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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/31/2025 has been entered.
Status of claims
Claims 6, 8-10, 14 and 16-23 as amended on 12/31/2025 are pending and under examination in the instant office action.
Claim Rejections - 35 USC § 112
Indefinite
Claims 9, 10 and 19 as presently amended 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 9 is indefinite because it recites amounts of 2 components such as 12% of grape seed extract and 24% of enzyme (total 36%) in the preceding claim 1, wherein in the preceding claim 1 the total amount of these 2 components should 100% as result of closed language “consisting of”. Thus, there is some confusion and uncertainty in the claim 9, thereby, indefiniteness.
Claim 10 is rendered uncertain and/or indefinite by the phrase “comprises” in relationship to the formulation I of claim 6 which is limited by language “consisting of” in the preceding claim 6. There is an uncertainty with regard to either components or their doses.
Claim 19 is rendered uncertain and/or indefinite by the phrase “comprises” in relationship to each Formulation E, I, J and K of claim 6 which are limited by language “consisting of” in the preceding claim 6. There is an uncertainty with regard to either components or their doses.
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 8-10, 19 and 23 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 8 recites that Formulation E “further comprises” additional extracts in the Formulation E of claim 6, wherein the Formulation E of claim 6 is closed to incorporation of any additional components by the virtue of language “consisting of”. Thus, claim 8 fails to further limit the subject matter of the claim upon which it depends.
Claim 9 fails to further limit the subject matter of the claim 6 upon which it depends because total amount is 12%+24%=36% which is less than the expected 100% for the only 2 components in formulation E of claim 6 as result of closed language “consisting of” in the claim 6 for formulation E.
Claim 10 is rendered uncertain by the phrase “comprises” in relationship to the formulation I of claim 6 which is limited by language “consisting of” in the preceding claim 6. There is an uncertainty with regard to either components or their doses. Thus, claim 10 fails to further limit the subject matter of the claim upon which it depends.
Claim 19 is rendered uncertain by the phrase “comprises” in relationship to each Formulation E, I, J and K of claim 6 which are limited by language “consisting of” in the preceding claim 6. There is an uncertainty with regard to either components or their doses. Thus, claim 19 ails to further limit the subject matter of the claim upon which it depends.
Claim 23 recites that each of Formulation E, I, J and K “further comprises” additional agents (not the optional carrier) , wherein the Formulation E of claim 6 is closed to incorporation of any additional agents by the virtue of language “consisting of”. Thus, claim 23 fails to further limit the subject matter of the claim upon which it depends.
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 § 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.
Claim 6, 8-10, 14 and 16-23 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,818,233 (Perkes), US 6,914,073 (Boulos et al), US 7,250,161 (Ghosal), US 7,429,569 (Halevie-Goldman) and US 8,557,236 (McCrink et al).
US 6,818,233 (Perkes) discloses a dietary supplement composition for inhibiting LDL cholesterol oxidation and beneficial for patients with coronary artery disease or cardiovascular disorders, wherein the composition comprises a grape seed extract and an enzyme blend with fungal protease, acid stable protease and bromelain (see abstract; col. 1, lines 17-43; col. 9, line 14-45), wherein this composition also contains grape skin extract, ginkgo biloba extract, bilberry extract and quercetin (col. 9, lines 15-15), wherein the grape seed extract is present in 12% amount and enzyme blend is present in 24% (col. 9, lines 15-20; and wherein the composition is in capsule form (col. 9, line 14). The dietary supplements of the cited US 6,818,233 (Perkes) are clearly provided as capsules (col. 9, lines 14 and 31; col.10, line 27; col. 14, line 38). The additional components are pharmaceutically acceptable filers, lubricants.
Thus, the composition disclosed by the cited US 6,818,233 (Perkes) is substantially the same as the claimed formulation E (at least as claim 8 depending on claim 6, claim 9, and claim 19). The cited US 6,818,233 (Perkes) clearly acknowledges that the composition comprising a grape seed extract and an enzyme blend (fungal protease, acid stable protease and bromelain) is effective for inhibiting platelet activity and LDL cholesterol oxidation (col. 2, lines 10-12; examples 2-3). The dietary supplements of the cited US 6,818,233 (Perkes) are clearly provided as capsules (col. 9, lines 14 and 31; col.10, line 27; col. 14, line 38). The capsules are commonly made with gelatin as base inert material in view of the cited US 7,250,161 (Ghosal); for example: see col. 7, line 58; see col. 8, lines 34 and 38, see col. 10, lines 5 and 11; see col. 13, lines 59 and 62; wherein capsules comprise gelatin, glycerin, water and a generic colorant such as borage seed oil which is commonly golden in color (col. 13, lines 59-64).
However, the cited US 6,818,233 (Perkes) is silent about providing other dietary supplements such as vitamin K-2 plus vitamin D-3 (claimed formulation I); such as coenzyme Q10, tocotrienol and alpha-lipoic acid (claimed formulation J) and such as sterol and omega 3 (claimed formulation K) in the composition beneficial for cardiovascular health.
Nevertheless, the cited US 6,914,073 (Boulos et al) teaches and discloses a dietary supplement composition beneficial for cardiovascular health comprising beneficial vitamins and additives (abstract); wherein the beneficial vitamins include vitamin K-2 (col. 6, line 24) in amount up to 200 µg (col. 2, lines 45-46), vitamin D-3 (col. 6, line 32; col. 7, lines 25-29) in amount 200-800 IU (col. 7, lines 3) as in the claimed formulation I. The cited US 6,914,073 (Boulos et al) also teaches that beneficial additives are coenzyme Q10, alpha-lipoic acid (col. 8, line 26), vitamin E or tocotrienol (col. 7, line 67) as in claimed formulation J. The cited US 6,914,073 (Boulos et al) also teaches that beneficial additives area sterol or beta-sitosterol (col. 8, line 28) and omega 3 fatty acids or fish oil with EPA and DHA (col. 8, lines 26-28). T
Thus, the ingredients of compositions of the cited US 6,914,073 (Boulos et al) comprise same components as in the claim-recited formulations I, J and K; and, thus, correspond to the claim-recited formulations I, J and K.
Further, the cited US 6,914,073 (Boulos et al) teaches that compositions are provided and/or suitable to be provided in forms of capsules (col. 9, line 12). The single dose of formulation in capsule form can be one and more capsules (col. 9, lines 19-21). The dosage forms are formulated accordingly well knonw manufacturing techniques in the pharmaceutical industry (col. 9, lines 22-26).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add beneficial vitamins and additives taught and suggested by US 6,914,073 (Boulos et al) in capsule forms to a product with a composition comprising grape seed extract and enzyme blend in capsule forms of US 6,818,233 (Perkes) with a reasonable expectation of success in providing a multi-supplement composition beneficial for cardiovascular health because these ingredients have been known and provided in compositions for beneficial for cardiovascular health as adequately taught/suggested by the cited references and they were provided in capsule forms as taught/suggested by the cited references.
Further, with regard to amounts of ingredients in the formulation J and formulation K:
First, it is noted that the cited prior art references (US 6,914,073 (Boulos et al) and US 6,818,233 (Perkes)) both recognize doses or amounts of active ingredients for benefits in cardiovascular health; and, thus, it would be obvious to one skill in the art to optimize doses as intended for treating patients with various severities of cardiovascular problems.
Nevertheless, the claimed doses have been known and suggested in the prior art.
For example as applied to claim-recited formulation J: US 7,429,569 (Halevie-Goldman) teaches incorporation of co-factors including coenzyme Q10, alpha-lipoic acid and vitamin E (tocotrienol) into nutritional or pharmaceutical compositions (col. 8, lines 15-40) for treating cardiovascular disorders (col. 2, lines 40-45 ), wherein the recommended doses are 60 mg CoQ10, total 1600 IU for vitamin E (tocotrienols), 30 mg alpha-lipoic acid (col. 2, lines 40-45 ), which fall within the claimed concentration ranges. The cited formulation is provided and/or suitable to be provided in capsule forms (col.16, lines 18-20).
For example as applied to claim-recited formulation K: US 8,557,236 (McCrink et al) teaches compositions for cardiovascular support comprising phytosterols in amount 35-55% (col. 4, lines 46-48), CoQ10 in amount 5-25% or 10-450 mg (col. 4, lines 35-36 and 44-46) in combination with Omega 3 fatty acid Fish oil comprising EPA and DHA acids (col. 4, lines 4-10). The cited formulation is provided and/or suitable to be provided in capsule forms (col. 2, 43-44).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to combine compositions of US 6,818,233 (Perkes) and US 6,914,073 (Boulos et al) in amounts of co-factors and phytosterols as taught or suggested by US 7,429,569 (Halevie-Goldman) and US 8,557,236 (McCrink et al) with a reasonable expectation of success in providing a multi-supplement composition beneficial for cardiovascular health because all ingredients have been known and provided in compositions for support of cardiovascular health as adequately taught/suggested by the cited references combined and because the doses of active ingredients recommend for cardiovascular health have been known, taught and/or suggested by the prior art of record. Thus, it would be obvious to one skill in the art to optimize doses for each and all components in combination as intended for treating patients depending on severities of cardiovascular problems.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary. The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references.
Therefore, the claims are properly rejected under 35 USC § 103.
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.
Claims 6 and 8-23 as amended remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claim recites a composition with several plant extracts, enzymes, vitamins, co-factors, fatty acids, wherein all claim-recited compounds are naturally occurring products or products of nature. Thus, the combination of claim-recited ingredients is a combination of products of nature.
The amounts recited in claims do not structurally or materially change the nature of components, wherein the components remain natural products regardless their amounts. Although some sub-mixtures or formulations are closed to incorporation of addition ingredients by language “consisting of”, each formulation and a composition comprising several formulations as a whole still remains a mixture of natural components. Structurally and materially each formulation and a combination of formulation is not markedly different from a mixture of natural components recited in the claims.
Therefore, this judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The forms of composition such as a “capsule” or several capsules do not materially modify or structurally change the composition since a generic capsule as recited in the claims is a mere container. Gelatin is a natural ingredient. Therefore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Response to Arguments
Applicant's arguments filed 12/31/2025 have been fully considered but they are not found persuasive.
With regard to claim rejection under 35 U.S.C. 101 Applicants appear to argue that the claimed product is not a product of nature because claims recite several compositions that are closed to incorporation of other ingredients by the language “consisting of” and because some ingredients are limited by amounts (last response page 12 of 13).
The arguments are not found persuasive. The amounts recited in claims do not structurally or materially change the nature of components, wherein the components remain natural products regardless their amounts. Although some sub-mixtures or formulations are closed to incorporation of addition ingredients by language “consisting of”, each formulation and a composition comprising several formulations as a whole still remains a mixture of natural components. Structurally and materially each formulation and a combination of formulation is not markedly different from a mixture of natural components recited in the claims.
With regard to claim rejection under 35 USC § 103 Applicants’ main argument is that the cited prior art does not teach or suggests that each formulations of particular ingredients are provided in forms of capsules.
This arguments is not found persuasive because all cited references teach the dietary supplement ingredients are provided and/or suitable to be provided in forms of capsules.
For example: The dietary supplements of the cited US 6,818,233 (Perkes), that are same as in the claimed formulation E as explained above, are clearly provided as capsules (col. 9, lines 14 and 31; col.10, line 27; col. 14, line 38).
For example: The ingredients of compositions of the cited US 6,914,073 (Boulos et al) comprise same components as in the claim-recited formulations I, J and K; and, thus, correspond to the claim-recited formulations I, J and K as explained above. The cited US 6,914,073 (Boulos et al) teaches that compositions are provided and/or suitable to be provided in forms of capsules (col. 9, line 12). The single dose of formulation in capsule form can be one and more capsules (col. 9, lines 19-21). The dosage forms are formulated accordingly well knonw manufacturing techniques in the pharmaceutical industry (col. 9, lines 22-26).
For example: the composition of US 7,429,569 (Halevie-Goldman), that comprise co-factors including coenzyme Q10, alpha-lipoic acid and vitamin E (tocotrienol) in amounts which fall within the claimed concentration ranges as explained above, are provided and/or suitable to be provided in capsule forms (col. 16, lines 18-20).
For example: the composiotns of US 8,557,236 (McCrink et al), that are relied upon for the claimed amounts for phytosterols, CoQ10, Omega 3 fatty acid Fish oil comprising EPA and DHA acids, are provided and/or suitable to be provided in capsule forms (col. 2, 43-44).
Even if a single reference does not disclose each and every claim-recited ingredient in a capsule, the cited references in a combination teach and suggest all claimed components to be provided in capsule forms which is a common and suitable practice for oral supplements. Thus, whatever differences might be intended, they are not clear or patentably distinct as claimed, as disclosed in the instant specification and as argued.
In particular and with regard to the disclosure by US 6,914,073 (Boulos et al) Applicant appear to argue that only vitamins (vitamin E as argued) is encapsulated but then blended with minerals. Yet, the claimed multi-supplement composition as a whole is open to incorporation of other ingredients by the virtue of the language “comprises”; for example: see claim 6, line 2.
The criticality of separation of each “closed” formulation into one or more capsules but provided as a single multi-supplement composition which is open to other supplements is unclear as claimed, as argued and as disclosed. The as-filed specification does appear to describe applications of a single multi-supplement that combines 4 claimed formulation E, I, J and K in order to establish differences, if any, with various blends of identical ingredients taught/suggested by the prior art.
No claims are allowed.
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Vera Afremova
February 3, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653