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 .
Priority
This application is a continuation of application 15/734,353 filed 07/16/2021 which is a 371 of PCT/EP2019/064804 filed 06/06/2019. This application also claims foreign priority to application DE102018208929.9 filed 06/06/2018. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 07/11/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 7 is objected to because of the following informalities:
“differs from than the first pulse repetition rate” should be corrected to:
“differs from the first pulse repetition rate”
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-14 and 17 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,201,821 B2 (hereinafter “Reference Patent 1”). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application (19/030,573)
Reference Patent 1 (US 12,201,821 B2)
1. A method for determining a flow rate of blood flowing through a cardiac assist system, comprising:
performing a first pulsed Doppler measurement at a first pulse repetition rate using an ultrasonic sensor of the cardiac assist system;
performing a second pulsed Doppler measurement at a second pulse repetition rate using the ultrasonic sensor of the cardiac assist system, wherein the second pulse repetition rate differs from the first pulse repetition rate; and
determining the flow rate using measurement results of the first pulsed Doppler measurement and the second pulsed Doppler measurement using a linear Diophantine equation.
1. A method for determining a flow rate v of blood flowing through a cardiac assist system, comprising:
performing a first pulsed Doppler measurement at a first pulse repetition rate PRF1 using an ultrasonic sensor of the cardiac assist system;
performing a second pulsed Doppler measurement at a second pulse repetition rate PRF2 using the ultrasonic sensor of the assist system, wherein the second pulse repetition rate PRF2 is greater than the first pulse repetition rate PRF1; and
determining the flow rate using measurement results of the first pulsed Doppler measurement and the second pulsed Doppler measurement by solving for an integer n-1, an integer n2, and a main component f1 of the first pulsed Doppler measurement and a main component f2 of the second pulsed Doppler measurement using a linear Diophantine equation, wherein the linear Diophantine equation comprises …
2. The method of Claim 1, wherein at least one of
performing the first pulsed doppler measurement and
performing the second pulsed doppler measurement comprises emitting a new ultrasonic pulse using an ultrasonic element only after an echo of an immediately previously emitted ultrasonic pulse has been received by the ultrasonic sensor.
2. The method of claim 1, wherein at least one of
performing a first pulsed doppler measurement and
performing a second pulsed doppler measurement comprises emitting a new ultrasonic pulse using an ultrasonic element only after an echo of an immediately previously emitted ultrasonic pulse has been received by the ultrasonic sensor.
3. The method of Claim 1, wherein the first pulse repetition rate or the second pulse repetition rate is smaller than twice a maximum occurring Doppler shift.
3. The method of claim 1, wherein PRF1 or PRF2 is smaller than twice a maximum occurring Doppler shift.
4. The method of Claim 1, wherein determining the flow rate comprises using a correlation between a detected main frequency component of a Doppler frequency spectrum of the first pulsed Doppler measurement and the first pulse repetition rate or the second pulsed Doppler measurement and the second pulse repetition rate.
4. The method of claim 1, wherein determining the flow rate comprises using a correlation between a detected main frequency component of the Doppler frequency spectrum of the first pulsed Doppler measurement and the first pulse repetition rate PRF-1 or the second pulsed Doppler measurement and the second pulse repetition rate PRF2.
5. The method of Claim 1, wherein determining the flow rate comprises solving the linear Diophantine equation using Bezout coefficients or an exhaustion method.
5. The method of claim 1, wherein determining the flow rate comprises solving the linear Diophantine equation using Bezout coefficients or an exhaustion method.
6. The method of Claim 1, wherein an observation window of the ultrasonic sensor is in a range of 25 mm to 55 mm from an ultrasonic element of the ultrasonic sensor.
6. The method of claim 1, wherein an observation window of the ultrasonic sensor is in a range of 25 mm to 55 mm from an ultrasonic element of the ultrasonic sensor.
7. A cardiac assist system comprising:
an ultrasonic sensor configured to perform a first pulsed Doppler measurement at a first pulse repetition rate and a second pulsed Doppler measurement at a second pulse repetition rate, wherein the second pulse repetition rate differs from than the first pulse repetition rate; and
a processing unit configured to:
determine a flow rate of a fluid flowing through the cardiac assist system using measurement results of the first pulsed Doppler measurement and the second pulsed Doppler measurement,
wherein determining the flow rate using the measurement results of the first pulsed Doppler measurement and the second pulsed Doppler measurement comprises using a linear Diophantine equation.
7. A cardiac assist system comprising:
an ultrasonic sensor configured to perform a first pulsed Doppler measurement at a first pulse repetition rate PRF1 and a second pulsed Doppler measurement at a second pulse repetition rate PRF2, wherein PRF2 is greater than PRF1; and
a processing unit configured to:
determine a flow rate of a fluid flowing through the cardiac assist system using measurement results of the first pulsed Doppler measurement and the second pulsed Doppler measurement,
wherein determining the flow rate using the measurement results of the first pulsed Doppler measurement and the second pulsed Doppler measurement comprises solving for an integer n1, an integer n2 and a main component f1 of the first pulsed Doppler measurement and a main component f2 of the second pulsed Doppler measurement using a linear Diophantine equation comprising: …
8. The cardiac assist system of Claim 7, wherein the processing unit is configured to solve the linear Diophantine equation using Bezout coefficients or an exhaustion method to determine the flow rate.
8. The cardiac assist system of claim 7, wherein the processing unit is configured to solve the linear Diophantine equation using Bezout coefficients or an exhaustion method to determine the flow rate.
9. The cardiac assist system of Claim 7, wherein the processing unit is configured to calculate a fluid flow based on the flow rate.
9. The cardiac assist system of claim 7, wherein the processing unit is configured to calculate a fluid flow based on the flow rate.
10. The cardiac assist system of Claim 7, wherein the ultrasonic sensor comprises an observation window in a range of 25 mm to 55 mm from an ultrasonic element of the ultrasonic sensor.
10. The system of claim 7, wherein the ultrasonic sensor comprises an observation window in a range of 25 mm to 55 mm from an ultrasonic element of the ultrasonic sensor.
11. The cardiac assist system of Claim 7, further comprising a cannula, wherein the ultrasonic sensor is configured to perform the first pulsed Doppler measurement and the second pulsed Doppler measurement within the cannula.
11. The system of claim 7, further comprising a cannula, wherein the ultrasonic sensor is configured to perform the first pulsed Doppler measurement and the second pulsed Doppler measurement within the cannula.
12. The cardiac assist system of Claim 11, wherein the ultrasonic sensor is integrated into a tip of the cannula.
12. The system of claim 11, wherein the ultrasonic sensor is integrated into the tip of the cannula.
13.The method of Claim 1,
wherein the ultrasonic sensor is configured to perform the first pulsed Doppler measurement and the second pulsed Doppler measurement within a cannula of the cardiac assist system.
7. A cardiac assist system comprising:
an ultrasonic sensor…
11. The system of claim 7, further comprising a cannula,
wherein the ultrasonic sensor is configured to perform the first pulsed Doppler measurement and the second pulsed Doppler measurement within the cannula.
14. The method of Claim 13,
wherein the ultrasonic sensor is integrated into a tip of the cannula.
7. A cardiac assist system comprising:
an ultrasonic sensor…
11. The system of claim 7, further comprising a cannula…
12. The system of claim 11,
wherein the ultrasonic sensor is integrated into the tip of the cannula.
17. The method of Claim 1, further comprising
determining a fluid flow based on the flow rate.
7. A cardiac assist system comprising…
9. The cardiac assist system of claim 7, wherein the processing unit is configured to
calculate a fluid flow based on the flow rate.
Claims 15-16 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 12,201,821 B2 (hereinafter “Reference Patent 1”) in view of Prem (US6293901).
Regarding claim 15, Reference Patent 1 teaches the invention as claimed above in claim 1.
However, Reference Patent 1 fails to teach wherein an observation window of the ultrasonic sensor is positioned downstream of the ultrasonic sensor.
In an analogous cardiac assist device field of endeavor, Prem teaches such a feature. Prem teaches a blood pump (51) configured to pump blood from the left ventricle (43) to the aorta (50) (Fig. 4, Column 8 line 51 – Column 9 line 26). Prem teaches the pump (51) includes an ultrasonic flow sensor (91) positioned upstream from the pump (51) (Fig. 4, Column 8 lines 55-67). Prem teaches wherein the ultrasonic flow sensor (91) monitors blood flow through the pump (51), therefore teaching wherein an observation window of the ultrasonic sensor (91) is positioned downstream (i.e. at the pump 51) of the ultrasonic sensor (91) (Fig. 4, Column 8 lines 57-59).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Reference Patent 1 to have the observation window be positioned downstream from the ultrasonic sensor as taught by Prem (Fig. 4, Column 8 line 51 – Column 9 line 26). In this configuration, the ultrasonic sensor may measure blood flow through the pump and provide feedback to a controller of the pump to adjust the rotary velocity of the pump to prevent excessive blood damage as recognized by Prem (Fig. 4, Column 8 lines 57-65).
Regarding claim 16, Reference Patent 1 teaches the invention as claimed above in claim 1.
However, Reference Patent 1 fails to teach wherein the ultrasonic sensor is positioned upstream of a flow machine of the cardiac assist system.
In an analogous cardiac assist device field of endeavor, Prem teaches such a feature. Prem teaches a circulatory system (cardiac assist system) including a blood pump (51) configured to pump blood from the left ventricle (43) to the aorta (50) (Fig. 4, Column 8 line 51 – Column 9 line 26). Prem teaches the pump (51) includes an ultrasonic flow sensor (91) positioned upstream from the pump (51) (Fig. 4, Column 8 lines 55-67). Prem therefore teaches wherein the ultrasonic sensor (91) is positioned upstream of a flow machine (i.e. blood pump 51) of a cardiac assist system.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Reference Patent 1 to position the ultrasonic sensor upstream of the blood pump as taught by Prem (Fig. 4, Column 8 lines 55-67). By placing said sensor upstream from the flow machine or blood pump, input flow may additionally be measured, or blood flow through the pump may be monitored during a low-flow phase as recognized by Prem (Column 8 lines 57-61).
Regarding claim 18, Reference Patent 1 teaches the invention as claimed above in claim 7.
However, Reference Patent 1 fails to teach wherein an observation window of the ultrasonic sensor is positioned downstream of the ultrasonic sensor.
In an analogous cardiac assist device field of endeavor, Prem teaches such a feature. Prem teaches a blood pump (51) configured to pump blood from the left ventricle (43) to the aorta (50) (Fig. 4, Column 8 line 51 – Column 9 line 26). Prem teaches the pump (51) includes an ultrasonic flow sensor (91) positioned upstream from the pump (51) (Fig. 4, Column 8 lines 55-67). Prem teaches wherein the ultrasonic flow sensor (91) monitors blood flow through the pump (51), therefore teaching wherein an observation window of the ultrasonic sensor (91) is positioned downstream (i.e. at the pump 51) of the ultrasonic sensor (91) (Fig. 4, Column 8 lines 57-59).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Reference Patent 1 to have the observation window be positioned downstream from the ultrasonic sensor as taught by Prem (Fig. 4, Column 8 line 51 – Column 9 line 26). In this configuration, the ultrasonic sensor may measure blood flow through the pump and provide feedback to a controller of the pump to adjust the rotary velocity of the pump to prevent excessive blood damage as recognized by Prem (Fig. 4, Column 8 lines 57-65).
Regarding claim 19, Reference Patent 1 teaches the invention as claimed above in claim 7.
However, Reference Patent 1 fails to teach wherein the ultrasonic sensor is positioned upstream of a flow machine of the cardiac assist system.
In an analogous cardiac assist device field of endeavor, Prem teaches such a feature. Prem teaches a circulatory system (cardiac assist system) including a blood pump (51) configured to pump blood from the left ventricle (43) to the aorta (50) (Fig. 4, Column 8 line 51 – Column 9 line 26). Prem teaches the pump (51) includes an ultrasonic flow sensor (91) positioned upstream from the pump (51) (Fig. 4, Column 8 lines 55-67). Prem therefore teaches wherein the ultrasonic sensor (91) is positioned upstream of a flow machine (i.e. blood pump 51) of a cardiac assist system.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Reference Patent 1 to position the ultrasonic sensor upstream of the blood pump as taught by Prem (Fig. 4, Column 8 lines 55-67). By placing said sensor upstream from the flow machine or blood pump, input flow may additionally be measured, or blood flow through the pump may be monitored during a low-flow phase as recognized by Prem (Column 8 lines 57-61).
Allowable Subject Matter
Claims 1-19 are rejected for non-statutory double patenting as discussed above. However, claims 1-19 would be allowable if a proper Terminal Disclaimer is filed to overcome the non-statutory double patenting rejections above. The following is a statement of reasons for the indication of allowable subject matter:
Within the context of claims 1 and 7, no prior art was found to teach or reasonably suggest to the ordinarily skilled artisan “determining the flow rate using measurement results of the first pulsed Doppler measurement and the second pulsed Doppler measurement using a linear Diophantine equation”.
The invention provides a solution for the maximum pulse repetition rate (PRFmax) being less than a minimum pulse repetition rate (PRFmin) when taking into account the Nyquist sampling theorem. A violation of the Nyquist sampling theorem is caused by comparatively long transit times between an ultrasonic sensor and the observation window in a cardiac assist system, and when the Nyquist sampling theorem is not met, ambiguities (aliasing) will occur in a measured Doppler shift. By measuring two pulsed dopplers which have different pulse repetition rates, an ambiguous (aliased) measurement result of the ultrasonic sensor may be corrected for, and thus flow rate may be accurately determined. While dual pulse repetition frequency (PRF) and multi-PRF methods are known in the art for measuring blood flow rate, no prior art was found for teaching the use of a linear Diophantine equation with first and second pulsed Doppler measurements for determining flow rate.
Examiner Remarks
Regarding Patent Eligibility
Notwithstanding the explicit recitation of mathematics (i.e. use of a linear Diophantine equation) involved in determining the flow rate, the invention is nonetheless considered to be patent eligible (i.e., not directed to an abstract idea) because the measurement steps amount to more than just mere data collection: 1) collecting two Doppler measurements is intrinsic to the aforementioned solution itself; and 2) it is unconventional as conventional Doppler measurements require only one measurement for solving for Doppler frequency shift. Additionally, the aforementioned mathematics can be considered to be practically applied to the technological field of Doppler ultrasound (particularly, as used to measure blood flow in a cardiac assist system) because the invention as a whole solves the aforementioned Nyquist problem that would otherwise arise when measuring blood flow through a cardiac assist system; i.e., it results in improved (more accurate) blood flow measurements of blood flowing through a cardiac assist system. Therefore, the claims as a whole recite significantly more than just the mathematics itself.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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/TOMMY T LY/ Examiner, Art Unit 3797
/COLIN T. SAKAMOTO/ Primary Examiner, Art Unit 3798