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. With the amendment filed on November 7, 2025, claim 1 has been amended. Claims 1-20 are currently pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 1-11 and 20 in the reply filed on November 7, 2025 is acknowledged. Applicant has additionally elected the following species:
(Borrelia-specific peptide probes) SEQ ID NO: 360, SEQ ID NO: 362, SEQ ID NO: 365, SEQ ID NO: 367, SEQ ID NO: 371, SEQ ID NO: 372, SEQ ID NO: 373, SEQ ID NO: 373, SEQ ID NO: 376, and SEQ ID NO: 421; (Ehrlichia-specific peptide probes) SEQ ID NO: 590 and SEQ ID NO: 591; (Anaplasma-specific peptide probes) SEQ ID NO: 616, SEQ ID NO: 619, SEQ ID NO: 625, SEQ ID NO: 626, SEQ ID NO: 630, SEQ ID NO: 636 and SEQ ID NO: 637; and (Babesia-specific peptide probes) SEQ ID NO: 570, SEQ ID NO: 575, SEQ ID NO: 576, and SEQ ID NO: 581.
Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 7, 2025.
Claims 1-11 and 20 are currently under examination.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on September 20, 2023; June 23, 2023; March 22, 2023 and November 14, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Specification
4. The disclosure is objected to because of the following informalities: the specification contain references to skipped SEQ ID NOs under the new ST.26 rules; see for example SEQ ID Nos: 362, 376, 630, 576, and 581. Disclosures that refer to skipped sequences are improper. SEQ ID NOs containing prohibited sequence types under ST.26 will appear in the sequence listing but will not have sequence data, i.e., appear as “000” within the listing. While the sequence listing itself may contain a skipped sequence, reference to a “skipped” sequence within the disclosure is improper. Applicant is encouraged to review the entire specification and to remove any reference to the relevant SEQ ID NO from the specification. Appropriate correction is required.
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code; see for example paragraph 0119. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
6. The disclosure is objected to because of the following informalities: In paragraph 0326, the word ‘spreak’ should be ‘spread’.
Appropriate correction is required.
Claim Objections
7. Claim 1 is objected to because of the following informalities: Said claim contain references to skipped SEQ ID NOs under the new ST.26 rules; see for example SEQ ID NOs: 362, 376, 630, 576, and 581. A reference to skipped sequences are improper. SEQ ID NOs containing prohibited sequence types under ST.26 will appear in the sequence listing but will not have sequence data, i.e., appear as “000” within the listing. While the sequence listing itself may contain a skipped sequence, reference to a “skipped” sequence within the claim is improper. Appropriate correction is required.
8. Claim 1 is objected to because of the following informalities: ‘Borrellia’ should be spelled ‘Borrelia’. Appropriate correction is required.
9. Claim 3 is objected to because of the following informalities: Said claim depends upon a rejected based claim. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
10. Claims 1, 4-11 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 29-30 of U.S. Patent No. 10,871,494 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to, in part, a multiplex array for tick-borne infections, the multiplex array comprising an array surface and at least two peptide probes, wherein the at least two peptide probes extend from the array surface, wherein a first peptide probe of the at least two peptide probes is capable of binding to an antibody associated with a first tick-borne infections and a second peptide probe of the at least two peptide probes is capable of binding to an antibody associated with a second tick-borne infection, wherein the first tick-borne infection and the second tick-borne infection are distinct tick-borne infections selected from the group consisting of: Borrelia infection, an Ehrlichia infection, and Anaplasma infection, and a Babesia infection, wherein when the at least two peptide probes comprises a Anaplasma-specific peptide probe, the Anaplasma-specific peptide probe comprises a binding motif selected from SEQ ID NO: 616, SEQ ID NO: 619, SEQ ID NO: 625, SEQ ID NO: 626, SEQ ID NO: 630, SEQ ID NO: 636 and SEQ ID NO: 637.
Moreover, the patented claims are drawn to an array comprising an array surface and at least five peptide probes, wherein each of the at least five peptide probes comprises a binding motif selected from the group consisting of SEQ ID NO: 616, SEQ ID NO: 619, SEQ ID NO: 625, SEQ ID NO: 626, SEQ ID NO: 630, SEQ ID NO: 636 and SEQ ID NO: 637, extended from the array surface. The patented claims provides at least two Anaplasma--specific peptide probes. Thus, the patented claims are anticipated by the pending claims.
Claim Rejections - 35 USC § 102
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.
11. Claim(s) 1, 2, 4, 6, 7, 9, 11 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watt et al., WO 2007/097923 A2; 8/30/07.
Independent claim 1 is drawn to a multiplex array for tick-borne infections, the multiplex array comprising an array surface and at least two peptide probes, wherein the at least two peptide probes extend from the array surface, wherein a first peptide probe of the at least two peptide probes is capable of binding to an antibody associated with a first tick-borne infections and a second peptide probe of the at least two peptide probes is capable of binding to an antibody associated with a second tick-borne infection, wherein the first tick-borne infection and the second tick-borne infection are distinct tick-borne infections selected from the group consisting of: Borrelia infection, an Ehrlichia infection, and Anaplasma infection, and a Babesia infection,
wherein when the at least two peptide probes comprises a Borrelia-specific peptide probe, the Borrelia-specific peptide probe comprises a binding motif selected from the group consisting of: SEQ ID NO: 360, SEQ ID NO: 362, SEQ ID NO: 365, SEQ ID NO: 367, SEQ ID NO: 371, SEQ ID NO: 372, SEQ ID NO: 373, SEQ ID NO: 373, SEQ ID NO: 376, and SEQ ID NO: 421;
wherein when the at least two peptide probes comprises a Ehrlichia-specific peptide probe, the Ehrlichia-specific peptide probe comprises a binding motif selected from the group consisting of: SEQ ID NO: 590 and SEQ ID NO: 591;
wherein when the at least two peptide probes comprises a Anaplasma-specific peptide probe, the Anaplasma-specific peptide probe comprises a binding motif selected from the group consisting of: SEQ ID NO: 616, SEQ ID NO: 619, SEQ ID NO: 625, SEQ ID NO: 626, SEQ ID NO: 630, SEQ ID NO: 636 and SEQ ID NO: 637;
wherein when the at least two peptide probes comprises a Babesia-specific peptide probe, the Babesia-specific peptide probe comprises a binding motif selected from the group consisting of: SEQ ID NO: 570, SEQ ID NO: 575, SEQ ID NO: 576, and SEQ ID NO: 581.
Watt et al. disclose means for producing libraries of peptide structures for screen applications. The display methods will be apparent to the skilled artisan and include, for example, peptides that may be arrayed on a solid surface, e.g. a microarray, or only a plurality of solid surfaces, e.g., a plurality of beads or in microwells (see page 41, lines 20-24; meeting claims 4-5). Further, the peptides useful for high-throughput screening of peptides may be directly onto a solid surface or immobilized on a solid surface, e.g. using methods known in the art. For example a parallel array or pool of peptides is produced (see page 41, lines 26-31). Alternatively, the peptides are expressed on the surface of a phage, viral particle or a cell (see page 42, lines 1-3 and page 53, lines 30-31; meets claims 6-7). In some instances, a library of peptides are expressed within a cell or within a population of cells (see page 54, lines 1-2; meets claim 9). Lastly, Watt discloses that the peptide libraries of the present invention are useful for the diagnosis of a disease or disorder. The peptide is immobilized on a solid substrate and labelled with a detectable marker. A kit is proved for the diagnosis of a disease or disorder (see page 98, lines 6-12; meets claims 11 and 20).
A peptide capable of binding to a target is immobilized on a solid substrate. A second peptide capable of binding to a distinct site on the target is labelled with a detectable marker. Watt discloses that the at least two peptide probes comprising Borrelia-specific probes, Babesia-specific probes, as well as Anaplasma-specific probes (see SCV results; meets claim 1-2).
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SEQ ID NO: 365
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SEQ ID NO: 616
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SEQ ID NO: 570
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Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
12. Claim(s) 1, 4, and 11 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by La Rosa et al., US 2004/0031072 A1; Published: 2/12/04.
Independent claim 1 is drawn to a multiplex array for tick-borne infections, the multiplex array comprising an array surface and at least two peptide probes, wherein the at least two peptide probes extend from the array surface, wherein a first peptide probe of the at least two peptide probes is capable of binding to an antibody associated with a first tick-borne infections and a second peptide probe of the at least two peptide probes is capable of binding to an antibody associated with a second tick-borne infection, wherein the first tick-borne infection and the second tick-borne infection are distinct tick-borne infections selected from the group consisting of: Borrelia infection, an Ehrlichia infection, and Anaplasma infection, and a Babesia infection,
wherein when the at least two peptide probes comprises a Borrelia-specific peptide probe, the Borrelia-specific peptide probe comprises a binding motif selected from the group consisting of: SEQ ID NO: 360, SEQ ID NO: 362, SEQ ID NO: 365, SEQ ID NO: 367, SEQ ID NO: 371, SEQ ID NO: 372, SEQ ID NO: 373, SEQ ID NO: 373, SEQ ID NO: 376, and SEQ ID NO: 421;
wherein when the at least two peptide probes comprises a Ehrlichia-specific peptide probe, the Ehrlichia-specific peptide probe comprises a binding motif selected from the group consisting of: SEQ ID NO: 590 and SEQ ID NO: 591;
wherein when the at least two peptide probes comprises a Anaplasma-specific peptide probe, the Anaplasma-specific peptide probe comprises a binding motif selected from the group consisting of: SEQ ID NO: 616, SEQ ID NO: 619, SEQ ID NO: 625, SEQ ID NO: 626, SEQ ID NO: 630, SEQ ID NO: 636 and SEQ ID NO: 637;
wherein when the at least two peptide probes comprises a Babesia-specific peptide probe, the Babesia-specific peptide probe comprises a binding motif selected from the group consisting of: SEQ ID NO: 570, SEQ ID NO: 575, SEQ ID NO: 576, and SEQ ID NO: 581.
La Rosa discloses polypeptide molecules used to prepare arrays of target molecules arranged on a surface of a substrate. The target molecules are preferably known molecules, e.g. polypeptides, which are capable of binding to specific probes, such as specific antibodies. For high-density microarrays each spotted element may contain up to about 10 7 or more copies of the target molecule, e.g. single stranded cDNA, on glass substrates or nylon substrates (see paragraph 0093; meets claim 1 and 4). Arrays with target molecules from a single species can be used with probe molecules from the same species or a different species due to the ability of cross species homologous genes to hybridize (see paragraph 0094; meets claim 1). It is understood that the molecules of the invention may be labeled with reagents that facilitate detection of the molecule (see paragraph 0024; meets claim 11).
Moreover, La Rosa discloses that commonly preferred sequence length of a query sequence is from about 10 to 100 or more amino acids. There are a variety of motifs known in the art (see paragraph 0105). Lastly, La Rosa discloses that the at least two peptide probes comprising Borrelia-specific probes as well as Anaplasma-specific probes (see SCV results; meets claim 1).
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SEQ ID NO: 365
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SEQ ID NO: 616
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SEQ ID NO: 626
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SEQ ID NO: 636
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SEQ ID NO: 421
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Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Conclusion
13. No claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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, Gary B Nickol can be reached at 571-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 December 11, 2025
/BRIAN GANGLE/Primary Examiner, Art Unit 1645