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 before the effective filing date of the claimed invention to modify the composition of Llosa et al. to comprise the claimed weight percentages of BDB and BD 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 BD, 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed invention 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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), 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed invention to modify the composition of the ‘932 patent to comprise the claimed weight percentages of BDB and BD 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 BD, 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 before the effective filing date of the claimed 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 before the effective filing date of the claimed 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 filed 6/9/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 2-3 that the cited references do not teach the component percent ranges, ratios, and specific weight ratios recited by claim 1, and therefore the Office has failed to show that all the claimed limitations are disclosed in the prior art.
This is not persuasive since Llosa recognizes the combination of BHB and BD present in a composition for producing nutritional ketosis (paragraphs 2, 28 and 59), where using each of the components alone is understood to be undesirable e.g., BD alone is unstable, leads to intoxication, is unpalatable, and costly (paragraphs 35 and 46). The reference teaches a mixture of BHB and BD “safely leads to therapeutic levels of ketones in blood (paragraph 36), where the “ratios of this embodiment can be altered as one of ordinary skill in the art will appreciate…to achieve preferred results” (paragraph 72) and the dosage of BHB can vary based on body weight, desired effect, and application (paragraphs 59-64 and 66). The reference discloses a plurality of ranges for the amount of each component, expressed in different manners e.g., molar ratio or concentration ratio (paragraphs 27, 49 and 72). While the claimed ranges i.e., 25-85 wt% BDB and 15-75 wt% BD, are not explicitly taught, the cited teachings indicate to one of ordinary skill that the relative amounts of BHB and BD in a ketogenic composition can be varied. The motivation to optimize includes safely elevating blood ketone levels based on body weight, effect, and application as stated above. Additionally, it is not clear from the evidence of record if the claimed ranges of BHB and BD are critical as explained in further detail below.
Applicant argues on page 3 the meaning of “energy” in the context of McConnell is unclear and therefore fails as evidence that the prior art disclosed the claimed element, the reference does not provide any explanation for what is meant by “the energy of the nutritional composition”, and there is no nexus between the % energy of McConnell and the claimed weight ratio.
This is not persuasive since one of ordinary skill in the art understands “energy” refers to caloric content, where carbohydrates contain about 4 kcal per gram as evidenced by Energy NPL (page 1 “Energy: Requirements and Function”). Therefore, the skilled artisan would recognize McConnell teaches varying the amount of digestible carbohydrates (and necessarily changing relative weight ratio) in the composition based on the above stated energy/mass relationship. The ratio would have been subjected to routine experimentation and optimization as stated for claim 1.
Applicant argues on page 3 that McConnell does not teach at least 10 grams of a combination of the carbohydrate and substrate, and the obviousness statement is conclusory.
This is not persuasive since, as stated in the prior art rejection, the evidence of record is insufficient to establish criticality of the claimed range with respect to unexpected results. Applicant’s examples 17-19 recite varying amounts of ketogenic substrate combined with 20-50 g of digestible carbohydrate or hydrothermally modified starch. Example 12 recites 10 grams ketogenic substrate and “exact same amounts of…sweetener and natural flavoring.” However, the minimum combined weight of each example is well over 10 grams. It is unclear if the alleged results are observed for values above and below the claimed lower boundary of 10 grams. The presented evidence is not commensurate in scope with the claimed range and insufficient to establish criticality of said range. See MPEP 716.02(d) II.
Regarding obviousness, the prior art recognizes “digestible carbohydrate” to encompass a variety of known substances e.g., sugars and starches. Likewise, it is well-known to add varying amounts of said substances to a food composition to achieve a desired flavor, texture/mouthfeel, and nutritional profile. Since the evidence of record is insufficient to establish criticality of the claimed range, since Llosa teaches varying dosages of the ketogenic composition including values above 10 grams (paragraphs 62-64), and since the relative amount of digestible carbohydrates can be varied as taught by McConnell, the claimed values would have been prima facie obvious as a matter of routine optimization as stated in the prior art rejection. See also MPEP 2144.05 II.
Applicant argues on page 4 that ketogenic compounds are merely optional add-ons in McConnell and minimally present when ketosis is targeted to avoid interfering with ketone production, McConnell provides no examples of BHB acid + BD substrates, no carb:keto ratios, and no motivation to add carbs to induce ketosis. Applicant argues Llosa aims for ketosis but warns high carbs suppress ketosis, where adding carbs directly to Llosa’s composition, especially at ratios up to 12.5:1 as claimed, would render Llosa’s composition unsatisfactory for its intended purpose.
This is not persuasive since McConnell is cited to teach that the amount of digestible carbohydrate can be varied based on application. The reference states “digestible carbohydrates provide about 35% to about 55% of the energy of the nutritional composition when the composition is the sole source of nutrition” or “less than about 10%; especially if the composition is intended to place the ASD patient in a state of ketosis” (paragraph 94). This suggests to one of ordinary skill that compositions comprising ketogenic compounds can also include varying amounts of digestible carbohydrates.
Regarding the BHB acid + BD substrates, McConnell teaches “suitable ketogenic compounds include…hydroxybutyrates and their derivatives…butane-1,3-diol” (paragraph 88). Regardless, the reference is not relied on to teach the compounds. Llosa already teaches BHB acid + BD substrates as stated for claim 1.
Regarding McConnell not teaching carb:keto ratios and providing no motivation to add carbs to induce ketosis, the reference suggests to one of ordinary skill in the art that the amount of digestible carbohydrate in the composition can be varied as explained above. While the claimed range of carb:keto weight ratio is not explicitly taught, the values are prima facie obvious due to insufficient evidence of range criticality and routine optimization for desired flavor, mouthfeel/texture, and nutritional profile.
Regarding Llosa disclosing a high carb diet suppressing ketosis and modification to include up to 12.5:1 carbohydrate to ketogenic substrate rendering the composition unsatisfactory for its intended purpose, the cited prior art does not indicate that the digestible carbohydrate content in the composition must scale equally to the overall carbohydrate content of a user’s diet. Further, the claimed range encompasses a carb:keto ratio as low as 0.4:1. A modified composition including the digestible carbohydrate and ketogenic substrate in a ratio within the claimed range can be administered to a user who consumes an overall diet comprising mostly protein and fats such that the 5% carbohydrate level for ketosis disclosed by Llosa is satisfied. For example, a composition comprising 10 grams digestible carbohydrate to 10 grams ketogenic substrate (i.e., 1:1) would satisfy the claimed range of ratios while contributing about 40 kcal carbohydrate to the user’s daily caloric intake. Assuming a 2,000-kcal diet, the contribution of said carbohydrate would be about 2%.
Additionally, Llosa teaches there are “several ways to increase ketone levels [in the body]” (paragraph 38), where the “a diet of…5% carbohydrates” method to maintain ketosis over a prolonged period is “obviously not maintainable” (paragraph 39). The reference then teaches BHB (including its acid form) and BD can be used to promote ketosis (paragraphs 40-41 and 45-46). The above teachings suggest to one of ordinary skill that the 5% carbohydrate diet may not be necessary to induce ketosis in an individual, and that the combination of BHB and BD can be used to facilitate ketosis without a requiring a restricted diet that is “obviously not maintainable”.
Applicant argues on page 4 that Llosa teaches away from modification since the reference discloses glucose must be taken prior to the ketones due to interactions between the two.
This is not persuasive since claim 1 does not limit the digestible carbohydrate to only glucose, and since McConnell teaches suitable digestible carbohydrates can also be hydrolyzed or modified starch or corn starch, syrups and plant carbohydrates, sugar alcohols, etc. Even if glucose must be taken before the ketogenic substrate, Llosa does not recite or otherwise indicate interactions between said substrate and any of the disclosed digestible carbohydrate alternatives.
Applicant argues on page 5 the Office fails to point to a disclosure in Llosa that would lead one of ordinary skill to select the claimed ratios, ranges, and amounts, said amounts shown in the disclosed data to have critical physiological results and taste characteristics necessary to be unexpectedly effective in raising circulating ketone levels and being palatable. Applicant argues the Office provides a conclusory statement which lacks reasonable expectation of success.
This is not persuasive for the same reasons stated for the response to Applicant’s “reason 1” above. Llosa teaches a ketogenic composition comprising BHB and BD, where the relative amounts of each can be varied through routine experimentation and optimization based on a variety of established factors. The evidence of record is does not sufficiently show criticality of the claimed range for the combined weight of each substance and the weight ratio of carbohydrate to ketogenic substrate as explained above. Likewise, the evidence is insufficient to show the weight percentage ranges for BHV and BD are critical. Specifically, Applicant’s example 11 discloses three beverages according to the invention, but each beverage includes BHV. Comparative beverages one and two do not contain BHV, which indicates its presence contributes to the alleged results. However, claim 1 does not require BHV, which questions whether the claimed composition obtains the same results as those in example 11. The same applies to the data of figure 1, which requires BHV. Regarding example 12, data is shown only for a single point in each claimed range at 53.6 wt% BHB and 46.4 wt% BD. There is no data to show the alleged results are obtained at the upper and lower bounds of the respective claimed ranges. Therefore, the evidence of record is not commensurate in scope with the claimed ranges.
Applicant argues on pages 5-6 that Llosa teaches minimizing BD in the composition and states BD causes issues, which teaches away from modifying the composition to include BD in the claimed weight percentage range, and would instead motivate one of ordinary skill to similarly minimize the amount of BD while keeping the carbohydrate separate from the ketones.
This is not persuasive for the same reasons stated for the response to “reason 1” above i.e., Llosa teaches optimization of the compounds to account for recommended limitations, palatability, deleterious side effects, and preferred results (paragraphs 48 and 72). Further, the reference explicitly states the disclosed ranges are “preferred embodiments” that are “not rigid” (paragraph 49), which suggests the relative amount of BD can be increased to within the claimed range. See also MPEP 2123. While the reference discloses issues with BD, said issues are directed to use of BD “by itself” and as “a primary source for achieving ketosis” (paragraph 46). One of ordinary skill would not consider the minimum 15 wt% BD in the claimed blend to be a “primary source” for ketosis, and therefore the disclosure does not constitute a teaching away from using values within the claimed range.
Applicant argues on pages 6-7 that there is no evidence on record of any specific weight ratio of digestible carbohydrate to the ketogenic substrate, which is not amenable to routine optimization, and therefore a prima facie case of obviousness has not been established.
This is not persuasive since McConnell teaches the digestible carbohydrate provides 35-55% or less than 10% of the energy of the composition as stated above, which can be expressed as a range of weight ratios based on the energy density of each component (Energy NPL). One of ordinary skill in the art would have been capable of deriving component weight ratio from McConnell’s energy content teaching using publicly available caloric values.
Applicant argues on page 8 that the specification as filed demonstrates unexpected results associated with the claimed percentages safely inducing ketosis for longer than previously thought possible, citing page 29 of the specification and figure 2. Applicant argues the cited prior art does not disclose the claimed weight percentages of BHB and BD, thus the results are unexpected over the cited references, and taste test data of Applicant’s example 11 shows higher scores than the compositions of Llosa.
This is not persuasive since the evidence in the specification is not commensurate in scope with the claimed ranges as explained for the response to “reason 4” above. Further, the cited portion of the specification (and figure 2) provides results for a composition including BHV along with the BHB and BD, where data is shown as the percentage of “D-BHB/BHV” in the blend. However, claim 1 as currently drafted does not require BHV to be present. The weight percentages of BHB and BD themselves are unclear since they cannot be determined from the data. Therefore, it is unclear if the claimed composition would achieve the same results as those in figure 2. The data of example 11 is similarly insufficient as explained for “reason 4”.
Applicant argues on page 9 that the ratios of BHB to BD taught by Llosa are significantly different than the ranges of claim 9, where the reference teaches more BHB than BD, and there is no reason to modify the ratios through routine optimization.
This is not persuasive the claimed ratio range encompasses embodiments in which more BHB is present e.g., “7:3” or “6:4”, there is insufficient evidence of record to establish criticality, and Llosa suggests modification as explained above.
Applicant argues on pages 9-10 that Hageman and Brown do not teach the claimed ketogenic substrate and component percentages and ratios.
This is not persuasive since the argued features are rendered obvious by Llosa as explained above. One cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues on page 10 that Martin is directed to compositions that provide ketone bodies in the form of oligomers and/or derivatives of 3-hydroxyacids, whereas the claimed composition recites D-BHV, and the reference does not teach the claimed component percentages and ratios.
This is not persuasive since the Martin recognizes BHV as a 3-hydroxyacid suitable for use alongside BHB in a ketogenic composition, and provides suggestion to optimize the relative amounts of hydroxyacids (paragraph 53). BHV is disclosed to be advantageous due to “a higher energy content” associated with the even number of carbons in the BHV (paragraph 15). While the reference teaches oligomers, there is no indication that the “derivatives” exclude the claimed D-BHV. In particular, Llosa teaches 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). Since Llosa already teaches increasing ketone body levels with D-BHB as stated for claim 1, providing BHV as a D enantiomer would have been readily obvious for the same reasons. Additionally, the claimed component percentages and ratios are not persuasive for the same reasons stated throughout the response above.
The non-statutory double patenting rejections are necessitated by the encompassing subject matter between the respective claims, and the teachings of the cited prior art. The rejections are maintained.
Applicant’s request for rejoinder has been considered but the request is premature for the reasons stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kuriyama (US 2010/0210726 A1) teaches a composition for promoting ketone body production comprising BHB and BHV acids (abstract; paragraph 31).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/B.K/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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