DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
The amendment filed on 5/18/2026 in response to the Non-Final rejection of 2/24/2026 is acknowledged and has been entered. Claims 1-7 and 13 are currently pending and under consideration.
Rejections Withdrawn:
The rejection of Claim(s) 1-8 and 13 under 35 U.S.C. 102(a)(1) as being anticipated by Rossignol, Jean Francois (US5578621, 1996-11-26) referred to herein as Rossignol as evidenced by Kwiecinski and Horswill (Curr. Opin Microbiol. 2020; 53: 51-60) is withdrawn in view of Applicants amendment.
The rejection of Claim(s) 9-12 under 35 U.S.C. 103 as being unpatentable over Rossignol, Jean Francois (US5578621, 1996-11-26) referred to herein as Rossignol as evidenced by Kwiecinski and Horswill (Curr. Opin Microbiol. 2020; 53: 51-60), as applied to claims 1-8 and 13 above, in view of Gesser et al. (International Journal of Antimicrobial Agents 2004; 23: 235-239) is withdrawn in view of Applicants amendment.
The provisional rejection of Claims 1-8 and 13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 7-9, 11-12 and 14-15 of copending Application No. 18252760 in view of Fernandez et al. (Gut 2018; 67: 1870-1880) is withdrawn in view of Applicants amendment.
Rejection Maintained, but amended in view of Applicants Amendments:
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, 3-7 and 13 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al. (CN111743899, 2020-10-09, IDS). US2023/0077704A1 is being used as the English Translation and referenced herein.
Zhong et al. teach a method of treating coronavirus or an infection caused by coronavirus comprising administering nitazoxanide, wherein the infection includes, but is not limited to, pneumonia, sepsis and septic shock (paragraph 0013, claim 11 of PGPUB).
In response to this rejection, Applicants contend that Zhong discloses the use of NTZ in the treatment of diseases or infection caused by SARS-CoV-2, including sepsis and septic shock, wherein the experiments show that nitazoxanide activity in inhibiting SARS-CoV-2 virus. In particular, Applicants contend that Zhong teaches that the pharmacological activity of NTZ is based on the antiviral activity, but fails to teach that nitazoxanide can effectively treat sepsis caused by SARS-CoV-2 infection.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments, the examiner acknowledges and does not dispute Applicants reference to the teachings of Zhang in that discloses the use of NTZ in the treatment of diseases or infection caused by SARS-CoV-2, including sepsis and septic shock and further, that there is not specific experimentation on treating SARS-CoV-2 virus induced sepsis. However, the Examiner recognizes that
When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). Specifically, in In re Antor Media Corp., the court stated:
"Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement."
In re Antor Media Corp., 689 F.3d at 1289, 103 USPQ2d at 1559.
Moreover, the examiner recognizes that "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See MPEP 2121.
Claim(s) 1-7 and 13 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ali and Pullano (American Journal of Gastroenterology 2008; 103:A337-S338).
Ali and Pullano teach nitazoxanide as a rescue treatment for refractory fulminant Clostridium difficile colitis (Title). Specifically, Ali and Pullano teach administering 500 mg of nitazoxanide to a patient with refractory C. Difficile pancolitis whom developed septic shock and respiratory distress prior to administration (71 year old female). Moreover, Ali and Pullano teach that Nitazoxanide was continued for 10 days, wherein over the course of several days, revers resolved, WBC count improved significantly, she was extubated and continued to improve clinically (2nd to last sentence of 71 year old female).
In response to this rejection, Applicants contend that Ali described nitazoxanide as a rescue therapy for two patients with severe, refractory fulminant Clostridium difficile colitis. In particular, Applicants contend that nitazoxanide was used in combination with other drugs, wherein Ali states:
“it is unclear whether nitazoxanide is effective as an add on therapy only or if it can work well as monotherapy”.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments, the examiner recognizes that the instant claims do not appear exclude prior treatments using antibiotics. Moreover, the instant claims do not appear to limit the method to any time frame. In the instant case, the examiner recognizes that Ali teaches that despite receiving oral metronidazole, vancomycin, saccharomyces boulardi and cholestyramine, her clinical status remained unchanged. As such, Ali appears to stop treatment with the other therapies prior to the administration of nitazoxanide, wherein nitazoxanide is the only therapy given to the patient suffering from septic shock for 10 days. Moreover, it is important to note that there appears to be a distinction between the use of nitazoxanide within the two patients. For example, for the 52 year old patient, Ali specifically makes a note that nitazoxanide was an add on therapy. This would infer that it was used in combination with other agents in the 52 year old patient. This does not seem the case for the 71 year old patient. Thus, while the Examiner acknowledges that Ali states “it is unclear whether nitazoxanide is effective as an add on therapy only or if it can work well as monotherapy”, the Examiner recognizes that the prior art appears to be administering nitazoxanide in an amount taught by the specification to be therapeutically effective, alone, to a patient suffering from septic shock. As such, the claimed limitations appear to be met.
Conclusion
Therefore, No Claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Musher et al. (CID 2006; 43; 421-427).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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