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 .
DETAILED ACTION
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 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.
Response to Restriction/Election
Applicant’s election of without traverse of Group I, claims 1-10 and 15-18 in response to restriction requirement is acknowledged. Therefore, claims 11-14 are withdrawn from further consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Applicants preserve their right to file a divisional on the non-elected subject matter.
Status of the claims
Claims 1-10 and 15-18 are examined on merits in this office action.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vigneault et al. (WO2014144495A1; Cited in the IDS filed 10/2/2024) in view of Bushey et al. (Cell Reports 2016).
In regards to claims 1-5, 17 and 18, Vigneault discloses methods encompassing single cell bar-coding for antibody discovery (title) and the antibody discovery is from a patient (para [00487]) wherein the patient can be a cancer patient (paras [00536] and [00526]). Vigneault teaches isolating single cell (i.e. partitioning single cell) (e.g. B-cells (para [00442-00443], [00460]), determining nucleic acid sequences, recombinantly linking heavy and light chains of antibody sequences and fusing the transcripts with unique molecular ID (UID; i.e. nucleic acid barcode) (paragraph [00821]; claims 238, 252, 274, 299, 303; see also “SINGLE CELL BARCODING” of page 75). Vigneault teaches determining binding profiles of the recombinantly produced antibody for binding and comparing with control set of paired VH and VL antibody (claims 299, 302, 303, 470).
Vigneault, as described above, teaches providing recombinant antibody having unique barcode sequence using determined nucleic acid sequence from an single isolated (partitioned) immune cell (e.g. B-cell) and determining the produced antibody for functional specificity and affinity (claim 470).
Vigneault however, does not teach determining the specificity and binding affinity with a second cancer sample and identifying the antibody as a cancer-specific antibody.
Bushey teaches therapeutic antibody for cancer (Title). Bushey teaches association between autoantibodies against complement factor H (CFH) and early-stage lung cancer. Bushey teaches that complement factor H (CFH) prevent complement-mediated cytotoxicity (CDC) and recombinant CFH antibody produced from isolated B-cells causes complement activation and release of anaphylatoxins, promotes CDC of tumor cell lines (Summary). Bushey teaches preparing recombinant complement factor H (CFH) antibody using an isolated single B-cell from a tumor patient and using the recombinant CFH antibody to induce complement-dependent cytotoxicity (CDC) of tumor cells (Graphical abstract, “In Brief” and “Highlights” section). Bushey discloses testing cloned recombinant antibody produced from a single isolated B-cell with other cancer samples (i.e. second tumor sample) to identify the produced antibody from the isolated B-cells as a cancer-specific (tumor-specific antibody).
Therefore, from the description in mind of Bushey, one of ordinary skilled in the art can easily envisage test binding of the recombinantly produced barcoded antibody of Vigneault produced from an isolated B-cell from cancer sample with other types of cancer samples with the expectation of providing therapeutic antibody in view of Bushey with a reasonable expectation of success. Since Vigneault teaches isolating single immune cell including B-cell from various samples including cancer sample, and since Vigneault teaches producing recombinant antibody having specific barcode sequence from the single isolated cell, from the reading in mind of Bushey, it would be obvious to one of ordinary skilled in the art to easily envisage utilizing the recombinant antibody from the isolated B-cell of the cancer patient for therapeutic application with a reasonable expectation of success. From the reading in mind of Bushey, one of ordinary skilled in the art would obviously consider contacting the produced antibody of Bushey from cancer cell with cancer sample from the same subject or various other cancer sample from other subject to test its ability to function as a therapeutic antibody and tumor specificity.
In regards to claim 6, as described above, Vigneault teaches determining binding profiles of the recombinantly produced antibody for binding and comparing with control set and one of ordinary skilled in the art can easily envisage utilizing a control sample for testing binding affinity with a reasonable expectation of success.
In regards to claims 6-10, Vigneault teaches plurality of isolated cells for providing library of sequences (claims 1, 70, 239, 252, 288, 294-295) and since the basic concept of identifying tumor-specific antibody from isolated single B-cells has been found to be obvious over Vigneault in view of Bushey, multiplexing with various isolated B-cells with the expectation of identifying various tumor-specific antibody from the various isolated B-cells with the expectation of obtaining therapeutic antibodies and different variations of processes would be withing the purview of one of ordinary skilled in the art.
In regards to claims 15-16, Bushey teaches that the specificity of the recombinant antibody was determined from bidding to CFH (protein marker) (page 1507 of Bushey) and Vigneault teaches screen for a particular property of the antibody, such as binding ability, binding specificity, and one skilled in the art understands that in order to determine specificity, different binding of the antibody can be utilized such as binding to the protein target, binding to expressed mRNA or binding to the antigen expressed on cells and once the antibody is produced, different processes for determining its binding specificity are within the purview of one of ordinary skilled in the art.
Conclusion
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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