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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04 December 2025 has been entered.
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WITHDRAWN REJECTIONS
The rejection of claim 43 under 35 U.S.C. § 101 is withdrawn due to claim amendment.
The rejection of claims 1-5, 8-21 and 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn due to claim amendment.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rejection of claims 1-4, 10-21 and 44-45 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, has been withdrawn due to claim amendment.
REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 10-21 and 44-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “and the fasting mimicking diet for days 2, 3, 4, 5 provides a total…”.It is unclear if the claim means “for days 2, 3, 4 and 5”, or “for days 2, 3, 4 or 5”. The metes and bound of the claim are unclear. Appropriate correction is required. All dependent claims are included in this rejection.
Claims 12-18 recite “FMD”. It is unclear what “FMD” means. If the Applicant is using “FMD” as an abbreviation for “fasting-mimicking diet” (as recited in claim 1) the base claim should be rewritten to recite “fasting-mimicking diet (FMD)”. Appropriate correction is required. All dependent claims are included in this rejection.
Claim 16 recites “mixed tocopherols (vitamin E)”. The use of parentheses makes it unclear if Vitamin E is an example of the mixed tocopherols, or a require component. The metes and bounds of the claim are unclear. Appropriate correction is required.
Claim 45 recites “1-4 consecutive days”. As written, the claim is interpreted to mean the diet is administered for 1, 2, 3 or 4 days. It is unclear how 1 day can be consecutive. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites “or any additional days”. Claim 1 has been amended to recite 5 to 10 consecutive days”. “Any additional days” does not further limit 5 to 10 days.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 human version of a fasting mimicking diet (FMD) for humans ([0144] [0145]). Longo teaches the FMD is for 5 days ([0144]). Longo teaches “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” ([0144]).
Longo teaches “It is a plant-based diet 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 (Brandhorst et al., 2015)” ([0144]). Figure 6B discloses lower IGF-1, glucose and increased ketone bodies on an FMD diet. 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 art teaches the FMD is provided from a diet package proportioned. Days that follow each other are interpreted to be consecutive.
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 the human treated with the FMD will have improved muscle mass and muscle strength as recited in claim 1.
The following is also noted:
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 the ability of animals to survive food deprivation is an adaptive response accompanied by the atrophy of many tissues and organs to minimize energy expenditure. This atrophy and its reversal following the return to a normal diet involves stem cell-based regeneration in the hematopoietic and nervous systems ([0004]).
The diet can be administered to subjects in need of promoting muscle rejuvenation in subjects ([0036]). The fasting mimicking diet promotes muscle rejuvenation associated with stem cell generation ([0079]; also see claim 9 of Longo). Said stem cells are from skeletal muscle ([0083]).
The deficiencies of Longo are:
Although Longo teaches a person (human) in need of muscle regeneration, Longo does not explicitly state the subject in need of muscle regeneration 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 a 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 a 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 a FMD containing soup and Brandhorst teaches a 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 a 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 a 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 04 December 2025. The Applicant argues the claims are directed to treating a human with muscle atrophy. The Applicant argues the prior art does not teach treating a subject with muscle atrophy. The Applicant argues the amounts taught by Longo are broader are directed to treating diabetes and promoting generalized multi-organ regeneration.
In response: As set forth above, Longo explicitly teaches the diet can be used to treat subjects identified as benefiting or needing promotion of muscle rejuvenation. It is also noted Longo never teaches treating “generalized” multiorgan regeneration as alleged by the Applicant.
The Applicant argues Fisher does not teach the claimed diet, and teaches malnutrition is a source of muscle wasting on page 5. The Applicant argues Fisher teaches adapting a diet that provides sufficient calories, protein and other nutrients that promote muscle development on page 6. The Applicant argues the calorie restricted diet taught by Longo is antithetical to this teaching.
In response: Fisher is not relied upon to teach an FMD. 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.
The Applicant argues the prior art does not teach the specific calorie and macronutrient amounts recited in claim 1. The Applicant argues all of the caloric ranges and amounts of macronutrients recited claim 1 are critical.
In response: The Applicant has not provided any evidence of criticality. The claimed ranges are rendered obvious on the grounds set forth above.
The Applicant has provided only arguments alleging criticality. The Applicant has not provided evidence demonstrating each claimed amount recited in claim 1 is critical.
As set forth above, and acknowledged by the Applicant, 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 the human treated by Longo will have improved muscle mass and muscle strength.
Therefore the arguments are not persuasive.
Conclusion
No claims are allowed.
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) 270-8439.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE M MOSS/ Examiner, Art Unit 1653