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 .
DETAILED ACTION
Priority and Status of Claims
1. This application is a CON of 17745011 05/16/2022 PAT 12083104, which is a CON of 16/795,665 02/20/2020 PAT 11364229, which is a CON of PCT/IB2018/056277 with a filing date 08/20/2018, and claim the foreign priority of INDIA IN201741029536 08/21/2017.
2. Claims 19-26 are pending in the application.
Double Patenting
3. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 19-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable independently over claims 1 and 5 of Kocherlakota et al. US 12,083,104, and over claim 1 of Kocherlakota et al. US 11,364,229 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a parenteral formulation comprising: i. palonosetron; ii. a NK1 receptor antagonist selected from a group consisting of aprepitant, rolapitant and fosaprepitant; iii. a corticosteroid selected from dexamethasone and methylprednisolone; and iv. pharmaceutically acceptable excipients, wherein an assay of individual actives is not less than 95% of an initial value when stored at 2-8° C, and wherein (a) concentration of palonosetron ranges from 0.0005 mg/ml to 5 mg/ml; (b) concentration of NK1 receptor antagonist ranges from 0.5 mg/ml to 100 mg/ml; (c) concentration of dexamethasone ranges from 0.01 mg/ml to 50 mg/ml, see claims 19-20.
Kocherlakota et al. ‘104 claims a parenteral formulation comprising: i. palonosetron; ii. a NK1 receptor antagonist selected from a group consisting of aprepitant, rolapitant, and fosaprepitant; iii. a corticosteroid selected from dexamethasone and methylprednisolone; and iv. pharmaceutically acceptable excipients, and wherein (a) the concentration of palonosetron ranges from 0.0005 mg/ml to 5 mg/ml, (b) the concentration of the NK1 receptor antagonist ranges from 0.5 mg/ml to 100 mg/ml, and (c) the concentration of methylprednisolone ranges from about 1 mg/ml to 100 mg/ml; further wherein total impurities in the parenteral formulation are less than 10% w/w when stored at 2-8° C, see claims 1 and 5 in columns 16-17.
Kocherlakota et al. ‘229 claims a parenteral formulation comprising: i. palonosetron; ii. fosaprepitant; iii. dexamethasone; and iv. pharmaceutically acceptable excipients, wherein (a) the concentration of palonosetron ranges from 0.0005 mg/ml to 5 mg/ml, (b) the concentration of fosaprepitant ranges from 0.5 mg/ml to 10 mg/ml, (c) the concentration of dexamethasone ranges from 0.01 mg/ml to 50 mg/ml; and wherein the total impurities in the parenteral formulation are less than 10% w/w, when stored at 2-8° C, see claim 1 in column 17.
The difference between instant claims and Kocherlakota et al. ‘104 and ‘229 is that the instant claims are embraced within the scope of Kocherlakota et al. ‘104 and ‘229.
One having ordinary skill in the art would find the claims 19-20 prima facie obvious because one would be motivated to employ the compositions of Kocherlakota et al. ‘104 and ‘229 to obtain instant invention.
The motivation to make the claimed compositions derived from the known compositions of Kocherlakota et al. ‘104 and ‘229 would possess similar activity to that which is claimed in the reference.
Claim Objections
4. Claims 21-26 are objected to as being dependent on rejected claim 19.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
June 29, 2026
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