Notice of Pre-AIA or AIA Status
The present application, 18277394, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1,3, 22, 33, 35, 54, 65, 73, 77, 81, 88-93 are pending.
Election/Restrictions
Applicant's election with traverse of Group III (claim 65) in the reply filed on 1/22/2026, is acknowledged. The traversal is on the ground(s) that Groups I (e.g., claim 22), II (e.g., claim 54), and III all cover a generically-modified non-human animal comprising a human or chimeric CD3E, CD3D and CD3G. In addition, the claims in Group IV contain all limitations of claim 65. Thus, Groups I-IV are so linked as to form a single general inventive concept under PCT 13.1.. This is not found persuasive because Groups I, II, and III are drawn to products that are transgenic animals. Group IV is drawn to a method of determining therapeutic effectiveness of use of an antibody which not a transgenic animal, and so is a different category of invention from the other groups. Furthermore, the technical feature that represents a contribution over the prior art, and so is not a special technical feature linking claims.
The finding of lack of unity is withdrawn over Groups I, II, and III, but the requirement is still deemed proper and is maintained for Group IV.
Therefore, claims 73, 77 and 81 are withdrawn from consideration.
Priority
The filing receipt, mailed 3/13/2024, states that this application was is a 371 of PCT/CN2022/076966, filed 02/18/2022, and claims foreign priority benefit of CHINA 202110189578.6, filed 02/19/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/8/2025, 2/12/2024, 9/25/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1. Claim(s) 1, 3, 22, 33, 35, 54, 65, 88, 89, 91-93 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson, US 20170164588 A1.
Olson, US 20170164588 A1, published 2017-06-15, “NON-HUMAN ANIMALS EXPRESSING HUMANIZED CD3 COMPLEX,” throughout the publication and abstract, discloses non-human animals that are genetically modified to comprise in their genome humanized CD3 proteins expressing humanized CD3 proteins are provided. Olson, at Fig. 2 and para [0022], state:
[0022] FIG. 2 is the schematic representation (not to scale) of the humanized CD3γδε large targeting vector. FIG. 2A depicts the large targeting vector before the selection cassette (Neo) deletion, with human CD3E, CD3D, and CD3G sequence knock-in locations indicated. A, B, C, D, E, F, and G indicate location of the junction nucleic acid sequences represented in Table 1. FIG. 2B depicts the large targeting vector after deletion of the selection cassette (Neo); similarly to FIG. 2A, locations of the human CD3E, CD3D, and CD3G are indicated. A-B, C, D, E, F, and G are locations of the junction nucleic acid sequences represented in Tables 1 and 3.
Olson, at para [0022], describing Fig. 2B as indicating, similarly to FIG. 2A, the locations of the human CD3E, CD3D, and CD3G. Olson, at, e.g., para [0006], [0007], [0039], teaches the CD3 complex “operably linked”, e.g. to a promoter.
Olson teaches replacement of the mouse CD3 locus using unique targeting vectors from human and mouse artificial chromosomes. Olson states:
[0109] The mouse CD3 locus was humanized by construction of unique targeting vectors from human and mouse bacterial artificial chromosomes (BAC) DNA using VELOCIGENE® technology (see, e.g., U.S. Pat. No. 6,586,251 and Valenzuela et al. (2003) High-throughput engineering of the mouse genome couple with high-resolution expression analysis. Nat. Biotech. 21(6): 652-659, both incorporated herein by reference). DNA from mouse BAC bMQ-425K11 was modified by homologous recombination to replace the genomic DNA encoding portions of mouse CD3ε, CD3δ, and CD3γ genes (mouse CD3 genes located within close proximity to one another on chromosome 9) with corresponding portions of CD3ε, CD3δ, and CD3γ genes derived from human BAC RP11-414G21 (human CD3 genes are located within close proximity to one another on chromosome 11), respectively.
Olson, at para [0109].
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.
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.
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson, US 20170164588 A1 as applied to claims 1, 3, 22, 33, 35, 54, 65, 88, 89, 91-93 above, and further in view of Shen, US 20190373869 A1.
The prior art of Olsen is relied upon, as in the above anticipation rejection.
Olsen does not teach 5’ and 3’ UTR in an human or chimeric CD3 replacement region in a transgenic non-human animal.
Shen, US 20190373869 A1, throughout the publication and abstract, and at e.g., para [0206], teaches
[0206] The genome of the genetically modified animal can comprise a replacement at an endogenous CD3e gene locus of a sequence encoding a region of endogenous CD3e with a sequence encoding a corresponding region of human CD3e. In some embodiments, the sequence that is replaced is any sequence within the endogenous CD3e gene locus, e.g., exon 1, exon 2, exon 3, exon 4, exon 5, exon 6, exon 7, exon 8, 5′-UTR, 3′-UTR, the first intron, the second intron, and the third intron, the fourth intron, the fifth intron, the sixth intron, the seventh intron, etc. In some embodiments, the sequence that is replaced is within the regulatory region of the endogenous CD3e gene. In some embodiments, the sequence that is replaced is exon 2, exon 3, exon 4, exon 5, exon 6 or part thereof, of an endogenous mouse CD3e gene locus.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined 5’ and 3’ UTR in an replacement region in a non-human animal with a sequence encoding a human or chimeric CD3.
One of ordinary skill in the art would have motivated to have replaced a CD3 region that did not replace endogenous 5’ and 3’ UTR to influence gene expression.
Conclusion
1. Claims 1,3, 22, 33, 35, 54, 65, 73, 77, 81, 88-93 are rejected.
2. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631