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 .
DETAILED ACTION
The Amendments filed on 6/15/2026 has been received and entered.
Claims 1-15 and 17-18 are pending. Claims 1-14 are examined on the merits. Claims 15 and 16-17 are withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
Election/Restrictions
Applicant’s election with traverse of Claims 1-14 (from an interview on 2/27/2026), the species Vitis vinifera, maltodextrin, in the reply filed on 2/5/2026 is acknowledged. However, because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/5/2026 and 2/27/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/26/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claim Rejections - 35 USC § 101
Claims 1-10 and 12-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1-10 are directed to a composition comprising natural products. Flavanol monomers can be catechins, which are found in grapes. Epsilon-viniferin is found in grapes. Extracts of Vitis vinifera are found in grapes. Stilbenes are found in grapes. Licorice is a plant. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims fruits and spice, which are food or beverages. 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, in claims 1-10, the homogenized form of the ingredients mixed together would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition contains a mixture of products that are found in nature (the individual natural molecules) and thus must be evaluated as per the described analysis. As for Claim 12, in the form of a powder or solution would be a product of nature because dried plants or grapes can be crushed by falling and be crushed by rocks or animals to form a powder. A solution can be made when plants are crushed and form a juice, which is a solution. Mixing together various natural molecules doesn’t change those molecules per se; they are simply mixed together and thus would have the same characteristics as the same molecules prior to being mixed together.
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.
The homogenized composition of the different plants and vegetables together are non-natural. However, a composition can be used in many different ways and thus not integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then 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.” In this case, the amounts of Claims 1-5, 7, 9 are amounts of molecules that can be found in grapes. The mixing of homogenized fruits is well understood, routine, and conventional method of making a product for supplementing nutrition such as a fruit juice or powder (see Liu, 2013, J American Society for Nutrition Adv Nutr, 4: 3845-3925). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
Claim(s) 1-4 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ramirez et al. (US 20180271928 A1) further in view of von Maltzahn et al. (US 2016023702 A1). This is not a new rejection.
Ramirez et al. teaches a vitis vinifera fruit and red wine extract with bioactive compounds: 4.32 mg epicatechin, 2.72 mg catechin, 2.07 mg gallic acid, 0.9 mg trans-resveratrol, 0.47 mg rutin, 0.42 mg epsilon-viniferin, 0.28 mg p-coumaric acid, 0.14 mg ferulic acid and 0.04 mg quercetin per gram. The at least 15% of flavanol monomers are catechins and epicatechins, which are 62%. The mixture of molecules from extract of Vitis vinifera are all taught. Stilbenes at least 100 ppm is taught by trans resveratrol because resveratrol is 3,5,4′-trihydroxy-trans-stilbene. The ratio of Claim 4 is 7.04 to 0.42, which is about 16. The weight of Claim 3 is met. The polyphenols of vitis vinifera extract is at least 50%; thus, Claims 7 and 9 limitation are met. Grape extract would involve grape pomace and grape seed; thus, Claim 8 limitation is met. Grams is a powder unit; thus, Claim 12 is limitation is met. Grape is a food and food can be a drug; thus, Claims 13-14 limitations are met.
However, Ramirez et al. does not teach 0.42 mg epsilon-viniferin is at least 15 ppm, licorice extract and maltodextrin.
von Maltzahn et al. teaches a pharmaceutical compositions and medical foods thereof, optionally comprising micronutrients, polyphenols, prebiotics, probiotics, or other agents are provided and methods of making same (Abstract) comprising a single dosage with maltodextrin [0555] and flavoring agent licorice [0314].
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add maltodextrin and licorice because von Maltzahn et al. teaches a pharmaceutical compositions and medical foods thereof, optionally comprising micronutrients, polyphenols, prebiotics, probiotics, or other agents are provided and methods of making same (Abstract) comprising a single dosage with maltodextrin [0555] and flavoring agent licorice [0314]. One would have been motivated to make composition with maltodextrin and licorice for the expected benefit of making a composition of polyphenols from vitis vinifera as taught by Ramirez et al. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
The reference teaches using epsilon-viniferin is at least 15 ppm. However, the reference does not specifically teach using all of the specific dosages claimed by applicant. The amount of a specific dosage in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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 reference teaches that the dosage and administration can be varied. Thus, the reference has recognized these parameters as variables. It would have been customary for an artisan of ordinary skill to determine the optimal dosage in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage amount would have been obvious at the time of applicant’s invention.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ramirez et al. (US 20180271928 A1) and von Maltzahn et al. (US 20160213702 A1) as applied to claims 1-4 and 6-14 above, and further in view of Lemaire et al. (US 8980342 B2). This is not a new rejection.
The teachings of Ramirez et al. and von Maltzahn et al. are set forth above and applied as before.
The combination of Ramirez et al. and von Maltzahn et al. do not specifically teach the flavanol dimers (PAC B1 and B2) is greater than 5%.
Lemaire et al. teaches a grape extract comprising concentrations of flavanol monomers of greater than about 5% by weight, and more preferably within a range from about 12% by weight to about 50% by weight, and a concentration of flavanol dimers preferably greater than about 2% by weight, and more preferably within a range from about 6% by weight to about 20% by weight. The flavanol monomers preferably include catechin, epicatechin, epicatechin gallate, and gallic acid. The flavanol dimers preferably include procyanidin B1, procyanidin B2, procyanidin B3, procyanidin B4, and procyanidin B2-O-gallate (Abstract). Nutritional profile of the grape extract (Powergrape .TM. grape extract, NATUREX). Loss of drying [JO Mar. 11, 1977] 3.50% Proteins (Nx6.25) [JO Mar. 11, 1977] 1.40% Lipids [JO Mar. 11, 1977] 0.30% Ash [JO Mar. 11, 1977] 1.38% Soluble sugars [JO Mar. 11, 1977] 3.00% Total polyphenols [Folin-Ciocalteau] 90.42% Including flavanol monomers [HPLC] 12.00% Including flavanol dimers[HPLC] 6.00% TOTAL 100.00% (Table 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add flavanol dimers because Lemaire et al. teaches a grape extract comprising concentrations of flavanol monomers of greater than about 5% by weight, and more preferably within a range from about 12% by weight to about 50% by weight, and a concentration of flavanol dimers preferably greater than about 2% by weight, and more preferably within a range from about 6% by weight to about 20% by weight. The flavanol monomers preferably include catechin, epicatechin, epicatechin gallate, and gallic acid. The flavanol dimers preferably include procyanidin B1, procyanidin B2, procyanidin B3, procyanidin B4, and procyanidin B2-O-gallate (Abstract). Nutritional profile of the grape extract (Powergrape .TM. grape extract, NATUREX). Loss of drying [JO Mar. 11, 1977] 3.50% Proteins (Nx6.25) [JO Mar. 11, 1977] 1.40% Lipids [JO Mar. 11, 1977] 0.30% Ash [JO Mar. 11, 1977] 1.38% Soluble sugars [JO Mar. 11, 1977] 3.00% Total polyphenols [Folin-Ciocalteau] 90.42% Including flavanol monomers [HPLC] 12.00% Including flavanol dimers[HPLC] 6.00% TOTAL 100.00% (Table 2). One would have been motivated to make composition with flavanol dimers for the expected benefit of making a composition of polyphenols from vitis vinifera as taught by Ramirez et al. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Double Patenting
Claims 1-9, 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11266705 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because molecules in the extracts of vitis vinifera mixture are not all present.
U.S. Patent No. 11266705 B2 teaches:
1. A nutritional or therapeutic agent consisting essentially of a mix obtained from Vitis vinifera and Vaccinium angustifolium extracts, wherein the mix contains: at least 1% of catechins and/or epicatechins, the percentage being given by weight in relation to the total weight of the mix, at least 5 ppm (parts per million in the mix) of ferulic acid; and at least 200 ppm of resveratrol; malvidin 3-glucoside at a concentration of at least 300 ppm, at least 50 ppm of quercetin and/or quercetin glycosides, and at least 500 ppm of anthocyanidins; and wherein the nutritional or therapeutic agent formulated as a tablet, capsule, gel capsule, microcapsule, suspension, emulsion, food supplement, drink or food for humans or animals.
2. The agent according to claim 1, characterized in that the mix comprises at least 5% of catechins and/or epicatechins, the percentage being given by weight in relation to the total weight of the mix.
3. The agent according to claim 1, characterized in that the mix comprises at least 10 ppm (parts per million in the mix) of ferulic acid.
4. The agent according to claim 1, characterized in that the extract of Vitis vinifera has a flavanol polymer content of less than 0.5% by weight of the total weight of the polyphenols of the extract.
5. The agent according to claim 1, for use as a drug for humans or animals.
However, at least 15 ppm E-viniferin, maltodextrin are not taught.
These references show that it was well known in the art at the time of the invention to use the claimed ingredients in compositions of extracts of vitis vinifera. 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. In re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); In re Susi, 58 CCPA 1074, 1079-80; 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960).
Based on the disclosure by these references that these substances are used in compositions to treat cancer, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions from extracts of Vitis vinifera. 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 In re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; In re Crockett 126 USPQ 186.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add maltodextrin because excipients or coating agents, such as maltodextrin are used for composition structure (TABLE 4). One would have been motivated to make composition with maltodextrin for the expected benefit of making a composition of polyphenols from vitis vinifera as taught by U.S. Patent No. 11266705 B2. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Claims 1-9, 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11263200 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because molecules in the extracts of vitis vinifera mixture are not all present.
U.S. Patent No. 11263200 B2 teaches:
1. A nutritional or therapeutic agent comprising at least one molecule mix obtained from Vitis vinifera and Vaccinium angustifolium extract, wherein the mix contains: at least 1% of catechins and/or epicatechins, the percentage being given by weight in relation to the total weight of the mix, at least 5 ppm (parts per million in the mix) of ferulic acid, malvidin 3-glucoside at a concentration of at least 300 ppm, resveratrol, at least 50 ppm of quercetin and/or quercetin glycosides, and at least 500 ppm of anthocyanidins, wherein the nutritional or therapeutic agent formulated as a tablet, capsule, gel capsule, powder, solution, microcapsule, suspension, emulsion, food supplement, drink and food for humans or animals.
2. The nutritional or therapeutic agent of claim 1, wherein the molecule mix comprises at least 5% of catechins and/or epicatechins, the percentage being given by weight in relation to the total weight of the mix.
3. The nutritional or therapeutic agent according to claim 1, wherein the molecule mix comprises at least 10 ppm (parts per million in the mix) of ferulic acid.
4. The nutritional or therapeutic agent of claim 1, wherein the mix is formed by: an extract of Vitis vinifera and/or an extract of Vaccinium angustifolium, and an extract obtained from Vitis vinifera and Vaccinium angustifolium.
5. The nutritional or therapeutic agent of claim 4, wherein the extract of Vitis vinifera has a flavanol polymer content of less than 0.5% by weight of the total weight of the polyphenols of the extract.
6. The nutritional or therapeutic agent of claim 1, wherein the molecule mix comprises: at least 200 ppm of resveratrol.
7. A therapeutic composition for humans or animals, the therapeutic composition comprising the nutritional or therapeutic agent of claim 1.
However, at least 15 ppm E-viniferin, maltodextrin are not taught.
These references show that it was well known in the art at the time of the invention to use the claimed ingredients in compositions of extracts of vitis vinifera. 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. In re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); In re Susi, 58 CCPA 1074, 1079-80; 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960).
Based on the disclosure by these references that these substances are used in compositions to treat cancer, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions from extracts of Vitis vinifera. 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 In re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; In re Crockett 126 USPQ 186.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add maltodextrin because excipients or coating agents, such as maltodextrin are used for composition structure (TABLE 4). One would have been motivated to make composition with maltodextrin for the expected benefit of making a composition of polyphenols from vitis vinifera as taught by U.S. Patent No. 11263200 B2. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Claims 1-4 and 6-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 17/295535 (US 20220016195 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because molecules in the extracts of vitis vinifera mixture are not all present.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
However, at least 15 ppm E-viniferin, maltodextrin are not taught.
19. A composition comprising a mixture of molecules obtained from Vitis vinifera and Vaccinum angustifolium, said mixture comprising: at least 1% of catechins and/or epicatechins, the percentage being given by weight relative to the total weight of the mixture, at least 5 ppm (parts per million in the mixture) of ferulic acid, and at least 200 ppm of resveratrol, for single-dose use taken on a one-time, non-repeated basis to improve or maintain the cognitive functions of a sick human being or of a sick animal, the single dose being taken less than 5 hours before the desired effect.
These references show that it was well known in the art at the time of the invention to use the claimed ingredients in compositions of extracts of vitis vinifera. 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. In re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); In re Susi, 58 CCPA 1074, 1079-80; 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960).
Based on the disclosure by these references that these substances are used in compositions to treat cancer, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions from extracts of Vitis vinifera. 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 In re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; In re Crockett 126 USPQ 186.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add maltodextrin because excipients or coating agents, such as maltodextrin are used for composition structure [0078]. One would have been motivated to make composition with maltodextrin for the expected benefit of making a composition of polyphenols from vitis vinifera as taught by U.S. 20220016195 A1. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Response to Arguments
Applicant argues that the claimed dosage treats neurological disease, cognitive dysfunction and improves skin.
In response to Applicant’s argument, the inherent or innate characteristics of the naturally occurring counterpart cannot show a markedly difference. The differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference. There is no difference in function, structure or other properties. Here, Ramirez et al. teaches the vitis vinifera fruit and red wine extract with bioactive compounds: 4.32 mg epicatechin, 2.72 mg catechin, 2.07 mg gallic acid, 0.9 mg trans-resveratrol, 0.47 mg rutin, 0.42 mg epsilon-viniferin, 0.28 mg p-coumaric acid, 0.14 mg ferulic acid and 0.04 mg quercetin per gram. The at least 15% of flavanol monomers are catechins and epicatechins, which are 62%. The 0.42 mg epsilon-viniferin is at least 15 ppm. The mixture of molecules from extract of Vitis vinifera are all taught. The molecules would have the inherent activities as claimed.
Applicant argues that the amounts are not taught.
In response to Applicant’s argument, Ramirez et al. teaches the vitis vinifera fruit and red wine extract with bioactive compounds: 4.32 mg epicatechin, 2.72 mg catechin, 2.07 mg gallic acid, 0.9 mg trans-resveratrol, 0.47 mg rutin, 0.42 mg epsilon-viniferin, 0.28 mg p-coumaric acid, 0.14 mg ferulic acid and 0.04 mg quercetin per gram. The at least 15% of flavanol monomers are catechins and epicatechins, which are 62%. The amount of a specific dosage in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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 reference teaches that the dosage and administration can be varied. Thus, the reference has recognized these parameters as variables. It would have been customary for an artisan of ordinary skill to determine the optimal dosage in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage amount would have been obvious at the time of applicant’s invention.
Applicant’s argue that there is synergistic effect for tyrosinase activity in Examples 8 and 9.
In response to Applicant’s argument, synergistic effect to be convincing the experimental amounts need to be commensurate in scope with the claimed amounts. Examples 8 and 9 show flavanol monomers of 35 microMolar and epsilon-viniferin at 0.005 microMolar. The claimed amounts are not the same. Therefore, the synergistic effect is not convincing.
Applicant argues that the synergistic effect will overcome a Double Patenting rejection.
In response to Applicant’s argument, a Double Patenting rejection can be overcome by amending the claims, filing a Terminal Disclaimer or deleting the claims. Please respond accordingly.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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