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 .
Priority
Acknowledgement is made to the applicant’s claim to domestic benefit of provisional applications 63/226,057and 63/203,644 both filed on July 27, 2021.
Status of the claims
The claims filed on 06/23/2026 accordingly with Applicant’s response to the non-final office action mailed on 12/23/2024 are entered onto the record. Claims 1-19 are pending and currently examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/24/2025 complies with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered on the merits.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on
December 23, 2024:
Claim 1, 5,8 and 10 objections are withdrawn accordingly with amendments filed on 06/23/2026
Claim 2, regarding “glycerides” is withdrawn accordingly with amendments filed on 06/23/2026
Claim 2, regarding “dihydroxybergamottin” is withdrawn accordingly with amendments filed on 06/23/2026
Claim 2, regarding “flavonoids” is withdrawn accordingly with amendments filed on 06/23/2026
Claim 2, regarding “Zingiber officinale” is withdrawn accordingly with amendments filed on 06/23/2026
Claim 2, regarding “forskolin” is withdrawn accordingly with amendments filed on 06/23/2026
Claim 2, regarding “sceletium tortuosum” is withdrawn accordingly with amendments filed on 06/23/2026
Claim 2, regarding “ubiquinone (01)” is withdrawn accordingly with amendments filed on 06/23/2026
Claim 9 under 35 U.S.C. 112(d) is withdrawn accordingly with the amendments filed on 06/23/2026
Response to Arguments
Applicant's arguments filed on 06/23/2026 have been fully considered but they are not persuasive.
Regarding the rejection of claim 1-4, 6, and 7 under 35 U.S.C. 101, the previous action stated that the claimed invention was directed to a product of nature and did not recite any additional elements that amount to significantly more than the judicial exception, and are therefore not eligible subject matter. Applicant argues “Here, the claimed compositions exhibit new and unexpected properties. The specification provides experimental data showing that the combination of paraxanthine and tyrosine produces a synergistic increase in grip strength, energy, and mood in animal models, which is greater than the sum of the effects of each component alone.” The arguments that the synergistic effects are new and unexpected properties of the claimed composition and amount to significantly more than the judicial exception are not found persuasive regarding the synergistic effects of paraxanthine and tyrosine.
For example, Regarding Cook’s pole climbing test escape latency (para. [0073]) the paraxanthine group performed “(16.38±2.33 seconds)”, control group performed “(6.38±1.41 seconds)”, tyrosine group performed “(8.25±1.04 seconds)” and the paraxanthine plus tyrosine group performed “(5.88±0.83 seconds)”. However, this data suggests that the longer escape latency of the paraxanthine group is slower or worse that than the faster control mice to respond to the buzzer stimulus and ascend the pole. Further, the data of the combination treated mice appears to be less than 10% faster than the control treated mice when evaluating the percent difference between “control (6.38±1.41 seconds)” and “paraxanthine plus tyrosine group (5.88±0.83 seconds)” which would does not suggest a synergistic effect.
Similarly, when evaluating “duration of mobility/active swimming” the data show that combination treated mice performed less than 10% better than controls and either of the individually treated groups (see para. [080]).
Similarly, when revaluating energy and mood by mobility/active swimming the data show that the combination treated mice performed less than 5% better than either of the individually treated groups (see para. [085]) and when for the duration of immobility the effects of the combination treatment are around 1% compared to either individually treated groups (see para. [086]).
While there is a greater beneficial effect of the combination treatment as evaluated on the grip strength test (see para. [078] and Fig. 1), in view of the rest of the data and disclosure Applicant’s arguments that the “claims are directed to compositions and methods that achieve specific, non-naturally occurring results, such as synergistic enhancement of muscle strength, cognitive function, and mood” is not supported by the disclosure.
Thus, the rejection of claims 1-4, 6, and 7 under 35 U.S.C. 101 is deemed proper.
Regarding Applicant argues that “A careful examination of Bhargava demonstrates that the reference does not provide, either expressly or inherently, the teaching, suggestion, or motivation required under Graham and KSR to select paraxanthine from Bhargava's list of "methylated xanthines," to select tyrosine from a longer and unrelated list of "amino acids," and then to combine only those two ingredients while excluding caffeine-Bhargava' s central active component-and the myriad other actives that Bhargava consistently formulates together.” Applicant further argues “Bhargava's disclosure is fundamentally directed to caffeine-based energy "shots" that deliver sustained alertness through a carefully balanced formulation of caffeine, choline derivatives, amino acids such as taurine, vitamins, and a host of additional components including glucuronolactone and citric or malic acid.”
However, this is not found to be persuasive. Bhargava is directed more accurately to “edible energy composition[s] that includes a methylated xanthine” (see pg.1 Summary, para 1, and claim 1). Furthermore, the first recitation of caffeine occurs with the first recitation of paraxanthine as preferred embodiments of methylated xanthine (see pg. 4, para. 5,). Therefore, one of skill in the art relying on the teachings of Bhargava's disclosure may as likely to select either caffeine of paraxanthine as the more preferred methylated xanthine to produce compositions disclosed therein, especially given that neither caffeine or paraxanthine are exemplified by the presentation of data to suggest one performs better than the other. Bhargav additionally discloses benefits of the compositions disclosed therein beyond sustained alertness. For example, “vitamin B6 is also involved in gluconeogenesis” (see pg. 6, para. 2), and “tyrosine, through its effect on neurotransmitters, is used to treat conditions including mood enhancement” (see pg. 8, para. 1).
MPEP 2143 (I) (A) regarding combining prior art elements according to known methods to yield predictable results. The prior art teach each individual component of the claimed supplemental composition of the instantly claimed invention as components with known benefits (e.g., increased alertness or mood enhancement). Furthermore, the prior art teach that each of the individual components of the instantly claimed invention are found in combination with other known beneficial components. Thus, one of skill in the art in the same endeavor of dietary and health supplements and energy compositions could have combined the components of Bhargava by known methods with no change in their respective functions (i.e., providing a nutritional/health benefit), and the combination would yield nothing more than predictable results of a health supplement. See KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Applicant further argues “Claim 1 further requires that the two species be present "in a ratio from about 1:4 to about 1:30."Bhargava is completely silent on any ratio that links the xanthine component to the amino-acid component. The absence of any disclosed range or preferred relationship for the two sub-classes precludes a finding of obviousness.” However, Bhargava disclose preferred embodiments with ranges of amounts of the methylated xanthine (see pg. 8, para. 2). For example, “the methylated xanthine is present in an amount from about 0.05% to about 0.5% by weight (i.e. w/w)”. Bhargava further disclose the amounts of amino acids in preferred embodiements (see pg. 9, para. 2). For example, “amino acids are present in an amount from about 0.05% to about 0.5% by weight”. Therefore, one of skill in the art relying on the teachings of Bhargava to make a composition may make a composition comprising 0.125% of a methylated xanthine (e.g., paraxanthine) and 0.5% of an amino acid (e.g., tyrosine) resulting in a 1:4 ratio, or, alternatively, a composition comprising 0.05% methylated xanthine (e.g., paraxanthine) and 1.5% of an amino acid (e.g., tyrosine) resulting in a 1:30 ratio.
Regarding claim 8, Applicant argues that “Claim 8 recites administering an effective amount of the claimed composition to produce a synergistic increase in athletic performance or energy relative to each ingredient alone.” However, claim 8 does not recite “synergistic effect” and thus is not directed to a synergistic effect. Furthermore, a synergistic effect would be interpreted as an intended use/result and is not afforded any patentable weight when evaluating the patentability of a composition unless the synergistic effect results any further structural limitation or structural difference between the claimed invention and the prior art. (see MPEP §2111.02 II). Since the prior art reads on the claimed composition with the known health, dietary, and energy benefits one of skill in the art would be motivated to use the claimed composition for the method of claim 8.
Regarding claim 14, Applicant argues that “Claim 14 requires enhancement of at least one enumerated cognitive metric (attention, working memory, etc.). Bhargava's broad statement that its composition "may provide a feeling of alertness" is qualitative and speculative.” However, these arguments are not persuasive. The instant disclosure provides a broad definition of cognitive function, including “but not limited to” attention, information processing, working memory, etc. (see para. [025]. As discussed in the prior non-final office action mailed on Dec. 23, 2024 and restated below, Bhargava also discloses that the composition may also provide a significant increase in the power of attention, continuity of attention, quality of working memory, quality of episodic memory, speed of memory and self-related alertness, the sum of the benefits providing a perceived feeling of energy. (pg.2, paragraph 5 - pg.3, paragraph 1).
Regarding claim 19, as discussed above intended uses of compositions are not afforded patentable weight where the prior art teaches the claimed invention unless the intended use results in a structural change to the claimed invention. Therefore, where the prior art teaches the method and composition, for example, edible energy composition that includes a methylated xanthine, a choline derivative, amino acids, vitamins, taurine, glucuronolactone, acidulants and at least one flavorant (pg. 1, paragraph 4), it reads on the claimed invention. Further, Bhragava also teaches ranges of amounts of taurine in various embodiments of the compositions disclosed therein (see pg. 10, para. 3). One of skill in the art, relying on the teachings of Bhragava, through routine experimentation, would have arrived at the ranges and amounts that read on instant claim 19. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144 (II)(A).
Thus, the rejection of claims 1-4, 8-10,12,14 -19 under 35 U.S.C. 103 is deemed proper.
Claim Interpretation
Claim 2, regarding “glycerides”, the recitation of “including” is considered a list of preferred embodiments and is not interpreted to limit the scope of glycerides, therefore, where the prior art teaches any glycerides it shall read on this claim feature. Additionally, In the specification triglycerides and MCTs independently of each other and not as MCTs being a preferred embodiment or limitation of glycerides (e.g., para. [008] and [033]).
Claim 2, regarding “dihydroxybergamottin”, the recitation of “a CYP3A4 inhibitor, dihydroxybergamottin” is interpreted to limit the scope of CYP3A4 inhibitor, therefore, where the prior art teaches dihydroxybergamottin it shall read on this claim feature.
Claim 2, regarding “flavonoids”, the recitation of “such as” is considered a list of preferred embodiments and is not interpreted to limit the scope of flavonoids, therefore, where the prior art teaches any flavonoid it shall read on this claim feature.
Claim 2, regarding “fish oil”, the recitation of “comprising” is open ended claim language and is not interpreted to limit the scope of fish oil, therefore, where the prior art teaches any fish oil it shall read on this claim feature.
Claim 2, regarding “Zingiber officinale”, the recitation of “such as” is considered a list of preferred embodiments and is not interpreted to limit the scope of Zingiber officinale, therefore, where the prior art teaches any Zingiber officinale it shall read on this claim feature.
Claim Objections
Claim 2 is objected to because of the following informalities:
recitation of “flavonoids” appears twice in claim 2 lines 7 and 18; line 18 is interpreted as a typographical error and should be appropriately amended. Appropriate correction is required.
Examiner notes inconsistencies in naming schema, e.g., “MSM (methylsulfonylmethane)” as compared to “2-(dimethylamino)ethanol (DMAE)”. It is suggested that naming schema remain consistent and correction is suggested to update where appropriate to recite the name of the ingredient first and then the acronym in parentheses.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2 and 3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 has been presently amended to recite “lauroyl macrogol and pharmaceutically acceptable derivatives thereof” however, pharmaceutically acceptable derivatives of lauroyl macrogol has no corresponding recitation or description in the instant specification and is therefore new matter and unclear as to what the limitation encompasses.
Claim 3 has been presently amended to recite “methylxanthine core with a single methyl substitution at the N-3 position”, “tyrosine ethyl ester”, and “comprising a tyrosine residue covalently linked through an amide or ester bond to an aliphatic C1-C4 chjain”, however, there is no corresponding recitation or description in the instant specification and is therefore new matter
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 2 and 3 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 2 recites “further comprising… selected from the group consisting of… and combinations thereof.” The claim is indefinite for reciting both alternative limitations of open claim language (i.e., further comprising”) and the closed claim language of a Markush group (i.e., “selected from… and combinations thereof”). The indefinite rejection applies to claim 3 for similar recitation of both open and closed alternative limitations. Correction is required. Examiner suggests that if open language is preferred the claims be recite, for example in claim 2, “further comprising a further active ingredient, wherein the further active ingredient is: … or combinations thereof.” See MPEP§ 2173.059h) for further information.
Claim 2 further recites “fish oil, comprising omega-3 fatty acids and specialized pro-resolving lipid mediators (epoxide derivatives)”. the recitation of (epoxide derivatives) is unclear if this is intended to limit the scope of the specialized pro-resolving lipid mediators.
Claim 2 further recites “wasabia japonica (wasabi extract for Tea Tree Oil) in line 14. It is unclear if the “for” adjacent to “Tea” is a typographical error or if the wasabi extract is specific to tea tree oil or if an entirely different ingredient was intended. The scope of the claim is unclear. This is maintained from the previous office action as the amendments did not address this particular rejection.
Claim 2 further recites “Huperzine A (Chinese clubmoss or Huperzia serrata, L-Dopa, Mucuna pruriens and forskolin (Coleus forskohlii)” in line 25-26. The recitation is missing a closing parenthesis. It is unclear if the limitation intends to encompass all the active ingredients as listed in the parentheses as a limitation of Huperzine A or if the ingredients are intended to be listed separately. Therefore, the scope of the claim is indefinite. This is maintained from the previous office action as the amendments did not address this particular rejection.
Claim 3 recites “paraxanthine congener” and “paraxanthine analog”. Although paragraph 9 of the specification gives examples of what a paraxanthine and tyrosine congener or analog can be, the terms “congeners” and “analogs” are not defined. It is unclear if the scope of what encompasses a paraxanthine and tyrosine congener or analog is functional or structural. Thus, the claim is rendered indefinite.
Claim 9 recites the limitation " the administration of paraxanthine and taurine" in line 1 of the claim without any previous recitation of an administration of paraxanthine and taurine. It is unclear if the applicant is intending to claim a composition comprising an effective amount of paraxanthine and tyrosine from claim 8, which claim 9 depends upon, or a composition comprising paraxanthine and taurine. Therefore, the scope of claim 9 is indefinite. For the purposes of examination, claim 9 will be interpreted as “the administration of paraxanthine and tyrosine” because it depends on claim 8 which has a composition comprising an effective amount of paraxanthine and tyrosine.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 and 9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2, regarding “flavonoids”, the recitation of “such as” is indefinite because it is considered a list of preferred embodiments, and thus is not clear whether the claimed narrower range is a limitation of flavonoids. (see MPEP §2173.05(d)).
Claim 4, which depends from claim 3, claim 4 recites more species of the “tyrosine congener or analog” than are recited in claim 3 and therefore is broader in scope than claim 3 and thus fails to further limit the scope of the claim from which it depends.
Claim 9, which depends from claim 8, recites the method of claim 8 in which tyrosine is omitted and replaced by taurine. Claim 9 is not a proper dependent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 6 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite a dietary supplement comprising of naturally occurring amino acids, plants and/or their extracts or oils.
Although the combination claimed is novel and does not occur in nature, there is no indication that mixing them together in the amounts recited in claims 1 changes the structure, function, or other properties of the natural products in any marked way. Instead, each of the natural components retains its naturally occurring structure and properties whether that be as a mood enhancer, energy enhancer, strength booster, cognition booster, etc. which are the same properties they have in their natural state. There is no showing that the claimed mixture as a whole does or has any markedly different characteristics compared to the closest naturally occurring counterpart. Thus, the answer to step 2A prong 1 is yes – the claims recite products of nature. There are no additional elements present in the claim and thus the answer to step 2A prong 2 and step 2B are NO and the claims do not qualify as eligible subject matter.
An analogous case to the claimed mixture is Funk Brothers, which was held ineligible because each species of bacteria in the mixture (like each component in the claimed mixture) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”). While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk Brothers, 333 U.S. at 128 n.1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-4, 8-10,12,14 -19 are rejected as being unpatentable under 35 U.S.C. 103 over Bhargava (WO 2013/173265 A1, Nov. 21, 2013) (IDS reference).
Regarding claim 1, 3 and 4 Bhargava teaches an edible energy composition that includes methylated xanthine, a choline derivative, amino acids, vitamins, taurine, acidulants and at least one flavorant (pg.1 paragraph 4). Embodiments of methylated xanthines including, but not limited to, caffeine, theobromine, aminophylline, theophylline and paraxanthine and includes precursors, structurally-similar compounds, analogs and metabolites of methylated xanthines (pg.8 paragraph 2). The energy composition may further include one or more amino acids including, without limitation, precursors, structurally-similar compounds and analogs, metabolites, salts, esters or isomeric forms of amino acids. In preferred embodiments, the amino acids include, but are not limited to, N-acetyl L-tyrosine, tyrosine and phenylalanine. (pg.9, paragraph 2).
Regarding claim 2, Bhargava teaches a set of components that may be introduced into the composition (pg.15-20, Table 1-Table 5).
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention, to select any one of the methylated xanthines listed above, in combination with one of the preferred amino acids, and or any one of the components, listed in Table 1 – Table 5, as a further active ingredient to arrive at the same composition in instant claims 1 - 4.
Regarding claim 1,10,12, and 16 Bhargava teaches the embodiment, where the methylated xanthine is present in an amount from about 0.05% to about 0.5 % by weight (i.e., w/w) (or for some liquid forms from about 0.0005 g/ml to about 0.005 g/ml). In another embodiment, the methylated xanthine is present in an amount from about 0.35% to about 0.45% w/w (or from about 0.0035 g/ml to about 0.0045 g/ml). In still other embodiments, the methylated xanthine is present in an amount from about 0.37 % to about 0.39% (or from about 0.0037 g/ml to about 0.0039 g/ml) or the methylated xanthine is present in an amount from about 0.32 % to about 0.34 % by weight (or from about 0.0032 g/ml to about 0.0034 g/ml). (pg.8 paragraph 2). The energy composition may further include one or more amino acids including, without limitation, precursors, structurally-similar compounds and analogs, metabolites, salts, esters or isomeric forms of amino acids. In preferred embodiments, the amino acids include, but are not limited to, N-acetyl L-tyrosine, tyrosine and phenylalanine. In one embodiment, amino acids are present in an amount from 0.5% to 5.0% by weight or from about 0.005 g /ml to about 0.05 g/ml. In one embodiment, amino acids are present in an amount from about 1% to about 4% by weight (or from about 0.01 to about 0.04 g/ml), In still another embodiment, amino acids are present in an amount from about 1% to about 3% by weight (or from about 0.01 g/ml to about 0.03 g/ml). (pg.9, paragraph 2).
It would have taken no more than the relative skills of one of ordinary skill in the art, through routine experimentation, to have arrived at the range of ratios and amounts, stated in the instant claims 1,10,12 and 16, to elicit a predictable result in a subject. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144 (II)(A).
Regarding claim 8, 14 and 15 Bhargava teaches that the use of the composition provides certain benefits. For example, the composition may counter, reduce or prevent drowsiness. The composition may also provide a feeling of alertness and mental acuity. The composition may also provide a significant increase in the power of attention, continuity of attention, quality of working memory, quality of episodic memory, speed of memory and self-related alertness, the sum of the benefits providing a perceived feeling of energy. (pg.2, paragraph 5 - pg.3, paragraph 1). Bhargava teaches all of the claimed limitations of claims 8,14, and 15. Therefore, it would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention, to combine paraxanthine and tyrosine to achieve a predictable outcome in the cognitive and physiological response in a subject.
Regarding claim 9 and 18, Bhargava teaches the cognitive and physiological effects of the composition are sustained for an extended period of time and that the effect of the composition on alertness and energy is greater than would be observed than when ingesting an equivalent amount of any if the ingredients alone. In other words, the ingredients of the composition act synergistically to produce benefits to a consumer that exceed the benefits achieved when the ingredients are taken individually. (pg. 3, paragraph 2). Bhargava teaches all of the claimed limitations of claim 9 and 18. Therefore, it would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention, to combine the administration of paraxanthine and tyrosine to produce a synergistic increase in energy relative to the administration of paraxanthine and tyrosine alone.
Regarding claim 17, Bhargava teaches that methylated xanthines competitively block the binding of adenosine to its target sites in the human nervous system, Consequently, the mood-altering and sleep-inducing effects of adenosine are mitigated and xanthines thus prevent the body from being affected by the depressing effects of adenosine (pg.4, paragraph 5). Bhargava also teaches that tyrosine, through its effect on neurotransmitters, is used to treat conditions including mood enhancement (pg.8, paragraph 1). Bhargava teaches all of the claimed limitations of claim 17. Therefore, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention, to combine paraxanthine’s ability to competitively block the binding of adenosine to its target site with a previously established use of tyrosine to treat conditions affecting mood. One of ordinary skill in the art would have been motivated to do with reasonable expectation of success that a combination of paraxanthine and tyrosine will result in an overall enhancement in the mood of the subject.
Regarding claim 19, Bhargava teaches an edible energy composition that includes a methylated xanthine, a choline derivative, amino acids, vitamins, taurine, glucuronolactone, acidulants and at least one flavorant (pg. 1, paragraph 4). The composition may also include taurine, including derivatives of taurine which may include precursors, structurally-similar compounds, analogs and/or metabolites. In one embodiment, taurine is present in an amount from about 0,2% to about 1.6 % by weight (or from about 0.002g/ml to about 0.016 g/ml). In one embodiment, taurine is present in an amount from about 0,4 % to about ,2 % by weight (or from about 0.004g/ml to about 0.0 2 g/ml). In still another embodiment, taurine is present in an amount from about 0.7 % to about 1.0 % (or from about 0.007 g/ml to about 0.010 g/ml) (pg.10, paragraph 3).
As discussed above, Bhargava teaches that the advantage of combining the ingredients of the composition results in a synergistic enhancement in energy to produce benefits to a consumer that exceed the benefits achieved when the ingredients are taken individually. It would have taken no more than the relative skills of one of ordinary skill in the art, through routine experimentation, to have arrived at the range of ratios and amounts, stated in the instant claim 19, to elicit a predictable result in a subject. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144 (II)(A).
Claim 13 is rejected as being unpatentable under 35 U.S.C. 103 over Bhargava (WO 2013/173265 A1, Nov. 21, 2013) (IDS reference) as applied to claims 1-4, 8-10,12,14 -19 above in further view of Ferré et al (J. Caffeine Research, 2013) (hereinafter Ferré) (IDS reference).
The teachings of Bhargava are discussed above.
Bhargava does not explicitly state wherein the composition is substantially free of caffeine.
However, Ferré teaches that paraxanthine, the main metabolite of caffeine, produces a significantly stronger locomotor activation than caffeine (abstract). Paraxanthine also has less anxiogenic activity and reduced toxicity compared to caffeine (pg. 75, column 1, paragraph 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to make a formulation substantially free of caffeine because it is known in the art that paraxanthine results in stronger locomotor activity and is less toxic as than caffeine. One of ordinary skill in the art would have been motivated to do so because paraxanthine is a major metabolite of caffeine and exhibits similar advantageous properties of caffeine without the unwanted side effects of caffeine.
Claim 11 is rejected as being unpatentable under 35 U.S.C. 103 over Bhargava (WO 2013/173265 A1, Nov. 21, 2013) (IDS reference) as applied to claims 1-4, 8-10,12,14 -19 above, in further view of Geissler (US2014/080847A1, Mar. 20, 2014).
The teachings of Bhargava are discussed above.
Bhargava do not teach the method wherein the subject experiences increased endurance or increased strength.
However, Geissler teaches a method of decreasing sense of fatigue of the mammal; improving mood of the mammal; increasing vigor of the mammal; increasing lipolysis in the mammal; increasing energy expenditure of the mammal; increasing physical endurance of the mammal; increasing strength output of the mammal (pg.3, paragraph 0019), wherein the composition comprises 1,4-DMPA in combination with a substance selected from the group consisting of caffeine (1,3,7-trimethylxanthine), theophylline, paraxanthine, phenethylamine, arginine α-ketoglutarate, rauwolscine, higenamine (also known as norcoclaurine), citicoline, yohimbine, tyrosine, n-acetyl-1-tyrosine, creatine, β-alanine, caffeic acid, and a plant extract (pg.2 paragraph 0013).
The perceived feeling of energy and mood-altering effects taught by Bhargava in combination with the benefits of paraxanthine without the unfavorable side effects of caffeine taught by Ferré would have motivated one of ordinary skill in the art to select paraxanthine and tyrosine form the composition taught by Geissler. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to select paraxanthine and tyrosine from the composition taught by Geissler to increase endurance and strength, because Bhargava teaches that a composition comprising paraxanthine and tyrosine acts synergistically to produce benefits to a consumer that exceed the benefits achieved when the ingredients are taken individually.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Bhargava (WO 2013/173265 A1, Nov. 21, 2013) as applied to claims 1-4, 8-10,12,14 -19 above in further view of Karami et al (J Food Sci Technol, Jan. 01, 2019) (hereinafter Kamari).
The teachings of Bhargava are discussed above.
Bhargava does teach wherein tyrosine is present in polymeric form and wherein the polymeric form is Dityrosine (Tyr-Tyr), Trityrosine (Tyr-Tyr-Tyr), Tetratyrosine (Tyr-Tyr- Tyr-Tyr) or a peptide containing the foregoing. Bhargava also does not teach wherein the tyrosine is present as Lysyltyrosine or Leucine-Tyrosine.
However, Karami teaches that bioactive peptide are sequences between 2 and 20 amino acids that can inhibit chronic diseases by modulating and improving physiological functions. Bioactive peptides can affect pro-health or functional properties of food products (abstract) and there is a correlation between their peptides structure and functional properties (pg. 536, left column). Karami also teaches that peptides containing two tyrosine residues had higher antioxidant activity than the corresponding peptides containing two His residues, and that a tyrosine-(histidine-leucine-arginine)-tyrosine peptide exhibited the highest antioxidant activity (pg. 538, left column).
Furthermore, bioactive peptides with various structures shows their functional activity such as: antioxidant activity, ACE inhibitor activity, hypocholesterolemic activity and also, they were found to improve water-holding capacity, foaming capacity, emulsifying properties and solubility in products in Table 1,2,3 and 4.
As discussed above, various polymeric forms of tyrosine confer different pro-health or functional properties. Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date, to select any of the desired functional properties wherein tyrosine is in its polymeric form taught by Karami and combine it with the teachings of Bhargava to arrive at the same composition in instant claims 5 and 6.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bhargava (WO 2013/173265 A1, Nov. 21, 2013) as applied to claims 1-4, 8-10,12,14 -19 above in further view of Kosegi et al. (JP-2799178-B2, Sep. 17, 1998) (hereinafter Kosegi) (IDS reference).
The teachings of Bhargava are discussed above.
Bhargava does teach wherein tyrosine is present in a dipeptide having the structure L-Tyr-X, wherein X is an amino acid.
However, Kosegi teaches that the tyrosine exhibits low solubility in compositions making it difficult to prescribe the required amount in a composition (pg. 2 paragraph 1). Kosegi also teaches that this pharmaceutical problem can be solved by using a dipeptide of Tyr (pg.2 paragraph 5). Furthermore, Kosegi teaches several preferred dipeptides containing a tyrosine residue (pg.3 paragraph 7); L-Threonyl-L-tyrosine (Thr-Tyr), L-Leucyl-L-tyrosine (Leu-Tyr), L-Isoleucyl-L-tyrosine (Ile-Tyr), L-Valyl-L-tyrosine (Val-Tyr), L-Tyrosyl-glycine (Tyr-Gly), L-Tyrosyl-L-alanine (Tyr-Ala), L-Tyrosyl-L-leucine (Tyr-Leu), L-Tyrosyl-L-isoleucine (Tyr-Ile), L-Tyrosyl-L-valine (Tyr-Val), L-Tyrosyl-L-aspartic acid (Tyr-Asp), L-Tyrosyl-L-lysine (Tyr-Lys), L-Tyrosyl-L-threonine (Tyr-Thr), L-Tyrosyl-L-glutamic acid (Tyr-Glu), L-Tyrosyl-L-glutamine (Tyr-Gln).
According to Kosegi, the issue of low solubility of tyrosine and the solution to formulate it as a dipeptide, to increase its solubility has been well known in the art. One of ordinary skill in the art would have been motivated to use tyrosine in its dipeptide form to increase its solubility in any composition containing tyrosine. Furthermore, Kosegi presents preferred dipeptides containing tyrosine residues having the structure L-Tyr-X, where in X is an amino acid. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to formulate tyrosine as a dipeptide taught by Kosegi in the composition taught by Bhargava to enable tyrosine to exert its nutritional effects.
Conclusion
Claims 1 – 19 are rejected
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALAN J FOWLER/ Examiner, Art Unit 1691
/RENEE CLAYTOR/ Supervisory Patent Examiner, Art Unit 1691
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