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 CoQ10 in the reply filed on 4/29/2026 is acknowledged.
The elected species reads on claims 1-4, and 10-17.
Claims 5-9 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/29/2026.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 4/29/2026.
Priority
This Application is a continuation in part of application 16/888,183, which also claims priority to US provisional application 62/855,861.
The effective filing date is 05/31/2019.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 04/07/2023. is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-4 and 10-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to plant extracts (natural phenomenon) without significantly more. The claims recite a composition comprising a quillaja extract and another active ingredient (CoQ10, which can be derived from other plants). The claims (per broadest reasonable interpretation) are interpreted as nothing other than plant extracts (hence a judicial exception). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Moreover, limitations drawn to weight percentages and release times constitute well-understood, routine, conventional activities previously known to the industry, as the industry does know how to select only specific weight percentages and release times.
Step 1: Is the broadest reasonable interpretation of the claims as a whole drawn to a process, machine, manufacture, or composition of matter?
Yes, the broadest reasonable interpretation of the claims is drawn to a combined plant extract (a quillaja extract and CoQ10, which can be derived from broccoli/spinach), which is a composition of matter.
Revised Step 2A:
Prong One: Do the claims recite natural phenomenon?
Yes, the broadest reasonable interpretation of the claims is drawn to a combined plant extract (natural phenomenon) comprising a quillaja extract and another active ingredient (CoQ10, which can be derived from other plants). Thus, quillaja extract and CoQ10 are naturally occurring (natural phenomenon).
Prong Two: Do the claims recite additional elements that integrate the judicial exception (JE) into a practical application?
No, the claims do not recite additional elements that integrate the JE into a practical application.
Step 2B: Do the claims recite additional elements that amount to significantly more than the judicial exceptions (JE)?
No, the claims do not recite additional elements that amount to significantly more than the JE. The instant claims are interpreted (broadest reasonable interpretation) as drawn to plant extracts comprising quillaja extract and CoQ10.
Thus, claims 1-4 and 10-17 are not patent eligible and are rejected under 35 U.S.C. 101.
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.
Claims 13 and 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation of 10%-40%, and the claim also recites 20%-30% which is the narrower statement of the range/limitation. Claim 13 also recites to different ranges (12:75 to about 75:25; and 25:75 to 75:25). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 10-12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amazon (“Designs for Health CoQnol 100mg (60 soft gels)”, Amazon, April 5, 2016).
Amazon anticipates a composition (supplement) which contains quillaja extract and ubiquinol (the reduced form of CoQ10 from claim 4) (page 1). This anticipates claim 1, 4, and 15.
Amazon anticipates a nutritional supplement of claim 2 (page 1). Amazon anticipates ubiquinol (which is a quinone) of claim 3.
Amazon anticipates the active ingredient is geranylgeraniol of claims 10-11 (page 1). Amazon anticipates ubiquinol of claim 12.
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.
Claim(s) 1-4 and 10, 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trials (“The Absorption of Bioactive Berberine in Human”,ClinicalTrials.gov ID NCT03438292, Version published 03/13/2019) and in view of Mantle (Mantle et al., “Coenzyme Q10 and cardiovascular disease: and overview”, Br J Cardiol, October 2015) in view of Resnik (Silvia Resnik, “Quillaia Extracts”, Chemical and Technical Assessment, 2004) and Zhang (Zhang et al., “Medium-Chain triglycerides promote macrophage reverse cholesterol transport and improve atherosclerosis in ApoE-deficient mice fed a high-fat diet”, Nutrition Research, September 2016)
Clinical Trials teaches that “Quillaja extract provides additional benefits of anti-inflammation and cholesterol lowering to dietary supplement” (page 7). This helps teach claims 1-2.
Clinical Trials teaches that Quillaja extract is a natural GRAS (generally recognized as safe) food-grade surfactant/emulsifier ingredient rich in saponins and sapogenins (page 6).
Clinical trials teaches that Quillaja saponin DS-1 promoted the absorption of insulin and aminoglycoside antibiotics via the ocular and nasal route by reducing permeability of epithelial barrier (page 6).
Clinical trials teaches a soft capsule (page 9). This teaches claim 15.
Clinical trials does not teach CoQ10.
Mantle teaches that CoQ10 may protect against atherosclerosis by inhibiting the oxidation of LDL-cholesterol (page 6). Despite a relatively low level of CoQ10 (0.5–0.8 mol/LDL particle) in LDL-cholesterol compared with alpha tocopherol (8–15 mol/LDL particle), CoQ10 has been shown to be the first line of defense against oxidative stress (page 6). This helps teach claims 1, 3-4.
Mantle teaches that CoQ10 is also known as ubiquinone (Introduction). This teaches claims 10 and 12.
Mantle teaches that For dietary supplements, oil-based formulations show enhanced bioavailability (page 4). There is a correlation between supplemental CoQ10 intake and plasma level, up to approximately 300 mg/day (page 4). Absorption of CoQ10 is non-linear, with increasing doses absorbed to a decreasing degree (page 4). Higher daily doses of CoQ10 are, therefore, best taken in 100 mg split doses (page 4). This helps teach claim 13.
Mantle teaches a dietary supplement form that was orally administered (abstract and Congestive Heart Failure). This teaches claim 15.
None of the reference above teach triglycerides.
Resnik teaches that Quillaja extract (Type 1) contains 20-26 % g of saponins, whereas Quillaia extract (Type 2) generally contain 75-90 % of saponins. This teaches claim 14.
Resnik teaches that Quillaja extract can be used in drinks in a concentration up to 500 mg/kg (page 6). This helps teach claim 13.
None of the reference above teach triglycerides.
ZHANG teaches that medium-chain triglycerides (MCTs) could reduce body fat mass and improve the metabolism of cholesterol (abstract). ZHANG also teaches that MCTs can improve atherosclerosis by promoting the reverse cholesterol transport (RCT) process (abstract). This teaches claims 16 and 17.
The artisan would have found it obvious to combine CoQ10, Quillaja extract, and MCTs. Clinical Trials teaches that Quillaja extract lowers cholesterol (which protects against atherosclerosis) (page 7). Mantle teaches that CoQ10 protects against atherosclerosis (page 6). ZHANG teaches that MCTs can improve atherosclerosis (abstract). It is prima facie obvious to combine one atherosclerosis treatment with others in order to form a composition to be used for the very same purpose (preventing/protecting against atherosclerosis). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claims 1-4, and 10. This also teaches claim 16 and 17.
Resnik teaches that Quillaja extract can be used in drinks in a concentration up to 500 mg/kg (page 6). Mantle teaches that supplemental CoQ10 dose of up to 300 mg/day (page 4). Examiner calculates a ratio of 0.6. This falls within the range of claim 13. This teaches claim 13.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 10-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-11 of U.S. Patent No. 11622947 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Reference claims 1-2 anticipate instant claim 1 and 13.
Reference claims 3 anticipates instant claim 2.
Ref. claim 4 anticipates instant claim 3.
Ref. claim 5 anticipates instant claim 4.
Ref. claims 6-7 anticipate instant claims 10 and 12.
Ref. claim 8 anticipates instant claim 15.
Ref. claim 9 anticipates instant claim 14.
Ref. claims 10-11 anticipate instant claims 16-17.
Conclusion
No claims are allowed as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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