Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 04 December 2025.
PRIORITY
The Applicant claims priority to Provisional Application 63/121,134 filed on 03 December 2020. The Provisional Application provides support for 1 to 10 days. It does not provide support for 5 to 10 consecutive days. Support for this limitation is found in the specification filed on 03 December 2021. The Provisional Application does not provide support for a diet package proportioned to attain fasting-like effect on serum levels of IGF-1, IGFBP1, glucose and ketone bodies. The Provisional Application does not provide support for: algal oil (claim 10); nutrition bars and soups to be consumed for breakfast lunch and dinner (claim 11); all of the soup components recited in claims 13-14 (e.g., chicory root fiber, leeks, basil, oregano, etc.); nutrition bars formulated from the ingredients in claims 16 and 18; a second FMD bar; a second FMD formulated with the ingredients recited in claim 18.
CLAIMS UNDER EXAMINATION
Claims 1-4, 10-21 and 44-45 have been examined on their merits.
WITHDRAWN REJECTIONS
The rejection of claims 1-4, 10-21 and 44-45 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn due to claim amendment.
The rejection of claim 4 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, has been withdrawn due to claim amendment.
REJECTIONS
Claim Rejections - 35 USC § 103
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, 3-4, 10-11, 19-21 and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Longo et al. (previously cited; Drug combinations and methods to stimulate embryonic-like regeneration to treat diabetes and other diseases. US20170232053A1) in view of Fisher et al.
Longo teaches a fasting mimicking diet (FMD) for humans ([0144] [0145]). The diet is administered to subjects in need of promoting muscle regeneration ([0079]). At [0144] Longo teaches the following:
the FMD is for 5 days;
“Day 1 of the FMD supplies 4600 kJ (11% protein, 46% fat, 43% carbohydrate), whereas days 2-5 provide 3000 kJ (9% protein, 44% fat, 47% carbohydrate) per day”
the diet is “designed to attain fasting-like effects on the serum levels of IGF-I, IGFBP1, glucose and ketone bodies while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects”.
Figure 6B discloses lower IGF-1, glucose and increased ketone bodies. Longo teaches increased IGFBP1 ([0082]). Longo teaches “all items to be consumed per day were individually boxed to allow the subjects to choose when to eat while avoiding accidentally consuming components of the following day” ([0144]). Therefore the FMD is provided from a diet package. Days that follow each other are interpreted to be consecutive.
Longo teaches the diet can be formulated to provide from 4.5 to 7 kilocalories per pound of subject for a first day (day 1) and then 3 to 5 kilocalories per pound of subject per day for the second to the final day ([0038]). Longo teaches the following at [0039]:
The fasting mimicking diet provides less than 40 grams of sugar for day 1, less than 30 grams of sugar for days 2 to 5 and any remaining days, less than 28 grams of protein for day 1, less than 18 grams of protein for days 2 to 5 and any remaining days, 20-100 or 20-30 grams of monounsaturated fats or more to reach a higher calorie consumption (i.e., to reach a higher predetermined calorie consumption) for day 1, 6-30 or 6-10 grams of polyunsaturated fats or more to reach a higher calorie consumption for day 1, 2-12 grams of saturated fats or more to reach a higher calorie consumption for day 1, 10-50 or 10-15 grams of monounsaturated fats or more to reach a higher calorie consumption for days 2 to 5 and any remaining days, 3-15 or 3-5 grams of polyunsaturated fats or more to reach a higher calorie consumption for days 2 to 5 and any remaining days, 1-12 or 1-6 grams of saturated fats or more to reach a higher calorie consumption for days 2 to 5, or any remaining days, and a micronutrient composition on each day and any remaining days.
Longo teaches a diet packaged and proportioned to attain fasting-like effects: lowered serum IGF-1 and glucose, and increased ketone bodies and IGFBP-1. Claim 1 states this effect will increase satellite cell activation and improve muscle mass and muscle strength. Therefore a human with atrophy receiving FMD will have improved muscle mass and muscle strength as recited in claim 1.
The deficiencies of Longo are:
Longo teaches treating a human in need of muscle regeneration. Longo does not explicitly state the human has muscle atrophy. Longo does not anticipate the claimed ranges of total calorie, sugar, proteins and fats for each day.
Fisher teaches muscle wasting (i.e., atrophy) is the loss of muscle (first paragraph). Fisher teaches adopting a diet that provides sufficient calories and nutrients to promote muscle development (see page 6, “Nutritional Therapy”).
It would have been obvious to administer the diet taught by Longo to a subject with muscle atrophy. One would have been motivated to do so since Fisher teaches adopting a diet that promotes muscle development to treat atrophy, and Longo’s FMD promotes muscle regeneration (development). One would have had a reasonable expectation of success since Longo teaches atrophy can be reversed by stem cell-based regeneration, and teaches the FMD promotes muscle rejuvenation associated with stem cell generation. One would have expected similar results since both references are directed to treating muscle.
It would have been obvious to administer a total calorie consumption between 3.5 to 5 kcal per pound on day 1 and 2.4-4 kcal on the additional days of the diet. One would have been motivated to do so since Longo teaches the diet provides from 4.5 to 7 kilocalories per pound of subject for a first day (day 1) and 3 to 5 kilocalories per pound of subject per day for the second to the final day. One would optimize the amount based on the desired calorie consumption as taught by Longo. It would have been obvious to administer a diet with the claimed amounts of sugar and fats. Longo teaches ranges that overlap with the claimed amounts of each component. See MPEP 2133.03 The skilled artisan would optimize the amounts since Longo teaches doing so to reach the desired calorie consumption for each day of the diet and the desired nutritional goal of rebuilding muscle. Because the claimed method is rendered obvious, it would be expected to increase satellite cell activation and improve muscle mass and muscle strength in the subject. Therefore claim 1 is rendered obvious.
Longo teaches administration for 1-10 days ([0034). Therefore claim 3 is included in this rejection.
The diet can provide 800 kcal/day ([0037]). This amount reads on 800-1250 kcal on day 1 and 500 to 950 kcal on days 2-5 or any additional days. Therefore claim 4 is included in this rejection.
The diet can include soups ([0145]), nutrition bars ([0050]), kale crackers ([0050]), olives ([0055]), algal oil ([0076]), tea ([0050]) and supplements containing vitamins and minerals ([0157]). Also see [0145]. Therefore claim 10 is included in this rejection. The art teaches the foods are to be consumed for breakfast, lunch and dinner ([0145]). Therefore claim 11 is included in this rejection. Longo teaches an energy drink containing glycerin ([0072]). Glycerin reads on a glucose substitute. Therefore claim 19 is included in this rejection.
Longo teaches the diet can be repeated at predetermined intervals ([0034]). Repeating the diet is interpreted to read on a second time period. Therefore claim 20 is included in this rejection. The art teaches cycles ([0081]). Therefore claim 21 is included in this rejection.
Because the claimed method is rendered obvious, it would have the effect on satellite cells recited in claim 44.
Regarding independent claim 45: the teachings of Longo are reiterated. The claim recites 1 to 4 consecutive days. The 5 day diet taught by Longo includes 1 to 4 days.
It would have been obvious to administer the diet taught by Longo to a subject with muscle atrophy. One would have been motivated to do so since Fisher teaches adopting a diet that promotes muscle development to treat atrophy, and Longo’s FMD promotes muscle regeneration (development). One would have had a reasonable expectation of success since Longo teaches atrophy can be reversed by stem cell-based regeneration, and teaches the FMD promotes muscle rejuvenation associated with stem cell generation. One would have expected similar results since both references are directed to treating muscle.
It would have been obvious to administer a total calorie consumption between 3.5 to 5 kcal per pound on day 1 and 2.4-4 kcal on the additional days of the diet. One would have been motivated to do so since Longo teaches the diet provides from 4.5 to 7 kilocalories per pound of subject for a first day (day 1) and 3 to 5 kilocalories per pound of subject per day for the second to the final day. One would optimize the amount based on the desired calorie consumption as taught by Longo. It would have been obvious to administer a diet with the claimed amounts of sugar and fats. Longo teaches ranges that overlap with the claimed amounts of each component. See MPEP 2133.03 The skilled artisan would optimize the amounts since Longo teaches doing so to reach the desired calorie consumption for each day of the diet and the desired nutritional goal of rebuilding muscle. Because the claimed method is rendered obvious, it would be expected to increase satellite cell activation and improve muscle mass and muscle strength in the subject. Therefore claim 45 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Longo in view of Fisher as applied to claim 1 above, and further in view of Adrienne et al. (previously cited; ProLon 5-Day Fasting Mimicking Diet: Review And Experience Log. GiryaGIrl. 29 July 2020).
Claim 1 is rejected on the grounds set forth above. The teachings of Longo and Fisher are reiterated. Longo teaches the diet can include soups ([0145]), nutrition bars ([0050]), kale crackers ([0050]), olives ([0055]), tea containing spearmint (hence, herbal tea; [0050]) and supplements containing vitamins and minerals ([0157]). Also see [0145]. The soup contains a freeze dried (hence, lyophilized) component (basil) ([0148]). Examiner notes the art also teaches “dried” components are in the soup ([0147]-[0150]).
While Longo teaches a soup containing lyophilized and dried components, the art does not explicitly teach the soup is lyophilized (claim 2).
Adrienne et al. disclose a 5 day meal program in a box. The author states it is a “fasting mimicking (FMD) 5 day program” (see bottom of page 2). The FMD contains soups, bars, teas, kale crackers, olives, algal oil, and NR-1 (vegetable powder pressed with vitamins/minerals) (see page 7). The disclosure teaches the soups are powdered (hence, lyophilized) (see page 7).
It would have been obvious to include a lyophilized soup. One would have been motivated to do so since Longo teaches a FMD including a dried soup and Adrienne teaches a FMD can include a soup that is dried by lyophilization. Because Longo teaches all items to be consumed per day are individually boxed, the skilled artisan would lyophilize a soup for storage in a box. One would have had a reasonable expectation of success since Adrienne teaches soup can be lyophilized. One would have expected similar results since both references are directed to an FMD. Therefore claim 2 is included in this rejection.
Therefore Applicant’s invention is rendered obvious.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Longo et al. in view of Fisher as applied to claim 11 above, and further in view of Empowered Beyond Weight Loss (previously cited; Copycat Prolon L-Bar Choco Crisp Bar Recipe. 02 September 2021).
Claim 11 is rejected on the grounds set forth above. The teachings of the prior art are reiterated. Longo teaches a nut-containing nutrition bar and a cocoa-containing nutrition bar ([0050]). The cocoa-containing nutrition bar (L-Bar ChocoCrisp) includes
almond butter, almonds, and brown rice crispy (PGP10235) ([0054]).
Longo does not teach the limitations recited in claims 17-18.
Empowered Beyond Weight Loss teaches The L-Bar Proprietary Choco Crisp Bar comprises 90 calories, 4.5 grams total fat, 1 gram saturated fat, 0 grams trans fat, 3 grams protein and 14 grams of carbohydrates per serving size. This formulation reads on claim 17. The bar comprises inulin, almond butter, brown rice crispy, cocoa powder, almonds, chocolate chips, rolled oats, brown rice syrup, flaxseed oil, rice dextrin, grape juice and salt. This reads on claim 18.
It would have been obvious to combine the teachings of the prior art by administering a second bar with the claimed formulation. One would have been motivated to do so since Longo teaches a Choco Crisp cocoa-containing nutrition bar for an FMD diet and Empowered Beyond Weight Loss teaches a Choco Crisp Bar with the claimed nutritional content and therefore formulating the food into a bar would provide a convenient easy meal supplement. One would have had a reasonable expectation of success since Empowered Beyond Weight Loss teaches the bar can be used in an FMD. One would have expected similar results since both references are directed to an FMD. Therefore claim 17 is included in this rejection.
It would have been obvious to administer a second bar made with the claimed ingredients. One would have been motivated to do so since Longo teaches a cocoa-containing nutrition bar for an FMD diet and Empowered Beyond Weight Loss teaches a Choco Crisp Bar made with the claimed ingredients. One would have had a reasonable expectation of success since Empowered Beyond Weight Loss teaches the bar can be used in an FMD. One would have expected similar results since both references are directed to an FMD. Therefore claim 18 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Longo in view of Fisher as applied to claim 11 above, and further in view of
Brandhorst et al. (previously cited; Fasting Mimicking Diet. WO2018/152160).
Claim 11 is rejected on the grounds set forth above. The teachings of the prior art are reiterated. Longo teaches the diet includes soups. The art is silent regarding the nutritional content of the soup. Longo teaches nutrition bars. The art is silent regarding the nutritional content of the bars.
Brandhorst teaches a fasting mimicking diet (FMD) (Abstract). Brandhorst teaches the FMD includes soup ([0006]), bars ([0007]), an olive containing composition ([0007]), a cracker composition ([0007]), a supplement containing minerals and vitamins ([00109]) and an algal oil composition ([0060]). The soup disclosed by Brandhorst in Figure 7A contains 1 g saturated fat, 0 g trans fat, 2 grams of protein and 19 grams carbohydrate per serving. The energy bar disclosed in Figure 7E of Brandhorst reads on the components recited in claim 15. The nut-containing nutrition bar taught by Brandhorst at [0037] reads on claim 16.
It would have been obvious to use the soup taught by Brandhorst in the diet disclosed by Longo. One would have been motivated to do so since Longo teaches an FMD containing soup and Brandhorst teaches an FMD containing a soup with the claimed nutritional content. One would have had a reasonable expectation of success since Brandhorst teaches the soup can be used in an FMD. One would have expected similar results since both references are directed to a FMD with soup. Therefore claim 12 is rendered obvious.
Longo teaches a soup containing quinoa and cabbage ([0066]). Therefore claims 13-14 are included in this rejection.
It would have been obvious to use the bars taught by Brandhorst in the diet disclosed by Longo. One would have been motivated to do so since Longo teaches a FMD containing bars and Brandhorst teaches an FMD containing bars with the claimed nutritional content. One would have had a reasonable expectation of success since Brandhorst teaches the soup can be used in an FMD. One would have expected similar results since both references are directed to an FMD with nutrition bars. Therefore claims 15-16 are rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
APPLICANT’S ARGUMENT’S
The arguments made in the response filed on 26 June 2026.
Argument 1: The Applicant argues the prior art references do not teach a diet package proportioned to attain fasting-like effects characterized by lowered serum IGF-1, lowered serum glucose, increased IGFBP-1, and increased ketone bodies, thereby increasing satellite cell activation and improving muscle mass and muscle strength in the subject.
Response: Long to teaches a diet package that is proportioned. Longo teaches
the diet is designed to attain fasting-like effects on the serum levels of IGF-I, IGFBP1, glucose and ketone bodies. Figure 6B discloses lower IGF-1, glucose and increased ketone bodies. Longo also teaches increased IGFBP1 ([0082]). Therefore this argument is not persuasive.
Argument 2: The Applicant argues Fisher teaches that adopting a diet providing sufficient calories, protein, and other nutrients that promote muscle development may help treat muscle wasting. The Applicant argues Longo is not applicable because it is a calorie-restricted and low-protein diet. Therefore one would not provide Longo’s diet to a person in need of sufficient calories.
Response: Longo teaches administering an FMD to treat a subject in need of muscle regeneration. While Fisher teaches malnutrition can cause muscle atrophy, it does not teach the diet taught by Longo results in malnutrition. Longo explicitly teaches the FMD mimics the effects of fasting, but provides some nutritional component so that fasting is mimicked while a subject is not completely starved ([0033]). As noted by the Applicant. Fisher teaches adapting a diet that provides sufficient calories, protein and other nutrients that promote muscle development. Longo teaches a diet that promotes muscle development. Therefore the arguments are not persuasive.
Argument 3: The Applicant argues the Examiner has improperly asserted the human treated by Longo will have improved muscle mass and muscle strength.
Response: In the previous response filed on 04 December 2025, the Applicant “acknowledges that Longo discloses a fasting-mimicking diet (FMD) designed to attain fasting-like effects on serum IGF-1, IGFBP1, glucose and ketone bodies, and that Longo expressly states this FMD can be used to promote regeneration… in muscle” (see page 9, second paragraph of Arguments). Longo teaches a proportioned package.
Claim 1 states each of these characteristics thereby improves muscle mass and muscle strength in a human subject with atrophy. As set forth above, Longo does not explicitly teach the subject in need of muscle rejuvenation has atrophy.
Treating a human with atrophy is rendered obvious. Therefore a human with atrophy receiving FMD will have improved muscle mass and muscle strength as recited in claim 1.
Argument 4: The Applicant argues Longo is directed to stimulating embryonic-like regeneration to treat diabetes and other diseases, and not treating atrophy.
Response: Longo teaches the FMD is administered to subjects identified as benefiting or needing promotion of muscle rejuvenation. Fisher teaches adopting a diet that promotes muscle development to treat atrophy. One would administer Longo’s FMD to a patient with atrophy since the FMD promotes muscle regeneration.
Argument 4: The Applicant argues the specification disclose unexpected results.
A single cycle of the calorie- and protein-restricted FMD was sufficient to improve
muscle strength relative to baseline, whereas muscle strength in the control group naturally and progressively declined (Fig. 1A and accompanying description). The
FMD increases skeletal-muscle protein content (Fig. 1C) and increases
satellite cell activation, including Myf5-positive activated satellite cells (Fig. 1D), myoblasts (Fig. 1E), and Pax7-positive satellite cells (Fig. 1F).
Response: Increased activation of Myf5-positive activated satellite cells, myoblasts and Pax7-positive satellite cells is not a claim limitation. Increased skeletal muscle protein content is not a claim limitation. The Applicant has not provided evidence demonstrating each claimed amount recited in claim 1 is critical. Therefore the arguments are not persuasive.
CONCLUSION
No Claims Are Allowed
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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