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 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2007/0104616; hereinafter “Keenan”) in view of Jahangir (US 2020/0023110).
Regarding claim 1, Keenan teaches a method for purging a blood pump, the method comprising: providing a blood pump in fluid communication with a purging device (e.g. ¶¶ 128), wherein the purging device comprises: a purge reservoir configured to be fluidically connected to the blood pump and to receive a purge fluid (e.g. Fig. 53, #15); and a supplemental reservoir configured to be fluidically connected to the blood pump and to receive a supplemental purge fluid (e.g. Fig. 53, #4026); inserting at least a portion of the blood pump into a patient (e.g. Fig. 53, #11); operating the blood pump (e.g. ¶¶ 128); providing a flow of the purge fluid from the purge reservoir to the blood pump (e.g. ¶¶ 106, 114, 122-125); measuring, by a measuring device, a purge flow parameter at the blood pump (e.g. ¶¶ 106, 114, 122-125, etc.); and identifying a remediation protocol upon determination, by a controller, that the purge flow parameter at the blood pump meets a predetermined threshold purge flow parameter (e.g. ¶¶ 90, 103, etc.).
Keenan fails to expressly disclose the use of an intravascular pump as claimed. In the same field of endeavor Jahangir teaches a similar method for purging an intravascular blood pump in order to prevent clotting (e.g. ¶¶ 32-37). 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 technique of Keenan to apply similar purging strategies to intravascular blood pumps, as known and taught by Jahangir, in order to yield the predictable results of avoiding clots from forming on the elements of the device.
Regarding claim 2, Keenan teaches the remediation protocol comprises: stopping the flow of the purge fluid from the purge reservoir to the blood pump, and starting a flow of the supplemental purge fluid from the supplemental reservoir to the blood pump; measuring, by the measuring device, a supplemental purge flow parameter at the blood pump; and stopping the flow of the supplemental purge fluid from the supplemental reservoir to the blood pump upon determination, by the controller, that the supplemental purge flow parameter at the blood pump has fallen below or exceeds the predetermined threshold purge flow parameter indicating the supplemental purge fluid is no longer required, and resuming the flow of the purge fluid from the purge reservoir to the blood pump (e.g. ¶¶ 120-124).
Regarding claim 3, Keenan teaches the flow of the supplemental purge fluid is stopped and the flow of the purge fluid is resumed upon determination, by the controller, that the supplemental purge flow parameter at the blood pump exceeds the predetermined threshold purge flow parameter (e.g. ¶¶ 113-118).
Regarding claim 4, Keenan teaches the flow of the supplemental purge fluid is stopped and the flow of the purge fluid is resumed upon determination, by the controller, that the supplemental purge flow parameter at the blood pump exceeds the predetermined threshold purge flow parameter by a predetermined amount, wherein the predetermined amount is at least 30% over a 24-hour period or at least 20% over a 12-hour period (e.g. ¶¶ 113-118).
Regarding claim 5, Keenan teaches the purge flow parameter is a purge flow rate and the predetermined threshold purge flow parameter is a decrease in the purge flow rate by a predetermined amount, wherein the predetermined amount is at least 30% within a 24-hour period or at least 20% over a 12-hour period (e.g. ¶¶ 113-118).
Regarding claim 6, Keenan teaches the purge flow parameter is a purge flow rate and the predetermined threshold purge flow parameter is a decrease in the purge flow rate to below 3 mL/hour within a 6-hour period (e.g. ¶¶ 115).
Regarding claim 7, Keenan teaches the purge flow parameter is a purge pressure and the predetermined threshold purge flow parameter is an increase in the purge pressure by a predetermined amount, wherein the predetermined amount is at least 30% within a 24-hour period or at least 20% over a 12-hour period (e.g. ¶¶ 113-118).
Regarding claim 8, Keenan teaches the purge flow parameter is a purge pressure and the predetermined threshold purge flow parameter is an increase in the purge pressure to greater than 700 mmHg within a 24-hour period (e.g. ¶¶ 128-134).
Regarding claim 9, Keenan teaches deaerating the supplemental purge fluid prior to supplying the supplemental purge fluid to the blood pump (e.g. ¶¶ 145-148).
Regarding claim 10, Keenan teaches detecting no kinking in one or more tubing of the blood pump and the purging device (e.g. ¶¶ 121).
Regarding claim 11, Keenan teaches the purge fluid comprises aqueous dextrose (e.g. ¶¶ 89).
Regarding claim 12-15, Keenan teaches the purge fluid further comprises the anticoagulant, heparin, and the direct thrombin inhibitor is lepirudin, desirudin, argatroban, bivalirudin, or mixtures thereof (e.g. ¶¶ 475-481).
Regarding claims 16-17, Keenan teaches the pH controlling and buffering agent is sodium bicarbonate (e.g. ¶¶ 457).
Regarding claims 18-21, Keenan teaches the supplemental purge fluid comprises tissue plasminogen activator (tPA), dextrose, and a tpA concentration of 2 -mg/50mLto4 mg/50 mL (e.g. ¶¶ 70-73).
Regarding claim 22, Keenan teaches the blood pump comprises a motor section and a pump section, and wherein the purge fluid and the supplemental purge fluid are supplied to the motor section (e.g. ¶¶ 468-475).
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.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796