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 .
DETAILED ACTION
Claims 1, 2, 4-8, 10, 12, 15, 22, 23, 24, 26, 39-43 and 45 are currently pending in the instant application. Applicants have amended claims 4-8, 10, 12, 15, 22, 26, 39-43 and 45 and canceled claims 3, 9, 11, 13, 14, 16-21, 25, 27-38, 44 and 46 in an amendment filed on January 19, 2023. Claims 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 23, 24, 26, 39 and 40 are rejected and claims 41-43 and 45 are objected in this Office Action.
I. Priority
The instant application is a 371 of PCT/US2021/042196, filed on July 19, 2021 which claims benefit of US Provisional Application 63/054,072, filed on July 20, 2020.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 19, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
III. Rejections
35 USC § 103 - OBVIOUSNESS REJECTION
The following is a quotation of 35 U.S.C. § 103(a) that forms the basis for all
obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 23, 24, 26, 39 and 40 are rejected under 35 U.S.C. § 103 as being unpatentable over Rossignol, et al. (WO 2017/173056 A1) or Rossignol, et al. (WO 2018/195035 A1). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Rossignol, et al. (WO 2017/173056 A1) teaches the use of thiazolide compounds such as tizoxanide against viruses belonging to the Picornaviridae family or Paramyxoviridae family. The invention includes pharmaceutical acceptable salts of tizoxanide (see page 14). Examples of pharmaceutical acceptable salts include salts with organic bases such as methylamine, diethylamine and ethanolamine (see page 16). Therapeutically acceptable salts include nontoxic quaternary amine cations such as pyridine, N-methylpiperidine, N-methylmorpholine, etc.(see page 18).
Rossignol, et al. (WO 2018/195035 A1) teaches the use of thiazolide compounds such as tizoxanide for inhibiting PDIA2. The invention includes pharmaceutical acceptable salts of tizoxanide (see page 7). Examples of pharmaceutical acceptable salts include salts with organic bases such as methylamine, diethylamine and ethanolamine (see page 9). Therapeutically acceptable salts include nontoxic quaternary amine cations such as pyridine, N-methylpiperidine, N-methylmorpholine, etc.(see page 9).
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Rossignol, et al. (WO 2017/173056 A1) or Rossignol, et al. (WO 2018/195035 A1) and the instant invention is that the instant invention is drawn to amine salts of tizoxanide whereas the prior art broadly teaches amine salts of this compound.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
In In re Williams, 89 USPQ 396 (CCPA1951), it was well established that it is obvious to form salts from known acids. For example, it is obvious to prepare an amine salt form of tizoxanide when the art teaches the free base of tizoxanide but broadly teaches pharmaceutically acceptable salts (i.e., ethanolamine) of tizoxanide with reasonable expectation of success. Specifically, preparing pharmaceutically acceptable salts are well known in the art and within the knowledge and ability of one having ordinary skill in the art. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare pharmaceutically acceptable amine salt forms based on the teachings of the preferred embodiments in the prior art. For example, a skilled artisan would be motivated to prepare an ethanolamine salt of tizoxanide instead of the free base form of the compound as seen in the prior art reference of Rossignol, et al. (WO 2017/173056 A1) or Rossignol, et al. (WO 2018/195035 A1) because both references broadly teaches amine containing salts can be prepared. A strong prima facie obviousness has been established.
IV. Objections
Dependent Claim Objections
Dependent Claims 41-43 and 45 are objected to as being dependent upon a rejected based claim. To overcome this objection, Applicant should rewrite said claims in an independent form and include the limitations of the base claim and any intervening claim.
V. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Joseph McKane can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626