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 1-6, 8, 9 and 12-30 are pending upon entry of amendment filed on 1/14/26.
Accordingly, claims 15 and 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1-6, 8, 9, 12-14, 16-18 and 21-30 are under consideration in the instant application.
4. In light of Applicant’s amendment to the claims filed on 1/14/26, the rejection under 35 U.S.C.102(a)(1) and (a)(2) has been withdrawn (see sections 6-7 of the office action mailed on 10/29/25). The currently amended claims recite use of succinate buffer.
5. The following rejections remain.
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claims 1-6, 8, 9, 12-14, 16-18 and 21-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2018/0147292 (of record) in view of U.S. Pub 2007/0031402 (of record) for the reasons set forth in the office action mailed on 10/29/25.
The ‘292 publication teaches antibody drug conjugate set forth in Formulas recited in claims 1 and 10 as described in Formula 27 (note p. 25). The Formula 27 includes GGFG as part of a linker and it encompasses the structure of claim 10. The prior art formula 27 includes the structures in claim 1, 12 and 13 and the core structure is derived from Formula 1 (see p.27-31).
Further, the ‘292 publication teaches the formulation comprising histidine buffer and the pH of the composition includes pH 5 (p. 25). The ‘292 publication teaches HER2 antibody as antibody to be conjugated ([0036, 0057]) and claims 12-13 including trastzumab are included in this rejection (note [154], readable upon humanized HER2).
The disclosure of the ‘292 publication differs from the instant claimed invention in that it does not teach the use polysorbate, saccharides as in claims 5-9, and 12 and lyophilized, reconstituted and/or an article of manufacture of composition as in claim 16-18 of the instant application, respectively.
The ‘402 publication teaches use of 1-50mM of histidine as well as succinate buffer (note claim 20), at pH 4.5-7.3 and polysorbate of 0.005-0.2% and sucrose of 5-10% in the presence of antibody drug conjugate (p.2). The ’292 publication further teaches the antibody drug conjugate formulation improves stability by reducing aggregates, the formulation may be lyophilized and reconstituted (p.12). Claims 9 and 13 are included in this rejection; it is not inventive to discover optimum ranges and workable concentration by routine experimentation where the general condition is taught by the prior art. See MPEP2145. In addition, the formulation may be prepared to a kit (p. 12).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the excipient concentrations, lyophilization and kit format as taught by the ‘402 publication into the antibody drug conjugate compositions taught by the ‘292 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of kit adds convenience and provision of lyophilization, specific excipient combinations improve stability of antibody drug conjugate by reducing aggregates.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s response filed on 1/14/26 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references fails to teach each and every element of the claimed compound, no reasonable expectation of success in combining the references and the claimed formulation showed unexpected properties in improved properties.
To support, Applicant adds the succinate buffer is not added or the compound in claims 1, 12 and 13 has not been recited or more anti-cancer effect and the combination is not obvious over the cited references.
However, unlike Applicant’s assertion, addition of succinate buffer is recited in ‘402 publication in claim 20 in addition to histidine or replacing histidine. The genus of structures in p.25-32 of the ‘292 publication reads on Y being O-(CH2)m-CR1R2-C(O)- of formula (Pc-L-Y-D) of claims 1, 12 and 13. Note Formula 34 uses GGFG; claims 12-13 use GGFG and meets the limitations of claims 12-13. In addition, in lack of specific anti-tumor effect that is being unexpected, the ‘292 publication teaches the antibody-drug conjugate in treatment of various cancers ([273-278]). As such, the combination of the references teach each and every element of the claimed invention and the rejection is maintained.
9. 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.
10. Claims 1-6, 8, 9, 12-14, 16-18 and 21-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Application No. 18/029075 in view of U.S. Pub 2007/0031402.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘075 application recites a pharmaceutical composition antibody drug conjugates set forth in claim 1 and 13 of the instant application.
The claims of the ‘075 application differ in that they do not recite excipient combination, lyophilization and article of manufacture.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the excipient concentrations, lyophilization and kit format as taught by the ‘402 publication into the antibody drug conjugate compositions taught by the ‘075 application.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of kit adds convenience and provision of lyophilization, specific excipient combinations improve stability of antibody drug conjugate by reducing aggregates.
In light of the discussion above in section 8 of this office action, rejection is maintained.
11. Claims 1-6, 8, 9, 12-14, 16-18 and 21-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Application No. 18/580602 in view of U.S. Pub 2007/0031402.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘602 application recites a pharmaceutical composition antibody drug conjugates set forth in claim 1 and 13 of the instant application.
The claims of the ‘602 application differ in that they do not recite excipient combination, lyophilization and article of manufacture.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the excipient concentrations, lyophilization and kit format as taught by the ‘402 publication into the antibody drug conjugate compositions taught by the ‘602 application.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of kit adds convenience and provision of lyophilization, specific excipient combinations improve stability of antibody drug conjugate by reducing aggregates.
In light of the discussion above in section 8 of this office action, rejection is maintained.
12. No claims are allowable.
13. 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.
14. 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
February 24, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641