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 .
Status of the claims
Claims 73, 74 and 76-86 are pending and are examined.
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 73, 74, 76, 78, 79, 81, 82 and 84-86 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.
Specifically, it is not clear if the subsequent peptide to be administered (second, third, etc.) are to picked from the group consisting of SEO ID NO: 65, 70, 114, 119, 120, 477, 491 and 493 or from a totally undisclosed group of peptides.
As such, the metes and bounds of the claims could not be determined.
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 73, 74, 76, 78-79, 81-82 and 84-86 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for initiating an anti-tumor-response against a B-cell malignancy with peptides represented by SEQ ID NOs: 65, 110, 114, and 220, administered in a pharmaceutical composition, does not reasonably provide enablement for all the peptides claimed in the independent claim 73 and in the form of a cell comprising the antigenic peptide, a nucleic acid, a host cell comprising the antigenic peptide or a cytotoxic T lymphocyte. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claims are drawn to a method for treating a B-cell malignancy or initiating, enhancing or prolonging an anti-tumor-response against a B-cell malignancy, comprising administering at least one antigenic peptide comprising or consisting of an amino acid sequence as set forth in any one of SEO ID NO: 65, 70, 114, 119, 120, 477 491 and 493, an immunogenic compound comprising the antigenic peptide, a nanoparticle comprising the antigenic peptide, a nucleic acid comprising the antigenic peptide, a cell comprising the antigenic peptide, a cytotoxic T lymphocyte specific for the antigenic peptide, a pharmaceutical composition comprising the antigenic peptide, a combination comprising (1) the at least one antigenic peptide comprising or consisting of an amino acid sequence as set forth in any one of SEO ID NO: 65, 70, 114, 119, 120, 477, 491 and 493, and (2) at least one other antigenic peptide.
The Application is in the field of tumor antigen-based vaccination, which is a relatively new field of cancer immunotherapy. Even though this approach might sound easy to implement and use, the reality is that there are numerous obstacles towards a successful therapy. For example, most of the tumor-associated antigens (TAAs) and tumor-specific antigens (TSAs) are (existing) human proteins and are, thus, considered as self-antigens. During thymic selection process, T cells that recognize peptide/self MHC complexes with sufficient affinity are clonally depleted. By offering a protection against auto-immune disease, this mechanism of T cell repertoire selection also reduce the possibility to develop immunity against TAAs and TSAs. This is exemplified by the fact that cancer-reactive TCRs are generally of weak affinity. Furthermore, until now, most of the vaccine trials performed with selected TAAs and TSAs with high binding affinity for MHC have not been shown to elicit strong immunity, probably reflecting the consequence of thymic selection. A potent anti-tumoral response will thus depend on the presentation of immunoreactive peptides and the presence of a sufficient number of reactive cells “trained” to recognize these antigens (see Specification [0006]).
Hence each antigen and vaccination methods needs to go a thorough process of testing with uncertain or unpredictable results a priori.
The specification disclosed a method of increasing/initiating immunogenicity of peptides MS4A1-B4, CD22-B1, CD37-B1 and TNFRSF13C-B1(SEQ ID NOs: 65, 110, 114 and 220, respectively) in HLA-A2 HHD-DR1 or HHD-DR3 humanized mice (example 2). No other peptides from the group claimed were tested and no other way of administrating the peptides (nucleic acid comprising the antigenic peptide, a cell comprising the antigenic peptide or a cytotoxic T lymphocyte specific for the antigenic peptide) were disclosed.
As indicated supra and recognized by Applicant, there is a lot of incertitude in applying vaccine-based therapy method in cancer immunotherapy. This aspect would guide a skilled artisan to perform a vast amount of experimentation with unpredictable results. This amount of experimentation is considered undue and thus the Application ids considered enabled only for methods for initiating an anti-tumor-response against a B-cell malignancy with peptides represented by SEQ ID NOs: 65, 110, 114, and 220, administered in a pharmaceutical composition.
Allowable Subject Matter
Claims 77, 80 and 83 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 claims are allowed. Claims 73, 74, 76, 78-79, 81-82 and 84-86 are rejected and claims 77, 80 and 83 are objected to.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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