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 .
Applicant’s arguments, filed 12/15/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-4, 6, 7, 9-12, and 20-23, are pending and under examination.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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 9 stands 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.
As discussed in the prior Office Action, claim 9 recites “wherein the quercetin has a bioavailability of greater than 1, or about 2 to about 100, or about 25 to about 75, or about 40 to about 60,” and it is unclear what a bioavailability of greater than 1, etc., means where the Examiner is not sure if these values are a weight percentage based on the weight of the quercetin in the composition, or something else. Further, the instant specification does not provide any guidance as to what these numerical values refer to. For purposes of examination, the Examiner is relying upon the working embodiments in the instant specification for whether or not quercetin will have a bioavailability as instantly claimed.
Response to Arguments
Applicants assert that the term “bioavailability” was well known in the art at the time of Applicants’ priority filing. Applicants assert the skilled artisan would have appreciated that “bioavailability” refers to the degree and rate at which a substance is absorbed into a living system. Therefore, Applicants assert the term “bioavailability” is definite.
This argument is not persuasive. The examiner does not disagree that the term “bioavailability” was known in the prior art, however, the term “bioavailability” is not where the issue of lack of clarity lies. Here, as previously discussed, it is unclear what the numerical values represent when the bioavailability is greater than 1, etc. For example, a bioavailability of greater than 1 wt% based on the total weight of quercetin? Greater than 1 vol% based on the total volume of quercetin? Does a bioavailability of greater than 1 mean greater than 100 wt% of the total weight of quercetin? Or do the numerical values represent something else entirely? The instant specification does not appear to provide any guidance as to what these numerical values refer to. Accordingly, the claims stand rejected for the same reasons above and of record.
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.
Claims 1, 2, 6, 12, and 20-23, stand rejected under 35 U.S.C. 103 as being unpatentable over Mazed et al (US 20110274680 A1), in view of Jouni et al (US 20130095204 A1, cited on IDS dated 07/11/2024), as evidenced by Lonza (L-OptiZinc® Zinc Mono-L-methionine, retrieved 2025).
Mazed et al disclose a dietary supplement composition in the form of a solid softgels comprising beta glucan at 200 mg, quercetin at 200 mg, vitamin A at 0.3 mg (i.e., 300 mcg RAE), vitamin C at 100 mg, vitamin D3 at 0.008 mg, and zinc (as L-OptiZinc®) at 5 mg (table 3). As evidenced by the instant specification, cholecalciferol (i.e., vitamin D3) is a suitable vitamin D (see pg 9 1st ¶). As evidenced by Lonza, L-OptiZinc® is an amino acid chelated zinc. The amount of ingredients may range +/- 50% (table 3).
Mazed et al are discussed above but do not teach the amount of quercetin, vitamin C, or zinc, as instantly claimed, nor wherein beta glucan is beta-1,3-glucan.
Jouni et al teach nutritional phytonutrient supplements, where it was known to include quercetin in amounts ranging from 0.01-150 mg, vitamin C from 26-126 mg, and zinc from 3.5-13 mg (¶ 128, tables 1-16). Phytonutrients were known to be associated with various health benefits, including improved cardiovascular health, neurological benefits, improved general health, etc. (¶¶ 4, 6). A subject’s national needs were known to vary with age, and the exact composition can vary depending on the population of interest, dietary intake information, age of the subject, etc. (¶¶ 125, 165, 179). The compositions further comprise beta-glucan, including beta-1,3-glucan, etc. (¶ 93, tables 1-16).
Regarding claim 1, the composition disclosed by Mazed et al comprises beta glucan, quercetin, vitamin A, vitamin C, and vitamin D, and zinc, thereby meeting the required components of claim 1.
Regarding the amount of beta glucan of claim 1, beta glucan is included at 200 mg, falling within the claimed range.
Regarding the amount of quercetin of claim 1, it would have been obvious to adjust the amount of quercetin to other amounts known to be suitable for nutritional supplement compositions, such as from 0.01-150 mg, depending on the nutritional needs of a subject, the age of the subject, population of interest, etc., as taught by Jouni et al.
Regarding the amount of vitamin A of claim 1, vitamin A is included at 300 mcg RAE, falling within the claimed range.
Regarding the amount of vitamin C of claim 1, it would have been obvious to adjust the amount of vitamin C to other amounts known to be suitable for nutritional supplement compositions, such as from 26-126 mg, depending on the nutritional needs of a subject, the age of the subject, population of interest, etc., as taught by Jouni et al.
Regarding the amount of vitamin D of claim 1, vitamin D is included at 0.008 mg, falling within the claimed range.
Regarding the amount of zinc of claim 1, it would have been obvious to adjust the amount of zinc to other amounts known to be suitable for nutritional supplement compositions, such as from 3.5-13 mg, depending on the nutritional needs of a subject, the age of the subject, population of interest, etc., as taught by Jouni et al.
Further, the skilled artisan would reasonably be expected to determine the working ranges for each individual nutrient, depending on the nutritional needs of an individual subject, where the skilled artisan would recognize that nutritional needs can vary greatly between subjects. Accordingly, it would have been obvious for the skilled artisan to routinely optimize the amount of nutrients in the supplemental formulations to meet the needs of a desired subject. 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. Where 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. See MPEP 2144.05(II)(A).
Regarding claim 2, it would have been obvious to select from known forms of beta glucan suitable for nutritional supplement compositions, such as beta-1,3-glucan, as taught by Jouni et al.
Regarding claim 6, the zinc present in the composition made obvious above is an amino acid chelated zinc, as evidenced above.
Regarding claim 12, the solid softgels of Mazed et al reads on a capsule, where the instant specification lists soft gelatin as a suitable capsule form (see pg 12 of the instant specification).
Regarding claim 20, beta glucan is present in the composition made obvious above in an amount of 200 mg, falling within the claimed range.
Regarding claim 21, where the amount of vitamin A may range +/- 50%, as taught by Mazed et al, the amount of vitamin A can range from 150-450 mcg RAE, overlapping the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, it would have been obvious for the skilled artisan to routinely optimize the amount of each component, for the same reasons discussed above.
Regarding claim 22, where the amount of vitamin D3 may range +/- 50%, as taught by Mazed et al, the amount of vitamin D3 can range from 0.004-0.012 mg, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, it would have been obvious for the skilled artisan to routinely optimize the amount of each component, for the same reasons discussed above.
Regarding claim 23, it would have been obvious to modify the composition made obvious above comprising beta glucan, quercetin, vitamin A, vitamin C, vitamin D, and zinc, in amounts overlapping those instantly claimed, for the same reasons discussed above, as applied to each and every component.
Response to Arguments
Applicants assert independent claim 1 has been amended to narrow the range of each component, and asserts Mazed et al fails to disclose the newly amended limitations.
Respectfully, this argument is not persuasive. Jouni et al is newly cited for addressing the newly amended claimed limitations, and makes obvious the ranges for the same reasons discussed above.
Claims 2, 10, and 11, stand rejected under 35 U.S.C. 103 as being unpatentable over Mazed et al (US 20110274680 A1) and Jouni et al (US 20130095204 A1, cited on IDS dated 07/11/2024), as applied to claim 1, 2, 6, 12, and 20-23 above, and further in view of LeBrun et al (US 20190262381 A1, cited on IDS dated 07/11/2024).
Mazed et al and Jouni et al are discussed above but do not teach wherein the beta glucan was isolated from algae, nor wherein the algae is Euglena gracillis algae. Further, the inclusion of beta-1,3-glucan is made obvious above, and additional motivation for selecting beta-1,3-glucan is provided by Lebrun et al.
LeBrun et al teach supplement compositions comprising beta glucan and zinc that can be used in combination with quercetin (abs, ¶ 97), where the beta glucan is predominantly beta-1,3-glucan and can be derived and extracted from Euglena gracillis, where the use of algae derived beta glucans as a nutritional supplement may provide lower-cost and potentially higher purity immune modulating supplements for human and animal supplement applications (¶¶ 11, 76). Further, beta glucan from algae removes the need for potentially harmful or expensive solvent based extraction processes (¶ 11). Beta-1,3-glucan can be orally administered to promote immune system health, prevent disease, reduce mortality, reduce the effects of stress, etc. (¶¶ 17, 50).
Regarding claim 2, the selection of beta-1,3-glucan is made obvious by Jouni et al above, and additional motivation for selecting beta-1,3-glucan is provided by LeBrun et al, where beta-1,3-glucan was known to be suitable for disease prevention, immune health, etc.
Regarding claims 10 and 11, it would have been obvious to use a known source of beta glucan that was known to be suitable for nutritional supplements, such as beta glucan from Euglena gracillis algae, which was known to be a lower cost source of beta glucan, have potentially higher immune modulating supplements, etc., as taught by LeBrun et al.
Response to Arguments
Applicants assert independent claim 1 has been amended to narrow the range of each component, and asserts Mazed et al in view of LeBrun et al fail to disclose the newly amended limitations.
Respectfully, this argument is not persuasive. Jouni et al is newly cited for addressing the newly amended claimed limitations, and makes obvious the ranges for the same reasons discussed above.
Claims 3 and 9 stand rejected under 35 U.S.C. 103 as being unpatentable over Mazed et al (US 20110274680 A1) and Jouni et al (US 20130095204 A1, cited on IDS dated 07/11/2024), as applied to claims 1, 2, 6, 12, and 20-23 above, and further in view of Rondanelli et al (Life, 2022, 12(1):66, cited on IDS dated 07/11/2024), as evidenced by Zhang et al (US 20170014374 A1, hereinafter ‘374).
Mazed et al and Jouni et al are discussed above but do not teach wherein the quercetin is in a blend comprising Sophora japonica extract and one or more phospholipids, nor specifically disclosing the bioavailability of quercetin.
Rondanelli et al teach supplement compositions comprising quercetin, wherein quercetin from Sophora japonica (i.e., a quercetin extract) was formulated with Phytosome® to optimize its oral bioavailability, wherein the quercetin phytosome enhanced plasmic levels of quercetin and improves quercetin absorption by up to 20 times after oral administration vs unformulated quercetin (pg 9 ¶¶ 3-4). As evidenced by ‘374, quercetin phytosome is a mixture of Sophora japonica extract and a phosphatidylcholine complex (i.e., a blend).
Regarding claim 3, where Mazed et al and Jouni et al make obvious an oral supplement composition comprising quercetin as instantly claimed, it would have been obvious to modify the composition by substituting the quercetin with the quercetin Sophora japonica extract and phosphatidylcholine blend of Rondanelli et al, where the blend of Rondanelli et al was known to improve quercetin absorption by up to 20 times vs unformulated quercetin for oral supplements, in order to increase the bioavailability of quercetin.
Regarding claim 9, as noted above, the Examiner is relying upon the instant working examples to determine whether or not quercetin has a bioavailability as instantly claimed. Where the instant working embodiments all use a quercetin blend of Sophora japonica extract and phospholipids, it appears that the quercetin blend made obvious above has a bioavailability that meets the limitations of instant claim 9.
Response to Arguments
Applicants assert independent claim 1 has been amended to narrow the range of each component, and asserts Rondanelli et al and Zhang et al fail to remedy the deficiencies of Mazed et al.
Respectfully, this argument is not persuasive. Jouni et al is newly cited for addressing the newly amended claimed limitations, and makes obvious the ranges for the same reasons discussed above.
Claim 4 stands rejected under 35 U.S.C. 103 as being unpatentable over Mazed et al (US 20110274680 A1) and Jouni et al (US 20130095204 A1, cited on IDS dated 07/11/2024), as applied to claims 1, 2, 6, 12, and 20-23 above, and further in view of Zhang et al (Fitoterapia 2016, 113, pp. 102-109).
Mazed et al and Jouni et al are discussed above but do not teach wherein the quercetin is complexed to one or more phospholipids.
Zhang et al teach the bioavailability of quercetin is relatively low due to its low solubility, and it was known that quercetin complexed with phospholipids improves the bioavailability of quercetin, thereby allowing better absorption of quercetin (abs, pg 107 1st ¶).
It would have been obvious to substitute the quercetin in the composition made obvious above with quercetin forms that were known to improve the bioavailability of quercetin, such as the quercetin complexed with phospholipids of Zhang et al, thereby allowing better absorption of quercetin.
Response to Arguments
Applicants assert independent claim 1 has been amended to narrow the range of each component, and asserts Zhang et al fail to remedy the deficiencies of Mazed et al.
Respectfully, this argument is not persuasive. Jouni et al is newly cited for addressing the newly amended claimed limitations, and makes obvious the ranges for the same reasons discussed above.
Claim 7 stands rejected under 35 U.S.C. 103 as being unpatentable over Mazed et al (US 20110274680 A1) and Jouni et al (US 20130095204 A1, cited on IDS dated 07/11/2024), as applied to claims 1, 2, 6, 12, and 20-23 above, and further in view of Rabovsky et al (US 20100009901 A1).
Mazed et al and Jouni et al are discussed above but do not teach wherein the zinc is a zinc amino acid compound conjugated with a polysaccharide.
Rabovsky et al teach dietary supplements where it was known to use zinc amino acid polysaccharide complexes to increase solubility of zinc, where the solubility of zinc amino acid polysaccharide complex is greater than the mineral administered as a mineral amino acid (¶ 197). The human body requires zinc, and soluble forms are needed in order to increase bioavailable within the bloodstream (¶ 3).
It would have been obvious to substitute the zinc amino acid chelate in the composition made obvious above with a zinc amino acid polysaccharide complex of Rabovsky et al, where the reference teaches it was known to have increased solubility over mineral amino acid, in order to increase the bioavailability of zinc.
Response to Arguments
Applicants assert independent claim 1 has been amended to narrow the range of each component, and asserts Rabovsky et al fail to remedy the deficiencies of Mazed et al.
Respectfully, this argument is not persuasive. Jouni et al is newly cited for addressing the newly amended claimed limitations, and makes obvious the ranges for the same reasons discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612