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 .
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.
Restriction Requirement
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I. Claims 1-12, drawn to a composition comprising supplement composition comprising an approximate 2:1 molar ratio of taurine, classified in class A61K 31/145.
Group II. Claims 13-18, drawn to a method of producing a supplement composition for use as a dietary supplement, or as an additive in a food or beverage product, classified in class A61K 31/145.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed can be made by another and materially different process, such as dissolving the malic acid and taurine in water to form a solution without a titration step, and subsequently spray drying.
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Election of Species
If Applicant elects Invention II election of one of the following species is required:
a) the process of claims 13-15, or
b) the process of claims 16-18.
The species are independent or distinct because claims to the different species recite the mutually exclusive steps of each process. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election. The election of the species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species.
Should applicant traverse on the ground that the species are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other species. Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141. Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i). The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101,102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01
Telephonic Election
During a telephone conversation with attorney Monique Morneault on February 13, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Status
Claims 1-18 are pending.
Claims 13-18 are withdrawn.
Claims 1-12 are examined on the merits in this prosecution.
Objection to the Specification
In paragraph [0044], ninth line, the term “nematodes” is misspelled.
CLAIM REJECTIONS
Statutory Rejection Under 35 U.S.C. 101: Rejection Based on
Two Applications with Identical Claims
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-12 of copending Application No. 18/432,775 (reference application).
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Indefiniteness Rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2, 3, and 12 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 pre-AIA the applicant regards as the invention.
Claim 2 is rejected as indefinite since the instant specification does not provide a standard for measuring the degree intended by the term “approximately” as pertaining to the term “a human dose of approximately 5 grams per day.”
Claim 3 is rejected as indefinite since the instant specification does not provide a standard for measuring the degree intended by the term “approximately” as pertaining to the limitation “an animal dose of approximately 70 mg/ kg body weight per day.”
See MPEP 2173.05(b)(I).
Claim 12 is rejected as indefinite in view of the recitation “wherein the composition provides a plurality of health benefits including improvements to aging and improvements to energy levels.” As set forth in MPEP 2173.05(d): “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.
Obviousness Rejection
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 1, 3, 6-8, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta (WO 2019/053580 A1; cited in IDS dated 7/15/2024).
The term approximate in claim 1 is interpreted as in the instant specification, [0008]), or a “composition of taurine and malic acid in the range of 2.1:1 molar ratio to 1.9:1 molar ratio (calculated to the range of 1.91:1 to 1.82:1 mass ratio, or the range of 33.79% to 36.06% by weight malic acid to 2 decimal places).”
Gupta teaches an energy drink comprising caffeine along with nutritional supplements are selected from the group consisting of taurine, malic acid, at least one additional amino acid, at least one bioactive nutrient additive, at least one vitaminic additive, at least one herbal additive, at least one sweetener, glucuronolactone, at least one mineral additive, cocoa, coenzyme Q10, and combinations thereof (pg 2, [0011]).
Gupta teaches the amount of taurine in the energy drink as 5000 mg and the amount of malic acid as 1200 to 2400 mg (pgs 4-5, [0017]). As calculated by the Examiner, the weight ratio of taurine to malic acid is 2.08:1. While not overlapping the claimed mass ratio of 1.9:1, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close,” in the absence of evidence to the contrary. In this instant, the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties. See MPEP 2144.05(I).
For claims 3 and 6, Gupta teaches the amount of taurine in the energy drink as 5000 mg and the amount of malic acid as 2400 mg, yielding a final composition of 7400 mg. as such, an animal weighing approximately 106 kg would require such a dose.
For claim 7, the instant specification discloses a supplements having a unique composition of taurine and malic acid, and providing various health benefits, including ergogenic effects of enhanced physical performance, stamina, and recovery, as well as beneficial for supporting an active lifestyle and nutrition and providing an energy enhancement ([0001] and [0006]). As an energy drink, the Gupta composition, taught as a mixture comprising a weight ratio of taurine to malic acid very close to the claimed range, may be optimized by one of ordinary skill utilizing routine optimization. The person of ordinary skill in the art would have found it obvious to optimize within the range taught by Gupta because Gupta teaches a composition comprising malic acid and taurine that is useful for the same purpose as the instantly claimed composition.
For claim 8, Gupta teaches caffeine in the composition (Abstract), as well as creatine (pg 7, [0026]; pg 11, [0046]).
For claim 10, Gupta teaches the composition in the form of a drink or beverage (Title).
For claim 11, Gupta teaches the form of a supplement (pg 2, [0011]).
For claim 12, Gupta teaches the composition as an energy drink (pg 1, [0003]).
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Gupta. However, the claimed combination of components, including the malic acid and taurine, is taught as known and used for administration to a subject to increase energy. Further, Gupta teaches administration with caffeine and creatine. It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer the claimed combination of ingredients, including taurine and malic acid, to a subject to increase energy in the form of a beverage with a reasonable expectation of success that the treatment would be efficacious, as taught by Gupta.
2) Claims 2, 4-5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta (cited above), in view of Marshall (US 2021/0228663 A1).
The teachings of Gupta are discussed above.
Gupta does not teach a composition comprising a human dose of approximately 5 grams per day, or the combinations recited in claims 4 and 5, respectively, or the excipients recited in claim 9.
Marshall teaches the missing elements of Gupta.
Marshall teaches a composition with the following properties (pg 3, [0025]):
nutritional supplements containing malic acid (malate) as a chelate, not only deliver a well-absorbed, stable form of an essential mineral such as magnesium ( e.g., magnesium malate) to the body, but also have the extra benefit that malic acid provides as a potent detoxifier
of aluminum and as a direct fuel (energy) source in mitochondrial ATP production. Some of the vital cellular functions that these organic chelates support include: antioxidation (glycine, taurine), *glutathione biosynthesis and upregulation (glycine, taurine), detoxification (glycine, malate, taurine), neurotransmitter and receptor modulation (glycine, taurine), regulation of inflammation (glycine, taurine), and mitochondrial energy production (malate, taurine).
Marshall teaches the composition comprises an amount taurine of 100-2,000 milligrams and an amount of malic acid of 100-2,000 milligrams (pg 14, claim 1).
As such, the combination of Gupta and Marshall teach an effective amount of taurine in 100 to 5000 mg, and an effective amount of malic acid of from 100 to 2400 mg, overlapping the range or amount limitations of claims 2, 4, and 5, since, as set forth in MPEP 2144.05(I), “A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case.” In this instance, both the compositions of Gupta and Marshall are useful for the same purpose, namely to increase the energy level of a subject.
Routine optimization of the amounts of each of malic acid and taurine in Gupta’s composition utilizing the ranges taught by Marshall would have led to the claimed range of each of taurine and malic acid because both Gupta and Marshall teach compositions comprising taurine and malic acid that provide a boost of energy levels. The person of ordinary skill in the art would have found it obvious to optimize within the ranges taught by Gupta and Marshall because Gupta teaches a range of 5000 mg of taurine and 1200 to 2400 mg of malic acid and Marshall teaches a range of taurine of 100-2,000 mg and a range of malic acid of 100-2,000 mg, and it is prima facie obvious to determine an optimized range between the ranges recited in multiple prior art references since both Gupta and Marshall are teaching compositions to achieve the same end goal.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612