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 .
Specification
The disclosure is objected to because of the following informalities:
“medical device 12” has improper references to number 21, 26, 126, 226. This should be changed to appropriate references as some of this numbers also refer to different elements.
Para 67 has an improper reference to “the elongate member 26 taken along line 3-3 of FIG. 1”. This should be changed to “the elongate member 26 taken along line 3-3 of FIG. 2”.
Page 13-14, “hub” has improper references to both number 28 and 48.
Page 46 has improper reference to “FIGS. 20-22 illustrate”. This should be changed to “FIGS. 20-21 illustrate”, as there is no Figure 22 in the drawings.
Page 45-48, “displays 300, 400, 500”, where there is no display 500 in the drawing.
In Para 173, “pump 22” has improper references, and should change to “pump 18”.
Appropriate correction is required.
Claim Objections
Claim 14, 18, and 20 are objected to because of the following informalities:
In Claim 14, "a user" lacks proper antecedents basis, should recites "the/said user".
In Claim 18, "a third physiological parameter" lacks proper antecedents basis, should recites "the/said third physiological parameter".
In Claim 20, “the hub” should recite “a hub”, because this is the first recitation of this limitation in the claim.
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 11, 13-14, and 18 are 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.
Regarding Claim 11, recites “the third medical device” which is not present in any of the previous claims. It is unclear which medical device is being referred to or if it’s a different/new medical device.
Regarding Claim 13, “the input button is configured to permit a user to manipulate the first medical device, the second medical device or both the first medical device and the second medical device”, is indefinite for failing to particularly point out and distinctly claim the subject matter. The claim(s) are considered indefinite because it is unclear and there is a question or doubt as to whether the feature introduced as an input button configured to perform all recited function or multiple buttons are present, specifically when “both” devices are manipulated.
Regarding Claim 14, “the first medical device is an expandable member and the second medical device is an expandable member”, is indefinite for failing to particularly point out and distinctly claim the subject matter. Claim 14 ultimately depend on claim 4, which already recites “wherein the first medical device is a first expandable member and the second medical device is a second expandable member”. It is unclear if “an expandable member” recited in claim 14 is the same in claim 4 or a different expandable member, such that the metes and bounds of the claim cannot be determined. Also, if it’s the same as claim 4, proper antecedents basis requires.
Regarding Claim 18, “a seventh visual representation of a third physiological parameter”, and “a sensor” is indefinite for failing to particularly point out and distinctly claim the subject matter. Claim 18 ultimately depend on claim 15, which already recites “a fifth visual representation of a third physiological parameter” and “a third sensor”. It is unclear if “the third physiological parameter” and “a sensor” recited in claim 18 is the same in claim 15 or a different parameter and sensor, such that the metes and bounds of the claim cannot be determined. Also, if it’s the same as claim 15, proper antecedents basis requires.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20210299431 A1 to Anand et al. (hereinafter “Anand”) in view of US 20230181246 A1 to Katz et al. (hereinafter “Katz”) and further in view of US 11197619 B2 to Glover et al. (hereinafter “Glover”).
Regarding Claim 1, 8, 15, 18, and 20, Anand teaches a medical device system for treating a heart (see Para 04: “An example medical device system for treating a heart”), the system comprising:
a control system (see Abstract: “a control system”, and Para 4) including a display unit, wherein the display unit is configured to display: a first visual representation of a first medical device disposed in a first anatomical location; a second visual representation of a second medical device disposed in a second anatomical location;
a third visual representation of a first physiological parameter, wherein the first physiological parameter is measured by a first sensor disposed at a first location proximate the first medical device (see Para 04: “a first sensing member having a first end positioned adjacent the first expandable member … the first sensing member designed to sense a first parameter”, and Fig 2 (sensing members 32a/34a/32b/34b, where two sensor proximate the first medical device and two proximate the second medical device), also Para 17, 59, 65-68); and a fourth visual representation of a second physiological parameter, wherein the second physiological parameter is measured by a second sensor disposed at a second sensor location proximate the second medical device (see Para 04: “a second sensing member having a first end positioned adjacent the second expandable member … the second sensing member designed to sense a second parameter.”, and Fig 2 (sensing members 32a/34a/32b/34b, where two sensor proximate the first medical device and two proximate the second medical device), also Para 17, 59, 62, 65-68).
Addition elements of Claim 8, 15, 18, and 20:
Anand also teaches wherein the third physiological parameter is measured by a sensor disposed along the third anatomical location (see Para 65: “one or more of the sensing members 32a/34a/32b/34b may sense a change in a physiological parameter (e.g., an increase in blood pressure) in the areas surrounding the superior vena cava 36, the inferior vena cava 38 and/or the right atrium 42.”, and Fig 2 (sensing members 32a/34a/32b/34b, where two sensor proximate the first medical device and two proximate the second medical device), also Para 66-67, 11), and
wherein the fourth physiological parameter is measured by a fourth sensor disposed at a fourth sensor location proximate the second medical device (see Para 65: “one or more of the sensing members 32a/34a/32b/34b may sense a change in a physiological parameter (e.g., an increase in blood pressure) in the areas surrounding the superior vena cava 36, the inferior vena cava 38 and/or the right atrium 42.”, and Fig 2 (sensing members 32a/34a/32b/34b, where two sensor proximate the first medical device and two proximate the second medical device), also Para 66-67, 11),
a control system having a processor (see Para 17: “medical device system for treating a heart includes a control system having a processor”, also Para 51 and Fig.1),
a catheter shaft having a lumen (see Para 54: “the elongate member 30a may include one or more individual lumens extending therein”, also Para 55-56) and a first end coupled to the hub (see Para 54: “the elongate member 30a may include an inflation lumen (not shown in FIG. 2, but visible in FIG. 5) which may be in fluid communication with the pump 18 (which, in turn, may be in fluid communication with the saline reservoir 20)”, also Para 51-52, 65, 75-96),
a first expandable member disposed along the catheter shaft (see Para 53: “The expandable member 28a may include a distal end and a proximal end. The proximal end of the expandable member 28a may be coupled to the elongate member 30a”, also Fig. 2-4) and coupled to the processor, wherein the first expandable member is configured to be positioned in the superior vena cava (see Para 04: “a first expandable member coupled to the processor, wherein the first expandable member is configured to be positioned in the superior vena cava”, also Para 9-10, 17);
a second expandable member disposed along the catheter shaft (see Para 56: “the second medical device 26b may include an expandable member 28b … The expandable member 28b may include a distal end and a proximal end. The proximal end of the expandable member 28b may be coupled to the elongate member 30b”, also Fig. 2-4) and coupled to the processor, wherein the second expandable member is configured to be positioned in the inferior vena cava (see Para 04: “a second expandable member coupled to the processor, wherein the second expandable member is configured to be positioned in the inferior vena cava”, also Para 9-10, 17);
a first sensing member having a first end positioned proximate the first expandable member and a second end coupled to the control system, the first sensing member designed to sense a first physiological parameter (see Para 04: “The system also includes a first sensing member having a first end positioned adjacent the first expandable member and a second end coupled to the control system, the first sensing member designed to sense a first parameter”, also Para 17-18, 55); and
a second sensing member having a first end positioned proximate the second expandable member and a second end coupled to the control system, the second sensing member designed to sense a second physiological parameter (see Para 04: “a second sensing member having a first end positioned adjacent the second expandable member and a second end coupled to the control system, the second sensing member designed to sense a second parameter”, also Para 17-18, 58);
Anand teaches the medical device system having a control system and multiple sensing member designed to sense one or more physiological parameters/characteristics occurring in a patient. However, does not teach a display unit to display visual representation of the medical device in an anatomical location and sensed physiological parameters from the sensors.
Katz teaches a systems and methods herein provide a mapping engine that generates detailed cardiac vein ablation visualizations by extracting and analyzing electrical activity of the heart and by analyzing interior and/or exterior 3D maps of the heart (see Para 19, and Para 6-7), including a display unit (see Para 20: “a display device 27”), wherein the display unit is configured to display:
a first visual representation of a first medical device disposed in a first anatomical location; a second visual representation of a second medical device disposed in a second anatomical location, display a third anatomical location (see Para 28: “modeling the endocardial anatomy in three-dimensions (3D) and rendering the model or anatomical map 20 for display on the display device 27, … displaying real-time location and orientation of multiple catheters within the heart chamber”, also Para 21, 29, 42-46, 49, 81-86 (examiner interpretation of displaying multiple catheter could be first, second, third, or any additional number of disposed device in different anatomical location));
Accordingly, it would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filling date of the invention to combine Katz teaching to modify the invention of Anand in order to incorporate visual representation of anatomical location of the medical device to provide medical professionals with an improved monitoring procedures, understanding and visual clarity of the device location, and more precision that furthers improve efficiency and success of cardiac procedures (see Para 19).
Katz teach visual presentation of anatomical location (“biometric data” see Para 39) but does not appear to specifically teach display of visual representation of a multiple physiological parameter sensed by the multiple sensor.
Another reference, Glover, teach a system and apparatus comprising a multi-sensor catheter or a multi-sensor guidewire for use in cardiology, and more particularly to a pulmonary artery catheter for right heart catheterization and related diagnostic measurements (see Para 1), where a third visual representation of a first physiological parameter, a fourth visual representation of a second physiological parameter, a fifth visual representation of a third physiological parameter, a sixth visual representation of a fourth physiological parameter (see Para 36-39: “the system can process optical data from each sensor and display concurrent blood pressure waveforms … in addition to displaying pressure waveforms from the aorta and the left ventricle, the system may display a plurality of numeric values …”, also Para 65-73 (displaying data for each sensor is interpreted to number of sensor related to the number of visualization of the physiological parameter)).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filling date of the invention to combine Glover teaching to further modify the invention of Anand in order to incorporate visual representation of physiological parameters sensed by multiple sensors to monitor patient data in real time at multiple location by the medical professionals, thereby improving monitoring efficiency and clinical decision making.
Regarding Claim 2, Anand further teaches the modified medical device system of claim above, wherein the first anatomical location is a superior vena cava (see Para 23: “a first medical device into the superior vena cava”, also Para 4, 9-10, 17, 49, 53, 59-60, …).
Regarding Claim 3, Anand further teaches the modified medical device system of claim above, wherein the second anatomical location is an inferior vena cava (see Para 23: “a second medical device into the inferior vena cava”, also Para 4, 9-10, 17, 49, 53, 59-60, …).
Regarding Claim 4, Anand further teaches the modified medical device system of claim above, wherein the first medical device is a first expandable member and the second medical device is a second expandable member ((see Para 23: “the first medical device including a first expandable member … the second medical device including a second expandable member”, also Para 4, 10, 17, 53, 55-56, Fig.2).
Regarding Claim 5, Anand further teaches the modified medical device system of claim above, wherein the first sensor is disposed proximal of the first expandable member (see Para 98: “the medical device 310 may include one or more sensing members positioned adjacent to the first expandable member 328a and/or the second expandable member 328b … For example, FIG. 13 illustrates the sensing members 332a and 334a positioned adjacent to the first expandable member 328a …”, also Para 53-59, Fig. 13 (sensing members 332a is disposed proximal of the first expandable member 328a) and Fig.2).
Regarding Claim 6, Anand further teaches the modified medical device system of claim above, wherein the second sensor is disposed distal of the second expandable member (see Para 98: “the medical device 310 may include one or more sensing members positioned adjacent to the first expandable member 328a and/or the second expandable member 328b … the sensing members 332b and 334b positioned adjacent to the second expandable member 328b …”, also Para 53-59, Fig. 13 (sensing members 334b is disposed distal of the second expandable member 328a) and Fig.2).
Regarding Claim 7, Anand further teaches the modified medical device system of claim above, wherein the first physiological parameter and the second physiological parameter is a blood pressure (see Para 59-60: “the sensing members 32a/34a/32b/34b may all be configured to sense a change in one or more physiological parameters/characteristics occurring in a patient 24 … The MEMS pressure sensor may be able to detect and respond rapidly to very small changes in blood pressure”, also Para 05, 65-66, 68-69).
Regarding Claim 9, Anand further teaches the modified medical device system of claim above, wherein the third anatomical location is a pulmonary artery (see Para 58-60: “a sensing member 32b extending out of a portion of the elongate member 30b, whereby the distal end of the sensing member 32b may be positioned proximal of the expandable member 28b. Further, FIG. 2 illustrates a sensing member 34b extending out of the distal end region of the second medical device 26b, whereby a portion of the second sensing member 34b is positioned distally of the first expandable member 28b … the sensing members 34a/34b may include a pressure sensor designed to measure the right atrial pressure in a region adjacent to the right atrium 42”, also Para 65 and Fig. 2; (sensing member (for example Fig. 2 (34a/34b)) can extend distally and, in a region adjacent to the right atrium. It would be obvious to a person skilled in the art to extend further distally and aiming to acquire pressure data close to pulmonary artery)).
Regarding Claim 10, Anand further teaches the modified medical device system of claim above, wherein the third physiological parameter is selected from the group consisting of a cardiac output, a stroke output, a mean arterial pressure and a blood pressure (see Para 65: “one or more of the sensing members 32a/34a/32b/34b may sense a change in a physiological parameter (e.g., an increase in blood pressure) in the areas surrounding the superior vena cava 36, the inferior vena cava 38 and/or the right atrium 42”, also Para 60, 66, 68).
Regarding Claim 11, Anand further teaches the modified medical device system of claim above, wherein the third medical device includes a pulmonary catheter (see Para 61-62: “each of the sensing members 32a/34a/32b/34b may include a pressure sensing catheter”, (thought it doesn’t specifically teach the catheter to be pulmonary catheter, it would be obvious to one in ordinary skill to use a different type of catheter in place of pressure sensing catheter)).
Regarding Claim 12, Glover further teaches the modified medical device system of claim above, wherein the display unit is configured to further display a pressure waveform corresponding to the first physiological parameter (see Para 36: “the system can process optical data from each sensor and display concurrent blood pressure waveforms”, also Para 37-39).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filling date of the invention to combine Glover teaching to further modify the invention of Anand in order to display measured parameter by a pressure waveform to provide information regarding changes that can be difficult to conveyed by only numerical value, thereby improving real-time physiological assessment and monitoring, also clinical decision making.
Regarding Claim 13 and 14, Katz further teaches the modified medical device system of claim above, wherein the display unit is configured to further display an input button, and wherein the input button is configured to permit a user to manipulate the first medical device, the second medical device or both the first medical device and the second medical device, wherein the input button is configured to permit a user to immediately stop inflation of the first expandable member, the second expandable member or both the first and the second expandable members (see Para 44-46: “the display device 27 can include a touchscreen that can be configured to accept inputs from the physician 24 … the physician 24 may manipulate the elements of the system 10 and/or the body part rendering using one or more input devices, such as a touch pad, a mouse, a keyboard, a gesture recognition apparatus, or the like. For example, an input device can be used to change a position of the catheter 14”, also Para 35, 41).
Similarly, Glover teaches wherein the display unit is configured to further display an input button, and wherein the input button is configured to permit a user to manipulate the first medical device, the second medical device or both the first medical device and the second medical device, wherein the input button is configured to permit a user to immediately stop inflation of the first expandable member, the second expandable member or both the first and the second expandable members (see Para 33: “The control unit 2151 houses a control system comprising a controller with appropriate functionality … provides a user interface, e.g. a keypad 2154, and touch screen display 2152, suitable for tactile user input … port 2010-1 is connected to a small air filled syringe 2100 for inflation/deflation of the balloon …”, also Para 29-32, 72).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filling date of the invention to combine Katz and/or Glover teaching to further modify the invention of Anand in order to include an input button in the display for manipulating the medical device, because incorporating user control into the display enables the medical professionals to operate the device directly from the same display used for monitoring, thereby reduce the need to switch between separate control interfaces. By including immediate stop control allows rapid interruption of device operation, thereby the system achieve enhance procedural safety and user control.
Regarding Claim 16, Anand further teaches the modified medical device system of claim above, wherein the first anatomical location is a superior vena cava (see Para 23: “a first medical device into the superior vena cava”), and wherein the first medical device is a first expandable member (see Para 23: “the first medical device including a first expandable member”), and wherein the first sensor is disposed proximal of the first expandable member and wherein the third sensor is disposed distal of the first expandable member (see Fig. 2 (sensing members 32a and 34a)).
Regarding Claim 17, Anand further teaches the modified medical device system of claim above, wherein the second anatomical location is an inferior vena cava (see Para 23: “a second medical device into the inferior vena cava”), and wherein the second medical device is a second expandable member (see Para 23: “the second medical device including a second expandable member”), and wherein the second sensor is disposed proximal of the second expandable member and wherein the fourth sensor is disposed distal of the first expandable member (see Fig. 2 (sensing members 32b and 34b)).
Regarding Claim 19, Anand further teaches the modified medical device system of claim above, wherein the third anatomical location is a pulmonary artery (see Para 58-60: “a sensing member 32b extending out of a portion of the elongate member 30b, whereby the distal end of the sensing member 32b may be positioned proximal of the expandable member 28b. Further, FIG. 2 illustrates a sensing member 34b extending out of the distal end region of the second medical device 26b, whereby a portion of the second sensing member 34b is positioned distally of the first expandable member 28b … the sensing members 34a/34b may include a pressure sensor designed to measure the right atrial pressure in a region adjacent to the right atrium 42”, also Para 65 and Fig. 2; (sensing member (for example Fig. 2 (34a/34b)) can extend distally and, in a region adjacent to the right atrium. It would be obvious to a person skilled in the art to extend further distally and aiming to acquire pressure data close to pulmonary artery)), and wherein the third physiological parameter is selected from the group consisting of a cardiac output, a stroke output, a mean arterial pressure and a blood pressure (see Para 65: “one or more of the sensing members 32a/34a/32b/34b may sense a change in a physiological parameter (e.g., an increase in blood pressure) in the areas surrounding the superior vena cava 36, the inferior vena cava 38 and/or the right atrium 42”, and Para 60, 66, 68).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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