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 .
Response to Amendment
The Amendment filed March 3, 2026 in response to the Non-final rejection of February 3, 2026 is acknowledged and has been entered.
Claims 1, 15-18, and 27 were amended or previously presented.
Claims 21-24 have been withdrawn from further consideration by the examiner under 37 CFR 1.142(b) as being drawn to non-elected inventions.
Claims 1, 15-18, and 27 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Rejections Withdrawn
The rejection of Claims 1, and 15-18 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of applicant’s amendments and arguments thereto.
The rejection of Claim(s) 1, and 15-17 under 35 U.S.C. 102(a)(2) as being anticipated by US 2019/0382477 (Drake et al., June 1, 2018) is withdrawn in view of applicant’s amendments and arguments thereto.
New Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Enenkel et al., (EP2966085A1, 1-13-2016, IDS)
Species note: Applicant’s elected species (SEQ ID NO:5) is free of the art. The next species searched was SEQ ID NO:12.
As to claim 1, Enenkel et al., teach a polypeptide complex comprising, from N-terminus to C-terminus [0030], antibodies and fragments such as an Fab domain [0039] linked to a hinge region. Enenkel et al. teach that the antibody of the invention has a variant human IgG1 heavy chain constant (CH) region comprising at least a CH1 and/or an upper hinge region [0072]. The reference further teaches [page 22, see line 46] a hinge region comprising SEQ ID NO:12.
Query Match 100.0%; Score 99; Length 23;
Best Local Similarity 100.0%;
Matches 15; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EPKSCDKTPPCPPCP 15
|||||||||||||||
Db 1 EPKSCDKTPPCPPCP 15
As to claims 15-17, the reference further teaches [0037-0038] that the complex can comprise Fc regions or Fc-fusion proteins. Fc-fusion proteins can be constructed by genetic engineering approaches by introducing the CH2 domain of the heavy chain immunoglobulin constant region comprising the N-linked glycosylation site into another expression construct comprising, for example, other immunoglobulin domains, enzymatically active protein portions, or effector domains. An Fc-fusion protein may further comprise the hinge region (encompasses operably linked). Enenkel teaches [0037] that the Fc polypeptide can be human IgG1. The term "Fc region" (fragment crystallizable region) as used herein refers to the C-terminal region of an antibody heavy chain. The Fc region of a full antibody usually comprises two CH2 domains and two CH3 domains. A preferred immunoglobulin CH2 domain within the context of the present invention is a human IgG1 CH2 domain. The reference further teaches [0096] that the Fc region can comprise IgG2 and IgG4. “Thus the antibody comprises only the CH1 region or the upper hinge region of IgG2 or IgG4P or in the case that both the CH1 region and the upper hinge region are from IgG2 or IgG4P the antibody comprises a CH2 and/or CH3 region of IgG1.”
As to claim 18, Enenkel et al., teach [0150] that the polypeptide complex may further comprise drug conjugates.
Allowable Subject Matter
Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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