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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5 January 2026 has been entered.
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous 112 rejection, which is now withdrawn. After further consideration, an updated rejection is presented 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 2-9, 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Jarvik et al. (USP# 7,264,606; hereinafter “Jarvik”), in view of Bonde et al. (US 2016/0151553; hereinafter “Bonde”), further in view of Mann et al. (USP# 5,230,607; hereinafter “Mann”).
Regarding claims 2, 13, and 18, Jarvik discloses a system comprising: an implantable blood pump configured to pump blood within a patient (e.g. Col 2, ll 29-55); and a control circuit (e.g. Fig. 10, #100) configured to: stop operation of the implantable blood pump in response to detecting a stop condition (e.g. Col 12, ll 19-31 – “if a bubble condition is sensed, the pump is immediately caused to shut down…” – where the examiner considers the shut down to be the initiation of a pump lockout mode), prevent resumption of operation of the blood pump in response to the first pump restart input, and receive a second pump restart input while the pump lockout mode of the blood pump is activated, and control the implantable blood to resume the operation in response to receiving the second pump restart input (e.g. Col 12, ll 19-31 – “…motor does not start again automatically, but must be manually restarted by depressing the restart pump button…” – where the examiner is interpreting the restart pump button as the second pump restart input and the automatic restart as the primary pump restart), wherein the second pump cannot automatically execute as it based on conditions, and is not capable of being directly accessed by a patient as it first must be cleared by clinician.
Bonde discloses a blood pump (e.g. Abstract) with a control circuit configured to: stop operation of the blood pump in response to detecting a plurality of stop conditions, the conditions including exceeding a maximum commutation frequency, overvoltage, overcurrent, and exceeding a rated temperature, after which the pump may be automatically restarted (where the examiner considers automatic restarts, in both references, to be the first pump restart input) after a predetermined time period or once the temperature returns to a desirable state (e.g. ¶¶ 43 – the resolution of the issue would indicate a “clearance of the stop condition” as claimed).
It would have been obvious to one of ordinary skill at the time the invention was filed to provide in the system of Jarvik, wherein less serious conditions as presented in and taught by Bonde, result in automatic stopping/restarting of the pump, in order to ensure proper pump/patient safety. In this modified/combined system, the automatic restart of Bonde corresponds to the claimed first pump restart input and the manual restart of Jarvik corresponds to the second pump restart input, the lockout mode as claimed is considered to be the shut down where Jarvik’s serious condition requires a manual restart and would not allow a timer or temperature stop condition, for example, to trigger the first pump restart or automatic restart as in Bonde.
As added evidence that, when making such a combination, the resultant system would yield wherein there is a first input (an automatic restart trigger) which may restart the pump in some conditions and a lockout mode wherein a second restart input (i.e. a manual restart) is required, Mann, discloses the notion of automatically stopping the pump under some conditions, restarting it automatically in a first condition, but initiating a pump lockout mode, preventing resumption of operation and allowing resumption in response to a manual restart (e.g. Abstract). It would have been obvious to apply this same principle to a blood pump since, as shown in Jarvik and Bonde, blood pumps are also known to have conditions that warrant automatically stopping the pump, conditions that warrant restarting the pump automatically, and more serious conditions in which requiring a pump lockout mode where a manual restart would be desirable.
Regarding claims 3, 14-15, and 19, Bonde as referenced above discloses the control circuit is configured to control the blood pump to cease operation in response to detecting at least one of an operational error at the blood pump (e.g. ¶¶ 43).
Regarding claim 4, Bonde as referenced above discloses the control circuit is configured to control the blood pump to cease operation in response to detecting a suction condition (e.g. ¶¶ 38, 59, 71, etc.).
Regarding claims 5, 16, and 20, Bonde as referenced above discloses the control circuit is configured to initiate the pump lockout mode in response to determining an amount of time since the operation of the blood pump was ceased is greater than or equal to a predetermined amount of time (e.g. ¶¶ 43 – “designated or programmed time period (e.g. 0-2 seconds), the motor may be restarted”).
Regarding claims 6 and 17, Bonde as referenced above discloses an interface, wherein the control circuit is configured to receive data indicative of at least one of the first pump restart input or the second pump restart input via the interface (e.g. ¶¶ 43).
Regarding claim 7, Bonde as referenced above discloses a user interface, wherein the first pump restart input is an automatic input and the second pump restart input is a manual input received by the control circuit from a user via the user interface (e.g. ¶¶ 11-15, 42, 51, etc.).
Regarding claims 8, Mann as referenced above discloses the second pump restart input is inaccessible to the patient (e.g. Fig. 11A, #130).
Regarding claims 9 and 21, Bonde as referenced above discloses the control circuit is configured to control the blood pump to resume operation in response to receiving the first pump restart input or the second pump restart input by at least determining at least one of a clearance of high pressure condition, a clearance of suction condition, a clearance of low flow condition, or a clearance of overheating condition (e.g. ¶¶ 43).
Regarding claim 11, Mann as referenced above discloses the first and second pump restart inputs differ in that the second pump restart input includes an instruction to clear the pump lockout mode (e.g. Abstract).
Regarding claim 12, Bonde as referenced above discloses the control circuit is configured to cause an alert to be provided to the patient or a clinician in response to initiation of the pump lockout mode (e.g. ¶¶ 52).
Conclusion
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