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 1-27, 29-38, 40-47 and 48-117 have been canceled. Claims 118-130 are new. Claims 28, 39 and 118-130 are pending and are under examination.
Election/Restrictions
Applicant’s election without traverse of Group II claims 28 and 39 in the reply filed on 11/13/25 is acknowledged.
Claims 1-19, 48, 59, 70, 77, 98 and 115 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/13/25.
Applicant's election with traverse of the species Ecaj_0126 in the reply filed on 11/13/25 is acknowledged. The traversal is on the ground(s) that additional species could be searched without an undue burden. This is not found persuasive because search burden is not a requirement for restrictions filed under 35 USC 371.
As set forth in the restriction requirement, the technical feature of the Ehrlichia polypeptides of Table 1, is not a special technical feature as it does not make a contribution over the prior art in view of UniprotKB accession no. Q2GFW (cited in IDS) which discloses Ehrlichia chaffeensis Ech_0875 that comprises a sequence with 100% sequence identity to SEQ ID NO: 1. The requirement is still deemed proper and is therefore made FINAL.
Claims to the elected species Ecaj_0126 is free of prior art. Therefore, the search has been extended to other sequences, for example those set forth in claims 122-124 including Ech_1128 (SEQ ID NO: 8), Ecaj_0151 (SEQ ID NO: 23) and Ecaj_0636.
Claims 1-19, 48, 59, 70, 77, 98, 115, 124, and 130 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/13/25.
Information Disclosure Statement
The information disclosure statement filed 6/12/24 has been considered and an initialed copy is enclosed.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 28 is objected to because of the following informalities: In line 8, please insert “to” between “specific” and “an Ehrlichia”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28, 39 and 118-130 are 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 claims refer to polypeptides in Table 1. Reference to Figures or Tables). Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). MPEP 2173.05(s). In the instant case, all of the polypeptides in table 1 are identified by sequence identification number (SEQ ID NO:) which can easily be listed in the claims.
Claims 122-124 and 128-130 are rendered vague and indefinite by the use of the terms such as ”Ecaj_0126” or “Ech_0875” or “Ecaj_0151”. The designation appears to constitute a laboratory designation that does not convey the structure of the underlying protein. These proteins are also identified by “SEQ ID NO” in the specification which can be recited in lieu of the laboratory designations.
In claim 121, an ELISA (enzyme linked immunosorbent assay) is the as an enzyme linked immunoassay despite the slight difference is wording.
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.
Claim(s) 28, 39, 118-121, 123, 125-127 and 129 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rikihisa et al. US 6,544,517 April 8, 2003.
Claim 28: Rikisha et al disclose a method of detecting antibodies that specifically bind an Ehrlichia chaffeensis or E. canis organism in a bodily fluid test sample obtained from a patient, comprising:
(a) contacting an isolated polypeptide OMP-1R comprising or consisting of a sequence of Table 1, wherein the sequence in Table 1 is SEQ ID NO: 8 (Ech_1128)which has 100% amino acid sequence identity with SEQ ID NO: 16 (OMP-1R) disclosed in Rikihisa et al, with the test sample, under conditions that allow peptide-antibody complexes to form;
(b) detecting the peptide-antibody complexes;
wherein the detection of the peptide-antibody complexes is an indication that antibodies specific for an Ehrlichia organism are present in the test sample, and wherein the absence of the peptide- antibody complexes is an indication that antibodies specific to an Ehrlichia organism are not present in the test sample.
See OMP-1R protein sequence in figure 10B (SEQ ID NO: 16), and sequence alignment below; column 13 lines 50-67, column 14 lines 1-21 and column 4 lines 1-8.
Claim 39: Rikihisa et al disclose a method of identifying an Ehrlichia infection in a mammalian subject comprising:
(a) contacting a bodily fluid biological sample from the subject with an isolated polypeptide OMP-1R comprising or consisting of a sequence of Table 1 , wherein the sequence in Table 1 is SEQ ID NO: 8 which has 100% amino acid sequence identity with SEQ ID NO: 16 (OMP-1R) disclosed in Rikihisa et al under conditions that allow peptide-antibody complexes to form;
and (b) detecting the peptide-antibody complexes; wherein the detection of the peptide-antibody complexes is an indication that the subject has an Ehrlichia infection.
See OMP-1R protein sequence in figure 10B (SEQ ID NO: 16) and sequence alignment below; column 13 lines 50-67, column 14 lines 1-21 and column 4 lines 1-8.
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Claim 118-119: Rikihisa et al disclose the Ehrlichia organism is an Ehrlichia chaffeensis or an Ehrlichia canis organism. See column 13 lines 50-67, column 14 lines 1-21 and column 4 lines 1-8.
Claim 120-121: Rikihisa et al disclose the step of detecting comprises performing an enzyme-linked immunoassay (ELISA) or an immunoblot assay such as a Western blot assay. See column 13 lines 50-67 and column 14 lines 1-21.
Claim 123: Rikihisa et al disclose the isolated polypeptide is OMP-1R (SEQ ID NO: 16) which has 100% amino acid sequence identity with SEQ ID NO: 8 corresponding to the sequence of Ech_1128.
Claim 125: Rikihisa et al disclose the step of detecting comprises performing an enzyme-linked immunoassay (ELISA) or an immunoblot assay such as a Western blot assay. See column 13 lines 50-67 and column 14 lines 1-21.
Claim 126-127: Rikihisa et al disclose the subject is a human or dog. See abstract and column 4 lines 1-8.
Claim 129: Rikihisa et al disclose the isolated polypeptide is OMP-1R (SEQ ID NO: 16) which has 100% amino acid sequence identity with SEQ ID NO: 8 corresponding to the sequence of Ech_1128.
Claim(s) 28, 39, 118-122, and 125-128 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlyon et al. US 2015/0174226 6/25/2015.
Claim 28: Carlyon et al disclose a method of detecting antibodies that specifically bind a Anaplasmatacaea (defined as to include Ehrlichia species), in a biological test sample, comprising: (a) contacting an isolated polypeptide of the invention (see table 1 SEQ ID NO: 23) comprising or consisting of SEQ ID NO: 55 (Ecaj_0636), with the test sample, under conditions that allow peptide-antibody complexes to form;
(b) detecting the peptide-antibody complexes; wherein the detection of the peptide-antibody complexes is an indication that antibodies specific for an Ehrlichia organism are present in the test sample, and wherein the absence of the peptide- antibody complexes is an indication that antibodies specific an Ehrlichia organism are not present in the test sample.
See abstract, paragraph 41 and paragraph 51,
Claim 39: Carlyon et al disclose a method of identifying an Anaplasmatacaea (defined as to include Ehrlichia species) Ehrlichia infection in a mammalian subject comprising:(a) contacting a biological sample from the subject with an isolated polypeptide of the invention (see table 1 SEQ ID NO: 23) comprising or consisting of SEQ ID NO: 55 (Ecaj_0636) under conditions that allow peptide-antibody complexes to form; and (b) detecting the peptide-antibody complexes; wherein the detection of the peptide-antibody complexes is an indication that the subject has an Ehrlichia infection.
See abstract, paragraph 41 and paragraph 51,
Sequence alignment with SEQ ID NO: 55 (Ecaj_0636)
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Claim 118-119: the Ehrlichia organism is E. chaffeensis or E. canis. See paragraph 41.
Claim 120-121: Carlyon et al disclose that detecting peptide-antibody complexes can be carried out using enzyme-linked immunoassay (ELISA). See paragraph 53 and claim 13
Claim 122: Carlyon et al disclose the isolated polypeptide is Ecaj_0636 (SEQ ID NO: 55).
Claim 125: Carlyon et al disclose that detecting peptide-antibody complexes can be carried out using enzyme-linked immunoassay (ELISA). See paragraph 53 and claim 13
Claim 126: Carlyon et al disclose the subject is a human. See paragraph 51.
Claim 127: Carlyon et al disclose the biological sample is from mammals susceptible to infection by Anasplamataceae (see paragraph 51) and disclose that mammals susceptible to infection by Anasplamataceae includes a dog (see paragraph 41).
Claim 128: Carlyon et al the isolated polypeptide is Ecaj_0636, (SEQ ID NO: 55).
Claim(s) 28, 39, 119-121, 124-125, 127 and 130 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bowie et al. Potential value of major antigenic protein 2 for serological diagnosis of heartwater and related ehrlichial infections. Clin. Diagn. Lab. Immunol. 6:209-215 (1999).
Claim 28: Bowie et al disclose a method of detecting antibodies that specifically bind an Ehrlichia organism in a test sample, comprising:
(a) contacting an isolated polypeptide comprising or consisting of a sequence SEQ ID NO: 23 (Ecaj_0151) which corresponds to MAP2, with the test sample, under conditions that allow peptide-antibody complexes to form;
(b) detecting the peptide-antibody complexes; wherein the detection of the peptide-antibody complexes is an indication that antibodies specific for an Ehrlichia organism are present in the test sample, and wherein the absence of the peptide- antibody complexes is an indication that antibodies specific an Ehrlichia organism are not present in the test sample.
See serum from a dog infected with E. canis (positive) or from a healthy dog (negative) was tested in an indirect ELISA against recombinant MAP2. Figure 5B on p. 213.
Claim 39: Bowie et al disclose a method of identifying an Ehrlichia infection in a mammalian subject comprising:
(a) contacting a biological sample from the subject with an isolated polypeptide comprising or consisting of SEQ ID NO: 23 (Ecaj_0151) which corresponds to MAP2, under conditions that allow peptide-antibody complexes to form; and
(b) detecting the peptide-antibody complexes; wherein the detection of the peptide-antibody complexes is an indication that the subject has an Ehrlichia infection.
See serum from a dog infected with E. canis (positive) or from a healthy dog (negative) was tested in an indirect ELISA against recombinant MAP2. Figure 5B on p. 213.
Claim 119: Bowie et al disclose the Ehrlichia organism is an Ehrlichia canis organism.
Claim 120-121: Bowie the step of detecting comprises performing an enzyme-linked immunoassay (indirect ELISA).
Claim 124: the isolated polypeptide is Ecaj_0151. See sequence alignment below.
Claim 125: Bowie et al disclose the step of detecting comprises performing an enzyme-linked immunoassay (indirect ELISA).
Claim 127: Bowie et al disclose the subject is a dog.
Claim 130: Bowie et al disclose the isolated polypeptide is Ecaj_0151.
See alignment with SEQ ID NO: 23 (Ecaj_0151) below:
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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.
Claims 28, 39, and 118-121, 124-127 and 130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,461,099 . Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘099 claims disclose.
A method of detecting antibodies that specifically bind an Ehrlichia organism in a test sample, comprising: (a) contacting an isolated polypeptide of Ecaj_0104, with the test sample, under conditions that allow peptide-antibody complexes to form; (b) detecting the peptide-antibody complexes; wherein the detection of the peptide-antibody complexes is an indication that antibodies specific for an Ehrlichia organism are present in the test sample, and wherein the absence of the peptide-antibody complexes is an indication that antibodies specific to an Ehrlichia organism are not present in the test sample.
The method of claim 1, wherein the Ehrlichia organism is an Ehrlichia chaffeensis organism.
The method of claim 1, wherein the step of detecting comprises performing an enzyme-linked immunoassay, a radioimmunoassay, an immunoprecipitation, a fluorescence immunoassay, a chemiluminescent assay, an immunoblot assay, a lateral flow assay, a flow cytometry assay, a multiplex immunoassay, a mass spectrometry assay, or a particulate-based assay.
The method of claim 3, wherein the step of detecting comprises a lateral flow assay or an enzyme-linked immunoassay, wherein the enzyme-linked immunoassay is an ELISA.
A method of identifying an Ehrlichia infection in a mammalian subject comprising: (a) contacting a biological sample from the subject with an isolated polypeptide Ecaj_0104, under conditions that allow peptide-antibody complexes to form; and (b) detecting the peptide-antibody complexes; wherein the detection of the peptide-antibody complexes is an indication that the subject has an Ehrlichia infection.
The method of claim 5, wherein the step of detecting comprises performing an enzyme-linked immunoassay, a radioimmunoassay, an immunoprecipitation, a fluorescence immunoassay, a chemiluminescent assay, an immunoblot assay, a lateral flow assay, a flow cytometry assay, a multiplex immunoassay, a dipstick test, or a particulate-based assay.
The method of claim 5, wherein the subject is a human.
The method of claim 5, wherein the subject is a dog.
Status of Claims
Claims 28, 39 and 118-130 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645