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 Status
Claims 15, 17-19 and 23-37 are pending.
Claims 1-14, 16 and 20-22 have been canceled.
Claims 15 and 17-19 are withdrawn.
Claims 23-37 have been added.
Claims 23-37 are currently under consideration.
Claims 23-37 are rejected.
Acknowledgement of Receipt
This Office Action is in response to the Applicants’ amendments and remarks filed 12/01/2025.
New Rejections
Applicant’s amendments have necessitated the following grounds of rejection:
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 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 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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.
Applicant Claims
A composition comprising malate, glycine, lithium, pterostilbene, fisetin, alpha-keto-glutarate, anthocyanins, and vitamin C (independent instant claim 23), further comprising glucosamine, spermidine, ginger extract, rhodiola, and hyaluronic acid, wherein the agents are formulated for delayed release and/or extended release. Applicants claim a composition comprising (i) the composition of instant claim 23 and (ii) a pharmaceutically acceptable carrier (independent instant claim 31). Applicants claim a composition comprising malate, glycine, micro-dosed lithium, pterostilbene, fisetin, alpha-ketoglutarate, vitamin C, ginger extract, Rhodiola rosea, hyaluronic acid, glucosamine, and L-theanine, further comprising certain amounts (mg) thereof (instant claim 33) and further comprising xylitol, malic acid, flavoring, silicon dioxide, calcium silicate, and rebaudioside A (instant claim 34).
Claims 23-37 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzio et al. (US 2008/0292607 A1, pub. 11/27/2008) in view of Horn et al. (US 2018/0071273 A1, pub. 03/15/2018), Andrade Nunes et al. (US 2013/0156869 A1, pub. 06/20/2013), Verburgh et al. (US 2018/0352843, pub. 12/13/2018), Prieto et al. (US 2014/0212388 A1, pub. 07/31/2014), and Fliri et al. (WO 2020/081513 A1, filed 10/16/2018) evidenced by Janssens and Houtkooper (Biogerontology, Identification of longevity compounds with minimized probabilities of side effects (2020) 21:709-719), Simonetti et al. (J. Agric. Food Chem. 2003, 51, 6618−662) and Mauer et al. (Food Research International 45 (2012) 369-380) herein referenced Mazzio, Horn, Nunes, Verburgh, Prieto, Fliri, Janssens and Houtkooper, Simonetti, and Mauer, respectively.
The applied reference, Verburgh, has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Mazzio discloses comprehensive nutraceutical formulations to mitigate the degenerative factors associated with Parkinson’s disease (abstract). Mazzio teaches that the formulations comprise anthocyanins, and are further combined with specific macro/micro nutrients, trace elements, amino acids, flavonoids and concentrated plant sources (abstract, claim 1). Mazzio teaches alpha-ketoglutarate (AKG), sodium malate (i.e., malic acid), fisetin, L-glycine ([0011], Tables 1-2 on pgs. 18, 20, 22, 24-25; claims 1, 3, 13). Mazzio teaches the inclusion of vitamin C and resveratrol (polyphenol) ([0044], [0046] see component B). It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to utilize the malate, glycine, fisetin, AKG, anthocyanins, and vitamin C taught by Mazzio with expected results. One would be motivated to do so with a reasonable expectation of success because Mazzio teaches AKG as nutraceutical agent known to block cell death (pg. 22, Table 1; claim 1).
Regarding claim 23, Mazzio does not teach lithium and pterostilbene.
Horn discloses nutritional compositions comprising a synergistic effective amount of a NAD-pre cursor and ATP booster to treat mitochondrial energy disorders diseases (abstract). Horn teaches pterostilbene ([0018], [0104], example 1, claims 11, 32) and that it is an anti-inflammatory that modulates neurological disease ([0083]). Horn also discloses AKG and glycine ([0016], claim 9). It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply the pterostilbene taught by Horn in the composition of Mazzio with expected results. One would be motivated to do so because Horn discloses that Parkinson's disease is a mitochondrial energy disease ([0025]) which is focus of Mazzio (abstract). Horn teaches and suggests that glycine, which is also taught by Mazzio ([0009]), together with pterostilbene protects mitochondria ([0018]).
Lithium is not taught by Mazzio and Horn.
Nunes discloses the use of lithium compounds in micro-doses for the treatment of Alzheimer’s disease (abstract, [0022-0025], claims 1-2, 5). Nunes conducted a study in which patients were administered lithium 0.28 mg per dose ([0065]). It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the low dose lithium of Nunes in compositions taught by Mazzio in view of Horn with expected results. One would be motivated to do so with a reasonable expectation of success because Mazzio ([0020]) and Nunes ([0017]) are directed to non-toxic (combinations) and are focused on diseases that affect neuroprotective functions.
Regarding claim 24, Mazzio, Horn, and Nunes do not teach glucosamine.
Verburgh discloses that an embodiment to slow down and mitigate ageing can comprise at least one of the protein-homeostasis-influencing saccharide-based substances: trehalose, mannitol, glucosamine and/or acetyl-glucosamine ([0030-0032], [0084], claim 2). Verburgh teaches lithium as the at least one senescence-retarding substance in the composition (claims 2-3, 10, 12). The composition can be administered or co-administered in slow release dosage forms ([0081]). It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply the glucosamine of Verburgh to the teachings of Mazzio in view of Horn, and Nunes with expected results. One would be motivated to do so with a reasonable expectation of success because Verburgh teaches that there is a synergistic effect on aging and health by combining prebiotics with substances like Krebs cycle metabolites (e.g. malate), lithium, anti-amyloidogenic substances (e.g. caffeine), glycine, gingko biloba and protein-homeostasis-influencing saccharide-based substances (e.g., trehalose, acetyl-glucosamine and/or glucosamine), or combinations thereof ([0056]).
Regarding claim 25, Mazzio, Horn, Nunes and Verburgh do not teach spermidine.
Fliri discloses novel compositions to address the root cause of inflammation (abstract). Fliri discloses compositions that down regulate excessive inflammation and support cellular and molecular functions involved in healing processes ([0018]). Fliri’s compositions consist of a first group of ingredients selected from the group that includes lithium, spermidine, and glucosamine (abstract, [0008], claim 1). Fliri also discloses pterostilbene (claim 20) fisetin, and anthocyanins ([00122]).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the spermidine of Fliri to the compositions of Mazzio in view of Horn, Nunes, and Verburgh with expected results. One would be motivated to do so with a reasonable expectation of success because Fliri teaches and suggests that spermidine is a viable component to compositions that contribute to reducing inflammation. As evidenced by Janssens and Houtkooper, spermidine, as well as glucosamine, and low dose lithium are associated with lower mortality and/or longevity (see Discussion, pg. 716).
Regarding claim 26, Mazzio discloses a formulation that includes ginger ([0052], pg. 20, Tables 1 and 2; claim 1). Verburgh discloses ginger extract ([0060]).
Regarding claim 27, Horn discloses rhodiola rosea ([0079], [0103]).
Regarding claim 28, Mazzio, Horn, Nunes, Verburgh, and Fliri do not teach hyaluronic acid (HA).
Prieto discloses compositions to provide a health supplement comprising: a silica compound, biotin, hyaluronic acid, methyl sulfonyl methane (MSM), dimethylethanolamine (DMEA), omega-3-oil and at least one additional ingredient selected from the group consisting of Gingerroot (Zingiber officinale), Vitamin C, alpha-ketoglutarate choline (abstract, [0021-0022], claims 1, 3, 17-18). Prieto provides HA as an essential ingredient ([0034]). These following components are also taught: vitamin C ([0035]), calcium as a mineral ([0036]), plant extracts ([0037]), amino acids consisting of glycine ([0040]); alpha-ketoglutarate choline ([0041]), ascorbic acid ([0042]), curcumin, reduced form of NADP (nicotinamide adenine dinucleotide phosphate), resveratrol (polyphenol) ([0043]), and as well as other components that may be included ([0035-0036]).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the HA taught by Prieto in the composition of Mazzio in view of Horn, Nunes, Verburgh, and Fliri with expected results. One would be motivated to do so with a reasonable expectation of success because Prieto teaches that HA can help with many joint disorders ([0010]).
Regarding claims 29-30 and 35-36, Horn teaches that the compositions may be formulated so that they release the active ingredient(s) only, or preferentially, in a delayed manner ([0087]).
Regarding claims 31 and 37, Mazzio teaches that the formulations may contain the active ingredients in the presence of carriers ([0053]).
Regarding claims 32-34, Horn discloses L-theanine ([0018], claim 11). Verburgh teaches micro-dosed lithium by disclosing lithium in an amount from about 1 microgram to 50 milligram per liter, per dose or per drink ([0068]) to read on the claimed 1 mg of micro-dosed lithium. MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Specifically regarding the claimed amounts (mg) in claims 33-34, Mazzio discloses a composition comprising a safe and therapeutically effective amounts (claim 1). For instance, Mazzio teaches ascorbic acid (vitamin C) at 50 mg (pg. 19, Table 1) and ginger extract at 20/100 mg (pg. 22, Table 1). Specifically with respect to lithium, Nunes teaches that lithium doses depend on factors such as patient weight and severity of the condition with suggested daily doses being between 1 mg and 2000 mg ([0014]) to read on the recited amount of 1 mg. One skilled in the art would know to optimize by routine experimentation to deliver a safe and effective amount(s) in the finished product. MPEP 2144.05 states that 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. In this case, evidence has yet to be provided to show the criticality of the claimed ranges compared to the cited prior art of record.
Regarding claim 34 (i.e., xylitol, malic acid, flavoring, rebaudioside A), Verburgh teaches xylitol ([0085]). Verburgh explains how Krebs cycle metabolites and their ionized and non-ionized forms, e.g., malate and malic acid, fumarate and fumaric acid, are interchangeable ([0086]).Mazzio teaches flavorings, sugars, alcohols, and sweeteners ([0053]). Verburgh teaches stevia as a high-potency sweetener ([0042]). As evidenced by Simonetti, stevia contains Rebaudioside A (abstract).
Regarding claim 34 (i.e., silicon dioxide, calcium silicate), Prieto teaches that silicon dioxide, i.e., silica, SiO2, stimulates cell metabolism and cell formation, prevents the aging process; is important for structure and function of connective tissues ([0009]). Prieto teaches that the composition comprises mineral consisting of calcium (claim 8). As evidenced by Mauer, silicon dioxide and calcium silicate are anticaking agents (abstract). Prieto teaches that anticaking agents are important in dry mixtures to be reconstituted ([0033]). A person of ordinary skill in the art would immediately recognize these components as anticaking agents and would have been motivated to incorporate them in the powdered compositions.
Response to Arguments
Applicants’ arguments are based on newly amended limitations which have been addressed by the new grounds of rejection above.
Applicants’ arguments have been fully considered but they are not persuasive.
Applicants argue pterostilbene is not taught by Mazzio and Nunes (Remarks, pg. 7, paragraph 4).
The Examiner respectfully asserts that Horn teaches pterostilbene.
Applicants argue as a general matter, it is in fact unreasonable to expect a combination of two or more lifespan-extending compounds to have an additive or synergistic effect, citing Phelps et al. and Admasu et al. regarding non-CR mimetic drugs (Remarks, pg. 7 last paragraph to pg. 8, paragraph 3; pg. 9, last paragraph).
In response, the Examiner respectfully submits that Applicant is required to present a comparison with the closest prior art of record. The fact that the inventor 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. Here the cited art, e.g., Mazzio and Horn, teaches compositions that are useful for the same purpose (e.g., Parkinson’s disease, mitochondrial energy diseases), in order to form a third composition which is to be used for the very same purpose. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. As such, the ordinary artisan has the normal desire to improve upon what is already generally known and would make the combination of all the claimed ingredients with a reasonable expectation of success.
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
All claims under consideration remain rejected; no claims are allowed. Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614