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 .
Status of the Application
Claims 1-20 have been examined in this application. This communication is the first action on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/12/2024 and 07/02/2025 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Objections
Independent claims 1 and 13 recite (emphasis added): “determine that an operating parameter of the system deviates from a symmetric waveform”, which is confusing. The Specification does not provide a clear definition of said term.
Specifically, in cardiology, the term "symmetric waveform" is most often used in the context of the T wave on an electrocardiogram (ECG), wherein a normal T wave, representing electrical recovery, is typically slightly asymmetric; its peak is closer to its end than its beginning. A T wave that is symmetrical and deep (often >3mm) is usually a sign of a cardiac pathology, such as myocardial ischemia, etc. Thus, within a cardiac cycle on an ECG, a symmetric T wave is generally considered an abnormal finding that warrants further clinical investigation. If so, the recited limitations do not make sense.
Alternatively, symmetry is also a conceptual principle used in cardiac function assessment, where the activity of the left and right ventricles, and the processes of systole (contraction) and early diastole (relaxation), are seen as having mirror behaviors or "two levels of symmetry" which can be used to derive new diagnostic indexes. However, in standard visual ECG interpretation, T wave symmetry is the most common and clinically significant reference. Same rationale applied to claims 3-4 and 15-16.
Also, claims 2, 14 and 19 recite “…the operating parameter deviates from a square waveform,” which is confusing. The square waveform may refer to a fast flush test - a quick saline flush on an arterial line that creates a square-like pattern on the monitor to check system damping; a ventricular square-wave response during a stress test; or defibrillation studies square waves. It’s unclear which application of said waveforms is actually considered.
The Examiner recommends to amend the claims in order to clarify patentable subject matter.
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.
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, 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, 6, 8, 13-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Moyer et al. (US 2018/0353667A1) (IDS of 07/02/2024) in view of Alwatban et al. (US 2023/0131738 A1).
Claims 1 and 13. Moyer et al. (Moyer) discloses a percutaneous circulatory support system, comprising: a housing configured to be positioned within a patient; an impeller (a rotor of the IMPELLA© pump) carried within the housing; a motor operably coupled to the rotor the impeller; and a controller operably coupled to the motor Figs. 1, 3; [0002]; [0041].
While Moyer discloses the rotor of the IMPELLA© pump, Moyer does not explicitly teach the impeller of said pump, which is disclosed in Alwatban et al. (Alwatban). [0005]; [0010]; [0028]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Moyer to include the recited limitations, as disclosed in Alwatban, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Moyer, as modified by Alwatban, further teaches:
the controller being configured to:
drive the motor, the motor thereby rotating the rotor of the impeller relative to the housing to cause blood to flow through the housing; Moyer, [0006]; [0031]; [0041]; [0043]; [0044]; Alwatban, [0005]; [0028]
determine that an operating parameter of the system deviates from a symmetric waveform; [0048]-[0052]; [0056]-[0058]; [0067], and
in response to determining that the operating parameter deviates from the symmetric waveform, provide an alert of aortic valve insufficiency. Moyer; [0061]; [0066]-[0069]; Alwatban, [0005]
Claims 2, 14 and 19. The percutaneous circulatory support system of Claim 1, wherein the controller is configured to determine that the operating parameter deviates from a square waveform. Same rationale as applied to claims 1 and 13.
Claims 3 and 15. The percutaneous circulatory support system of Claim 1, wherein the controller is configured to determine that the operating parameter deviates from the symmetric waveform within a cardiac cycle of the patient. Same rationale as applied to claims 1 and 13.
Claims 4 and 16. The percutaneous circulatory support system of Claim 3, wherein the controller is configured to determine that the operating parameter deviates from the symmetric waveform during the cardiac cycle of the patient by comparing an increase in the operating parameter during systolic contraction to a decrease in the operating parameter following the dicrotic notch. Same rationale as applied to claims 1 and 13.
Claims 8 and 20. The method of Claim 13, wherein the operating parameter is a commanded voltage, and the method further comprises providing, via the controller, the commanded voltage to the motor to drive the motor. Same rationale as applied to claims 1 and 13.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Moyer in view of Alwatban and further in view of Wampler (US 2019/0160213 A1).
Claims 7 and 18. Moyer does not specifically teach wherein the controller is further configured to receive feedback from the motor and adjust the operating parameter based on the feedback, which is disclosed in Wampler. [0025]; [0026]; [0028]; [0029]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Moyer to include the recited limitations, as disclosed in Wampler, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Allowable Subject Matter
Claims 9-12 are allowed.
The following is an examiner’s statement of reasons for allowance:
As per independent claim 9, Moyer in view of Alwatban disclose a percutaneous circulatory support system, comprising: a housing configured to be positioned within a patient; an impeller carried within the housing; a motor operably coupled to the impeller; and a controller operably coupled to the motor, the controller being configured to: provide a commanded voltage to the motor, the motor thereby rotating the impeller relative to the housing to cause blood to flow through the housing; low pass filter a first portion of the commanded voltage rate to provide an upper voltage envelope corresponding to an increase in the commanded voltage. Moyer, Figs. 1, 3; [0002]; [0041]; Alwatban. [0005]; [0009]; [0010]; [0050]. Further, Siess et al. (Siess) discloses high pass filtering the operating parameter to provide a parameter rate; C. 17, L. 1-7; C. 20, L. 32-44; C. 22, L. 40-53; cl. 6. Furlthre, XIANG et al. (XIANG) discloses a technique for using a low-pass filter and band-pass filter to separate the vibration ultrasonic composite signal, obtaining the vibration signal and the ultrasonic signal, and using the envelope detection circuit to take out the upper envelope line of the ultrasonic signal, combining the voltage phase information to draw the PRPD pattern, realizing the diagnosis of partial discharge, wherein the use of the envelope detection circuit can greatly reduce the requirement of the sampling rate and reduce the power consumption of the whole detection device.
However, the cited prior art of record neither anticipates, nor, alone or combined, renders obvious as a whole the specific combination of the inventive features as recited in the independent claim. The remaining dependent claims are considered allowable, as they are dependent and based off of an allowable independent claim.
Further, dependent claims 5-6 and 17 have been examined with respect to the prior art and are objected to as being dependent upon a rejected base claim, but may be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Igor Borissov whose telephone number is 571-272-6801. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Kambiz Abdi can be reached on 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 12/31/2025