DETAILED ACTION
Background
The amendment dated October 27, 2025 (amendment) amending claims 1, 16-17 and 34 has been entered. Claims 16-19, 23-25, 30-31 and 33-34 as filed with the amendment have been examined. Claims 1-3, 5, 7-10, 14-15, 32 and 35 have been withdrawn from consideration as drawn to a non-elected invention. Claims 4, 6, 11-13, 20-22 and 26-29 have been canceled. In view of the amendment, all outstanding claim objections have been withdrawn.
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 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 17-19, 23-25, 30-31 and 33 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 17 recites the limitation "said food formulation" in the last line. There is insufficient antecedent basis for this limitation in the claim. Claim 17 does not recite a food formulation and is an independent claim.
The Office interprets the recited amounts of MCT as being based on the total weight of lipids in the recited baked food product.
In each of claims 23 and 24, the recited ketogenic ratio is indefinite because it fails to identify the units for the ratio. Is the recited ketogenic ratio a weight ratio, a volume ratio, or a ratio of some other unitary ratio of lipids and carbohydrates?
The Office interprets the recited ketogenic ratio as being a weight ratio of lipids to carbohydrates.
Claims 18-19, 25, 30-31 and 33 are rejected as being based on a rejected base claim.
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 16-19, 25, 30-31 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0303997 A1 to Fulton (Fulton) in view of CN 108703180 A to Qian et al. (Qian), both of record.
All references to Qian refer to the Espace.net machine translation, a copy of which was included in an earlier Office action.
Unless otherwise indicated, all percentages (%) are assumed to be weight %s (wt%) and wt% and mass % are considered as interchangeable.
Regarding instant claims 16-18 and 33, Fulton at Abstract discloses starch-free high-fiber baked food products which (at [0016]) include cookies or biscuits and bread that comprise protein, fat and fiber. At [0004] Fulton discloses its baked food product used for treating or managing cancer (“tumors” - claim 33) and Alzheimer’s disease (claim 33) At [0024], Fulton discloses baked food products comprising from 10 to 40 wt% of fat, from 3 to 30 wt% protein, and from 10 to 40 wt% fiber from psyllium and coconut (“vegetable fiber”), which each of the claimed 10 to 38 wt% vegetable fibers in claim 16 and the claimed 12 to 40 wt% vegetable fibers in claim 17, based on the total weight of the baked food product, overlaps. The baked food product disclosed in Fulton at [0024] further comprises a digestible carbohydrate content (“carbohydrate”) of 4 wt% or less and from 10 to 40 wt% of fat, which each of the claimed 15 to 60 wt% of lipids in claim 16, the claimed 17 to 62 wt% of lipids in claim 17 and the claimed 25 to 35 wt% of lipids in claim 18, based on the total weight of the baked food product, overlaps. The claimed 0.5 to 8 wt% of carbohydrates in claims 16 and 17, based on the total weight of the recited baked food product, both overlap the 4 wt% or less of carbohydrates in the baked food product disclosed in Fulton at [0024]. The Office considers baked food products for “physiological and/or pathological conditions of individuals by means of the ketogenic diet”- claim 16 and “for managing a ketogenic diet”- claim 17 as including those disclosed in Fulton.
Further and regarding instant claims 25 and 34, each of the claimed 0.25 to 14 wt% of proteins in claim 16, the claimed 0.25 to 15 wt% proteins in claim 17, the claimed 0.25 to 10 wt% of proteins in claim 25, and the claimed 0.25 to 5 wt% of proteins in claim 34, based on the total weight of the recited baked food product, overlaps the 3 to 30 wt% of protein in the baked food product disclosed at [0024] of Fulton. And, at [0041], Fulton discloses as its proteins animal proteins (“consist exclusively of animal proteins” - claims 16 and 17) including egg proteins, milk proteins and connective tissue proteins including collagen and gelatin that provide improved dough handling and baking properties.
Before the effective date of the present invention, the ordinary skilled artisan would have found it obvious in view of Fulton to include in its disclosed baked food product the claimed amounts of each of its disclosed lipids, proteins, carbohydrates and vegetable fibers, based on the total weight of the recited baked food product. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan in Fulton would have desired to use the claimed amount of lipids in claims 16, 17 and 18, the claimed amount of proteins In claims 16, 17, 25 and 34, the claimed amount of carbohydrates in claims 16 and 17, and the claimed amount of vegetable fibers in claims 16 and 17, based on the total weight of its baked food product, because Fulton discloses that the claimed amounts of lipids, proteins, carbohydrates and vegetable fibers provide a desirable baked food product for treating Alzheimer’s disease and tumors.
The Office considers the claimed baked food product “consisting essentially of” the recited amounts of lipids, proteins, carbohydrates and vegetable fibers as including the baked food product of Fulton because none of the materials in the Fulton baked food product detract from the basic and novel characteristics of a baked food product for treating physiological and/or pathological conditions of individuals by means of the ketogenic diet or for managing a ketogenic diet.
Fulton does not disclose an example wherein its lipids comprise medium-chain triglycerides (MCTs) having aliphatic carbon chains comprising from 6 to 12 carbon atoms and derived from caprylic acid or capric acid or lauric acid, or combinations thereof. Further, Fulton does not disclose a lipid wherein the MCTs constitute from 30% to 60% by weight of a total quantity by weight of lipids present in said food formulation as in claim 16 or by weight of lipids present in the baked food product as in claim 17. However, at [0047] bridging pages 6 and 7, Fulton discloses coconut oil. The Office considers the claimed medium-chain triglyceride (MCT) having aliphatic carbon chains comprising from 6 to 12 carbon atoms to include the coconut oil disclosed in Fulton as disclosed at page 4, 2nd full paragraph; and, further, considers the claimed lipid derived from one, more or all of octanoic (caprylic acid) capric acid and lauric acid to include the coconut oil disclosed in Fulton.
Qian at page 1, Abstract discloses a ketogenic biscuit. At the 1st paragraph of page 9, Qian discloses administering the ketogenic biscuit to epilepsy patients to eat as food therapy material. Further, Qian at Example 2 on page 9 discloses a ketogenic biscuit comprising 15 parts of inulin, 30 parts of MCT oil, 30 parts of γ-linolenic acid, 3 parts of egg powder, 0.5 part of baking powder, 0.4 parts of baking soda powder and 0.1 part of rice bran fatty alcohol in 100 weight parts. The Example 2 biscuit of Qian comprises 50 wt% of MCT oil, based on the weight of all lipids in its food formulation (claim 16) and all lipids in its baked food product (claim 17). At page 5, 2nd full paragraph, Qian discloses that MCTs are the best ingredient for the ketogenic diet as they have a fast digestion rate and energy supply and provide brain nutrition while, at the same time they do not synthesize fatty acids.
Before the effective date of the present invention, the ordinary skilled artisan would have found it obvious in view of Qian for Fulton to use as its lipid 30 to 60 wt% of MCT on the weight of lipids as blend of MCT oil with γ-linolenic acid or another fat suitable for baking. Both references disclose low carbohydrate baked food products comprising vegetable fiber and coconut oil for treating neurogenerative disorders. The ordinary skilled artisan in Fulton would have desired to seek the health benefits provided by making its product with a mixture of MCT oil and γ-linolenic acid or another fat as in Qian containing 30 to 60 wt% of the MCT oil, based on the total weight of lipids in its baked food product.
Regarding instant claim 19, the Office considers the claimed mixture of medium-chain triglycerides to include the coconut oil disclosed at [0047] of Fulton.
Regarding instant claim 30, Fulton at [0034] discloses fiber as a mixture of soluble vegetable fibers and insoluble vegetable fibers.
Regarding instant claim 31, the Office considers the claimed baked food product for treating drug-resistant epilepsy or neurodegenerative diseases to include the dietary treatment disclosed in Fulton at [0004] for Alzheimer’s disease.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0303997 A1 to Fulton (Fulton) in view of CN 108703180 A to Qian et al. (Qian) as applied to claim 17, above, and further in view of US 20160081383 A1 to Gamberi et al. (Gamberi), of record.
The cited Gamberi reference is equivalent to EP 3001914 A1 to Gamberi et al.
All references to Qian refer to the Espace.net machine translation, a copy of which was included in an earlier Office action.
Unless otherwise indicated, all percentages (%) are assumed to be weight %s (wt%) and wt% and mass % are considered as interchangeable.
As applied to claim 17, Fulton at [0024] and [0045] as modified by Qian at Abstract on page 1 discloses a baked food product for managing a ketogenic diet comprising 17 to 62 wt% lipid comprising 30 to 60 wt% of lipids as an MCT oil having aliphatic carbon chains comprising from 6 to 12 carbon atoms, between 10 and 38 wt% of vegetable fibers, from 0.25 to 15 wt% of proteins and from 0.5 to 10 wt% carbohydrates.
Regarding instant claims 23-24, Fulton as modified by Qian does not disclose an example of a baked food product as bread having a ketogenic ratio of lipids to proteins and carbohydrates of between 1.5:1 and 2.5:1 as in claim 23 and does not disclose an example of a baked food product as at least one of biscuits, crackers, breadsticks, sweet snacks, savory snacks and other baked products that has a ketogenic ratio between lipids and sum of carbohydrates and proteins comprised between 1.5:1 and 6:1. However, Fulton discloses at [0016] bread and cookies or biscuits as a baked food product.
The Office interprets the recited ketogenic ratio as being a weight ratio of lipids to carbohydrates.
Gamberi at [0017] discloses baked food products like bread, crackers or breadsticks comprising plant flours with fats in a composition made up of (at [0018]-[0022]) from 10 to 40% plant proteins, from 5 to 35% of soluble plant fibers, from 5 to 30% of insoluble plant fibers or “vegetable fibers”, from 5 to 50% of lipids, and from 0.5 to 10 wt% carbohydrates. Further 24, Gamberi discloses at [0025] and in claim 14 baked food products having a ketogenic ratio of lipids to proteins and carbohydrates of 2:1 and of from 2:1 to 5:1.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Gamberi for Fulton to make a baked food product as a bread having a ketogenic ratio of lipids to proteins and carbohydrates of between 1.5:1 and 2.5:1 as in claim 23 and to make a baked food product at least one of biscuits, crackers, breadsticks, sweet snacks, savory snacks and other baked products having a ketogenic ratio between lipids and sum of carbohydrates and proteins comprised between 1.5:1 and 6:1. Both references disclose dietary baked food products having a high fat and fiber content, the same or similar protein content and a low carbohydrate content. The ordinary skilled artisan in Fulton would have desired to limit the amount of protein in its baked food products as in Gamberi while keeping its mucilaginous fiber and fat content high (as at [0016] of Fulton) to provide a workable dough having a desirable ketogenic ratio for the consumer.
Response to Arguments
In view of the amendment dated October 27, 2025, the following rejections have been withdrawn as moot:
The rejections of claims 16-19, 24-25, 31 and 33-34 under 35 U.S.C. 103 as being 8. unpatentable over CN 108703180 A to Qian et al. in view of US 2010/0303997 A1 to Fulton.
Applicant’s arguments with respect to Qian as a primary reference have been considered but are moot because the new ground of rejection does not rely on Qian for any teaching or matter specifically challenged in the argument.
Regarding the positions taken in the remarks accompanying the amendment dated October 27, 2025, the Office has fully considered the positions taken and does not find the positions persuasive because the positions do not challenge the propriety of combining Fulton with Qian or with Qian and Gamberi.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2019/153070A1 to Oladiwura (Oladiwura). Oladiwura at abstract discloses a dough for the ketogenic diet and (at [0051]) discloses a bread comprising per 100 g, 45 wt% water, 19 wt% of egg, 4.5 g of sugar and carbohydrates, 11 g of protein and 15 g of fibre.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791