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
Restriction/Election
1. Applicant’s election without traverse of Group I (claims 3-23, 33, and 28 (in part)) in the reply filed on 05/21/2026 is acknowledged. Applicant also species (a) without traverse.
2. Claims 3-36 are pending. Claims 3-23, 28, and 33 are currently under consideration. Claims 24-27, 29-32, and 34-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species.
Information Disclosure Statement
3. The information disclosure statement filed on 09/15/2025, 04/09/2024, 12/14/2023 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 04/20/2023 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
5. The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claim 4 is rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 4 is drawn to an isolated protein comprising a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 1, 3, 5, 7, 9, 11, or 13, and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 2, 4, 6, 8, 10, 12, or 14. Thus, claim 4 is drawn to an isolated protein comprising a random combination of a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 1, 3, 5, 7, 9, 11, or 13 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 2, 4, 6, 8, 10, 12, or 14.
The specification discloses antigen binding regions that bind DLL3 comprising a particular pair of VH and VL (see, e.g., page 9, the 2nd paragraph; page 66, paragraphs 3-4). The specification does not disclose antigen binding regions with a random combination of heavy chain variable regions/ light chain variable regions as instantly claimed in claim 4. It is well established in the art that the formation of an intact antigen binding site of an antibody routinely requires the association of the complete heavy and light chain variable regions of a given antibody. It is expected that proper association of heavy and light chain variable regions is required in order to form a functional antigen binding site (Paul, Fundamental Immunology, 3rd Edition, 1993, pages 292-295; in particular page 293, column 1, lines 3-8; column 1, line 31 to column 2, line 9; column 2, lines 27-30). Vajdos et al. teach that amino acid sequence and conformation of each of the CDRs of the heavy and light chains is critical for maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (J. Mal. Biol. 320:415-428, 2002; in particular page 416).
For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the disclosure is insufficient to support the broad genus of isolated proteins comprising a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 1, 3, 5, 7, 9, 11, or 13, and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 2, 4, 6, 8, 10, 12, or 14.
Claim Objection
7. Claims 3-23, 28, and 33 are objected to because they recite non-elected subject matter.
Conclusion
8. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
June 4, 2026
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