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 Application
This Office Action is in response to Applicant's arguments filed on March 23, 2026. Claim(s) 1-15, 21, and 24-30 are pending. Claims 13-15, 21, and 24-30 are withdrawn. Claims 1-12 are examined on the merits herein.
Response to Arguments
In view of applicant’s amendments, the 102 (a)(1) rejection over claim 11 is as being anticipated by over Damaj (US 2019/0167699) of record is hereby withdrawn.
Applicant’s arguments and amendments with respect to the 103 rejection over claims 1-7 and 10-12 as being unpatentable over Damaj (US 2019/0167699) of record as evidenced by USDA Database for Flavonoid Content have been fully considered.
Applicant argues:
As noted above, Damaj is directed to a dietary supplement for prostate function support. Although Damaj includes quercetin, it is entirely silent as to 6,7-DHB. Damaj does not identify 6,7-DHB as a component of its composition, does not disclose adding 6,7-DHB to quercetin, and does not disclose any amount or concentration of 6,7-DHB, let alone the presently claimed range of 1 mg to 50 mg. Most importantly, Damaj does not teach or suggest that any component should be selected or administered in an amount sufficient to enhance the bioavailability of quercetin. The Office acknowledges in the office action on page 8 that Damaj does not specifically teach 6,7-DHB in an amount sufficient to enhance quercetin bioavailability. That acknowledgement is dispositive of a central claim limitation. The present claims are not directed merely to quercetin in a formulation rather, they require the presence of 6,7-DHB in a defined amount and for enhancement of quercetin bioavailability. Damaj does not provide this teaching. To overcome the deficiencies of the Damaj reference, the Office cited USDA Database for Flavonoid Content. The USDA Database for Flavonoid Content does not remedy the deficiencies of Damaj. At most, such a database reports the occurrence or amount of flavonoids in foods. It does not disclose the claimed co-formulation of quercetin with 6,7-DHB, does not disclose the specific concentration of 6,7-DHB now recited in claims 1, 3, and 11, and does not teach that 6,7- DHB at those concentrations enhances quercetin bioavailability.
Regarding the arguments above, examiner respectfully notes applicant’s contention that Damaj is silent on the teaching of 6,7-DHB is unpersuasive. By applicant’s own admission in the specification (page 2, lines 17-20) and claim 4, the source of 6,7-DHB is present in the form of nettle root extract. The teaching of stinging nettle in Damaj addresses the limitation regarding the presence of 6,7-DHB in the composition. As set forth on record, Damaj teaches a composition comprising green tea extract and stinging nettle. The USDA database for Flavonoid Content reference was employed to exemplify that green tea is a source of quercetin. Thus, the combination of green tea extract and stinging nettle addresses the limitations of the instant claims regarding the presence of the two active ingredients in the claimed composition. Furthermore, while Damaj’s compositions are intended as a dietary supplement for prostate function, the instant claims are drawn to a composition. Therefore, if the composition is taught, the limitations of the claims are met. Moreover, applicant’s contention that the prior art does not appreciate the role of 6,7-DHB in enhancing the bioavailability of quercetin is not persuasive. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. While there must be motivation to make the claimed invention, there is no requirement that the prior art provide the same reason as the applicant to make the claimed invention. MPEP 2144 Sources of Rationale Supporting a Rejection Under 35 U.S.C. 103. /www.uspto..qov/web/offices/pac/mpep/documents/2100 2144.htm>.
Additionally, regarding the finding that 6,7-DHB enhances the bioavailability of quercetin does not warrant novelty. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). >In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Id.< See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
Based on the foregoing reasons, applicant’s arguments are not persuasive and said rejection is hereby maintained.
Applicant’s arguments and amendments with respect to the 103 rejection over claims 8 and 9 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) have been fully considered.
Applicant argues:
As discussed above, Damaj does not disclose 6,7-DHB, does not disclose the presently claimed amounts of 6,7-DHB, and does not teach enhancement of quercetin bioavailability. The office cites Emokpae to cure the deficiencies of Damaj. Emokpae does not cure these deficiencies. Rather Emokpae teaches D-Ribose-L-cysteine (DRLC), an analog of cysteine that boosts glutathione (GSH) content and its effects in an LPS-induced mouse model. Emokpae is silent with respect to quercetin and 6,7-DHB. A person of ordinary skill in the art would not have considered Emokpae relevant to the problem addressed by the present invention. Emokpae evaluates oxidative stress biomarkers, acetylcholinesterase activity, proinflammatory cytokines, and NF-kB expression, and concludes that DRLC works through inhibition of oxidative stress, release of proinflammatory cytokines, and expression of NF-kB. See, page 10 of Emokpae. Emokpae further discusses studies glutathione-related antioxidant and anti-inflammatory effects in an LPS-induced mouse memory model, rather than any effect on quercetin bioavailability.
Arguments regarding the silence on the teaching of 6,7-DHB and its role in enhancing the bioavailability of quercetin have been addressed in the arguments above. As set forth on the record, that while the Emokpae reference does not teach a6,7-DHB and quercetin, the reference was employed to teach the addition of D-ribose-L-cysteine. All components are taught as playing an antioxidative role in the compositions. Therefore, one of ordinary skill in the art would find it 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).
Based on the foregoing reasons, applicant’s arguments are not persuasive and said rejection is hereby maintained.
Any rejection/objection from the previous Office action not set forth on record below is hereby withdrawn.
The maintained/modified rejections are made in the Final Office action below as necessitated by amendment.
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]) (meeting the limitation of 6,7-DHB) 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.
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 extension fee 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.
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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)270-3280. 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 1622
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