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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 19 requires the peptide of claim 1, wherein said peptide is produced by solid phase synthesis, expression in a yeast cell or expression in a bacterial cell. Solid phase synthesis will produce a peptide identical to the instant SEQ ID NO:113. Both expression in yeast or bacterial cells will produce a peptide identical to SEQ ID NO:113. It is noted that yeast can carry out post-translational modification, such as glycosylation, but the instant peptide does not comprise the motif required for glycosylation, Asn-X-Ser/Thr. Thus, the peptide produced by any of the processes of claim 19 will be identical to the peptide of claim 1 and not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 2 states that the peptide of claim 1 has the ability to bind to an MHCI molecule and when bound is capable of being recognized by CD8T cells. The specification teaches that SEQ ID NO:113 binds to HLA-A2 (page 20, line 3 under “Detailed Description”). The specification teaches that
In case of a MHC class I epitope being used as an antigen, the T cells are CD8-positive T cells (page 144, last two lines).
Because SEQ ID NO: 113 is presented by HLA-A2, it is a MHC class I eptiope, and the recognizing T cells are CD8 positive T cells according to the specification. The ability of SEQ ID NO: 113 to bind to MHC class I and be recognized by a CD8 T cell is an inherent property of SEQ ID NO:113. Thus, claim 2 fails to further limit claim 1 being drawn to the identical peptide..
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.
Claim 8 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.
(A)Claim 8 is vague and indefinite in the recitation of an incorrect Markush group format. Claim 8 recites CpG oligonucleotides and derivatives, poly-(I:C) and derivatives rather than CpG oligonucleotides, derivatives of CpG oligonucleotides, poly-(I:C), poly-(I:C) derivatives. Thus claim 8 is not in the format of “selected from the group consisting of A, B C and D” and it is unclear what constitutes the elements of the group.
(B)The recitation of the species of oligonucleotides, derivatives, particulate formulations and virosomes in the plural is vague and indefinite in that it is unclear if multiple oligonucleotides, derivatives, particulate formulations and virosomes are needed to satisfy the claim limitations.
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.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re wands, 858 F.2d 731, 737.8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Claim 2 requires that the peptide of claim 1 has the ability to bind to an MHC-I molecule, and wherein said peptide, when bound to the MHC is capable of being recognized by CD8 T cells.
The specification teaches that the peptide of SEQ ID NO:113 is over-presented on tumors relative to normal tissues (pages 162-163, Table 9). When given the broadest reasonable interpretation “MHC I molecule” includes HLA-A*01, -A*03, -A*11, A*23 to A*34 and HLA-B alleles (Hurley et al, Tissue Antigens, 1997, Vol. 50, pp. 401-418, see Tables 1 and 2, pp. 404-410). The specification teaches that SEQ ID NO:113 binds to HLA-A*02 (page 20, line 3 under “Detailed Description). The specification fails to provide any objective evidence that a peptide consisting of SEQ ID NO: 113 is expressed in the context of other types of HLA molecules outside of HLA-A*02 on tumor cells or APC cells. One of skill in the art would understand that SEQ ID NO:113 may bind to other MHC I antigens with non-optimal affinity. The art teaches that T cell activation is determined by the TCR-pMHC binding parameters but there is no predictive model relating the TCR-pMHC binding interaction to a T cell activation that is consistent with the published data and that there is a need for additional quantitative experimental data to establish a more definitive model (Lever et al, Nature Reviews Immunology, 2014, Vol. 14, pp. 619-629, see page 619, first column, lines 10-17 and second column, lines 26-28). The specification fails to provide any teachings of guidance regarding the potential display of SEQ ID NO: 113 by other HLA-A or HLA-B antigens, and the resulting ability of the display of SEQ ID NO: 113 in a non-HLA-A*02 cleft to recognize and activate CD8+T cell. One of skill in the art would be subject to undue experimentation in order use the peptide in the context of other MHC I antigens outside that of HLA-A*02.
Claims 1, 3-7, 14-18 and 20 are allowed.
Claims 9-13 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.
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