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 .
CONTINUING DATA
This application has PRO 63/667,464 07/03/2024
This application has PRO 63/519,358 08/14/2023
Claims 1-20 are pending.
Claim Rejections - 35 USC § 112
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.
Claims 3-4 and 18 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “a pyridoxine,” and the claim also recites “optionally wherein the pyridoxine is selected from the group consisting of,” which is the narrower statement of the range/limitation.
In the present instance, claim 4 recites the broad recitation “herpesvirus,” and the claim also recites “optionally wherein the herpesvirus is a herpes simplex virus,” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 18 recites a method of reducing frequency of a herpesvirus infection. It is unclear whether reducing frequency means that the subject already has a herpesvirus infection, or is at risk of repeatedly being reinfected, or whether the subject does not yet have herpesvirus. Paragraph [00184] of the specification recites a method of reducing frequency of recurrent outbreaks. It is unclear whether reducing the frequency of recurring outbreaks is what is actually intended in claim 18.
Claim Rejections - 35 USC § 102
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 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(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phillips (US 2020/0108086 A1, 2020).
Phillips teaches a composition in oral dosage form comprising 1,000-5,000 mg lysine, an ascorbic compound, a flavonoid glycoside, a threonine, a taurine, a pyridoxine, and a carrier. See claim 1. A single dose comprises from about 2 g to about 3.5 g L-lysine monohydrochloride; from about 0.1 g to about 1.5 g ascorbic acid; from about 0.2 g to about 0.8 g hesperidin; from about 0.1 g to about 0.5 g rutin; from about 0.04 g to about 0.08 g pyridoxine hydrochloride; from about 0.01 g to about 0.08 g threonine; and from about 0.02 g to about 0.4 g taurine. See claim 18. The dosage form further comprised from about 0.5 g to about 0.75 g calcium ascorbate; from about 0.1 g to about 0.5 g niacinamide ascorbate; and from about 0.01 g to about 0.1 g ascorbyl palmitate. See claim 19. The dosage form was a powder, capsule, lozenge, troche, tablet, liquid, or caplet. See claim 2. The dosage form may also comprise vehicle, binder, disintegrating agent, etc. [0094]. The threonine is L-threonine [0088].
The composition is used to decrease viral activity or reduce viral infection in a cell comprising a herpes virus infection such as herpes simplex or herpes zoster. See claims 21 and 43. The composition is used for treatment or prophylaxis of a viral infection in a patient. See abstract. The rejected claims encompass preventing a herpesvirus infection in a patient, so the patient is not required to have a herpesvirus infection at the time of treatment. Claim 18 is unclear as set forth above, but to the extent that claim 18 encompasses treatment of a subject which does not have herpesvirus, claim 18 is included in this rejection.
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.
Claim(s) 1-9 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (US 2020/0108086 A1, 2020).
Phillips teaches a composition in oral dosage form comprising 1,000-5,000 mg lysine, an ascorbic compound, a flavonoid glycoside, a threonine, a taurine, a pyridoxine, and a carrier. See claim 1. A single dose comprises from about 2 g to about 3.5 g L-lysine monohydrochloride; from about 0.1 g to about 1.5 g ascorbic acid; from about 0.2 g to about 0.8 g hesperidin; from about 0.1 g to about 0.5 g rutin; from about 0.04 g to about 0.08 g pyridoxine hydrochloride; from about 0.01 g to about 0.08 g threonine; and from about 0.02 g to about 0.4 g taurine. See claim 18. The dosage form further comprised from about 0.5 g to about 0.75 g calcium ascorbate; from about 0.1 g to about 0.5 g niacinamide ascorbate; and from about 0.01 g to about 0.1 g ascorbyl palmitate. See claim 19. The dosage form is a powder, capsule, lozenge, troche, tablet, liquid, or caplet. See claim 2. The dosage form may also comprise vehicle, binder, disintegrating agent, etc. [0094].
The composition is used to decrease viral activity or reduce viral infection in a cell comprising a herpes virus infection such as herpes simplex or herpes zoster. See claims 21 and 43. The composition is used for treatment or prophylaxis of a viral infection in a patient. See abstract and paragraph [0110].
A composition containing lysine, vitamin C and hesperidin had previously been used for treating herpes infection [0015]. Lysine was also previously known to treat herpes simplex virus or herpes zoster viruses [0082].
Phillips teaches treatment of a herpes virus infection in a cell, and treatment of viral infections in a subject generally, but does not explicitly teach administration of the composition to a subject suffering from herpesvirus infection.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to administer the Phillips composition to a subject to treat herpesvirus because Phillips teaches that the composition is used to treat viral infections, and that the composition is used to treat herpesvirus in a cell, and also that several of the active agents in the composition are known for treating herpesvirus. Treatment of herpesvirus in a subject flows naturally from Phillips’s teachings that the composition is used to treat viruses in a subject and herpesvirus in a cell.
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 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9034834. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘834 patent claims a single oral dose comprising about 2 g to about 3.5 g L-lysine monohydrochloride; from about 0.1 g to about 1.5 g ascorbic acid; from about 0.2 g to about 0.8 g hesperidin; from about 0.1 g to about 0.5 g rutin; from about 0.04 g to about 0.08 g pyridoxine hydrochloride; from about 0.01 g to about 0.08 g threonine; and from about 0.02 g to about 0.4 g taurine; further comprising from about 0.5 g to about 0.75 g calcium ascorbate; from about 0.1 g to about 0.5 g niacinamide ascorbate; and from about 0.01 g to about 0.1 g ascorbyl palmitate. See claims 9-10. The composition is a powder, capsule, lozenge, troche, tablet, liquid, or caplet (claim 6). The ‘834 claims anticipate current claims 11-16.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to include a vehicle, sweetener, flavoring, etc. to the ‘834 composition because it is an oral dosage form such as a lozenge.
Claims 1-10 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9034834 in view of Wilkinson (WO 92/15315, cited on IDS).
The ‘834 patent claims an antiviral composition for treating a viral infection which is an influenza viral infection.
The ‘834 patent does not claim treatment of a herpesvirus infection.
Wilkinson teaches that herpes infection may be treated using lysine, vitamin C, and hesperidin. See abstract. The infection is a herpes simplex infection (see claim 6).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat herpesvirus using the ‘834 composition because the ‘834 composition is used to treat a viral infection and three of the components of the ‘834 composition are known in the art for treating herpes virus.
Claims 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9907809. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘809 patent claims a single antiviral oral dose comprising about 2 g to about 3.5 g L-lysine monohydrochloride; from about 0.1 g to about 1.5 g ascorbic acid; from about 0.2 g to about 0.8 g hesperidin; from about 0.1 g to about 0.5 g rutin; from about 0.04 g to about 0.08 g pyridoxine hydrochloride; from about 0.01 g to about 0.08 g threonine; and from about 0.02 g to about 0.4 g taurine; further comprising from about 0.5 g to about 0.75 g calcium ascorbate; from about 0.1 g to about 0.5 g niacinamide ascorbate; and from about 0.01 g to about 0.1 g ascorbyl palmitate. See claims 16-17. The composition is a powder, capsule, lozenge, troche, tablet, liquid, or caplet (claim 2), and it also includes a binder or sweetener, etc. (claim 12). The ‘809 claims anticipate current claims 11-17.
Claims 1-10 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9907809 in view of Wilkinson (WO 92/15315, cited on IDS).
The ‘809 patent claims an antiviral composition as set forth above.
The ‘809 patent does not claim treatment of a herpesvirus infection.
Wilkinson teaches that herpes infection may be treated using lysine, vitamin C, and hesperidin. See abstract. The infection is a herpes simplex infection (see claim 6).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat herpesvirus using the ‘809 composition because the ‘809 composition is used to treat a viral infection and three of the components of the ‘809 composition are known in the art for treating herpes virus.
Claims 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10478447. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘447 patent claims method for treating a viral infection comprising administering a single oral dose comprising 1,000-5,000 mg L-lysine monohydrochloride, ascorbic acid, calcium ascorbate, niacinamide ascorbate, ascorbyl palmitate, hesperidin, rutin, pyridoxine hydrochloride, threonine, and taurine, and further comprising calcium ascorbate, niacinamide ascorbate, and ascorbyl palmitate. See claims1 and 9-10. The composition is a powder, capsule, lozenge, troche, tablet, liquid, or caplet (claim 3). The ‘447 claims anticipate current claims 11-16.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to include a vehicle, sweetener, flavoring, etc. to the ‘447 composition because it is an oral dosage form such as a lozenge.
Claims 1-10 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10478447 in view of Wilkinson (WO 92/15315, cited on IDS).
The ‘447 patent claims a method for treating a viral infection as set forth above.
The ‘447 patent does not claim treatment of a herpesvirus infection.
Wilkinson teaches that herpes infection may be treated using lysine, vitamin C, and hesperidin. See abstract. The infection is a herpes simplex infection (see claim 6).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat herpesvirus using the ‘447 composition because the ‘447 composition is used to treat a viral infection and three of the components of the ‘447 composition are known in the art for treating herpes virus.
Claims 11-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11224606. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘606 patent claims method for treating a viral infection in a cell comprising administering 2 g to about 3.5 g L-lysine monohydrochloride; from about 0.1 g to about 1.5 g ascorbic acid; from about 0.2 g to about 0.8 g hesperidin; from about 0.1 g to about 0.5 g rutin; from about 0.04 g to about 0.08 g pyridoxine hydrochloride; from about 0.01 g to about 0.08 g threonine; and from about 0.02 g to about 0.4 g taurine, and further comprising about 0.5 g to about 0.75 g calcium ascorbate; from about 0.1 g to about 0.5 g niacinamide ascorbate; and from about 0.01 g to about 0.1 g ascorbyl palmitate. Claims 9-10. The ‘606 claims anticipate current claims 11-15.
Claims 1-10 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11224606 in view of Wilkinson (WO 92/15315, cited on IDS).
The ‘606 patent claims a method for treating a viral infection in a cell as set forth above.
The ‘606 patent does not claim treatment of a herpesvirus infection.
Wilkinson teaches that herpes infection may be treated using lysine, vitamin C, and hesperidin. See abstract. The infection is a herpes simplex infection (see claim 6). The composition is administered orally (claim 13) in such as a tablet containing a binder (page 10, last paragraph).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat herpesvirus using the ‘606 composition because the ‘606 composition is used to treat a viral infection in a cell and three of the components of the ‘606 composition are known in the art for treating herpes virus in a subject. It would have been obvious to orally administer the composition in the form a tablet which also contained a binder because Wilkinson teaches treatment of herpes using a tablet composition.
Claims 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11826377. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘377 patent claims an antiviral composition comprising about 2 g to about 3.5 g L-lysine monohydrochloride; from about 0.1 g to about 1.5 g ascorbic acid; from about 0.2 g to about 0.8 g hesperidin; from about 0.1 g to about 0.5 g rutin; from about 0.04 g to about 0.08 g pyridoxine hydrochloride; from about 0.01 g to about 0.08 g threonine; and from about 0.02 g to about 0.4 g taurine; further comprising from about 0.5 g to about 0.75 g calcium ascorbate; from about 0.1 g to about 0.5 g niacinamide ascorbate; and from about 0.01 g to about 0.1 g ascorbyl palmitate. See claims 16-17. The composition is a powder, capsule, lozenge, troche, tablet, liquid, or caplet (claim 18). The ‘377 claims anticipate current claims 11-16.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to include a vehicle, sweetener, flavoring, etc. to the ‘377 composition because it is an oral dosage form such as a lozenge.
Claims 1-10 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11826377 in view of Wilkinson (WO 92/15315, cited on IDS).
The ‘377 patent claims an antiviral composition for treating a viral infection which is an influenza viral infection.
The ‘377 patent does not claim treatment of a herpesvirus infection.
Wilkinson teaches that herpes infection may be treated using lysine, vitamin C, and hesperidin. See abstract. The infection is a herpes simplex infection (see claim 6).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat herpesvirus using the ‘377 composition because the ‘377 composition is used to treat a viral infection and three of the components of the ‘377 composition are known in the art for treating herpes virus.
Claims 11-14 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12702677. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘677 patent claims an antiviral supplement tablet comprising about 2 g to about 3.5 g L-lysine monohydrochloride; from about 0.1 g to about 1.5 g ascorbic acid; from about 0.2 g to about 0.8 g hesperidin; from about 0.1 g to about 0.5 g rutin; from about 0.04 g to about 0.08 g pyridoxine hydrochloride; from about 0.01 g to about 0.08 g threonine; and from about 0.02 g to about 0.4 g taurine See claim 16. The ‘377 claims anticipate current claims 11-16.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to include a vehicle, binder, etc. to the ‘677 composition because it is a tablet.
Claims 1-10 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12702677 in view of Wilkinson (WO 92/15315, cited on IDS).
The ‘677 patent claims an antiviral composition.
The ‘677 patent does not claim treatment of a herpesvirus infection.
Wilkinson teaches that herpes infection may be treated using lysine, vitamin C, and hesperidin. See abstract. The infection is a herpes simplex infection (see claim 6).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat herpesvirus using the ‘677 composition because the ‘677 composition is used to treat a viral infection and three of the components of the ‘677 composition are known in the art for treating herpes virus.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693
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