DETAILED ACTION
The present application is a domestic application filed 21 March 2024, which is a continuation of US Application No. 17/549,343 (now abandoned), filed 13 December 2021, which is a continuation of US Application Number 16/287,049 (now abandoned), filed 27 February 2019, which is a continuation of US Application No. 15/420,695 (now abandoned), filed 31 January 2017, which claims priority to US Provisional Application No. 62/290,741, filed 03 February 2016.
Claims 1-24 are pending in the current application and are examined on the merits herein.
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 .
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 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.
Claims 1-11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lines (US Patent No. 8,901,109 cited in PTO-892) in view of Abu Bakar (US Patent Application Publication No. 2015/0080461, cited in PTO-892), Ioos et al. (Medecine et maladies infectieuses, 2014, vol. 44, pp. 302-307, cited in IDS submitted 21 March 2024) and further in view of Tappe et al. (Euro. Surveill., 2014, vol. 19, no. 4, pp. II=20685, cited in IDS submitted 21 March 2024).
Lines teaches quercetin is a natural antioxidant, and inhibits acute and chronic phases of free-radical induced diseases (col.1:21-26)]. Lines found the combination of quercetin, vitamin B3 and vitamin C result in a significantly higher concentration of quercetin in plasma, than quercetin alone (col.2:32-43). Lines teaches administering a composition comprising quercetin, vitamin B3, vitamin C and folic acid (claim 1). The composition can further contain EGCG (col. 3:31-34). Quercetin refers to both quercetin aglycon and quercetin derivatives including for example quercetin-3-O-glucoside (col.2:52-60, i.e. isoquercetin). Lines teaches an exemplary composition having 5.25 wt.% quercetin, 0.25 wt.% vitamin B3, and 7.81 wt.% vitamin C plus 200 µg folic acid per chew (paragraph [0013]). An exemplary composition has 250 mg quercetin, 12.9 mg vitamin B3, and 382.8 mg vitamin C (paragraph [0013]).
Lines also teaches treating subjects suffering a disorder associated with C-reactive protein, including viral infections, comprising administering a dosage comprising 100 mg to 2 g quercetin, wherein each dose or serving should contain 100-800 µg folic acid, and wherein the dose can be administered once or periodically per day (paragraphs [0008], [0012] and [0018]). Lines teaches the amount in the composition should be sufficient to lower C-reactive protein levels (p.3, paragraph [0021] and claims 20-21), as well as provide improvements in fatigue recovery (paragraph [0006]).
Lines do not expressly disclose treating Zika virus infection (present claim 1).
Abu Bakar teaches a composition comprising quercetin for the prophylaxis or treatment of flavivirus infection, (claim 1). Abu Bakar teaches quercetin is in a range of 0.1 to 100% by weight (claim 2); and 29-35 µg/mL has antiviral activity (claims 4 and 5). Abu Bakar teaches flavivirus infections include dengue virus and dengue infection (claims 6 and 7).
Ioos et al. teach Zika virus is a mosquito-born flavivirus, wherein “a great number of cases and some with neurological and autoimmune implications have been reported in a context of concurrent circulation of dengue virus” (abstract). Ioos et al. teach the clinical presentation of Zika virus is a “dengue-like syndrome”, (abstract). Ioos et al. teach Zika virus infection can cause a broad range of symptoms presenting as a “dengue-like” syndrome, including arthralgia, edema of extremities, mild fever, headaches, retro-orbital pain, conjunctival hyperemia, maculopapular rashes, pruritic, vertigo, myalgia and digestive disorder (p.303, 2. Clinical presentation). Ioos et al. teach treatment of Zika virus primarily entails treating symptoms of said Zika virus infection (p.304, first paragraph).
Tappe et al. teach a subject confirmed to have Zika virus infection had elevated levels of C-reactive protein 10 days after disease onset (p.1, fourth paragraph). Tappe et al. also teach the subject complained of “ongoing exhaustion” (p.1, fourth paragraph), and that the “patient reported a clinical picture resembling dengue fever” (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer a composition comprising quercetin, vitamin B3 and vitamin C to treat Zika virus infection in a subject in need thereof.
The recitation “treating Zika virus infection…subject in need thereof” in present claim 1 is broadly and reasonably interpreted to include treating symptoms of Zika virus infection. Paragraph 0018 of the present Specification recites “treatment of subjects in need thereof…can lessen negative side effects caused by replication of the Flaviviridae virus”. Additionally, paragraph 0046 of the Specification recites “treating…refer to the administration of an effective amount of the above-described composition to a subject who needs to improve one or more of the above-mentioned conditions or has one or more of the just-mentioned disorders, or a symptom or a predisposition of one of more of these conditions, or to prevent, cure, alleviate, relieve, remedy, or ameliorate one or more of these disorders, or the symptoms or the predispositions of one or more of them”.
The amount of quercetin, vitamin B3, vitamin C and folic acid disclosed by Lines is identical to the amount recited in the present Specification as an exemplary amount (see paragraph 0039 of the present Specification). Thus, the amount of vitamin B3, vitamin C and folic acid disclosed by Lines is “an effective amount” as recited in present claim 1.
The skilled artisan would have been motivated to administer the composition of Lines to a subject infected with Zika virus to treat said subject because Lines teaches the composition can be used to treat viral infections; Abu Bakar teaches quercetin is an active agent for treating dengue virus infections, wherein both Zika and dengue virus belong to the same class of viruses known as Flaviviridae; and Ioos et al. describe Zika symptoms as “dengue-like”, wherein many of the same symptoms present in dengue viral infections is also present in Zika viral infections.
The ordinary artisan would have known from the teaching of Ioos et al. that treating Zika virus infections entails treating symptoms of the viral infection. Since Ioos et al. teach symptoms of Zika virus are “dengue-like” because they entail substantially the same symptoms present in Dengue infections, the ordinary artisan would have looked to the teaching of Abu Bakar because Abu Bakar teaches treating dengue viral infections.
The ordinary artisan would have had a reasonable expectation of success in treating Zika virus infections with the quercetin/vitamin B3/vitamin C/folate composition of Lines because Abu Bakar teaches quercetin can be used to treat dengue virus infections and symptoms of dengue virus infection significantly overlap with those of Zika virus, and Zika and Dengue belong to the same class of viruses.
In addition to the reasons discussed above, the skilled artisan would have been motivated to treat a subject with Zika virus because Tappe et al. found a subject suffering from Zika infection had elevated C-reactive protein levels and suffered from “ongoing exhaustion”, wherein Lines expressly teaches the quercetin/vitamin B3/vitamin C and folic acid composition lowers levels of C-reactive protein and treats fatigue.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 12-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Eur. J. Nutr., 2014, vol. 53, pp. 1669-1683, cited in IDS submitted 21 March 2024) in view of Lines (cited above).
Wu et al. teach administering quercetin to pregnant and obese female rats had an ameliorating effect on maternal blood lipids, especially cholesterol, improved glucose metabolism, insulin sensitivity, alleviated ER stress, and related inflammation in the offspring of the obese dams ( abstract). Quercetin has been reported to have anti-adipogenic activity, can increase insulin activity, ameliorate leptin dysfunction, and has anti-inflammatory and anti-oxidant activity (p.1670, second para). Quercetin has been reported to have no maternal or fetal toxicity even with a daily intake of 2,000 mg/kg body weight during gestation in rats.
Wu et al. do not expressly disclose administering at least one or more of vitamin B3, vitamin C and a folate compound (present claim 1).
Lines teaches as discussed above. Lines further teaches treating inflammatory diseases and lowering cholesterol levels (paras [0007], [0008], [0017], [0018], [0021]; claims 22 and 23).
The recitation “preventing or reducing the risk of microcephaly in a fetus, the method comprising administering to a pregnant woman carrying the fetus…” in present claim 12 is broadly and reasonably interpreted to include administering the quercetin composition to any pregnant woman.
From Wu et al., the ordinary artisan would have looked to the teaching of Lines because they are both concerned with delivering quercetin to exert an anti-inflammatory and cholesterol reducing effect. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the quercetin/vitamin B3/vitamin C mixture of Lines et al. to a pregnant woman because the mixture resulted in a significantly higher concentration of quercetin in plasma, than quercetin alone. Thus, one of ordinary skill in the art would have expected the composition comprising quercetin, vitamin B3 and vitamin C to be at least as effective as quercetin alone, if not significantly more effective because of the expected higher plasma concentrations of quercetin.
Lines further teaches the synergistic composition can include folate and EGCG. The skilled artisan would have also known from Lines, quercetin can be administered as isoquercetin.
The ordinary artisan would have had a reasonable expectation of success because quercetin is safe and non-toxic in pregnant mammals even at high concentrations, and demonstrated to have a preventive/beneficial effect on the fetus.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
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 12-15, 17, 18 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,440,704 in view of Wu et al. (cited above).
The claims of the ‘704 Patent are directed towards a method for lowering cholesterol levels in a patient, the method comprising administering a composition comprising quercetin, vitamin B3, and vitamin C as the only active ingredients.
The claims of the ‘704 Patent do not expressly disclose administering the composition to a pregnant woman.
Wu et al. teach as discussed above.
The recitation “preventing or reducing the risk of microcephaly in a fetus, the method comprising administering to a pregnant woman carrying the fetus…” in present claim 12 is broadly and reasonably interpreted to include administering the quercetin composition to any pregnant woman.
From Wu et al., one having ordinary skill in the art would have known quercetin has beneficial/protective effects in pregnant females, including lowering cholesterol levels.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the quercetin/vitamin B3/vitamin C mixture of the ‘704 Patent to a pregnant woman because the mixture resulted in a significantly higher concentration of quercetin in plasma, than quercetin alone.
The ordinary artisan would have had a reasonable expectation of success because quercetin is safe and non-toxic in pregnant mammals even at high concentrations, and demonstrated to have a preventive/beneficial effect on the fetus.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claims 12-14, 16, 17, 18 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 8,574,619 in view of Wu et al. (cited above).
The claims of the ‘619 Patent are directed towards a method for lowering cholesterol levels in a patient, the method comprising administering a composition comprising quercetin, vitamin B3, and vitamin C. The composition further contains folic acid.
The claims of the ‘619 Patent do not expressly disclose administering the composition to a pregnant woman.
Wu et al. teach as discussed above.
The recitation “preventing or reducing the risk of microcephaly in a fetus, the method comprising administering to a pregnant woman carrying the fetus…” in present claim 12 is broadly and reasonably interpreted to include administering the quercetin composition to any pregnant woman.
From Wu et al., one having ordinary skill in the art would have known quercetin has beneficial/protective effects in pregnant females, including lowering cholesterol levels.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the quercetin/vitamin B3/vitamin C mixture of the ‘619 Patent to a pregnant woman because the mixture resulted in a significantly higher concentration of quercetin in plasma, than quercetin alone.
The ordinary artisan would have had a reasonable expectation of success because quercetin is safe and non-toxic in pregnant mammals even at high concentrations, and demonstrated to have a preventive/beneficial effect on the fetus.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claims 12-15, 17, 18, 21, 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 7,745,486 in view of Wu et al. (cited above) and Lines.
The claims of the ‘486 Patent are drawn towards a composition comprising quercetin, vitamin B3 and vitamin C as the only active ingredients. Claim 14 specifies the composition further comprises EGCG.
The recitation “preventing or reducing the risk of microcephaly in a fetus, the method comprising administering to a pregnant woman carrying the fetus…” in present claim 12 is broadly and reasonably interpreted to include administering the quercetin composition to any pregnant woman.
From Wu et al., the ordinary artisan would have looked to the teaching of Lines because they are both concerned with delivering quercetin to exert an anti-inflammatory and cholesterol reducing effect. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the quercetin/vitamin B3/vitamin C mixture of Lines et al. to a pregnant woman because the mixture resulted in a significantly higher concentration of quercetin in plasma, than quercetin alone. Lines further teaches the synergistic composition can include folate and EGCG. The skilled artisan would have also known from Lines, quercetin can be administered as isoquercetin.
it would have been obvious to administer the composition of the ‘486 Patent with a reasonable expectation of success because it is the same as the composition of Lines.
The ordinary artisan would have had a reasonable expectation of success because quercetin is safe and non-toxic in pregnant mammals even at high concentrations, and demonstrated to have a preventive/beneficial effect on the fetus.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
Prosecution Insights