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 .
It is to be noted that the effective filing date of present application is still not May 17, 2019 (filing date of provisional application 62/849,758) nor November 20 2018 (filing date of provisional application 62/769,979), but December 17, 2019 for the following reason: In the last Office Action, the Examiner informed applicant that neither of the provisional applications provides support for the (at that time) newly added limitation of instant claim 1, “wherein the theacrine, the wasabi extract, and the copper-(I)-nicotinate complex are present in the combination at a weight ratio of about 125 (theacrine) : 185 (wasabi extract) : 1 (copper-(I)-nicotinate complex); and wherein the formulation is effective at the weight ratio to upregulate gene expression of SIRT1 and NAMPT in cells exposed to the formulation.” In their response to the last Office Action, applicant deleted the first wherein clause from instant claim 1. However, applicant did not delete the second wherein clause as to the dosage unit of the formulation being effective to upregulate gene expression of “NAMPT” (such limitation is not supported in either of the provisional applications). Therefore, currently, the effective filing date of present application is December 17, 2019. Thus, instant 103 rejections over NAD(3) NAD+BoosterTR (Year:2018) in view of Nogueiras et al (Physiol Rev. vol.92(3) (July 2012), pg.1479-1514) still stand (see Paragraphs 8-10 below) – however, these 103 rejections will be withdrawn if applicant delete “NAMPT” in instant claim 1.
Even though applicant deleted the wherein clause about the weight ratio of about 125 (theacrine): 185 (wasabi extract):1 (copper (I) nicotinate complex), previous 103 rejections over Lopez et al (US 2015/0132280 A1) in view of Hussein Aly Ibraheim (US 2011/0274773 A1) and “Wasabi in a pill”, World of Wasabi (an internet article published on February 17, 2011) will not be reinstated due to the newly added limitation as to the amount of (b) wasabi extract which is required to be in a range of 20-400 mg. Lopez in view of Hussein Aly Ibraheim and “Wasabi in a pill” (an internet article) does not teach or suggest such amount for the wasabi extract (the amount taught by the prior art, “Wasabi in a pill”, is 750 mg).
In view of applicant’s amendment, previous 112(a) rejection on claims 1, 2, 5, 7-17 and 26 is hereby withdrawn.
Applicant canceled claim 27, which was previously rejected under 35 U.S.C. 112(d).
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.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 5, 7, 12, 13 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over "NAD(3) NAD+BoosterTR” – images of a product advertisement webpage obtained from https://hpnsupplements.com/products/nad3-30?srsltid=AfmBOoqvhKwGW14VG-EJx3lqQwdRh2t1b8o0Fj8ofU_-caRZ90417XBge (Year:2018) (cited in IDS filed on December 16, 2024) in view of Nogueiras et al (“SIRTUIN 1 AND SIRTUIN 3: PHYSIOLOGICAL MODULATORS OF METABOLISM”, Physiol Rev. vol.92(3) (July 2012), pg.1479-1514) (with (i) Claudio et al (US 2010/0062435 A1), which is being cited here merely to support the Examiner’s assertion that increased life span of cells and increased telomerase activity are concomitant; (ii) Lopez et al (US 2015/0132280 A1), which is being cited here merely to support the Examiner’s assertion that theacrine is only found in a few varieties of tea, such as kucha tea, genus Camellia; and (iii) a Wikipedia webpage https://en.wikipedia.org/wiki/Wasabi, which is cited here merely to support the Examiner’s assertion that Wasabia japonica contains allyl isothiocyanate).
The product advertisement for NAD(3) NAD+BoosterTR (referred as “NAD(3)” hereinafter) teaches (see 2nd and 3rd pages of the reference) that its supplement product activates key sirtuin levels including SIRT1 and that 2 capsules (for oral administration) of the supplement product contain 312 mg of NAD3 formula, which is a combination of theacrine, Wasabia japonica (instant wasabi extract) and copper nicotinic acid (instant copper(I) nicotinate complex) (the 7th page of the advertisement shows that the capsules also contain other ingredients, which are microcrystalline cellulose and Hypromellose (instant nutritionally or pharmaceutically acceptable carriers)).
As to the newly added limitation “wherein a dosage unit of the formulation has the theacrine present in an amount of between 20-200 mg, the wasabi extract present in an amount of between 20-400 mg, and the copper-(I)-nicotinate complex present in an amount of between 1-20 mg”, the reference teaches that its supplement product contains 312 mg of the combination of theacrine, Wasabia japonica and copper nicotinic acid and further teaches that in the supplement product, niacin (from copper nicotinic acid) is present in the amount of 810 mcg and copper (from copper nicotinic acid) is present in the amount of 192 mcg. This means that the amount for the copper nicotinic acid would be 1,002 mcg, which is 1.002 mg. Such amount falls within instant range 1-20 mg for the amount of copper (I) nicotinate complex and thus teaches instant range. Although the prior art does not give individual amounts for the theacrine or Wasabia japonica, under the prior art’s teachings that (i) the total amounts for the theacrine, Wasabia japonica and copper nicotinic acid is 312 mg, (ii) the amount for the copper nicotinic acid is 1.002 mg, and that (iii) its supplemental product is used to activate SIRT1 level (i.e., upregulate gene expression of SIRT1), instant ranges for the amount of theacrine and wasabi extract would have been obvious to one skilled in the art since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, it is the Examiner’s position that such discovered optimum amounts for the theacrine and wasabi extract (along with 1.002 mg of copper nicotinic acid) would also result in the upregulation of gene expression of NAMPT because as evidenced by Nogueiras (see pg.7, last three lines in 4th paragraph under “A. Cellular Energy: NAD+/NADH Ratios and the NAD+ Salvage Pathway”), NAMPT and SIRT1 are known to be directly correlated. Also, once the gene expressions of SIRT1 and NAMPT are upregulated, it would naturally reduce cellular aging, improve cellular stress resilience and/or increase longevity in cells exposed to the formulation (besides the prior art NAD(3) teaches (see the 2nd page) that its product increases telomere production for DNA, and this means increased life span (i.e., increased longevity) since increased life span of cells and increased telomerase activity are concomitant, as evidenced by Claudio et al ([0014]).
Thus, NAD(3) in view of Nogueiras renders obvious instant claims 1 and 26.
With respect to instant claim 2, as evidenced by Lopez et al ([0003]), theacrine is only found in a few varieties of tea, such as kucha tea, genus Camellia. Thus, it would be obvious to one skilled in the art to provide theacrine as a Camellia sp. extract with a reasonable expectation of success. Thus, NAD(3) in view of Nogueiras renders obvious instant claim 2.
With respect to instant claim 5, as evidenced by the Wikipedia webpage https://en.wikipedia.org/wiki/Wasabi, Wasabia japonica contains allyl isothiocyanate. Thus, NAD(3) in view of Nogueiras renders obvious instant claim 5.
With respect to instant claims 7, 12 and 13, NAD(3) indicates (see 3rd page) that the supplement contains 810 mcg of niacin (instant NAD enhancing agent of claim 13). Thus, NAD(3) in view of Nogueiras renders obvious instant claims 7, 12 and 13.
Claim(s) 7, 10, 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over "NAD(3) NAD+BoosterTR” – images of a product advertisement webpage obtained from https://hpnsupplements.com/products/nad3-30?srsltid=AfmBOoqvhKwGW14VG-EJx3lqQwdRh2t1b8o0Fj8ofU_-caRZ90417XBge (Year:2018) (cited in IDS filed on December 16, 2024) in view of Nogueiras et al (“SIRTUIN 1 AND SIRTUIN 3: PHYSIOLOGICAL MODULATORS OF METABOLISM”, Physiol Rev. vol.92(3) (July 2012), pg.1479-1514), as applied to claim 1 above, and further in view of Lopez et al (US 2015/0132280 A1).
NAD(3) in view of Nogueiras does not teach the use of instant SIRT enhancing agent. Lopez, a reference which teaches (abstract, [0043]) a theacrine-based dietary supplement comprising theacrine and optionally other compounds (including extracts, such as Wasabia japonica), teaches (claims 1-3) that a theacrine-based dietary supplement may further comprise at least one additional active ingredient such as catechins: Lopez teaches ([0004]-[0005]) that theacrine has beneficial qualities such as serving as an effective antioxidant, anti-inflammatory and may have anti-obesity properties and teaches that such beneficial effects may be at least partially attributable to an assortment of purine alkaloids (including theacrine) and phenolic compounds such as catechins. It would have been obvious to one skilled in the art to further add catechins (instant SIRT enhancing agent of claim 11 as well as instant polyphenol of claim 16) in the supplement product of NAD(3) with a reasonable expectation of further achieving antioxidant, anti-inflammatory and anti-obesity effects for the supplement product of NAD(3), as taught by Lopez. Thus, NAD(3) in view of Nogueiras, and further in view of Lopez renders obvious instant claims 7, 10, 11 and 16.
Claim(s) 7 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over "NAD(3) NAD+BoosterTR” – images of a product advertisement webpage obtained from https://hpnsupplements.com/products/nad3-30?srsltid=AfmBOoqvhKwGW14VG-EJx3lqQwdRh2t1b8o0Fj8ofU_-caRZ90417XBge (Year:2018) (cited in IDS filed on December 16, 2024) in view of Nogueiras et al (“SIRTUIN 1 AND SIRTUIN 3: PHYSIOLOGICAL MODULATORS OF METABOLISM”, Physiol Rev. vol.92(3) (July 2012), pg.1479-1514), as applied to claim 1 above, and further in view of Wu et al (“The effect of selenium, as selenomethionine, on genome stability and cytotoxicity in human lymphocytes measured using the cytokinesis-block micronucleus cytome assay”, Mutagenesis, vol.24(3) (2009), pg.225-232).
NAD(3) in view of Nogueiras does not teach adding instant selenium to the supplemental product. However, as evidenced by Wu et al (pg.229, right-hand column, last paragraph), selenium (as sodium selenite) is known to increase telomerase activity and extended telomere length in human. Since NAD(3) indicates (see 2nd page) that its supplement product also aims to increases telomere production for DNA, it would have been obvious to one skilled in the art to further include selenium in the supplemental product of NAD(3) with a reasonable expectation of further increasing telomerase activity and extending telomere length. Thus, NAD(3) in view of Nogueiras, and further in view of Wu renders obvious instant claims 7 and 15-17 (instant claim 17 does not require the presence of the polyphenol. It only requires that if the one or more additional nutritional ingredients include a polyphenol, the polyphenol has to be grape seed extract).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5, 7, 10-13, 16 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 19 of copending Application No. 17/790,905 in view of Nogueiras et al “SIRTUIN 1 AND SIRTUIN 3: PHYSIOLOGICAL MODULATORS OF METABOLISM”, Physiol Rev. vol.92(3) (July 2012), pg.1479-1514 and Lopez et al (US 2015/0132280 A1).
Claim 12 of App.’023 teaches the following:
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Furthermore, claim 19 of App.’023 teaches that the cytoprotective formulation of claim 12 comprises about 60-1,500 mg of a mixture comprising theacrine (as the purine alkaloid), cuprous niacin (instant copper(I) nicotinate complex) (as the metal-containing antioxidant) and Wasabia japonica (instant wasabi extract) (as the source of isothiocyanate). Even though claims of App.’023 do not explicitly teach individual amounts for theacrine, cuprous niacin and Wasabia japonica, since claims 12 and 19 of App.’023 teach that the cytoprotective formulation comprising about 60-1,500 mg for the combination of theacrine, cuprous niacin and Wasabia japonica, which is being used for increasing the expression of NAMPT in the cell of a mammal, instant ranges for the amounts of theacrine, cuprous niacin (instant copper(I) nicotinate complex) and Wasabia japonica (instant wasabi extract) would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra. Furthermore, such discovered optimum ranges for the amounts of theacrine, cuprous niacin and Wasabia japonica that would result in the increased expression of NAMPT would also result in the increased expression of SIRT1 because as evidenced by Nogueiras et al (see pg.7, 4th paragraph under “A. Cellular Energy: NAD+/NADH Ratios and the NAD+ Salvage Pathway”), NAMPT and SIRT1 are known to be directly correlated. With respect to instant limitation “wherein the cytoprotective formulation is formulated for oral administration with a nutritionally or pharmaceutically acceptable carrier, or for topical administration”, even though claim 12 of App.’905 teaches a step of contacting the cell (of a mammal) with the cytoprotective composition for at least 6 hours in an amount effective to increase the expression of NAMPT in the cell of the mammal, claims 12 and 19 of App.’905 do not explicitly teach whether such contacting step comprises an oral administration or a topical administration. Lopez et al, a reference which teaches (abstract, [0043]) a theacrine-based dietary supplement comprising theacrine and optionally other compounds (including extracts such as Wasabia japonica), teaches (claims 4-6 and [0071]-[0072], claim 4) that such supplement may further comprise a nutraceutically or a pharmaceutically acceptable carrier and may be administered orally or topically. It would be obvious to one skilled in the art to formulate the cytoprotective formulation of claims 12 and 19 of App.’905 together with a nutritionally or pharmaceutically acceptable carrier in a solid oral dosage form or a topical form for administration with a reasonable expectation of success.
Thus, as explained above, claims 12 and 19 of App.’905 in view of Nogueiras and Lopez teach a cytoprotective formulation as described in instant claim 1, and therefore, such cytoprotective formulation would naturally be capable of reducing cellular ageing, improving cellular stress resilience and/or increasing longevity as recited in claim 1. Thus, claims 12 and 19 of App.’905 in view of Nogueiras and Lopez render obvious instant claims 1, 5 and 26.
With respect to instant claim 2, as evidenced by Lopez ([0003]) theacrine is only found in a few varieties of tea, such as kucha tea, genus Camellia. Thus, it would be obvious to one skilled in the art to provide theacrine as a Camellia sp. extract with a reasonable expectation of success. Thus, claims 12 and 19 of App.’905 in view of Nogueiras and Lopez render obvious instant claim 2.
With respect to instant claims 7, 10, 11 and 16, although claims 12 and 19 of App.’905 do not teach that their cytoprotective formulation comprising theacrine (purine alkaloid) further comprises one or more additional nutritional ingredients, Lopez teaches (claims 1-3) that a theacrine-based dietary supplement may further comprise at least one additional active ingredient such as catechins: Lopez teaches ([0004]-[0005]) that theacrine has beneficial qualities such as serving as an effective antioxidant, anti-inflammatory and may have anti-obesity properties and teaches that such beneficial effects may be at least partially attributable to an assortment of purine alkaloids (including theacrine) and phenolic compounds such as catechins. Thus, it would be obvious to one skilled in the art to further include catechins (instant SIRT enhancing agent of claim 11 and instant polyphenol of claim 16) in the cytoprotective formulation of claims 12 and 19 of App.’905 with a reasonable expectation of achieving antioxidant, anti-inflammatory and anti-obesity effects, as taught by Lopez. Thus, claims 12 and 19 of App.’905 in view of Nogueiras and Lopez render obvious instant claims 7, 10, 11 and 16. With respect to instant claims 12 and 13, since claim 19 of App.’023 teaches that the cytoprotective formulation of claim 12 comprises cuprous niacin, which is a source of niacin, claims 12 and 19 of App.’905 in view of Nogueiras and Lopez renders obvious instant claims 12 and 13 as well.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 8, 9 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. NAD(3) NAD+BoosterTR in view of Nogueiras (and further in view of the other cited prior arts) does not teach or suggest ketogenic compound(s) of instant claims 8 and 9 or tributyrin of instant claim 14.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
May 30, 2026
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