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
Election/Restriction
Applicant elected without traverse, species b): medium-chain triglycerides (MCT), in the reply filed on 03/17/2026. Applicant identified claims 1, 7 and 8 as read on the elected species.
Claims 2-6 and 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.
Status of Claims
Claims 1-12 are pending in the instant application.
Claims 2-6 and 10-11 are withdrawn as being drawn to a nonelected species.
Claims 1, 7- 9 and 12 are currently under examination in this office action.
Priority
This instant application 18/279,807 filed 08/31/2023, is a 371 national stage application of International Application No. PCT/IT2022/050031 filed on 02/23/2022, which claims priority to foreign application ITALY 102021000005009 filed 03/04/2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The certified copy of ITALY 102021000005009 was filed on 08/31/2023.
Information Disclosure Statement
The information disclosure statement filed 08/31/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the relevant reference listed in IDS are being considered by the Examiner.
Claim Objections
Claims 1, 7- 9 and 12 are objected to because of the following informalities:
Claim 1 recites lipids between 10% and 20% by weight with respect to the total weight of the product, of which short-chain fatty acids.... The phrase “of which” is not clear and not followed by a complete sentence to define the scope of lipid component.
Claims 7 and 8 recite “characterized in that” which is not concise, and should be “wherein” , “deriving” should be derived.
Claims 9 and 12 recite “characterized in that” which is not concise, and should be “wherein”.
Appropriate correction is required.
Specification
The disclosure is objected to because there is no CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
Drawings
The drawings are objected to because Fig. 1a and 2a recite “ % su 100g” . It’s not clear what “% su” means. There are only Tables and no Figures are included in the Drawing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claims 1, 7-9 and 12 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of full scope of instantly claimed food product genus . This is a written description rejection, rather than an enablement rejection under 35 U.S.C. 112, first paragraph. Applicant is directed to the MPEP 2163 and Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
MPEP 2163.02 states “ Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed.”
Instant claims are drawn to food product genus comprising various amount of lipids, carbohydrates, protein, fiber genus which comprises vast verity of lipid, carbohydrate, protein and fiber species. MPEP 2163 II states; “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above)”. While applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. “A representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus” MPEP 2163 II.
Instant specification discloses food product comprising protein, fiber, and vegetable oils/fats (See Fig. 1a and 2a) without specified lipid component as recited in instant claims. Instant specification discloses composition comprising MCT and polyunsaturate acid in general ( Fig. 1b and 2b). Instant specification does NOT disclose working example of food product comprising MCT derived from decanoic acid or octanoic acid at the ratio as recited in claims 7 and 8, or any specific fatty acid, or any specific type of protein and/or fiber as claimed. Instant specification does not disclose working example where the food product is tested/evaluated for treating symptoms of any neurological disease. One of ordinary skilled in the art would not recognize from the disclosure that the applicant was in possession of the full scope of instantly claimed lipid food product genus. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. Applicant is reminded that MPEP 2161 II makes clear that “ The written description requirement is separate and distinct from the enablement requirement”.
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.
Claims 1, 7-9 and 12 rejected under 35 U.S.C. 112(b), 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 lipids between 10% and 20% by weight with respect to the total weight of the product, of which short-chain fatty acids... and medium-chain triglycerides (MCTs).... The phrase “of which” is ambiguous not followed by a complete sentence to clearly define the scope of lipid component. It’s not clear if the lipids are exclusively short-chain fatty acids and/or medium-chain triglycerides (MCTs), or the lipids comprise, or consist of, short-chain fatty acids and medium-chain triglycerides (MCTs). The lack of clarity regarding the lipid component renders the scope of claim 1 indefinite.
Instant claim 1 recites a liquid food product suitable to manage the ketogenic diet and in particular to treat the symptoms of neurological diseases. There are insufficient antecedent basis for the ketogenic diet and the symptoms limitation as recited in claim 1.
The limitation “ manage the ketogenic diet” is also vague and ambiguous. It’s not clear how the ketogenic diet is managed by the liquid food product, and a person of ordinary skilled in the art would not know the metes and bounds of limitation by managing the ketogenic diet and treating the symptoms of neurological diseases. Please note the intended function of product does not necessary further contribute to the structural limitation of the lipid food product. As stated in MPEP 2173.05: “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”.
The limitation in particular to treat the symptoms of neurological diseases of claim 1 is narrow recitation of intended function of instant liquid food product. 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.
Claims 7-9 and 12 are also rejected due to dependency on claim 1.
Claim 9 recites fibers are prebiotic fibers able to stimulate the bacterial flora to produce endogenous SCFA. The limitation “to stimulate the bacterial flora to produce endogenous SCFA” is intended function of the fibers which does not necessarily contribute to the structural limitation of fiber. An ordinary skilled in the art would not be appraised the scope of the fiber as recited.
Claim 12 recites “said proteins comprise, or consist exclusively of, proteins of vegetable origin, in particular legume proteins, more particularly pea proteins”. The transitional phrase “comprise” and “consist exclusively of” are drawn to different scope of proteins. “in particular” and “ more particularly” are 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. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
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, 7, 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nestec ( EP2813149 A1).
Nestec discloses a compositions (e.g. ketogenic or dietetic composition) suitable for the treatment of neurological diseases (e.g. epilepsy, etc. ), metabolic disease and other disease, wherein the ketogenic composition comprises about 4 to about 12% by weight protein, less than 5% by weight carbohydrate and about 25 to about 38% by weight fat (See abstract, [0001]-[0002]; [0016], [0027], claims 1-25).
Nestec teaches traditional ketogenic diet typically employs fat to carbohydrate to protein in a ratio of 4:1:1 (See [0006]) and further teaches embodiments wherein the ratio of fat to the sum of proteins and carbohydrates is about 4:1 (See [0052]; claims 12-13).
Nestec discloses medium chain triglycerides (MCTs) composed of 6 to 12 carbons and benefit of MCT in ketogenic diet: MCT are rapidly oxidized, rendering many ketone bodies and supplying a quick source of energy, MCTs are hydrolyzed both faster and more completely than long-chain triglycerides LCTs, etc. (See [0007], [0010]-[0012], [0033]). Please note C8 MCT is derived from octanoic acid and C10 MCT is derived from decanoic acid (which reads on instant claim 7). Nestec teaches the amount of MCT typically range from about 0 to about 23% by weight, preferably about 12 to about 16% by weight MCTs (See [0034]). Nestec discloses ketogenic composition contains about 0 to about 23% by weight medium chain triglycerides and/or about 6 to about 35 % by weight long chain triglycerides (See [0047]).
Nestec also discloses embodiments comprising polyunsaturate fatty acid (e.g. linoleic acid or α-linoleic acid) at about 0.1 to about 5% by weight (See [0028] [0031], [0157]).
Regarding the carbohydrate component, Nestec teaches embodiments comprising preferably from 0 to about 2%, or about 0.05 to about 2%, more preferably 0 to about 1%, or about 0.05 to about 1% carbohydrate ( See [0038]).
Regarding the fiber component, Nestec teaches soluble or insoluble fiber (e.g. pea fiber) ranging from about 0.1 to about 2.5% by weight, preferably from 0.5 to 2% by weight, etc.(See [0045]-0046], [0256]). Please not limitation “to stimulate the bacterial flora to produce endogenous SCFA” is intended function of the fibers which does not necessarily contribute to the structural limitation of fiber.
Regarding the protein component, Nestec teaches embodiments comprising variety of protein, e.g. whey protein, pea protein, etc. (See [0023])(which reads on instant claim 12).
Regarding water, Nestec teaches mixing about 4 to about 12% by weight protein, less than 5% by weight ( preferably from 0 to 4.5 % by weight ) of carbohydrate and about 25 to about 38% by weight fat with water (See [0135] [0137], claim 22), wherein the water component is calculated to about 45% (e.g. 100 -12-5-38%) to 71% (100 -4-0-25%).
Nestec collectively teaches ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount that falls within or overlaps with instant recited range.
The difference of Nestec ketogenic composition and instant claimed invention is the amount of lipid/ fat, carbohydrate, protein, fiber and water. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), See MPEP 2144.05.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore the range of ketogenic components based on the teachings of Nestec together with experimentation and optimization based on the general knowledge of ketogenic diet for treatment of neurological diseases, and arrive at instantly claimed invention with reasonable expectation of success. At the time of instantly claimed invention was made, it’s already known that ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount was made for the treatment of neurological diseases as taught by Nestec. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.
As stated in MPEP 2144.05, " It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
One of ordinary skilled in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with optimization based on general knowledge of ketogenic diet. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1, 7-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nestec ( EP2813149 A1) in view of Augustin et al. (The Lancet Neurology 2018; 17: 84–93, Mechanisms of action for the medium-chain triglyceride ketogenic diet in neurological and metabolic disorders).
The collective teachings of Nestec is elaborated in preceding 103 rejection and applied as before. Nestec teaches ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount.
Nestec is silent about the ratio of MCT derived from decanoic acid and octanoic acid.
Augustin review mechanisms of action for the medium-chain triglyceride ketogenic diet in treatment neurological and metabolic disorders (See whole article). Augustin explicitly teaches ketogenic diet comprising about 60% octanoic acid (an eight-carbon fatty acid) and about 40% decanoic acid (a ten-carbon fatty acid) (See page 84, left column).
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore alternative ketogenic diet based on the combined teachings of Nestec, and Augustin, together with experimentation and optimization based on the general knowledge of ketogenic diet for treatment of neurological diseases, and arrive at instantly claimed invention with reasonable expectation of success. At the time of instantly claimed invention was made, it’s already known that ketogenic composition comprising lipid/ fat, carbohydrate, protein, and water at various amount could be made for the treatment of neurological diseases as taught by Nestec. Augustin further teaches MCT derived from decanoic acid and octanoic acid and ratio thereof. A skilled artisan would be motivated to incorporate MCT derived from decanoic acid and octanoic acid for treatment of neurological disease taught by Augustin and reasonably expected the ketogenic diet comprising MCT derived from decanoic acid and octanoic acid would be beneficial for treatment of neurological disease. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with optimization based on general knowledge of cancer treatment. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable in view of O'Donnell et al. (US20150164840A1).
O'Donnell teaches nutritional product for human, comprising lipid (e.g. decanoic acid and octanoic acid, linoleic acid, etc. ), protein, carbohydrate, fiber, etc. for the prevention of a disease associated with mitochondria dysfunction (e.g. epilepsy) (See abstract, [0001], [0004], [0076]; Examples; claims 1-39, 43-44 and 46-47).
O'Donnell teaches amount of digestible carbohydrates is 0-9 per 100 g dry mass. the amount of protein is 5-20 per 100 g dry mass, the amount of lipids is 0.1-100 g per 100 g dry mass, but may be 60-80 g per 100 g dry mass (See [0068]; [0076]). O'Donnell teaches embodiments comprising fiber (See [0076]).
O'Donnell teaches the composition in the form of milk, liquid, etc. (See [0033] ) and embodiments reconstituted in water or liquid formula(See [0065]-[0067]). O'Donnell teaches embodiments comprising lipid, protein, carbohydrates and fiber that are reconstituted into liquid formulation, wherein the water/liquid is calculated to be 75% (See [0076]).
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O'Donnell teaches decanoic acid, a medium chain fatty acid that increases in plasma concentration as a result of a ketogenic diet in which MCT forms a part, has a direct effect on mitochondrial function and availability in cells in vitro, and may be beneficial for the treatment of epilepsy, and other neurological disease/disorders e.g. Parkinson's disease, dementias, Alzheimer's disease (See [0013]-[0014]). O'Donnell teaches ketogenic ratio (i.e. the ratio of fat and the combined grams of protein and carbohydrate) of 0.2:1 to 5:1 or 1:1 to 4:1, and the majority of fat is decanoic acid (See [0019], [0050]-[0052], claims 17-18). O'Donnell teaches embodiments comprising decanoic acid and octanoic acid at various ratio, e.g. 2:1 (See [0015]-[0016], claims 1-9).
O'Donnell also teaches embodiments comprising polyunsaturated fatty acids, e.g. omega-3 fatty acids, linoleic acid and alpha linolenic acid, etc. at more than 0.5%, preferably 1.0-10% wt. (See [0057] [0076]).
O'Donnell collectively teaches ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount that falls within or overlaps with instant recited range.
The difference of O'Donnell ketogenic composition and instant claimed invention is the amount of lipid/ fat, carbohydrate, protein, fiber and water. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), See MPEP 2144.05.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore the range of ketogenic components based on the teachings of O'Donnell together with experimentation and optimization based on the general knowledge of ketogenic diet and arrive at instantly claimed invention with reasonable expectation of success. At the time of instantly claimed invention was made, it’s already known that ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount was made for the treatment of neurological diseases as taught by O'Donnell. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with optimization based on general knowledge of cancer treatment. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1, 7-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nestec ( EP2813149A1), in view of O'Donnell et al. (US20150164840A1).
The collective teachings of Nestec and O'Donnell are elaborated in preceding 103 rejection and applied as before. Both Nestec and O'Donnell teach ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount.
Nestec is silent about the ratio of MCT derived from decanoic acid and octanoic acid. O'Donnell teaches embodiments comprising decanoic acid and octanoic acid at various ratio.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore alternative ketogenic diet based on the combined teachings of Nestec, and O'Donnell, together with experimentation and optimization based on the general knowledge of ketogenic diet and arrive at instantly claimed invention with reasonable expectation of success. At the time of instantly claimed invention was made, it’s already known that ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount could be made for the treatment of neurological diseases as taught by Nestec and O'Donnell. O'Donnell further teaches MCT derived from decanoic acid and octanoic acid and ratio thereof. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further explore more ketogenic diet for treatment of neurological disease. A skilled artisan would be motivated to incorporate MCT derived from decanoic acid and octanoic acid for treatment of neurological disease. taught by O'Donnell and reasonably expected the ketogenic diet comprising MCT derived from decanoic acid and octanoic acid would be beneficial for treatment of neurological disease.
As stated in MPEP 2144.05, " It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with optimization based on general knowledge of cancer treatment. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US20180110241A1, Applicant’s IDS dated 08/31/2023) in view of O'Donnell et al. (US20150164840A1).
Olson discloses a aqueous/liquid ketogenic composition for management of epilepsy, comprising lipids/fat , hydrolyzed proteins, carbohydrates, water, oil, emulsifier, vitamins and minerals, etc. (See abstract, [0004] [0005], [0039], claims 1-34). Olson teaches the ratio of fat to combined protein and net carbohydrate is from 3: 1 to 4:1 and at least 10 % of calories are from medium chain triglycerides ( MCTS) at various amount (See [0005], [0020] , [0031]).
Olson teaches the fat comprise various amount of medium chain triglycerides MCT ( e.g. 10% to about 30%), short chain fatty acids/triglyceride, long chain fatty acids/triglyceride, or combination thereof (See [0031]). Olson also teaches embodiments further comprising docosahexaenoic acid (DHA)(See [0031]). Olson teaches composition that provide at least recommended daily intake ( RDI ) of linoleic and / or alpha linolenic acid for children 8 years and younger (See [0007], claim 10).
Regarding the protein, Olson teaches protein is about 2 % and about 5 % of the total weight of the composition (See claim 11) and embodiments comprising different type of protein (e.g. whey protein) or combination thereof, wherein the protein has low allergenicity (See [0027], claims 12-13).
Regarding the carbohydrate, Olson teaches embodiments wherein carbohydrate is less than about 1% of the total weight of the composition (See claim 18). Olson teaches the aqueous ketogenic compositions comprise carbohydrate, such as starch, gum and/or fiber (See [0037]).
Olson teaches embodiments comprising water (about 75% to 90%), protein (2-6%) , MCT and carbohydrate (less than 2%) (See [0039], Table 1).
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Olson is silent about the fiber component and MCT derived from decanoic acid and octanoic acid. O'Donnell teaches embodiments comprising fiber and decanoic acid and octanoic acid at various ratio.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore alternative ketogenic diet based on the combined teachings of Olson, and O'Donnell, together with experimentation and optimization based on the general knowledge of ketogenic diet and arrive at instantly claimed invention with reasonable expectation of success. At the time of instantly claimed invention was made, it’s already known that ketogenic composition comprising lipid/ fat, carbohydrate, protein, and water at various amount could be made for the treatment of neurological diseases as taught by Olson and O'Donnell. O'Donnell further teaches fiber component and MCT derived from decanoic acid and octanoic acid and ratio thereof. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages. A skilled artisan would be motivated to incorporate fiber and MCT derived from decanoic acid and octanoic acid for treatment of neurological disease taught by O'Donnell and reasonably expected the ketogenic diet comprising MCT derived from decanoic acid and octanoic acid would be beneficial for treatment of neurological disease. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with optimization based on general knowledge of cancer treatment. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-10, 14-19 of copending U.S. patent application No. 17/782,620 in view of O'Donnell et al. (US20150164840A1). This is a provisional nonstatutory double patenting rejection.
Reference claims are directed to a baked food product for treating physiological and/or pathological conditions of individuals by means of a ketogenic diet, said food formulation comprising consisting essentially of : lipids between 15% and 60% by weight; proteins between 0.25% and 14% by weight; carbohydrates between 0.5% and 8% by weight; vegetable fibers between 10% and 38% by weight; wherein said percentages are with respect to the total weight of the formulation, and wherein said lipids comprise medium-chain triglycerides (MCTs), having aliphatic carbon chains comprising from 6 to 12 carbon atoms derived from caprylic acid or capric acid or lauric acid, or combinations thereof, and wherein the MCTs constitute from 30% to 60% by weight of a total quantity by weight of lipids present in said food formulation.
The difference of reference claims and instant claims are different food form and amount of MCT, carbohydrate, protein, fiber and water.
The collective teachings of O'Donnell is elaborated in preceding 103 rejection and applied as before. O'Donnell teaches ketogenic food product comprising lipid/ fat, carbohydrate, protein, fiber that could be reconstituted into liquid formulation. O'Donnell teaches embodiments comprising decanoic acid and octanoic acid at various ratio.
It would have been prima facie obvious to one of ordinary skilled in the art to explore different food product comprising lipids, proteins, carbohydrates and vegetable fibers based on the combined teaching of reference claims and O'Donnell , together with experimentation and optimization based on general knowledge of ketogenic diet. As stated in MPEP 2144.05, " It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
The instant application shares at least one common inventor /applicant with the reference patent application. Furthermore, the instant application is not related to reference application based on the record, thus no 35 USC 121 shield exists.
Conclusion
No claims are allowed.
Reference made of record but not relied upon in this office action.
Lei et al. (Neurochemistry International, Vol. 95; 3 March 2016; pp. 75-84, Applicant’s IDS dated 08/31/2023). Lei reviews three groups of fatty acids (SCFA, MCFA and LCFA) and their therapeutic potential in neurological disorder (See whole article). Lei teaches MCFA is a good alternative energy source through ketogenesis, and medium chain triglyceride (MCT, caprylic triglyceride C8) approved by FDA as a prescription medical food for clinical dietary management associated with mild to moderate AD (See page 79 and 80). Lei teaches short chain fatty acids (e.g. butyric acid) are a product of intestinal microbiota metabolism of dietary fibre and their derivatives are used as an anti-convulsant and other neurodegenerative conditions (e.g. Alzheimer's Disease, etc) ( See abstract; page 76, right column; Figure 1). Lei expliptely teaches butyric acid and its derivative sodium butyrate exhibit anti-inflammatory activity and beneficial for treatment of neuropathological disease/conditions (See page 77, right column).
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/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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