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
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on July 20,2026, wherein claims 7-9 are cancelled, new claims 13-17 are added, and claims 1 and 12 are amended.
Election/Restriction
Applicant elected without traverse, species b): medium-chain triglycerides (MCT), in the reply filed on 03/17/2026.
Claims 2-6 and 10-11 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.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 1-6 and 10-17 are pending in the instant application.
Claims 2-6 and 10-11 remain withdrawn.
Claims 1 and 12- 17 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 on 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.
Drawings
The drawings filed on July 20, 2026 are objected to because Fig. 1a and 2a recite “ % per 100/g” which should read % per100 g. Further, the numbers in the Table should not be separated by comma , “16, 1” , “0,01”, “68,07”, etc.
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.
Action Summary/ Response to Arguments
Applicant's remarks filed on July 20, 2026 have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s persuasive arguments. The text of those sections of Title 35 US Code not included in this action can be found in the prior office action.
Applicant’s arguments regarding the rejections under 35 USC § 112(a) and 35 USC § 103 are fully considered, but NOT persuasive. Applicant does not present any evidence that instant claimed ketogenic diet is superior to those taught by prior art on the record. Thus, the 35 USC § 103 rejections are reapplied as necessitated by amendment. Claim 1 and 12-17 are rejected as being unpatentable under 35 USC § 103: 1) Nestec (EP2813149 A1) in view of Augustin; 2) Nestec (EP2813149 A1) in view of O'Donnell (US20150164840A1); 3) Olson (US20180110241A1) in view of O'Donnell (US20150164840A1) and Nestec ( EP2813149 A1). Please see response to argument in following 35 USC § 103 rejections.
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 and 12-17 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 vast variety of lipid, carbohydrate, protein, fiber, etc. 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 in general (See Fig. 1a and 2a) without specified lipid component. 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 claim 1, or any specific type of protein and/or fiber as claimed. Instant Table 1 and 2 discloses vegetable fiber, NOT prebiotic fiber as recited in claim 1.
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”.
Applicant argues claim 1 is amended to incorporate limitations of medium-chain triglycerides and prebiotic fibers, and does not recite a broad genus of these components of the liquid food product.
RESPONSE: Applicant’s argument is fully considered, but NOT persuasive. As disclosed by instant Spec (PGPub US 2024/0130992 A1 [0090]-[0091] : the term "lipids" and its derivatives, such as "lipid fraction", is used in a broad sense to include not only esters, in particular mono-, di- or triglycerides, of fatty acids, but also fatty acids, for example short- or medium-chain, or their salts. The lipids, in particular the glycerides, can comprise simple monoglycerides, and/or diglycerides and/or triglycerides, that is, comprising a single type of fatty acid, or mixed, that is, comprising fatty acids of different types.
Instant specification discloses composition comprising MCT and polyunsaturate acid in general ( Fig. 1b and 2b). As such, instant claimed lipids are extremely broad genus. Instant Spec does not disclose working example comprising specified lipid component. 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 claim 1, or any specific type of protein and/or fiber as claimed.
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 and 12-17 are 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 (newly applied as necessitated by amendment).
Claim 1 is amended to recite prebiotic fibers that are 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. 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). An ordinary skilled in the art would not know what prebiotic fiber are able to stimulate the bacterial flora to produce endogenous SCFA. Thus, the scope of prebiotic fiber and claim 1 are indefinite.
Claim 12-17 are rejected due to dependency on claim 1.
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 and 12-17 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) (newly reapplied as necessitated by amendment).
Nestec discloses a compositions (e.g. ketogenic or dietetic composition) suitable for the treatment of malnutrition, 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], [0047], 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 [0051]-[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 . 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 note 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 of claims 12-17, Nestec teaches embodiments comprising variety of protein, e.g. whey protein, pea protein, etc. at various amount, e.g. 4 to 12 wt% (See [0023]). It’s noted that pea protein is considered a legume protein because it is extracted from peas, which belong to the legume family.
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.
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 taught by Augustin in the ketogenic diet for 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 ketogenic diet for treatment of neurological disease. 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.
Applicant argues there is no basis that "routine optimization" of Nestec would produce the present invention... Examiner has not indicated for which of these disease targets the optimization is to occur... optimization of a composition for treatment of a diseases would involve a clinical trial with human patients... and there is no basis for the assertion that the teachings of Augustin
could somehow be combined with routine optimization of Nestec (Remarks, page13-15).
RESPONSE: Applicant's argument have been fully considered, but NOT persuasive. Nestec teaches ketogenic diet that are suitable for treatment of malnutrition and in the treatment of neurological
diseases, particularly epilepsy and related diseases, which read on claims of instant application dated 08/31/2023. Ketogenic diet is not pharmaceutical composition and does not necessarily need clinical trial for optimization. Nestec teaches embodiments of ketogenic diet comprising various amount of lipid/fat (MCT), protein, sugar, fiber, water, etc. Augustin explicitly teaches ketogenic diet comprising MCT from about 60% octanoic acid (an eight-carbon fatty acid) and about 40% decanoic acid (a ten-carbon fatty acid) in treatment of neurological and metabolic disorders. A skilled artisan would be motivated to incorporate MCT derived from decanoic acid and octanoic acid taught by Augustin in the ketogenic diet and reasonably expected the ketogenic diet comprising MCT derived from decanoic acid and octanoic acid would be beneficial for treatment of neurological disease. Applicant does not present any evidence that instant claimed ketogenic diet is superior to those taught by prior art. Thus, the 103 rejection is maintained/reapplied.
Claims 1 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nestec ( EP2813149A1), in view of O'Donnell et al. (US20150164840A1) (newly reapplied as necessitated by amendment).
The collective teachings of Nestec is elaborated in preceding 103 rejection and applied as before. Nestec collectively 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.
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 per100 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.
Both Nestec and O'Donnell teach ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount.
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 diet 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 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 ketogenic diet in treatment of neurological disease. 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.
Response to Arguments
Applicant argues that claims 1 and 12 are not obvious over Nestec alone, there is no basis for the assertion that "routine optimization" of O'Donnell would produce the present invention taken alone... further citation of O'Donnell does not overcome the deficiency of Nestec with regard to the pending claims(Remarks, page 16).
RESPONSE: Applicant's argument have been fully considered, but NOT persuasive. Both Nestec and O'Donnell teach ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount that are suitable in the treatment of neurological diseases, particularly epilepsy. O'Donnell 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 and reasonably expected the ketogenic diet comprising MCT derived from decanoic acid and octanoic acid would be beneficial for treatment of neurological disease.
Claims 1 and 12-17 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) and Nestec ( EP2813149 A1) (newly reapplied as necessitated by amendment).
Olson discloses 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. The collective teachings of O'Donnell is elaborated in preceding 103 rejection and applied as before. O'Donnell teaches embodiments comprising fiber and decanoic acid and octanoic acid at various ratio.
Olson is silent about the protein of vegetable origin. The collective teachings of Nestec is elaborated in preceding 103 rejection and applied as before. Nestec collectively teaches ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount. Nestec teaches pea protein that reads on instant claims 12 -17.
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, O'Donnell and Nestec, 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, O'Donnell and Nestec. O'Donnell further teaches fiber component and MCT derived from decanoic acid and octanoic acid and ratio thereof. Nestec teaches pea protein that reads on instant claims 12 -17. 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 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 ketogenic diet in treatment of neurological disease . 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.
Response to Arguments
Applicant argues that Olson et al. cannot be simply modified based on O'Donnell to produce the present invention... "routine optimization" of Olson et al. or a combination of Olson et al. with O'Donnell et al. cannot produce the present invention.
RESPONSE: Applicant's argument have been fully considered, but NOT persuasive. Olson and O'Donnell teach ketogenic composition comprising lipid/ fat, carbohydrate, protein, fiber and water at various amount that are suitable in the treatment of neurological diseases. O'Donnell 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 and reasonably expected the ketogenic diet comprising MCT derived from decanoic acid and octanoic acid would be beneficial for treatment of neurological disease.
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 12-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-10, 14-19, 23 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 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.
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/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
