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 .
Specification
The specification is objected to because of the following informalities. The title of the invention “INHIBITION OF COVID-19 VIRUS BY MULTIPLE COMPONENT FORMULATIONS” is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “INHIBITION OF COVID-19 VIRUS BY FORMULATIONS CONTAINING CURCUMIN, HARMINE AND ISOVANILLIN COMPONENTS”. Appropriate correction is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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 14 and 15 provide for the use of a multiple component antiviral formulation comprising a mixture of a curcumin component, a harmine component, and an isovanillin component, and/or the isomers, tautomers, enantiomers, esters, derivatives, metal complexes, prodrugs, solvates, metabolites, and pharmaceutically acceptable salts of any or all of the foregoing, for inhibition of replication of SARS-CoV-2 virus in a subject in need thereof, or for the treatment of a human subject exposed to or suffering from COVID-19, but since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claims 14 and 15 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim Rejections - 35 USC § 103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1-13 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by U.S. Pat. No. 10,092,550 to Zaid et al. (“Zaid”).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Applicant’s specification
Applicant’s specification, with reference to US PG Pub 20240390294, discloses that the present disclosure provides improved methods for inhibiting the SARS-CoV-2 virus. In one aspect of the invention, the methods comprise or consist essentially, or even consist of, the use of a multiple-component antiviral formulation demonstrating preclinical synergy between the three components. Generally, the formulations comprise respective quantities of a curcumin component, a harmine component, and an isovanillin component and variants thereof, and which may also include additional minor ingredients. ([0007]-[0008]). However, nowhere does the specification provide data supporting such synergy. To the extent of actual testing conducted, there is no data showing that the individual components curcumin, harmine and isovanillin were tested for inhibiting the SARS-CoV-2 virus individually, and compared to their efficacy in combination. The only data shown is with one single combination of the three ingredients, called GZ17-6.02. “[0034] The single most preferred GZ17-6.02 antiviral formulation, and that tested in the examples, was made by dispersing relative quantities of solid synthetic isovanillin (771 mg, 98% by weight purity), synthetic harmine (130.3 mg, 99% by weight purity), and a commercially available curcumin product derived by the treatment of turmeric (98.7 mg, containing 99.76% by weight curcuminoids, namely 71.38% curcumin, 15.68% demethoxycurcumin, and 12.70% bisdemethoxycurcumin), at a weight ratio of 771:130.3:98.7 (isovanillin:harmine:curcumin product). Additional details regarding this formulation as a synergistic anticancer agent are described in detail in U.S. Pat. No. 9,402,834, filed May 26, 2015, and U.S. Pat. No. 10,092,550, filed Oct. 28, 2016, each incorporated by reference in its entirety herein, especially as it relates to three-component formulations of isovanillin, harmine, and curcumin.” Thus, Applicant’s specification explicitly provides that the tested formulation according to the invention is known in the art, such as disclosed in U.S. Pat. No. 10,092,550 to Zaid (“Zaid”).
Applicant’s claims are directed, with reference to claim 1, to a multiple-component antiviral formulation comprising a mixture of a curcumin component, a harmine component, and an isovanillin component, and/or the isomers, tautomers, enantiomers, esters, derivatives, metal complexes, prodrugs, solvates, metabolites, and pharmaceutically acceptable salts of any or all of the foregoing, for use in inhibiting replication of SARS-CoV-2 virus in a subject in need thereof. The limitation “for use in inhibiting replication of SARS-CoV-2 virus in a subject in need thereof” is interpreted as an intended use the claimed multiple-component antiviral formulation, which is not given any patentable weight. Similarly, the “wherein” clauses of how the formulation is administered in claims 11 and 12 are also interpreted as intended use of the claimed multiple-component antiviral formulation, which is not given any patentable weight.
Rejection
Zaid discloses a multi-component therapeutic composition comprising a combination of a curcumin component, a harmine component, and an isovanillin component for the treatment of cancer. (Abstract). With reference to Examples 1-28, Zaid discloses that the GZ17-6.02 product of the Examples was made by dispersing quantities of solid synthetic isovanillin (771 mg, 98% by weight purity), synthetic harmine (130.3 mg, 99% by weight purity), and a commercially available curcumin product derived by the treatment of turmeric (98.7 mg, containing 99.76% by weight curcuminoids, namely 71.38% curcumin, 15.68% demethoxycurcumin, and 12.70% bisdemethoxycurcumin), in a 1 mL ethanol at a weight ratio of 771:130.3:98.7 (isovanillin:harmine:curcumin product) in ethanol followed by sonication of the dispersion. (col. 86, ll. 37-47). Per Zaid, in the case of the preferred three-component compositions of the invention, made by combining individual quantities of normally highly purified curcumin component(s), harmine component(s), and isovanillin component(s), the as-added amounts should give weight ratios of about 10:1.7:0.85 (isovanillin component(s):harmine component(s):curcumin component(s)), but more broadly, the ratios are approximately 0.1-25:0.1-5:0.1-5 (isovanillin component(s): harmine component(s): curcumin component(s)). In this respect, it will be seen that the isovanillin component(s) of the preferred GZ17-6.02 product is/are the preponderant component(s) in the compositions on a weight basis, with the harmine and curcumin component(s) being present in lesser amounts on a weight basis. Generally, the isovanillin component(s) in the most preferred product should be present at a level at least three times (more preferably at least five times) greater than that of each of the harmine and curcumin component(s), again on a weight basis. However, the invention is not limited to such weight ratios. (col. 84, l. 56- col. 85, l. 7). This discloses the weight percent, ratios, and additional curcuminoids of Applicant’s claims. Zaid discloses that the composition exhibits anti-cancer synergy with respect to a number of cancers. (claims 12-15).
Per Zaid, the dosages may be administered in any convenient manner, such as by oral, rectal, nasal, ophthalmic, parenteral (including intraperitoneal, gastrointestinal, intrathecal, intravenous, cutaneous (e.g., dermal patch), subcutaneous (e.g. injection or implant), or intramuscular) administrations. The dosage forms of the invention may be in the form of liquids, gels, suspensions, solutions, or solids (e.g., tablets, pills, or capsules). (col. 39, ll. 22-29). One of skill in the art would understand this to include homogenous mixture and powder. Per Zaid, the compositions should be dosed of from about 5 to 2000 mg per day, and more usually from about 100-800 mg per day. Such dosages may be based on a single administration per day, but more usually multiple administrations per day. (col. 86, ll. 18-21). Zaid discloses that GZ17-6.02 was administered with food. (Example 85). Per Zaid, the curcumin, harmine, and isovanillin component(s) may be obtained as synthetic compounds of high purity, or from modified naturally occurring sources. In either case, however, it is preferred that the component(s) be purified to a level of at least about 50% by weight, more preferably at least about 70% by weight, still more preferably at least about 90% by weight, and most preferably at least about 98% by weight. (col. 40, ll. 56-63).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,092,550. Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter.
Claim 1 of the instant application is directed to multiple-component antiviral formulation comprising a mixture of a curcumin component, a harmine component, and an isovanillin component, and/or the isomers, tautomers, enantiomers, esters, derivatives, metal complexes, prodrugs, solvates, metabolites, and pharmaceutically acceptable salts of any or all of the foregoing, for use in inhibiting replication of SARS-CoV-2 virus in a subject in need thereof.
Claim 1 of the issued patent is directed to a therapeutic anti-cancer composition comprising at least one each of a curcumin component, a harmine component, and an isovanillin component, where said components are different, said curcumin component is selected from the group consisting of curcumin . . ., said harmine component is selected from the group consisting of harmine . . ., and said isovanillin component is selected from the group consisting of isovanillin . . . with the total weight amount of isovanillin component(s) being preponderant, and with the total weight amounts of curcumin component(s) and harmine component(s) being present in lesser amounts, the curcumin, harmine, and isovanillin components being selected and present in amounts to provide anti-cancer synergy for the composition.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,402,834. Although the claims at issue are not identical, they are not patentably distinct from each other because they are not patentably distinct.
Claim 1 of the instant application is directed to multiple-component antiviral formulation comprising a mixture of a curcumin component, a harmine component, and an isovanillin component, and/or the isomers, tautomers, enantiomers, esters, derivatives, metal complexes, prodrugs, solvates, metabolites, and pharmaceutically acceptable salts of any or all of the foregoing, for use in inhibiting replication of SARS-CoV-2 virus in a subject in need thereof.
Claim 1 of the issued patent is directed to an anti-cancer composition comprising the combination of at least one curcumin component comprising curcumin, at least one harmine component comprising harmine, and at least one isovanillin component comprising isovanillin, wherein the components of the composition are different and said composition exhibits anti-cancer synergy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
Prosecution Insights