CTNF 18/272,980 CTNF 91371 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Status of the Claims Claims 1 – 17 are pending. Claims 5 – 7 and 13 – 17 are rejected. Claims 1 – 4 and 8 – 12 are withdrawn. Election/Restriction Applicant’s election without traverse of Group II, claims 5 – 7 and 13 – 17, in the reply filed on March 13, 2026 is acknowledged. Applicant specifically elected the species of Compound 2 as presented below: PNG media_image1.png 174 195 media_image1.png Greyscale . Examination : The elected species is not allowable over the prior art. Claims 1 – 4 and 8 – 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Priority PNG media_image2.png 88 386 media_image2.png Greyscale Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, the filing date of the priority document is not perfected unless Applicant has filed both, a certified copy of the document and an English language translation (if the document is not in English) (see, 37 CFR 1.55(g)(3)). Accordingly, the claims do not receive the filing date of the earlier filed priority document and are examined with an effective filing date of January 20, 2022 (the filing date of the PCT Application). Information Disclosure Statement The information disclosure statement (IDS) submitted on July 18, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification The specification amendment filed on July 18, 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. Specifically, the following new phrase is not supported by the application (as filed on July 18, 2023): “the contents of which applications are incorporated herein by reference in their entireties for all purposes”. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. See MPEP 211.02 and MPEP 201.06(c)(IV). PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to 371 applications. When a benefit claim is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. This objection may be overcome by deleting the phrase “the contents of which applications are incorporated herein by reference in their entireties for all purposes”. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 5 – 7 and 13 – 17 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kang et al., J. Med. Chem. 2020, 63 (22), pp. 13669-13679 (publ. November 4, 2020), cited in IDS dated July 18, 2023 . Kang et al. teach Klebsiella pneumoniae is “one of the most critical opportunistic pathogens… K. pneumoniae is responsible for infections of the upper respiratory tract, urinary tract, and bloodstream and causes pneumonia”. See, e.g., pp. 13669, 1 st paragraph. Kang et al. teach there are four major types of toxin-antitoxin (TA) systems, including protein antitoxins in type II and IV. The protein antitoxins “bind directly to a protein toxin and inhibit the activity of the toxin (type II) or neutralize the toxic activity of the toxin without direct binding, such as by triggering opposite effects to the target (type IV)”. See, e.g., pp. 13669, 3 rd paragraph. Kang et al. teach Compound 2 : PNG media_image1.png 174 195 media_image1.png Greyscale . See, e.g., Abstract. The prior art anticipates the instant claims as presented below: Regarding claims 5 – 7, 13 – 14 and 16 – 17 , please note that the limitations “a compound that inhibits the binding of VapB and VapC in a Klebsiella pneumoniae toxin-antitoxin complex VapBC” and “the compound exhibits antibacterial activity against Klebsiella pneumoniae ” are directed to properties of the compound. MPEP §2112.01(I)-(II) states: “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) … Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) . A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.” Wang et al. teaches a composition comprising compound 2 exhibits IC50 value of 0.40 μM and is very efficient at disrupting the VapBC complex. See, e.g., pp. 13674, 5 th paragraph. The data from Figure 5B (in-part) is presented below: PNG media_image3.png 425 429 media_image3.png Greyscale . See, e.g., pp. 13673, Figure 5B. Since Wang et al. teach the identical compound 2 as claimed in instant claims, the compound would inherently also possess the same properties of inhibiting the binding of VapB and VapC in a Klebsiella pneumoniae toxin-antitoxin complex VapBC and exhibiting antibacterial activity against Klebsiella pneumoniae . Regarding claim 16 , please note the limitation “effective to prevent or treat pneumonia” is intended use limitations as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires the compound effective to prevent or treat pneumonia, but does not impart any specific limitations to the structure. Based on the teachings of Kang et al., the compound is capable of being effective to prevent or treat pneumonia . 07-15 AIA Claim s 5, 7 and 13 – 17 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by McKenzie et al., Journal of Bacteriology (2012), 194 (9), pp. 2189-2204 . McKenzie et al. teach VapBC “modules have been implicated in controlling bacterial growth in the intracellular environment and regulating rates of nitrogen fixation and biomass production during symbiosis in a host plant”. See, e.g., pp. 2189, 3 rd paragraph. McKenzie measures “the genome-wide transcriptional response to VapC overexpression (in comparison to VapBC overexpression) and identified a cohort of genes specifically targeted by VapC (operons for sugar transport)”. See, e.g., pp. 2190, 1 st paragraph. McKenzie teaches that single-stranded RNA gene substrate, MSMEG_2124 (DhaF) , act as a glycerol transporter for glycerol metabolism in organisms such as Mycobacteria smegmatis and Klebsiella pneumoniae. See, e.g., pp. 2193, 4 th paragraph. The prior art anticipates the instant claims as presented below: Regarding claims 5, 7, 13 – 14 and 16 – 17 , please note that the limitations “a compound that inhibits the binding of VapB and VapC in a Klebsiella pneumoniae toxin-antitoxin complex VapBC” and “the compound exhibits antibacterity activity against Klebsiella pneumoniae ” are directed to properties of the compound. MPEP §2112.01(I)-(II) states: “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) … Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) . A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.” McKenzie et al. teach a composition comprising MSMEG_2124 (DhaF) exhibits a decrease in n-fold change of 2.73, is very efficient as glycerol uptake facilitator to downregulate VapC induction in vivo . See, e.g., pp. 2199, Figure 5. Since Mckenzie et al. teach a compound as claimed in instant claim 5, the compound would inherently also possess the same properties of inhibiting the binding of VapB and VapC in a Klebsiella pneumoniae toxin-antitoxin complex VapBC and exhibiting antibacterial activity against Klebsiella pneumoniae . Regarding claim 16 , please note the limitation “effective to prevent or treat pneumonia” is intended use limitations as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires the compound effective to prevent or treat pneumonia, but does not impart any specific limitations to the structure. Based on the teachings of McKenzie et al., the compound is capable of being effective to prevent or treat pneumonia. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST. 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, Amy L. Clark can be reached at (571) 272-1310. 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. /Sagar Patel/Examiner, Art Unit 1626 /KAMAL A SAEED/Primary Examiner, Art Unit 1626 Application/Control Number: 18/272,980 Page 2 Art Unit: 1626 Application/Control Number: 18/272,980 Page 3 Art Unit: 1626 Application/Control Number: 18/272,980 Page 4 Art Unit: 1626
Prosecution Insights