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 .
Election/Restrictions
Applicant’s election without traverse of group I, claim(s) 1-14 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Claim(s) 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Claim(s) 1-14 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 19, 2024 is being considered by the examiner. The signed IDS forms are attached with the instant office action.
Claim Objections
The disclosure is objected to because of the following informalities:
In claim 11, “zinc sulphate” should read “zinc sulfate”
In claim 11, “poly sorbate” should read “polysorbate” and
In claim 11, “monosaccharide’s” should read “monosaccharides”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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) 1-14 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims state that the claimed composition is a “synergistic herbal composition”. It is noted that applicant’s specification discusses comp 1-43 (which corresponds to examples 11-19, tables 4-12 for NAD concentrations and tables 13-21 for percentage of inhibition of CD38) which show that various compositions of the Punica granatum fruit rind (e.g. fruit peel) extract that contains the natural components: punicalagins, punicalin, ellagic acid, and gallic acid; along with added magnesium; may contain Punica granatum seed extract and Mangifera indica seed kernal extract with various ratios of the components. In addition, in lieu of the Mangifera indica extract, that may have been replaced with the Piper nigrum fruit extract, Syzygium cumini fruit extract or Tagetes erecta extract. Moreover, depending on the extract, it may have been extracted with different solvents. It is also noted that applicant’s specification asserts that comp 1-43 across examples 11-19 and tables 4-21 produces an unexpected, synergistic effect in comparison with the individual ingredients (page 23 of the specification). However, it is not clear if these examples explain a synergistic result.
The specification states that the aforementioned compositions had unexpectedly showed synergistic activity in boosting NAD and inhibiting CD38 levels (page 23 of the specification). Within tables 4-12 (for NAD concentrations) and tables 13-21 (for percentage inhibition of CD38), the combinations of the ingredients within the compositions (comp #) does indeed show substantial increases when comparing the additive (calculated) column to the observed column. The combination within the observed column does show a better result as compared to the additive (calculated) column; however, it is unclear how the concentration (e.g. dose and ratio) of the individual ingredients (e.g. the Punica granatum extract, magnesium, Mangifera indica extract and/or Piper nigrum fruit extract and/or Tagetes erecta flower extract and/or Punica granatum seed extract) relates to both sections (e.g. the additive (calculated) column and the observed column) under % increase of NAD over control for tables 4-12 and % inhibition of CD38 activity for tables 13-21. The specification does illustrate that different solvents may be used for extraction of the plants described, choice of metal (e.g. magnesium) and a choice of at least one additional plant extract. An artisan within the field of molecular biology and biochemistry would not necessarily expect that the results shown for one of the compositions (either for NAD or CD38) would be the same for another composition. Generally speaking, CD38 is a naturally occurring molecule and it has a variety of functions; one of them being playing a role in modulating immune responses, cancer formation and cell cycle progression, just to name a few. As for NAD, that is a well-known coenzyme that is naturally responsible for a variety of day-to-day biochemical reactions within a system. In addition, metals such as magnesium, calcium and potassium naturally have extra added health benefits. Applicant’s specification list data in the form of dosages used, % increase, ratio, comp dose, additive (calculated) column and observed columns across examples, tables and compositions that further prove that the claims of the present invention are at their broadest because the claims are not limited to specific dosages or concentrations but rather a percentage of already naturally occurring ingredients within a plant extract, a percentage of the addition of a metal and/or an additional plant extract. Thus, the data presented in the specification is not considered to support the claim limitation that the results are “synergistic”. Given that synergism is unpredictable, in order to determine if the claimed composition is actually synergistic, the artisan would be forced to create a large list of compositions that use a number of solvents for the extraction of Punica granatum, compare and contrast the effects of the removal of specific naturally occurring compounds from P. granatum, while also using different metals (e.g. magnesium, calcium or potassium) at various concentrations and including additional plant extracts that also have been extracted using a variety of solvents with comparing and contrasting the effects of the removal of specific naturally occurring compounds from the additional plant extract(s) on NAD and CD38 levels and their associated pathways to effectively prove synergism. Applicant’s specification does not necessarily prove synergism but more so provides an indirect hypothesis in which the results have been positively exceeded based on prior calculated values compared to the actual result within a system. Proof of synergism will greatly exceed beyond applicant’s current data because one could consider (at the very least) the effects of synergism on a variety of pathways that would impact cellular molecules and not only focus on the cellular molecules themselves. This is clearly a burden of undue experimentation. Thus, the claims are not considered to be enabled for “synergistic” compositions.
Claim(s) 1-14 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(s) 1-14 are indefinite because it is unclear what “synergistic herbal composition” means; the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim 2 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 4 is indefinite due to the use of improper Markush language. The claim states that it is drawn to “amelioration of the conditions associated with aging or age-related decline in NAD levels is selected from but not limited to…”. The use of “not limited to” implies that the Markush grouping requires a material selected from an open list of alternatives and it is improper because it implies that there are other members of the group without stating what these members are (see MPEP section 2173.05(h)).
Claim 8 is indefinite because the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In addition, the use of “not limited to” implies that the Markush grouping requires a material selected from an open list of alternatives and it is improper because it implies that there are other members of the group without stating what these members are (see MPEP section 2173.05(h)).
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.
Claim 11 is indefinite because it is unclear what “polycarbohydrates” means; the specification lists examples pertaining to “polycarbohydrates” but does not list the exact meaning of the phrase. In addition, it is unclear what “dietically” means; the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim 11 is also indefinite due to the use of the phrase “such as” at numerous places in the claim. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In addition, the claims are indefinite due to the use of the phrase “not limited to” at numerous places in the claim. This phrase is indefinite because it implies that the Markush grouping requires a material selected from an open list of alternatives and it is improper because it implies that there are other members of the group without stating what these members are (see MPEP section 2173.05(h)). Claim 11 is also indefinite due to the use of “etc.” at multiple places in the claim. It is unclear what ingredients are encompassed by “etc.”
Claim 11 contains the trademarks/trade names “glucidex 12D”, “neusilin” and “veegum”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an ingredient in the claim and, accordingly, the identification/description is indefinite.
Claim 11 is also indefinite because it is unclear what preservatives are encompassed by “Class I & Class II preservatives.”
Claim 12 is indefinite because it states that it can be drawn to “any suitable form”; however, it is not clear what characteristics a form must have in order to be considered “suitable.” In addition, the claim is indefinite due to the use of the phrase “such as”.
Claim 13 is indefinite due to the use of phrase “can be contemplated/made into the dosage form…”. This is a passive, narrative phrase which is inconsistent with US claim construction. Claim 13 is also indefinite due to the use of the phrase “such as”. In addition, claim 13 is indefinite due to the multiple uses of “like”. It is unclear what characteristics a formulation must possess in order to be considered a “like” formulation.
Claim 14 is indefinite due to the phrase “for obtaining the desired therapeutic benefit.” This is a narrative phrase inconsistent with US claim construction. In addition, it is unclear what is encompassed by the “desired” benefit.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10, 11, and 13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 is only drawn to “optional” limitations. Thus, claim 10 does not further limit claim 1 because it does not require any limitation since the whole claim is optional.
Claim 13 does not further limit claim 1 because it states that it is drawn to “contemplating” the stated formulations. This mental step does not place any further structural limitations on claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-14 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, applicant’s 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, mold, and fungus. 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 synergistic 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, applicant's intended use of a synergistic 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.
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) 1-14 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) and Ishida (JP 4658348 B2 – English translation provided).
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 (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 does not teach that the Punica granatum extract is selected from Punica granatum fruit rind extract and Punica granatum whole fruit extract (as mentioned in claim 3 of the present invention. Kaufman does not teach the ranges of at least one phytochemical, the concentration of the metal complex within the Punica granatum extract and does not teach the range of Mangifera indica (as mentioned within claim(s) 5 and 6 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).
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 1 of the present invention (e.g. punicalagins, punicalin, ellagic acid and gallic acid) would intrinsically be present within an extract of Punica granatum, whether it 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) 5-6 and 9, the aforementioned references do not explicitly teach the concentration ranges of at least one of the phytochemicals (e.g. ellagic acid), all three of the metal compounds (e.g. magnesium, potassium and calcium), extracts or fraction or phytochemical or mixtures thereof that are derived from Mangifera indica and a phytochemical reference marker compound or pharmacologically active marker. 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.
Moreover, 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. 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 synergistic 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 ellagic 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, like a human. Lastly, it would be obvious to one of ordinary skill in the art to include a phytochemical marker compound (e.g. ellagic 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.
Conclusion
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
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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