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 .
Election/Restrictions
Applicant’s election of Group II in the reply filed on 09/04/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant's election with traverse of species which is (iii) antibody with the CDRs of CDH17E2 and -H2 in the reply filed on 09/04/2025 is acknowledged. The traversal is on the ground(s) that the differences in the CDRs for (i)-(iii) are few in number and most positions are identical, therefore, the examination would be largely coextensive and not an undue burden (an alignment of CDRs is provided). The species do not require different fields of search since they all relate to use of antibody molecules that specifically bind CDH117. This is not found persuasive because each species requires its own non-coextensive sequence search. Each set of heavy and light chains requires its own unique search. Further, the instant CDR with the most differences between antibody species is heavy chain CDR3 (HCDR3), which is acknowledge in the prior art as providing significant contact with the antigen (e.g., MacCallum et al., J. Mol. Biol. 262:732-745, 1996, p. 733, col. 2, paragraphs 1-3, cited in the IDS filed 4/2/25). Additionally, US Patent 9,181,339 B2 teaches an anti-CDH17 antibody comprising the HCDR1-3 and LCDR1-3 of (iv; SEQ IDNO:76-78 and 79-81, respectively) in heavy and light chain variable domain sequences SEQ ID NO:138 and 139, respectively. It does not teach the elected species, supporting the difference between the antibodies species as being distinct.
The requirement is still deemed proper and is therefore made FINAL.
Note the invention of Group II was not claimed in either priority parent application.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: ANTIBODY 17-EXPRESSING CELLS
Claim Objections
Claim 17 is objected to because of the following informalities: Claim 17 in line 1 uses the abbreviation “CDH17”, but should also recite the full name of the protein with the first occurrence of the abbreviation, i.e., cadherin-17 (see specification on p. 3, line 11). Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17, 18, 70 and 74-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 10, 11, 13, 26, 28 of U.S. Patent No. 10,858,438 B2 (‘438) in view of WO 2012/054084 A1 (cited in the IDS filed 04/02/2025).
The patent claims a bispecific binding molecule that binds both TRAIL-R2 and CDH17 and comprises not only the heavy and light chain variable region (VH and VL, respectively) CDR1-3 of the instant claim 17 (iii) antibody molecule (SEQ ID NO:70-75), but also the full VH and VL of instant claim 18 (SEQ ID NO:114 and 115, or 116 and 117, see claims 1, 3, 10, 26, 28 of ‘438, and instant claims) The patent also claims a pharmaceutical composition comprising the CDH17-binding molecule (claims 11 and 13 of ‘435). The patent does not claim a method of identifying a CDH17-expressing cell by contacting the cell with the antibody and by detecting binding of the antibody molecule to said CDH17-expressing cell.
WO 2012/054084 A1 teaches antibodies that bind CDH17. It is further taught that an antibody binding CDH17 can be used to detect the presence of CDH17 antigen in a sample by allowing the formation of a complex between the antibody and CDH17, and detecting the complex in the sample, which is indicative of the presence of CDH17 therein (p. 53, lines 21-26). The method can also be used to detect levels of cells expressing CDH17 on their membranes (p. 51, lines 7-9). The antibodies specific for CDH17 “can be used to specifically detect CDH17 expression on the surface of cells….” This includes expression on tumor cells, such as gastric, pancreatic and colorectal cancer cells (p. 50, line 41, through p. 51, line 4).
It would have been obvious to the artisan of ordinary skill to have used the antibody molecule of ‘438 to detect the CDH17-expressing cells because that would allow detection of particular cancer cells from a patient sample, which may impact the patient’s treatment. The bispecific antibody molecule of ‘438 in which the CDH17-binding portion is an immunoglobulin molecule (e.g., claim 3 of ‘438) anticipates and/or renders obvious a monospecific CDH17 antibody molecule.
Claims 17, 18, 70 and 74-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, 13, 14, 16, 18, 24, 27, 28 and 34-36 of U.S. Patent No. 11,851,495 B2 (‘495) in view of WO 2012/054084 A1 (cited in the IDS filed 04/02/2025).
The patent claims a method of treating cancer, including colorectal, gastric and pancreatic cancer, by administering a bispecific binding molecule that binds both TRAIL-R2 and CDH17 and comprises the full VH and VL of the instant CDH17-binding antibody of instant claim 18 (SEQ ID NO:114 and 115, or 116 and 117, see claims 1, 2, 5, 7, 13, 14, 16, 18, 24, 27, 28 and 34-36 of ‘495, and instant claims). This VH and VL respectively comprise the VH and VL CDR1-3 of the antibody molecule of instant claim 17 (iii: SEQ ID NO:70-75). The patent does not claim a method of identifying a CDH17-expressing cell by contacting the cell with the antibody and by detecting binding of the antibody molecule to said CDH17-expressing cell.
WO 2012/054084 A1 teaches antibodies that bind CDH17. It is further taught that an antibody binding CDH17 can be used to detect the presence of CDH17 antigen in a sample by allowing the formation of a complex between the antibody and CDH17, and detecting the complex in the sample, which is indicative of the presence of CDH17 therein (p. 53, lines 21-26). The method can also be used to detect levels of cells expressing CDH17 on their membranes (p. 51, lines 7-9). The antibodies specific for CDH17 “can be used to specifically detect CDH17 expression on the surface of cells….” This includes expression on tumor cells, such as gastric, pancreatic and colorectal cancer cells (p. 50, line 41, through p. 51, line 4).
It would have been obvious to the artisan of ordinary skill to have used the antibody of ‘495 to detect the CDH17-expressing cells because that would allow detection of particular cancer cells, especially gastric, colorectal or pancreatic cancer cells, from a patient sample, which may impact the patient’s treatment. The bispecific antibody molecule of ‘495 in which the CDH17-binding portion is an immunoglobulin molecule (e.g., claim 7 of ‘495) anticipates and/or renders obvious a monospecific CDH17 antibody molecule.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Kaufman, whose telephone number is (571) 272-0873. Examiner Kaufman can generally be reached Monday through Friday 7am-3:30pm, Eastern Time.
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Claire Kaufman
/Claire Kaufman/
Primary Examiner, Art Unit 1674
February 21, 2026