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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed January 30th, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
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 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application US 2017/0232032 A1 to Vecht-Lifshitz (herein after Vecht-Lifshitz’032; cited on the IRS form) in view of US Patent No. US 10980756 B1 to Glick (herein after Glick’756; cited on the IDS dated September 13th, 2023) and International Publication Number WO 2014/169221 A2 to Bent (herein after Bent’221; cited on the IDS dated September 13th, 2023).
Regarding claims 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75, Vecht-Lifshitz’032 teaches the treatment of disorders and diseases that may be viral disorders and diseases (page 1paragraph 0006). Additionally, Vecht-Lifshitz’032 teaches an embodiment of the present invention the RNA virus is selected from families Arenaviridae, Filoviridae (claim 4), Bunyaviridae, Flaviviridae (claim 4), and Rhabdoviridae (claim 4) (page 2 paragraph 0046). Moreover, Vecht-Lifshitz’032 teaches an embodiment for the treatment of the RNA virus, Ebola (claim 5), using a composition that includes an S-adenosyl homocysteine hydrolase (SAHH) inhibitor and a DOT1L inhibitor (claim 39); and b) at least one INF alpha inhibitor; and optionally at least one of; i. at least one a-glucosidase inhibitor; ii. at least one endothelial barrier enhancer; iii. at least one cathepsin B inhibitor; and iv. at least one collagen precursor (page 1 paragraphs 0026 – 0032).
Additionally, Vecht-Lifshitz’032 teaches the use of curcumin (claims 2 and 39) as a TNF alpha inhibitor useful in the treatment of Ebola and other viral diseases at a suggested dosage of 2 grams, that is 2000 mg per day (claims 2, 19, and 39) (page 6 Table 1 row 2), Alpha lipoic acid (claims 2 and 39) as a component of the pharmaceutical composition (page 3 paragraph 0081), genistein (claims 2 and 39) as a known in the art TNF alpha inhibitor (page 5 paragraph 0148), and metformin (claims 2 and 39) as an antibiotic compound (page 13 paragraph 0204). Moreover, Vecht-Lifshitz’032 teaches that compositions of the disclosure may comprise additional; active agents selected from a group that consisting of antiviral agents (claims 15 and 39) (page 13 paragraph 0203) such as acyclovir, lamivaudine (claims 16 and 39)(page 15 paragraph 0209), and methylprednisolone (page 14 paragraph 0205). Furthermore, Vecht-Lifshitz’032 teach that the compositions of the present invention may be provided in any suitable dosage form which may be injectable, infusible, inhalable, edible, oral (claim 29) or combinations thereof, as are known in the art (page 9 paragraph 0154).
However, Vecht-Lifshitz’032 fails to a method of treating or preventing a disease or condition associated with a viral infection in a subject wherein the method comprises a step of administering a combination of agents comprising alpha lipoic acid dosed within a range of 600-1200 mg/day, curcumin dosed within a range of 200-3000 mg/day, genistein dosed within a range of 60-600 mg/day, melatonin dosed within a range of 1-40 mg/day, metformin dosed within a range of 250-2000 mg/day, and naltrexone at a low dose within a range of 1.75-7.0 mg/day (claims 2, and 39).
Nevertheless, Glick’756 teach compounds and compositions that are useful in methods of treating coronavirus (claim 6) infections (column 1 lines 15 – 16). Moreover, Glick’756 teach that coronavirus includes SARS-CoV and SARS-CoV-2 (claim 7) (column 1 lines 45 – 52). Additionally, Glick’756 teach the administration of niclosamide compounds in the methods (column 2 lines 10 – 11). Glick’756 teach that the subject can then be administered one or more doses of a therapy as described herein and the levels of SARS-CoV-2 RNA can be monitored, for example, after the first dose, second dose, third dose, etc. or after one week, two weeks, three weeks, four weeks, etc (column 20 line 66 – 67, column 21 lines 1 – 5) to indicate responsiveness to therapy for further administration of one or more doses of the therapy (claim 10) (column 22 lines 9 – 12).
Furthermore, Glick’756 teaches embodiments of one or more secondary active pharmaceutical ingredient from a list that includes genistein (column 38 lines 18); metformin (column 49 line 59); and naltrexone (column 50 line 44). Glick’756 teach that the compositions of the disclosure can be administered prior to exposure to the coronavirus (claim 9) or immediately after exposure or presumed exposure to the coronavirus (claim 8) (column 8 lines 47 – 49). Likewise, Glick’756 teach that the one or more additional therapeutic agents is administered to the subject at about the same time as contacting with or administering the niclosamide (column 29 lines 11 – 13) in the same dosage form (claim 33) (column 29 line 18) or in separate dosage forms (claim 75) (column 29 lines 21 – 22). Moreover, Glick’756 teach that pharmaceutical composition thereof can be administered to subject in need thereof by any accepted route of administration which include, but are not limited to, buccal (claim 30) (column 59 lines 64 – 67).
However, the prior art of Vecht-Lifshitz’032 and Glick’756 fail to a method of treating or preventing a disease or condition associated with a viral infection in a subject wherein the method comprises a step of administering a combination of agents comprising alpha lipoic acid dosed within a range of 600-1200 mg/day (claim 18), curcumin dosed within a range of 200-3000 mg/day (claim 19), genistein dosed within a range of 60-600 mg/day (claim 21), melatonin dosed within a range of 1-40 mg/day (claim 25), metformin dosed within a range of 250-2000 mg/day (claim 23), and naltrexone at a low dose within a range of 1.75-7.0 mg/day (claims 2, 27, and 39).
Nevertheless, Bent’221 teach a combination or supplement which includes curcumin at a daily dose of 2400 mg (claims 2, 19, and 39); melatonin at a daily dose of 10 mg (claim 25); naltrexone at a daily dose of 4.5 mg (claim 27); metformin at a daily dose of 500 mg; alpha lipoic acid at a daily dose of 1200 mg/day (claim 17); genistein (pure) at a daily dose of 8400 mg (page 59 Table 13). Moreover, Bent’221 teach that the maximum recommended daily dose for metformin is 2550 mg with clinically significant responses not seen at doses below 1500 mg/day (claim 23) (page 49 paragraph 00216 lines 23 – 26). Furthermore, Bent’221 teach that metformin therapy is typically initiated with a lower starting dose (e.g., 500 mg once or twice/day or 85- mg/day), with gradually increasing subsequent doses ( e.g., increasing in increments of 500 mg/week or 850 mg/2 weeks) (page 49 paragraph 00216 lines 26 – 28).
While claim 21, recites genistein at a dosage of about 500 mg/day; the prior art does teach the administration at about 8400 mg (6 x 1400 mg) for the treatment of cancers of the epithelial origin (page 59 Table 13). Moreover, Bent’221 teach that while this combination was specifically designed with reference to actual cancer patients and background data, it was realized that the approach of addressing critical pathways and processes, particularly angiogenesis and other metabolic and signaling pathways, that are dysregulated in cancer but may be returned toward normal state by the administration of nutraceutical, chemotherapeutic and/or non-chemotherapeutic combinations (page 59 paragraph 00268 lines 13 – 17). Thus for it would have been within the scope and skill of one of ordinary skill in the art to optimize all the components of the Bent’221 composition; but especially genistein for a suitable composition for the treatment of viral infections as taught by the prior art of Vecht-Lifshitz’032 and Glick’756. 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. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 (II)(A)).
While the prior art of Vecht-Lifshitz’032, Glick’756, and Bent’221 fail to exemplify a composition comprising curcumin, alpha lipoic acid, genistein, melatonin, naltrexone, and metformin for the treatment of viral infections Vecht-Lifshitz’032 and Glick’756 do recite that curcumin, alpha lipoic acid, genistein, melatonin, naltrexone, and metformin separately were useful in compositions against RNA viruses. Therefore, since the prior art of Vecht-Lifshitz’03 and Glick’756 teach curcumin, alpha lipoic acid, genistein, melatonin, naltrexone, and metformin separately were useful in compositions against the RNA viruses it would be prima facie obvious to one of ordinary skill in the art to combine curcumin, alpha lipoic acid, genistein and metformin into a single composition for a method of treating an RNA virus. Thus 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. (MPEP2144.06(I)).
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the composition taught by Bent’221 in view of Vecht-Lifshitz’03 and Glick’756 that is in a method of treating a disease or condition associated with a viral infect. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success because the prior art of Vecht-Lifshitz’03 and Glick’756 teach curcumin, alpha lipoic acid, genistein, melatonin, naltrexone, and metformin separately were useful in compositions against the RNA viruses it would be prima facie obvious to one of ordinary skill in the art to combine curcumin, alpha lipoic acid, genistein and metformin into a single composition for a method of treating an RNA virus. Thus 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. (MPEP2144.06(I)).
Response to Arguments
Applicant's arguments and claim amendments filed January 30th, 2026, with respect to the prior art rejections of claims 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75 have been fully considered but they are not persuasive.
Applicant argues that the prior art reference of Vecht-Lifshitz’032 does not teach the recitations of newly amended claims 2 and 39 (see applicants remarks page 8 paragraphs 2 – 3).
The examiner has modified the prior art rejection of Vecht-Lifshitz’032 in view of Glick’756 and Bent’221 to teach the new recitation of claims 2 and 39.
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 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. US 10195219 to Bent (herein after Bent’219) in view of US Patent Application US 2017/0232032 A1 to Vecht-Lifshitz (herein after Vecht-Lifshitz’032; cited on the IRS form) and US Patent No. US 10980756 B1 to Glick (herein after Glick’756; cited on the IDS dated September 13th, 2023).
Bent’219 recites a combination comprising at least one oral dose of metformin within a range of 500-1000 mg (instant claim 39), at least one oral 50 mg dose of cyclophosphamide, at least one oral 1200 mg dose of alpha-lipoic acid (instant claim 39), at least one oral dose of curcumin in an amount of 750-4500 mg/day (instant claim 39); at least one oral dose of genistein at 500 mg/day (instant claim 39), at least one oral 10 mg dose of melatonin (instant claim 39), and at least one oral dose of naltrexone within range of 1.5-4.5 mg/day (reference claims 7; instant claim 39).
However, Bent’219 fails to recite a method of treating or preventing a disease or condition associated with a viral infection (instant claim 2).
Nevertheless, the teachings of Vecht-Lifshitz’032 and Glick’756 as they relate to the prior art rejection of instant claims 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to use the composition of Bent’219 in view of Vecht-Lifshitz’032 and Glick’756 that is in a method of treating or preventing a disease or condition associated with a viral infection. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success because the prior art of Vecht-Lifshitz’032 and Glick’756 teach that curcumin, alpha lipoic acid, genistein, melatonin, naltrexone, and metformin separately were useful in compositions against RNA viruses. Therefore, since the prior art of Vecht-Lifshitz’03 and Glick’756 teach curcumin, alpha lipoic acid, genistein, melatonin, naltrexone, and metformin separately were useful in compositions against the RNA viruses it would be prima facie obvious to one of ordinary skill in the art to combine curcumin, alpha lipoic acid, genistein and metformin into a single composition for a method of treating an RNA virus. Thus 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. (MPEP2144.06(I)).
Claims 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 90, 93 – 98, and 100 –104 of copending Application No. 17/366830 to Bent (herein after Bent’830) in view of US Patent Application US 2017/0232032 A1 to Vecht-Lifshitz (herein after Vecht-Lifshitz’032; cited on the IRS form), US Patent No. US 10980756 B1 to Glick (herein after Glick’756; cited on the IDS dated September 13th, 2023), and International Publication Number WO 2014/169221 A2 to Bent (herein after Bent’221; cited on the IDS dated September 13th, 2023).
Bent’830 recites a pharmaceutical composition comprising genistein, alpha lipoic acid, metformin, and cyclophosphamide (reference claim 90; instant claim 39); wherein the metformin is present in an amount of 50 - 2000 mg (reference claim 93 – 95; instant claim 39); wherein the alpha lipoic acid is present in an amount of 300-1200 mg (reference claim 96; instant claim 39); wherein the pharmaceutical composition is in solid form (reference claim 97); wherein the pharmaceutical composition has been formulated for oral administration (reference claim 98); wherein the pharmaceutical composition is a powder that has been formulated for application to the tongue (reference claim 100); wherein the pharmaceutical composition has been formulated as a unit dose (reference claim 101); wherein the alpha lipoic acid is R-alpha-lipoic acid (reference claim 102); and further comprising curcumin (reference claim 103). Moreover, Bent’830 recites a combination therapy comprising: (i) the pharmaceutical composition of (reference) claim 90, (ii) curcumin, (iii) genistein, (iv) melatonin, and (v) naltrexone (reference claim 104; instant claim 39).
However, Bent’830 fails to recite a method of treating or preventing a disease or condition associated with a viral infection in a subject wherein the method comprises a step of administering a combination of agents comprising alpha lipoic acid dosed within a range of 600-1200 mg/day (claim 18), curcumin dosed within a range of 200-3000 mg/day (claim 19), genistein dosed within a range of 60-600 mg/day (claim 21), melatonin dosed within a range of 1-40 mg/day (claim 25), metformin dosed within a range of 250-2000 mg/day (claim 23), and naltrexone at a low dose within a range of 1.75-7.0 mg/day (claims 2, 27, and 39).
Nevertheless, the teachings of Vecht-Lifshitz’032, Glick’756, and Bent’221 as they relate to the prior art rejection of instant claims 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of copending application in Bent’830 in view of Bent’221 that is for a composition comprising alpha lipoic acid dosed within a range of 600-1200 mg/day, curcumin dosed within a range of 200-3000 mg/day, genistein dosed within a range of 60-600 mg/day, melatonin dosed within a range of 1-40 mg/day, metformin dosed within a range of 250-2000 mg/day, and naltrexone at a low dose within a range of 1.75-7.0 mg/day in view of Vecht-Lifshitz’03 and Glick’756 that is the use the composition in a method of treating a disease or condition associated with a viral infect. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success because the prior art of Vecht-Lifshitz’03 and Glick’756 teach curcumin, alpha lipoic acid, genistein, melatonin, naltrexone, and metformin separately were useful in compositions against the RNA viruses it would be prima facie obvious to one of ordinary skill in the art to combine curcumin, alpha lipoic acid, genistein and metformin into a single composition for a method of treating an RNA virus. Thus 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. (MPEP2144.06(I)).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments and claim amendments filed January 30th, 2026, with respect to the provisional non-statutory double patenting (NSDP) rejection and NSDP rejection of instant claims 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75 over claim 7 of U.S. Patent No. US 10195219 to Bent (herein after Bent’219), and claims 90, 93 – 98, and 100 –104 of copending Application No. 17/366830 to Bent (herein after Bent’830) have been fully considered but they are not persuasive.
Applicant argues that the invention of Bent’219 and copending application Bent’830 in view of Vecht-Lifshitz’032 are not obvious over newly amended instant claims 2 and 39 (see applicants remarks page 9 paragraph 1).
The examiner has modified the provisional NSDP and NSDP rejections of instant claims 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75 over claim 7 of U.S. Patent No. US 10195219 to Bent (herein after Bent’219), and claims 90, 93 – 98, and 100 –104 of copending Application No. 17/366830 to Bent (herein after Bent’830) in view of Vecht-Lifshitz’032, Glick’756, and Bent’221 to teach the new recitation of claims 2 and 39.
Conclusion
Claims 2, 4 – 10, 15 – 17, 19, 21, 23, 25, 27, 29 – 30, 33, 39, and 75 are rejected.
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.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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