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
The Office Action is in response to the application filed March 18, 2024. Claims 1-18 are being examined on the merits herein.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of US 11,931,333. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a topical treatment composition for therapeutic or prophylactic treatment of herpes infections, comprising: a liquid carrier comprising dimethyl sulfoxide (DMSO) and a diluent, wherein the liquid carrier comprises at least 40 wt% DMSO and up to 60 wt% diluent; and an anti-viral agent comprising at least one water soluble quaternary ammonium compound as recited in claim 1. The patented claims are drawn to method of treating a herpes infection comprising topically applying a topical treatment composition to a treatment site of a person in need thereof, the topical treatment composition comprising: a liquid carrier comprising dimethyl sulfoxide (DMSO) and a diluent; and an anti-viral agent comprising at least one water soluble quaternary ammonium compound included at a concentration so that, when applied to the treatment site together with the DMSO, treats the herpes infection by providing anti-viral activity at the treatment site, wherein the liquid carrier comprises 50-70% DMSO and 50-30% diluent and the at least one water soluble quaternary ammonium compound comprises benzalkonium chloride.
The two inventions overlap greatly in scope of the composition and therefore the instant claims are deemed anticipated
Claim Rejections - 35 USC § 102
(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) 1-9 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beauchamp (US 5,753,270).
Beauchamp teaches a preparation which is compatible with the skin for the treatment of labial disease and acne. The preparation comprises a mixture of: (a) at least one compound selected from an antiseptic compound and an anesthetic compound which is: (i) a terpene, (ii) a phenolic compound, or (iii) an alcohol; (b) a quaternary ammonium antiseptic compound; (c) an antiseptic compound selected from compounds containing iodine, salts thereof and complexes thereof dissolved in an organic skin penetrating solvent, wherein said solvent comprises acetone.
Beauchamp teaches the organic skin penetrating solvent may be in the range exceeding about 50%. The at least one antiseptic and/or anesthetic compound may comprise eugenol, camphor, hexetidine or anethol or the like. The organic skin penetrating solvent may comprise Dimethyl Sulfoxide (DMSO), azone, propylene glycol, dimethyl formamide, dimethyl acetamide, ethyl or isopropyl alcohol or the like in water. The quaternary ammonium antiseptic compound may be benzalkonium chloride, cetyl trimethylammonium bromide (CTAB) and cetyl pyridium chloride or the like (page 5, lines 25-34), thereby meeting the limitations of claims 1-9 and 14.
Beauchamp teaches the composition may be formulated as a galenical form, selected from a gel, cream, lotion, ointment, or paste (claim 12; page 3, lines 44-49), thereby meeting the limitations of claim 13.
Beauchamp teaches the compositions are useful in the treatment of herpes (see examples 1-3).
Based on the foregoing reasons, the instant claims are anticipated over the cited art.
Claim Rejections - 35 USC § 103
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 of this title, 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 1-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dixon (US 4,499,084) in view of Stinchcomb (US 2010/0273895).
Dixon teaches an antiviral composition for treating herpes simplex virus disease and a method for administering the antiviral composition by topical application on the infected portion of the human body. The antiviral composition comprises a mixture of an antiviral agent, ara-A, and a solvent carrier medium, dimethyl sulfoxide.
Regarding claims 1-6 and 16, Dixon teaches treating herpes simplex virus disease in humans comprising the step of topically applying every two to four hours to infected portions of the human body an antiviral composition comprising a solvent carrier which will translocate throughout the body and penetrate cell walls and an antiviral agent which interferes with viral deoxynucleic acid synthesis causing inhibition of viral maturation, wherein the solvent carrier includes dimethyl sulfoxide and wherein the antiviral agent is a purine analog of ara-A and is selected from the group consisting of acyclovir and ribavirin (column 5, lines 31-41; claim 6).
Regarding claim 7, Dixon teaches by percentage weight: ara-A is 0.1 to 10.0 percent of the total composition, dimethyl sulfoxide is 50 percent to less than 100 percent of the solvent carrier, and demineralized water is greater than 0 percent up to 50 percent of the solvent carrier (claim 7; claim 10; column 4, examples 1 and 2).
Regarding claim 12, Dixon teaches treatment of herpes simplex virus disease should begin as soon as prodromal symptoms are apparent. The prodrome or prodromal symptoms are the tingling, itching, burning sensations that occur a few hours to one to two days prior to manifestation of blisters or lesions. Usually if treatment is started at this early stage, the infection is aborted, and sores do not appear. When treatment is begun after lesions are present, the lesions resolve two to three days quicker than when left untreated (column 4, lines 4-12).
Regarding claim 8, Dixon teaches the antiviral composition may be applied topically on the affected area with a cotton swab or gauze (column 4, lines 22-24).
Dixon teaches the antiviral composition may further comprise a local anesthetic (column 5, lines 7-11; claim 3).
Regarding claim 13, Dixon teaches also 1-2 percent carboxymethylcellulose might be added to the mixture to provide a gel which may be preferred for topical application for vaginal and cervical herpes (column 5, lines 15-18).
Regarding claims 13 and 14, Dixon teaches acyclovir and ribavirin, which are similar to ara-A in that all three are purine analogs, will, when mixed with DMSO, provide clinical benefits against oral and genital herpes (column 5, lines 36-39).
Dixon teaches Ara-A is active against a broad spectrum of DNA viruses (these are viruses which contain deoxyribonucleic acid as the predominant nucleic acid type) both in vitro (in the test tube) and in vivo (in animal models or in man). These viruses include the varicella-zoster virus (chicken pox and shingles), the Epstein-Barr (E-B) virus of infectious mononucleosis, vaccinia virus, cytomegalovirus and others (column 3, lines 12-19).
Dixon does not teach a quaternary ammonium compound as required the claims, diluents such as those recited in claim 1, a cannabinoid component as required by the limitations of claim 10, or a terpene or essential oil as required by the limitations of claim 14.
Stinchcomb teaches transdermal or topical administration of pharmaceutical compositions comprising a cannabinoid and methods of treatment thereof to a person in need thereof (abstract; [0001]).
Stinchcomb teaches a class of penetration enhancers are cationic surfactants, such as cetyltrimethylammonium bromide, tetradecyltrimethylammonium, octyltrimethyl ammonium bromide, benzalkonium chloride, octadecyltrimethylammonium chloride, cetylpyridinium chloride, dodecyltrimethylammonium chloride and hexadecyltrimethylammonium chloride ([0064]; [0073]).
Stinchcomb teaches cannabidiol has been found to have localized benefits from topical administration. Topically administered cannabinoids have been found to be useful to alleviate pain and other conditions originating at or near the surface of the skin, pain associated with post herpetic neuralgia, shingles, among others ([0017]; claim 46).
Regarding claim 9, Stinchcomb teaches penetration enhancers are fatty alcohols, such as oleyl alcohol, caprylic alcohol, decyl alcohol, lauryl alcohol, 2-lauryl alcohol, myristyl alcohol, cetyl alcohol, stearyl alcohol, oleyl alcohol, linoleyl alcohol and linolenyl alcohol. Polyols, including propylene glycol, polyethylene glycol, ethylene glycol, diethylene glycol, triethylene glycol, dipropylene glycol, glycerol, propanediol, butanediol, pentanediol, hexanetriol, propylene glycol mono laurate and diethylene glycol monomethyl ether (transcutol) can also enhance penetration. Some polyols, such as propylene glycol may function as a penetration enhancer by solvating alpha-kertin and occupying hydrogen bonding sites, thereby reducing the amount of active-tissue binding [0061].
Regarding claims 10 and 11, Stinchcomb teaches cannabidiol and are suitable for transdermal, oral, buccal, sublingual, injectable, topical, follicular, nasal, ocular, rectal or vaginal administration. The compositions described include a vehicle or carrier for the administration of cannabidiol (and/or one or more cannabidiol prodrug) as well as optionally including pharmaceutically acceptable excipients such as solvents, thickening agents, neutralizers, solubilizing agents, wetting agents, penetration enhancers, lubricants, emollients, binders, taste enhancers, antioxidants, disintegrates, substances added to mask or counteract a disagreeable odor, fragrances or tastes, and substances added to improve appearance or texture of the composition [0054].
Regarding claim 14, Stinchcomb teaches an additional class of penetration enhancers are terpenes, which include hydrocarbons, such as d-limonene, alpha-pinene and beta carene; alcohols, such as, alpha-terpineol, terpinen-4-ol and carvol [0065].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have envisioned an antiviral composition for treating herpes simplex virus disease and a method for administering the antiviral composition by topical application on the infected portion of the human body comprising a mixture of an antiviral agent, acyclovir, and dimethyl sulfoxide as taught by Dixon. The skilled artisan would have been motivated to further include a quaternary ammonium compounds and diluents such those recited in claim 1 of the invention and cannabinoids in the composition of Dixon. The motivation, provided by Stinchcomb, teaches that quaternary ammonium compounds are a class of penetration enhancer as are diluents such as propylene glycol.
Dixon teaches the antiviral composition may further comprise a local anesthetic (column 5, lines 7-11; claim 3).
Stinchcomb teaches cannabidiol has been found to have localized benefits from topical administration. It would have been obvious to the skilled artisan to have employed cannabidiol as the local anesthetic which may be present in Dixon’s antiviral compositions.
Furthermore, the skilled artisan would be motivated to incorporate terpenes in the formulation of Dixon as Stinchcomb teaches an additional class of penetration enhancers are terpenes.
Regarding claims 17 and 18, the limitations require a first topical component comprising DMSO, diluent, and an antiviral component which Dixon teaches and a second topical component comprising DMSO, diluent, and cannabinoid or lysine. As discussed above, Stinchcomb renders obvious the deficiency of quaternary ammonium compound and cannabinoid in the formulations as taught by Dixon. The skilled artisan would be further motivated to combine the two topical applications as both are useful in treating herpes and herpes related ailments. 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, with respect to claim 17, it would have been further prima facie obvious to one of ordinary skill in the art to prepare a kit based on the combined prior art because the grouping together of various objects or compositions directed to a common purpose (i.e. forming a kit) when all the individual objects or compositions are prima facie obvious over the prior art does not make the kit patentable. The idea of preparing a kit based on a prima facie obvious composition flows logically from the perspective of providing organization, convenience and quality control.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over
Dixon (US 4,499,084) in view of Stinchcomb (US 2010/0273895) as applied to claims 1-14 and 16-18 in the 103 rejection above in further view of O’Neil (US 8,470,769).
Dixon and Stinchcomb are discussed above.
Neither reference teaches in addition to the topical formulation for treating herpes, an additional component of lysine.
O’Neil teaches a method for the treatment of a bacterial infection in a subject, comprising administering to the subject a peptide, or pharmaceutically acceptable salt thereof, wherein the peptide comprises 100 to 200 contiguous lysine residues (claim 1.)
O’Neil teaches the lysine composition may be administered by a route selected from the group consisting of oral, parenteral, rectal, dermal, transdermal, intrathoracic, intrapulmonary, and intranasal routes (claim 7).
O’Neil teaches a viral pathogen may be derived from a virus selected from the group consisting of: Human Immunodeficiency Virus (HIV1 & 2); Human T Cell Leukaemia Virus (HTLV 1 & 2); Ebola virus; human papilloma virus (e.g. HPV-2, HPV-5, HPV-8 HPV-16, HPV-18, HPV-31, HPV-33, HPV-52, HPV-54 and HPV-56); papovavirus; rhinovirus; poliovirus; herpesvirus; adenovirus; Epstein Barr virus; influenza virus; hepatitis B and C viruses; Variola virus; rotavirus; and SARS coronavirus (column 8, lines 31-32).
O’Neil teaches formulations can contain pharmaceutically acceptable carriers, vehicles and adjuvants that are well-known in the art. It is possible, for example, to prepare solutions using one or more organic solvent(s) that is/are acceptable from the physiological standpoint, chosen, in addition to water, from solvents such as acetone, acetic acid, ethanol, isopropyl alcohol, dimethyl sulfoxide (column 27, lined 33-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the composition of a first topical component comprising DMSO, diluent, and a quaternary ammonium compound, and an antiviral component as taught by Dixon and Stinchcomb with an additional oral dose of lysine. As discussed above, O’Neil renders obvious the deficiency of lysine in the formulations as taught by Dixon and Stinchcomb. Lysine is employed in formulations for the treatment of herpes. The skilled artisan would be motivated to combine the topical application as well as the oral lysine administration as both are useful in treating herpes and herpes related ailments. 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).
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1-18 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)270-3280. 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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