DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Claims 24, 26, 28-51, 53 and 55 are pending upon entry of amendment filed on 3/10/26.
3. Applicant’s IDS filed on 3/10/26 has been acknowledged.
4. New title filed on 3/10/26 has been acknowledged.
5. In light of Applicant’s amendment to the claims filed on 3/10/26, the rejection under 35 U.S.C. 112(b), 35 U.S.C. 102(b)(e) and 103 (see sections 6-12 of the office action mailed on 10/21/25) has been withdrawn.
6. The following rejections remain.
7. 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.
8. Claims 24, 28-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 of U.S. Pat. 10,022,319.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite antibody formulations comprising basic amino acid –aspartate or basic amino acid-glutamate with antibody.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
9. Claims 24, 26, 28-51, 53 and 55 are rejected are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 of U.S. Pat. 10,022,319 in view of U.S. Pub. 2010/0028372.
The claims of the ‘319 patent differ in that it does not teach the use of TRIS as in claims 26 of the instant application.
It would have been obvious to one of skill in the art at the time the invention was made to use TRIS as replacement/displacement buffer as taught by the 372 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the TRIS is known to work better at certain pH ranges ([158] of the ‘372 publication) and improves therapeutic applicability with the generally known to stabilize biopharmaceutical formulations.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
10. No claims are allowable.
11. 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.
12. 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 at 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
April 21, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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