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 and 3-4, of record 7/9/2026, are pending and subject to prosecution. Claims 1 and 3-4 are amended. Claims 2 and 5 are cancelled.
This is a non-final Office action.
Status of Prior Rejections/Objections
RE: Objection to claims 1-5:
The cancellation of claims 2 and 5 renders the objection thereto moot.
The amendment to claims 1 and 3-4 is effective to obviate the objection. The objection is withdrawn.
RE: Rejection of claim 4 under 35 U.S.C. 112(b):
The amendment to claim 4 is effective to obviate the rejection. The rejection is withdrawn.
RE: Rejection of claims 1 and 3 rejected under 35 U.S.C. 103 over Frenette et al. (US 20200270349 A1) in view of Lee et al. (Journal of Clinical Investigation, 2016):
Claims 1 and 3 were amended to require that the “UT2 gene-deficient transgenic mouse is a myeloid leukemia disease model”. This limitation is not considered to have patentable weight because it imposes no real structural element on the UT2 gene-deficient transgenic mouse rendered obvious by the prior art. Because a UT2 gene-deficient transgenic mouse used, for example, as a lymphoid leukemia disease model would seemingly be no different than the claimed mouse used as a myeloid leukemia disease model, the rejection is maintained in modified form to address the amended limitations.
RE: Rejection of claims 1 and 3-5 under 35 U.S.C. 103 over Frenette et al. (US 20200270349 A1) in view of Lee et al. (Journal of Clinical Investigation, 2016), further in view of Drenberg et al. (Nature Communications, 2019):
The cancellation of claim 5 renders the rejection thereto moot.
Upon further consideration, the rejection over claims 1 and 3 is also withdrawn.
Maintained Rejections
Claim Interpretation
Claim 1 is directed to a UT2-deficient mouse prepared by crossing UT2 floxed mice and Mx1-Cre mice expressing Cre-recombinase specifically for hematopoietic cells. The mouse is defined using product-by-process language. Product-by-process limitations are considered only in so far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product as claimed is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant application, the method of claim 1 distinguishes the claimed mouse from a UT2-deficient mouse generated by other means because the genome of the claimed mouse will comprise loxP sites and a Cre recombinase transgene.
Claims 1 and 3 recite the limitation wherein the UT2 gene-deficient transgenic mouse is a myeloid leukemia disease model. Functional limitations that are not associated with a structural element in the claimed invention are not interpreted as being further limiting. See MPEP 2111.04. Because “is a myeloid leukemia model” does not provide any structure that would serve to distinguish the claimed invention from any other UT2 gene-deficient transgenic mouse, the limitation is not considered to have patentable weight.
Claim 4 recites the limitation “test materials”, which is interpreted as referring to unknown candidate substances used in screening to test whether they affect expression level of genes or expression or activity of a protein, consistent with ¶0033 of the instant application’s PG Pub.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Frenette et al. (US 20200270349 A1), of record, in view of Lee et al. (Journal of Clinical Investigation, 2016), of record.
Regarding claims 1 and 3: Frenette et al. teach methods of inhibiting or treating myeloproliferative conditions such as acute or chronic myeloid leukemia (See Abstract and ¶0012-0013). Mice having a deletion of MAEA were produced (See ¶0128-0129 and fig. 31). MAEAfl/fl mice were generated and crossed with Csfr1-Cre or Mx1-Cre mice strains to delete MAEA in the monocytic-macrophage or general hematopoietic lineages, respectively (which reads on “specifically in hematopoietic cells”) (See ¶0128-0129 and 0140). Genotyping was done by ear clip genomic DNA PCR (which reads on “selecting mice with a UT2 gene knocked out… from second-generation mice resulting from the crossing”) (See ¶0129). MAEA-deleted (MAEACsf1r-Cre) mice were viable but died prematurely between 4-8 months of age from a myeloproliferative syndrome characterized by thrombocytosis, anemia and increased infiltration of myeloid cells in the lung and liver (See ¶0049 and 0155). Frenette et al. therefore teach methods for generating a leukemia mouse model by Cre-lox recombination but do not teach mice specifically having a UT2 gene deficiency.
Lee et al. teach a profound decrease in copy number and expression of UT2 as being associated with hematological malignancies such as myeloma and leukemia (See Abstract; page 1302, col. 2, ¶4; and fig. 3). B lymphoblast and plasma cell lines in which UT2 was depleted by sgRNA were transplanted into immunodeficient and irradiated mice to generate an in vivo model (See page 1306, col. 2, full ¶1).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Frenette et al. to delete expression of UT2 rather than MAEA to generate a mouse model for myeloma and/or leukemia. One would have been motivated to make this modification because Lee et al. teach that UT2 deletion is profoundly associated with hematological malignancies such as myeloma and leukemia (See page 1302, col. 2, ¶4). There would be a reasonable expectation of success in making this modification because one of ordinary skill could readily generate mice having MAEA alleles flanked by loxP sequences for breeding with Mx1-Cre mice and because Lee et al. demonstrate that UT2-depleted model mice can be produced (See page 1306, col. 2, full ¶1).
Allowable Subject Matter
Claim 4 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
While Lee et al. indicate a role for UT2 in hematopoietic malignancies including plasma cell leukemia or lymphoid leukemia (Abstract; page 1302, col. 2, ¶4; and fig. 3), there is no teaching that UT2 has a role in myeloid leukemia. One of ordinary skill in the art would therefore not have found it obvious to use a UT2 gene-deficient mouse specifically for screening therapeutic agents for myeloid leukemia.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M Babic, can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER S SPENCE/Examiner, Art Unit 1633
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