Office Action 2: Notice of Allowance (2025-01-29)

CLAIMS:
Amendments to the Claims

This listing of claims will replace all prior versions, and listings, of claims in the application.

1\. (Withdrawn) An isolated antigen binding protein that specifically binds to Klebsiella pneumoniae 02 antigen, wherein said antigen binding protein induces opsonophagocytic killing (OPK) of Klebsiella.

2\. - 67. (Canceled)366

68\. (Withdrawn) An isolated nucleic acid molecule encoding the antigen binding protein thereof according to claim 1.

69-73. (Canceled)7072

74\. - 84. (Canceled)7583

85\. (Currently Amended) A method for treating or ameliorating a Klebsiella infection in a subject in need thereof comprising administering to said subject an effective amount of an antigen binding protein that specifically binds to Klebsiella pneumoniae 02 antigen and comprises a set of Complementarity-Determining Regions (CDRs): HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of:SEQ. ID. NOs: 10-13, \[\[14\]\]DVNor SEQ ID NO: 15, and SEQ ID NO:16, respectively;
SEQ. ID. NOs: 19-22, \[\[23\]\]DVNor SEQ ID NO: 24, and SEQ ID NO: 25, respectively;
SEQ. ID. NOs: 28-31, \[\[32\]\]DASor SEQ ID NO: 33, and SEQ ID NO: 34, respectively;
SEQ. ID. NOs: 37-40, \[\[41\]\]DMSor SEQ ID NO: 42, and SEQ ID NO: 43, respectively;
SEQ. ID. NOs: 46-49, \[\[50\]\]DVNor SEQ ID NO: 51, and SEQ ID NO: 52, respectively;
SEQ. ID. NOs: 166-168, 175, \[\[176\]\]DVNor SEQ ID NO: 177, and SEQ ID NO: 178, respectively;

SEQ. ID. NOs: 169-171, 179, \[\[180\]\]DVNor SEQ ID NO: 181, and SEQ ID NO: 182, respectively;
SEQ. ID. NOs: 55-58, \[\[59\]\]DMSor SEQ ID NO: 60, and SEQ ID NO: 61, respectively;
SEQ. ID. NOs: 64-67, \[\[68\]\]AASor SEQ ID NO: 69, and SEQ ID NO: 70, respectively;
SEQ. ID. NOs: 73-78, respectively;
SEQ. ID. NOs: 82-85, \[\[86\]\]EVSor SEQ ID NO: 87, and SEQ ID NO: 88, respectively;
SEQ. ID. NOs: 91-94, \[\[95\]\]DNNor SEQ ID NO: 96, and SEQ ID NO: 97, respectively;
SEQ. ID. NOs: 100-103, \[\[104\]\]ENNor SEQ ID NO: 105, and SEQ ID NO: 106, respectively;
SEQ. ID. NOs: 109-112, \[\[113\]\]ENNor SEQ ID NO: 114, and SEQ ID NO: 115, respectively;
SEQ. ID. NOs: 118-121, \[\[122\]\]EVNor SEQ ID NO: 123, and SEQ ID NO: 124, respectively;
SEQ. ID. NOs: 127-130, \[\[131\]\]GASor SEQ ID NO: 132, and SEQ ID NO: 133, respectively;
or SEQ. ID. NOs: 172-174, 183, \[\[184\]\]EVNor SEQ ID NO: 185, and SEQ ID NO: 186, respectively.

86\. (Currently Amended) A method for inhibiting the growth of Klebsiella, or reducing the number of Klebsiella in a subject infected with Klebsiella comprising administering to a subject in need thereof an antigen binding protein that specifically binds to Klebsiella pneumoniae 02 antigen and comprises a set of Complementarity-Determining Regions (CDRs): HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of:
SEQ. ID. NOs: 10-13, DVN or SEQ ID NO: 15, and SEQ ID NO:16, respectively;
SEQ. ID. NOs: 19-22, DVN or SEQ ID NO: 24, and SEQ ID NO: 25, respectively;

SEQ. ID. NOs: 28-31, DAS or SEQ ID NO: 33, and SEQ ID NO: 34, respectively;
SEQ. ID. NOs: 37-40, DMS or SEQ ID NO: 42, and SEQ ID NO: 43, respectively;
SEQ. ID. NOs: 46-49, DVN or SEQ ID NO: 51, and SEQ ID NO: 52, respectively;
SEQ. ID. NOs: 166-168, 175, DVN or SEQ ID NO: 177, and SEQ ID NO: 178, respectively;
SEQ. ID. NOs: 169-171, 179, DVN or SEQ ID NO: 181, and SEQ ID NO: 182, respectively;
SEQ. ID. NOs: 55-58, DMS or SEQ ID NO: 60, and SEQ ID NO: 61, respectively;
SEQ. ID. NOs: 64-67, AAS or SEQ ID NO: 69, and SEQ ID NO: 70, respectively;
SEQ. ID. NOs: 73-78, respectively;
SEQ. ID. NOs: 82-85, EVS or SEQ ID NO: 87, and SEQ ID NO: 88, respectively;
SEQ. ID. NOs: 91-94, DNN or SEQ ID NO: 96, and SEQ ID NO: 97, respectively;
SEQ. ID. NOs: 100-103, ENN or SEQ ID NO: 105, and SEQ ID NO: 106, respectively;
SEQ. ID. NOs: 109-112, ENN or SEQ ID NO: 114, and SEQ ID NO: 115, respectively;
SEQ. ID. NOs: 118-121, EVN or SEQ ID NO: 123, and SEQ ID NO: 124, respectively;
SEQ. ID. NOs: 127-130, GAS or SEQ ID NO: 132, and SEQ ID NO: 133, respectively; or SEQ. ID. NOs: 172-174,183, \[\[184\]\]EVN or SEQ ID NO: 185, and SEQ ID NO: 186,
respectively.

87\. - 88. (Canceled)

89\. (Previously Presented) The method of claim 85, wherein the Klebsiella is antibiotic-resistant.

90\. (Currently Amended) The method of claim 89, wherein the Klebsiella \[\[Klebsiella\]\] is resistant to cephalosporin, quinolone,carbapene,meropenem, fluoroquinolone, tetracycline, chloramphenicol, trimethoprim, sulfonamide, and/or colistin.

91\. (Withdrawn) A method for sensitizing an antibiotic-resistant Klebsiella strain to antibiotics comprising contacting the antibody-resistant Klebsiella strain with an antigen binding protein that that specifically binds to Klebsiella pneumoniae 02 antigen.

92\. (Previously Presented) The method of claim 85, further comprising administering an antibiotic.

93\. (Original) The method of claim 92, wherein the antigen binding protein and the antibiotic provide a synergistic therapeutic effect.

94\. -95. (Canceled)

96\. (Previously Presented) The method of claim 92, wherein the antibiotic is meropenem, carbapenems, fluoroquinolone, tetracycline, chloramphenicol, trimethoprim, sulfonamide, and/or colistin.

97\. (Previously Presented) The method of claim 89, wherein antigen binding protein also specifically binds Klebsiellapneumoniae 01 antigen.

98\. (Previously Presented) The method of claim 89, wherein the antigen binding protein that specifically binds to Klebsiella pneumoniae 02 antigen is an antibody or antigen binding fragment thereof.

99\. (Canceled)

100\. (Previously Presented) The method of claim 85, wherein the Klebsiella is K pneumoniae, K oxytoca, K planticola, K ozaenae, K rhinosclermoatis and/or K granulomatis.

101\. (Original) The method of claim 100, wherein the Klebsiella is K pneumoniae.

102\. - 103. (Canceled)

104\. (New) The method of claim 85, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of: SEQ. ID. NOs: 109-112, ENN, and SEQ ID NO:

115, respectively; and wherein the antigen-binding protein is an antibody.

105\. (New) The method of claim 104, wherein the antibody comprises a VH comprising the amino acid sequence of SEQ ID NO: 116 and a VL comprising the amino acid sequence of SEQ ID NO:
117.

106\. (New) The method of claim 86, wherein the HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprise the amino acid sequences of: SEQ. ID. NOs: 109-112, ENN, and SEQ ID NO:

115, respectively; and wherein the antigen-binding protein is an antibody.

107\. (New) The method of claim 106, wherein the antibody comprises a VH comprising the amino acid sequence of SEQ ID NO: 116 and a VL comprising the amino acid sequence of SEQ ID NO:
117.

OFFICE 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 .
DETAILED ACTION
1.	Applicant’s response filed on October 17, 2024 is acknowledged.  Claims 1, 68, 85, 86, 89-93, 96-98, 100, 101 and 104-107 are currently pending. Claims 85, 86, and 90 have been amended. Claims 74, 102 and 103 have been canceled. Claims 104-107 have been added.  Claims 1, 68 and 91 were previously withdrawn.  Claims 85, 86, 89, 90, 92, 93, 96-98, 100, 101 and 104-107 are currently under examination.
Allowable Subject Matter
2.    This application is in condition for allowance except for the presence of claims 1, 68 and 91,  directed to an isolated antigen binding protein (claim 1), an isolated nucleic acid molecules (claim 68) and a method for sensitizing an antibiotic-resistant Klebsiella strain (claim 91), which is non-elected without traverse.  Accordingly, claims 1, 68 and 91 have been cancelled. Claims 85, 86, 89, 90, 92, 93, 96-98, 100, 101 and 104-107 are allowed.
Amendment
3.    An Examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
The application has been amended as follows:
In the claims:
Claims 1, 68 and 91 have been cancelled.
4.	Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance”.
5.

APPLICANT REBUTTAL: Remarks
Reconsideration of this Application is respectfully requested.
Upon entry of the foregoing amendment, claims 1, 68, 85-86, 89-93, 96-98, 100, 101, and 104-107 are pending in the application, with claims 1, 85, and 91 being the independent claims. Claims 1, 68, and 91 are withdrawn. Claims 85, 86, and 90 are sought to be amended. Claims 74, 102, and 103 are sought to be canceled without prejudice to or disclaimer of the subject matter therein. New claims 104-107 are sought to be added. The specification has also been amended as discussed below. These changes are believed to introduce no new matter, and their entry is respectfully requested.
Based on the above amendment and the following remarks, Applicants respectfully request that the Examiner reconsider all outstanding objections and rejections and that they be withdrawn.
Election/Restriction
The Office requires restriction to one of four identified Groups of claims (Groups I-IV).
Office Action at page 2. Applicants confirm election of the invention of Group III, represented by claims 85, 86, 89, 90, 92, 93, 96-98, and 100-101 (as well as new claims 104-107).
Objection to the Specification
The Specification is objected to because the specification allegedly contains references to skipped SEQ ID NOs under the new ST.26 rules. Office Action at page 6. Without acquiescing to the propriety of the objections and solely to expedite prosecution, the specification has been amended to remove references to skipped SEQ ID NOs.
The specification is also objected to for containing an embedded hyperlink and/or other form of browser-executable code. Office Action at page 7. Without acquiescing to the propriety of the objections and solely to expedite prosecution, the specification has been amended to remove embedded hyperlinks and/or other forms of browser-executable code.
Accordingly, Applicants respectfully request that the objections to the specification be withdrawn.
Objection to the Claims
Claim 85 and 102 are objected to for containing references to skipped SEQ ID NOs under the new ST.26 rules. Without acquiescing to the propriety of the objections and solely to expedite prosecution, i) claim 85 is sought to be amended to remove references to skipped SEQ ID NOs, and ii) claim 102 has been canceled, mooting the rejection with respect to that claim.
Accordingly, Applicants respectfully request that the objection to the claims be withdrawn.
Rejection under 35 U.S.C. § 112(a)
Claims 85, 89-90, 92, 93, 96-98 and 100-103 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as allegedly failing to comply with the written description requirement. According to the Office Action, the specification has "not adequately described methods of treating, preventing and ameliorating all conditions associated with a [sic] Klebsiella infections generally or by using the composition as claimed." Office Action at page 10. The Office Action also alleges that the "specification does not provide substantive evidence that the broadly claimed method is capable of inducing protective immunity," which the Examiner argues is required for the "intended potential purpose of prevention." Id. Without acquiescing to the
propriety of the objections and solely to expedite prosecution, i) claim 85 has been amended to remove the term "preventing" and to be directed to a method for treating or ameliorating a Klebsiella infection, and ii) claims 102-103 have been canceled, mooting the rejection with respect to those claims. Accordingly, Applicants respectfully request that the written description rejection of the claims be withdrawn.
Conclusion