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 have been fully considered but they are not found persuasive. Applicant contends that the combination of Nix and Moyer is improper due to Moyer failing to obviate the estimation of the native cardiac output of the subject based on a relationship between arterial pulsatility of the subject and the flow rate that is generated by the blood pump. The examiner respectfully disagrees and notes that although the secondary reference of Moyer is not concerned with pulsatility, the primary reference of Nix does rely on arterial pulsatility. Furthermore, Moyer is relied upon for the estimation of native cardiac output, which is discussed throughout the disclosure, including a specific calculation to use the aortic pressure – which is naturally pulsatile. When considered in combination with the teachings of the primary reference of Nix, one would clearly recognize that the pulsatile aortic flow would be the relationship relied upon when combining the references. Accordingly, the rejection is maintained 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nix et al. (US 2019/0209755; hereinafter “Nix”) in view of Moyer et al. (US 2018/0353667; hereinafter “Moyer”).
Regarding claim 1, Nix discloses an apparatus, comprising: a ventricular assist device comprising a blood pump configured to be placed inside a left ventricle of a subject and to pump blood from the subject's left ventricle to an aorta of the subject (e.g. ¶¶ 95); a blood pressure sensor configured to measure aortic pressure of the subject (e.g. ¶¶ 78, 97, etc.); a computer processor configured to: vary a flow rate that is that is generated by the blood pump (e.g. ¶¶ 50-55); determine a relationship between arterial pulsatility of the subject and the flow rate that is generated by the blood pump, based upon aortic pressure that is measured by the blood pressure sensor as the flow rate that is generated by the blood pump is varied (e.g. ¶¶ 74-78, 97, 122-144, etc.); and estimate cardiac output of the subject at least partially based upon the relationship (e.g. ¶¶ 24, 43, 99, 144, etc. – where Qh is the cardiac output which is regularly estimated and known based on the aortic pressure and pulsatility).
It is unclear as to whether Nix discloses the estimation of native cardiac output. In the same field of endeavor, Moyer discloses the estimation of native cardiac output of the subject at least partially based upon the cardiac relationship (e.g. ¶¶ 32, 57, 63, etc.). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to apply the known technique of determining native cardiac output as taught by Moyer, to the known device of Nix, in order to effectively determine and apply flow according to the appropriate parameters for arterial pulsatility.
Regarding claim 6, Nix teaches a method comprising: pumping blood from a left ventricle of a subject to an aorta of the subject using a ventricular assist device (e.g. ¶¶ 95); measuring aortic pressure of the subject by operating a blood pressure sensor (e.g. ¶¶ 78, 97, etc.); operating a computer processor to: vary a flow rate that is that is generated by the blood pump (e.g. ¶¶ 50-55); determine a relationship between arterial pulsatility of the subject and the flow rate that is generated by the blood pump, based upon aortic pressure that is measured by the blood pressure sensor as the flow rate that is generated by the blood pump is varied (e.g. ¶¶ 74-78, 97, 122-144, etc.); and estimate native cardiac output of the subject at least partially based upon the relationship (e.g. ¶¶ 24, 43, 99, 144, etc. – where Qh is the cardiac output which is regularly estimated and known based on the aortic pressure and pulsatility).
Regarding claims 2 and 7, Nix discloses pumping blood from the subject's left ventricle to the subject's aorta of the subject comprises pumping blood from the subject's left ventricle to the subject's aorta using an impeller and operating the computer processor to vary the flow rate that is that is generated by the blood pump comprises operating the computer processor to vary a rotation rate of the impeller (e.g. ¶¶ 93, 102, 119, etc.).
Regarding claims 3 and 8, Nix discloses pumping blood from the subject's left ventricle to the subject's aorta of the subject comprises pumping blood from the subject's left ventricle to the subject's aorta using a continuous flow blood pump, which is configured to generate continuous flow when the blood pump is operating at its maximum pumping rate (e.g. ¶¶ 14-22, 86, etc.).
Regarding claims 4 and 9, Nix discloses the processor is configured to extrapolate the relationship between the subject's arterial pulsatility and the flow rate that is generated by the blood pump to derive what the pump flow rate would be when the subject's arterial pulsatility reaches zero, and wherein the computer processor is configured to determine the subject's native cardiac output based on what the pump flow rate would be when the subject's arterial pulsatility reaches zero (e.g. ¶¶ 56, 87, 144-155, etc.).
Regarding claims 5 and 10, Nix discloses the processor is configured to determine that the derived flow rate when the subject's arterial pulsatility reaches zero provides an approximation of the subject's native cardiac output (e.g. ¶¶ 164-168).
Conclusion
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