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
This office action is in response to applicant’s reply filed on February 5, 2026.
Restrictions/Elections.
Applicant’s election without traverse of Group II (Claims 8-14) in the reply filed on February 5, 2026, is acknowledged.
Status of Claims
Claims 1-20 are currently pending and are the subject of this office action.
Claims 1-7 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 5, 2026.
Claims 8-14 are presently under examination.
Priority
The current application is a CIP of U.S. Patent Application No. 17/240,605, filed April 26, 2021.; which is a CON of U.S. Patent Application No. 16/819,079, filed March 14, 2020 and issued as U.S. Patent No. 11,013,705 on May 25, 2021, which claims priority to U.S. Provisional Patent Application No. 62/818,538, filed March 14, 2019; and further is a CIP of PCT Patent Application No. PCT/US2022/015796, filed February 9, 2022; which claims priority to U.S. Provisional Patent Application No. 63/147,747, filed February 9, 2021.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8, and its dependent claims recite: “A method of dietary management of renal health, comprising: administering to a subject a composition comprising….”
However, it is not clear who the subjects are. Are the subjects suffering from renal disease or are the subjects healthy patients that are trying to maintain and/or improve renal health?
The metes and bounds of the claims are not clearly defined.
Claim 14 recites: “subjects at risk for chronic kidney disease (CDK)”. It is assumed that a subject at risk for chronic kidney disease is a subject not yet suffering from CKD. So how is the skilled in the art supposed to identify a healthy subject that is at risk of having CKD from a healthy subject who is not at risk for CKD.
So, for prior art purposes it is going to be assumed that any subject not suffering from CKD is at risk for chronic CDK
The metes and bounds of the claim are not clearly defined.
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.
Claim(s) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et. al. (CN 107536035 (2018) machine translated).
NOTE: for this rejection it is going to be assumed that the subjects in need of a “dietary management of renal health” are healthy individuals or at least individuals that do not suffer from renal diseases (see above 112(b) rejection)
For claim 8, Wu teaches (see abstract and see claims 1-3) a method of administering a dietary formulation (I.e. functional food) to a subject, wherein the dietary formulation comprises: 50-75% of BHB and 5-15% of sodium citrate, which results in a citate/BHB percentage ratio of 6.6% (5/75 x 100) to 30% (15/50 x 100), which overlaps with the instantly claimed ratio (at least 30%).
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
The prior art is silent regarding “management of renal health”. However: “management of renal health” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same formulation (a formulation comprising at least 30% citrate/BHB) is being administered to the same subjects (subjects that do not suffer from renal disease). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “management of renal health”, by practicing the method made obvious by the prior art: “the administration of a dietary composition comprising at least 30% citrate/BHB to individuals not suffering from renal disease", one will also be “managing renal health”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("managing renal health”) of the method made obvious by the prior art (“the administration of a dietary composition comprising at least 30% citrate/BHB to individuals not suffering from renal disease").
MPEP 2145 II states: “The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious”. Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
All this will result in the practice of claim 8 with a reasonable expectation of success.
For claims 9-11, the prior art does not teach that:
“The composition is configured to be diluted in a liquid to yield a solution comprising a therapeutic effective amount of BHB with a concentration of 80 mM or less and a therapeutic effective amount of citrate with a concentration of 60 mM or less”.
However, the above phrase does not require any active steps and simply describes a property of the composition claimed: that if diluted under certain condition it will afford a solution comprising a therapeutic effective amount of BHB with a concentration of 80 mM or less and a therapeutic effective amount of citrate with a concentration of 60 mM or less.
The composition of the prior art (Wu) teaches the same or similar composition, as such it is fair to assume that it will have the same or similar properties, like: “being configured to be diluted in a liquid to yield a solution comprising a therapeutic effective amount of BHB with a concentration of 80 mM or less and a therapeutic effective amount of citrate with a concentration of 60 mM or less”.
The office does not have the facilities and resources to provide the factual evidence needed to establish that the composition disclosed by Wu does not possess the same material, structural and functional characteristics of the composition claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the composition used in the claimed method is different from the composition taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
All this will result in the practice of claims 9-11 with a reasonable expectation of success.
For claim 12, Wu teaches the presence of calcium carbonate, so at least some fraction of BHB will be in the form of a Calcium salt, thus resulting in the practice of claim 12 with a reasonable expectation of success.
For claim 13, Wu teaches the presence of calcium carbonate, so at least some fraction of BHB will be in the form of a Calcium salt. Wu also teaches that the concentration of BHB and citrate can be respectively 50% and 15%, which implies a BHB/citrate ratio of 77:23, which is close to the instantly claimed ratios (63:37 or 60.3:39.7).
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claim 13 with a reasonable expectation of success.
For claim 14, the prior art does not teach that the subject was diagnosed or is at risk for chronic disease. However, as stated in the 112(b) rejection above, a healthy subject, not yet suffering from CKD is considered “at risk for chronic disease”, thus resulting in the practice of claim14 with a reasonable expectation of success.
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
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 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 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zandi-Nejad et. al. (US 2009/0247589) and Holland (US 2019/0059432).
For claims 8, and 12-14, Zandi-Nejad teaches a method of treating chronic kidney disease (CKD) comprising the administration of a composition comprising a therapeutically effective amount of BHB (beta hydroxy butyrate; see claims 30-31 and 35). Zandi-Nejad does not teach the administration of a citrate (a crystal precipitation inhibitor).
However, Holland teaches a method of reducing the incidence of nephrolithiasis (kidney stones) in patients afflicted with chronic kidney disease (CKD) comprising the administration of a composition comprising a therapeutically effective amount of potassium and/or magnesium citrate (see abstract, [0045], [0048], [0050], [0052], [0057], [0058] and claims 17 and 21). Holland further teaches a method of reducing nephrolithiasis in patients suffering from CKD (see [0050] for example).
Holland further teaches that “Moreover, it is known that a history of kidney stones is a risk factor for CKD formation” (see [0006]).
Zandi-Nejad further teaches that “all dosage forms may be prepared using methods that are standard in the art that are taught in reference works such as Remington’s Pharmaceutical Sciences” (see [0021)). Since the administration of drugs with dietary supplements and/or food is so common in the pharmaceutical art in order to optimize the absorption of drugs. Further, Holland teaches that the citrate salts can be administered as dietary supplements (see title, abstract and entire document).
Zandi-Nejad and Holland do not teach for the weight percentage of citrate.
However, the amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results.
Moreover, the determination of known effective amounts of known active agents to be administered to treat the same disease is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. As Zandi-Nejad and Holland teach the range of dosages of BHB and citrate that are used to treat CDK, the dosage is considered a result effective variable. Thus, it would also have been obvious to have chosen a dosage from among those known to be effective in methods of treating cancer.
Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
A prima facie case of obviousness may be established even though a prior art reference does not disclose any particular range, but teaches that the claimed parameters are known to affect results or properties
In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (“Discovery of an optimum value of a result effective variable…is ordinarily within the skill of the art.”).
Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to administer to a patient suffering from CKD and kidney stones a dietary supplement comprising BHB, which is effective in treating CKD, and a citrate, since citrates have proven to be effective in reducing the incidence of kidney stones in patients with CKD, thus resulting in the treatment of CKD and kidney stones in patients in need thereof. The skilled in the art will be able to use a BHB/citrate ratio that has the best efficacy in treating CKD, thus resulting in the practice of claims 8 and 12-14 with a reasonable expectation of success.
For claims 9-11, the prior art does not teach that:
“The composition is configured to be diluted in a liquid to yield a solution comprising a therapeutic effective amount of BHB with a concentration of 80 mM or less and a therapeutic effective amount of citrate with a concentration of 60 mM or less”.
However, the above phrase does not require any active steps and simply describes a property of the composition claimed: that if diluted under certain condition it will afford a solution comprising a therapeutic effective amount of BHB with a concentration of 80 mM or less and a therapeutic effective amount of citrate with a concentration of 60 mM or less.
The composition of the prior art (Zandi-Nejad and Holland) teaches the same or similar composition, as such it is fair to assume that it will have the same or similar properties, like: “being configured to be diluted in a liquid to yield a solution comprising a therapeutic effective amount of BHB with a concentration of 80 mM or less and a therapeutic effective amount of citrate with a concentration of 60 mM or less”.
The office does not have the facilities and resources to provide the factual evidence needed to establish that the composition made obvious by the prior art does not possess the same material, structural and functional characteristics of the composition claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the composition used in the claimed method is different from the composition taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
All this will result in the practice of claims 9-11 with a reasonable expectation of success.
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 8-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,013,705. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘705 patent disclose methods for treating kidney diseases comprising the administration of compositions comprising BHB and citrate, wherein the citrate is at least 10%.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
February 19, 2026.
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