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 PCT/US2023/74243 filed 14 September 2023, which claims the benefit of domestic priority from US Provisional Application no. 63/407,100 filed 15 September 2022.
Claim Objections
Claim 27 objected to because of the following informalities: a “the” appears to be missing between the “…path between gas pump assembly”. 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 14 recites the limitation "said ECG circuitry" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 25 recites the limitation "liquid accumulator sensor" in line 4. There is insufficient antecedent basis for this limitation in the claim. The claim previously introduces a “liquid accumulator” not a "liquid accumulator sensor". It is considered that the claim should read “a liquid sensor adjacent the liquid accumulator”. Appropriate correction is required.
Claim 28 recites the limitation "adjacent to the baffles and/or narrowed cross-sectional area of the flow path" in lines 2-3. There is insufficient antecedent basis for this limitation in the base claim 25. Appropriate correction is required.
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 (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 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) 1-7, 9, 10, 12-14, 17, and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega et al. (US Publication no. 2021/0379357) in view of Freed et al. (US Patent no. 6,042,532 – disclosed by Applicant).
In regard to claim 1, Noriega et al. disclose a cardiac assist system (figure 1, system 10, para 54) comprising:
a pneumatic effector 20 assembly configured to be implanted proximate a patient's heart to enhance heart contraction (para 54, a pneumatic end effector at distal end of catheter body 18; para 71);
an external drive unit 14 including (para 56):
(a) a gas pump assembly 52 connectable to the pneumatic effector assembly 20 (para 57-61); and
(b) control circuitry 54 configured to operate the gas pump assembly 52 to actuate the pneumatic effector assembly 20 in response to the patient's sensed heart rhythm (para 35);
an isolation valve 60b located between the gas pump assembly 52 and an inlet 46 (connected tube) to the pneumatic effector 20 (para 57, a plurality of valves 60a-d direct air through the system and the pump assembly, wherein valve 60b may be construed to comprise an isolation valve between the pump assembly 52 and connecting tube 46).
Noriega et al. substantially teach the underlying pneumatic cardiac assist system. However, Noriega et al. does not teach a pressure sensor located between the isolation valve and the inlet to the pneumatic effector; wherein the control circuitry is configured to receive changes in pressure sensed by the pressure sensor when the isolation valve is closed to isolate the pneumatic effector.
Freed et al. discloses a pressure control system for a pneumatic cardiac assist device. Freed et al. includes a control valve 32 positioned between a drive unit 48 and inflatable chamber 10 wherein it is considered that control valve 32 operates as a isolation valve as in Noriega et al. (figs. 3 and 4, col 8 lines 1-61). Freed et al. also include a pressure sensor 36 located between valve 32 and inflatable chamber 10. The pressure sensor 36 is in communication with the control means 40,40a of the device. Pressure sensor 36 measures differential pressure across valve 32 during inflation and deflation of the inflatable chamber 10 and when chamber 10 is isolated from the drive unit 40 (col 8 lines 56-61). Control means 40 obtains pressure measurements from pressure sensor 36 when chamber 10 is isolated from the drive unit 80 which maintains the desired pressure in the pressure reservoir (col 9 lines 6-15).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the pneumatic cardiac assist device of Noriega et al. to incorporate the pressure sensor between the isolation valve and pneumatic effector since Freed et al. demonstrates the configuration for measuring pressure in the pneumatic effector independent of the pump to ensure the effector maintains adequate pressure while providing assist.
In regard to claim 2, Noriega et al. teach that the external drive unit 14 includes a console 48 containing he pump and control circuitry 54 (para 56). However, Noriega et al. do not teach the isolation valve located within the external drive housing. Freed et al. show in figures 3-4 that the valve 32 and pressure sensor 36 are located within external drive unit 18 (col 5 lines 1-15). It would have been obvious to one of ordinary skill in the art to modify Noriega et al. to incorporate valve 60b into the external console since Freed et al. teaches the valve as part of the external control apparatus and such modification would consolidate the pneumatic control components within the external drive.
In regard to claim 3, Noriega et al. is considered to shows in figure 2A the isolation valve 60b located between external drive unit 52A/54 and the pneumatic effector assembly (connector cable 46).
In regard to claim 4, Noriega et al. teach that the pneumatic effector assembly comprises: a catheter body 18 having a proximal end, a distal end (figure 1, the distal end may comprise balloon 20, and the proximal end comprise hub 38), and at least one gas exchange lumen therebetween (para 32, “..to supply a driving gas received from the cannula through a gas lumen in the catheter body to the pneumatic effector”) ;
a pneumatic effector 20 at the distal end of the catheter body configured (1) to be implanted proximate a patient's heart to enhance left ventricular contraction (para 71) and (2) to receive and exhaust an inflation gas through the gas exchange lumen (para 61; and a hub 38 at the proximal end of the catheter body 18 configured to be detachably connected to a gas pump assembly of the external drive unit (hub 38 is detachable connected to external console 48 via cannula 44) (para 54-57)
Noriega et al. do not teach that the pressure sensor is located in or on the hub and configured to sense pressure in the at least one gas exchange lumen. Freed et al. teach positioning pressure sensor 36 on the inflatable chamber side of isolation valve 32 so that the sensor 36 measures the pressure communicated to the inflatable chamber 10 when isolation (col 8 lines 56-61). Freed et al. teaches that the pressure sensor is located on the patient side of the isolation valve 32 so that the pressure in the isolated inflation chamber 10 may be measured when the valve is closed. Noriega et al. teach the hub 38 at the proximal end of catheter 18 provides the fluid interface between the external drive unit and gas exchange lumen extending to the pneumatic effector. The hub would be a suitable location for placing the sensor It would have been obvious to one of ordinary skill in the art to include a pressure sensor in the catheter of Noriega et al. and to modify the position of the sensor in or near hub 38 to measure the pressure in the pneumatic effector in order to simplify manufacture, facilitate service or replacement of the sensor, and protect the sensor from mechanical stresses imparted on the device while still performing pressure monitoring functions.
In regard to claim 5, Noriega et al. teach that the hub 38 is attached directly to the proximal end of the catheter body 18 (para 54, port 24 with port body 38 located at proximal end of catheter 18).
In regard to claim 6, Noriega et al. teach that the hub 38 further comprises a cannula 44 and wherein the pneumatic effector assembly includes an implantable port 24/38 attached directly to the proximal end of the catheter body 18, wherein said implantable port is configured to percutaneously receive the cannula 44 (para 54-56).
In regard to claim 7, Freed et al. teach the control circuitry 18 is configured to calculate a pressure change gradient of any change in pressure received from the pressure sensor (col 12 line 27 – col 13 line 9, Freed et al. teach determining pressure related changes over time including the direction of the change (i.e., the gradient); col 2 lines 32-55 discuss maintaining the gradient pressure).
In regard to claim 9, Noriega et al. teach that a connecting tube 46 having a pump end attachable to the gas pump assembly 52 and a hub end attachable to the hub 38, wherein the connecting tube 48 connects the gas pump assembly 52 to the pneumatic effector assembly 20 (figure 1, para 56).
In regard to claim 10, Noriega et al. teach the pneumatic effector assembly 20 is configured to be implanted beneath a patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle (para 71).
In regard to claim 12, Noriega et al. teach at least one ECG electrode 56 (para 56).
In regard to claim 13, Noriega et al. teach the at least one ECG electrode 56 is located on the pneumatic effector assembly and configured to provide the control circuitry with the patient's heart rhythm (para 21, 36).
In regard to claim 14, Noriega et al. teach the at least one ECG electrode is configured to attach externally to the patient and is connected to said ECG circuitry by an external lead (para 21-22, 36)
In regard to claim 17, Noriega et al. teach the isolation valve is closed at the end of deflation during systole and opened at the beginning of inflation during diastole (para 35, the control circuitry is typically configured to operate the pump assembly to actuate a pneumatic effector on the implantable cardiac assist catheter in response to the patient's sensed heart rhythm; para 57 and 72 as well). Freed et al. also teach closing and opening valves at selected portions of the cardiac cycle (col 9 lines 16-29).
In regard to claim 49, Noriega et al. discloses an external drive unit 14 for use with an implantable cardiac assist catheter 10 having a pneumatic effector assembly 20, said external drive unit comprising:
a gas pump assembly 52 having a port connectable to the pneumatic effector assembly 20 (para 57-61; assembly 20 connected to pump 52 through catheter 18, hub 38, and connecting tube 46);
control circuitry 54 configured to operate the gas pump assembly 52 to actuate the pneumatic effector assembly 20 in response to a patient's sensed heart rhythm (para 35);
an isolation valve 60b located between an outlet of the gas pump assembly 52 and the port (para 57, a plurality of valves 60a-d direct air through the system and the pump assembly, wherein valve 60b may be construed to comprise an isolation valve between the pump assembly 52 and connecting tube 46).
Noriega et al. substantially teach the underlying pneumatic cardiac assist system. However, Noriega et al. does not teach a pressure sensor located between the isolation valve and the inlet to the pneumatic effector; wherein the control circuitry is configured to receive changes in pressure sensed by the pressure sensor when the isolation valve is closed to isolate the pneumatic effector.
Freed et al. discloses a pressure control system for a pneumatic cardiac assist device. Freed et al. includes a control valve 32 positioned between a drive unit 48 and inflatable chamber 10 wherein it is considered that control valve 32 operates as a isolation valve as in Noriega et al. (figs. 3 and 4, col 8 lines 1-61). Freed et al. also include a pressure sensor 36 located between valve 32 and inflatable chamber 10. The pressure sensor 36 is in communication with the control means 40,40a of the device. Pressure sensor 36 measures differential pressure across valve 32 during inflation and deflation of the inflatable chamber 10 and when chamber 10 is isolated from the drive unit 40 (col 8 lines 56-61). Control means 40 obtains pressure measurements from pressure sensor 36 when chamber 10 is isolated from the drive unit 80 which maintains the desired pressure in the pressure reservoir (col 9 lines 6-15).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the pneumatic cardiac assist device of Noriega et al. to incorporate the pressure sensor between the isolation valve and pneumatic effector since Freed et al. demonstrates the configuration for measuring pressure in the pneumatic effector independent of the pump to ensure the effector maintains adequate pressure while providing assist.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega et al. (US Publication no. 2021/0379357) in view of Freed et al. (US Patent no. 6,042,532 – disclosed by Applicant), further in view of Criscione et al. (US Publication no. 2021/0379356).
In regard to claim 8, Noriega et al. in view of Freed et al. describe the invention substantially as claimed, however do not teach that a calculated pressure change gradient larger than a predetermined threshold indicates that there is a pressure leak in the pneumatic effector assembly. Criscione et al. describes a cardiac assist device that supplies compression according to the cardiac cycle (para 12). The device uses a vacuum pump and pressure pump to supply the compression driven in synchrony with heart contraction (para 54). A pressure sensor is incorporated to assess performance of the device, wherein a deviation in pressure (presumably from some baseline or defined threshold) can be monitored in order to detect a leak or weakening of the device (para 63). While a threshold is not expressly taught, it is implied in order to serve as the guidepost to ascertain that a deviation occurs. Therefore, it is considered to have been obvious to one of ordinary skill in the art to monitor for leaks as it is explicitly taught by Criscione et al. to indicate if the device is properly functioning.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega et al. (US Publication no. 2021/0379357) in view of Freed et al. (US Patent no. 6,042,532 – disclosed by Applicant), further in view of Choy et al. (US Patent no. 4,771,765).
In regard to claim 11, Noriega et al. in view of Freed et al. describe the invention substantially as claimed, however do not teach that the pneumatic effector assembly is configured to be implanted in a heart chamber. Choy et al. describe an inflatable cardiac assist device. Figure 2 shows the assist device comprising a pneumatic effector 16 inserted within the left ventricle. Therefore, it is considered to have been obvious to one of ordinary skill in the art to place the assist device in the left ventricle since it is explicitly shown in Choy et al. to facilitate complete evacuation of blood during systole (col 1 lines 12-18).
Claim(s) 25 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega et al. (US Publication no. 2021/0379357) in view of Freed et al. (US Patent no. 6,042,532 – disclosed by Applicant), further in view of Milder et al. (US Patent no. 5,041,051).
In regard to claims 25 and 50, Noriega et al. in view of Freed et al. describe the invention substantially as claimed, however do not teach a liquid accumulator in-line between an outlet of the gas pump assembly and an inlet of the pneumatic effector; and a liquid sensor adjacent the liquid accumulator sensor. Milder et al. describes a fluid driven cardiac assist for insertion in the body (col 1 lines 5-11). Milder et al. is directed to detecting a leak in such device, wherein the leak detection is determined using liquid accumulator 6 in-line between an outlet of the gas pump 3 assembly and an inlet of the pneumatic effector 1; and a liquid sensor 8 adjacent the liquid accumulator 6 (figure 1, col 2 lines 1-40, the liquid accumulator is the disclosed moisture remover 6 and a leak is detected based upon an increase in humidity of the system). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify Noriega et al. and Freed et al. to incorporate a fluid accumulator and fluid sensor in the cardiac assist device since Milder et al. explicitly teach that detecting and collecting moisture aids in detecting a leak in a fluid driven device.
Claim(s) 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega et al. (US Publication no. 2021/0379357) in view of Freed et al. (US Patent no. 6,042,532 – disclosed by Applicant) and Milder et al. (US Patent no. 5,041,051), further in view of Klobucar et al. (US Patent no. 6,623,551).
In regard to claim 27, Noriega et al. in view of Freed et al. and Milder et al. are considered to substantially describe the invention as claimed, however do not teach the liquid accumulator comprises a flow path between gas pump assembly and the pneumatic effector, said flow path having baffles and/or a narrowed cross-sectional area to collect liquid entrained in gas flowing through the flow path. Milder et al. addresses the liquid accumulator and flow path, however, does not address use of baffles. Klobucher et al. teaches the use of baffles for separating liquid from a gas stream (col 1 lines 18-20). Any moisture in the stream will deposit as droplets on the baffles and drain into a collection system (col 3 lines 20-31). Modification of the liquid accumulator of Milder et al. to incorporate baffles is considered to have been obvious to one of ordinary skill in the art since Klobuchar et al. explicitly teach that baffles are known to aid in separation and removal of an unwanted liquid such as humidity/condensate from a gas line. Moreover, in view of the alternative recitation in the claim, a narrowed-cross sectional pathway is considered to be an obvious suitable alternative equivalent from removing the condensate to the baffles, wherein selection of this alternative would be motivated by choice in design.
In regard to claim 28, Noriega et al. in view of Freed et al., Milder et al., and Klobuchar et al. are considered to substantially describe the invention as claimed, however do not teach the liquid sensor is located in a hub adjacent to the baffles and/or narrowed cross-sectional area of the flow path. Milder et al. teaches the moisture sensor in line with fluid accumulator. Modification of the sensor to be adjacent the baffle of Klobuchar et al. is considered to have been obvious as the rearrangement of parts. Placement of the sensor adjacent the baffles or at the expected location of liquid accumulation would predictable facilitate detection of collected liquid. The rearrangement of parts has been held to only require routine skill.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 28 July 2026
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