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 .
Claim Objections
Claims 1, 17, 20-21 are objected to because of the following informalities: Claim 1 should recite “fasting-mimicking diet or FMD” so that it provides clarity for the abbreviation “FMD” recited in Claim 22. Claim 17 includes a typographical error of the word “(Original)” in the body of the claim and should be removed. Claim 20 is objected to because it is not in the proper format as the claim should have a single period at the end of the claim. Claim 21 includes a typographical error in the recited amount of servings “1, 1, 2, or 3” and should be corrected.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 8 and 17 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 5 recites “the fasting-mimicking diet component provides 10-50% of the normal calorie intake” and this is indefinite in light of Claim 1 reciting “less than 50% of the normal calorie intake” as Claim 5 provides for 50% of the normal calorie intake which does not meet the limitations of Claim 1. Therefore, the metes and bounds of Claim 5 are indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “at least three cycles”, and the claim also recites “more preferably at least five cycles” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 17 recites the limitation "at least 50% of the calories from fatty acids are from coconut oil and tree nuts” in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim because Claim 1 does not introduce fatty acids which are only introduced in Claim 15.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Longo et al. (USPA 2016/0331016), made of record by Applicant.
Regarding Claims 1, 8, 10, Longo teaches a method comprising administering a fasting-mimicking diet component to a human subject three cycles of a low protein low calorie and high nourishment diet for 5 days following by approximately 3 weeks of a normal diet (Paragraphs 30, 51, and 59), where the fasting-mimicking diet is both protein and sugar restriction as Longo teaches very low protein or no protein diet and low carbohydrate and low sugar-containing diet (Paragraphs 10, 31 and 60). Longo teaches the fasting-mimicking diet provides less than 50% of the normal calorie intake of the human subject as Longo teaches a refinement of the embodiment with the first day providing 1000-1200kcal diet and for the next 4 days a daily diet of 650-800kcal (Paragraph 63), therefore providing less than 50% calorie restriction. Longo teaches the normal diet for approximately 3 weeks after the fasting-mimicking diet, which therefore teaches administering a re-feeding diet component for a second time period, the re-feeding diet providing 60-100% of the normal calorie intake of the human subject. Longo teaches the human is subjected to the above diet for three cycles, therefore meeting the limitation of multiple cycles. While Longo teaches the claimed method steps and teaches the specific method steps recited in Claim 2 as seen below, Longo does not specifically teach the claimed method for enhancing lean body mass and/or muscle mass in a human subject in need thereof. However, since Longo teaches the claimed method steps, one of ordinary skill in the art would have reasonably expected the claimed method of enhancing lean body mass and/or muscle mass to also be achieved. Therefore, the claimed method would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, in light of the teachings of Longo. It has also been found that 'It is well settled that a patent cannot be properly granted for [an invention] which would flow naturally from the teaching of the prior art.' See Ex parte Obiaya, 227 USPQ 58, 60 (Bd.Pat. App. & Inter. 1985) as cited in MPEP 2145 II.
Regarding Claims 2, 12 and 13, Longo teaches where the fasting-mimicking diet component includes rations for a fasting-mimicking diet to be administered for the first time period, where the fasting mimicking diet provides the subject with at most 50% of a subjects normal caloric intake for the first through fifth day, as Longo teaches a refinement of the embodiment with the first day providing 1000-1200kcal diet and for the next 4 days a daily diet of 650-800kcal and teaches the diet includes rations including soups/broth, soft drinks, nut bars and supplements (Paragraph 63), therefore providing at most 50% calorie restriction in the first through fifth day, the diet being a low protein diet that provides less than 28g protein on the first day and less than 18g protein on the second to fifth days, and less than 30g sugar on day 1 and less than 20 g sugar on second to fifth days, and less than 12g saturated fat on day 1 and less than 6 g saturated fats on second to fifth days (Paragraph 60). Since Longo teaches the above amounts of protein and sugar during days 1-5 of the fasting-mimicking diet, one of ordinary skill in the art would have reasonably expected the claimed percentages of protein and sugar in the fasting-mimicking diet would also be met by the method of Longo.
Regarding Claims 3 and 4, Longo teaches a method comprising administering a fasting-mimicking diet component to a human subject three cycles of a low protein low calorie and high nourishment diet for 5 days following by approximately 3 weeks of a normal diet (Paragraphs 30, 51, and 59), therefore teaching a first time period in the claimed range, as 5 days equals 120 hours, and the second time period is 21 days, which is within the claimed range for the second time period. Regarding Claim 4 and the second time period recited as 25-26 days, Longo teaches the second time period is “approximately 3 weeks”, which is approximately 21 days, and slightly less than the 25-26 days recited. However, since Longo teaches “approximately” which provides for amounts of time more or less than the disclosed time frame, and since Longo teaches methodology to ensure a particular result, it would have been well within the skill of one of ordinary skill in the art to have adjusted the re-feeding period longer or shorter depending on the desired outcome. Such experimentation would have been well within the skill of one or ordinary skill in the diet and experimentation art.
Regarding Claims 5-7, 11 and 14, Longo teaches that the consumption guidelines for the FMD (fasting-mimicking diet) include nutrition facts relative to calories, macro and micronutrients and teaches calories consumed according to user’s body weight, where total calorie consumption is 10-16 calorie/kg for day 1 and 7-11 calories/kg for days 2 to 5 (Paragraph 60). Since Longo teaches calories/kg consumption during the FMD that overlap with the claimed calories/kg body weight recited in Claim 14, one of ordinary skill in the art would have reasonably expected the fasting mimicking diet taught by Longo to provide the claimed percentage of normal calorie intake of the human subject, as well as the limitation of the FMD providing less than 400kcal/day, as claimed.
Regarding Claim 9, Longo teaches the FMD should contain between 20 and 30 grams of monounsaturated on day 1 and 10-15g on days 2-5 and 6 to 10g polyunsaturated fats on days 1 and 3-5g of polyunsaturated fatty acids on days 2 to 5 (Paragraph 60), which is understood to meet the limitation of a “high” content of mono and polyunsaturated fatty acids in the FMD, as claimed, along with reduced amount of protein and sugars, as set forth in the rejection of Claim 2. Regarding the limitation of at least 40% of the calories being derived from fats, Longo teaches of a particularly useful diet having at most 50% of the subject’s normal caloric intake with at least 50% of the kcalories being derived from fat (Paragraph 66).
Regarding Claim 15, Longo teaches up to 5% of calories from protein of the total calories consumed and the low protein diet is 100% calories of protein from plant sources (Paragraph 53), with ketogenic high fat diets having 60% of the consumed calories from fat, therefore meeting the limitation of at least 60% of calories from fatty acids and 20% from carbohydrates (Paragraph 31). Longo teaches the FMD diet should contain 12-25g glycerol per day on days 2-5 and in a refinement, glycerol is provided at 0.1g per lb body weight/day (Paragraph 60). While the % of calories from glycerol are not specifically taught, since Longo teaches a small amount of glycerol is part of the FMD diet, it would have been well within the skill of one of ordinary skill in the art to have determined the optimal amount of glycerol, depending on outcomes desired.
Regarding Claim 16, Longo teaches various vegetables included in the FMD diet (Paragraph 61), therefore teaching where the FMD component comprises complex carbohydrates from plant sources.
Regarding Claim 17, Longo teaches the fats on all days are derived from a combination of various nuts and coconut oil (Paragraph 60), therefore meeting the claimed limitation.
Regarding Claim 20, Longo is taken as cited above in the rejection of Claims 2, 9 and 16 for the claimed limitations as Longo teaches the FMD should contain less than 28g protein on the first day and less than 18g protein on the second to fifth days, and less than 30g sugar on day 1 and less than 20 g sugar on second to fifth days, and less than 12g saturated fat on day 1 and less than 6 g saturated fats on second to fifth days (Paragraph 60), and also teaches 20 and 30 grams of monounsaturated on day 1 and 10-15g on days 2-5 and 6 to 10g polyunsaturated fats on days 1 and 3-5g of polyunsaturated fatty acids on days 2 to 5 (Paragraph 60), where protein is mostly or completely from plant sources as set forth above.
Regarding Claims 21 and 22, Longo teaches the FMD includes soup compositions and nutrition bars, where the 5 day supply of the diet includes these types of rations (Paragraph 63-64). While Longo does not specify the particular nutritional requirements of the soup compositions or bars per serving as claimed, since Longo teaches the general nutritional requirements for the FMD, as set forth in Claims 2 and 20, for example, one of ordinary skill in the art would have reasonably expected that the FMD rations taught by Longo would provide the disclosed nutritional specifications per serving, in terms of total kcal per serving, fat, carbohydrates and protein. In addition, it would have been obvious to one of ordinary skill in the art to have optimized the per serving nutritional requirements of the FMD rations depending on the particular outcome desired.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Longo et al. (USPA 2016/0331016), made of record by Applicant, in view of VanHouten, “My three-day fasting mimicking diet experiment” (2018).
Regarding Claims 18-19, Longo is relied upon as above in the rejection of Claim 1 but does not teach where the human subject performs a daily muscle training during the second time period.
VanHouten teaches of her experience with a three-year fasting mimicking diet and recommends against normal high intensity/heavy lifting during the fasting mimicking diet portion (Page 5), where the heavy lifting is understood to meet the limitation of muscle training. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have performed daily muscle training after the fasting mimicking diet portion and during regular diet/second time period, in light of the teachings of the prior art and the recommendations of athletes trying out fasting mimicking diets. While VanHouten does not specifically teach the total daily energy expenditure for the daily muscle training, it is submitted that it would have been well within the skill of one of ordinary skill in the art to have performed the desired amount of exercise to result in a desired daily energy expenditure depending on exercise outcomes desired.
Conclusion
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JENNA A. WATTS
Primary Examiner
Art Unit 1791
/JENNA A WATTS/Primary Examiner, Art Unit 1791 1/23/2025