DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 97-129 are pending upon entry of amendment filed on 11/18/25.
Claims 97-129 are under consideration in the instant application.
3. Applicant’s IDS filed on 11/18/25 has been acknowledged.
4. The following rejections remain.
The rejections are modified to reflect the currently amended claims.
5. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 97-129 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 89-104 of U.S. Application No. 17/821837 (of record) in view of U.S. Pub 2006/0088523 (of record) for the reasons set forth in the office action mailed on 8/25/25.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘837 application recites antibody comprising CD137 and CD274 as set forth in SEQ ID NO15-17 and 21 (encompassing Seq ID NO9-14, 18-24, respectively).
The claims of the ‘837 application differs from the instant claimed invention in that it does not teach the compositions comprising histidine, 100-400mM of sugar, 0.001-0.1% of non-ionic surfactant as in claim 1 of the instant application.
The ‘523 publication teaches antibody compositions comprising histidine buffer at 10-50mM, about 240mM of sugar, 0.01-0.1% of polysorbate 20 at pH 5.5(claims 1-73) for stabilizing antibody to reduce aggregates.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to antibody formulations taught by the ‘523 publication into the multispecific antibody taught by the ‘837 application.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the composition comprising histidine, sugar and polysorbate 20 stabilizes various antibodies and would expect to stabilize antibody comprise CD137 and 274.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s response filed on 11/18/25 has been fully considered but they were not persuasive.
Applicant has asserted the ‘523 publication relates monospecific antibody while the instant application relates bispecific antibody which is a separate class of antibody. The formulation that is suitable for monoclonal monospecific antibody does not work for different class of antibody and the combination of the references is not obvious.
Applicant has further asserted that the ‘523 publication fails to teach the currently amended concentrations of antibody, excipient and pH as in claim 97 of the instant application.
Unlike Applicant’s assertion that the ‘523 publication fails to teach bispecific antibody, the ‘523 publication includes bispecific antibody (note p. 24). Further, given the bispecific antibody is taught by the ‘837 application, the deficiency is remedied.
In addition, the ‘523 publication uses histidine, sugar and polysorbate combinations in different structure of antibodies and provides reasonable expectation of success. As evidenced by claims 1, 35-38 and Example 2, the teachings of the ‘523 publication suggests antibody formulation comprising about 20mg/ml of antibody, 20mM of histidine buffer in the presence of 120mM of sucrose and 0.02% polysorbate. Applicant is reminded that the teachings of the ‘523 publication teaches the product is also stable at pH 5-6 [415]. Throughout the examples and specification, the ‘523 publication recites pH 5.5 as well and the recited “about 5.8” reads on the prior art teaching of pH 6. The combination of references remains obvious and the rejection is maintained.
7. Claims 97-129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Pat. 10,968,280 (of record) in view of U.S. Pub 2006/0088523 (of record) for the reasons set forth in the office action mailed on 8/25/25.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘280 patent recites antibody comprising CD137 and CD274 as set forth in SEQ ID NO15-17 and 21 (encompassing CDRs set forth in SEQ IDs 9-14 and 19-24, respectively).
The claims of the ‘280 patent differs from the instant claimed invention in that it does not teach the compositions comprising histidine, 100-400mM of sugar, 0.001-0.1% of non-ionic surfactant as in claim 1 of the instant application.
The ‘523 publication teaches antibody compositions comprising histidine buffer at 10-50mM, about 240mM of sugar, 0.01-0.1% of polysorbate 20 at pH 5.5 (claims 1-73) for stabilizing antibody to reduce aggregates.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to antibody formulations taught by the ‘523 publication into the multispecific antibody taught by the ‘280 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the composition comprising histidine, sugar and polysorbate 20 stabilizes various antibodies and would expect to stabilize antibody comprise CD137 and 274.
In light of discussion above in section 6, the rejection is maintained.
8. Claims 97-129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Pat. 11,459,395 (of record) in view of U.S. Pub. 2006/0088523 (of record) for the reasons set forth in the office action mailed on 8/25/25.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘395 patent recites antibody comprising CD137 and CD274 as set forth in SEQ ID NO15-17 and 21 (encompassing CDRs set forth in SEQ ID Nos:9-14 and 18-24).
The claims of the ‘395 patent differs from the instant claimed invention in that it does not teach the compositions comprising histidine, 100-400mM of sugar, 0.001-0.1% of non-ionic surfactant as in claim 1 of the instant application.
The ‘523 publication teaches antibody compositions comprising histidine buffer at 10-50mM, about 240mM of sugar, 0.01-0.1% of polysorbate 20 at pH 5.5(claims 1-73) for stabilizing antibody to reduce aggregates.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to antibody formulations taught by the ‘523 publication into the multispecific antibody taught by the ‘395 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the composition comprising histidine, sugar and polysorbate 20 stabilizes various antibodies and would expect to stabilize antibody comprise CD137 and 274.
In light of discussion above in section 6, the rejection is maintained.
9. No claims are allowable.
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
January 7, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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