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 .
The amendment filed 7/14/2026 has been entered. Claims 1-27, 29-38 and 40-117 have been cancelled. Claims 28, 39, 122-124, 128-130 have been amended. Claims 28, 39 and 118-132 are pending and are under examination.
Claim Objection/Rejections Withdrawn
The objection to claim 28 is withdrawn in view of the amendment to the claims.
The rejection of claims 28, 39 and 118-130 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 28, 39, 118-121, 123, 125-127 and 129 under 35 U.S.C. 102(a)(1) as being anticipated by Rikihisa et al. US 6,544,517 April 8, 2003 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 28, 39, 118-122, and 125-128 under 35 U.S.C. 102(a)(1) as being anticipated by Carlyon et al. US 2015/0174226 6/25/2015 is withdrawn in view of the amendment to the claims.
The rejection of claims 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 Immunol. 6:209-215 (1999) is withdrawn in view of the amendment to the claims.
The rejection of 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on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,461,099 is withdrawn in view of the amendment to the claims.
New Claim Rejections Based on Amendment
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 123 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.
Claims 123 is rendered vague and indefinite by the use of the term “Ech_0875”. The designation appears to constitute a laboratory designation that does not convey the structure of the underlying protein. Please include the “SEQ ID NO” for “Ech_0875”, if applicable.
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.
Claim(s) 28, 119, 120 and 122 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohashi et al. J Clin Microbiol. 1998 Sep; 36(9):2671-2678 cited in IDS.
Claim 28 and claim 122: Ohashi et al disclose a method of detecting antibodies that specifically bind an Ehrlichia organism in a test sample by using a dot immunoblot assay, comprising:
contacting an isolated polypeptide comprising or consisting of Ecaj 0920 (SEQ ID NO:43) or a polypeptide having at least 95% sequence identity thereto, wherein said polypeptide is the p30 protein (accession number AF078553). See sequence alignment with SEQ ID NO: 43 in Appendix A. Ohashi discloses that the contact is made with plasma sample, under conditions such as incubation that allow peptide-antibody complexes to form; (b) detecting the peptide-antibody complexes with peroxidase conjugated affinity-purified anti-dog IgG; wherein the detection of the peptide-antibody complexes is an indication that antibodies specific for an Ehrlichia organism are present in the plasma 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 plasma sample. See under “Dot immunblot assay” on page 2674 and page 2676 figure 6.
Claim 119: Ohashi et al disclose the Ehrlichia organism is E. canis.
Claim 120: Ohashi et al disclose the step of detecting comprises performing a dot immunblot assay.
Claim(s) 28, 39, 118-119, 120-121, 124, 125, 127 and 130 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McBride et al. US 7722880 5/25/2010.
McBride et al disclose:
Claim 28 and claim 39: A method of detecting antibodies that specifically bind an Ehrlichia organism in a test sample and a method of identifying an Ehrlichia infection in a mammalian subject, comprising:
(a) contacting an isolated polypeptide comprising or consisting Ecaj 0128 SEQ ID no: 24 or a polypeptide having at least 95% sequence identity thereto (see sequence alignment in Appendix B), with the test sample wherein the test sample is antiserum from dogs infected with E. canis, under conditions that allow peptide-antibody complexes to form;
(b) detecting the peptide- antibody complexes in a Western blot assay; 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 is an indication that the subject has an Ehrlichia infection, 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 column 4 lines 3-18, example 7 under cloning, expression and immunoreactivity of the Fbp gene column 55 last line to column 56 lines 1-17.
118. The method of claim 28 wherein the Ehrlichia organism is an Ehrlichia chaffeensis organism. “In addition, both anti-E. canis and anti-E. chaffeensis Fbp antisera exhibited cross-reactivity with the orthologous Fbp of the other species (data not shown)”. See column 52 lines 20-67 and column 53 lines 1-6.
119. The method of claim 28, wherein the Ehrlichia organism is an Ehrlichia canis organism.
120-121. The method of claim 28, wherein the step of detecting comprises performing enzyme linked immunosorbent assay (ELISA), radioimmunoassay (RIA), immunoradiometric assay, fluoroimmunoassay, chemiluminescent assay, bioluminescent assay, and Western blot. See column 41-46.
124 and 130. The method of 28, wherein the isolated polypeptide is Ecaj_0128 (SEQ ID NO:24).
125. (Previously Presented) The method of claim 39, wherein the step of detecting comprises performing a Western immunoblot assay.
Claim 127: the subject is a dog. See column 4 lines 3-18, example 7 under cloning, expression and immunoreactivity of the Fbp gene column 55 last line to column 56 lines 1-17.
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.
Claim(s) 28 and 120-121 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohashi et al. J Clin Microbiol. 1998 Sep; 36(9):2671-2678 in view of McBride et al. US 7722880 5/25/2010.
Claim 28: Ohashi et al disclose a method of detecting antibodies that specifically bind an Ehrlichia organism in a test sample by using a dot immunoblot assay, comprising:
contacting an isolated polypeptide comprising or consisting of Ecaj 0920 (SEQ ID NO:43) or a polypeptide having at least 95% sequence identity thereto, wherein said polypeptide is the p30 protein (accession number AF078553). See sequence alignment with SEQ ID NO: 43 in Appendix A. Ohashi discloses that the contact is made with plasma sample, under conditions such as incubation that allow peptide-antibody complexes to form; (b) detecting the peptide-antibody complexes with peroxidase conjugated affinity-purified anti-dog IgG; wherein the detection of the peptide-antibody complexes is an indication that antibodies specific for an Ehrlichia organism are present in the plasma 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 plasma sample. See under “Dot immunblot assay” on page 2674 and page 2676 figure 6.
Claim 120: Ohashi et al disclose the step of detecting comprises performing a dot immunblot assay.
Ohashi does not disclose the step of detecting comprises performing an enzyme-linked immunoassay, a radioimmunoassay, an immunoprecipitation, a fluorescence immunoassay, a chemiluminescent assay, a lateral flow assay, a flow cytometry assay, a multiplex immunoassay, a mass spectrometry assay, or a particulate-based assay.
McBride et al disclose a method of detecting antibodies that specifically bind an Ehrlichia organism in a test sample where in the detection of peptide- antibody complexes comprises performing enzyme linked immunosorbent assay (ELISA), radioimmunoassay (RIA), immunoradiometric assay, fluoroimmunoassay, chemiluminescent assay, bioluminescent assay, and Western blot. See whole of McBride especially column 41-46.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have used other immunodetection methods in the method of Ohashi et al as taught by McBride et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that McBride et al disclose that enzyme linked immunosorbent assay (ELISA), radioimmunoassay (RIA), immunoradiometric assay, fluoroimmunoassay, chemiluminescent assay, bioluminescent assay, and Western blot can be used to detect antibodies to Ehrlichia in a sample using Ehrlichia protein.
Claim(s) 39 and 126 is/are rejected under 35 U.S.C. 103 as being unpatentable over McBride et al. US 7722880 5/25/2010.
McBride et al disclose:
Claim 39: A method of identifying an Ehrlichia infection in a mammalian subject, comprising:
(a) contacting an isolated polypeptide comprising or consisting Ecaj 0128 SEQ ID no: 24 or a polypeptide having at least 95% sequence identity thereto (see sequence alignment in Appendix B), with the test sample wherein the test sample is antiserum from dogs infected with E. canis, under conditions that allow peptide-antibody complexes to form;
(b) detecting the peptide- antibody complexes in a Western blot assay; 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 is an indication that the subject has an Ehrlichia infection, 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 column 4 lines 3-18, column 52 lines 20-67 and column 53 lines 1-6, example 7 under cloning, expression and immunoreactivity of the Fbp gene column 55 last line to column 56 lines 1-17.
McBride does not disclose the mammalian subject is a human.
McBride, however, discloses that the gene encoding the orthologous Fbp from E. chaffeensis, the closely related causative agent of human disease, exhibits 87% homology to the Fbp protein of E. canis. See column 3 lines 37-39. Furthermore, McBride et al disclose that both anti-E. canis and anti-E. chaffeensis Fbp antisera exhibited cross-reactivity with the orthologous Fbp of the other species (data not shown)”. See column 52 lines 20-67 and column 53 lines 1-6.
Thus, it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention that the method of McBride et al can be used to identify an E. chaffeensis infection in a human subject, wherein the method of McBride et al such that the biological sample would be substituted with serum from humans subjects suspected of being infected with E. chaffeensis, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do is that McBride et al disclose that the gene encoding the orthologous Fbp from E. chaffeensis, the closely related causative agent of human disease, exhibits 87% homology to the Fbp protein of E. canis and that both anti-E. canis and anti-E. chaffeensis Fbp antisera exhibited cross-reactivity with the orthologous Fbp of the other species”. Thus, it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date that the Fbp of E. canis can be used to identify E. chaffeensis infection in humans.
Status of Claims
Claim(s) 28, 39, 118-127 and 130 are rejected.
Claims 128-129 and 131-132 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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