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 .
Response to Arguments
Applicant's arguments filed 25 June 2026 have been fully considered but they are not persuasive.
Applicant argues that the Shimada reference does not anticipate the claimed method because it does not provide sufficient direction and guidance to enable one of ordinary skill to practice the claimed method. However, the MPEP clearly states that prior art references are presumed to be operable/enabling (see MPEP 2121(I)). Accordingly, Shimada is enabling.
Notably, Applicant is not arguing that the claimed elements are not disclosed by Shimada, only that the disclosed elements fail to enable one of ordinary skill in the art to practice the claimed method.
Applicant argues that “…Shimada provides no teaching of how to use nafamostat in combination with a PAN filter…” (reply at 3). Applicant’s argument does not take into account adequately the Office action or the express teachings of the prior art. As noted in the Office action (pages 2-3), Shimada discloses the use of a nafamostat anticoagulant in conjunction with use of a polyacrylonitrile (PAN) filter in the context of extracorporeal blood processing and treatment (see Shimada ¶0138, 0187). Applicant does not adequately explain why the explicit teachings of the two above noted components of the prior art, used together, do not constitute a “combination” of those components or otherwise expressly set forth the requirements of the claims.
Applicant further argues that “…the data of the subject application demonstrates that PAN filters cannot be saturated with nafamostat. Thus, care must be taken to initiate infusion of saline or heparinized saline solution to prime the extracorporeal circuit and then initiate infusion of a nafamostat solution immediately prior to initiation of blood flow through the filter.” (remarks at 3). This argument seemingly advances the position that, in Applicant’s determination, was challenging or required “care.” Whether Applicant had difficulty in addressing those challenges does not account for the express teachings of the prior art.
Applicant’s reliance on a two-stage priming process to overcome the difficulty of using PAN and nafamostat together has already been disclosed by Shimada (use of a PAN filter (¶0135) with a two step priming process comprising saline, then nafamostat, followed by blood infusion (¶0187)), and is not novel.
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
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 10 July 2026
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