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 1-5 are pending.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 refers to the method of “claims 1”. This objection can be obviated by amending the claim to recite, “The method of claim
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) 1-3 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Snyder et al. (US 2017/0051061, published February 23, 2017).
As to claims 1 and 5, Snyder et al. teach [0013] a method for treating a leukemia in a subject comprising administering to the subject a therapeutically effective amount of an antibody that specifically binds PD-1H (also known as “VISTA”). Specifically, the reference teaches [0013] that in some embodiments, the antibody or antibody fragment binds to VISTA, thereby modulating or enhancing an immunogenic response to cancer wherein the cancer is a leukemia. Snyder et al. further teaches [0121] that the anti-VISTA compounds and therapies described herein are co-administered with one or more immune checkpoint antibodies, such as, for example, nivolumab, pembrolizumab, tremelimumab, ipilimumab, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-TIM-3 antibody, anti-LAG-3v, anti-OX40 antibody and anti-GITR antibody.
As to claim 2-3, Snyder et al. further teaches [0013] that the leukemia can be acute myeloid leukemia or a myelodysplastic syndrome.
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, 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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (US 2017/0051061, published February 23, 2017) in view of Liu-Dumlao et al. (Curr Oncol Rep (2012) 14:387–394).
Snyder et al. teaches as set forth above and further teaches [0013] that the anti-VISTA antibodies can be used to treat lymphocytic leukemias such as “acute lymphoblastic leukemia (ALL)”.
As to claim 4, Snyder et al. does not specifically teach that the lymphoblastic leukemia comprises a “Philadelphia positive” acute lymphoblastic leukemia.
Liu-Dumlao et al. teach (introduction) that the Philadelphia chromosome (Ph) is the most common cytogenetic abnormality in adult patients with acute lymphoblastic leukemia (ALL), occurring in about 20% to 30% of all cases. The mutation results from a reciprocal translocation between the ABL-1 oncogene on the long arm of chromosome 9 and a breakpoint cluster region (BCR) on the long arm of chromosome 22, resulting in a fusion gene, BCR-ABL, that encodes an oncogenic protein with constitutively active tyrosine kinase activity. Liu-Dumlao et al. further teach (page 388) that with the advent of tyrosine kinase inhibitors (TKIs), there has been improvement in response rates and survival of patients with Ph-positive ALL and that it is now standard practice to incorporate TKIs into the frontline regimens for patients with newly diagnosed Ph-positive ALL.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious for Snyder et al. to have included acute lymphoblastic leukemia cells that were also Philadelphia positive (Ph+) because this is a common and well-known genetic mutation that occurs in 20-30% of all cases resulting in an oncogenic protein with constitutively active tyrosine kinase activity. Further, one would have been motivated to test for this chromosomal abnormality because Liu-Dumlao et al. teach that with the advent of tyrosine kinase inhibitors (TKIs), there has been improvement in response rates and survival of patients with Ph+ ALL and that it is now standard practice to incorporate TKIs into the frontline regimens for patients with newly diagnosed Ph-positive ALL. In fact, Snyder et al. teaches [0123] the inclusion of tyrosine kinase inhibitors such as imatinib, sorafenib and vemurafenib as additional anti-cancer therapies to be used in combination with the anti-VISTA compounds.
No claim is allowed.
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
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