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 Status
The remarks filed 08/12/2026 are acknowledged.
Claims 1-20 and 25-27 are pending.
Claims 21-24 and 28 are canceled.
Applicant's election with traverse of Group I, claims 1-10, 16-17, and 25-27, in the reply filed on 08/12/2024 is acknowledged. The traversal is on the ground(s) that the Ambady reference (WO2019116392; 06/16/2026 PTO-892) only generally discloses chimeric bacteriocin constructs comprising translocation, receptor-binding, and cargo/killing domains, and identifies limited klebicin categories such as Klebicin B, Klebicin C, Klebicin CCL, and Klebicin D, whereas the pending claims are directed to chimeric klebicin polypeptides having the specific structural requirement that the killing domain and at least one receptor-binding domain are derived from two different naturally-occurring klebicins, while excluding SEQ ID NO: 45, and Ambady does not disclose or suggest the presently claimed domain selections and arrangements, nor does it teach that such constructs would exhibit the technical effects demonstrated in the instant specification, including antibacterial activity, activity against resistant or insensitive strains, retained activity in serum, and reduced FoR. This is not found persuasive because Ambady teaches a chimeric bacteriocin polypeptide comprising (1) a receptor-mediated translocation domain comprising a translocation segment (TS; translocation domain) and a receptor binding segment (RBS; receptor-binding domain) and (2) a cargo domain, that the cargo domain is a killing segment (killing domain), and that each of the TS, RBS, and killing segment may be from different klebicins [pages 74-75, claims 1 and 4] and are naturally occurring [Table 1; claims 4, 6, and 8; 0031, 0035, 0037]. Absent evidence to the contrary, the chimeric bacteriocin polypeptide does not include an amino acid sequence of SEQ ID NO: 45 as instantly claimed. Applicant further points to specific chimeric bacteriocin polypeptides (i.e. SEQ ID NOs: 7, 33, 47, 51, 57, 59, 61, 65, and 67) that exhibit the technical effects demonstrated in the instant specification, including antibacterial activity, activity against resistant or insensitive strains, retained activity in serum, and reduced FoR, and argues that the claimed chimeric klebicin polypeptide is not merely a generic domain-swapped bacteriocin, but is a defined klebicin-derived construct associated with specific biological activity. This is not found persuasive because claim 1 is generic and does not encompass these specific structures that Applicant refers to nor does the claim encompass any specific biological activity of the polypeptide.
Applicant further argues that Groups I and II do not lack unity merely because Group I is directed to a polypeptide and Group II is directed to nucleic acids. Claims 11-15 are directed to nucleic acids, expression cassettes, vectors, host cells, and recombinant production methods specifically directed to the production of the polypeptides of claim 1, and that the Groups are linked by the same inventive chimeric klebicin construct. This is not found persuasive because as stated in the restriction requirement, there is no common structure between a protein and a nucleic acid, and therefore, they do not share a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of the following species in the reply filed on 08/12/2024 is acknowledged: (A) SEQ ID NO: 69 and (B) injection. Regarding Species Group A, the elected species is free of the art, and consistent with MPEP 803.02, the examiner has extended the search and examination to the non-elected species. Therefore, the election of species is withdrawn. Regarding Species Group B, upon further consideration, the election of species is withdrawn. In view of the withdrawal of the election of species requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the election of species requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 11-15 and 18-20 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/12/2024.
Therefore, claims 1-10, 16-17, and 25-27 are under examination.
Priority
The instant application is a 371 of PCT/IN2022/050631 and claims priority to Republic of India Application #IN202141031183. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Priority is given with the earliest effective filing date of 07/12/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/16/2026 and 07/14/2026 are in compliance with the provisions of 37 CFR 1.97, except where noted. The document lined through on the 02/16/2026 IDS (i.e. NPL Cite No. 15) was not considered because it was not attached. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because Figures 1-3 and 5-18 do not meet the
requirements of 37 CFR 1.84(a)(1) which requires that “india ink, or its equivalent that
secures solid black lines, must be used for drawings”. The background lines are pixelated and not solid. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 9 and 10 are rejected as being dependent upon a rejected base claim (i.e. claim 1) but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Interpretation
Table 1 of the instant specification defines the specific protein IDs claimed in instant claims 6-8 with the corresponding klebicin type. The specific protein IDs as claimed will be interpreted and searched based on the corresponding klebicin type. See Table 1 below:
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600
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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 1-2, 6, 16-17, 25 and 27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ambady (WO2019116392; 06/16/2026 PTO-892).
Regarding claim 1, Ambady teaches a chimeric bacteriocin polypeptide comprising (1) a receptor-mediated translocation domain comprising a translocation segment (TS; translocation domain) and a receptor binding segment (RBS; receptor-binding domain) and (2) a cargo domain, and that the cargo domain is a killing segment (killing domain), and that each of the TS, RBS, and killing segment may be from different klebicins [pages 74-75, claims 1 and 4] and are naturally occurring [Table 1; claims 4, 6, and 8; 0031, 0035, 0037]. Absent evidence to the contrary, the chimeric bacteriocin polypeptide does not include an amino acid sequence of SEQ ID NO: 45 as instantly claimed.
Regarding claim 2, Ambady teaches that bacteriocins produced by E. coli, called the colicins, were the first ones to be identified, and are well studied and well characterized, exhibit a three domain architecture with an N-terminal translocation domain, a receptor binding domain, and a C-terminal killing domain [0030]. Ambady also teaches the specific domain boundaries of the Klebicins of the invention, with the translocation domain being N-terminal and the killing domain being C-terminal to the receptor binding domain [page 12; Table 1].
Regarding claim 6, Ambady teaches that that P628 (i.e. Klebicin CCL) [0138] and its translocation domain and receptor binding domain can be used in the present invention [0031; Table 1].
Regarding claim 16, Ambady teaches pharmaceutical compositions comprising at least one bacteriocin polypeptide of the invention provided in a pharmaceutically acceptable excipient [0086].
Regarding claim 17, Ambady teaches that the routes of administration include oral, aerosol or other device for delivery to the lungs (i.e. inhalation) and intravenous (IV), intramuscular, intraperitoneal, and intrathecal (i.e. injection). Therefore, the composition would necessarily be formulated for administration by these routes.
Regarding claims 25 and 27, Ambady teaches that administration to the lungs is incorporated into an aerosol formulation (composition) specifically designed for administration (i.e. formulated for administration of the polypeptide by inhalation), an example being a Proventil inhaler (container) [0084] and that the therapeutic is administered until successful elimination of the pathogenic bacteria is achieved [0083]. Therefore, the composition necessarily comprises an effective amount.
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.
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 1-2, 4-6, 16-17, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Ambady (WO2019116392; 06/16/2026 PTO-892), as applied to claims 1-2, 6, 16-17, 25 and 27 above.
The teachings of Ambady are above. Further, regarding claim 4, Ambady teaches that many of the chimeric constructs of the invention will have linkers which attach the different components as a single polypeptide [0038] and that the linkers allow for spacing between domains [0112]. Regarding claim 5, Ambady teaches that P628 (i.e. Wild-type Klebicin CCL) killed K. pneumoniae in both LB and Fetal Bovine Serum (FBS) [0154].
However, Ambady does not specifically teach the linker is between the receptor-binding domain and the killing domain, as required by claim 4, or that the killing domain comprises a full-length naturally-occurring klebicin, as required by claim 5, in a manner as required by 35 U.S.C. 102.
Regarding claim 4, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have specifically had a linker between the receptor-binding domain and the killing domain because Ambady teaches that many of the chimeric constructs of the invention will have linkers which attach the different components as a single polypeptide and that the linkers allow for spacing between domains. Thus, one would be motivated to have used a linker in order to attach the receptor binding domain to the killing domain and to allow for spacing between the domains.
Regarding claim 5, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have specifically used the full-length naturally occurring Klebicin P628 with cytotoxic activity as the killing domain in the polypeptide. One would want to use the full-length naturally occurring Klebicin P628 as the killing domain because Ambady teaches that P628 killed K. pneumoniae and therefore has antibacterial (i.e. killing) activity.
Claims 1-6, 16-17, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Ambady (WO2019116392; 06/16/2026 PTO-892), as applied to claims 1-2, 4-6, 16-17, 25 and 27 above, in view of Denkovskiene et al., 2019 (instant PTO-892).
The teachings of Ambady are above.
However, Ambady does not specifically teach that the peptide comprises two receptor-binding domains derived from two different naturally-occurring klebicins.
Regarding claim 3, Denkovskiene teaches that bacteriocins cause killing after binding to a specific receptor on the outer membrane and being translocated through the cell, and binding to the specific receptors is dependent on the central (i.e. receptor binding) domains [page 2, first paragraph] and that several klebicins can be used for broad and efficient control of Klebsiella pathogens [page 2, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the chimeric bacteriocin polypeptide of Ambady to specifically comprise two receptor-binding domains derived from two different naturally-occurring klebicins. One would have been motivated to have modified the chimeric bacteriocin polypeptide of Ambady to comprise two receptor-binding domains derived from two different naturally-occurring klebicins because Denkovskiene teaches that bacteriocins cause killing after binding to a specific receptor that several klebicins can be used for broad and efficient control of Klebsiella pathogens. Thus, one would want to have two receptor-binding domains derived from two different naturally-occurring klebicins in order to broaden Klebsiella targeting and lower resistance frequency.
Claim 7 is included in this rejection because Denkovskiene teaches that KvarM (i.e. P801) demonstrated the broadest spectrum of activity, with 85% of antibiotic resistant Klebsiella strains being sensitive to the klebicin [page 5, fourth paragraph] and that KvarM can target Klebsiella strains belonging to K. pneumoniae, K. quasipneumoniae, K. variicola, K. oxytoca, and K. aerogenes species [page 8, third paragraph]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the killing domain in the chimeric bacteriocin polypeptide of Ambady to specifically comprise a full length P801 (KvarM). One would have been motivated to have made this modification because Denkovskiene teaches that KvarM demonstrated the broadest spectrum of activity, with 85% of antibiotic resistant Klebsiella strains being sensitive to the klebicin and that KvarM can target Klebsiella strains belonging to K. pneumoniae, K. quasipneumoniae, K. variicola, K. oxytoca, and K. aerogenes species.
Claim 8 is included in this rejection because Denkovskiene teaches that KpneM (i.e. P774) was active against all seven tested antibiotic resistant Klebsiella strains and KpneA (i.e. P764) targeted three strains [page 5, fifth paragraph – page 6, first paragraph]. Denkovskiene also teaches that in a biofilm assay that used the same Klebsiella strains as in liquid culture assays, KpneA completely eradicated biofilms [page 6, fourth paragraph]. Denkovskiene further teaches that the cytotoxicity of KpneM is peptidoglycan synthesis inhibitor and the cytotoxicity of KpneA is pore forming [Table 2]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the chimeric bacteriocin polypeptide of Ambady to specifically comprise two receptor-binding domains derived from P764 and P774. One would have been motivated to have modified the chimeric bacteriocin polypeptide of Ambady to comprise two receptor-binding domains derived from two different naturally-occurring klebicins because Denkovskiene teaches that teaches that KpneM (i.e. P774) cytotoxicity is as a peptidoglycan synthesis inhibitor and the cytotoxicity of KpneA (i.e. P764) is as pore forming. Thus, one would want to have two receptor-binding domains derived from klebicins with different cytotoxicity’s in order to broaden Klebsiella targeting and lower resistance frequency.
Claims 1-2, 4-6, 16-17, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ambady (WO2019116392; 06/16/2026 PTO-892), as applied to claims 1-2, 4-6, 16-17, 25 and 27 above, in view of MedlinePlus, 2019 (instant PTO-892).
The teachings of Ambady are above. To reiterate, Ambady teaches that the routes of administration include intramuscular (IM) (i.e. injection) and that the therapeutic (composition) is administered until successful elimination of the pathogenic bacteria is achieved [0083]. Therefore, the composition necessarily comprises an effective amount.
However, Ambady does not specifically teach a first container containing a composition comprising an effective amount of the polypeptide wherein the kit is formulated for administration of the polypeptide by injection.
Regarding claim 26, MedlinePlus teaches that in order to give an IM injection that medicine is in a syringe (container) and injected into the patient [page 2; How to Give the IM Injection].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically put the composition comprising the polypeptide of Ambady into a syringe formulated for administration by injection. One would have been motivated to have put the composition comprising the polypeptide of Ambady into a syringe formulated for administration by injection because Ambady teaches that composition can be administered intramuscularly, and MedlinePlus teaches that in order to give an IM injection that medicine is in a syringe (container) and injected into the patient.
Allowable Subject Matter
The art does not teach a polypeptide comprising SEQ ID NOs: 7, 33, 47, 51, 57, 59, 61, 65, 67, 69, 71, 73, or 75 as required by claims 9 and 10.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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