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 Preliminary Amendment
This Office Action is responsive to the preliminary amendment filed 13 March 2025. As per the amendment: claims 2 and 21-24 have been cancelled and no claims have been added or amended. Thus, claims 1, 3-20 and 25 are presently pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 10 March 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 4 objected to because of the following informalities:
Line 1 of claim 4 reads “where in” should read “wherein”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 currently depends from cancelled claim 2, and therefore the dependency of the claim is indefinite. For examination purposes, claim 3 will be read as if dependent on claim 1.
Claim 3 recites “d <10% of the length of the catheter”, however, the claim does not define what the d represents. For examination purposes, d will be interpreted to represent the distance of the first sensor from the pump housing as defined in specification ([0006]).
Claim 3 recites the limitation "the length of the catheter" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-7, 9-12, 16, 18-20, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spanier et al. (US Patent 9,669,142 B2), hereinafter Spanier.
Regarding claim 1, Spanier discloses a blood pump (Figure 1: intravascular blood pump), comprising:
A catheter (a catheter 10);
A pump housing (pumping device 50) operable coupled to a distal end of the catheter (Column 5, lines 31-34: “The intravascular blood pump comprises in addition to the catheter 10 a rotary pumping device 50 fastened at the distal end of the catheter hose 20”)
A first sensor disposed around the catheter or at a distal end of the catheter, and a second sensor disposed distal to the catheter (Abstract: at least one pressure sensor 30, 60, view Figure 1, Column 5, lines 45-48: “These optical fibers 28A, 28B are respectively part of an optical pressure sensor whose sensor heads 30 and 60 are located externally on the housing of the pump section 52”).
Regarding claim 4, Spanier discloses the blood pump of claim 1 (as shown above), wherein the first sensor is an optical sensor (Figure 2, Column 5, lines 46-47: “an optical pressure sensor whose sensor heads 30 and 60”).
Regarding claim 5, Spanier discloses the blood pump of claim 1 (as shown above), wherein the first sensor is an pressure sensor (Figure 2, Column 5, lines 46-47: “an optical pressure sensor whose sensor heads 30 and 60”).
Regarding claim 6, Spanier discloses the blood pump of claim 1 (as shown above), wherein the second sensor is an optical sensor (Figure 2, Column 5, lines 46-47: “an optical pressure sensor whose sensor heads 30 and 60”).
Regarding claim 7, Spanier discloses the blood pump of claim 1 (as shown above), wherein the second sensor is an pressure sensor (Figure 2, Column 5, lines 46-47: “an optical pressure sensor whose sensor heads 30 and 60”).
Regarding claim 9, Spanier discloses the blood pump of claim 1 (as shown above), further comprising a cannula (flow cannula 53) coupled to a distal end of the pump housing (view Figure 3, Column 5, lines 36-38: “a flow cannula 53 protruding in the distal direction from the inflow end of the pump section 52”)
Regarding claim 10, Spanier discloses the blood pump of claim 1 (as shown above), wherein the catheter comprises one or more lumens (lumen 27) extending from a first end to a second end (Figure 2 and 3, Column 5, lines 62-63).
Regarding claim 11, Spanier discloses the blood pump of claim 10 (as shown above), further comprising a plurality of optical fibers extending at least partially through one or more lumens (Column 5, lines 42-45: “a pressure-measuring catheter 26 having a lumen 27 in which an optical fiber 28A (which might also be a plurality of optical fibers or the optical fiber 28B) is freely movable.”, view Figure 3).
Regarding claim 12, Spanier discloses the blood pump of claim 10 (as shown above), further comprising one or more optical fibers, each of the one or more optical fibers disposed in each of the one or more lumens (view Figure 3, Column 6, lines 51-54: “The appurtenant optical fiber 28B is guided in a thin plastic hose 21 over a short distance of for example 5 cm within the catheter hose 20”, Column 5, lines 42-45: “a pressure-measuring catheter 26 having a lumen 27 in which an optical fiber 28A (which might also be a plurality of optical fibers or the optical fiber 28B) is freely movable.”)
Regarding claim 16, Spanier discloses the blood pump of claim 1 (as shown above), wherein the catheter comprises one or more walls defining a first lumen extending from a first end to a second end, each wall having a wall thickness (view Figure 2 and 3, Column 6, lines 51-54: “The appurtenant optical fiber 28B is guided in a thin plastic hose 21 over a short distance of for example 5 cm within the catheter hose 20”, Column 5, lines 42-45: “a pressure-measuring catheter 26 having a lumen 27 in which an optical fiber 28A (which might also be a plurality of optical fibers or the optical fiber 28B) is freely movable.”).
Regarding claim 18, Spanier discloses a blood pump system (Figure 1), comprising:
A blood pump of claim 1 (As shown above); and
A controller (evaluation device 100) operably coupled to the blood pump, the controller configured to received information from the first sensor and the second sensor (Column 5, lines 50-52: “The pressure transmitted by the sensor heads 30 and 60 is converted into electrical signals in the evaluation device 100 and displayed e.g. on a display screen 101.”, view Figure 1).
Regarding claim 19, Spanier discloses the blood pump system of claim 18 (as shown above), wherein the information from the first sensor includes values representative of a first pressure in a first part of a human body (Column 5, lines 53-55: “The measurement of both the aortic pressure by means of the sensor head 60 and the ventricular pressure by means of the sensor head 30 makes possible”).
Regarding claim 20, Spanier discloses the blood pump system of claim 19 (as shown above), wherein the information from the second sensor includes values representative of a second pressure in a second part of a human body (Column 5, lines 53-55: “The measurement of both the aortic pressure by means of the sensor head 60 and the ventricular pressure by means of the sensor head 30 makes possible”).
Regarding claim 25, Spanier discloses a method for operating a blood pump (Column 1, lines 11-16: “This invention relates to an intravascular rotary blood pump having one or more pressure sensors for measuring pressures within the patient's vascular system which are important for operating the blood pump and/or for assessing the patient's state of health.”), comprising:
Receiving a measured first pressure value from a sensor disposed on a catheter and a measured second pressure value from a sensor disposed distal to the catheter (Column 5, lines 50-52: “The pressure transmitted by the sensor heads 30 and 60 is converted into electrical signals in the evaluation device 100”)
Adjusting a speed of a blood pump motor based on the measured first pressure value and the measured second pressure value (Column 6, lines 21-26: “pressure-dependent electrical signal is generated. The evaluation of the optical image or optical pattern delivered by the camera and the computation of the pressure are effected by a computer attached to the camera, which also controls the power supply to the motor-operated pumping device 50 in dependence on the effected evaluation of the pressure signal.”, Column 5, lines 53-59).
Alternatively, claim(s) 1, 4-9, and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tan et al. (US 2020/0405929 A1), Tan.
Regarding claim 1, Tan et al. (US 2020/0405929 A1) discloses a blood pump (the blood pump system 100), comprising: a catheter (a catheter 102); a pump housing (pump housing 104) operably coupled to a distal end of the catheter ([0011] “a pump housing disposed distal of the distal end of the catheter”); a first sensor disposed around the catheter or at a distal end of the catheter; and a second sensor disposed distal to the catheter ([0027] “The blood pump system 100 may further include a pressure sensor and/or optical sensor 126 located on the catheter 102 as shown, or located elsewhere on the blood pump system 100.”)
Regarding claim 4, Tan discloses the blood pump of claim 1 (as shown above), where in the first sensor is an optical sensor ([0027] optical sensor 126).
Regarding claim 5, Tan discloses the blood pump of claim 1 (as shown above), wherein the first sensor is a pressure sensor ([0027] pressure sensor 126).
Regarding claim 6, Tan discloses the blood pump of claim 1 (as shown above), where in the second sensor is an optical sensor ([0027] optical sensor 126).
Regarding claim 7, Tan discloses the blood pump of claim 1 (as shown above), wherein the second sensor is a pressure sensor ([0027] pressure sensor 126).
Regarding claim 8, Tan discloses the blood pump of claim 1 (as shown above), wherein the pump housing is an expandable pump housing ([0075] “The mechanical circulatory support system of A1 or A2, wherein the mechanical circulatory support device is one of…a percutaneous expandable blood pump positioned in the right or left heart.”)
Regarding claim 9, Tan discloses the blood pump of claim 1 (as shown above), further comprising a cannula (cannula 108) coupled to a distal end of the pump housing ([0024] “The cannula 108 extends from a distal end of the pump housing 104”).
Regarding claim 13, Tan discloses the blood pump of claim 1 (as shown above), further comprising at least one additional sensor disposed around the catheter ([0032] “The electrode 212, may further be positioned on a most distal portion of the flexible projection 216.”, [0163] “wherein the electrode is configured to function as a sensor”).
Regarding claim 14, Tan discloses the blood pump of claim 1 (as shown above), further comprising at least one additional sensor (electrode 112) disposed distal to the catheter ([0032] “The electrode 212, may further be positioned on a most distal portion of the flexible projection 216.”, [0163] “wherein the electrode is configured to function as a sensor”).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spanier.
Regarding claim 3, Spanier discloses the blood pump of claim 2 (as shown above). Spanier fails to explicitly disclose wherein d ≤ 10% of the length of the catheter.
However, in this instance, a device having the claimed relative dimensions would not perform differently than the prior art device disclosed by Spanier at least because both devices are directed to intracardiac blood pumps with pressure sensors. Therefore, the claimed invention is obvious over and not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A) which states: In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Additionally, it would have been obvious to try, by one of ordinary skill in the art before the effective filing date of the claimed invention, to have d ≤ 10% of the length of the catheter, since where the general conditions of the claim are disclosed in prior art, discovering the optimum or workable ranges involves only routine skill in the art, recognizing that one would position the sensor according to its functionality. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spanier as applied to claim 1 above, and further in view of Siess et al. (US Patent 5,964,694 A), hereinafter Siess’694.
Regarding claim 8, Spanier discloses the blood pump of claim 1 (as shown above). Spanier fails to disclose wherein the pump housing is an expandable pump housing.
However, Siess’694 teaches an intravascular microaxial pump (Abstract) wherein the pump housing is an expandable pump housing (Figure 12 and 13, Column 10, lines 30-36: “FIG. 12 illustrates an embodiment that includes a flexible sealing element 88. The seal generally has the shape of a truncated cone and is attached to the pump housing 32 by its smaller distal end. Its larger, proximally extending end is expandable to engage the wall of the vessel 86 and conversely, is collapsible to lie against the pump housing 20.”, Column 10, lines 47-49: “an expandable annular balloon 90 is fitted about the pump housing 32.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Spanier to incorporate the teachings of Siess’694 to have the pump housing be an expandable pump housing, as these prior art references are directed to intracardiac blood pumps. One would be motivated to do this engage the surrounding vessel and seal the annular space between the pump housing and vessel wall to prevent backflow thereby boosting efficiency, as recognized by Siess’694 (Column 10, lines 38-42).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spanier as applied to claim 1 above, and further in view of Siess (US Patent 6,139,487 A), hereinafter Siess.
Regarding claim 13, Spanier discloses the blood pump of claim 1 (as shown above). Spanier fails to explicitly teach the pump further comprising at least one additional sensor disposed around the catheter.
However, Siess teaches an intracardiac pump with pressure sensors (Abstract) and the pump further comprising at least one additional sensor disposed around the catheter (Column 4, lines 40-41: temperature sensor, Column 4, line 46-47: oxygen sensor)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Spanier to incorporate the teachings of Siess to have the pump further comprise at least one additional sensor disposed around the catheter, as these prior art references are directed to intracardiac blood pumps with pressure sensors. One would be motivated to do this to more effectively and efficiently operate the pump based on sensed data. Additionally, Examiner would like to make note that although Siess doesn’t not explicitly teach the additional sensor disposed around the catheter it is within general skill level of a worker in the art to appropriately position such a sensor around the catheter for sensing data.
Regarding claim 14, Spanier discloses the blood pump of claim 1 (as shown above). Spanier fails to explicitly teach the pump further comprising at least one additional sensor disposed distal to the catheter.
However, Siess teaches an intracardiac pump with pressure sensors (Abstract) and the pump further comprising at least one additional sensor disposed distal to the catheter (Column 4, lines 40-41: temperature sensor, Column 4, line 46-47: oxygen sensor)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Spanier to incorporate the teachings of Siess to have the pump further comprise at least one additional sensor distal to the catheter, as these prior art references are directed to intracardiac blood pumps with pressure sensors. One would be motivated to do this to more effectively and efficiently operate the pump based on sensed data. Additionally, Examiner would like to make note that although Siess doesn’t not explicitly teach the additional sensor disposed distal to the catheter it is within general skill level of a worker in the art to appropriately position such a sensor around the catheter for sensing pertinent data.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spanier as applied to claim 1 above, and further in view of Moyer et al. (US 2018/0353667 A1), hereinafter Moyer.
Regarding claim 15, Spanier discloses the blood pump of claim 1 (as shown above). Spanier fails to disclose wherein the first sensor is disposed at a coupling between the catheter and the pump housing.
However, Moyer teaches a system, device, and method for using a blood pump to obtain measurements of cardiac function wherein the first sensor is disposed at a coupling between the catheter and the pump housing (view Figure 1, pressure sensor 112 is placed between 106 catheter and motor 108, [0041] “The intravascular heart pump system includes a catheter 106, a motor 108, a pump outlet 110, a cannula 111, a pump inlet 114, and a pressure sensor 112. The motor 108 is coupled at its proximal end to the catheter 106 and at its distal end to the cannula 111.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Spanier to incorporate the teachings of Moyer to have the first sensor disposed at a coupling between the catheter and the pump housing, as these prior art references are directed to blood pumps with sensors. One would be motivated to do this sense the pressure in the aorta to properly place the system, as recognized by Moyer ([0045]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spanier as applied to claim 16 above, and further in view of Boyce et al. (US 2023/0405303 A1), hereinafter Boyce.
Regarding claim 17, Spanier discloses the blood pump of claim 16 (as shown above). Spanier fails to disclose wherein one or more sensor lumens extend through at least one wall of the one or more walls.
However, Boyce teaches a catheter blood pump wherein one or more sensor lumens extend through at least one wall of the one or more wall (view Figure 6L, [0105] “the cannula 35 can be configured to hold the fiberoptic pressure sensor 400 so that an open end of a channel 401e exposes the sensor head 400h in a longitudinal direction to the local environment (FIG. 6L)”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Spanier to incorporate the teachings of Boyce to have the one or more sensor lumens extend through at least one wall of the one or more wall, as these prior art references are directed to blood pumps. One would be motivated to do this to expose the sensor to the environmental conditions for effective sensing.
Conclusion
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/ATTIYA SAYYADA HUSSAINI/ Examiner, Art Unit 3792
/NIKETA PATEL/ Supervisory Patent Examiner, Art Unit 3792
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