DETAILED ACTION
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 .
Election/Restrictions
Claims 50-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 December 2025. Claims 45-51 are examined herein.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 45-51 and 64 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by EP 3501561 A1 to Shimada.
In the specification and figures, Shimada discloses the method as claimed by Applicant. With regard to claims 45 and 51, Shimada discloses a method of treating a patient comprising using an extracorporeal circuit with a filter (see ¶0001, 0002). Shimada discloses that the filter may comprise polyacrylonitrile, wherein the circuit is primed with a physiological saline, that is then replaced with a nafamostat mesylate solution and patient blood (see ¶0138, 0187).
With regard to claim 46, Shimada discloses that “while the anticoagulant is added to blood diverted outside the body, the blood is injected into the inlet of the blood processing filter,” indicating that the nafamostat solution infusion occurs between 0 and 5 minutes prior to blood flow (see ¶0187)
With regard to claims 47-50, Applicant is setting forth the result of a claimed method. If the steps of a method claim are provided in the prior art, it follows naturally that the result of the prior art method would be the same as those claimed by Applicant. A clause in a method claim is not given any weight when it simply expresses the intended result of a recited process (see MPEP 2111.04(I)). Without any additional information such as concentration or processing time, the instant claims do not patentably distinguish over the prior art.
With regard to claim 51, Simada discloses that the patient blood may flow through the extracorporeal circuit at a rate of 10-22mL/min, within the range claimed by Applicant (see ¶0187).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 7,308,303 Whitehurst et al
Chronic anticoagulant therapy and mitigating thrombolysis
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 20 January 2026