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 APPLICANT’S AMENDMENT
1. Applicants amendment filed on 01/16/26 is acknowledged.
2. Claims 1,3-5,10-13,15,19-22, 24-30,34,35,36,38, and 44 are pending.
3. Claims 36,38 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,3-5,10-13,15,19-22, 24-30,34,35,36,38,and 44 read on a composition comprising anti-IL-33 antibody, 190to 25 mM of arginine and are under consideration in the instant application.
4. In view of Applicant’s amendment ( filed on 01/16/26) and statement that the claimed composition comprising recited amount of antibody, i.e. about 150mg/ml and claimed formulation that achieves markedly reduced viscosity, i.e. decoupling concentration from viscosity for a self-associating antibody was completely surprising and counterintuitive the previous rejections of claims under first paragraph of 35 U.S.C. 112(a,b) and under 35 U.S.C. 103 is hereby withdrawn. ( see Applicant’s response filed on 01/16/26 page 8)
5. Claims 1,3-5,10-13,15,19-22, 24-30,34,35,36,38,and 44 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications No: 20250136676, 20230174637; US 20230110203 for the same reasons set forth in the previous Office Action mailed on 10/21/25.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the instant Application are drawn to composition that is used in methods of treating recited in claims of copending Applications No: 20250136676, 20230174637; US 20230110203 and wherein was disclosed in the specification of said Patents.
This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested to hold that provisional double patenting rejection in abeyance until allowable subject matter is identified.
6. No claim is allowed.
7. THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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