Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
Claims 80-99 are pending and examined on the merits herein.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Grounds of Rejection Withdrawn
Previous rejection of claims 82 and 84 under 35 U.S.C. 112(b) are withdrawn in view of claim amendments.
Rejections Maintained
It is acknowledged that the office action mailed 10/26/2025 contained an inadvertant typographical error in the heading of the 103 rejection that indicated the rejection only applied to claims 80-81 and 89-99 but as noted by the applicant the body of the rejection addressed all pending claims (remarks page 9). The typographical error did not change “the thrust of the rejection” and Applicants had a fair opportunity to respond. Therefore, it is proper for this to be a Final Office Action.
The rejection of claims 80-85 and 87-99 under 35 U.S.C. 103 as being unpatentable over Kufer (US 2010/0150918 A1; IDS entered November 13, 2018), Kannan (World Bispecific Antibody Summit, September 27–28, 2011, Boston, MA, mAbs, 4:1, 4-13; PTO-892), Zhou (WO 2011/063348 A1; IDS entered November 13, 2018), and Sun (WO 2013/096221 A1; IDS entered November 13, 2018) is maintained for reasons of record and for the reasons set forth below.
The rejection of claim 86 under 35 U.S.C. 103 as being unpatentable over Kufer (US 2010/0150918 A1; IDS entered November 13, 2018), Kannan (World Bispecific Antibody Summit, September 27–28, 2011, Boston, MA, mAbs, 4:1, 4-13; PTO-892), Zhou (WO 2011/063348 A1; IDS entered November 13, 2018), and Sun (WO 2013/096221 A1; IDS entered November 13, 2018) as applied to claims 80-85 and 87-99 above and further in view of Ast (WO 2013/026837 A1; IDS entered November 13, 2018) ) is maintained for reasons of record and for the reasons set forth below.
The rejection of claims 80-83 and 89-99 on the grounds of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No.11,753,475 in view of Zhou (WO 2011/063348 A1; IDS entered November 13, 2018) and Sun (WO 2013/096221 A1; IDS entered November 13, 2018) is maintained for reasons of record and for the reasons set forth below.
Response to Arguments
Applicant's arguments filed 04/23/2026 have been fully considered but they are not persuasive. Applicants have argued the obviousness rejection under 35 USC 103 and the obvious double patenting rejection with similar arguments.
Applicant submits: The claims, as amended, each require that the Bi-Fc polypeptide is a monomer.
In response: Independent claim 80 already included a limitation that required the Bi-Fc to be a monomer which was addressed in the OA mailed 10/23/2025.
Adding the limitation that the Bi-Fc is a monomer to independent claim 83 does not change the thrust of the previous rejection as the two independent claims were addressed in the same 103 rejection and the limitation of the Bi-Fc being a monomer was already addressed in the OA mailed 10/23/2025. Therefore this amendment does not overcome the obviousness argument previously presented.
Applicant Submits: Kannan's discussion of monomeric Fc is limited to: (a) formation of stable monomeric Fc using K392D, K409D, and Y349T mutations; (b) FcRn binding in vitro; (c) stability studies and (d) PK analysis showing improved exposure. See Kannan, at page 12. Notably, Kannan does not provide any tumor cell killing data or in vivo efficacy data for monomeric Fc constructs. The person of ordinary skill in the art would have had no reasonable expectation of success that a monomeric Bi-Fc polypeptide, which by definition lacks the second Fc polypeptide chain present in heterodimeric constructs, would effectively redirect T cells to kill tumor cells in vivo.
Similarly, Zhou and Sun do not provide any in vivo data demonstrating that bispecific scFv constructs attached to a monomeric Fc would be effective for tumor cell killing. Zhou apparently discloses monomeric Fc polypeptides and their pharmacokinetic properties, but does not demonstrate efficacy of monomeric bispecific constructs in tumor cell killing. Sun apparently discloses insertions between positions 384 and 385 to improve FcRn binding and half-life, but likewise does not demonstrate in vivo tumor cell killing efficacy for monomeric constructs.
In Response: Applicants do not dispute the teachings of the prior art as to the claimed composition- only that the combined prior art does not provide a reasonable expectation of success for monomeric Bi- Fc constructs because none of the cited references demonstrate in vivo efficacy for such molecules. This argument has been considered but is not found relevant because applicants appear to be arguing limitations that are not found in the claims and the obviousness rationale was based on forming the claimed product. There is no requirement in the claims that support a search and examination of in vivo properties.
Applicant further submits: The Examiner relies on Zhou for the Y349T mutation and Sun for the insertion between positions 384 and 385. However, for the same reasons discussed above in the § 103 rejections, the combination of the patented claims with Zhou and Sun does not render the pending claims obvious.
As explained above, neither Zhou nor Sun provides any in vivo data demonstrating that bispecific scFv constructs attached to a monomeric Fc with the claimed insertions would be effective for tumor cell killing. The results for such constructs would not have been predictable. The prior art combination does not provide any evidence that a monomeric Bi-Fc polypeptide, which by definition lacks the second Fc polypeptide chain present in heterodimeric constructs, would effectively redirect T cells to kill tumor cells in vivo.
In Response: This argument has been considered but is not found relevant because applicants appear to be arguing limitations that are not found in the claims and the obviousness rationale was based on forming the claimed product as detailed above for the 103 rejections.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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/AMBER K FAUST/ Examiner, Art Unit 1643
/GARY B NICKOL/ Primary Examiner, Art Unit 1643
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