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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on August 15, 2025. Claim(s) 1-15, 21, and 24-30 are pending. Claim(s) 13-15, 21, and 24-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a composition comprising quercetin and 6,7-dihydroxybergamottin (6,7- DHB), wherein 6,7-DHB is present in an amount sufficient to enhance the bioavailability of quercetin with traverse of the restriction requirement in the reply is acknowledged.
The traversal is on the grounds that Applicants submit that unity of invention is present. Examiner respectfully notes that (MPEP 1801):
“An international application should relate to only one invention or, if there is more than one invention, the inclusion of those inventions in one international application is only permitted if all inventions are so linked as to form a single general inventive concept (PCT Rule 13.1). With respect to a group of inventions claimed in an international application, unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” is defined in PCT Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art. The determination is made on the contents of the claims as interpreted in light of the description and drawings (if any). Whether or not any particular technical feature makes a “contribution” over the prior art, and therefore constitutes a “special technical feature,” should be considered with respect to novelty and inventive step. For example, a document discovered in the international search shows that there is a presumption of lack of novelty or inventive step in a main claim, so that there may be no technical relationship left over the prior art among the claimed inventions involving one or more of the same or corresponding special technical features, leaving two or more dependent claims without a single general inventive concept. Lack of unity of invention may be directly evident “a priori,” that is, before considering the claims in relation to any prior art, or may only become apparent “a posteriori,” that is, after taking the prior art into consideration. For example, independent claims to A +X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.”
In the instant case, WO 1999/049851 teaches nutraceutical compositons taken orally as a method of improving hormonal balance in women. The composition is taught to comprise green tea extract (quercetin) and grapefruit concentrate (6,7-DHB) (page 41, example 7). Therefore, the special technical feature does not make a contribution over the prior art.
The requirement is deemed proper and is therefore made FINAL. Claim(s) 1-12 are examined herein insofar as they read on the elected invention.
Objection
Claim 8 should be amended to “further” comprise D-ribose-L-cysteine. Corrective action is required.
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 11 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by over Damaj (US 2019/0167699) of record.
Damaj teaches a unit dosage form suitable for oral administration in a human comprising: 300 mg±30 mg of Saw Palmetto; 450 mg±45 mg of Beta-Sitosterol; 150 mg±15 mg of Pygeum Africanum; 75 mg±7.5 mg of Green Tea extract; 15 mg±1.5 mg of Lycopene; and 30 mg±3 mg of Stinging Nettle (claim 1; [0007]-[0016]) and may further comprise quercetin [0019].
Damaj teaches the specific nutraceutical formulation for ProstaVarx, as prostate support formula (Figures 3 and 4).
Based on the foregoing reasons, the instant claims are deemed anticipated over the cited art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Damaj (US 2019/0167699) of record as evidenced by USDA Database for Flavonoid Content.
At the outset, regarding claim 12, Examiner notes for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. MPEP 2111.03.
Damaj teaches a unit dosage form suitable for oral administration in a human comprising: 300 mg±30 mg of Saw Palmetto; 450 mg±45 mg of Beta-Sitosterol; 150 mg±15 mg of Pygeum Africanum; 75 mg±7.5 mg of Green Tea extract; 15 mg±1.5 mg of Lycopene; and 30 mg±3 mg of Stinging Nettle (claim 1; [0007]-[0016]) and may further comprise quercetin [0019].
Furthermore, Damaj teaches green tea extract in the oral formulations. Green tea extracts inherently contains quercetin.
As evidenced by the USDA database for Flavonoid content, 100g of dry green tea leaves contains on average 223.97 mg of quercetin (pages 93-94, entry 99061).
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Damaj teaches the unit dosage form further comprises zinc (claim 4).
Damaj teaches the unit dosage form further comprises one or more excipients selected from gelatin, magnesium stearate, stearic acid, and microcrystalline cellulose (claim 10).
Damaj teaches FIG. 1 shows ingredients of the present invention: Saw Palmetto, Beta Sitosterol, Quercetin, Stinging Nettle, Pygeum Africanum, and Green Tea [0026].
Damaj teaches the specific nutraceutical formulation for ProstaVarx, as prostate support formula (Figures 3 and 4).
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Damaj does not specifically teach 6,7-DHB is present in an amount sufficient to enhance that bioavailability of quercetin.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the concentration of the quercetin in the formulation to arrive at the instant invention. Generally, mere optimization of ranges will not support the, patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382 "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." MPEP 2114.04.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Damaj (US 2019/0167699) of record as applied to claims 1-7 and 10-12 in the 103 rejection above in view of Emokpae (Drug Dev Res., 2020).
Damaj is discussed above.
Damaj does not teach the composition further comprising D-ribose-L-cysteine and the amounts required by the limitations of the instant claims.
Emokpae teaches D-ribose-L-cysteine, an analogue of cysteine, has been shown to boost cellular antioxidant capacity by enhancing intracellular biosynthesis of glutathione (GSH) (abstract).
Emokpae teaches D-ribose-L-cysteine is employed in doses of 25, 50, or 100 mg/kg (page 621-622, bridging ¶).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the antioxidant formulations as taught by Damaj and also employed the antioxidant D-ribose-L-cysteine in the composition. The examiner respectfully points out the following from MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art.', In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
Furthermore, the skilled artisan would have found it obvious to vary the concentration of the D-ribose-L-cysteine in the formulation to arrive at the instant invention. Generally, mere optimization of ranges will not support the, patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382 "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." MPEP 2114.04.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1-12 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-32800-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627
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