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 1-20 are presented for examination.
Applicant’s drawings filed March 11, 2024 have been received and entered.
Applicant’s information disclosure statements filed July 20, 2024 and December 10, 2025 have been received and entered.
Applicant’s election filed January 5, 2026 in response to the restriction requirement of November 6, 2025 has been received and entered. The applicants elected the invention described in claims 11-20 (Group II) without traverse. Note claims 2, 3 and 9 will be examined also because they depend on claim 11.
Claims 1, 4-8 and 10 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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 2, 3, 9 and 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-19 of U.S. Patent No. 11,925,653 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application teaches a plurality of antimicrobial compounds or agents provided for utilization and causing at least one of inhibiting growth of an aerobic microorganism and killing an aerobic microorganism comprising at least: a fosfomycin; and a diaminopyrimidine, and the patented application teaches a plurality of antimicrobial compounds or agents provided over a course for use in inhibiting growth of a microorganism or killing the microorganism comprising: a fosfomycin, a sulfonamide; and a diaminopyrimidine.
Note the only difference between the patented application’s claims and the present application’s claims lies in that the patented application’s claims have additional agent, a sulfonamide, combined with presently two claimed active agents (a fosfomycin and a diaminopyrimidine).
The patented application’s claims would anticipate the present application’s claims because the present application’s claims recite “comprising” and thus opens the claims to the inclusion of additional agents.
Claims 2, 3, 9 and 11-20 are not allowed.
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 2, 3, 9, 11-16 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 17/836,959 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the present application teaches a plurality of antimicrobial compounds or agents provided for utilization and causing at least one of inhibiting growth of an aerobic microorganism and killing an aerobic microorganism comprising at least: a fosfomycin; and a diaminopyrimidine, and the copending application teaches a plurality of co-agents for utilization as an antimicrobial medicament against one or more pathogenic anaerobes in an anaerobic environment comprising: a fosfomycin, a sulfonamide; and a diaminopyrimidine.
Note the only difference between the copending application’s claims and the present application’s claims lies in that the copending application’s claims have additional agent, a sulfonamide, combined with presently two claimed active agents (a fosfomycin and a diaminopyrimidine).
The copending application’s claims would anticipate the present application’s claims because the present application’s claims recite “comprising” and thus opens the claims to the inclusion of additional agents.
Claims 2, 3, 9, 11-16 and 18-20 are not allowed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 2, 3, 9 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 3 and 9 are rendered indefinite by the phrase “The composition of claim 11”. Note claim 11 is “A plurality of antimicrobial compounds or agent .”. Please amend claims 2, 3 and 9 to recite “The plurality of antimicrobial compounds or agents of claim 11” as like the other dependent claims.
Claim 17 is rendered indefinite and vague because the claim recites “a mean inhibitory concentration of at least one of the fosfomycin and the diaminopyrimidine, when evaluated individually in vitro against the aerobic microorganism for inhibiting growth, is below a resistance breakpoint identified for the at least one of the fosfomycin and the diaminopyrimidine, the resistance breakpoint having previously been identified by at least one of the Clinical Laboratories Standards Institute, and the European Committee on Antimicrobial Susceptibility Testing”. What is this resistance breakpoint of the fosfomycin and the diaminopyrimidine previously identified by at least one of the Clinical Laboratories Standards Institute and the European Committee on Antimicrobial Susceptibility Testing? Claim 17 does not disclose these critical resistance breakpoints.
Claims 2, 3, 9 and 17 are not allowed.
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) 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chakraborty et al., "A Novel Combination of Selective Agents for Isolation of Leptospira Species", Microbiology and Immunology, Vol. 55, No. 7, pages 494-501 (2011).
Chakraborty et al. teach a novel combination of antimicrobial agents, a fosfomycin (Fosfomycin), a diaminopyrimidine (trimethoprim) (see the abstract). Note page 496, column 1, under Effects of antimicrobial combinations, the antimicrobial combinations inhibit the growth of both Gram-positive and Gram-negative bacterial. Also note page 498, Table 3, shows the various Gram-positive and Gram-negative bacteria inhibited by the antimicrobial combination.
Clearly, applicant’s plurality of antimicrobial compounds or agents is anticipated in the cited reference; therefore, applicant’s instant invention is unpatentable.
Claims 11 and 12 are not allowed.
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.
Claim(s) 2 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chakraborty et al., "A Novel Combination of Selective Agents for Isolation of Leptospira Species", Microbiology and Immunology, Vol. 55, No. 7, pages 494-501 (2011).
Chakraborty et al. were discussed above supra for a plurality of antimicrobial compounds or agents comprising a fosfomycin, and a diaminopyrimidine.
The instant invention differs from the cited reference in that the cited reference does not teach the ratios of each antimicrobial compound or agent is combined to form the instant composition. However, to determine a ratio for each individual antimicrobial compound or agent having the optimum effectiveness together is well within the level of one having ordinary skill in the art, and the skilled artisan would have been motivated to determine optimum ratios of each antimicrobial compound or agent to get the maximum effectiveness in the absence of evidence to the contrary.
The instant invention differs from the cited reference in that the cited reference does not teach the dosage amounts of each individual antimicrobial active agent(s) together. However, to determine the dosage amounts may be calculated according to body weight, body surface area or organ sizes. Further refinement of the calculations necessary to determine the appropriate dosage involving each of the above active agent(s) is routinely made by those of ordinary skill in the art and is within the ability of tasks routinely performed by them without undue experimentation.
Clams 2 and 11-13 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff 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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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629