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(s) 1-5 and 7-19 are pending.
Election/Restrictions
Applicants’ election without traverse of group I, claim(s) 1-5 and 7-14 and the election of species for claim(s) 1, 15 and 19 (Mangifera indica) in the reply filed on March 25, 2026 is acknowledged. In addition, the election of species will be applied to the rest of the claims.
Claim(s) 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1-5 and 7-14 are examined on the merits.
Withdrawn Objections
Applicants’ arguments filed July 10, 2026 have been fully considered. In regard to the objection of claim 11, applicant has amended the claim as appropriate and therefore, the objection of claim 11 has been withdrawn.
Withdrawn Rejections
Applicants’ arguments filed July 10, 2026 have been fully considered.
In regard to the rejection under 35 U.S.C. § 112(a) for enablement, applicant has amended claim(s) 1-5 and 7-14 to overcome the rejection. Thus, the rejection of claim(s) 1-5 and 7-14 under 35 U.S.C. § 112(a) have been withdrawn.
In regard to the rejections under 35 U.S.C. § 112(b) for indefiniteness, applicant has amended claim(s) 4, 8 and 11-14 to overcome the rejections. Thus, the rejections of claim(s) 4, 8 and 11-14 under 35 U.S.C. § 112(b) have been withdrawn.
In regard to the rejection under 35 U.S.C. § 112(d) for an improper dependent, applicant has amended claim(s) 10, 11 and 13 to overcome the rejection. Thus, the rejection of claim(s) 10, 11 and 13 under 35 U.S.C. § 112(d) have been withdrawn.
Pending Rejection(s):
Claim Rejections - 35 USC § 112
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.
Claim(s) 1-5 and 7-14 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 1 is indefinite because it is unclear what “conditions associated with” means. The specification does not specifically list a complete list of the conditions that would be associated with aging or age-related decline in NAD levels. In addition, it is unclear what "age-related decline in NAD levels" means; it is unclear if the applicant means that a decrease or increase in NAD levels contributes to an age-related decline. Moreover, it is unclear what "age-related decline" means; it is unclear if the applicant means that as the subject gets older, that would contribute to the development of a disease or illnesses or condition that is dependent on high NAD levels or if there would be a decline in NAD levels as a subject ages, that would contribute to the development of a disease or illness or condition. Thus, the metes and bounds of the claim are unclear.
Claim 9 is indefinite because it is unclear what "phytochemical reference marker", "phytochemical marker compound" or "pharmacologically active marker" means; the specification does not list the exact meaning of the phrases. Thus, the metes and bounds of the claim are unclear.
Response to Arguments
Applicants’ arguments filed July 10, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. § 112(b) for indefiniteness are found to be non-persuasive.
Regarding the 35 U.S.C. § 112(b) rejection for indefiniteness, examiner will acknowledge on the record that the non-final rejection sent out on May 01, 2026 had a typo error marking claim 2 as indefinite when the indefiniteness rejection was for claim 1. Beginning on page 10 of applicant arguments, applicant states that the examiner should reference par. 0016 and 0002 of the specification for support and that “applicant respectfully asserts that an ordinarily skilled artisan would clearly interpret that an “age-related decline in NAD levels” refers to the phenomenon of NAD levels decreasing within a subject as the subject ages”. In par. 0015 of the published application, the conditions listed are non-limiting and are not a complete list of the conditions that would be associated with aging or age-related decline in NAD levels in regard to the indefiniteness rejection of claim 1 for “conditions associated with”. In terms of "age-related decline in NAD levels" and "age-related decline", applicant refers to par. 0002 of the published application which still does not rectify the issue stated in the 112(b) rejection above.
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.
Claim(s) 1-5 and 7-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising a Punica granatum extract, optionally containing a Punica granatum seed extract and at least one additional ingredient selected from the extract, fraction, phytochemical or mixtures thereof derived from Mangifera indica encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes. The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature.
In this case, applicant's claims recite a Punica granatum extract, optionally containing a Punica granatum seed extract and at least one additional ingredient selected from the extract, fraction, phytochemical or mixtures thereof derived from Mangifera indica. In addition, applicants’ claims further recite the combination of a Punica granatum extract, optionally containing a Punica granatum seed extract and at least one additional ingredient selected from the extract, fraction, phytochemical or mixtures thereof derived from Mangifera indica and a metal selected from magnesium, calcium and potassium. Punica granatum and Mangifera indica are naturally occurring plants and the metals (e.g. magnesium, potassium and calcium are naturally occurring compounds). Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception... " To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties…"
In this case, extraction of plants only concentrates and portions the naturally occurring compounds in the plants; substances which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally- found in the plant material; i.e., the compound is not inventive or "man-made." Thus, each of the extracts in turn is a mixture of the naturally occurring compounds found in the particular plants. Combining the extracts from the individual plants leads to a combination of the naturally occurring compounds from each of the plants. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extracts are only a mixture of the naturally occurring compounds found in the plant. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. Moreover, the closest naturally occurring counterpart for each ingredient is the ingredient itself. There is no indication that mixing the following ingredients together: a Punica granatum extract, optionally containing a Punica granatum seed extract, at least one additional ingredient selected from the extract, fraction, phytochemical or mixtures thereof derived from Mangifera indica and a metal selected from magnesium, calcium and potassium as commensurate in scope with the stated claims changes the structure, function, or other properties of the components in any marked way in comparison with the closest naturally occurring counterpart. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are directed to a composition with an intended use as a herbal composition. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'treatment or prophylaxis' consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself."
However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. In this case, the additional element is the mixing of the claimed ingredients. Mixing specific ingredients, such as Punica granatum extract, Punica granatum seed extract, Mangifera indica and a metal does not amount to significantly more than a combination of judicial exception because mixing ingredients is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter. In addition, applicants’ intended use of a herbal composition is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicants’ arguments filed July 10, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. § 101 for natural products are found to be non-persuasive.
Regarding the 35 U.S.C. § 101 rejection for natural products, based on applicants’ arguments across pages 14-16 of applicants’ arguments, the argument is found to not be persuasive. A P. granatum extract that has punicalagins, punicalin, ellagic acid, gallic acid or mixtures thereof, a Mangifera indica extract and a magnesium, calcium or potassium are all naturally occurring. As stated above within the 35 U.S.C. § 101 rejection, extraction of plants only concentrates and portions the naturally occurring compounds in the plants and that the creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, the claimed product or composition of the present invention does not possess markedly different characteristics when compared to its natural counterparts. In addition, applicant states at the bottom of page 15 going into page 16 of applicants’ arguments that “PGRMg-1 showed a 22.79% increase in NAD levels over control, PGS-2 showed a 2.29% increase, and MI-4 showed a 2.61% increase. But the composition containing all three showed a 36.87% increase, significantly higher than the expected additive increase of 27.69%, suggesting that the mixture has a synergistic effect. Applicant respectfully asserts that this effect suffices as a markedly distinct biological or pharmacological function, or chemical or physical properties, in order to be markedly different from the respective natural counterparts and accordingly requests withdrawal of the 35 U.S.C. § 101 rejection”; what applicant is arguing is not commensurate in scope; in other words, what is presently claimed is far broader than what the applicant is arguing. All of the ingredients claimed by the applicant are all found in nature and combining those components or compounds together within a single composition does not avoid the natural products issue under 35 U.S.C. § 101. Thus, the rejection over claim(s) 1-5 and 7-14 under 35 U.S.C. § 101 rejection for natural products is maintained.
Claim Rejections - 35 USC § 103
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(s) 1-5 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (CA 3002989 A1) in view of Gupta (U.S. Pub. No. 2004/0146539 A1), Sumathy et al (Asian Journal of Pharmaceutical and Clinical Research, (Year: 2013), vol. 6, suppl. 2, pp. 1-4), Ishida (JP 4658348 B2 - English translation provided) and Kim (WO 2019212997 A1)
Kaufman teaches a composition that can include pomegranate extract (paragraph 0119). Kaufman teaches the composition that can include, magnesium, calcium and potassium (paragraph 0119). Kaufman teaches the composition [has] increased protection of the skin against cutaneous skin aging (paragraph 0123). Kaufman teaches [that] the assembly of lipid structured nanoparticle compositions in the present disclosure may include glucose, fructose (which are monosaccharides) (paragraph 0042). Kaufman teaches formulating lipid structured nanoparticles containing nutraceuticals into solid dose forms including dissolvable tablets (paragraph 0116). Kaufman teaches [that] the lipid structured nanoparticles may be incorporated into lozenges, lollipops, gum, gels (paragraph 0019). Kaufman teaches "solid lipid nanoparticles" essentially have a solid form. These dynamic structures arc synthesized from natural lipid surfactants and contain an encapsulated inner core phase. They provide controlled release (paragraph 0033). Kaufman teaches [that the composition includes] suitable excipients (par. 00191).
Kaufman does not teach wherein a concentration of the Punica granatum extract containing a metal complex or chelate or metal salt of at least one phytochemical varies in a range of 5%- 80% by weight of the herbal composition, the Punica granatum seed extract varies in a range of 0%-50% by weight of the herbal composition and the extract, fraction phytochemical, or mixture thereof derived from Mangifera indica, Piper nigrum, Tagetes erecta, or Syzygium cumini varies in a range of 5%-50% by weight of the herbal composition (as stated within claim 1 of the present invention). Kaufman does not teach that the Punica granatum extract comprises Punica granatum fruit rind extract or Punica granatum whole fruit extract (as mentioned in claim 3 of the present invention. Kaufman does not teach wherein the punicalagins are in the range of 1.0-40% by weight of the herbal composition, the punicalin is in the range of 0.5-5% by weight of the herbal composition, the ellagic acid is in the range of 0.5-5% by weight of the herbal composition and the gallic acid is in the range of 0.1-5% by weight of the herbal composition; and the metal complex or chelate or metal salt comprises a metal wherein the metal magnesium, calcium, or potassium and is present in the range of 0.1-5.0% by weight of the herbal composition (as mentioned in claim 5 of the present invention). Kaufman does not teach what plant part was used for the extract or fraction of pomegranate (as mentioned in claim 7 of the present invention). Kaufman does not teach any of the select solvents used for the pomegranate extract (as mentioned in claim 8 of the present invention). Kaufman does not teach a phytochemical reference marker compound or pharmaceutically active marker within a specific concentration range (as stated within claim 9 of the present invention).
Gupta teaches a synergistic pharmaceutical composition for [the] external body [that has benefits] for the treatment of skin aging, skin wrinkles reduction (abstract and claim 1). Gupta teaches a synergistic pharmaceutical composition [that can] include ellagic acid (Punica granatum), Mangiferin (Mangifera indica) (claim 1 and 3). Gupta teaches [that] these compositions include a body beneficial composition selected from certain nutraceutical, cosmetic, and pharmaceutical ingredients, a composition to promote collagen and elastin synthesis in the skin, and a cosmetically or pharmaceutically acceptable delivery system (paragraph 0042).
Sumathy et al discusses the use of a fruit peel extract of punica granatum (abstract and page 1). Sumathy et al teaches that the antioxidants [from the punica granatum fruit peel extract] has an effect on cellular aging ([which, in turn would have an effect on the skin given that the skin is composed of cells]) (page 1, under 'Introduction'). Sumathy et al discusses the preparation of pomegranate peel extract using methanol (page 1).
Ishida teaches a composition [that improves] skin aging (paragraph 0011). Ishida teaches a pharmaceutical composition that contains pomegranate seed extract 10 parts by weight (paragraph 0123).
Kim teaches a [composition that comprises a] pomegranate extract (par. 0005). Kim teaches [that the composition has the following compounds:] punicalagin, punicalin, gallic acid (par. 0034, 0041 and 0045). Kim teaches [that] the composition comprises an amount of the first component and an amount of the second component effective to treat or prevent a disease or condition [such as a] mitochondrial disease or condition [that] is selected from the group consisting of aging (par. 0130). Kim teaches [that] in some embodiments, the dry form provides an amount of polyphenol measured in gallic acid equivalents at greater than about 20% (par. 0036).
Regarding claim(s) 1-4, 7-8 and 10-14, one of ordinary skill in the art would reasonably expect that the composition as taught by Kaufman can be modified to include that the nutraceutical or pharmaceutical composition can include a phytochemical such as ellagic acid (that is derived from Punica granatum) and Mangiferin (that is derived from Manifera indica) both taught by Gupta. In addition, the Punica granatum extract as taught by Kaufman can be modified to include that it included the Punica granatum fruit rind (e.g. fruit peel) extract that was subjected to a methanol extraction as taught by Sumathy et al. Moreover, the composition would include the information that the components stated within claim(s) 1 and 5 of the present invention (e.g. punicalagins, punicalin, ellagic acid and gallic acid) would be present within an extract of Punica granatum as taught by Gupta and Kim, whether the components/compounds was from the fruit peel extract of Punica granatum as taught by Sumathy et al or if it was from the fruit of Punica granatum itself. Also, Kaufman could be modified to include that the extract of the seed of Punica granatum as taught by Ishida can be added to the composition which also has beneficial effects for the skin.
Regarding claim(s) 1, 5 and 9, the aforementioned references do not explicitly teach the concentration ranges of the components or compounds listed in the ranges as claimed by the applicant. However, as discussed in MPEP section 2144.05(II)(A), "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. '[W]here 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." The references combined teach the use of each of the components within a composition that includes the Punica granatum extract (which also includes metal complexes from Punica granatum), that can include Punica granatum seed extract, Mangifera indica extract, and at least one phytochemical. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the components produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant's claimed invention.
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions for skin or cellular aging. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions for skin or cellular aging, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions for skin or cellular aging. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
One of ordinary skill in the art would reasonably expect to combine all these references in order to achieve a composition in this case, a herbal product in the form of a tablet that includes optimized ranges of the extract of Punica granatum that contains a phytochemical like ellagic acid and an additional ingredient, like the Mangifera indica extract to promote anti-aging of the skin.
One of ordinary skill in the art would be motivated to combine all of the references in order to remedy the deficiencies within Kaufman in order to provide a herbal composition that contains an extract that would react to form metal complexes where necessary that would also comprise a minimum or a group of two phytochemical compounds such as punicalagins, punicalin, ellagic acid, gallic acid and mangiferin that can be delivered in the form of a tablet or incorporated into a candy, like a lollipop that would serve in skin-enhancing or anti-aging functions for a subject. Lastly, it would be obvious to one of ordinary skill in the art to include a phytochemical marker compound (e.g. punicalagins, punicalin, ellagic acid and/or gallic acid) that can serve as a phytochemical reference marker that one skilled in the art can use as a guide to help assess the presence of phytochemicals present within a composition that would be administered.
Response to Arguments
Applicants’ arguments filed July 10, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. § 103 for obviousness are found to be non-persuasive.
Regarding the 35 U.S.C. § 103 rejection for obviousness, beginning on page 16 and going to page 19 of applicants’ arguments, applicant states “the disclosure ([referring to Kaufman]) is silent as to an optimal amount of pomegranate extract, or even an optimal amount of any of the preceding variables, disclosing only that the nutraceutical factor should make up 1-60% of the nanoparticle carrier composition it is to be used for. Kaufman [00119] (page 17 of applicants’ arguments)… Applicant respectfully asserts that the inventive concept in the present disclosure is far more than routine optimization (page 17 of applicants’ arguments)…Similarly, Applicant asserts that the mere fact that Kaufman discloses pomegranate extract-which is not substantially more than the common knowledge of the existence and properties of pomegranate extract held by the ordinarily skilled artisan-does not suffice to render presently pending independent claim 1 obvious. Even considering the disclosure of mere Mangiferin in Gupta, and the disclosure of pomegranate seed extract in Ishida, a skilled artisan would not immediately envisage the optimal ratios of Punica granatum extract, Punica granatum seed extract, and extract, fraction, phytochemical, or mixture thereof derived from Mangifera indica as required by presently pending independent claim 1, absent improper hindsight reliance on the present disclosure (page 18 of applicants’ arguments) ….Finally, the present combination is not trivial, because the instant disclosure notes that the combination as required by presently pending independent claim 1 produces an observed increase in NAD levels significantly higher than the expected additive effect of the separate components, 1 [0065] (page 18 of applicants’ arguments)…. Thus, considering the references cited by the Office Action there was no motivation to experiment in order to produce the invention featuring the specific ranges as required by the presently pending claims (page 19 of applicants’ arguments)”. Regarding applicants’ remarks across pages 16-19, each component of the present invention’s composition has been shown to be known within the art to be used to assist with aging associated with the skin or general aging. Although the combination of the aforementioned references may teach a different or additional intended uses, that does not mean that the component or compound would only have that one effect or effects; it is possible for the components/compounds to have a vast array of effects intrinsically when ingested by a subject in need. In addition, it is considered obvious to one of ordinary skill in the art, biochemistry and in drug development to optimize the ranges of components/compounds needed within a composition in order to elicit a desired response within a subject which is why claim(s) 1, 5 and 9 are seen as obvious to optimize. For example, those skilled in the art understand the importance of having low levels of a metal like magnesium, calcium or potassium; low levels of those metals within a composition is critical because it is important to have just enough of a metal in order for there to not be an issue with digestion once the metal is consumed. Moreover, it is also obvious to optimize the amount of plant extract(s) within a composition due to some, if not all plants having an issue with potency, efficacy, and solubility within organs in which, all of these can tie back to bioassays. One of ordinary skill in biochemistry and drug development would reasonably expect for one to experiment with various concentrations of a composition, including that of a herbal composition given that a composition can include a number of pharmaceutically acceptable carriers, excipients, and diluents, plant extract(s) as well as particular compounds in order to observe various interactions in order to create the optimal composition to administer to a subject in need that is looking into the amelioration of the conditions associated with aging or age-related decline in NAD levels. Furthermore, given applicants’ remark stating “notably, a generic disclosure (like the one in Kaufman of mere “pomegranate extract”) will only anticipate a claimed species when the species can be “at once envisaged” from the disclosure” (page 17 of applicants’ arguments). Based on the combination of the aforementioned references and given that aging affects 100% of the population, it is very common that an individual would want to delay the process of aging and generally, the standard way of observing the process of aging is through watching the physical skin. Thus, one would reasonably expect to use the references namely, Kaufman, Gupta, Sumathy et al, Ishida and Kim in order to create a composition and optimize the components within the composition that would work at the cellular level to delay aging within an individual. Thus, the rejection under 35 U.S.C. § 103 for obviousness for claim(s) 1-5 and 7-14 are maintained.
No claim(s) are allowed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
