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 .
Election/Restrictions
Applicant’s election of a single species of compound, Compound 8, in the reply filed on 08/10/2026 is acknowledged.
PNG
media_image1.png
226
596
media_image1.png
Greyscale
Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-15 are pending. Claims 2, 3, 4, 5, 6 and 7 are withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1, 8-15 are hereby examined on the merits.
Priority
This application filed 11/10/2023 is a National Stage entry of PCT/JP2022/020285, International Filing Date: 05/13/2022 claims foreign priority to 2021-081860, filed 05/13/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/07/2026 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
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.
Claim 12 recites the limitation "wherein the resistant …bacterium" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests correcting the claim number upon which the instant claim depends, to overcome the antecedent basis rejection.
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) 1, 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Aileen Rubio et al., hereinafter Rubio (Aileen Rubio et al., ACS Infect. Dis. 2018, 4, 1436−1438) in view of James A. Cowan et al., hereinafter Cowan (James A. Cowan et al., WO2013/109927A2; EFD: 18 Jan 2012) further in view of George Makris et al., hereinafter Makris (George Makris et al., Bioconjugate Chem. 2018, 29, 4040−4049).
PNG
media_image2.png
134
154
media_image2.png
Greyscale
Regarding claim 1, the Applicant’s elected species of Compound 8, represented by formula (IV). Accordingly, Rubio discloses β-lactam antibiotics, specifically doripenem (see Fig 1, page 1437 and represented below) wherein ‘Rb’ is specifically ([chemical formula 3]; structure on the left in instant claim and is the elected species).
Rubio does not teach ‘Ra’ i.e. [Chemical Formula 2] elected species (IIIf).
Cowan and Makris teach ‘Ra’. Cowan teaches that antibiotics target pathogens through selective binding to bioactive macromolecules within a bacterial cell. By incorporating a metal binding moiety to such antimicrobial agents, antibiotic derivatives can be rendered more potent as antimicrobials through the ability to generate reactive oxygen species and oxidative stress as part of a “dual warhead” approach to antimicrobial therapeutics [0007] [0017]. Specifically, Cowan teaches metal binding moieties including 1, 4, 7-triazacyclononane (TACN) and derivatives thereof (last three lines [0043]). Makris teaches macrocyclic derivatives of 1,4,7-triazacyclononane (TACN), ligands such as NOTA and NODAGA, widely used as BFCs for the radiolabeling of small and large molecules, such as peptides, proteins, and antibodies (see page 4041, 3rd paragraph).
PNG
media_image3.png
89
210
media_image3.png
Greyscale
Notably, Makris teaches pyrrolidine conjugated with NODAGA via amide bond formation (see figure in Abstract; also represented on the left).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify doripenem, disclosed in Rubio, and introduce the TACN derivative NODAGA as disclosed in Makris and Cowan. One motivated to do so would have a reasonable expectation of success, as Cowan specifically teaches that antibiotic derivatives are rendered more potent as antimicrobials through the ability to generate reactive oxygen species and oxidative stress by incorporating a metal binding moiety to such antimicrobial agents, as part of a “dual warhead” approach to antimicrobial therapeutics [0007] [0017]. Thus, one would have recognized that applying the teaching of Rubio to the method of Makris and Cowan, would have yielded predictable results and improved the potency of the antibiotic (See MPEP § 2143 l(A)(D)).
Regarding claim 8, Rubio teaches doripenem as noted in the rejection above (i.e. [chemical formula 4] structure on the left in instant claims).
Regarding claim 9, the rejection is noted above.
Regarding claim 10, the rejection has been noted above.
Regarding claim 11, Examiner interprets ‘for use….bacterium’ as intended use. As the
teachings in Cowan, Rubio and Makris provide a compound that is 100 % identical to the claimed Compound 8, it would be capable of the same intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children's Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (see MPEP §2111. 02 (II)). As previously noted, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Regarding claim 12, the rejection is noted above.
Regarding claim 13, Examiner interprets ‘for use….antibiotic’ as intended use. Accordingly, the rejection is as noted above.
Regarding claim 14, the rejection under claim 1 has been set forth above.
Regarding claim 15, the rejection under claim 1 has been set forth above.
Claim(s) 1, 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Louis Lteif et al., hereinafter Lteif (Louis Lteif et al., Pharmacy. 2019, 7, 94) in view of James A. Cowan et al., hereinafter Cowan (James A. Cowan et al., WO2013/109927A2; EFD: 18 Jan 2012) further in view of George Makris et al., hereinafter Makris (George Makris et al., Bioconjugate Chem. 2018, 29, 4040−4049).
For the purpose of compact prosecution, species search/examination was extended to the non-elected species (I).
Regarding claim 1, Lteif teaches Penicillins (see Fig 1) which is 100 % identical to Formula (I).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penicillin, disclosed in Lteif, and introduce the TACN derivative NODAGA as disclosed in Makris and Cowan. One motivated to do so would have a reasonable expectation of success, as Cowan specifically teaches that antibiotic derivatives are rendered more potent as antimicrobials through the ability to generate reactive oxygen species and oxidative stress by incorporating a metal binding moiety to such antimicrobial agents, as part of a “dual warhead” approach to antimicrobial therapeutics [0007] [0017]. Thus, one would have recognized that applying the teaching of Lteif to the method of Makris and Cowan, would have yielded predictable results and improved the potency of the antibiotic (See MPEP § 2143 l(A)(D)).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights