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 with respect to the previous rejection(s) of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as expounded below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 10-12, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan et al. (US 2020/0268952; hereinafter “Nitzan”) in view of Walters et al. (US 2012/0172656; hereinafter “Walters”).
Regarding claim 1, Nitzan discloses a percutaneous circulatory support device, comprising: an impeller housing (e.g. Fig 2 – where the examiner considers the entire structure proximal to #231 tip to be the impeller housing); an impeller disposed within the impeller housing (e.g. Fig. 2, #205), the impeller being rotatable relative to the impeller housing to cause blood to flow through the percutaneous circulatory support device (e.g. ¶¶ 9 – “…impeller shaft flares outwards near a distal end of the impeller such that when the impeller is rotated, the impeller pumps blood through the impeller housing and out of the one or more outlets.”; 99-101, etc.); and a reservoir disposed within the impeller housing (e.g. ¶¶ 139 – medicant lumen – where the examiner considers the anticoagulant delivered through this lumen and the volume/cavity within that lumen to be a reservoir), the reservoir carrying at least one anticoagulant (e.g. ¶¶ 139 – “medicant lumen”) and being configured to release the at least one anticoagulant into blood flowing through the percutaneous circulatory support device (e.g. ¶¶ 5, 148-149).
Nitzan fails to expressly disclose an impeller shaft extending through the reservoir. In the same field of endeavor, Walters discloses a percutaneous circulatory support device with an impeller and impeller shaft that extends through the body of the device, extending through the reservoir, where the reservoir is considered the plurality of lumens dispersed circumferentially about the catheter body, around the impeller shaft (e.g. ¶¶ 66-68; Fig. 5, #300 – where the examiner considers the flow pathway of the lumens to be the reservoir). It would have been obvious, to one of ordinary skill in the art, to modify the reservoir of Nitzan, to have the reservoir made up of the plurality of lumens extend on circumferentially around the central impeller shaft, as taught with the lumens of Waters, with the impeller shaft extending through the middle of the reservoir, in order to yield the predictable results providing quick release of fluid that is temperature controlled as it positioned intravascularly in the patient.
Regarding claim 10, Nitzan discloses a percutaneous circulatory support device, comprising: an impeller housing (e.g. Fig 2 – where the examiner considers the entire structure proximal to #231 tip to be the impeller housing); an impeller disposed within the impeller housing (e.g. Fig. 2, #205), the impeller being rotatable relative to the impeller housing to cause blood to flow and through the percutaneous circulatory support device (e.g. ¶¶ 9 – “…impeller shaft flares outwards near a distal end of the impeller such that when the impeller is rotated, the impeller pumps blood through the impeller housing and out of the one or more outlets.”; ¶¶ 99-101, etc.); and a reservoir coupled to the impeller housing and being disposed proximally relative to the impeller (e.g. ¶¶ 139 – where the examiner considers the anticoagulant delivered through this lumen and the volume within that lumen to be equivalent to the reservoir), the reservoir carrying at least one anticoagulant (e.g. ¶¶ 139 – “medicant lumen”) and being configured to release the at least one anticoagulant into blood flowing through the percutaneous circulatory support device (e.g. ¶¶ 5, 148-149).
Nitzan fails to expressly disclose an impeller shaft extending through the reservoir. In the same field of endeavor, Walters discloses a percutaneous circulatory support device with an impeller and impeller shaft that extends through the body of the device, extending through the reservoir, where the reservoir is considered the plurality of lumens dispersed circumferentially about the catheter body, around the impeller shaft (e.g. ¶¶ 66-68; Fig. 5, #300 – where the examiner considers the flow pathway of the lumens to be the reservoir). It would have been obvious, to one of ordinary skill in the art, to modify the reservoir of Nitzan, to have the reservoir made up of the plurality of lumens extend on circumferentially around the central impeller shaft, as taught with the lumens of Waters, with the impeller shaft extending through the middle of the reservoir, in order to yield the predictable results providing quick release of fluid that is temperature controlled as it positioned intravascularly in the patient.
Regarding claim 17, Nitzan teaches a method for using a percutaneous circulatory support device, comprising: positioning the percutaneous circulatory support device at a target location within a patient (e.g. ¶¶ 131); rotating an impeller of the percutaneous circulatory support device to cause blood to flow through the percutaneous circulatory support device (e.g. ¶¶ 9 – “…impeller shaft flares outwards near a distal end of the impeller such that when the impeller is rotated, the impeller pumps blood through the impeller housing and out of the one or more outlets.”; ¶¶ 99-101, etc.); the impeller fixed to an impeller shaft (e.g. Fig. 2, #205); and releasing at least one anticoagulant from a reservoir of the percutaneous circulatory support device into blood flowing through the percutaneous circulatory support device (e.g. ¶¶ 139 – where the examiner considers the anticoagulant delivered through this lumen and the volume within that lumen to be equivalent to the reservoir).
Nitzan fails to expressly disclose an impeller shaft extending through the reservoir. In the same field of endeavor, Walters discloses a percutaneous circulatory support device with an impeller and impeller shaft that extends through the body of the device, extending through the reservoir, where the reservoir is considered the plurality of lumens dispersed circumferentially about the catheter body, around the impeller shaft (e.g. ¶¶ 66-68; Fig. 5, #300 – where the examiner considers the flow pathway of the lumens to be the reservoir). It would have been obvious, to one of ordinary skill in the art, to modify the reservoir of Nitzan, to have the reservoir made up of the plurality of lumens extend on circumferentially around the central impeller shaft, as taught with the lumens of Waters, with the impeller shaft extending through the middle of the reservoir, in order to yield the predictable results providing quick release of fluid that is temperature controlled as it positioned intravascularly in the patient.
Regarding claim 2-3, 11, and 18-19, Nitzan discloses the at least one anticoagulant comprises heparin (e.g. ¶¶ 5, 151, etc.).
Regarding claims 4, 12, and 20, Nitzan discloses a motor operatively coupled to the impeller, the motor rotating the impeller relative to the impeller housing to cause blood to flow through the percutaneous circulatory support device (e.g. ¶¶ 8, 15, etc.).
Regarding claim 9, Nitzan discloses the impeller housing further comprises an outlet, and the outlet extends both proximally and distally beyond the reservoir (e.g. ¶¶ 93, 100-101, etc.).
Claims 5-9 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Grippi, further in view of Muller et al. (USP# 10,576,192; hereinafter “Muller”). Nitzan fails to expressly disclose a driving magnet operatively coupled to the motor and a driven magnet operatively coupled to the driving magnet, the motor rotating the impeller, via the driving magnet and the driven magnet, relative to the impeller housing to cause blood to flow through the percutaneous circulatory support device. In the same field of endeavor, Muller discloses a percutaneous circulatory support device/system with a driving magnet operatively coupled to the motor and a driven magnet operatively coupled to the driving magnet, the motor rotating the impeller, via the driving magnet and the driven magnet, relative to the impeller housing to cause blood to flow through the percutaneous circulatory support device (e.g. Col 4, ll 9-21). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of a driving magnet operatively coupled to the motor and a driven magnet operatively coupled to the driving magnet, the motor rotating the impeller, via the driving magnet and the driven magnet, as taught by Muller, to improve the similar device of Nitzan, by providing another option for a reliable and known manner of powering impellers.
Conclusion
Applicant's amendment dated 31 October 2025 in response to the Office Action dated 10 September 2025, necessitates the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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