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 1-8, 10-29, 37, 40-53, 55, 57, 59, 60, 65, 66, 68-71, 73-94 and 101-105 are pending upon entry of amendment filed on 6/8/26.
Claims 69-71, 73-94 and 101-104 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 1-8, 10-29, 37, 40-53, 55, 57, 59, 60, 65, 66, 68 and 105 are under consideration.
3. Applicant’s IDS filed on 6/8/26 has been acknowledged.
4. The new title filed on 6/8/26 has been entered.
5. The declaration of John Kumer under 37 CFR.1.132 filed on 6/8/26 has been acknowledged.
The declaration states the specification is fully enabled for composition comprising 2ug/ml of APVO414 and APVO436 in IVSS effectively prevents adsorption.
IN light of the declaration, the rejection under 35 U.S.C.112 (a) has been withdrawn.
6. In light of the declaration of Kumer filed on 6/8/26, and the amendment to the claims filed on 6/8/26, the rejections under 35 U.S.C.112(a), 102(a)(1) and 102(a)(2) have been withdrawn (see sections 6-8 and 10-12 of the office action mailed on 2/10/26).
7. The following rejection remains.
8. 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.
9. 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.
10. Claim 51 is rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub.2008/0112953 (of record) in view of WO2018/057802 (IDS reference, of record) or U.S. Pub. 2013/0129723 (of record) for the reasons set forth in the office action mailed on 2/10/26.
The ‘953 publication teaches compositions comprising about 1-200 mM of succinate buffer at about 5.8, about 0.001-0.01% of polysorbate inclusive of 0.004-008% (p.8-10, [0091-0093], claims 48-70). In addition, the ‘953 publication further teaches that the composition is being delivered in syringes and intravenously (p.14, [0084], [121] ) and containers comprising the compositions. Further, the ‘953 publication teaches that the composition comprises antibody, includes fragments, scFv, IgG2 (p. 10-14). Given that the container is safe and sterile and made of glass, claim 66 that is being free of latex is included in this rejection.
Moreover, the ‘953 publication teaches that the composition comprising succinate and polysorbate stabilizes antibody and reduces aggregates (p. 8) and the administration routes include intravenous (p.9).
The disclosure of the ‘953 publication differs from the instant claimed invention in that it does not teach the use of CD3xCD123 bispecific antibody as in claims 12-28, 53, 57, 59-60 and IL10xCD86 as in claims 29 and 55 of the instant application.
The ‘802 publication teaches TRI130 that is identical to the CD3XCD123 of antibody having the claimed SEQ ID NO:18,27 and 31 (note SEQ ID NO:132, 312, 323) having the CDR’s set forth in SEQ ID NO:10-15, 19-24 as in claims 19-28. The bispecific antibody is configured to have CH2-CH3 and domains of IgG1-4 (p. 11-15, 19-28). The ‘802 publication teaches addition of pharmaceutically acceptable carrier for intravenous administration (p. 107) and the dose ranges from 0.1ug-100mg/kg (p. 106). Further, the ‘802 publication teaches dose adjustment response in Tables 11-12 for 10-100 fold differences. As the dose may vary from 0.1ug-100mg and the dose response is from 10-100, claims 36, 37, 42-43 and 52 reciting low ranges of antibody concentration and formulating excipients in concentrated form as the concentration of succinate buffer vary from 1-200mM are included in this rejection.
Likewise, the ‘723 publication teaches bispecific antibody comprising IL-10 and CD86 ([0052]) that associates with B cell malignancy and therapeutically effective in treatment of cancer (p. 29-35).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize CD3xCD123 bispecific antibody or IL-10xCD86 bispecific antibodies as taught by ‘802 or ‘723 publications into the succinate and polysorbate formulation taught by the ‘953 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 succinate and stabilizes various antibodies 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 6/8/26 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references does not result in the claimed invention and does not teach the currently amended limitations of 0.01-2ug/ml of therapeutic protein.
Unlike Applicant’s assertion, claim 51 does not require the limitations of 0.01-2ug/ml of therapeutic protein. The rejection is maintained.
11. The following new ground of rejection is necessitated by Applicants’ amendment filed on 6/8/26.
12. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
13. Claims 1-8, 10-29, 37, 40-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
The specification or the original claims as filed does not provide a written description the phrases “therapeutic protein at concentration of about 0.01ug/ml to about 2.0ug/ml”. Although the limitation is supported with 1-10mM of succinate buffer and 0.001-0.01% of polysorbate 80 as in [0012] at most, the currently amended limitation is not supported with succinate and polysorbate without any concentration ranges as in claim 1 in context.
The currently amended range is not supported by the original claims or instant specification.
The instant claims now recite a limitation which was not clearly disclosed in the specification as filed, and now changes the scope of instant disclosure as filed.
Such limitations recited in the present claims, which did not appear in the specification as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C.112.
14. No claims are allowable.
15. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
16. 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
August 5, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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