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 .
Claims 1-20 are pending and examined on the merits.
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 7 and 15 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 7 and 15 recite “at least one adjuvant” selected from a group including “CpG oligonucleotides and derivatives”, poly-(I:C) and derivatives, “particulate formulations with poly(lactide-co-glycolide”, and “virosomes”. It is unclear if the selection must include plural particulate formulations; plural CpG oligonucleotides and derivatives together; poly-(I:C) together with plural derivatives; or plural virosomes.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-20 are reliant on a genus of expression vectors that 3ncode and alpha beta TCR that specifically recognizes the peptide consisting of SEQ ID NO: 46 when presented in the context of MHC I. The specification fails to provide a written description of the encoded TCR. It is well-known in the art that the heterodimer of the α and β subunits of the TCR form the recognition unit of the receptor (Sahin et al, U.S. 2013/0273647, see Figure 1). The art teaches that N-terminal domains of both the α and β subunits encompass sequence variability akin to the variable domains of immunoglobulins (Sahin et al, page 1, paragraph [0007], lines 5-7), and which include areas of hypervariability corresponding to the CDR regions of immunoglobulins (Sahin et al, paragraph [0008], lines 1-3). The specification does not provide a written description of the N-terminal domains of paired alpha and beta chains, or the CDR regions of the paired alpha and beta chains responsible for recognition of SEQ ID NO:46 when presented in the context of MHC I. One of skill in the art would not be able to envisage any member of the genus of expression vectors encoding the TCR receptor because it is not possible to describe the hypervariable CDR sequences of the TCR responsible for recognition based on a description of a peptide being recognized. One of skill in the art would reasonably conclude that applicant was not in possession of the genus of expression vectors relied upon in the instant claims at the time of filing.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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