DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-3, 9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Llosa et al. (US 2018/0057846 A1) in view of McConnell et al. (US 2020/0101094 A1).
Regarding claim 1, Llosa et al. teaches a composition for producing nutritional ketosis (paragraph 59) comprising (D)-β-hydroxybutyrate free acid i.e., β-hydroxybutyric acid, and (D)-1,3-butanediol (paragraphs 2 and 28). The prior is hereon referred to as “BHB” and the latter “BD”. Since both BHB and BD are present, the combination of the two within the composition is construed to read on “ketogenic substrate”.
Llosa et al. does not teach the claimed range of weight percentages for the respective components. However, the reference teaches BHB in free acid form alone has an upper limit for therapeutic doses due to the possibility of acute acidosis or GI distress, and BD alone is unstable in the presence of low pH and can lead to intoxication (paragraph 35); BD is also unpalatable and costly (paragraph 46). The solution to the above issue is to use a mixture of BHB and BD which safely leads to therapeutic levels of ketones in blood (paragraph 36). The mixture can be optimized to maximize ketone production, yet tailor the ingredients to account for recommended limitations, palatability, and deleterious side effects (paragraph 48). The amounts can be varied such that the composition comprises a molar ratio of 10-15 parts free acid BDB and 1-5 parts BD (paragraph 49), a concentration ratio of 51-99% and 1-10%, respectively, or a molar ratio of 4:1 BHB to BD, where the ratio can be altered based on desired results (paragraphs 27 and 72). Further, the dosage of BHB can vary based on body weight, desired effect, and application (paragraphs 59-64 and 66).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to comprise the claimed weight percentages of BDB and DB relative to the ketogenic substrate since the reference specifically teaches optimizing the relative amounts of the two substances in order to minimize the drawbacks associated with using only a single substance, where the amount of BDB is greater than DB, since Applicant has not provided sufficient evidence that the claimed ranges are critical or yield unexpected results, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired flavor, cost, application for treatment particular issues, intended user, and safely elevating ketones in blood.
Llosa et al. does not teach the composition comprising a digestible carbohydrate present in the claimed weight ratio to the ketogenic substrate.
McConnell et al. teaches a composition comprising a ketogenic compound including hydroxybutyrate derivatives and butanediol (paragraph 88), where the composition is a nutritional composition containing digestible carbohydrates (paragraph 90). Said carbohydrates include hydrolyzed or modified starch or corn starch, syrups and plant carbohydrates, sugar alcohols, etc., where the amount of carbohydrate can be adjusted based on desired amount of provided nutrition/energy and application e.g., about 35-55% of the energy of the composition or less than about 10% (paragraph 94).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to include the digestible carbohydrates in the claimed range of weight ratios to the ketogenic substrate since the reference already teaches the substrate can be used in foodstuffs (paragraphs 4, 50, and 57) and suggests combining the ketogenic substate with at least some carbohydrate (claim 17), since the prior art recognizes a nutritional composition combining ketogenic substrates with digestible carbohydrates in desired amounts, since the evidence of record does not indicate criticality or unexpected results with the claimed features and ranges, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as the particular application, intended consumer, type of food product, desired flavor, and nutritional profile.
Llosa et al. does not teach the composition comprising at least 10 grams of a combination of the carbohydrate and the ketogenic substrate.
Llosa et al. teaches the ketogenic substrate is provided in varying doses based on the particular application, consumer’s body weight, and treatment (paragraphs 59-64). McConnell et al. teaches the amount of energy provided by the digestible carbohydrate can be varied e.g., 35-55% or less than 10% (paragraph 94). Thus, the prior art recognizes that the two can be provided together as stated above, where the relative amounts can be varied as desired.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to comprise at least 10 grams of the digestible carbohydrate and ketogenic substrate since the prior art recognizes adjusting relative values of the two in composition, since there is no evidence of unexpected results associated with the claimed feature, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as those disclosed by the cited prior art and stated in the modifications above.
Regarding claim 2, Llosa et al. does not teach the claimed amounts of carbohydrate and ketogenic substrate.
However, the combination applied to claim 1 teaches a composition comprising digestible carbohydrate and ketogenic substrate, where the relative amounts of the two can be varied based on the above stated factors.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to have the claimed amounts of said carbohydrate and substrate for the same reasons stated for claim 1, particularly since there is no evidence of criticality or unexpected results associated with the claimed features and ranges, and since the values would have been used during the course of routine experimentation and optimization procedures based on the stated factors.
Regarding claim 3, Llosa et al. does not explicitly teach 3-20 grams BDB and 0.5-8 grams BD.
However, the reference teaches the amounts can be varied such that the composition comprises 10-15 parts free acid BDB and 1-5 parts BD (paragraph 49), or a molar ratio of 51-99% and 1-10%, respectively, where the ratio can be altered based on desired results (paragraphs 27 and 72). Further, the dosage of BHB can vary based on body weight, desired effect, and application (paragraphs 59-64 and 66).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to have the claimed amounts of said BDB and BD for the same reasons stated for claim 1, particularly since the evidence of record does not indicate criticality or unexpected results with the claimed features and ranges, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as the desired flavor, cost, application for treatment particular issues, intended user, type of food product, nutritional profile, and safely elevating ketones in blood.
Regarding claim 9, the claim recites alternatives. For the sake of examination, the alternative “3:7 to 7:3” is chosen. LLosa et al. teaches the composition comprises a molar ratio of 10-15 parts free acid BDB and 1-5 parts BD (paragraph 49), where the relative amounts of each component can be varied based on various features as stated for claim 1.
While the claimed molar ratio range is not explicitly taught, it would have been obvious to one of ordinary skill in the art to modify the composition of Llosa et al. to have the claimed molar ratio of BHB to BD for the same reasons stated for claim 1, particularly since the evidence of record does not indicate criticality or unexpected results with the claimed features and ranges, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as the desired flavor, cost, application for treatment particular issues, intended user, type of food product, nutritional profile, and safely elevating ketones in blood.
Regarding claim 14, the claim recites alternatives due to the presence of “and/or”. The term “or” is selected, and the alternative “free of esters” is chosen for examination. Therefore, the claim is interpreted such that salts of BHB, BHV, and BD are not excluded.
Llosa et al. teaches the ketone blend can include “two or more of” BHB salts, BHB free acid, BD, and ketone ester (paragraph 25). Since only a minimum of two of the stated compounds are required, an embodiment exists in which the blend includes only BHB free acid, BHB salt, and BD. Further, the reference acknowledges that ketone esters are a good driver of ketosis but exorbitantly expensive (paragraph 47), where preferred embodiments utilize an optimized mix of the above (non-ester) compounds to approach the maximal efficacy of ketone esters (paragraph 49).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to exclude esters of the claimed components since the prior art recognizes that ketone blends do not require esters, since there is no evidence or unexpected results associated with the claimed feature, and to tailor the ketogenic blend based on desired effect while minimizing cost of materials and manufacture.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Llosa et al. in view of McConnell et al. as applied to claim 1 above, and further in view of Hageman et al. (US 2020/0146326 A1).
Regarding claim 4, the combination applied to claim 1 teaches a digestible carbohydrate as stated for said claim, but does not teach the carbohydrate has a glycemic index of 30-55.
Hageman et al. teaches a nutritional composition for transitioning to and/or maintaining a ketogenic metabolism (paragraph 21) comprising known digestible carbohydrates such as digestible starch, sugars and sugar alcohols, where the carbohydrates have a GI of 55 or less (paragraph 101). GI is recognized to be a ranking of the postprandial effect of a specific food on raising blood glucose levels, where a score below 55 is considered to be “low” GI (paragraph 47). A low glycemic index diet allows for a greater intake of digestible carbohydrates (paragraph 11).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to use a digestible carbohydrate having a GI of 30-55 since the prior art acknowledges such substances are used in ketogenic compositions, in order to provide a “low” GI carbohydrate to minimize undesired impact on blood glucose levels (e.g., for a diabetic user), since the evidence of record does not indicate criticality or unexpected results associated with the claimed range, and since the values would have been used during routine experimentation and optimization due to factors such as the particular application, intended consumer, type of food product, desired flavor, and nutritional profile.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Llosa et al. in view of McConnell et al. as applied to claim 1 above, and further in view of Brown et al. (US 2006/0025381 A1).
Regarding claim 5, McConnell et al. as applied to the combination of claim 1 teaches modified starch, but does not teach hydrothermally modified starch.
Brown et al. teaches modification of starch to control and/or regulate blood glucose levels, as well as impart a desired digestibility, where the modification can be done hydrothermally (paragraphs 2 and 34).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to use hydrothermally modified starch since the prior art recognizes the process for modifying starches, since there is no evidence of criticality or unexpected results associated with the claimed features, to facilitate control and/or regulation of blood glucose levels, impart digestibility, and to combine prior art elements according to known methods to yield predictable results of adjusting flavor, texture, consistency, and nutritional profile of the final product.
Regarding claims 6-7, McConnell et al. as applied to the combination of claim 1 teaches modified corn starch, and the combination applied to claim 5 teaches hydrothermally modified starch.
The combination does not teach the modified starch has a molecular weight between 500 and 700 kg/mol.
Brown et al. further teaches modifications include molecular weight reduction for viscosity control. Additionally, the starch can be sourced from corn (paragraph 27).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to use hydrothermally modified corn starch having the claimed molecular weight since the prior art recognizes modifying corn starch to a desired molecular weight for controlling viscosity, since the evidence of record does not indicate criticality or unexpected results associated with the claimed feature, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired viscosity for particular types of applications (e.g., to form a food, a beverage, or other delivery means).
Claims 8 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Llosa et al. in view of McConnell et al. as applied to claims 1 and 9 above, and further in view of Martin (US 2002/0013339 A1).
Regarding claim 8, the combination applied to claim 1 does not teach the ketogenic substrate comprises (D)-β-hydroxyvaleric acid (BHV), and the claimed molar ratios of the BHB to BHV.
Llosa et al. teaches that only the D enantiomer of molecules is active in the body, where L enantiomers are unnatural (paragraphs 22 and 41), and the D enantiomer is preferred (paragraph 28).
Martin et al. teaches nutritional or therapeutic compositions for increasing ketone body levels in blood and comprising hydroxyacids (abstract), where the hydroxyacids include 3-hydroxyvaleric acid i.e., β-hydroxyvaleric acid, along with BHB (paragraph 20; claim 9), where the length of the BHV oligomer is chosen such that the derivative has a suitable digestion rate for sustained release of the respective monomer. The BHV is advantageous since it has a higher energy content than oligomers of 3-hydroxyacids having an even number of carbons (paragraph 15). The reference teaches one of ordinary skill can readily select the appropriate hydroxyacid and amounts thereof for administration, where the particular composition used will depend on the target ketone blood levels, as well as route and frequency of administration, to provide for slow release of ketone bodies (paragraph 53).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Llosa et al. to include (D)-BHV in the claimed molar ratios of BHB to BHV since the reference already teaches using a mixture of ketogenic components to safely increase ketones to therapeutic levels (paragraph 46), since the substance is recognized by the prior art to increase ketone levels, and therefore to combine prior art elements according to known methods to yield predictable results and since it was “obvious to try” a recognized ketogenic substance, see MPEP 2143 I.(A) and (E), to provide an enantiomer compatible with the body, since there is no evidence of criticality or unexpected results associated with the claimed features, and since the values would have been used during routine experimentation and optimization due to factors such as energy content of the ketogenic substate and effectiveness of increasing ketone levels in the body over a desired release period.
Regarding claims 10-11, the combination applied to claims 8 teaches a ketogenic composition comprising BHB, BHV, and BD, but does not teach the claimed molar ratios between said components.
However, Llosa et al. teaches adjusting the relative amounts of BHB and BD based on various factors as stated for claim 1, and BHV is recognized to elevate ketone body levels in blood while providing higher energy content as stated for claim 8.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition to have the claimed molar ratios of BHB:BHV:BD since the prior art recognizes adjusting relative amounts of each component for use in a ketogenic composition, since the evidence of record does not indicate criticality or unexpected results associated with the claimed ratios, and since the claimed values would have been used during routine experimentation and optimization due to factors such as those stated for claims 1 and 8.
Regarding claims 12-13, Llosa et al. teaches adjusting the relative amounts of BHB and BD as stated for claims 1 and 9, and the combination applied to claim 8 teaches adding a desired amount of BHV. It is noted that the combination applied to claim 8 is also applied to claim 13 and would have been obvious for the same reasons.
While the claimed weight percentages of BHB, BHV, and BD are not explicitly taught, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition to have the claimed weight percentages of BHB, BHV, and BD since the prior art recognizes adjusting relative amounts of each component for use in a ketogenic composition, since the evidence of record does not indicate criticality or unexpected results associated with the claimed amounts, and since the values would have been used during routine experimentation and optimization due to factors such as those stated for claims 1 and 8-9.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 (particularly claim 1) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 26-28 (particularly claims 1-2) of U.S. Patent No. 11,044,932 B1 in view of Llosa et al. and McConnell et al.
The ‘932 patent teaches a composition comprising 25-85 wt% BHB with BHV, 15-75 wt% BD, and a consumable carrier (claims 1-2), but does not teach the claimed amount of BHB without BHV, a digestible carbohydrate, the ratio of carbohydrate to ketogenic substrate, and at least 10 grams of a combination of the carbohydrate and substrate.
Llosa et al. teaches BHB in free acid form alone has an upper limit for therapeutic doses due to the possibility of acute acidosis or GI distress, and BD alone is unstable in the presence of low pH and can lead to intoxication (paragraph 35); BD is also unpalatable and costly (paragraph 46). The solution to the above issue is to use a mixture of BHB and BD which safely leads to therapeutic levels of ketones in blood (paragraph 36). The mixture can be optimized to maximize ketone production, yet tailor the ingredients to account for recommended limitations, palatability, and deleterious side effects (paragraph 48). The amounts can be varied such that the composition comprises a molar ratio of 10-15 parts free acid BDB and 1-5 parts BD (paragraph 49), a concentration ratio of 51-99% and 1-10%, respectively, or a molar ratio of 4:1 BHB to BD, where the ratio can be altered based on desired results (paragraphs 27 and 72). Further, the dosage of BHB can vary based on body weight, desired effect, and application (paragraphs 59-64 and 66).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of the ‘932 patent to comprise the claimed weight percentages of BDB and DB relative to the ketogenic substrate since the reference specifically teaches optimizing the relative amounts of the two substances in order to minimize the drawbacks associated with using only a single substance, where the amount of BDB is greater than DB, since Applicant has not provided sufficient evidence that the claimed ranges are critical or yield unexpected results, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired flavor, cost, application for treatment particular issues, intended user, and safely elevating ketones in blood.
McConnell et al. teaches a composition comprising a ketogenic compound including hydroxybutyrate derivatives and butanediol (paragraph 88), where the composition is a nutritional composition containing digestible carbohydrates (paragraph 90). Said carbohydrates include hydrolyzed or modified starch or corn starch, syrups and plant carbohydrates, sugar alcohols, etc., where the amount of carbohydrate can be adjusted based on desired amount of provided nutrition/energy and application e.g., about 35-55% of the energy of the composition or less than about 10% (paragraph 94).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of the ‘932 patent to include the digestible carbohydrates in the claimed range of weight ratios to the ketogenic substrate since the Llosa et al. already teaches the substrate can be used in foodstuffs (paragraphs 4, 50, and 57) and suggests combining the ketogenic substate with at least some carbohydrate (claim 17), since the prior art recognizes a nutritional composition combining ketogenic substrates with digestible carbohydrates in desired amounts, since the evidence of record does not indicate criticality or unexpected results with the claimed features and ranges, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as the particular application, intended consumer, type of food product, desired flavor, and nutritional profile.
Llosa et al. further teaches the ketogenic substrate is provided in varying doses based on the particular application, consumer’s body weight, and treatment (paragraphs 59-64). McConnell et al. teaches the amount of energy provided by the digestible carbohydrate can be varied e.g., 35-55% or less than 10% (paragraph 94). Thus, the prior art recognizes that the two can be provided together as stated above, where the relative amounts can be varied as desired.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of the ‘932 patent to comprise at least 10 grams of the digestible carbohydrate and ketogenic substrate since the prior art recognizes adjusting relative values of the two in composition, since there is no evidence of unexpected results associated with the claimed feature, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as those disclosed by the cited prior art and stated in the modifications above.
Claims 1-14 (particularly claim 1) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 (particularly claims 1-2 and 10) of U.S. Patent No. 11,985,999 B2 in view of McConnell et al.
The ‘999 patent teaches a composition comprising 25-85 wt% BHB, 15-75 wt% BD, and a consumable carrier (claims 1-2 and 10), but does not teach the claimed amount digestible carbohydrate, the ratio of carbohydrate to ketogenic substrate, and at least 10 grams of a combination of the carbohydrate and substrate.
The modification applied to the ‘932 patent in view of McConnell et al. above renders obvious the features recited in claim 1 of the instant application. The same combination is applied to the ‘999 patent and would have been obvious for the same reasons.
Claims 1-14 (particularly claim 1) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 24-33 (particularly claims 21, 25 and 27-29) of U.S. Patent No. 12,439,945 B2 in view of Llosa et al. and McConnell et al.
The ‘945 patent teaches a composition comprising a mixture of BHB, BD, and a consumable carrier (claims 21, 25, 27-29), but does not teach the claimed weight percentages of BHB and BD, a digestible carbohydrate, the ratio of carbohydrate to ketogenic substrate, and at least 10 grams of a combination of the carbohydrate and substrate.
The modification applied to the ‘932 patent in view of Llosa et al. and McConnell et al. above renders obvious the features recited in claim 1 of the instant application. The same combination is applied to the ‘945 patent and would have been obvious for the same reasons.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 9/15/2025, with respect to the rejection of claims 3 and 9 under 35 USC 112(b) has been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Likewise, Applicant’s arguments, see pages 9-10, with respect to the rejection of claim 1 under 35 USC 103 has been fully considered and are persuasive. However, upon further consideration, new grounds of rejection are made in view of McConnell et al. It is noted that Steinberg, Ammann and Piorkowski are no longer relied upon in the instant rejection.
McConnell et al. teaches a composition comprising a ketogenic compound including hydroxybutyrate derivatives and butanediol (paragraph 88), where the composition is a nutritional composition containing digestible carbohydrates (paragraph 90). Said carbohydrates include hydrolyzed or modified starch or corn starch, syrups and plant carbohydrates, sugar alcohols, etc., where the amount of carbohydrate can be adjusted based on desired amount of provided nutrition/energy and application e.g., about 35-55% of the energy of the composition or less than about 10% (paragraph 94). McConnell et al. further teaches the amount of energy provided by the digestible carbohydrate can be varied e.g., 35-55% or less than 10% (paragraph 94). Thus, the prior art recognizes that the two can be provided together as stated above, where the relative amounts can be varied as desired. Llosa et al. teaches the ketogenic substrate is provided in varying doses based on the particular application, consumer’s body weight, and treatment (paragraphs 59-64).
Thus, one of ordinary skill in the art would have modified to the composition of Llosa et al. to include the digestible carbohydrates of McConnell for the reasons stated in the rejection above. Likewise, the relative amounts of ketogenic substrate and digestible carbohydrate would have been obvious for the reasons stated above.
Applicant argues that the claimed ratios, ranges and amounts are shown by the data in the specification to have critical physiological results and taste characteristics necessary to be unexpectedly effective in raising circulating ketone levels and being palatable, and the teaching of Llosa to vary the molar ratio lacks necessary reasonable expectation of successfully arriving at the claimed invention.
This is not persuasive since Llosa teaches BHB in free acid form alone has an upper limit for therapeutic doses due to the possibility of acute acidosis or GI distress, and BD alone is unstable in the presence of low pH and can lead to intoxication (paragraph 35); BD is also unpalatable and costly (paragraph 46). The solution to the above issue is to use a mixture of BHB and BD which safely leads to therapeutic levels of ketones in blood (paragraph 36). The mixture can be optimized to maximize ketone production, yet tailor the ingredients to account for recommended limitations, palatability, and deleterious side effects (paragraph 48). The amounts can be varied such that the composition comprises a molar ratio of 10-15 parts free acid BDB and 1-5 parts BD (paragraph 49), a concentration ratio of 51-99% and 1-10%, respectively, or a molar ratio of 4:1 BHB to BD, where the ratio can be altered based on desired results (paragraphs 27 and 72). Further, the dosage of BHB can vary based on body weight, desired effect, and application (paragraphs 59-64 and 66). Based on the teachings above, one of ordinary skill would have been motivated to adjust the relative amounts of BDB and BD in the ketogenic composition, where the claimed values would have been used during the course of routine experimentation and optimization procedures due to the factors stated for claim 1.
Further, criticality of the claimed ranges is not clear from the presented data. Specifically, it is not immediately clear from the specification if the results are commensurate in scope with the ranges recited by claim 1. Some of the data provides results for both BHB and BHV relative to BD, and it is unclear how much BHB is actually present in the examples, particularly since claim 1 does not require BHV. Likewise, Examiner acknowledges some of the data provides results for varying amounts of BHB and BD, but it is unclear if the results are observed over the entirety of the respective claimed ranges, and not observed outside said ranges. It is also unclear if the results are commensurate in scope with claimed weight ratios between the digestible carbohydrate and ketogenic substrate, as well as the “at least 10 grams of a combination…”
“To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.” In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960), see MPEP 716.02(c) II.
Applicant argues against the prior art combination applied to claims 4-7.
However, the argued references are no longer relied upon. Claim 4 is now rejected in view of Hageman, which teaches a ketogenic composition comprising known digestible carbohydrates having a GI of 55 or less (paragraphs 21 and 101), where a score below 55 is recognized to minimize the effect on raising blood glucose levels and allows for greater intake of digestible carbohydrates (paragraphs 11 and 47). Claims 5-7 are now rejected in view of Brown, where starch is hydrothermally modified to control and/or regulate blood glucose levels and impart a desired digestibility (paragraphs 2 and 34). Brown et al. further teaches modifications include molecular weight reduction for viscosity control. Additionally, the starch can be sourced from corn (paragraph 27). Thus, the cited prior art provides both teachings and motivations to modify the composition of Llosa as stated for said claims.
Applicant argues against the prior art combination applied to claims 8 and 10-13.
However, the argued reference (Henderson) is no longer relied upon. The claims are now rejected in view of Martin, which shows that BHV can be included with BHB in ketogenic compositions, where the length of the BHV oligomer is chosen such that the derivative has a suitable digestion rate for sustained release of the respective monomer. The BHV is advantageous since it has a higher energy content than oligomers of 3-hydroxyacids having an even number of carbons (paragraph 15). The reference teaches one of ordinary skill can readily select the appropriate hydroxyacid and amounts thereof for administration, where the particular composition used will depend on the target ketone blood levels, as well as route and frequency of administration, to provide for slow release of ketone bodies (paragraph 53). Adjusting the amount of BHV relative to BHB and BD would have been obvious for the same reasons stated for claim 1.
Applicant’s argument against the double patenting rejection has been fully considered, but the instant double patenting rejections were necessitated by McConnell.
Conclusion
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/BRYAN KIM/Examiner, Art Unit 1792