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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/10/2026 has been entered.
Claims 30-34 and 36-60 are pending and currently under consideration.
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).
Esue teaches a pharmaceutical composition comprising a monoclonal antibody at the concentration of 10 to 250 mg/mL, histidine-acetate and arginine-acetate buffer, pH4.5 to 6.5, polysorbate 20 at 0.01% to 0.1% (page 3, paragraphs [0013] and [0015]). Polysorbate in generally may be present at the concentration of 0.005% to 0.2% (page 24, paragraph [0108]). The histidine acetate buffer concentration is from 5 mM to 100 mM (claim 3). A polyol, such as mannitol, sucrose, or trehalose may optionally be included in the formulation (page 11, paragraph [0059]). Esue further teaches a formulation comprising an antibody that binds interleukins (paragraphs [0101] to [0103])
Esue does not teach a pharmaceutical formulation comprising a human antibody that specifically binds to human interleukin-4 alpha (hIL-4Rα) comprising a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:1 and a light chain variable region comprising the amino acid sequence of SEQ ID NO:5.
Martin et al. teach a human antibody that specifically binds hIL-4Rα or a human monoclonal antibody comprising a heavy chain variable region comprising SEQ ID NO: 1 and a light chain variable region comprising SEQ ID NO: 5, which is acknowledged in the instant specification (page 12, lines 20-24).
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. One would have been motivated to do so because Esue teaches a formulation comprising an antibody that binds interleukins (paragraphs [0101] to [0103]) and the formulation of Esue is expected to stabilize the antibody that specifically binds hIL-4Rα taught by Martin et al.
(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 30-34, 36-47, and 51-60 above, and further in view of Andya et al. (US 8,372,396 B2, Feb. 12, 2013; 102 (e) date: Oct. 20, 2004).
Esue and Martin et al. in combination teach a pharmaceutical composition comprising a human antibody that specifically binds to hIL-4Rα as applied to claims 30-34, 36-47, and 51-60 above.
Esue and Martin et al. do not teach the concentration of the thermal stabilizer, such as sucrose or trehalose, recited in claims 48-50.
Andya et al. teach a monoclonal antibody formulation comprising 10 to 250 mg/mL antibody, histidine-acetate buffer, pH5.5 to 6.5, 60 mM to 250 mM (2.0% w/v to 8.5% w/v) sucrose or trehalose, and 0.01% to 0.1% polysorbate 20 (column 9, the first paragraph). The histidine concentration is 20 mM and the acetate concentration is 11.6 mM (Example 10).
It would have been obvious for one skilled in the art to modify the formulation of taught by Esue and Martin et al. in combination and to make a formulation comprising the particular concentrations of sucrose or trehalose and the particular concentration of acetate-histidine buffer taught by Andya et al with a reasonable expectation of success. One would have been motivated to do so because determining the concentration of the thermal stabilizer, such as sucrose or trehalose, is routinely practiced by one of skill in the art and the formulation is expected to stabilize the antibody that specifically binds hIL-4Rα.
Conclusion
No claims are allowed.
Advisory Information
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 August 11, 2026
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