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
Applicants' response and amendments to the claims, filed 10/7/2025, are acknowledged and entered. Claims 3-4, 13, 20, and 26 have been cancelled by Applicant.
Claims 1-2, 6-7, 9-12, 17, 19, 23, 25, 30, and 33-34 are pending and under examination.
Claim Rejections - 35 USC § 112(b)
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 1-2, 6-7, 9-12, 17, 19, 23, 25, 30, and 33-34 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.
The temporal limitations in amended claims 1, 12, and 25, i.e., “…for at least 24 hours…” and “…for at least 6 hours…”, are unclear and ambiguous. The amended claims require that a cell is “contacted with” or “exposed to” the claimed cytoprotective composition for “at least 6 hours” or “at least 24 hours”. The only disclosure of such contacting/exposing cells to compositions of the invention in the disclosure relates solely to in vitro cell culture treatments of C2C12 and/or EOMA cells for “6-hours” or “24-hours”, i.e., cells are continuously cultured in a medium comprising a composition of the invention for 6 hours or 24 hours.
It is unclear whether the claimed “…for at least 24 hours…” and “…for at least 6 hours…” requires such continuous contact/exposure of cells or if the “at least 6 hours” and/or “at least 24 hours” can be discontinuous, e.g., exposure for 30 minutes and non-exposure for a period of time followed by exposure for 2 hours, etc.
Additionally, the claims clearly encompass contacting cells in vivo, i.e., in a subject. See Specification at [0012] (“…the contemplated composition comprising a cytoprotective formulation is administered to a subject for modulating expression or cellular activity of one or more of SIRT1, SIRT3, SIRT4, SIRT6, Nrf2, SOD3, ATG12, LCB3, NLRP3, PGC1a, NAMPT,
NMNAT, TOMM40, FOXO3/4/6, GLD-1, HSP25, SKN-1, CCL8, KLOTHO, PDK1, DRP1,
POT1, and/or DNA Methylation Epigenetic Clock”). Also see Specification at [0019] (“…the inventors contemplate a method of reducing oxidative stress in a cell of a mammal that includes a step of administering a cytoprotective composition to the mammal in an amount effective to reduce oxidative stress, wherein the cytoprotective composition includes a cytoprotective formulation comprising a combination of at least (a) a purine alkaloid, (b) an isothiocyanate or thioglucoside, and (c) a metal- containing antioxidant”). It is entirely unclear how Applicants intend to ensure that any given cell in a subject is contacted with or exposed to the claimed cytoprotective formulation “…for at least 24 hours…” or “…for at least 6 hours…” Such contacting/exposure will be completely dependent upon the individual pharmacokinetics of each recited component, e.g., absorption, distribution, metabolism, excretion (ADME). Applicants have presented no evidence that a cytoprotective formulation of the invention can be administered to a subject in a manner such that a cell of a subject is exposed to all components of the formulation “…for at least 6 hours…” or “…for at least 24 hours…”.
Claim Rejections - 35 USC § 112(a)
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 1-2, 6-7, and 9-11 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.
Amended claim 1 and claims dependent therefrom are drawn to a method for increasing cellular vitality of a cell under oxidative stress. The method comprises contacting the cell with a cytoprotective formulation, wherein the cell, when exposed to the oxidative stress and the cytoprotective formulation for at least 24 hours, has an increased viability as compared to the cell exposed to the oxidative stress alone. See Claim 1 (as amended). The amended claims clearly encompass contacting a cell under oxidative stress in a subject, e.g., a mammal. See Specification at [0019] (“…the inventors contemplate a method of reducing oxidative stress in a cell of a mammal that includes a step of administering a cytoprotective composition to the mammal in an amount effective to reduce oxidative stress, wherein the cytoprotective composition includes a cytoprotective formulation comprising a combination of at least (a) a purine alkaloid, (b) an isothiocyanate or thioglucoside, and (c) a metal- containing antioxidant”).
The originally filed disclosure does not describe, either explicitly or implicitly, exposing “a cell under oxidative stress” and the cytoprotective formulation “for at least 24 hours” as now claimed. The only disclosure of exposing a cell to oxidative stress for any time period relates specifically to in vitro “6-hour” and “24-hour” cell culture treatments of C2C12 cells with hydroxide peroxide and a cytoprotective formulation.
The now claimed “at least 24 hours” literally reads on cell exposures outside of the disclosed “6-hour” and “24-hour” cell culture treatments. The disclosure also does not disclose or describe contacting cells under oxidative stress in vivo, e.g., in a subject, for 24 hours, let alone for “at least 24 hours”. Furthermore, the only cells disclosed or described by Applicants “under oxidative stress” are C2C12 cells exposed to hydrogen peroxide, which does not provide written basis for any and all cells “under oxidative stress”.
The 6-hour and 24-hour in vitro cell culture treatments of C2C12 cells with and without hydrogen peroxide do not provide written basis for the now claimed “a cell under oxidative stress” exposed to the oxidative stress and the cytoprotective formulation “for at least 24 hours”.
Accordingly, amended claim 1 and claims dependent therefrom introduce New Matter into the claims.
Claims 12, 17, 19, and 23 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.
Amended claim 12 and claims dependent therefrom are drawn to a method increasing expression of nicotinamide phosphoribosyltransferase (NAMPT) in a cell of a mammal. The method comprises contacting the cell with a cytoprotective formulation “for at least 6 hours”. See Claim 12 (as amended). The amended claims clearly encompass administration to a subject. See Specification at [0012] (“…the contemplated composition comprising a cytoprotective formulation is administered to a subject for modulating expression or cellular activity of one or more of SIRT1, SIRT3, SIRT4, SIRT6, Nrf2, SOD3, ATG12, LCB3, NLRP3, PGC1a, NAMPT,
NMNAT, TOMM40, FOXO3/4/6, GLD-1, HSP25, SKN-1, CCL8, KLOTHO, PDK1, DRP1,
POT1, and/or DNA Methylation Epigenetic Clock”).
The originally filed disclosure does not describe, either explicitly or implicitly, contacting the cell with a cytoprotective formulation “for at least 6 hours” as now claimed. The only disclosure of contacting cells for any time period relates specifically to in vitro “6-hour” and “24-hour” cell culture treatments of C2C12 or EOMA (endothelial) cells with cytoprotective formulation.
The now claimed “at least 6 hours” literally reads on cell exposures outside of the disclosed “6-hour” cell culture treatments. The disclosure also does not disclose or describe contacting mammalian cells in vivo, e.g., in a subject, for 6 hours, let alone for “at least 6 hours”.
The 6-hour and 24-hour in vitro cell culture treatments of C2C12 and/or EOMA cells with and without hydrogen peroxide do not provide written basis for the now claimed “in a cell of a mammal” contacted with the cytoprotective formulation “for at least 6 hours”.
Accordingly, amended claim 12 and claims dependent therefrom introduce New Matter into the claims.
Claims 25, 30, and 33-34 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.
Amended claim 25 and claims dependent therefrom are drawn to a method increasing expression of PGC-1a) in a cell of a mammal. The method comprises contacting the cell with a cytoprotective composition “for at least 6 hours”. See Claim 25 (as amended). The amended claims clearly encompass administration to a subject. See Specification at [0012] (“…the contemplated composition comprising a cytoprotective formulation is administered to a subject for modulating expression or cellular activity of one or more of SIRT1, SIRT3, SIRT4, SIRT6, Nrf2, SOD3, ATG12, LCB3, NLRP3, PGC1a, NAMPT, NMNAT, TOMM40, FOXO3/4/6, GLD-1, HSP25, SKN-1, CCL8, KLOTHO, PDK1, DRP1, POT1, and/or DNA Methylation Epigenetic Clock”).
The originally filed disclosure does not describe, either explicitly or implicitly, contacting the cell with a cytoprotective composition “for at least 6 hours” as now claimed. The only disclosure of contacting cells for any time period relates specifically to in vitro “6-hour” and “24-hour” cell culture treatments of C2C12 or EOMA (endothelial) cells with a cytoprotective formulation.
The now claimed “at least 6 hours” literally reads on cell exposures outside of the disclosed “6-hour” cell culture treatments. The disclosure also does not disclose or describe contacting mammalian cells in vivo, e.g., in a subject, for 6 hours, let alone for “at least 6 hours”.
The 6-hour and 24-hour in vitro cell culture treatments of C2C12 and/or EOMA cells with and without hydrogen peroxide do not provide written basis for the now claimed “in a cell of a mammal” contacted with the cytoprotective formulation “for at least 6 hours”.
Accordingly, amended claim 25 and claims dependent therefrom introduce New Matter into the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6-7, 9, 12, 17, 19, 23, 25, 30, and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NAD(3) NAD+ Booster® (2018) (Cited in IDS filed 01/30/2025).
NAD(3) NAD+ Booster® teaches capsules comprising 810 mcg niacin (from Copper Nicotinic Acid), 192 mcg copper (from Copper Nicotinic Acid), and 312 mg of “NAD3” comprising Wasabia japonica1, theacrine, and copper nicotinic acid. The capsules are formulated for oral administration (capsules) and comprise a nutritionally or pharmaceutically acceptable carrier (microcrystalline cellulose and Hypromellose). NAD(3) NAD+ Booster® teaches to take 2 capsules daily upon waking.
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NAD(3) NAD+ Booster® teaches that the supplement activates sirtuins and influences NLRP3 gene expression.
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While NAD(3) NAD+ Booster® does not expressly teach that administering the supplement daily increases viability of cells exposed to oxidative stress, increases the expression of NAMPT in cells, and increases expression of PGC-1a in cells (claims 1, 12, and 25), a composition and its biological properties are not separable. Applicants teach administering 312 mg of NAD3™ to subjects (men and women), which is the same dose of NAD3 taught in NAD(3) NAD+ Booster® ([00180]-[00181]). Applicants teach blood samples are assayed at for levels of the claimed plasma senescence markers and ageing markers ([00183]). They further demonstrate that contacting cells in vitro with a composition comprising the same active agents taught in NAD(3) NAD+ Booster® increases viability of cells exposed to oxidative stress, increases the expression of NAMPT in cells, and increases expression of PGC-1a in the cells. Accordingly, as NAD(3) NAD+ Booster® teaches the same composition claimed and teaches administering the same amount of the composition disclosed by Applicants, increasing viability of cells exposed to oxidative stress, increasing the expression of NAMPT in cells, and increasing expression of PGC-1a in cells would be natural, inherent biological results of such administration. Thus, since the dosage amount of NAD3 as taught by NAD(3) NAD+ Booster® is the same dosage amount taught in the disclosure and comprises the same active ingredients, it would naturally follow that the NAD3 is administered in an amount effective to elicit the claimed biological results. Put another way, Applicants are not entitled to patent the same commercially available supplement taught in NAD(3) NAD+ Booster® simply by reciting biological effects naturally elicited by its administration to subjects.
Response to Arguments
Applicants argue that the limitations recited in the amended claims are not taught or suggested by the cited reference and that these properties do not necessarily flow from the cited references. In other words, Applicants argue, the art of record fails to provide factual basis to substantiate inherency.
In response, NAD(3) NAD+ Booster is the same “cytoprotective formulation” as that which is claimed. See Specification at [00180] (“Study of NAD3™ and NAD3™ + Tributyrin in subjects…” In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990) (“Products of identical chemical composition cannot have mutually exclusive properties.”). In the present case, the claimed invention recites latent properties of administering NAD(3) NAD+ Booster to a subject which appear to be inherent in the NAD(3) NAD+ Booster preparation known from NAD(3) NAD+ Booster.
Applicant’s purported discovery that administering NAD(3) NAD+ Booster to a subject increases viability of cells exposed to oxidative stress, increases the expression of NAMPT in cells, and increases expression of PGC-1a in cells does not render the method taught by the combined teachings of the cited prior art patentable. It is simply the discovery of a previously unappreciated properties of the prior art composition. Since NAD(3) NAD+ Booster has the same chemical composition and arrangement of elements as the cytoprotective formulation recited in the instant claims, the NAD(3) NAD+ Booster inherently has the claimed biological effects in cells when administered to a subject identified by Applicant when administered according to the method suggested by the combined teachings of the cited prior art. As NAD(3) NAD+ Booster teaches administering NAD(3) NAD+ Booster daily (“[t]ake 2 capsules daily upon waking…”), it logically follows that cells in a subject administered NAD(3) NAD+ Booster will be exposed to/contacted with the composition for “at least 6 hours” or “at least 24 hours” over a number of days of daily administration.
“From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (C.C.P.A. 1963). Moreover:
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.… Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (C.C.P.A. 1977).
In this case, because the dosage amount of NAD3 as taught by NAD(3) NAD+ Booster® is the same dosage amount taught in the disclosure and comprises the same active ingredients and is taught to be administered daily, the burden is on Applicants to prove that daily administration of 2 capsules of NAD(3) NAD+ Booster® to a subject does not elicit the claimed biological effects in cells of the subject.
Indeed, as discussed above the Specification itself demonstrates that contacting cells with a formulation comprising the same ingredients as NAD(3) NAD+ Booster® inherently increases viability of cells exposed to oxidative stress, increases the expression of NAMPT in cells, and increases expression of PGC-1a in cells. See Hospira, Inc. v. Fresenius Kabi, 946 F.3d 1322, 1329–30 (Fed. Cir. 2020) (“[T]he work of the inventor or the patentee can be used as the evidence of inherency.”); Par Pharm. Inc. v. TWI Pharms. Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (noting that “the patent itself” may “define[] the limitation at issue as a property that is necessarily present”) (citation omitted).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2, 6-7, 9-12, 17, 19, 23, 25, 30, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over LOPEZ ET AL. (US 2015/0132280 A1) (Cited in IDS filed 03/21/2023), IBRAHEIM (US 2011/0274773 A1) (Cited in IDS filed 03/21/2023), and NAD(3) NAD+ Booster® (2018) (Cited in IDS filed 01/30/2025).
LOPEZ teaches ([0009] and [0003]) a chemical composition comprising theacrine [a purine alkaloid as recited in claim 1 and expressly recited in claim 6]. Lopez teaches (claim 4 and [0070)) that its theacrine-containing composition further comprises a pharmaceutically acceptable carrier and that the composition can be administered by any route including orally. Lopez further teaches ([0009]) that the primary object of its invention is to provide a chemical composition comprising theacrine and optionally other compounds to provide a plurality of desirable effects and that the presence of the other compounds modulate the wide variety of effects of theacrine. With respect to the claimed isothiocyanate, after stating several times ([0004], [0010], [0013], and [0038]) that theacrine has beneficial qualities such as serving as an effective anti-inflammatory, Lopez teaches ([0041]) that theacrine may be combined with one or more of compounds listed in the paragraph including anti-inflammatory agents and further teaches ((0043]) that its theacrine may be combined with one or more of extracts listed in the paragraph. In this regard, Lopez lists only 15 different kinds of extracts in the paragraph, including Wasabia japonica2, for enhancing pain modulation and controlling inflammatory response. Thus, according to Lopez’s teaching, it would have been obvious to one skilled in the art to combine theacrine together with a Wasabia japonica extract (as an anti-inflammatory agent) with a reasonable expectation of obtaining enhanced pain modulation and controlled inflammatory response so as to achieve a theacrine composition serving as an effective anti-inflammatory.
Although Lopez does not teach the use of the claimed metal-containing antioxidant, e.g., a copper(I) nicotinate complex, Lopez teaches (Abstract, [0015], [0031], [0039], [0063], [0065]-[0067], claim 10, and claim 12) that uses for its theacrine-containing composition include reduction of fatigue and furthermore teaches ([0046]) that its theacrine may be combined with an anti- fatigue ingredient. As evidenced by IBRAHEIM, an effective amount of copper (I) nicotinate complex is known to ameliorate fatigue. Ibraheim teaches ([0007] and [0017]) using copper(I) nicotinate complex for promoting anti-fatigue and ameliorating infertility and muscle weakness. Ibraheim also teaches ([0020]) that its copper(l) nicotinate complex can be formulated in combination with other anti-inflammatory medicaments, and Lopez teaches that theacrine combined with Wasabia japonica extract controls the inflammatory response (which means that theacrine combined with Wasabia japonica extract work together as an anti-inflammatory medicament). Because Lopez teaches (throughout the reference) that its theacrine-containing composition is used to reduce fatigue and that the theacrine may be combined with an anti-fatigue ingredient, it would have been obvious to one skilled in the art to use copper(I) nicotinate complex in Lopez's composition (already containing theacrine and Wasabia japonica extract) with a reasonable expectation of achieving a theacrine composition, which not only serves as an effective anti-inflammatory (due to the combination of theacrine and Wasabia japonica extract) but also has a positive effect on fatigue (due to the combination of theacrine and copper (I) nicotinate complex). In this regard, Lopez clearly teaches ([0030]) that theacrine may be combined with other chemical compounds to provide a plurality of positive effects on a human and that the compositions may provide multiple benefits (e.g., serving as an effective anti-inflammatory as well as improving fatigue) simultaneously (see also [0052] where Lopez clearly teaches that its invention may be used for the treatment of a variety of conditions)). Thus, Lopez in view of Ibraheim renders prima facie obvious a composition comprising theacrine, Wasabia extract (containing an isothiocyanate), and copper (I) nicotinate complex as recited in claims 1 and 6-7. Regarding claims 10-11, which require the composition further comprises a SIRT enhancing agent, LOPEZ teaches ([0049] and claim 3) that its theacrine-based composition can include catechins (claimed SIRT enhancing agent recited in claim 11). Thus, Lopez and Ibraheim render obvious instant claims 10-11.
NAD(3) NAD+ Booster® teaches capsules comprising 810 mcg niacin (from Copper Nicotinic Acid), 192 mcg copper (from Copper Nicotinic Acid), and 312 mg of “NAD3” comprising Wasabia japonica3, theacrine, and copper nicotinic acid. The capsules are formulated for oral administration (capsules) and comprise a nutritionally or pharmaceutically acceptable carrier (microcrystalline cellulose and Hypromellose). NAD(3) NAD+ Booster® teaches to take 2 capsules daily.
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While NAD(3) NAD+ Booster® does not expressly teach that administering the supplement daily increases viability of cells exposed to oxidative stress, increases the expression of NAMPT in cells, and increases expression of PGC-1a in cells (claims 1, 12, and 25), a composition and its biological properties are not separable. Applicants teach administering 312 mg of NAD3™ to subjects (men and women), which is the same dose of NAD3 taught in NAD(3) NAD+ Booster® ([00180]-[00181]). Applicants teach blood samples are assayed at for levels of the claimed plasma senescence markers and ageing markers ([00183]). They further demonstrate that contacting cells in vitro with a composition comprising the same active agents taught in NAD(3) NAD+ Booster® increases viability of cells exposed to oxidative stress, increases the expression of NAMPT in cells, and increases expression of PGC-1a in the cells. Accordingly, as NAD(3) NAD+ Booster® teaches the same composition claimed and teaches administering the same amount of the composition disclosed by Applicants, increasing viability of cells exposed to oxidative stress, increasing the expression of NAMPT in cells, and increasing expression of PGC-1a in cells would be natural, inherent biological results of such administration. Thus, since the dosage amount of NAD3 as taught by NAD(3) NAD+ Booster® is the same dosage amount taught in the disclosure and comprises the same active ingredients, it would naturally follow that the NAD3 is administered in an amount effective to elicit the claimed biological results. Put another way, Applicants are not entitled to patent the same commercially available supplement taught in NAD(3) NAD+ Booster® simply by reciting biological effects naturally elicited by its administration to subjects.
Response to Arguments
Applicants argue that the limitations recited in the amended claims are not taught or suggested by the cited references.
In response, NAD(3) NAD+ Booster is the same “cytoprotective formulation” as that which is claimed. See Specification at [00180] (“Study of NAD3™ and NAD3™ + Tributyrin in subjects…” In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990) (“Products of identical chemical composition cannot have mutually exclusive properties.”). In the present case, the claimed invention recites latent properties of administering NAD(3) NAD+ Booster to a subject which appear to be inherent in the NAD(3) NAD+ Booster preparation known from NAD(3) NAD+ Booster.
Applicant’s purported discovery that administering NAD(3) NAD+ Booster to a subject increases viability of cells exposed to oxidative stress, increases the expression of NAMPT in cells, and increases expression of PGC-1a in cells does not render the method taught by the combined teachings of the cited prior art patentable. It is simply the discovery of a previously unappreciated properties of the prior art composition. Since NAD(3) NAD+ Booster has the same chemical composition and arrangement of elements as the cytoprotective formulation recited in the instant claims, the NAD(3) NAD+ Booster inherently has the claimed biological effects in cells when administered to a subject identified by Applicant when administered according to the method suggested by the combined teachings of the cited prior art. As NAD(3) NAD+ Booster teaches administering NAD(3) NAD+ Booster daily (“[t]ake 2 capsules daily upon waking…”), it logically follows that cells in a subject administered NAD(3) NAD+ Booster will be exposed to/contacted with the composition for “at least 6 hours” or “at least 24 hours” over a number of days of daily administration.
“From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (C.C.P.A. 1963). Moreover:
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.… Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (C.C.P.A. 1977).
In this case, because the dosage amount of NAD3 as taught by NAD(3) NAD+ Booster® is the same dosage amount taught in the disclosure and comprises the same active ingredients and is taught to be administered daily, the burden is on Applicants to prove that daily administration of 2 capsules of NAD(3) NAD+ Booster® to a subject does not elicit the claimed biological effects in cells of the subject.
Indeed, as discussed above the Specification itself demonstrates that contacting cells with a formulation comprising the same ingredients as NAD(3) NAD+ Booster® inherently increases viability of cells exposed to oxidative stress, increases the expression of NAMPT in cells, and increases expression of PGC-1a in cells. See Hospira, Inc. v. Fresenius Kabi, 946 F.3d 1322, 1329–30 (Fed. Cir. 2020) (“[T]he work of the inventor or the patentee can be used as the evidence of inherency.”); Par Pharm. Inc. v. TWI Pharms. Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (noting that “the patent itself” may “define[] the limitation at issue as a property that is necessarily present”) (citation omitted).
Conclusion
Claims 1-2, 6-7, 9-12, 17, 19, 23, 25, 30, and 33-34 are 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 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.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 7:30 am - 4:00 pm PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
500 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038
1 Wasabia japonica is synonymous with Eutrema japonicum as recited in claim 6. See HAGA ET AL. (2019) (“Wasabi (Japanese horseradish: Eutrema japonicum (Miq.) Koidz., syn. Wasabia japonica (Miq.) Matsum.)…”) cited in IDS filed 07/05/2022.
2 Wasabia japonica is synonymous with Eutrema japonicum as recited in claim 6. See HAGA ET AL. (2019) (“Wasabi (Japanese horseradish: Eutrema japonicum (Miq.) Koidz., syn. Wasabia japonica (Miq.) Matsum.)…”) cited in IDS filed 07/05/2022.
3 Wasabia japonica is synonymous with Eutrema japonicum as recited in claim 6. See HAGA ET AL. (2019) (“Wasabi (Japanese horseradish: Eutrema japonicum (Miq.) Koidz., syn. Wasabia japonica (Miq.) Matsum.)…”) cited in IDS filed 07/05/2022.