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 .
Status
Claims 1-20 are pending. Claims 12, 18 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species. Therefore, Claims 1-11, 13-17 and 20 are examined.
Election/Restrictions
Applicant's election with traverse of the following in the 9/8/2025 and 2/26/2026 replies is acknowledged:
Elected co-agent species:
fosfomycin (inhibitor of bacterial UDP-GlcNAc enolpyruvyl transferase),
trimethoprim (inhibitor of bacterial dihydrofolate reductase), and
sulfamethoxazole (inhibitor of bacterial dihydropteroate synthase),
Applicant further elected that each of these is separated from each other in different compositions;
Elected bacterial species:
Bacteroides fragilis (Gram-negative obligate anaerobe),
Clostridium perfringens (Gram-positive obligate anaerobe), and
Escherichia coli (aerobe).
The traversal is on the ground(s) that the restriction should not have been made because diaminopyrimidines, sulfonamides and fosfomycins are each in the same class, and agents acting as inhibitors of bacterial dihydrofolate reductase, dihydropteroate synthetase and UDP-GlcNAc enolpyruvyl transferase would be classified in a same class of antimicrobials. This is not found persuasive because the distinctness between different species is not determined by chemical class alone. Each of the elected agent-target-bacteria combinations represents a materially different Each combination encompass different structural features of obligate anaerobes different metabolic pathways in anaerobic and aerobic environments and different prior art search requirements.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12, 18 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/8/2025.
Information Disclosure Statement
The Information Disclosure Statements filed 12/12/2022, 02/03/2023, 12/08/2023 and 12/10/2025 have been considered by the Examiner. The submission(s) is/are in compliance with the provisions of 37 CFR §§ 1.97 and 1.98. Enclosed with this Office Action is a return-copy of the Forms PTO-1449 with the Examiner’s signature and indication of those references that have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See par. 0003 of specification.
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 1-11, 13-17 and 20 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 1 and 20 – mixed statutory classes (product reciting method steps).
Claim 1 is directed to a product (a plurality of co-agents) yet recites method steps in the body: the co-agents “are provided in at least one period to a subject in need thereof,” which providing “causes” one or more co-agents “to act as a synergist” and “causes antibacterial activity” with “the at least one period” selected from durations of about three hours or less. A single claim reciting both a product and a method of using that product is indefinite because it cannot be determined whether infringement occurs upon making the composition or upon performing the recited providing/administration. See MPEP § 2173.05(p). Claim 20 is directed to a kit and is rejected for similar reasons for reciting method steps in the body.
Claims 11, 13-17 – drawn to a “synergist” defined by function
Claim 11 is directed to “a synergist for an antibiotic combination” and defines the synergist as comprising fosfomycin that “causes synergistic action so as to transform therapeutic potential of the antibiotic combination.” The claim fails to provide the structural criteria required to distinguish a fosfomycin that is a “synergist” from any other fosfomycin. The fosfomycin of Claim 11 is structurally identical to fosfomycin used alone. The “synergist” is a synergist only because the claim recites that synergistic activity occurs. A POSA cannot determine what structure is required to fall within the claimed limitations. Claims 13-17 depend from Claim 11 and are therefore rejected for the same reason.
Claims 1 and 20 – “a plurality of co-agents” / single vs. separate compositions.
Claim 1 recites “a plurality of co-agents” comprising a fosfomycin, a diaminopyrimidine, and a sulfonamide, without specifying whether these reside in a single composition or separate compositions. It cannot be determined whether Claim 1 is directed to 1) a single composition that contains multiple agents as the “plurality”, 2) multiple compositions distinct from each other but grouped in some way (e.g., a kit – like in instant Claim 20), or 3) multiple compositions existing separately but referenced collectively. The term does not inherently mean or imply either possibility.
Claims 1 and 20 - “synergist” ambiguity / “causing one or more…to act as a synergist.”
Claim 1 recites “causing one or more of the plurality of co-agents to act as a synergist.” It is unclear which co-agent must act as the synergist, whether the identity is fixed to that agent, and how providing all three results in only “one or more” acting as the synergist while the others do not. The recitation does not particularly point out the required subject matter.
“Representative examples”
Claims 15-17 recite “wherein representative examples…are selected from…”. This phrase renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Dependent Claims 2-10 and 13-14 are also rejected to the extent they incorporate the indefinite language as outlined here. Therefore, the claimed invention is unclear, and one of ordinary skill in the art is not apprised of the metes and bounds of the claimed invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11, 13-17 and 20 are rejected under 35 U.S.C. 102a1/102a2 as being anticipated by Pace et al. (US 2018/0369259 - cited in 12/8/2023 IDS).
Claimed invention/construction
The claims are drawn to compositions and a kit (a product). In a product only structure limits. Two categories of recitation therefore impart no patentable weight and do not distinguish the instant claims from the prior art.
Prior art
Pace teaches a plurality of co-agents comprising a fosfomycin, a diaminopyridine, and a sulfonamide, each in a pharmaceutically acceptable form. Pace discloses antimicrobial pharmaceutical compositions comprising two or more of a fosfomycin, a sulfamethoxazole, and a trimethoprim and teaches that the components may be provided in separable forms or a premix. (Pace, 0031-0034.) The combination is effective against drug resistant microorganisms. (Pace, title.) Also provided are kits including one or more pharmaceutical compositions. A kit may include one or more additional agents, compounds with compositions described herein. The different components of the kit may be provided in different containers. The kit may be compartmentalized to receive the containers in close confinement. The kit may also contain instructions for using the described compositions with accompanying components. Illustrative examples of containers for said kits include, but are not limited to, small glass containers, plastic containers, composite containers, or strips of plastic or paper. (Pace, 0114.)
The remaining recitations of the material worked upon and intended use – e.g., that the plurality of co-agents are “provided in at least one period to a subject,” that this “causes” synergistic activity and “antibacterial activity against the one or more pathogenic anaerobes in an anaerobic environment,” and that “at least one of the one or more pathogenic anaerobes is an obligate anaerobe” – are given no patentable weight for the reasons set forth in the claim construction above. To the extent the synergism is considered, the property is necessarily present in the Pace combination.
Further recitations of properties of the 3-component combination, such as synergism and characteristics of the synergism in environments and against bacteria (the target), are inseparable from the products containing the components. Therefore, Claims 2-11, 14-17 and 20 are also anticipated.
Claim 13 limits Claim 11 wherein the synergist and antibiotic combination are in different formulations. As stated above, Pace teaches each agent in separable compositions.
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 1-11, 13-17 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,898,501 (cited in 12/12/2022 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim sets are drawn to the same subject matter of a 3 component combination of compositions containing that contain the same ingredients: Fosfomycin, sulfamethoxazole, and trimethoprim.
The reference claims differ from the elected separate compositions because the reference claims require at least 2 of the components together in a composition. However, the components in the reference claims may be provided in separable form. (Reference patent, column 7, lines 28, 40, 53-54, 66-67.) The patent reference details a plurality of co-agents comprising a fosfomycin, a diaminopyridine, and a sulfonamide, each in a pharmaceutically acceptable form. The reference discloses antimicrobial pharmaceutical compositions comprising two or more of a fosfomycin, a sulfamethoxazole, and a trimethoprim and teaches that the components may be provided in separable forms or a premix. (Reference patent, column 7.) Also provided are kits including one or more pharmaceutical compositions. A kit may include one or more additional agents, compounds with compositions described herein. The different components of the kit may be provided in different containers. The kit may be compartmentalized to receive the containers in close confinement. The kit may also contain instructions for using the described compositions with accompanying components. Illustrative examples of containers for said kits include, but are not limited to, small glass containers, plastic containers, composite containers, or strips of plastic or paper. (Reference patent, column 34, lines 39-60.) The combination is effective against drug resistant microorganisms. (Reference patent, title.)
Providing three antimicrobial agents in a single combined formulation is an obvious variant within the skill of the POSA. The choice to separate the components into distinct dosage forms is a routine formulation decision that does not impart patentable distinction.
The remaining recitations of the material worked upon and intended use – e.g., that the plurality of co-agents are “provided in at least one period to a subject,” that this “causes” synergistic activity and “antibacterial activity against the one or more pathogenic anaerobes in an anaerobic environment,” and that “at least one of the one or more pathogenic anaerobes is an obligate anaerobe” – are given no patentable weight for the reasons set forth in the claim construction above.
Further recitations of properties of the 3-component combination, such as synergism and characteristics of the synergism in environments and against bacteria (the target) are inseparable from the combination of all 3 components.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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