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 preliminary amendment filed on 11/03/2023 is acknowledged and has been entered.
Claims 1-13 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed on 11/03/2023 is acknowledged and has been considered except where lined through.
Claim Interpretation
Independent claim 1 recites “A method of treating sepsis in a subject in need thereof”. Claims 5 and 6 further limit claim 1 by reciting that the subject suffers from or is at risk. As such, the subject in need thereof is interpreted as one who either has sepsis or is at risk of developing sepsis as a result of an infection.
Claims 3, 4 and 7-9 contain the language “for use” which appears to be left over language from the original claims that were drawn to a compound. The examiner suggests removing this language by amended to “is used”. Moreover, the limitations of claim 3 and 4 are being interpreted as the action of the compound once it is administered to the patient population. Thus, if the same compound is administered to the same population it would appear that the claimed result would happen. See MPEP 2112.01.
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, 3-8 and 13 is/are 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).
Claim(s) 1-10 and 13 is/are 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 panacolitis 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 and then vancomycin PO was continued for another 2 weeks (2nd to last sentence of 71 year old female). Moreover, while claim 9 requires the compound for use with an antimicrobial agent, the claims do not specifically require that the compounds be used in combination at the same time. As such, a patient that has received the compound followed by a second agent would read on the claims.
Claim(s) 1-8 and 13 is/are rejected 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).
Rossignol teach a method of treating bacterial infections comprising administering to a host in need of treatment an effective amount of a mixture of a compound of formula (I)
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and a compound of formula II
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, wherein compound of formula II is the chemical structure of Nitazoxanide (claim 5 of the Patent). With regards to the bacteria, the Patent teaches that the composition is effective against gram positive and gram negative aerobic bacteria such as Staphylococcus aureas, Escherichia coli and Helicobacter pylori (Column 3, line 65 to column 4, line 2). While the prior art does not specifically teach that Staphylococcus aureas infection leads to sepsis, as evidenced by Kwiecinski and Horswill, Staphylococcus aureas is one of the leading causes of life-threatening bloodstream infections, such as sepsis (abstract).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9-12 is/are rejected 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).
Rossignol teach a method of treating bacterial infections comprising administering to a host in need of treatment an effective amount of a mixture of a compound of formula (I)
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and a compound of formula II
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, wherein compound of formula II is the chemical structure of Nitazoxanide (claim 5 of the Patent). With regards to the bacteria, the Patent teaches that the composition is effective again gram positive and gram negative aerobic bacteria such as Staphylococcus aureas, Escherichia coli and Helicobacter pylori (Column 3, line 65 to column 4, line 2). While the prior art does not specifically teach that Staphylococcus aureas infection leads to sepsis, as evidenced by Kwiecinski and Horswill, Staphylococcus aureas is one of the leading causes of life-threatening bloodstream infections, such as sepsis (abstract).
Rossignol does not specifically teach administration of the composition in combination with ertapenem.
Gesser et al. teach that ertapenem is highly active in vitro against methicillin-susceptible Staphylococcus aureas (page 235, 2nd column).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Rossignol to further include ertapenem in view of the teachings of Gesser et al. . One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Both prior art references teach that the compounds are useful for treating Staphylococcus aureas .
"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) (citations omitted) .
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 1-8 and 13 are provisionally rejected 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).
The copending application claims a method of treating liver failure in a subject in need thereof, the method comprising administering a compound to the subject, wherein the compound is selected from the group consisting of nitazoxanide, tizoxanide or tizoxanide glucuride, wherein the liver failure is acute on chronic liver failure (ACLF) (claim 1). Claims 4-5, 7-9, 11-12 and 14-15 further define the type of ACLF.
The copending application does not specifically claim that the patient has a bacterial infection or is at risk or has sepsis.
Fernandez et al. teach that patients with ACLF are highly predisposed to develop bacterial infections within a short follow-up period, wherein severe infections (spontaneous bacterial peritonitis, pneumonia, severe sepsis/septic shock, nosocomial infections and infections caused by multiresistant organisms) are more prevalent in patients with ACLF and are associated with more severe systemic inflammation, poorer clinical course and higher mortality (Significance of this study on this subject 2nd, 3rd and 4th bullet). Moreover, Fernandez et al. teach that infection control practices are essential in the management of patients with ACLF mortality (Significance of this study on this subject 7th bullet).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method claimed by the copending application to treat bacterial infections and/or reduce the risk of or treat sepsis in a patient with ACLF in view of the teachings of Fernandez et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Fernandez et al. teach that infection control practices are essential in the management of patients with ACLF mortality.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Therefore, No Claim is allowed.
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