducing stem-cell based regeneration of multiple organs and systems in a subject in need thereof comprising administering the composition of claim 1 (claims 27) where the health benefit includes one of neurogenesis, hematopoiesis, or promotion of pancreatic beta-cells (claim 28).
However, Longo et al. discloses a method of promoting pancreatic beta-cell regeneration via the administration of a diet ([0003], [0008], [0032]).
It would have been obvious to one having ordinary skill in the art to administer the composition of claim 1 as taught in Bhagat to a subject in need of promotion and induction of stem-cell based regeneration of systems, including pancreatic beta cells. Bhagat indicates that the diet is suited for the treatment of diabetes ([0014]) but does not provide detail regarding the nature of such a disorder. A skilled practitioner would be motivated to consult Longo et al. for further instruction in determining that diabetes is “characterized by progressive beta-cell failure” ([0006]). Since Longo et al. discloses that diabetes is characterized by beta-cell failure and teaches that administration of the diet treats such a condition ([0008]), a skilled practitioner would recognize that the treatment of diabetes as taught in Bhagat via the administration of a comparable diet would likely occur in a similar manner via the improvement of the beta-cell damage. As such, the claimed method of promoting and inducing stem-cell based regeneration of a system in a subject in need thereof comprising administering the composition of claim 1 (claims 27) where the health benefit includes promotion of pancreatic beta-cells (claim 28) would be obvious to a skilled practitioner.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 1 above, and further in view of Longo et al. (U.S. 2015/0004280 A1), Rifkin (U.S. 2013/0287899 A1), Knutzon (U.S. 2010/0310710 A1), and Theuer (U.S. 5,837,309).
Regarding claim 9, Bhagat discloses compositions as comprising carrots, kale leaf, tomatoes, spinach ([0141]), collard leaf powder ([0141]-[0142]), ascorbic acid ([0025], [0074]), beta carotene ([0150]), and folic acid ([0082]).
Bhagat does not disclose the compositions as comprising the remaining components.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include calcium carbonate, cholecalciferol, chromium picolinate, cupric sulfate, cyanocobalamin, DI-alpha tocopherol acetate, ferrous fumarate, manganese sulfate, niacinamide, phytonadione, potassium iodine, pyridoxine HCl, riboflavin, sodium selenate, thiamine mononitrate, sodium molybdate, zinc oxide ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Rifkin discloses a food product comprising functional ingredients ([0001]) that may include pantothenic acid ([0069], [0071]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising pantothenic acid. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Rifkin, in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of pantothenic acid in Rifkin as a functional ingredient of a food product renders its inclusion in the composition of Bhagat obvious.
Knutzon et al. discloses the addition of magnesium stearate to an edible product as a lubricant ([0125]). Knutzon et al. discloses the addition of tribasic calcium phosphate as a vitamin supplement in a milk substitute ([0196], [0203], [0206]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising magnesium stearate and tribasic calcium phosphate. Bhagat teaches the compositions may be administered as a capsule comprising a lubricant ([0125]) but does not detail suitable lubricants. A skilled practitioner would be motivated to consult Knutzon et al. for detail regarding a suitable lubricant. Since Knutzon et al. disclose the use of magnesium stearate as a lubricant in a capsule delivery form ([0125]), the inclusion of magnesium stearate in the composition of Bhagat would be obvious. Further, Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Knutzon et al., in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of tribasic calcium phosphate in Knutzon et al. as a vitamin supplement of a food product renders its inclusion in the composition of Bhagat obvious.
Theuer et al. discloses beet root powder for use as a food coloring agent (C9, L12-L15) in baby foods (C6, L47-L49).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising beet root powder. Bhagat teaches that the compositions may be prepared as baby foods ([0017], [0124]), which would prompt a skilled practitioner to consult Theuer et al. for clarification regarding ingredients typically included in baby foods. Since Theuer et al. teaches the addition of beet root powder as a coloring agent in baby foods (C9, L12-L15; C6, L47-L49), the inclusion of beet root powder in compositions of Bhagat would be obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 1 above, and further in view of Longo et al. (U.S. 2015/0004280 A1), Rifkin (U.S. 2013/0287899 A1), and Theuer (U.S. 5,837,309).
Regarding claim 10, Bhagat discloses the compositions as comprising vitamins A, D, E, B12, Ca, Fe, Cu, Mg, Mn, Se, and Zn ([0082]), vitamin C ([0074]), vitamin B6 ([0090]), vitamin B9 ([0083]), folic acid, calcium, iron, magnesium, zinc, selenium, copper, manganese ([0082]), kale leaves, carrot root, spinach leaves, and tomatoes ([0141]).
Bhagat does not disclose the compositions as comprising vitamins B1, B2, B3, K1, biotin, pantothenic acid, iodine, chromium, molybdenum, or beet root.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include vitamins B1, B2, B3, and biotin (B7), as well as iodine (potassium iodide), chromium (chromium picolinate), and molybdenum (sodium molybdate) ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Rifkin discloses a food product comprising functional ingredients ([0001]) that may include vitamin K1 ([0074]) and pantothenic acid ([0069], [0071]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising vitamin K1 and pantothenic acid. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Rifkin, in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of vitamin K1 and pantothenic acid in Rifkin as functional ingredients of a food product renders their inclusion in the composition of Bhagat obvious.
Theuer et al. discloses beet root for use as a food coloring agent (C9, L12-L15) in baby foods (C6, L47-L49).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising beet root. Bhagat teaches that the compositions may be prepared as baby foods ([0017], [0124]), which would prompt a skilled practitioner to consult Theuer et al. for clarification regarding ingredients typically included in baby foods. Since Theuer et al. teaches the addition of beet root as a coloring agent in baby foods (C9, L12-L15; C6, L47-L49), the inclusion of beet root in compositions of Bhagat would be obvious.
Claims 29-35, 39-51, 53, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1).
Regarding claim 29, Bhagat discloses a diet package system that may be provided in various discrete packages ([0012), and where the individual packages may comprise “drinks, snacks, meals, desserts, cereals, salad, side dish, sauces, desserts, spreads, etc.” ([0015], [0017]) in the form of “legume, grain, vegetable, fruit, meat, seafood, herb, spice, nut, seeds, oil, or butter” ([0039]-[0040]), and where the package may recite printed instructions specifying consumption of the meal portions during a single-day fasting interval within 12-24 hours ([0012], where the packages may be marked to provide frequency of consumption, including three times daily or once daily).
Though Bhagat does not explicitly disclose a diet package providing meal portions for a one-day fast that comprises the claimed components, the claimed diet package would be obvious in view of the disclosure of Bhagat for the following combination of reasons.
First, the claim is merely directed to a composite package comprising individually-packaged food elements that are all known food components, as will be established subsequently herein. Bhagat is so broad that it renders the inclusion of any known food components into packages in order to form a composite food package obvious, since the reference discloses that the food components may comprise “legume, grain, vegetable, fruit, meat, seafood, herb, spice, nut, seeds, oil, or butter” ([0039]-[0040]) and sweeteners ([0044]) that may variously constitute “drinks, snacks, meals, desserts, cereals, salad, side dish, sauces, desserts, spreads, etc.” ([0015], [0017]).
The descriptions of the package as being a “fasting mimicking diet package providing meal portions for a one-day fast” constitute statements of intended use and/or designations that do not materially limit the claimed composite food package. MPEP 2111.02.
Regarding a composition claim that is merely directed to a combination of food ingredients, please note In re Levin, 84 USPQ 232, and the cases cited therein, which are pertinent to such a claim. The court in Levin states:
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. Levin at 234.
The present claim does not require any coaction or cooperative relationship between any of the selected ingredients, especially one that produces a new/unexpected/useful function, and also does not require a minimum amount of any of the claimed components or the exclusion of any additional ingredients. The package merely is required to contain some “meal portion” that contains at least some minimal amount of the noted food components.
Given the determination that the general disclosure of Bhagat renders obvious the incorporation of essentially any food component into a diet package, the individually-claimed components are considered and shown to be known as food components as follows.
Bhagat discloses the food components as including:
a nut-containing ([0143]) nutrition bar ([0015]);
a micronutritional vegetable ([0141]) powder ([0142]) including vitamin and mineral supplements ([0082]-[0083]);
an oil composition ([0143]);
a soup composition ([0123], where a combination of vegetables, legumes, meat, herbs, and milks that may be in the form of a liquid or semi-liquid would be fairly deemed a “soup”);
a kale cracker composition ([0141], kale; [0123], “a bakery food product such as a bread”), and
an olive-containing composition ([0013]).
Duplication of any of the components, including the nut-containing composition and the soup composition, would be obvious. MPEP 2144.04 VI B (“mere duplication of parts has no patentable significance unless a new and unexpected result is produced”).
Raney et al. discloses algal oil in particular as being suited for use in food products ([0006], [0119]) as a source DHA ([0074]). A skilled practitioner would find the incorporation of algal oil into the package as taught by Bhagat to be obvious, since Bhagat teaches generally that the package may include an edible oil ([0143]) and indicates a preference for the inclusion of DHA ([0013]) and Raney et al. teaches algal oil as being suited as a source of DHA for use in food products.
As for claim 30, Bhagat discloses the inclusion of tea that may include lemon ([0180], Table 5, “Spices” and “Beverages”).
As for claim 31, Bhagat discloses the nut bar as containing almonds, macadamia, and pecan ([0143]). Raney et al. discloses the algal oil composition as including DHA ([0074]) and an Aurantiochytrium algal oil ([0069]).
As for claim 32, Bhagat discloses the inclusion of inulin ([0084]-[0086]), almonds ([0143]), almond butter ([0143], [0011]), crispy brown rice ([0141]), cocoa powder ([0141]-[0142]), flaxseed oil ([0143], [0119], Table 3, Lignans), rice dextrin ([0086], [0141]), grape juice ([0141], where grapes would comprise grape juice), and salt ([0082], where supplementation with sodium and chloride is considered to constitute salt). Bhagat further discloses the inclusion of chocolate (p. 7, Table 1, Flavonoids/Thearubigins; [0040]-[0041]). MPEP 2144.04 IV A/B indicates that changes in size/shape are insufficient to patentably distinguish a claimed product from the prior art, such that the disclosure in Bhagat of the use of chocolate is adequate to deem the use of chocolate chips obvious. Bhagat also discloses the inclusion of oats ([0141]), which renders the inclusion of any type of oats obvious, including rolled oats. Inclusion of these components in a second nut bar is within the scope of the disclosure of Bhagat in terms of the types of food components the ingredients may be contained in, as detailed previously in relation to claim 1.
As for claim 33, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious, such that any relative sizes between the first and second nut bars would be obvious. Bhagat further discloses the compositions as comprising almonds, macadamias, pecans ([0143]), honey ([0144]), flaxseed ([0143]), coconut flour ([0143]), and rosemary extract ([0141]).
As for claim 34, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious, such that any relative sizes between the first and second nut bars would be obvious. Bhagat further discloses the compositions as comprising almonds, macadamias, pecans ([0143]), honey ([0144]), flaxseed ([0143]), coconut flour ([0143]), and rosemary extract ([0141]).
As for claim 35, Bhagat discloses the compositions as comprising almonds, macadamias, pecans ([0143]), and blueberries ([0141]).
As for claim 39, Bhagat discloses the compositions as comprising almonds ([0143]), kale ([0141]), sesame seeds ([0143]), and tapioca flour ([0031], [0142], where a dry powder is considered to be a flour).
As for claim 40, Bhagat discloses the compositions as comprising almonds ([0143]), kale ([0141]), sesame seeds ([0143]), tapioca flour ([0031], [0142], where a dry powder is considered to be a flour), chia seeds ([0066]), flax seeds ([0143]), sunflower oil ([0026]), salt ([0082], where supplementation with sodium and chloride is considered to constitute salt), coconut sugar ([0143]), vinegar, chili pepper, black pepper, garlic, cumin seed, oregano (p. 23, Table 5, Spices), onion ([0141]), tocopherols ([0083]), and citric acid ([0141], as part of lemon or lime).
As for claim 41, Bhagat discloses the compositions as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), and yeast extract ([0144], [0142]).
As for claim 42, Bhagat discloses the compositions as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), yeast extract ([0144], [0142]), and tomato ([0141]).
As for claim 43, Bhagat discloses the composition as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), yeast extract ([0144], [0142]), tomato, basil, parsley, and whole grain brown rice ([0141]).
As for claims 44-46, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious. Claim 1 does not require any amount of any component, which thus may be in any size. A package size that provides 75% or less (claim 44), 50% or less (claim 45), or 25% or less (claim 46) of a daily recommended caloric intake for a subject would thus be obvious, since an especially small package would be presumed to fall well below the claimed threshold values.
As for claims 47-51, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious. Claim 1 does not require any amount or relative amount of any component, which thus may be in any size and provide any amount of each individual type of nutrient. Thus, providing a package wherein the combination of all components falls within the claimed ranges for fat, sugar, and protein, would be obvious to a skilled practitioner.
As for claims 53 and 54, Bhagat discloses administering the diet to a subject in need of inducing differential effects on disease factors and markers associated with aging (claim 53), including cholesterol (hypercholesterolemia) and triglycerides (weight gain, obesity) (claim 54) ([0014]).
Claims 36, 55 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 29 above, and further in view of Longo et al. (U.S. 2015/0004280 A1).
Regarding claim 36, Bhagat discloses the compositions as comprising vitamins A, E, K, B12, Ca, Fe, Cu, Mg, Mn, Se, and Zn ([0082]), vitamin C ([0074]), vitamin B6 ([0090]), vitamin B9 ([0083]).
Bhagat does not disclose the compositions as comprising D3, B1, B2, B3, B5, B7, iodine, chromium, or molybdenum.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include vitamins D3, B1, B2, B3, B5, and B7, as well as iodine (potassium iodide), chromium (chromium picolinate), and molybdenum (sodium molybdate) ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Regarding claims 55 and 56, Bhagat and Raney et al. disclose the composition of claim 29.
The cited prior art does not specifically disclose a method for promoting and inducing stem-cell based regeneration of multiple organs and systems in a subject in need thereof comprising administering the composition of claim 29 (claims 55) where the health benefit includes one of neurogenesis, hematopoiesis, or promotion of pancreatic beta-cells (claim 56).
However, Longo et al. discloses a method of promoting pancreatic beta-cell regeneration via the administration of a diet ([0003], [0008], [0032]).
It would have been obvious to one having ordinary skill in the art to administer the composition of claim 29 as taught in Bhagat to a subject in need of promotion and induction of stem-cell based regeneration of systems, including pancreatic beta cells. Bhagat indicates that the diet is suited for the treatment of diabetes ([0014]) but does not provide detail regarding the nature of such a disorder. A skilled practitioner would be motivated to consult Longo et al. for further instruction in determining that diabetes is “characterized by progressive beta-cell failure” ([0006]). Since Longo et al. discloses that diabetes is characterized by beta-cell failure and teaches that administration of the diet treats such a condition ([0008]), a skilled practitioner would recognize that the treatment of diabetes as taught in Bhagat via the administration of a comparable diet would likely occur in a similar manner via the improvement of the beta-cell damage. As such, the claimed method of promoting and inducing stem-cell based regeneration of a system in a subject in need thereof comprising administering the composition of claim 29 (claims 55) where the health benefit includes promotion of pancreatic beta-cells (claim 56) would be obvious to a skilled practitioner.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 29 above, and further in view of Longo et al. (U.S. 2015/0004280 A1), Rifkin (U.S. 2013/0287899 A1), Knutzon (U.S. 2010/0310710 A1), and Theuer (U.S. 5,837,309).
Regarding claim 37, Bhagat discloses compositions as comprising carrots, kale leaf, tomatoes, spinach ([0141]), collard leaf powder ([0141]-[0142]), ascorbic acid ([0025], [0074]), beta carotene ([0150]), and folic acid ([0082]).
Bhagat does not disclose the compositions as comprising the remaining components.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include calcium carbonate, cholecalciferol, chromium picolinate, cupric sulfate, cyanocobalamin, DI-alpha tocopherol acetate, ferrous fumarate, manganese sulfate, niacinamide, phytonadione, potassium iodine, pyridoxine HCl, riboflavin, sodium selenate, thiamine mononitrate, sodium molybdate, zinc oxide ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Rifkin discloses a food product comprising functional ingredients ([0001]) that may include pantothenic acid ([0069], [0071]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising pantothenic acid. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Rifkin, in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of pantothenic acid in Rifkin as a functional ingredient of a food product renders its inclusion in the composition of Bhagat obvious.
Knutzon et al. discloses the addition of magnesium stearate to an edible product as a lubricant ([0125]). Knutzon et al. discloses the addition of tribasic calcium phosphate as a vitamin supplement in a milk substitute ([0196], [0203], [0206]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising magnesium stearate and tribasic calcium phosphate. Bhagat teaches the compositions may be administered as a capsule comprising a lubricant ([0125]) but does not detail suitable lubricants. A skilled practitioner would be motivated to consult Knutzon et al. for detail regarding a suitable lubricant. Since Knutzon et al. disclose the use of magnesium stearate as a lubricant in a capsule delivery form ([0125]), the inclusion of magnesium stearate in the composition of Bhagat would be obvious. Further, Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Knutzon et al., in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of tribasic calcium phosphate in Knutzon et al. as a vitamin supplement of a food product renders its inclusion in the composition of Bhagat obvious.
Theuer et al. discloses beet root powder for use as a food coloring agent (C9, L12-L15) in baby foods (C6, L47-L49).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising beet root powder. Bhagat teaches that the compositions may be prepared as baby foods ([0017], [0124]), which would prompt a skilled practitioner to consult Theuer et al. for clarification regarding ingredients typically included in baby foods. Since Theuer et al. teaches the addition of beet root powder as a coloring agent in baby foods (C9, L12-L15; C6, L47-L49), the inclusion of beet root powder in compositions of Bhagat would be obvious.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 29 above, and further in view of Longo et al. (U.S. 2015/0004280 A1), Rifkin (U.S. 2013/0287899 A1), and Theuer (U.S. 5,837,309).
Regarding claim 38, Bhagat discloses the compositions as comprising vitamins A, D, E, B12, Ca, Fe, Cu, Mg, Mn, Se, and Zn ([0082]), vitamin C ([0074]), vitamin B6 ([0090]), vitamin B9 ([0083]), folic acid, calcium, iron, magnesium, zinc, selenium, copper, manganese ([0082]), kale leaves, carrot root, spinach leaves, and tomatoes ([0141]).
Bhagat does not disclose the compositions as comprising vitamins B1, B2, B3, K1, biotin, pantothenic acid, iodine, chromium, molybdenum, or beet root.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include vitamins B1, B2, B3, and biotin (B7), as well as iodine (potassium iodide), chromium (chromium picolinate), and molybdenum (sodium molybdate) ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Rifkin discloses a food product comprising functional ingredients ([0001]) that may include vitamin K1 ([0074]) and pantothenic acid ([0069], [0071]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising vitamin K1 and pantothenic acid. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Rifkin, in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of vitamin K1 and pantothenic acid in Rifkin as functional ingredients of a food product renders their inclusion in the composition of Bhagat obvious.
Theuer et al. discloses beet root for use as a food coloring agent (C9, L12-L15) in baby foods (C6, L47-L49).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising beet root. Bhagat teaches that the compositions may be prepared as baby foods ([0017], [0124]), which would prompt a skilled practitioner to consult Theuer et al. for clarification regarding ingredients typically included in baby foods. Since Theuer et al. teaches the addition of beet root as a coloring agent in baby foods (C9, L12-L15; C6, L47-L49), the inclusion of beet root in compositions of Bhagat would be obvious.
Claims 57-63, 67-79, 81, 82, and 86 are rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1).
Regarding claim 57, Bhagat discloses a diet package system that may be provided in various discrete packages ([0012], where the packages may be indicated for use “three times daily”), and where the individual packages may comprise “drinks, snacks, meals, desserts, cereals, salad, side dish, sauces, desserts, spreads, etc.” ([0015], [0017]) in the form of “legume, grain, vegetable, fruit, meat, seafood, herb, spice, nut, seeds, oil, or butter” ([0039]-[0040]), and where the package may recite printed instructions specifying consumption of the meal portions during a single-day fasting interval within 12-24 hours ([0012], where the packages may be marked to provide frequency of consumption, including three times daily or once daily).
Though Bhagat does not explicitly disclose a diet package providing breakfast, lunch, and dinner meal portions for a one-day fast that comprises predetermined compositions grouped into one or more of breakfast, lunch, or dinner, the claimed diet package would be obvious in view of the disclosure of Bhagat for the following combination of reasons.
First, the claim is merely directed to a composite package comprising individually-packaged food elements that are all known food components, as will be established subsequently herein. Bhagat is so broad that it renders the inclusion of any known food components into packages in order to form a composite food package obvious, since the reference discloses that the food components may comprise “legume, grain, vegetable, fruit, meat, seafood, herb, spice, nut, seeds, oil, or butter” ([0039]-[0040]) and sweeteners ([0044]) that may variously constitute “drinks, snacks, meals, desserts, cereals, salad, side dish, sauces, desserts, spreads, etc.” ([0015], [0017]).
The descriptions of the package as being a “fasting mimicking diet package providing breakfast, lunch, and dinner meal portions for a one-day fast” constitute statements of intended use and/or designations that do not materially limit the claimed composite food package. MPEP 2111.02.
Regarding a composition claim that is merely directed to a combination of food ingredients, please note In re Levin, 84 USPQ 232, and the cases cited therein, which are pertinent to such a claim. The court in Levin states:
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. Levin at 234.
The present claim does not require any coaction or cooperative relationship between any of the selected ingredients, especially one that produces a new/unexpected/useful function, and also does not require a minimum amount of any of the claimed components or the exclusion of any additional ingredients. The package merely is required to contain some “meal portion” that contains at least some minimal amount of the noted food components.
Given the determination that the general disclosure of Bhagat renders obvious the incorporation of essentially any food component into a diet package, the individually-claimed components are considered and shown to be known as food components as follows.
Bhagat discloses the food components as including:
a nut-containing ([0143]) nutrition bar ([0015]);
a micronutritional vegetable ([0141]) powder ([0142]) including vitamin and mineral supplements ([0082]-[0083]);
an oil composition ([0143]);
a soup composition ([0123], where a combination of vegetables, legumes, meat, herbs, and milks that may be in the form of a liquid or semi-liquid would be fairly deemed a “soup”);
a kale cracker composition ([0141], kale; [0123], “a bakery food product such as a bread”), and
an olive-containing composition ([0013]).
Duplication of any of the components, including the nut-containing composition and the soup composition, would be obvious. MPEP 2144.04 VI B (“mere duplication of parts has no patentable significance unless a new and unexpected result is produced”).
Raney et al. discloses algal oil in particular as being suited for use in food products ([0006], [0119]) as a source DHA ([0074]). A skilled practitioner would find the incorporation of algal oil into the package as taught by Bhagat to be obvious, since Bhagat teaches generally that the package may include an edible oil ([0143]) and indicates a preference for the inclusion of DHA ([0013]) and Raney et al. teaches algal oil as being suited as a source of DHA for use in food products.
As for claim 58, Bhagat discloses the inclusion of tea that may include lemon ([0180], Table 5, “Spices” and “Beverages”).
As for claim 59, Bhagat discloses the nut bar as containing almonds, macadamia, and pecan ([0143]). Raney et al. discloses the algal oil composition as including DHA ([0074]) and an Aurantiochytrium algal oil ([0069]).
As for claim 60, Bhagat discloses the inclusion of inulin ([0084]-[0086]), almonds ([0143]), almond butter ([0143], [0011]), crispy brown rice ([0141]), cocoa powder ([0141]-[0142]), flaxseed oil ([0143], [0119], Table 3, Lignans), rice dextrin ([0086], [0141]), grape juice ([0141], where grapes would comprise grape juice), and salt ([0082], where supplementation with sodium and chloride is considered to constitute salt). Bhagat further discloses the inclusion of chocolate (p. 7, Table 1, Flavonoids/Thearubigins; [0040]-[0041]). MPEP 2144.04 IV A/B indicates that changes in size/shape are insufficient to patentably distinguish a claimed product from the prior art, such that the disclosure in Bhagat of the use of chocolate is adequate to deem the use of chocolate chips obvious. Bhagat also discloses the inclusion of oats ([0141]), which renders the inclusion of any type of oats obvious, including rolled oats. Inclusion of these components in a second nut bar is within the scope of the disclosure of Bhagat in terms of the types of food components the ingredients may be contained in, as detailed previously in relation to claim 1.
As for claim 61, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious, such that any relative sizes between the first and second nut bars would be obvious. Bhagat further discloses the compositions as comprising almonds, macadamias, pecans ([0143]), honey ([0144]), flaxseed ([0143]), coconut flour ([0143]), and rosemary extract ([0141]).
As for claim 62, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious, such that any relative sizes between the first and second nut bars would be obvious. Bhagat further discloses the compositions as comprising almonds, macadamias, pecans ([0143]), honey ([0144]), flaxseed ([0143]), coconut flour ([0143]), and rosemary extract ([0141]).
As for claim 63, Bhagat discloses the compositions as comprising almonds, macadamias, pecans ([0143]), and blueberries ([0141]).
As for claim 67, Bhagat discloses the compositions as comprising almonds ([0143]), kale ([0141]), sesame seeds ([0143]), and tapioca flour ([0031], [0142], where a dry powder is considered to be a flour).
As for claim 68, Bhagat discloses the compositions as comprising almonds ([0143]), kale ([0141]), sesame seeds ([0143]), tapioca flour ([0031], [0142], where a dry powder is considered to be a flour), chia seeds ([0066]), flax seeds ([0143]), sunflower oil ([0026]), salt ([0082], where supplementation with sodium and chloride is considered to constitute salt), coconut sugar ([0143]), vinegar, chili pepper, black pepper, garlic, cumin seed, oregano (p. 23, Table 5, Spices), onion ([0141]), tocopherols ([0083]), and citric acid ([0141], as part of lemon or lime).
As for claim 69, Bhagat discloses the compositions as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), and yeast extract ([0144], [0142]).
As for claim 70, Bhagat discloses the compositions as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), yeast extract ([0144], [0142]), and tomato ([0141]).
As for claim 71, Bhagat discloses the composition as comprising rice flour ([0141]-[0142]), chicory root fiber (p. 16, Table 3, Prebiotics), onion ([0141]), olive oil ([0026]), yeast extract ([0144], [0142]), tomato, basil, parsley, and whole grain brown rice ([0141]).
As for claims 72-74, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious. Claim 1 does not require any amount of any component, which thus may be in any size. A package size that provides 75% or less (claim 16), 50% or less (claim 17), or 25% or less (claim 18) of a daily recommended caloric intake for a subject would thus be obvious, since an especially small package would be presumed to fall well below the claimed threshold values.
As for claims 75-79, MPEP 2144.04 IV A indicates that changes in size/proportion are prima facie obvious. Claim 1 does not require any amount or relative amount of any component, which thus may be in any size and provide any amount of each individual type of nutrient. Thus, providing a package wherein the combination of all components falls within the claimed ranges for fat, sugar, and protein, would be obvious to a skilled practitioner.
As for claims 81 and 82, Bhagat discloses administering the diet to a subject in need of inducing differential effects on disease factors and markers associated with aging (claim 81), including cholesterol (hypercholesterolemia) and triglycerides (weight gain, obesity) (claim 82) ([0014]).
As for claim 86, Bhagat discloses administering the diet daily ([0012]). The presently-claimed method occurs for only one day and does not require anything beyond that day; the method is considered complete upon the administration of one day’s worth of the diet. Following the completion of the method, a person would be free to consume whatever he may chose, including a second-day regimen of the diet, resumption of a regular diet, or fasting.
Claims 64, 83 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 1 above, and further in view of Longo et al. (U.S. 2015/0004280 A1).
Regarding claim 8, Bhagat discloses the compositions as comprising vitamins A, E, K, B12, Ca, Fe, Cu, Mg, Mn, Se, and Zn ([0082]), vitamin C ([0074]), vitamin B6 ([0090]), vitamin B9 ([0083]).
Bhagat does not disclose the compositions as comprising D3, B1, B2, B3, B5, B7, iodine, chromium, or molybdenum.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include vitamins D3, B1, B2, B3, B5, and B7, as well as iodine (potassium iodide), chromium (chromium picolinate), and molybdenum (sodium molybdate) ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Regarding claims 27 and 28, Bhagat and Raney et al. disclose the composition of claim 1.
The cited prior art does not specifically disclose a method for promoting and inducing stem-cell based regeneration of multiple organs and systems in a subject in need thereof comprising administering the composition of claim 1 (claims 27) where the health benefit includes one of neurogenesis, hematopoiesis, or promotion of pancreatic beta-cells (claim 28).
However, Longo et al. discloses a method of promoting pancreatic beta-cell regeneration via the administration of a diet ([0003], [0008], [0032]).
It would have been obvious to one having ordinary skill in the art to administer the composition of claim 1 as taught in Bhagat to a subject in need of promotion and induction of stem-cell based regeneration of systems, including pancreatic beta cells. Bhagat indicates that the diet is suited for the treatment of diabetes ([0014]) but does not provide detail regarding the nature of such a disorder. A skilled practitioner would be motivated to consult Longo et al. for further instruction in determining that diabetes is “characterized by progressive beta-cell failure” ([0006]). Since Longo et al. discloses that diabetes is characterized by beta-cell failure and teaches that administration of the diet treats such a condition ([0008]), a skilled practitioner would recognize that the treatment of diabetes as taught in Bhagat via the administration of a comparable diet would likely occur in a similar manner via the improvement of the beta-cell damage. As such, the claimed method of promoting and inducing stem-cell based regeneration of a system in a subject in need thereof comprising administering the composition of claim 1 (claims 27) where the health benefit includes promotion of pancreatic beta-cells (claim 28) would be obvious to a skilled practitioner.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 1 above, and further in view of Longo et al. (U.S. 2015/0004280 A1), Rifkin (U.S. 2013/0287899 A1), Knutzon (U.S. 2010/0310710 A1), and Theuer (U.S. 5,837,309).
Regarding claim 9, Bhagat discloses compositions as comprising carrots, kale leaf, tomatoes, spinach ([0141]), collard leaf powder ([0141]-[0142]), ascorbic acid ([0025], [0074]), beta carotene ([0150]), and folic acid ([0082]).
Bhagat does not disclose the compositions as comprising the remaining components.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include calcium carbonate, cholecalciferol, chromium picolinate, cupric sulfate, cyanocobalamin, DI-alpha tocopherol acetate, ferrous fumarate, manganese sulfate, niacinamide, phytonadione, potassium iodine, pyridoxine HCl, riboflavin, sodium selenate, thiamine mononitrate, sodium molybdate, zinc oxide ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Rifkin discloses a food product comprising functional ingredients ([0001]) that may include pantothenic acid ([0069], [0071]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising pantothenic acid. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Rifkin, in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of pantothenic acid in Rifkin as a functional ingredient of a food product renders its inclusion in the composition of Bhagat obvious.
Knutzon et al. discloses the addition of magnesium stearate to an edible product as a lubricant ([0125]). Knutzon et al. discloses the addition of tribasic calcium phosphate as a vitamin supplement in a milk substitute ([0196], [0203], [0206]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising magnesium stearate and tribasic calcium phosphate. Bhagat teaches the compositions may be administered as a capsule comprising a lubricant ([0125]) but does not detail suitable lubricants. A skilled practitioner would be motivated to consult Knutzon et al. for detail regarding a suitable lubricant. Since Knutzon et al. disclose the use of magnesium stearate as a lubricant in a capsule delivery form ([0125]), the inclusion of magnesium stearate in the composition of Bhagat would be obvious. Further, Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Knutzon et al., in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of tribasic calcium phosphate in Knutzon et al. as a vitamin supplement of a food product renders its inclusion in the composition of Bhagat obvious.
Theuer et al. discloses beet root powder for use as a food coloring agent (C9, L12-L15) in baby foods (C6, L47-L49).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising beet root powder. Bhagat teaches that the compositions may be prepared as baby foods ([0017], [0124]), which would prompt a skilled practitioner to consult Theuer et al. for clarification regarding ingredients typically included in baby foods. Since Theuer et al. teaches the addition of beet root powder as a coloring agent in baby foods (C9, L12-L15; C6, L47-L49), the inclusion of beet root powder in compositions of Bhagat would be obvious.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Bhagat (U.S. 2013/0261183 A1) in view of Raney et al. (U.S. 2013/0017594 A1) as applied to claim 1 above, and further in view of Longo et al. (U.S. 2015/0004280 A1), Rifkin (U.S. 2013/0287899 A1), and Theuer (U.S. 5,837,309).
Regarding claim 10, Bhagat discloses the compositions as comprising vitamins A, D, E, B12, Ca, Fe, Cu, Mg, Mn, Se, and Zn ([0082]), vitamin C ([0074]), vitamin B6 ([0090]), vitamin B9 ([0083]), folic acid, calcium, iron, magnesium, zinc, selenium, copper, manganese ([0082]), kale leaves, carrot root, spinach leaves, and tomatoes ([0141]).
Bhagat does not disclose the compositions as comprising vitamins B1, B2, B3, K1, biotin, pantothenic acid, iodine, chromium, molybdenum, or beet root.
However, Longo et al. discloses micronutrients suited for inclusion in a food product that include vitamins B1, B2, B3, and biotin (B7), as well as iodine (potassium iodide), chromium (chromium picolinate), and molybdenum (sodium molybdate) ([0036], Table 4).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising the noted vitamins and minerals. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Longo et al., in order to determine a broader number of suitable vitamins/minerals. The disclosure of the noted vitamins and minerals in Longo et al. as ingredients suited for inclusion in a food product renders their inclusion in the composition of Bhagat obvious.
Rifkin discloses a food product comprising functional ingredients ([0001]) that may include vitamin K1 ([0074]) and pantothenic acid ([0069], [0071]).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising vitamin K1 and pantothenic acid. Bhagat teaches generally the inclusion of vitamins and minerals ([0082]-[0083]; claim 56), which would prompt a skilled practitioner to consult an additional reference, such as Rifkin, in order to determine a broader number of suitable beneficial vitamins/minerals. The disclosure of vitamin K1 and pantothenic acid in Rifkin as functional ingredients of a food product renders their inclusion in the composition of Bhagat obvious.
Theuer et al. discloses beet root for use as a food coloring agent (C9, L12-L15) in baby foods (C6, L47-L49).
It would have been obvious to one having ordinary skill in the art to produce the compositions of Bhagat comprising beet root. Bhagat teaches that the compositions may be prepared as baby foods ([0017], [0124]), which would prompt a skilled practitioner to consult Theuer et al. for clarification regarding ingredients typically included in baby foods. Since Theuer et al. teaches the addition of beet root as a coloring agent in baby foods (C9, L12-L15; C6, L47-L49), the inclusion of beet root in compositions of Bhagat would be obvious.
Response to Arguments
Claim Rejections - 35 U.S.C. § 112: Applicant has overcome the 35 U.S.C. § 112(d) rejections of claims 24, 52, and 80 based on cancellation of the claims. Accordingly, the 35 U.S.C. § 112(d) rejections have been withdrawn.
Claim Rejections - 35 U.S.C. § 103 of:
claims 1-7 and 11-26 over Bhagat and Raney et al.; claims 8, 27, and 28 over Bhagat, Raney et al., and Longo et al.; claim 9 over Bhagat, Raney et al., Longo et al., Rifkin, Knutzon, and Theuer; claim 10 over Bhagat, Raney et al., Longo et al., Rifkin and Theuer;
claims 29-35 and 39-54 over Bhagat and Raney et al.; claims 36, 55, and 56 over Bhagat, Raney et al., and Longo et al.; claim 37 over Bhagat, Raney et al., Longo et al., Rifkin, Knutzon, and Theuer; claim 38 over Bhagat, Raney et al., Longo et al., Rifkin and Theuer; and
claims 57-63 and 67-82 over Bhagat and Raney et al.; claims 64, 83, and 84 over Bhagat, Raney et al., and Longo et al.; claim 65 over Bhagat, Raney et al., Longo et al., Rifkin, Knutzon, and Theuer; claim 66 over Bhagat, Raney et al., Longo et al., Rifkin and Theuer:
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that Bhagat is not “reasonably pertinent to the problem addressed by the claims—maintaining a fasting metabolic state within a single 12-24 hour interval using a one-day package with breakfast/lunch/dinner groupings and acute biomarker performance”, since Bhagat is directed toward multi-day usage of the packaged nutritional formulation (Applicant’s Remarks, p. 19, ¶3 – p. 20, ¶1). Applicant emphasized and alleged distinction that Bhagat is directed only to longer term administration of the diet than one day (Applicant’s Remarks, p. 20, ¶1).
However, the present claims are vastly broader than Applicant’s arguments, which are consequently unpersuasive. The composition claims (claims 1-23, 29-51, 57-79) are directed only to packaged food products. As noted in the claim rejections, the descriptions of the packages as being a “fasting mimicking diet package providing breakfast, lunch, and dinner meal portions for a one-day fast” constitute statements of intended use and/or designations that do not materially limit the claimed composite food package. MPEP 2111.02. The claims are not limited to administration only to humans, do not even require administration at all, do not require consuming the designated meal portions at conventional meal times or with any lag period between the meal portions, and do not require the exclusion of other food components from either the actual diet package or from being consumed concurrently with the claimed diet package. All of Applicant’s arguments directed to the effects of administering the claimed composition under specific parameters and the attempt to distinguish the claimed food packages from those of Bhagat on the basis of the length of the administration period are narrower in scope than the products that are actually claimed.
The method claims (claims 25-28, 53-56, and 81-86) are merely generalized administration requirements and a subsequent physiological effect, but again, the claimed methods are substantially broader in scope than Applicant’s arguments. The claims are not limited to administration only to humans, do not require consuming the designated meal portions at conventional meal times or with any lag period between the meal portions, do not require the exclusion of other food components from being consumed concurrently with the claimed diet package, and do not require any measurable effect to occur, since methods for “inducing” and “promoting” effects may be read as simply contributing to factors that would be seen as being conducive to causing the noted effects to occur. Again, all of Applicant’s arguments directed to the effects of administering the claimed composition under specific parameters and the attempt to distinguish the claimed food packages from those of Bhagat on the basis of the length of the administration period are narrower in scope than the products that are actually claimed. Applicant’s arguments are consequently unpersuasive.
Applicant next asserted that the presently-claimed products/methods produce unexpected results over Bhagat (Applicant’s Remarks, p. 20, ¶3 – p. 21, ¶4).
However, MPEP 716.02(d) states: “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.” The present claims are vastly broader in scope than the asserted data. The present composition claims are not limited to administration only to humans, do not even require administration at all, do not require consuming the designated meal portions at conventional meal times or with any lag period between the meal portions, and do not require the exclusion of other food components from either the actual diet package or from being consumed concurrently with the claimed diet package. The present method claims are not limited to administration only to humans, do not require consuming the designated meal portions at conventional meal times or with any lag period between the meal portions, do not require the exclusion of other food components from being consumed concurrently with the claimed diet package, and do not require any measurable effect to occur, since methods for “inducing” and “promoting” effects may be read as simply contributing to factors that would be seen as being conducive to causing the noted effects to occur. The assertion of unexpected results is thus insufficient for overcoming the showing of prima facie obviousness.
Applicant next asserted that there would be no reasonable expectation of success in combining Bhagat with Raney et al., alleging that the effects of Bhagat require prolonged administration of the diet rather than a single-day administration as in the present application (Applicant’s Remarks, p. 21, ¶3). Applicant argued that Bhagat operates by a different principle and serves a different purpose than those of the present application, again emphasizing the duration of administration between Bhagat and the present application (Applicant’s Remarks, p. 22, ¶1).
Again, Applicant’s arguments are vastly narrower than the scope of the present claims for reasons detailed previously herein and are consequently unpersuasive.
The rejections of claims 1-23, 25-51, 53-79, and 81-84 have been maintained herein.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Claims 1-23, 25-51, 53-79, and 81-86 are rejected.
No claims are allowed at this time.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793