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 03/13/2026 has been entered. Claim 35 is canceled. New claim 60 is added. Claims 30-34 and 36-60 are pending and currently under consideration.
Withdrawn Objections and/or Rejections
All rejections of claims 30-59 on the ground of nonstatutory obviousness-type double patenting set forth in the office action mailed on 12/16/2025 are withdrawn in view of the terminal disclaimer filed on 03/13/2026.
The rejection of claims 30-59 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dix et al. (US 2011/0171241 A1, Pub Date: Jul. 14, 2011; 102 (e) date: Jan. 8, 2010) in view of Martin et al. (US 7,608,693 B2, Oct. 27, 2009) is withdrawn in view of Applicant’s argument.
All rejections related to claim 35 are made moot by cancellation of the claim.
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 30-34, 36-47, and 51-60 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Esue (WO 2010/102241 A1, September 10, 2010) in view of Martin et al. (US 7,608,693 B2, Oct. 27, 2009). The basis for the rejection is set forth in the office action mailed on 12/16/2025.
(iii). Claims 48-50 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Esue (WO 2010/102241 A1, September 10, 2010) in view of Martin et al. (US 7,608,693 B2, Oct. 27, 2009) as applied to claims 30-47 and 51-59 above, and further in view of Andya et al. (US 8,372,396 B2, Feb. 12, 2013; 102 (e) date: Oct. 20, 2004). The basis for the rejection is set forth in the office action mailed on 12/16/2025.
(iv). Response to Applicant’s argument
Citing publications of Wang et al. (Journal of Pharmaceutical Sciences, 96(1):1-26, 2007) and Daugherty et al. (Advanced Drug Delivery Reviews, 58:686-706, 2006), Applicant argues that the formulation of any particular antibody requires formulation components to account for the structural differences in the proteins. Applicant argues that each antibody has unique stability requirements derived from differences in the amino acid sequence and that one formulation excipient stabilizing a specific antibody may not be suitable for another. Applicant argues that antibody formulation is inherently unpredictable, and each type of antibody generally requires empirical determination of appropriate excipients and formulation conditions to achieve acceptable stability.
Applicant’s argument has been fully considered but is not deemed to be persuasive.
Both Wang et al and Daugherty et al. discuss factors affecting antibody formulation stability, including protein concentrations, pH, buffering agents, and formulation excipients and provide guidelines for preparing antibody formulations. A thermal stabilizer (such as sucrose, mannitol, or trehalose), a non-ionic surfactant (such as polysorbate 20), a buffer (such as a histidine buffer, an acetate buffer, a phosphate buffer, a succinate buffer) are known in the art to stabilize an antibody formulation. In the instant case, claim 30, for example, is drawn to a broad genus of pharmaceutical formulations comprising an anti-hIL4Rα antibody. The formulation of claim 1 comprises a thermal stabilizer, a non-ionic surfactant, a histidine buffer, an acetate buffer, a succinate buffer, a phosphate buffer, or a citrate buffer; it does not require particular formulation components or excipient. In view of the teachings of Esue (WO 2010/102241 A1) in preparing a pharmaceutical formulation of a monoclonal antibody (e.g., IgG1, IgG4) (page 3, paragraph [0015]; Figures 1-8; claims 1-28) as well as the teachings in the related art, such as Wang et al and Daugherty et al. cited by Applicant, it would have been obvious for one skilled in the art to modify the formulation of Esue and to make a formulation comprising a human antibody that specifically binds hIL-4Rα taught by Martin et al with a reasonable expectation of success. Thus, the rejections are maintained.
Conclusion
No claims are allowed.
Advisory Information
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 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 mailing 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 April 8, 2026
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