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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/19/2026 has been entered.
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 02/19/2026, claim 14 is canceled. Currently, claims 1-12 are pending in the instant application.
Claim Rejections - 35 USC § 112 Second Paragraph - Withdrawn
Rejection of claim 14:
In light of Applicant’s amendment to the claims, the rejection is hereby withdrawn. Claim 14 has been canceled.
Double Patenting - Withdrawn
Rejections over copending application 18/372,979:
The rejections are hereby withdrawn. Application 18/372,979 has issued as US patent No. 12419886. The claims of the issued patent are now solely drawn to a composition rather than a method of use.
Double Patenting – Maintained
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11801244 (herein the ‘244 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the inventions are significantly overlapping in subject matter.
Rejections over US patent No. 11801244:
Applicant’s arguments are not persuasive. The rejections are hereby maintained. Applicant contends that the claims of the instant application are patentably distinct from the claims of the ‘244 patent. The arguments set forth by Applicant make reference to experimental results present in the disclosure of the instant application. Per Remarks (pages 7-8), Applicant contends that the provided data indicates a preferred minimum average peak level between 1000-1300 ng/mL for effective NK1 blockade, wherein such a blockade is obtained using an infusion time of 15-30 minutes, and reflects the recitation of at least claim 1. Applicant further alleges that the claims of the instant application are distinct from the ‘244 patent because it does not teach the aforementioned advantages gleaned from said clinical trial data. Examiner does not explicitly dispute the results of the data presented. However, Applicant is reminded that the double patenting rejections are largely predicated on the issue of overlapping claim scope. In the case of the ‘244 patent:
Claim 1 is drawn to a parenteral pharmaceutical composition comprising a compound of Formula (I) or a pharmaceutically acceptable salt, solvate or prodrug thereof, a solubilizer, and an infusion fluid
Claim 7 is drawn to a method for treating elevated intracranial pressure in a subject, wherein the method comprises administering an effective amount of the composition of claim 1 to the subject
With regards to the claims of the instant application:
Claim 1 recites a method of reducing ICP in a subject in need thereof, wherein the method comprises parenterally administering an aqueous preparation of a compound of Formula (I), or a pharmaceutically acceptable salt thereof, using an administration time of up to 30 minutes to achieve a Cmax of between 1000-1300 ng/mL, and wherein the administration takes place within 1-60 hours of TBI or stroke
Examiner agrees with Applicant only to the extent that the claims of the ‘244 patent do not explicitly recite limitations regarding administration time, Cmax range, and proximity time to TBI or stroke. However, these limitations do not nullify the intersection of breadth between the claims of the application and the claims of the ‘244 patent. Essentially, the limitations present in the method claim of the instant application create a narrower method which falls squarely within the method of claim 7 of the ‘244 patent, as said claim 7 only requires the administration of a composition comprising a compound of Formula (I) for the treatment of elevated ICP. Likewise, the composition of claim 1 of the ’244 patent only differs from the composition used in the method of claim 1 of the instant application in that it includes a solubilizer and infusion fluid. The inclusion of these components does not remove the composition from the bounds of claim 1 of the instant application because the composition recited in the instant application is a composition comprising a compound of Formula (I).
In conclusion, the double patenting rejection of claims 1-12 are hereby maintained, as the claims of the instant application and the ‘244 patent cannot be considered as patentably distinct from one another.
The outstanding double patenting rejections will be provided below for the purposes of record and clarity.
Reiterated rejections:
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11801244. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are significantly overlapping in subject matter.
Claim 1 of the instant application recites a method of reducing intracranial pressure (ICP) in a subject in need thereof, the method including the step pf parenterally administering an aqueous preparation of a compound of formula (I):
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Wherein R1 is H or C1-4 alkyl, to said subject for up to 30 minutes at a dose level to achieve a Cmax of between 1000ng/mL – 3000ng/mL.
Claim 1 of the ‘244 patent recites a parenteral pharmaceutical composition comprising:
A compound of formula (I)
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A solubilizer
An infusion fluid
Wherein the compound of formula (I) is in a 2HCL salt form, and wherein the wt/wt ratio of compound of formula (I) to solubilizer is about 1:40 to about 1:250.
Claim 7 of the ‘244 patent recites a method for treating elevated intracranial pressure in a subject in need thereof, the method comprising administering to said subject an effective amount of the parenteral pharmaceutical composition of claim 1.
The claims at hand are significantly overlapping. Claim 1 of the instant application is drawn to a method of reducing ICP by administering a composition comprising a compound of formula (I). Claim 1 of the ‘244 patent recites a composition comprising a compound of the same formula (I), while claim 7 recites a method of use of said composition in treating elevated intracranial pressure. A method of treating elevated intracranial pressure would encompass a method of lowering cranial pressure per broadest reasonable interpretation. While the claims are not verbatim identical, they are essentially directed towards the same subject matter.
Conclusion
Claims 1-12 are rejected.
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/ERIC TRAN/Examiner, Art Unit 1629
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