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. Claim Status Claims 1-20, filed 09/25/2023, are pending in the instant application and are examined on the merits herein. Information Disclosure Statement The information disclosure statement (IDS) submitted on 09/23/2025 has been considered by the examiner. Drawings Figures 1-2 and 4-7 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated as disclosed by Li ( Microbiol Spectr . 2022;10(5):e0174322 ; EPUB Sept 23, 2022) (Figures 1 and 4-7; Table 2) . See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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. Specification The disclosure is objected to because of the following informalities: Pg 10, line 9: Genus and species names should be italicized. Pg 18, line 1: unpaired quotation Appropriate correction is required. The use of the term s “ Sepharose ” (¶ [0051], pg 16), “ Pierce ” (¶ [0051], pg 16) , “ MICROLON ” (¶ [0053]), “ SpectraMax ” (¶ [0053]), “ RStudio ” (¶ [0057]), and “ GitHub ” (¶ [0057]), which are trade name s or mark s used in commerce, have been noted in this application. Each term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term . Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim (e.g. claim 1 ) with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. 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. Claim 19 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. The instant claim recites the antibody of claim 17 (comprising a peptide selected from a group consisting of SEQ ID NOs: 1-8; and a covalent label) has a pair of peptides selected from the group consisting of (1) SEQ ID NOs: 1 and 2, (2) SEQ ID NOs: 3 and 4; (3) SEQ ID NOs: 5 and 6; and (4) SEQ ID NOs: 7 and 8. It is unclear from the language of the claim if (a) the pairs recited in claim 19 are meant to dictate a second peptide depending on the first peptide initially selected from the list of sequences in the base claim (i.e. conditional claim limitation) or if (b) the antibody fragment of claim 17 further comprises an additional pair of peptides (i.e. 3 total peptides). As the metes and bounds of the claim are unclear , the claim is rendered indefinite. 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. Claims 1- 2, 5, 8, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li ( Microbiol Spectr . 2022;10(5):e0174322 ; EPUB Sept 23, 2022) . Li teaches four monoclonal antibodies that specifically bind to IR4 and IR6 peptides (identical to SEQ ID NOs: 16 and 14 respectively) (Table 1) with VH/VL sequences and pairings ( MAbs 1D11-4, 15E2-1, 17A8-1, and 28D3-1) identical to those recited in the instant claims (Table 2; Figure 6). 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 . Claims 3-4, 6-7, 9-10, 12-13 , and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim s 1-2, 5, 8, 11, and 14 above, and further in view of Wiehr ( Oncotarget . 2016;7(10):10990-11001 ) as evidenced by Price ( Chem Soc Rev. 2014;43(1):260-290 ) . Li teaches claims 1-2, 5, 8, 11 and 14 (identical IR4 and IR6 binding antibodies) as discussed above. Li further teaches standardized two-tiered testing for Lyme disease using ELISA and Western blotting to detect the presence of IgM and IgG antibodies against Borreliella antigens, has low sensitivity for early detection and does not distinguish between active infection and past exposure ( pg 2, ¶ 5) . Li further teaches antibodies specific for IR4 and IR6 could be developed as diagnostic s for direct detection of Lyme disease pathogen by labeling these invariant regions found in VlsE outer surface proteins on Borreliella species (i.e. bacterium) (abstract). Li also suggests labeling said IR specific Mabs with radioactive isotope ( 89 Zr) for sensitive in vivo detection of spirochete infection ( pg 10, last ¶). Li does not explicitly direct covalent labeling and methods for labeling bacterium. Wiehr teaches the feasibility of immunoPET (radioisotope labeled antibodies targeting bacterial outer membrane protein ; [ 64 Cu]NODAGA- YadA for Enterobacteriaceae detection ) as a method of in vivo imaging for diagnosis of bacterial infection (Abstract; Figure 3). Wiehr explicitly teaches chelator based conjugation ( pg 10997, right column, ¶ 4), which facilitates a covalent bond to the radiolabel as evidenced by Price ( pg 260, left column). A skilled artisan would recognize a need for accurate and sensitive detection of an active infection of Lyme disease causing bacteria based on the teachings of Li. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the antibody as taught by Li with a radiolabel as taught by Wiehr with a reasonable expectation of success as a method for sensitive detection Lyme disease causing bacteria as suggested by Li . Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Li ( Microbiol Spectr . 2022;10(5):e0174322 ; EPUB Sept 23, 2022) and Wiehr ( Oncotarget . 2016;7(10):10990-11001 ) as evidenced by Price ( Oncotarget . 2016;7(10):10990-11001 ) . Li teaches antibodies and antibody fragments identical to sequences recited in the instant claims (Table 1). Li further discloses current methods of detection (e.g. measuring the presence of IgM and IgG antibodies within patients samples against Borrelialla antigens) have low sensitivity and are unable to distinguish active infection and past exposure ( pg 2, ¶ 5). Li suggests an alternative method by labeling said IR specific Mabs with radioactive isotope ( 89 Zr) for sensitive in vivo detection of spirochete infection ( pg 10, last ¶). Li does not explicitly teach covalent labeling of antibodies. Wiehr teaches radiolabeling antibodies (via covalent bond as evidenced by Price discussed above) specific for bacterial surface antigens as a feasible method for the detection of in vivo bacterial infection (abstract). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify an known IR specific Mab as taught by Li with a radiolabel as taught by Wiehr and would be motivated to do so because Wiehr teaches ImmunoPET as a viable method for in vivo detection of bacterial infection. Conclusion No claims are currently allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT HANNAH SUNSHINE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7417 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-Th & Second Friday 8:30am-5pm EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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