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 . Claims included in prosecution are claims 1, 6, and 8.
Previous Rejections
Applicants' arguments, filed 6/5/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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, 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.
1. Claim(s) 1, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naik et al. (US 2017/0251674, Sep. 7, 2017) (hereinafter Naik) in view of Guerrant et al. (US 2015/0133366, May 14, 2015) (hereinafter Guerrant).
Naik discloses a method of modulating the flora of bacteria in an environment comprising administering an effective amount of a quorum sensing control composition comprising at least one quorum sensing control agent which is an adsorbent/catalytic inhibitor (Abstract). Diseases caused by drug-resistant Gram-negative bacteria, such as C. difficile, which exhibit resistance to current antibiotic treatments, could also be treated by administering effective amounts of an agent that inhibits or interferes with bacterial quorum sensing alone or in combination with antibiotics or other antibacterial agents to treat, for example, an animal, whether it be a human or companion animal (¶ [0009]). Suitable quorum sensing adsorbent/catalytic inhibitors include clays (¶ [0046]). Suitable clays include bentonites such as sodium bentonite (¶ [0055]). For oral, subcutaneous or spot-on, a dose of an adsorbent/catalytic inhibitor typically ranges from about 0.01 mg/kg to about 100 mg/kg (¶ [0111]). The quorum sensing control formulations may also include one or more antibiotics (¶ [0113]).
Naik differs from the instant claims insofar as not explicitly disclosing the dosage of the antibiotics and resulting ratios thereof nor wherein the antibiotic is vancomycin.
However, Guerrant discloses compositions and methods useful for preventing or treating a Clostridium difficile infection, including re-infection, using a low dose of antibiotics. By low dose is meant a dose that is lower than what is typically prescribed by a physician. For example, some of the commonly used anti-C. difficile antibiotics are routinely administered in the art in doses much higher. In one embodiment, depending on the particular antibiotic being administered and the route of administration, the dose ranges from about 0.1 mg/kg/day to
about 20 mg/kg/day (¶ [0012]). In one aspect, a useful compound of the invention is
vancomycin (¶ [0016]). Lower doses of antimicrobial agents enable better immunologic responses and protection from relapse or reinfection, and likely also cause lesser alterations of the gut flora, reducing recurrent disease and ultimately, death from the infection. This strategy also cause less adverse events (toxicity from drugs) and is more economical (¶ [0018]). A suitable dosage of the antibiotic is about 5.0 mg/kg (¶ [0022]). Administration routes are not limited but include oral and parenteral (¶ [0028]). In one embodiment, at least one antibiotic of the invention can be administered in conjunction with another therapeutic agent (¶ [0033]).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have modified the treatment method of Naik to include antibiotics such as vancomycin in a low dose such as 5.0 mg/kg motivated by the desire to achieve better immunologic responses, better protection from relapse or reinfection, less alterations of the gut flora, reduced recurrent disease, and reduced death from infection as taught by Guerrant. One of ordinary skill in the art would have had a reasonable expectation of success when attempting such a modification where Guerrant discloses that such antibiotics (i.e., and their respective dosages) can be administered in conjunction with another therapeutic agent using the same administration routes disclosed by Naik.
Regarding the ratio recited in instant claim 1, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the adsorbent/catalytic inhibitor (i.e., sodium bentonite) is included in the method/composition of Naik in view of Guerrant in an amount of from about 0.01 mg/kg to about 100 mg/kg, such as 50 mg/kg. A suitable dose of antibiotics in the method/composition of Naik in view of Guerrant is 5 mg/kg. This would result in a ratio of 10:1. Accordingly, the claimed ratio would have been obvious from one of ordinary skill in the art selecting an amount of sodium bentonite and an amount of antibiotics from the above ranges/amounts and such ratio overlapping with the claimed ratio.
Regarding the dosages recited in instant claim 8, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the adsorbent/catalytic inhibitor (i.e., sodium bentonite) is included in the method/composition of Naik in view of Guerrant in an amount of from about 0.01 mg/kg to about 100 mg/kg, such as 50 mg/kg. Further, suitable dose of antibiotics, such as vancomycin, in the method/composition of Naik in view of Guerrant is 5 mg/kg. Accordingly, because the amounts recited in the instant claims lie inside the ranges/amounts disclosed by Naik in view of Guerrant, the ranges/amounts disclosed by Naik in view of Guerrant meet the instantly recited limitations
Therefore, the combined teachings of Naik and Guerrant render obvious claims 1, 6, and 8.
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.
1. Claims 1, 6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,890,295 in view of Burnie et al. (US 2008/0038266, Feb. 14, 2008) (hereinafter Burnie).
The instant claims and the patented claims both recite a clay mineral complex comprising smectite and antibiotics for treating a bacterial infection.
The patented claims differ from the instant claims in that they disclose specific antibiotics such as gentamicin and do not disclose treating C. difficile.
However, Burnie teaches compounds, medicaments and treatments for Clostridium difficile infection (Abstract). Gentamicin is utilized in the method of treatment of infection Clostridium difficile (¶ [0047]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have utilized the composition of the patented claims in the method of the instant claims since gentamicin is a known and effective antibiotic for use in method of treating Clostridium difficile infections as taught by Burnie.
Response to Arguments
Applicant’s arguments with respect to claims 1, 6, and 8 have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made. The teachings of Naik in view of Guerrant are applied to meet the requirements of the new combination of limitations of “sodium bentonite and antibiotics, wherein a ratio of a content concentration of the sodium bentonite and a content concentration of the antibiotics is 9:1 to 11:1”.
Conclusion
Claims 1, 6, and 8 are rejected.
Claims 10-13 are withdrawn.
No claims are allowed.
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 Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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