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
The Amendments and Remarks filed 8/13/26 in response to the Office Action of 3/13/26 are acknowledged and have been entered.
Claims 73-90 are pending.
Claims 78, 79, 82, 85, 87, and 88 have been amended by Applicant.
Claims 73-90 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections Withdrawn
The rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
The rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12398207 B2 is withdrawn.
Rejections Maintained
Double Patenting
Claims 73-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11673972 B2. Patent SEQ ID NO:18 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73-77 are not patentably distinct from patent claims 1-7 because patent claims 1-7 are drawn to anti-CD3 scFv constructs, nucleic acids encoding said constructs, expression vectors comprising said nucleic acids, and host cells comprising said expression vectors that are species of instant claims 73-77. Instant claim 78 is not patentably distinct from patent claims 1 and 7 because the anti-CD3 scFv of patent claim 1 is disclosed as being made by culturing the host cell of patent claim 7 and recovering the ani-CD3 scFv (lines 34-46 of column 17, in particular). The heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79-80 and 85-86, the nucleic acids, expression vectors, and host cells of instant claims 81-83 and 87-89, and the methods of making the structures of instant claims 84 and 90 are not patentably distinct from patent claims 1-7 because the patent discloses the anti-CD3 scFv binding domains of the patent claims are to be generated in such heterodimeric structures (see Bottle-opener structure of patent Figure 1A and central-scFv structure of patent Figure 1B, in particular).
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 17-21 of U.S. Patent No. 10227410 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73-77 are not patentably distinct from patent claims 1-7 because patent claims 1-7 are drawn anti-CD3 scFv constructs, nucleic acids encoding said constructs, expression vectors comprising said nucleic acids, and host cells comprising said expression vectors that are species of instant claims 73-77. Although instant claims 73-78 and 85-90 are not identical to patent claims, they are not patentably distinct from each other because patent claims are directed to species of instant claims 73-78 and 85-90. Further, the heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79-80, the nucleic acids, expression vectors, and host cells of instant claims 81-83, and the methods of making the structures of instant claim 84 are not patentably distinct from patent claims 1, 5, and 17-21 because the patent discloses heterodimeric antibodies of the patent claims are to be generated in the Central-scFv structure of patent Figure 1B.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10259887 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of the instant claims.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-15 of U.S. Patent No. 10526417 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73-78 and 85-90 are not patentably distinct from patent claims 1-10 and 12-15 because patent claims 1-10 and 12-15 are drawn to species of instant claims 73-78 and 85-90. Further, the heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79-80, the nucleic acids, expression vectors, and host cells of instant claims 81-83, and the methods of making the structures of instant claim 84 are not patentably distinct from patent claims 1-10 and 12-15 because the patent discloses heterodimeric antibodies of the patent claims are to be generated in the Central-scFv structure of patent Figure 1B.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 14 and 20-23 of U.S. Patent No. 10982006 B2. Patent SEQ ID NO:89 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:85 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of the instant claims.
Response to Arguments
In the Reply of 8/13/26, Applicant submitted a terminal disclaimer to overcome this rejection. However, the terminal disclaimer has been disapproved by the Office with the following guidance:
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Double Patenting
Claims 73-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 11-13 of U.S. Patent No. 11225528 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of the instant claims.
Request
In the Reply of 8/13/26, Applicant requests this rejection be held in abeyance. The request is denied. The Office does not hold such rejections in abeyance.
Double Patenting
Claims 73-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, and 8-13 of U.S. Patent No. 11352442 B2. Patent SEQ ID NO:14 comprises instant SEQ ID NOs:14-17. Patent SEQ ID NO:10 comprises instant SEQ ID NOs:10-13. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73-78 and 85-90 are not patentably distinct from patent claims 1-10 and 12-15 because patent claims 1-10 and 12-15 are drawn to species of instant claims 73-78 and 85-90. Further, the heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79-80, the nucleic acids, expression vectors, and host cells of instant claims 81-83, and the methods of making the structures of instant claim 84 are not patentably distinct from patent claims 1-10 and 12-15 because the patent discloses heterodimeric antibodies of the patent claims are to be generated in the Central-scFv structure of patent Figure 1B.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-8 of U.S. Patent No. 11919956 B2. SEQ ID NO:161 of the patent comprises instant SEQ ID NOs:10-13 and SEQ ID NO:162 of the patent comprises instant SEQ ID NOs:14-17. Although the claims at issue are not identical, they are not patentably distinct from each other. Patent claims 1, 4, and 6-8 are directed to species of instant claims 73-77, 79-83, and 85-89. Instant claims 78, 84, and 90 are not patentably distinct from patent claim 8 because patented heterodimeric constructs are disclosed as being made by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs (paragraph spanning columns 27-28, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Response to Arguments
In the Reply of 8/13/26, Applicant submitted a terminal disclaimer to overcome this rejection. However, the terminal disclaimer has been disapproved by the Office with the following guidance:
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Double Patenting
Claims 73, 75-79, 81-85, and 87-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No.11530274. SEQ ID NO:173 of the patent comprises instant SEQ ID NOs:6-8. SEQ ID NO:169 of the patent comprises instant SEQ ID NOs: 2-4. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 73 is not patentably distinct from patent claim 6 because the bispecific antibody of patent claim 6 is a species of instant claim 73. The heterodimeric antibody structures comprising anti-CD3 scFv constructs of instant claims 79 and 85 are not patentably distinct from patent claim 6 because the patent discloses the bispecific constructs of the patent claims are to be generated in such heterodimeric structures (see Bottle-opener structure and central-scFv structure of patent Figure 18, in particular). Instant claims 75-78, 81-84, and 87-90 are not patentably distinct from patent claim 6 because the anti-CD3 scFv bispecifc constructs of patent claim 6 are disclosed as being made by culturing the host cells with expression vectors encoding said constructs and recovering the constructs (paragraph spanning columns 62-63, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73 and 75-78 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11053316 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent nucleic acid constructs, vectors, cells, and method of making are species of instant claims 75-78. Claim 73 is not patentably distinct from patent claim 6 because the method of claim 6 makes the product of instant claim 73.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73 and 75-78 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of U.S. Patent No. 10968276 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 73 is not patentably distinct from patent claims 2-3 because the patent claims are species of the instant claim. Instant claims 75-78 are not patentably distinct from patent claims 2-3 because the anti-CD3 scFv constructs of patent claims 2-3 are disclosed as being made by culturing the host cells with expression vectors encoding said constructs and recovering the constructs (first full paragraph of column 37, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73 and 75-78 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of U.S. Patent No. 10131710 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 73 is not patentably distinct from patent claims 2-3 because the patent claims are species of the instant claim. Instant claims 75-78 are not patentably distinct from patent claims 2-3 because the anti-CD3 scFv constructs of patent claims 2-3 are disclosed as being made by culturing the host cells with expression vectors encoding said constructs and recovering the constructs (first full paragraph of column 44, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73, 75-78, 85, and 87-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No.9701759 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 73 and 85 are not patentably distinct from patent claims 1-2 because the patent claims are species of the instant claims. Instant claims 75-78 and 87-90 are not patentably distinct from patent claims 2-3 because the anti-CD3 scFv constructs of patent claims 1-2 are disclosed as being made by culturing the host cells with expression vectors encoding said constructs and recovering the constructs (first full paragraph of column 4, in particular). Further, it is conventional and routine in the art to generate heterodimeric antibody constructs by culturing the host cells expressing nucleic acid expression vectors encoding the constructs and recovering the constructs.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Double Patenting
Claims 73, 75-78, 85, and 87-90 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10738133 B2. Patent SEQ ID NO:398 comprises instant SEQ ID NOs:6-8. Patent SEQ ID NO:397 comprises instant SEQ ID NOs:2-4. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of the instant claims.
Response to Arguments
In the Reply of 8/13/26, Applicant argues the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85.
The amendments to the claims and the arguments filed in the Reply of 8/13/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that the patent claims are not directed to species of the instant claims because the patent claims do not recite the anti-CD3 scFv has the VL-linker-VH orientation required by instant claims 73, 79, and 85, the examiner disagrees. scFv constructs have two possible orientations: VL-linker-VH or VL-linker-VH that one of skill in the art can readily envision (see paragraph spanning columns of page 3 of Ahmad et al (Clinical Development Immunology, 2012, article 980250, 15 pages): “In the scFv (single-chain fragment variable) construction, the order of domains can be either VH-linker-VL or VL-linker-VH….”). While the patent claims do not recite the orientation of the recited VH and VL components of the claimed scFv, a VL-linker-VH is readily envisioned from the patent claims. Such a disclosure, where the claimed species can be “at once envisaged” from the disclosure, anticipates the claimed species. See MPEP 2131.02(III).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm ET.
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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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