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 combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
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 Grippi et al. (US 2004/0071786; hereinafter “Grippi”).
Regarding claim 1, 10, and 17, Nitzan discloses a percutaneous circulatory support device, positioned at a target location within the patient (e.g. ¶¶ 131) 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. ¶¶ 93) in a proximal direction (e.g. ¶¶ 93, 100-101, 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 within that lumen to be equivalent to the reservoir), the reservoir carrying at least one anticoagulant and being configured to release the at least one anticoagulant into blood flowing through the percutaneous circulatory support device (e.g. ¶¶ 148-149).
Nitzan fails to expressly disclose the impeller shaft extending through the reservoir as claimed. In the same field of endeavor, Grippi discloses a device where the rotor shaft extends through a reservoir, which contains an anticoagulant to prevent clotting, in order to allow the appropriate amount of anticoagulant into the sample. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to modify the reservoir of Nitzan to have the impeller shaft extending through the reservoir as taught by Grippi, in order to allow for a more efficient packaging and allow introduction of the anticoagulant seamlessly into the blood.
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 necessitated 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796