Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application, Amendments, and/or Claims
Applicant's amendment filed on 08/27/2026 has been entered. Claims 1, 3-9, 11-18, 23-27, and 93-97 are pending and currently under consideration.
Withdrawn Objections and/or Rejections
The rejections of claims 1, 3-9, 11-18, 23-27, and 93-97 under 35 U.S.C. 101 and under 35 U.S.C. 112, first paragraph are withdrawn in view of amended claim 1.
The rejection of claims 1, 3-9, 11-18, 23-27, and 93-97 under 35 U.S.C. 112(b) is withdrawn in view of amended claim 1.
The rejection of claims 1, 3-9, 11-18, 23-27, and 93-97 under 35 U.S.C. 112(a) is withdrawn in view of Applicant’s argument.
Claim Rejections under 35 USC§ 103(a)
(i). The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
(ii). Claims 1, 3-9, 11-18, 23-27, and 93-97 are rejected under 35 U.S.C. 103(a) as being unpatentable over either US 2002/0028486 A1 (Mar. 7, 2002) or Coloma et al (J. Immunol. 162:2162-2170, 1999) in view of Newkirk (Clin. Exp. Immunol. 106, 259-264, 1996). The rejection is maintained on the basis set forth in the office action mailed on 06/16/2026.
Response to Applicant’s argument
Applicant argues that Morrison and Coloma do not Inherently Disclose the Claimed Method or Product. Applicant argues that the prior Art Fails to provide a motivation to combine with a reasonable expectation of success. Applicant argues that the cited art fails to provide any teaching, suggestion, or motivation to combine the references to arrive at the claimed method.
Applicant’s argument has been fully considered but is not deemed to be persuasive for the following reasons. Taking claim 1 as an example, US 2002/0028486 A1 and Coloma et al. teach steps (a)-(e) of claim 1, except step (f): processing the intermediate antigen-binding molecule recovered in (e) with a neuraminidase and/or a beta galactosidase to cleave one or more terminal sugars, thereby producing the antigen-binding molecule comprising a sugar chain linked to the sugar chain linking motif, wherein the sugar chain comprises a terminal galactose or terminal mannose,and wherein the sugar chain binds an asialoglycoprotein receptor or a mannose receptor.
However, it is well-known in the art that neuraminidase and β-galactosidase treatment can be used to make an antigen-binding molecule having a specific sugar chain and that an antibody having a high-mannose sugar chain is known to be prepared by sialidase (neuraminidase) and β-galactosidase treatment, by which galactose is removed from the sugar chain (Newkirk, Clin. Exp. Immunol. 106, 259-264, 1996). It would have been obvious for one skilled in the art to make an N-linked sugar chain comprising one, three or more terminal galactoses or to make an asialoglycoprotein receptor-binding domain with a reasonable expectation of success. One would have been motivated to do so because the procedures of modifying terminal sugars with a neuraminidase or a beta galactosidase are well-known in the art and routinely practiced in the field and one of skill in the art routinely make variations in an N-linking sugar chain as needed as demonstrated by Newkirk (Clin. Exp. Immunol. 106, 259-264, 1996).
With respect to the property of dependency of binding activity upon a pH condition recited in claims 3-9 and 15-18, It is noted that all claims 3-9 and 15-18 depend from claim 1, either directly or indirectly. Claim 1 recites “(a) providing a polypeptide sequence of a parent ant antigen-binding molecule comprising an antigen-binding domain that comprises a heavy chain variable region and a light chain variable region, and an FcRn binding domain”. In the response filed on 08/27/2026 (page 9, the first paragraph), Applicant states the following:
Second, the specific identity of the target antigen is immaterial to the inventive concept of the claimed process. In the claimed production method, the antigen-binding domain simply serves to bind a target, while the clearance mechanism is driven entirely by the engineered sugar chain linking motif and its receptor-binding functionality. The clearance pathway operates through receptor-mediated uptake (e.g., via asialoglycoprotein or mannose receptors) after the antibody binds its target in circulation. Because this clearance pathway is mediated strictly by the interaction between the tailored sugar chain and the host sugar chain receptor, it functions independently of the specific sequence, structure, or identity of the target antigen itself.
Since US2002/0028486 A1 or Coloma et al teach a method of producing an antigen-binding molecule that satisfies the structural requirement for an antigen binding molecule, the properties recited in claims 3-9 and 15-18 would be inherently to the structure of antigen-binding domain of the antigen binding molecule. Thus, the rejection is maintained.
Conclusion
No claims are allowed.
Advisory Information
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674 September 30, 2026
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