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 Objections
Claims 1,14, 27, 51, 53, 60 are objected to because of the following informalities: the claims recite peptides identified by SEQ ID NOs followed by non-standard designations in brackets, e.g., “[Peptide 17A]” or parentheses, e.g., “(TNC 874-882/Cit 876-877)”. A portion of the peptide of SEQ ID NO: 3 is underlined. Appropriate correction is required. This objection affects all dependent claims.
Claim 61 is objected to because of the following informalities: the claim recites “either claim 1” but does not recite an additional claim. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10, 12, 13, 22, 24-26, 38, 60, 61 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to peptides and nucleic acids derived from the human tenascin-C protein (Nies et al, 1991, Fig. 2, residues 872-885 and 2070-2083). Tenascin-C is processed into peptides which are citrullinated at arginine residues post-translationally in humans (Schwenzer et al, 2016, of record). The instant citrullinated peptides as claimed were found to comprise epitopes recognized by antibodies and T and B cells (considered antigen presenting cells, Discussion of Song et al) from human subjects (Song et al, 2021, “TNC17” and “TNC56”), and to bind the HLA molecule as recited in instant claim 5. This establishes that the claimed peptides are found naturally in humans as they were induced via the autoantigen process and bound to highly specific antibodies. The claimed peptides are considered to inherently exist in humans, otherwise the specific antigen binding molecules would not exist (such antigen binding molecules would be specific for the “hypocitrullinated” epitope). Likewise, the T and B cells and antibodies that bound the peptides are considered to be “solid” carriers that comprise a membrane. Further, the peptides are encoded by the tenascin-C gene (Nies et al) in the human genome (a nucleic acid sequence) but citrullinated post-translationally, thus, the polynucleotide of claim 61 is also found in nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited peptides and nucleic acids are no different in their biological properties than those found in the organism from which they were derived, i.e. the recited peptides and nucleic acid perform the same biological function (induce antigen binding sequences, encode an antigen) with the same structure (amino acid residues, nucleotides, cells) as the biological molecules found in nature. As such, the claimed peptides and nucleic acids cannot be considered to comprise “significantly more” than such molecules, or cells that bind them, found in nature.
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) 61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al (JBC, 1991).
Nies et al teach isolated an cDNA expression vector encoding the human tenascin-C protein that includes sequences encoding the claimed peptides (Fig. 2, residues 872-885 and 2070-2083, page 2823). This is considered encoding the citrullinated peptides of the claims because such citrullination of, e.g., arginine is done post-translationally and is not encoded by nucleic acid codons (i.e. a codon for citrulline is not found in the genetic code.).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638
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