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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/8/26 has been entered.
3. Claims 1-3, 5-11, 13-15 and 17-24 are pending upon entry of amendment filed on 7/8/26.
Claim 17 stands withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 1-3, 5-11, 13-15 and 18-24 are under consideration in the instant application.
4. IN light of Applicant’s amendment to the claims filed on 7/8/26, the rejection of record has been withdrawn.
The currently amended claims filed on 7/8/26 limit Fc multimers to SEQ ID Nos: 28 and 29.
5. The following new ground of rejection is set forth.
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 1-3, 5-11, 13-15 and 18-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2018/129255 (IDS reference, newly cited) in view of U.S. Pub 2006/0088523 (of record).
The ‘255 publication teaches Fc multimers that comprise SEQ ID NO:28-29 (note SEQ ID NO:70, 76, p.32) and the Fc domains comprise multiple Fc portions upto 10 (p.35, note claims). The ‘255 publication further teaches compositions comprising the Fc multimers and the compositions comprise buffer, sorbitol and polysorbate (p. 100). As the ‘434 publication teaches the claimed SEQ ID NO:28-29, it is expected to have 2-3 Fc portions, 2 Fc peptides, each comprise a hinge, CH2-CH3 constant domains recited by claims 12-14, claims 12-14 are included in this rejection.
The disclosure of the ‘255 publication differs from the instant claimed invention in that it does not teach the specific concentration and pH as recited in claims 1-7 of the instant application.
The ‘523 publication teaches the use of about 100mg/ml of antibody, 20mM of histidine and 240mM of sorbitol or sucrose with polysorbate at pH 6 with various antibody targets (p.32-34). The ‘523 publication further teaches that the antibody encompasses multimer targets (p. 16) and the use of methionine as antioxidant and polysorbate 80 (p. 34). The formulations enhance stability (p.33) and the formulation may be lyophilized.
In addition, the ‘523 publication teaches stable compositions comprising histidine, sucrose and polysorbate and further addition of methionine is suggested (p. 34).
As is evidenced by instant specification p.49, the use of 20mM histidine is used with 240 mM of sucrose, the ratio recited in claim 8 is met and included in this rejection.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize conditions and excipient combinations taught by the ‘523 publications into the Fc multimer compositions taught by the ‘255 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 specific buffer and stabilizer combination stabilize Fc multimer and the combination or composition is applicable to various antibody targets including Fc multimers.
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.
Unlike Applicant’s assertion that the Fc multimer is taught by the ‘255 publication and the formulations of the ‘255 publication allows addition of buffer, stabilizer and surfactant (p.73).
Although the ‘523 publication teaches the use of structurally different antibodies, the teachings of the ‘523 publication is not limited to HER2, DR5, VEGF or CD20. Rather, the ‘523 publication includes Fc variants that enhances effector functions as a part of antibody with various multispecific antibodies (note p. 8-11). Fc multimers of the ‘434 publication as well as the antibodies of the ‘523 publication may be co-formulated with anti-cancer drugs (p. 13-16). As such, the excipients may not be detrimental and widely used concentrations of the ‘523 publication may be expected to attributed to the Fc multimers. IN this perspective, the combination of the references provides reasonable expectation of success and the rejection is maintained.
9. No claims are allowable.
10. 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.
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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
August 31, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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