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 1-14, 18-19, and 38-41 are pending.
Specification
The disclosure is objected to because of the following informalities: Paragraph 0041, which discusses binding specificity states, “In the context of this disclosure, the antibody binds to human CD94 virus”. It’s not clear what is meant by “virus” in this context.
Appropriate correction or clarification is requested.
Drawings
Figure 3 is objected to because it appears that applicants’ intention is to display colors for the octet assay. Note the headings for each graph in Figure 3 state “Color: - by Sample ID”. Applicants are reminded that any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 4 is objected to because of the following informalities: The last line of claim 4 states, “administering one or more checkpoint inhibitor”. This objection can be obviated by pluralizing “inhibitor” to inhibitors.
Claim Rejections - 35 USC § 102
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) 1-5, 7-9, and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bezman et al. (US20200199226A1, published June 25, 2020)
As to claim 1, Bezman et al. teach [0450] provided herein are methods of modifying an immune response in a subject comprising administering to the subject an anti-NKG2A (natural killer cell inhibitory receptor group 2A) or antigen-binding fragment thereof, described herein such that the immune response in the subject is enhanced, stimulated or up-regulated. Bezman et al. further teaches [0132] that NKG2A is expressed on natural killer cells.
As to claim 2, the broadest reasonable interpretation of an “anti-CD94 specific antibody” includes antibodies that bind to the NKG2/CD94 complex. For example, the specification teaches [0090] that exemplary CD94 antibodies include those that bind to the extracellular domain of CD94, NKG2A or NKG2C. Bezman et al. teach [0132] that CD94 is expressed as a complex with NKG2A. Specifically, the reference teaches: NKG2A forms a heterodimer with CD94. Thus, the anti-NKG2A antibodies of the prior art are considered “anti-CD94” specific.
As to claims 3 and 11, the reference teaches [0062] treating individuals with cancer. Activated T cells would inherently target cancer cells in the individual. Further, administration of the antibody for therapeutic purposes would inherently induce an ADCC response or ADP.
As to claims 4-5, the reference teaches [0063] administering additional therapeutic agents. The one or more additional therapeutic agent(s) is an anti-PD-1 antibody, an anti-PD-L1 antibody, and/or an anti-CTLA-4 antibody.
As to claims 7-9, the reference teaches [0049] that the antibodies can be chimeric, human, and humanized or synthetic (e.g., Fab, Fab′, (Fab′)2, Fv, or scFv fragments).
As to claim 12, the reference teaches [0541] that the antibodies can be conjugated to toxins.
Claim(s) 1-3, 7-9, and 11-14 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moretta et al. (US20150125464, published May 07, 2015)
Similar to the above 102(a)(1) rejection, Moretta et al. teaches [0016, 0224] administration of anti-NKG2A antibodies (including NKG2A or CD94 see para 0114) for the purposes of treating cancer wherein said antibodies can be chimeric or humanized [0024] or human [0065-0068] and/or modified (e.g. synthetic) or linked to a toxin [0156].
Regarding claims 13-14, and 18, Moretta et al. teach [0223, and Claim 14] administering anti-NKG2A antibodies into an individual who receives transplanted cells which would improve the survivability of the transplanted cells (e.g. autologous or allogenic). Specifically, Moretta et al. teach that the invention provides a method of improving the engraftment of hematopoietic cells in a patient comprising the step administering to said patient a composition of this invention comprising an activating antibody. Improvement in grafting is manifest by any one of reduced incidence or severity of graft versus host disease, prolonged survival of the graft, or a reduction in or elimination of the symptoms of the disease being treated by the graft (e.g., a hematopoietic cancer). This method is preferably used in the treatment of leukemia.
Allowable Subject Matter
Claims 6, 10, and 19 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.
Claim 38-41 are allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jin et al. Cancer Res (2019) 79 (13_Suplement): 1503, Abstract.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643