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 .
Benefit of Earlier Filing Date
The instant application, filed 12 March 2024, is a national stage application of PCT/CN2021/129609, filed 09 November 2021. Acknowledgment is made of Applicant’s claim.
Restriction/Election
Requirement for Restriction/Election was mailed 29 May 2026.
Applicant’s Response to Requirement for Restriction/Election was received 29 July 2026.
Applicant’s election with traverse of Group I (Claims 1-8) in the Response filed 29 July 2026 is acknowledged.
Regarding the restriction requirement, the traversal is on the grounds that amended claims 1 and 5-17 are drawn to a single general inventive concept.
Applicant’s arguments in opposition to the restriction requirement have been fully considered and are persuasive as Examiner agrees CN110312715A is silent on compounds of Formulae (I-1), (I-2), (I-3), (I-4), (I-5), and (I-6), as recited by amended claim 1.
The Requirement for Restriction/Election of 29 May 2026 is withdrawn.
Status of the Claims
The listing of claims filed 29 July 2026 has been examined.
Claims 1 and 5-17 are pending.
Claims 1 and 5-14 are amended.
Claims 15-17 are newly added.
Claims 2-4 are cancelled.
Claims 1 and 5-17 are examined on the merits.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 31 October 2025, 30 September 2025, 22 May 2025, 27 June 2024, and 12 March 2024 are acknowledged and have been considered.
Claim Objections
Claims 6 and 13 are objected to because of the following informalities:
Claim 13 recites, “…said microorganism is selected from Acinetobacter baumannii or Pseudomonas aeruginosa.” [Emphasis added.] For consistency, Examiner requests “or” be changed to “and”.
Both “PaβN” and “PAβN” are used in claims 6 and 13 in reference to the same compound. For clarity, Examiner requests the capitalization be made consistent throughout the claims.
Appropriate corrections are requested.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 7-11, and 14-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Claim 1 recites, “… (b) a lactamase inhibitor or an efflux pump inhibitor.” A “lactamase inhibitor” and/or an “efflux pump inhibitor” could include compounds which are, presently, unrecognized as inhibiting lactamase or efflux pumps as well as undiscovered compounds which inhibit lactamase or efflux pumps.
Level of Skill & Knowledge in the Art
The level of skill and knowledge in the art is high.
Partial Disclosure
The instant Specification provides a list of possible lactamase inhibitors, including avibactam, vaborbactam, and relebactam (p. 14, Lines 1-3), as well as possible efflux pump inhibitors, including berberine, conessine, and PAβN (p. 14, Lines 6-7). The disclosed exemplary lactamase and efflux pump inhibitors are limited to known lactamase and efflux pump inhibitors. Thus, the exemplary inhibitors provided are insufficient to demonstrate possession of all lactamase and efflux pump inhibitors or put the public in possession of all the claimed compositions wherein component (b) is any lactamase inhibitor and/or any efflux pump inhibitor. Furthermore, the disclosed inhibitors have distinct structures and, consequently, may also differ in properties.
Physical and/or Chemical Properties/Functional Characteristics
The claimed compositions are allegedly useful to treat an infectious disease (Claim 9).
A review of the prior art identifies Neu (Neu and Fu, “Clavulanic Acid, a Novel Inhibitor of β-Lactamases”, Antimicrobial Agents and Chemotherapy, Nov 1978, Vol. 14, No. 5, p. 650-655). Neu discloses clavulanic acid (CAS Registry Number: 58001-44-8), shown below, potently inhibits β-lactamases (p. 650, Col. 1).
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Clavulanic acid lacks notable structural similarity with the instantly disclosed lactamase inhibitors (i.e., avibactam, vaborbactam, and relebactam). Accordingly, there is no structure/function correlation and no representative number of specific examples of lactamase inhibitors and efflux pump inhibitors to demonstrate which compositions retain activity.
Predictability of the Art
Medicinal chemistry is an experimental science with a low predictability level. Small changes in the structure of a compound can lead to large differences in their pharmacological activity.
Method of Making the Claimed Invention
Although the Specification provides methods for making Compounds (I-1) (p. 18, Line 33) and (I-2) (p. 20, Line 35), only three lactamase inhibitors and only three efflux pump inhibitors are disclosed. The disclosed experimental data is limited to avibactam, vaborbactam, and relebactam (p. 26, Lines 21-25 – p. 27, Lines 1-5) as well as berberine, conessine, and PAβN (p. 28, Lines 20-25 – p. 29, Lines 1-5). As such, the instant Specification and instant claims do not provide sufficient description such that one could anticipate which additional lactamase and/or efflux pump inhibitors may be present in the instantly claimed compositions because the examples illustrated in the experimental section are limited to only some lactamase and efflux pump inhibitors.
Written Description Conclusion
Substantial undue experimentation would be needed to practice Applicant’s invention because the Specification lacks sufficient detail to show which lactamase and/or efflux inhibitors, both known and unknown, are compatible with the instant invention.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. It is unquestionable that the claim is broad and generic with respect to all possible compounds encompassed by the phrases “lactamase inhibitor” and “efflux pump inhibitor” recited by claim 1. In the instant case, the Specification does not disclose a sufficient variety of species to reflect this variance in the genus. The Specification does not provide sufficient support for the myriad of compounds embraced by the claims, such as any lactamase or efflux pump inhibitor.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention.
Claims 7-11 and 14-17 are included in this rejection for relying on a rejected claim (i.e., Claim 1) without resolving the issue. Limiting the lactamase inhibitor and efflux pump inhibitor to those recited in claims 5 and 6, respectively, would overcome this rejection.
Claim Rejections - 35 USC § 112(b)
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.
Claim 10 is 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.
Claim 10 recites, “The method of claim 9, wherein said microorganism is a bacterium, especially, a Gram-negetive bacterium, such as Escherichia coli…” [Emphasis added.] The phrases “especially” and “such as” render claim 10 indefinite because it is unclear whether the limitations following the phrases are required by the claim. MPEP § 2173.05(d).
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.
Claims 1, 5, 7-12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wiegand (WO 2018/065636 A1; IDS dated 22 May 2025, Cite No. 3) in view of Glinka (WO 2014/164526 A1).
Regarding claims 1, 5, 7-12, and 14-17, Wiegand teaches antibiotic compounds, such as compounds of formula (I-b) (p.7, Lines 10-20), shown below.
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Wiegand indicates such compounds should be used in tandem with a β-lactamase inhibitor, such as clavulanic acid, tazobactam, sulbactam, and/or other β-lactamase inhibitors (p. 9, Lines 1-3). Additionally, Wiegand suggests the above compound may be used in the treatment or prophylaxis of bacterial infections caused by Escherichia coli and Klebsiella pneumoniae, as well as Enterobacter, Citrobacter, Serratia, Providencia, and Proteus species, in combination with diazabicyclooctane inhibitors like avibactam and relebactam or transition state analog β-lactamase inhibitors like vaborbactam (p. 16, Lines 1-14). Furthermore, Wiegand teaches compounds of formula (I-b) and the like can be co-administered with various other agents, including efflux pump inhibitors (p. 14, Line 32 – p. 15, Line 2). Wiegand suggests the compounds are, “…particularly useful in human and veterinary medicine for the prophylaxis and treatment of local and systemic infections which are caused for example by the following pathogens of by mixtures of the following pathogens: Aerobic Gram-negative bacteria… and also non-fermenters including but not limited to Pseudomonas spp. (P. aeruginosa)… and Acinetobacter spp. (A. baumanni…” (p. 22, Lines 6-16).
Wiegand indicates such compounds, “…may be administered at a ratio of 100:1 to 1:100, for example 10:1 to 1:10, such as 5:1 to 1:5.” (p. 15, Lines 18-22).
Furthermore, Wiegand discloses pharmaceutical compositions comprising the aforementioned antibiotic compounds may also contain pharmaceutically acceptable excipients such as bulking agents like cyclodextrins, solvents like propylene glycols, wetting agents like poloxamers, and/or carriers like albumin (p. 24, Lines 15-23).
Wiegand does not explicitly teach the same
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groups as recited in the instantly claimed compounds. Specifically, Wiegand does not explicitly teach the instantly recited group
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.
Glinka teaches antibiotic compounds, such as Compound 32 (p. 41, Col. 2), shown below.
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Note Glinka does teach the
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group at the oxime position which Wiegand lacks. Furthermore, Glinka’s compound is analogous as it shares the same core monobactam structure as Wiegand’s compounds.
Glinka indicates such compounds may be used in treating a bacterial infection (p. 3, ¶ [0011]), such as an infection caused by Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii, Enterobacter cloacae, Enterobacter aerogenes, Salmonella typhi, Serratia marcescens, Citrobacter freundii, Providencia rettgeri, Proteus vulgaris, Proteus mirabilis, and Shigella flexneri (p. 4, ¶ [0019]).
Glinka discloses pharmaceutical compositions comprising compounds like Compound 32 may also contain additional medicaments like a β-lactamase inhibitor and/or an efflux pump inhibitor (p. 4, ¶ [0016]).
Glinka does not explicitly teach the sulfuric acid group as recited in the instantly claimed compounds.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Wiegand would have found it prima facie obvious to prepare a pharmaceutical composition comprising an instantly recited compound of formula (I) based on the teachings of Glinka because both Glinka and Wiegand disclose structurally similar antibiotic compounds and a PHOSITA, while seeking to develop new and effective antibiotics, would have been motivated to try substituting the -SO3 from Wiegand’s compounds onto Glinka’s compounds at the same position which, for example, would have resulted in an instantly recited compound of formula (I-1), shown below.
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Phrased differently, because the compounds disclosed by Wiegand and Glinka are analogous monobactam compounds, it would have been obvious to substitute a
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group in the oxime position in Wiegand’s compound because Glinka discloses a
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group in the oxime position.
Furthermore, both Wiegand and Glinka provide a suggestion to prepare a pharmaceutical composition comprising such monobactam antibiotic compounds alongside a lactamase inhibitor and/or an efflux pump inhibitor, with Wiegand specifically mentioning lactamase inhibitors such as avibactam, vaborbactam, and relebactam. Additionally, Wiegand discloses the ratio of the monobactam compound to the inhibitor can be 10:1 to 1:10 or 5:1 to 1:5, which overlaps the instantly recited ranges.
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wiegand (WO 2018/065636 A1; IDS dated 22 May 2025, Cite No. 3) in view of Glinka (WO 2014/164526 A1) and further in view of Chamberland (WO 96/33285).
Regarding claims 6 and 13, Wiegand in view of Glinka teaches all of the claimed elements as stated above.
The combination of Wiegand and Glinka does not explicitly teach specific efflux pump inhibitors, namely berberine, conessine, and/or PAβN.
Chamberland teaches L-phenylalanyl-L-arginyl-β-naphthylamide (i.e., PaβN) is an efflux pump inhibitor (p. 61, Lines 31-32). Furthermore, Chamberland discloses, “…a method for treating a microbial infection in an animal, specifically including a mammal, by treating an animal suffering from such an infection with an antimicrobial agent and an efflux pump inhibitor…” (p. 24, Lines 1-5). Chamberland indicates such antimicrobial agents can include β-lactams (p. 24, Line 30) and specifically names azthreonam (i.e., aztreonam) as one possible β-lactam antibiotic (p. 25, Line 7). Additionally, Chamberland states efflux pump inhibitors, “…reduce the ability of an efflux pump to export antibacterial agents from the cytoplasm.” (p. 54, Lines 12-15).
Chamberland does not explicitly teach a compound of instantly recited formulae (I-1), (I-2), (I-3), (I-4), (I-5), or (I-6).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Wiegand and Glinka would have found it prima facie obvious to select PAβN as the efflux pump inhibitor in the instantly recited pharmaceutical composition based on the teachings of Chamberland because Chamberland identifies PAβN as an efflux pump inhibitor and suggests including efflux pump inhibitors in a pharmaceutical composition alongside antimicrobial agents like β-lactams, such as a monobactam like azthreonam. Since the compounds disclosed by Wiegand and Glinka are monobactam aztreonam-derivatives and both Wiegand and Glinka suggest co-administering such antimicrobial compounds with an efflux pump inhibitor, a PHOSITA would have been motivated to include the efflux pump inhibitor PAβN in a pharmaceutical composition comprising a monobactam antimicrobial compound as suggested by Chamberland.
Non-Statutory 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 and 5-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 8-9 of U.S. Patent No. 12,497,393 B2 in view of Wiegand (WO 2018/065636 A1) and Chamberland (WO 96/33285).
Patent ‘393 claims monobactam compounds including Compound (A-1) (Claim 4), shown below, which is structurally identical to the instantly recited compound of formula (I-1).
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Patent ‘393 claims a method of treating a Gram-negative bacterial infection in a subject in need thereof by administering a monobactam compound, such as Compound (A-1).
Patent ‘393 does not claim a pharmaceutical composition or mention a lactamase inhibitor and/or an efflux pump inhibitor.
Wiegand teaches antibiotic compounds, such as compounds of formula (I-b) (p.7, Lines 10-20), shown below.
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Wiegand indicates such compounds should be used in tandem with a β-lactamase inhibitor, such as clavulanic acid, tazobactam, sulbactam, and/or other β-lactamase inhibitors (p. 9, Lines 1-3). Additionally, Wiegand suggests the above compound may be used in the treatment or prophylaxis of bacterial infections caused by Escherichia coli and Klebsiella pneumoniae as well as Enterobacter, Citrobacter, Serratia, Providencia, and Proteus species in combination with diazabicyclooctane inhibitors like avibactam and relebactam or transition state analog β-lactamase inhibitors like vaborbactam (p. 16, Lines 1-14). Furthermore, Wiegand teaches compounds of formula (I-b) and the like can be co-administered with various other agents, including efflux pump inhibitors (p. 14, Line 32 – p. 15, Line 2). Wiegand suggests the compounds are, “…particularly useful in human and veterinary medicine for the prophylaxis and treatment of local and systemic infections which are caused for example by the following pathogens or by mixtures of the following pathogens: Aerobic Gram-negative bacteria… and also non-fermenters including but not limited to Pseudomonas spp. (P. aeruginosa)… and Acinetobacter spp. (A. baumanni…” (p. 22, Lines 6-16).
Wiegand does not explicitly teach a compound of instantly recited formulae (I-1), (I-2), (I-3), (I-4), (I-5), or (I-6).
Chamberland teaches L-phenylalanyl-L-arginyl-β-naphthylamide (i.e., PaβN) is an efflux pump inhibitor (p. 61, Lines 31-32). Furthermore, Chamberland discloses, “…a method for treating a microbial infection in an animal, specifically including a mammal, by treating an animal suffering from such an infection with an antimicrobial agent and an efflux pump inhibitor…” (p. 24, Lines 1-5). Chamberland indicates such antimicrobial agents can include β-lactams (p. 24, Line 30) and specifically names azthreonam (i.e., aztreonam) as one possible β-lactam antibiotic (p. 25, Line 7). Additionally, Chamberland states efflux pump inhibitors, “…reduce the ability of an efflux pump to export antibacterial agents from the cytoplasm.” (p. 54, Lines 12-15).
Chamberland does not explicitly teach a compound of instantly recited formulae (I-1), (I-2), (I-3), (I-4), (I-5), or (I-6).
A PHOSITA would have been motivated to prepare a pharmaceutical composition comprising, for example, Compound (A-1) disclosed by Patent ‘393/Compound (I-1) in the instant application as well as a lactamase inhibitor and/or an efflux pump inhibitor as disclosed by Wiegand and/or Chamberland because Wiegand and Chamberland suggest such inhibitors can increase the efficacy of the antimicrobial agent. Thus, A PHOSITA would have had a reasonable expectation of success in preparing a composition comprising an instantly recited monobactam compound and a lactamase inhibitor and/or an efflux pump inhibitor.
Because claims 1 and 5-17 in the instant application would have been obvious over claims 1-4 and 8-9 of U.S. Patent No. 12,497,393 B2 in view of Wiegand and Chamberland, claims 1 and 5-17 in the instant application are not patentably distinct from claims 1-4 and 8-9 of U.S. Patent No. 12,497,393 B2.
Conclusion
Claims 1 and 5-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ADAM C MILLIGAN can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.L.B./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
