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 ACTION
Status of the application
2. Claims 1-15 are pending in this office action.
Claims 1-15 have been rejected.
Claim Rejections - 35 USC § 112
3. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
4. Claims 1-15 are -rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
5. Claims 1, 13 recite "wherein the at least one of C4 or C6 fatty acids”. However, the specification does not reasonably provide enablement for the therapeutic use of all C4 or C6 fatty acids which is broadly claimed in claims 1, 13. It is well known that not all C4 and/or C6 fatty acids undergo the same metabolism. Therefore, it is not credible that all C4 and/or C6 fatty acids provide the same ketosis inducing efficacy as butyric acid etc. This means that the subject matter is enabled.
Therefore, an undue experimentation would be involved in determining how to practice and use applicant’s invention.
The test for undue experimentation as to whether or not all ‘dose regimen’ within the scope of claims 1, 13 can be used as claimed and whether claims 1-4, 6-8, 14-19 meet the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed.Cir. 1988).
As stated in MPEP §2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’.” These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5. The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation necessary needed to make or use the invention based on the disclosure. See In re Wands USPQ 2d 1400 (CAFC 1988).
If we consider at least two of the above eight factors, and discuss them below: For example,
(5) “The Level of Predictability in the Art”, the instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., administering claimed dose amount of whey protein micelles to an individual either pre-diabetic or a diabetic patient), then there is a lack of predictability in the art. Moreover, it is noted that it requires each embodiment to be individually assessed for physiological activity. The court has indicated that the more the unpredictable an area is the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species, what other species will work.
In the instant case, the specification fails to provide any data or evidence for all the C4 and/or C6 in an effective method.
(6) The Amount of Direction Provided by the Inventor and The Presence or Absence of Working Examples
The Specification fails to provide any working examples or specific guidance or direction on the therapeutic use in performing claim 1(i), (ii) and claim 13 (i), (ii) with respect to all C4 and/or C6 fatty acids. In the absence of such information, a person of ordinary skill in the art would reasonably require an undue quantity of experimentation in order to determine whether administering whey protein micelles to a patient would prevent a condition of a reduced concentration of plasma amino acids.
In light of the at least above factor(s), it is seen that undue experimentation would be necessary to make and use the invention of all these presently claimed invention.
Claim Objections
6. Claim 1 is objected to because of the following informalities: Claim 1 recites and starts with the phrase the phrase “At least one of C4” and ends in one sentence. This can be amended for better phrasing of the complete sentence containing claim 1. It is also to be noted that claim 1 recites coma (, ) before the phrase “In a subject”. Therefore, ‘In’ should be ‘in’ and not ‘IN’ after coma. Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-15 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.
Independent claims 1, 13 recite the term “ enhancing ketosis” which does not relate to therapeutic treatment. Even if we accept that the induction of ketosis may have beneficial effects for some patients , these conditions are not claimed. Claims 1, 13 do not encompass any therapeutic situation. Therefore, the term “in therapeutic need of ketosis” cannot remedy the lack of clarity. The fact that induction of ketosis might be beneficial in some clinical situations , does not mean that the patient is in ‘need of ketosis’.
Regarding the term “in non-ketogenic amounts” with respect to butyrogenic dietary fiber or butyrogenic dietary fiber blend as claimed in claims 1, 13, is not clear. The reason is it is not clear how the non- ketogenic amounts are assessed and what are the thresholds. It is also to be noted that the phrase “non-ketogenic ketogenic diet-booster composition” as claimed in independent claims 1, 13 and other dependent claims, are also unclear.
According to applicant’s specification (in PGPUB, paragraph [0101]), in the context of the invention, it has been stated that a “non-ketogenic ketogenic diet-booster composition” is a composition or combination of compounds which does not increase or enhance the production of ketones by itself (i.e. it is a non-ketogenic composition), but it improves and/or enhances (boosts) the production of the amount of ketones induced by a ketogenic diet, or ketogenic interventions such as intermittent time periods of fasting or carbohydrate restriction. The composition thus increases (‘boosts’) the ketone amount production of subjects on a ketogenic diet and allows to sustain ketosis, and preferably also increases the rate of ketone production without serving as or being a substrate for the production of ketone bodies. However, this renders the claim even less clear. The reason is in this case, the term ‘ketogenic’ is not equivalent to the induction of clinically defined ketosis. Further, this amount depends on the individual patient and would, therefore, require an individual adaption, which would therefore require an individual adaption. Therefore, independent claims 1, 13 are indefinite.
Claim 7 recites the term “preferably”. Claim 7 also recites the phrase “ three to four times per day or continuously”. This makes the claim 7 indefinite.
Claim 8 recites Markush group language which is supposed to be selected from the group consisting of A,B,C and D. However, claim 8 claims which is selected from the group consisting of A,B,C or D. Claim 8 should be amended to recite “and” instead of “;” [i.e. semicolon] in between vi) and vii) i.e. prior to vii).
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. 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.
12. Claim(s) 1-5, 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. US 2017/0266148 A1 in view of Holmes et al. (in Micrbiome 10:114, pages 1-16, 2022).
13. Regarding claims 1, 3, D’Agostino et al. discloses that Beta-hydroxybutyrate mineral salts in combination with medium chain fatty acids or an ester thereof such as medium chain triglycerides were used to induce ketosis, achieving blood ketone levels of (2-7 mmol/L) with or without dietary restriction (Abstract, [0032], [0033]). This can help initiating rapid ketosis and accelerating the rate of ketoadaptation, this invention is useful for the avoidance of glucose withdrawal symptoms commonly experienced by individuals initiating a ketogenic diet, and minimizes the loss of lean body mass during dietary restriction (Abstract). D’Agostino et al. also discloses that ketogenic diet containing C4 fatty acid e.g. butyric acid from n-butyrate ions from potassium butyrate or related compounds stimulates receptors in the stomach that the stomach is full and consuming butyric acid precursors prior to eating reduces food consumption which, eventually, improved a patient's ability to withstand rigorous exercise, improved hypercholesterolemia and hypertriglyceridemia, and reduced fatigue ([0020], [0021]). D’Agostino et al. also discloses that MCT contains hexanoic fatty acid (C6) ([0037]).
D’Agostino et al. also discloses that citric acid can be used as ketone precursor ([0039]) to meet claims 1 and 3.
D’Agostino et al. is silent about the claim limitation of ‘butyrogenic dietary
fiber” or ‘butyrogenic dietary fiber blend’ as claimed in claims 1,5, 13 and also ‘butyrogenic dietary fiber’ is inulin and ratio between butyrate and propionate as claimed in claim 5.
Holmes et al. discloses that prebiotic regimens e.g. microbially fermentable fibers are the substrates for the production of SCFA production from gut bacteria (page 1, col 2 , Under Background, first five lines) and these include at least inulin, Galacto oligo saccharide (GOS), etc. and having the ratio between butyrate and propionate is around 1.0 (considering Median value from Min-Max range).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify D’Agostino et al. with the teaching of Holmes et al. to include microbial fermentable fibers as prebiotic in order to achieve SCFA production for the benefit of having more ketogenic fatty acid in the system.
14. Regarding claim 2, the disclosed ketogenic components e.g. butyric acid (C4) derivative and hexanoic acid (C6) ([0037], claim 23 of D’Agostino et al.) are identical to the claimed ketogenic components and the disclosed induced ketosis (Abstract) exhibit similar effect as claimed induced ketosis of claim 1 from which claim 2 depends, therefore, the disclosed composition will have similar property “[wherein] enhancing ketosis means increasing blood ketone concentrations in a subject on a ketogenic diet using the non-ketogenic ketogenic diet-booster composition in comparison to the blood ketone concentration in a subject consuming the same ketogenic diet and not using the non-ketogenic ketogenic diet-booster composition”.
15. Regarding claim 4, D’Agostino et al. discloses that ketogenic components e.g. butyric acid (C4) derivative and hexanoic acid (C6) ([0037], claim 23 of D’Agostino et al.) can be used as supplements to achieve ketosis yields a significant elevation of blood ketones and reduction of blood glucose levels (Abstract).
16. Regarding claims 8, 9, D’Agostino et al. discloses that the use of a unique
combination of beta hydroxybutyrate and medium chain triglycerides in order to generate a unique blood ketone profile necessary for effectively entering therapeutic ketosis. There are at least two populations that would immediately benefit from this combination formulation. First, children with epilepsy benefit from ketosis as it has been shown to reduce seizures (at least in [0102]).
17. Regarding claim 10, D’Agostino et al. discloses that the use of a unique combination of beta hydroxybutyrate and medium chain triglycerides in order to generate a unique blood ketone profile necessary for effectively entering therapeutic ketosis to control epilepsy and to reduce seizures (at least in [0102]). Even if D’Agostino et al. is silent about the phrase ‘top level ketosis’, however , it can be interpreted as the ketosis which provides unique blood ketone profile necessary for effectively entering therapeutic ketosis as disclosed by D’Agostino et al. (at least in [0102]). However, it is to be noted that claim 10 has 112 second paragraph rejection as mentioned above.
18. Claims 6, 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. US 2017/0266148 A1 in view of Holmes et al. (in Micrbiome 10:114, 2022) as applied to claims 1 and 13 and further in view of Vlahakos et al. USPN 6613356.
19. Regarding claims 6, 7, 14, D’Agostino et al. discloses that in paragraph [0020] Vlahakos (U.S. Pat. No. 6,613,356) provides a weight-loss composition using n-butyrate ions from potassium butyrate or related compounds. Butyric acid stimulates receptors in the stomach that the stomach is full and food is stagnant in the stomach. Thus, consuming butyric acid precursors prior to eating reduces food consumption.
20. Regarding claim 6, regarding the amounts of C4 and C6 fatty acids, Vlahakos et al. discloses that the amount of butyrate varies and it depends on the body weight, BMI etc. Vlahakos et al. also discloses that the total daily amount of butyrate varies and it can be 800 mg three times a day also ( col 7 line 25). One of ordinary skill in the art would have been motivated to optimize the amount of butyrate with a reasonable expectation of success to achieve desired body weight loss, BMI value etc. ( col 7 lines 1-35).
Vlahakos et al. also discloses that the total daily amount of butyrate or its derivative can be administered by dividing the dose into three successive equal doses to an individual (at least claim 10 of Vlahakos et al.) which meets claim 7.
Vlahakos et al. also discloses that BMI depends on amount of butyrate duration of treatment and body weight and can be achieved at the lowest point of 24.5 (col 7 lines 10-12) which meets claim 14.
Absent showing of unexpected results, the specific amount of butyrate or its derivative and BMI is not considered to confer patentability to the claims. As the body weight, height, individual’s health condition, duration of treatment etc. are variables that can be modified, among others, by adjusting the amount of butyrate dose and duration of its application as additive in the diet, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of butyrate in D’Agostino et al. in view of Vlahakos et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired ketosis level, BMI etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
21. Claims 11, 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. US 2017/0266148 A1 as applied to claim 1 and further in view of Vlahakos et al. USPN 6613356 and in view of Schmidt et al. US 2018/0256612 A1 and in view of Nagel et al. (US 20190313682 A1).
22. Regarding claims 11, 12, 15, D’Agostino et al. discloses a weight-loss
composition using n-butyrate ions from potassium butyrate or related compounds. Butyric acid stimulates receptors in the stomach that the stomach is full and food is stagnant in the stomach ([0020]).
Regarding the amounts of C4 and C6 fatty acids, Vlahakos et al. discloses that the amount of butyrate varies and it depends on the body weight, BMI etc. Vlahakos et al. also discloses that the total daily amount of butyrate varies and it can be 800 mg three times a day also ( col 7 line 25). One of ordinary skill in the art would have been motivated to optimize the amount of butyrate with a reasonable expectation of success to achieve desired body weight loss, BMI value etc. ( col 7 lines 1-35).
Regarding citric acid, D’Agostino et al. also discloses that MCT contains hexanoic fatty acid (C6) ([0037]). D’Agostino et al. also discloses that citric acid can be used as ketone precursor ([0039]).
D’Agostino et al. in view of Vlahakos et al. are silent about NAD and/or NAD ribose and its amount.
Schimdt et al. discloses that [0005] Ketosis is facilitated by nicotinamide adenine dinucleotide (“NAD”) modulator ([0005], [0056]). Schmidt et al. also discloses that exogenous NAD modulator can be considered in the composition in an amount of a therapeutically effective amount (at least claim 1 of Schmidt et al.), wherein the amount of said exogenous NAD modulator ranges from about 0.001 mg to about 5,000 mg in said single unit form ( at least claim 13 of Schmidt et al.) wherein said exogenous NAD precursor comprises nicotinoyl riboside or a derivative thereof (at least claim 6 of Schmidt et al.).
D’Agostino et al. discloses that Beta-hydroxybutyrate mineral salts in combination with medium chain fatty acids or an ester thereof such as medium chain triglycerides were used to induce ketosis, achieving blood ketone levels of (2-7 mmol/L) with or without dietary restriction (Abstract, [0032], [0033]). It is evidenced by applicants’ specification that (in PGPUB [0100]) the term “Ketosis” refers to a subject having blood ketone levels above 0.5 mmol/L. Ketone levels sustained above 0.5 mmol/L and ideally in the range of 1 to 3 mmol/L offer therapeutic effects in humans Levels of ketones in the blood above 10 mmol/L are associated with signs of ketoacidosis. While ketosis refers to a state of elevated ketones, ketoacidosis is a pathological and potentially life-threatening condition amongst others resulting in a decrease in blood pH and may induce a coma (in PGPUB [0100]).
Additionally, Nagel et al. discloses a new class of compositions that can aid in diets in general in ketogenic diets ([0011]) to sustain nutritional ketogenesis ([0066]) that contains at least one butyrate derivative 0.1 gm to 5 gm ([0018]), medium chain fatty acid which can be hexanoic (i.e. C6) fatty acid ([0015]) can be 0.1 to 10 gm ([0017]), from 50mg to 200mg citric acid ([0021]) can be considered to serve as supplement ([0038]) and it can be administered to the subject once, twice, or three times per day ([0030]).
Therefore, one of ordinary skill in the art can consider the above disclosed range amounts of the ingredients to consider in a composition to serve as additive to provide ketone level to sustain nutritional ketosis (Nagel et al. [0011]) and D’Agostino et al. achieving blood ketone levels of 2-7 mmol/L (D’Agostino et al. Abstract, [0032], [0033]) which provides therapeutic ketone level but is not above 10 mmol/L which is pathological keto acidosis as evidnced by applicant’s specification (in PGPUB [0100]). It is within the skill of one of ordinary skill in the art to optimize the amounts of C4, C6 fatty acids, citrate and NAD or nicotinamide ribose from within the disclosed amounts as discussed above in order to achieve disclosed blood ketone levels of 2-7 mmol/L (in D’Agostino et al. in Abstract, [0032], [0033]) which is therapeutic level of ketosis and noy pathological ketoacidosis which is 10 mmol/L or above as evidenced by applicants specification (in PGPUB [0100]).
Absent showing of unexpected results, the specific amounts of ingredients individually, in the composition, is not considered to confer patentability to the claims. As the ketone body in the blood are variables that can be modified, among others, by adjusting the amount of the ingredients, in combination, as additive composition, to be administered which is based on the age, body weight, dose and duration of its application as additive in the diet, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of the ingredients in D’Agostino et al. in view of Vlahakos et al. and Nagel et al. , to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired ketosis level, BMI etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
23. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. US 2017/0266148 A1 in view of Holmes et al. (in Micrbiome 10:114, 2022).
24. Regarding claim 13, claim 13 is a method claim. D’Agostino et al. discloses that Beta-hydroxybutyrate mineral salts in combination with medium chain fatty acids or an ester thereof such as medium chain triglycerides were used to ‘induce ketosis’, achieving blood ketone levels of (2-7 mmol/L) with or without dietary restriction (Abstract, [0032], [0033]). Therefore, D’Agostino et al. discloses a method of inducing (i.e. would have obvious enhancing) ketosis. This can help initiating rapid ketosis and accelerating the rate of ketoadaptation, this invention is useful for the avoidance of glucose withdrawal symptoms commonly experienced by individuals initiating a ketogenic diet, and minimizes the loss of lean body mass during dietary restriction (Abstract). D’Agostino et al. also discloses that ketogenic diet containing C4 fatty acid e.g. butyric acid from n-butyrate ions from potassium butyrate or related compounds stimulates receptors in the stomach that the stomach is full and consuming butyric acid precursors prior to eating reduces food consumption which, eventually, improved a patient's ability to withstand rigorous exercise, improved hypercholesterolemia and hypertriglyceridemia, and reduced fatigue ([0020], [0021]). D’Agostino et al. also discloses that MCT contains hexanoic fatty acid (C6) ([0037]).
D’Agostino et al. also discloses that citric acid can be used as ketone
precursor ([0039]) to meet claims 1 and 3.
D’Agostino et al. is silent about the claim limitation of ‘butyrogenic dietary
fiber” or ‘butyrogenic dietary fiber blend’ as claimed in claim 13.
Holmes et al. discloses that prebiotic regimens e.g. microbially
fermentable fibers are the substrates for the production of SCFA production from gut bacteria (page 1, col 2 , Under Background, first five lines) and these include at least inulin, Galacto oligo saccharide (GOS), etc. and having the ratio between butyrate and propionate is around 1.0 (considering Median value from Min-Max range).
One of ordinary skill in the art before the effective filling date of the
claimed invention would have been motivated to modify D’Agostino et al. with the teaching of Holmes et al. to include microbial fermentable fibers as prebiotic in order to achieve SCFA production for the benefit of having more ketogenic fatty acid in the system.
It is to be noted that the disclosures by Homes et al. with the modification of D’Agostino et al. would have obvious prevent resistance to a ketogenic diet of claim 13 (ii) in a healthy subject with the administration of C4 or C6 fatty acids containing claimed types of diets in combination with butyrogenic dietary fiber blend.
Conclusion
25. One pertinent prior art by NPL Cohen et al. as filed 8/28/2024 (14 pages) by applicants, is not used because this prior art teaches butyrate (C4) and could be combined as functional ketogenic ingredients into ketogenic diet.
However, the currently used primary prior art by D’Agostino et al. discloses that Beta-hydroxybutyrate (C4) in combination with medium chain fatty acids (includes C6) and also citric acid, in combination, to induce ketosis, achieving blood ketone levels of (2-7 mmol/L) (Abstract, [0032], [0033], [0039]) as discussed in detail in this office action above.
26. Any inquiry concerning the communication or earlier communications from
the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful,
examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/Examiner, Art Unit 1792
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