DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. 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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 4/13/26 has been entered.
3. Claims 70-76 and 79-94 are pending upon entry of amendment filed on 11/26/25.
4. Applicant’s submission of IDS filed on 4/13/26 has been acknowledged.
5. Upon further consideration, the following new ground of rejection is set fort4/2h upon Applicant’s submission of IDS filed on 4/13/26 .
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claims 70-76 and 79-94 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 9,453,072 (IDS reference) in view of U.S. Pat. 8,945,559 (IDS reference) and EP1942939 (IDS reference, filed on 4/13/26).
The ‘072 patent teaches pharmaceutical compositions comprising human IL-33 (hIL-33) with various excipients (col. 23). The antibody includes human IgG heavy and light chains (col. 17-18) including isotypes IgG1 and IgG4 (col. 19).
The ‘072 patent further teaches claimed SEQ ID NO:2 and 10 which encompass the CDR’s set forth in SEQ ID NO:4, 6, 8, 12, 14 and 16, respectively (SEQ ID NO:282, 274, claims 1-3). Given that the IgG1 and IgG4 are known and cover the constant regions and the claimed SEQ ID NO:18 and 20 are included in this rejection.
Further, the ‘072 patent teaches the antibody formulations can be administered via subcutaneously or intravenously and delivered in various delivery systems including syringes, prefilled needless syringes (col. 24), bolus, and injectable pens (col. 23-24). Given that the prefilled syringes contain appropriate unit doses in reusable or disposable container (col. 24), claims 88-91 are included in this rejection. In addition, the bolus injector is considered as safety system delivery and claim 90 is included in this rejection.
Moreover, the injectable liquid preparations can be prepared in the presence of sugar, buffer, amino acids and/or surfactants (col. 24-25). The dosage of antibody is 10-250mg/ml (col. 25).
The ‘072 patent further teaches that the IL-33 antibody may be co-formulated with IL-4 and/or receptors thereof (col. 26).
The disclosure of the ‘072 patent differs from the instant claimed invention in that it does not teach the use of specific concentrations of excipients as in claims 70, viscosity of less than 15cP as in claim 70 of the instant application, respectively.
The ‘559 patent teaches stable pharmaceutical antibody compositions comprising IL-4R antibody at 1-175 mg/ml, acetate concentration at 10-15mM, sucrose at 2.5-10%, polysorbate about 0.1% and arginine at about 30mM at pH 5.9 with viscosity at 11cP (claims 1-25).
Although, claimed concentrations are recited such concentrations above, the extended concentration and pH are taught. The pH of about 5.6-6.2 (col. 2) and the viscosity reducing concentration of arginine may be upto 100mM (col. 3) are included.
As the ‘559 patent allows co-formulations with IL-4R receptors the formulations that is suitable for IL-4R is deemed suitable to stabilize hIL-33 antibody.
The ‘939 publication teaches addition of glutamic acid and salt thereof from 10mM to 200mM ([0044-0052]) for stabilization.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known concentrations of excipients and kits as taught by the ‘559 patent and ‘939 publication into the IL-33 antibody compositions taught by the ‘072 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known concentrations stabilizes antibody and reduces viscosity and kit packaging adds convenience. In lack of recitation of specific buffer, stabilizer and concentrations thereof in claim 1 of the instant application, the use of concentration of about 85mM of salt inclusive of glutamic acid as taught by the ‘939 publication, glutamic acid is expected to act as a viscosity modifier.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant is reminded that the claimed invention does not recite specific buffer, surfactant or stabilizer and the concentrations thereof. Given that the lack of specific combination of specific buffer, surfactant and stabilizer, the structure is not separable from the functional characteristics, the combination of buffer, surfactant, stabilizer taught by the ‘559 and ‘939 references readable upon the claimed invention.
9. No claims are allowable.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached on Mon-Fri 8:30-5. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
May 22, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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