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 .
Election/Restrictions
Claims 1-7 and 15 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/01/2025.
Applicant's election with traverse of claims 16-27 and 29-301 in the reply filed on 12/1/2025 is acknowledged. Applicant’s traversal has not found persuasive because the Applicant has failed to provide grounds for the traversal.
The requirement is still deemed proper and is therefore made FINAL.
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 16-18, 20, 22-27 and 29-30 are rejected under 35 are rejected under 35 U.S.C. 101 because they are directed to an abstract idea without significantly more. Claim 16 recites (additional limitations crossed out):
A method of improving sleep and/or subsequent behavioral outcomes of an individual in need thereof, the method comprising:
providing a dietary recommendation by evaluating a parameter of the individual selected from the group consisting of falling asleep time, sleep duration, sleep onset latency, wakeafter sleep onset, sleep efficiency, gender, age, body mass index, physical activity level, glycemic status, food preference, food sensitivity, caloric intake, nutrients, meal glycemic load, time of consumption and combinations thereof,
providing a nutritional composition based on the dietary recommendation, and
administering the nutritional composition to the individual,
wherein the nutritional composition is selected from the group consisting of a first composition comprising alpha-casozepine, a second composition comprising tryptophan, a third composition comprising mulberry leaf extract, and combinations thereof.
The above limitations as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people. That is nothing in the claim precludes the steps as being described as managing personal behavior or relationships or interactions between people. For example, the limitations describe a method for providing a dietary recommendation by evaluating a parameter of an individual, providing a nutritional composition based on the dietary recommendation, and administering the nutritional composition. The limitations describe the management of personal behavior. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. The claims feature no additional elements to perform the claimed steps. Accordingly, the claims do not feature additional elements that integrate the abstract idea into a practical application due to imposing any meaningful limits on practicing the abstract idea. The claims are therefore still directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the claims do not feature any additional elements. Therefore, the claims are not found to be patent eligible.
Claim 30 features limitations similar to those of claim 16, but for the limitation “order a nutritional composition based on the dietary recommendation” instead of the “providing a nutritional composition…” and “administering the nutritional composition…” limitations of claim 16, and is also directed to the same abstract idea. However, claim 30 features the additional element of a “non-transitory computer-readable medium” and a “device” to perform the steps. These additional elements are recited at a high level of generality (see at least Page 25) such that it amounts to no more than mere instructions to apply the exception using generic computing components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Claim 30 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a “non-transitory computer-readable medium” and a “device” to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. Therefore, the claim 30 is not found to be patent eligible.
Claims 17-18, 20, 22-27, and 29 are dependent on claim 16, and include all the limitations of claim 16. Therefore, they are also found to be directed to an abstract idea. The dependent claims have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more.
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 22 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “elderly person” in claim 22 is a relative term which renders the claim indefinite. The term “elderly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the inventive concept in regards to the phrase “elderly person…”.
The term “about 120 mg to about 5 g” in claim 26 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim(s) 16-17, 20, 22, 24, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardee (US 2017/0148348) in view of Mallee (WO 2020/078718).
Regarding claim 16, Hardee discloses A method of improving sleep and/or subsequent behavioural outcomes of an individual in need thereof, the method comprising:
providing a dietary recommendation by evaluating a parameter of the individual selected from the group consisting of falling asleep time, sleep duration, sleep onset latency, wakeafter sleep onset, sleep efficiency, gender, age, body mass index, physical activity level, glycemic status, food preference, food sensitivity, caloric intake, nutrients, meal glycemic load, time of consumption and combinations thereof, (See at least Para. [0011] – “Data that can be input into or monitored by the wearable electronic device (e.g., via its sensors) can also be received as input by the wearable electronic device from external electronic devices (e.g., the user's smartphone). For instance, the user's exercise activity can be manually entered, calculated and/or monitored by the wearable electronic device, or the user's exercise activity can be wirelessly received as input from the user's smartphone. Exercise activity can include the type and quantity of exercise ( e.g., run 5 miles, 50 sit ups, 100 jumping jacks, 20 pushups, etc.). The wearable electronic device can measure the user's movements, duration of the movements, intensity of the movements, and/or heart rate.”, Claim 1 – “ receiving input from at least one of a sensor and an interface of a wearable electronic device of a user, the input including physiological factors and environmental factors measured by the wearable electronic device; predicting at least one nutritional deficiency with a processor, the at least one nutritional deficiency being predicted based on the input;”, and Claim 6 – “The method according to claim 1, further comprising generating a meal recipe for the user, the meal recipe including a list of ingredients and instructions for preparing a meal, the meal recipe being generated with the processor based on the at least one nutritional deficiency.”
providing a nutritional composition based on the dietary recommendation, (See at least Para. [0023] – “The meal recipe can be generated based on the nutritional deficiency. The meal recipe can substitute new ingredients (with added health benefits, such as antioxidants) for something the user already has on his or her menu, or suggest different recipes. The processor 140 can also generate a dietary plan for the user, the dietary plan can include a list of meal recipes for at least one week. The dietary plan can be generated based on the nutritional deficiency. Additionally, the processor 140 can also generate a food additive for the user, the food additive can include a list of ingredients and instructions for preparing an additive to be added to food. The food additive (e.g., Vitamin A) can be generated based on the nutritional deficiency. Additives can include ingredients with known benefits for the use.
Hardee does not explicitly disclose administering the nutritional composition to the individual, wherein the nutritional composition is selected from the group consisting of a first composition comprising alpha-casozepine, a second composition comprising tryptophan, a third composition comprising mulberry leaf extract, and combinations thereof. (See Mallee, Claim 13 – “Nutritional composition for use according to any one of claims 11-12, comprising administering the composition to the subject in an amount that provides 0.3 to 0.6 gram of Trp, 0.3 to 0.6 gram of Cys, and 3.5 to 8 gram of GOS daily, preferably as a single serving.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to Hardee to utilize the teachings of Mallee since they are both in the same field of endeavor (i.e., supplementation to improve sleep quality), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 17, Hardee does not explicitly disclose The method of Claim 16, wherein the dietary recommendation comprises a recommendation for a meal comprising a nutrient selected from the group consisting of magnesium, zinc, tryptophan, B-vitamins, melatonin, glycine, protein, healthy fats, omega 3, fiber and combinations thereof. (see Claim 7 – “Nutritional composition according to any one of the preceding claims, wherein said composition further comprises one or more of magnesium, zinc, vitamin B3 and vitamin B6, preferably wherein said composition comprises magnesium, zinc, vitamin B3 and vitamin B6.”
Regarding claim 20, Hardee does not explicitly disclose The method of Claim 16, wherein the nutritional composition is administered to the individual concurrently with consumption of a meal. (See Mallee, Page 9 – “In a preferred embodiment, unit dosage forms of the compositions are consumed orally, including tablets, capsules, pills, lozenges, wafers, powders, liquids, emulsions, suspensions, solutions and the like. The composition can have the form of or can be included in a food or a beverage, such as a dietary supplement bar or shake.”)
Regarding claim 22, Hardee discloses The method of Claim 16, wherein the individual is selected from the group consisting of a child, an adolescent, an adult, and an elderly person (see Para. [0011] – “Moreover, the wearable electronic device can calculate calories burned based on the measurements and stored user parameters, such as, for example, weight, height, age, body fat percentage, gender, etc.”)
Regarding claim 24, Hardee discloses The method of Claim 16, wherein the dietary recommendation includes a single day meal plan. (See claim 7 – “The method according to 6, further comprising generating a dietary plan for the user, the dietary plan including a list of meal recipes for at least one week, the dietary plan being generated with the processor based on the at least one nutritional deficiency.”)
Regarding claim 25, Hardee discloses The method of Claim 16, wherein the dietary recommendation includes a multi-day meal plan. (See claim 7 – “The method according to 6, further comprising generating a dietary plan for the user, the dietary plan including a list of meal recipes for at least one week, the dietary plan being generated with the processor based on the at least one nutritional deficiency.”)
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardee (US 2017/0148348) in view of Mallee (WO 2020/078718), and in further view of “Effects of Mulberry Leaf Extract Rich in 1-Deoxynojirimycin on Blood Lipid Profiles in Humans” by Yoshihiro Kojima, published August 6, 2010, hereinafter referred to as Kojima2.
Regarding claim 18, Hardee and Mallee do not explicitly disclose the method of Claim 16, wherein the nutritional composition is administered to the individual at a predetermined time before consumption of a meal. (See Kojima, Page 1 – “The objective of this study was to evaluate the effects of DNJ-rich mulberry leaf extract on plasma lipid profiles in humans. An open-label, single-group study was conducted in 10 subjects with initial serum triglyceride (TG) level ≥200 mg/dl. Subjects ingested capsules containing DNJ-rich mulberry leaf extract at 12 mg three times daily before meals for 12 weeks. Our findings showed a modest decrease in serum TG level and beneficial changes in the lipoprotein profile following 12-week administration of DNJ-rich mulberry leaf extract. No significant changes in hematological or biochemical parameters were observed during the study period; no adverse events associated with DNJ-rich mulberry leaf extract occurred.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hardee and Mallee to utilize the teachings of Kojima since they are all in the same field of endeavor (i.e., analysis of effects of supplementation on health), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardee (US 2017/0148348) in view of Mallee (WO 2020/078718), and in further view of Grimmer (US 2018/0240542)
Regarding claim 23, Hardee and Mallee do not explicitly disclose The method of Claim 16, wherein the dietary recommendation is adapted to an individual preference selected from the group consisting of vegan, vegetarian, lactose-free, gluten-free and combination thereof. (See Grimmer, Para. [0202] – “In some embodiments, preference filter 1540 is applied to deprioritize foods that does not comply with a user's preference (e.g., vegetarian, dairy-free, gluten free, kosher, etc.). In some embodiments, the system removes a food that does not comply with a user's preference from a list of eligible foods for the user.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hardee and Mallee to utilize the teachings of Grimmer so that the suggested meals may address any dietary restrictions of the user.)
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardee (US 2017/0148348) in view of Mallee (WO 2020/078718), and in further view of “Melatonin-rich milk fortified with alpha s1 casein tryptic hydrolysate improves primary insomnia: a randomized placebo controlled trial” by Angela Campbell, published June 2, 2016, hereinafter referred to as Campbell3.
Regarding claim 26, Hardee and Mallee do not explicitly disclose The method of Claim 16, wherein the nutritional composition comprises the first composition and is administered along with a meal comprising at least one of (i) tryptophan from about 120 mg up to about 5 g, (ii) a sleep initiation beneficial micronutrient selected from the group consisting of magnesium, zinc, B-vitamins and combinations thereof, or (iii) a sleep functional ingredient is selected from the group consisting of melatonin, gamma aminobutyric acid (GABA), herbal extracts and combinations thereof. (See Campbell, Page 4 – “Subjects were instructed to take the milk drink 30 min prior to bedtime each night for 3 weeks. The sachets labeled A and B were identical. Both subjects and researchers were blinded to product details until after analysis of data. Product A contained a reduced lactose skim milk powder produced by separating milk produced from cows at night from milk produced at other times of the day, producing a readily soluble powder containing melatonin (85.5 pg/ml) and modified with an alpha s1-casein tryptic hydrolysate”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hardee and Mallee to utilize the teachings of Campbell since they are all in the same field of endeavor (i.e., supplementation to improve sleep quality), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 27 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardee (US 2017/0148348) in view of Mallee (WO 2020/078718), and in further view of “Effects of mulberry leaf and white kidney bean extract mix on postprandial glycemic control in pre-diabetic subjects aged 45–65 years: a randomized controlled trial” by Yan Liu, available October 2020, hereinafter referred to as Liu4.
Regarding claim 27, Hardee and Mallee do not explicitly disclose The method of Claim 16, wherein the nutritional composition comprises at least one of the second composition or the third composition and is administered along with an evening meal. (See Liu, Page 3 – “MWEM, in the form of a brown powder, containing 0.5 g mulberry leaf extract (TBHBio, Co., Ltd., Kunming, China) and 1.0 g white kidney bean extract (Purple Stone, Co., Ltd., Shanghai, China) per serving (1.5 g) was mixed and packaged in an aseptic production workshop by San He Fu Cheng Biotechnology Co., Ltd., Langfang, China.”, and “In the chronic effect test, the test group consumed MWEM 4.5 g daily (1.5 g with each meal) with usual diet for the 4-weeks intervention, while the control group continued with their usual diet.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hardee and Mallee to utilize the teachings of Liu since they are all in the same field of endeavor (i.e., encouragement of improvement to an individual’s health), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 29, Hardee and Mallee do not explicitly disclose “The method of Claim 16, wherein the nutritional composition comprises at least one of a glucosidase inhibitor or an amylase inhibitor, the glucosidase inhibitor is selected from the group consisting of 1-deoxynojirimycin (DNJ), mulberry leaf extract, mulberry fruit extract, phloridzin, arginine-proline (AP) dipeptide and combinations thereof, and the amylase inhibitor is selected from the group consisting of white kidney bean extract, wheat albumin and combinations thereof.” (See Liu, Page 3 – “MWEM, in the form of a brown powder, containing 0.5 g mulberry leaf extract (TBHBio, Co., Ltd., Kunming, China) and 1.0 g white kidney bean extract (Purple Stone, Co., Ltd., Shanghai, China) per serving (1.5 g) was mixed and packaged in an aseptic production workshop by San He Fu Cheng Biotechnology Co., Ltd., Langfang, China.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hardee and Mallee to utilize the teachings of Liu since they are all in the same field of endeavor (i.e., encouragement of improvement to an individual’s health), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.)
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardee (US 2017/0148348) in view of Mallee (WO 2020/078718), and “Instacart and PlateJoy Partner to Make Personalized Nutrition Real for All” by PlateJoy, Inc., available May 4, 2016, hereinafter referred to as Platejoy5.
Regarding claim 30, Hardee discloses A non-transitory computer-readable medium storing a program for improving sleep and/or subsequent behavioural outcomes of an individual in need thereof, that causes a device to:
provide a dietary recommendation by evaluating a parameter of the individual selected from the group consisting of falling asleep time, sleep duration, sleep onset latency, wakeafter sleep onset, sleep efficiency, gender, age, body mass index, physical activity level, glycemic status, food preference, food sensitivity, caloric intake, nutrients, meal glycemic load, time of consumption and combinations thereof, (“Data that can be input into or monitored by the wearable electronic device (e.g., via its sensors) can also be received as input by the wearable electronic device from external electronic devices (e.g., the user's smartphone). For instance, the user's exercise activity can be manually entered, calculated and/or monitored by the wearable electronic device, or the user's exercise activity can be wirelessly received as input from the user's smartphone. Exercise activity can include the type and quantity of exercise ( e.g., run 5 miles, 50 sit ups, 100 jumping jacks, 20 pushups, etc.). The wearable electronic device can measure the user's movements, duration of the movements, intensity of the movements, and/or heart rate.”, Claim 1 – “ receiving input from at least one of a sensor and an interface of a wearable electronic device of a user, the input including physiological factors and environmental factors measured by the wearable electronic device; predicting at least one nutritional deficiency with a processor, the at least one nutritional deficiency being predicted based on the input;”, and Claim 6 – “The method according to claim 1, further comprising generating a meal recipe for the user, the meal recipe including a list of ingredients and instructions for preparing a meal, the meal recipe being generated with the processor based on the at least one nutritional deficiency.”)
Hardee does not disclose order a nutritional composition based on the dietary recommendation, (See PlateJoy – “PlateJoy has spent three years developing the technology that turns an individual's nutrition data into ultra-personalized weekly menus. Backed by Y-Combinator in 2015, the company uses over 50 data points about your preferences and health goals to determine exactly what you should be eating, with recipes and shopping lists tailored to each customer.”, and “Starting today, the company can go one giant leap further: your custom groceries can be ordered 7 days a week via Instacart's one-hour delivery service in over 20 metro areas.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hardee to utilize the teachings of PlateJoy since it would provide users with access to the recommended meals/additives of Hardee.)
Hardee and PlateJoy do not explicitly disclose wherein the nutritional composition is selected from the group consisting of a first composition comprising alpha-casozepine, a second composition comprising tryptophan, a third composition comprising mulberry leaf extract and combination thereof. (See Mallee, Claim 13 – “Nutritional composition for use according to any one of claims 11-12, comprising administering the composition to the subject in an amount that provides 0.3 to 0.6 gram of Trp, 0.3 to 0.6 gram of Cys, and 3.5 to 8 gram of GOS daily, preferably as a single serving.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to Hardee and Platejoy to utilize the teachings of Mallee since they are Hardee and Mallee are in the same field of endeavor (i.e., supplementation to improve sleep quality), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Claims 19 and 21 were previously cancelled.
2 Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC2935155/pdf/jcbn-47-155.pdf
3 Available at https://link.springer.com/article/10.1007/s41105-016-0063-9
4 Available at https://www.sciencedirect.com/science/article/pii/S1756464620303418?via%3Dihub
5 Available at https://www.prnewswire.com/news-releases/instacart-and-platejoy-partner-to-make-personalized-nutrition-real-for-all-300262652.html