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
Claim 14 was canceled.
Claims 1-13 and 15-21 are pending.
Claims 16-20 were withdrawn from further consideration (see below).
Claims 1-13, 15 and 21 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/1/2025 is acknowledged.
Restriction between all product claims is vacated and Groups I, II and III in restriction requirement filed 10/1/2025 drawn to all product claims have been rejoined.
Claim(s) 16-20 were/was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/1/2025.
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 6 and 13 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.
Claim 6 recites “wherein the two polypeptides are” in line 1. However, subpart (xiv) of claim 6 recites three sequences of SEQ ID NO: 57, 58 and 59. Therefore, it is unclear what sequences the two polypeptides are.
Claim 13 recites “the fusion proteins of (i)-(xiv)”. There is insufficient antecedent basis for this limitation in the claim. Claim 13 depends from claim 11 and claim 11 does not recite subpart (i)-(xiv).
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) 1, 4-5, 7-9 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirchhoff et al (US2011/0171751; PTO-892).
Regarding claim 1, Kirchhoff teaches “Recombinant polypeptides are disclosed that are useful for diagnosing American trypanosomiasis, or Chagas disease, a disease caused by the infectious agent Trypanosoma cruzi” (abstract). Kirchhoff teaches “The present invention utilizes recombinant proteins for detecting T. cruzi infected blood. The invention utilizes specific polypeptide sequences that correspond to fusion proteins FP3, FP4, FP5, FP6, FP7, FP8, FP9 and FP10” [0013]. Kirchhoff teaches “FP3 corresponds essentially to the combination of Ag15 (FIG. 1), and by Protein C” [0027]. Kirchhoff teaches “Ag15 [SEQ ID NO. 2] in FIG. 1, is derived from the TCR27 gene of T. cruzi [SEQ ID NO. 1]” [0024]. Kirchhoff teaches “Protein C. This is a calcium binding protein of T. cruzi” [0026]. Therefore, FP3 fusion protein of Kirchhoff is fusion of two different T. cruzi proteins.
Regarding claim 4-5, Ag15 and Protein C taught by Kirchhoff are different polypeptides. Different proteins have different sequences as recited by instant claim 5.
Regarding claim 7-8, Kirchhoff teaches method of detecting the presence of anti-Trypanosoma cruzi antibodies in a sample from a subject (claim 31). Kirchhoff teaches “(B) detecting a specific binding interaction with an antibody in said sample, wherein the binding interaction comprises a specific binding between antibody in the sample and an epitope contained within the amino acid sequence set forth in FP3” (step B of claim 31). Therefore, fusion protein FP3 of Kirchhoff is antigenic for anti-Trypanosoma cruzi antibodies as recited by instant claim 7.
Regarding claim 9, wherein-clause of claim 9 describes the functional property of antibodies against the fusion protein, not the functional property of the claimed fusion protein itself. Therefore, wherein-clause of claim 9 does not change or limit the structure of the claimed fusion protein. Therefore, the claimed fusion protein of claim 9 is also anticipated by Kirchhoff because Kirchhoff teaches the same structure as the claimed fusion protein.
Regarding claim 11, Kirchhoff teaches “the polypeptide of step A is immobilized on a carrier molecule or a solid phase” (claim 32).
Claims 1, 4-5, 7-9, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reed et al (WO1997/018475A1; PTO-892).
Regarding claim 1, Reed teaches “Compounds and methods are provided for diagnosing Trypanosoma cruzi infection” (abstract). Reed teaches “the present invention provides combination polypeptides (corresponds to “fusion protein” of instant claim 1) comprising two or more polypeptides, each polypeptide comprising an epitope of a T. cruzi antigen”.
Regarding claim 4-5, Reed teaches Trypanosoma cruzi antigen TcHi29 which has 93% sequence identity to instant SEQ ID NO: 2 (SCV; result 6 of 2.rag). Reed teaches Trypanosoma cruzi antigen Tcc38 which has 98.7% sequence identity to instant SEQ ID NO: 7 (SCV; result 3 of 7.rag).
Regarding claims 7-8, Reed teaches “method for detecting T. cruzi infection in a biological sample comprising:
(a) contacting the biological sample with a polypeptide comprising an epitope of a T. cruzi antigen having an amino acid sequence encoded by a nucleotide sequence recited in SEQ ID NO: 1 - SEQ ID NO:22, or a variant of said antigen that differs only in conservative substitutions and/or modifications; and
(b) detecting in the biological sample the presence of antibodies that bind to the polypeptide, therefrom detecting T. cruzi infection in the biological sample” (claim 1). Because the polypeptide of Reed binds to anti-T.cruzi antibodies, the polypeptide of Reed is antigenic for the antibodies.
Regarding claim 9, wherein-clause of claim 9 describes the functional property of antibodies against the fusion protein, not the functional property of the claimed fusion protein itself. Therefore, wherein-clause of claim 9 does not change or limit the structure of the claimed fusion protein. Therefore, the claimed fusion protein of claim 9 is also anticipated by Reed because Reed teaches the same structure as the claimed fusion protein.
Regarding claim 11, Reed teaches “In a preferred embodiment, the assay involves the use of polypeptide immobilized on a solid support to bind to and remove the antibody from the sample”.
Regarding claim 15, Reed teaches “The solid support may be any solid material known to those of ordinary skill in the art to which the antigen may be attached. For example, the solid support may be a test well in a microtiter plate or a nitrocellulose or other suitable membrane. Alternatively, the support may be a bead or disc, such as glass, fiberglass, latex or a plastic material such as polystyrene or polyvinylchloride.”
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt accession number A0A2V2V607_TRYCR (hereinafter UniProt; integrated into UniProtKB/TrEMBL on 12-SEP-2018; PTO-892).
Regarding claim 1, UniProt teaches Putative calcium-binding protein sequence (UniProt accession number A0A2V2V607_TRYCR) from Trypanosoma cruzi (result 1 of 76.rup). Because instant claim 1 does not recite that two polypeptides are from two different proteins and because instant claim 1 recites that each T. cruzi polypeptide can be fragment of T. cruzi protein, two portions of one T. cruzi protein can be two polypeptides encompassed by instant claim 1. Therefore, broadest reasonable interpretation of the fusion protein of instant claim 1 can be Putative calcium-binding protein sequence taught by UniProt.
Regarding claim 10, UniProt teaches Putative calcium-binding protein sequence (UniProt accession number A0A2V2V607_TRYCR) from Trypanosoma cruzi which has 76.4% sequence identity to instant SEQ ID NO: 76 as shown below (result 1 of 76.rup).
result 1 of 76.rup
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261
978
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769
921
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Allowable Subject Matter
Claims 2-3, 12 and 21 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
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645