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 .
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.
Election/Restrictions
Claims 11-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/24/2025.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150366485 A1 (hereafter --Kassab--).
Regarding Claim 1, Kassab discloses a method of implanting a prosthetic heart valve, the method comprising: delivering the prosthetic heart valve to a native valve annulus while the prosthetic heart valve is crimped over a deflated balloon of a delivery device (see Figure 7A, see also paragraph [0134], see also paragraph [0152]); advancing fluid through the delivery device and into the balloon to inflate the balloon and to expand the prosthetic heart valve into the native valve annulus (see paragraph [0152], see also paragraphs [0145] and [0146]); while advancing fluid through the delivery device, monitoring a pressure within the delivery device (see paragraphs [0092] and [0093]); and displaying the monitored pressure on a display device in real time during monitoring the pressure (see paragraph [0115]).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150366485 A1 (hereafter --Kassab--), in view of US 5752522 A (hereafter --Murphy--), in even further view of US 20090312740 A1 (hereafter --Kim--).
Regarding Claim 2, Kassab discloses the method of claim 1, wherein the change in pressure over the change cross sectional area can be calculated for the system (see paragraph [0119] denoting that the change in cross sectional area divided by the change in pressure can be pressured for the system).
Kassab fails to disclose wherein displaying the monitored pressure on the display device in real time includes displaying the monitored pressure as a function of an area of the balloon as a procedural curve.
Kim discloses an automatic balloon inflation device (see paragraph [0040]), in which said inflation device fills up said balloon with fluid (see paragraph [0078]) and measures the pressure via a pressure transducer (see paragraph [0056] and [0057]), and wherein the device has a display device (see paragraphs [0060] and [0078]). Kim teaches wherein the display shows a pressure-volume curve during an inflation of the balloon catheter (see paragraph [0078]).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention for the display of Kassab to display a pressure-volume curve during an inflation of the balloon catheter on the display as taught by Kim, as by doing so would allow the user to monitor any marked increases in balloon pressure when maximal inflation has been achieved and when the balloon is apposed to the vessel wall, in order to take appropriate action (see paragraph [0078]).
Furthermore, Kassab as modified fails to disclose the display disclosing pressure as a function of an area of the balloon, even though Kassab does discuss being able to calculate the cross sectional area of the balloon (see paragraph [0119] denoting that the change in cross sectional area divided by the change in pressure can be pressured for the system).
Murphy discloses a method of measuring vessels in the body, using a balloon inflation system that is able to monitor the expansion of the balloon in the vessel and therefore monitor the amount of volume of fluid is injected into the balloon (see Abstract). Murphy teaches wherein the area of the balloon is estimated based on a volume of fluid advanced through the delivery device (see column 5, lines 47-53).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention for the control system of Kassab to use the volume values of the inflation fluid to calculate the cross-sectional area of the balloon at each value, further allowing the curve of the display device of Kassab as modified to display pressure as a function of area, since area and volume are directly proportional and able to be calculated from one another as taught by Murphy (see column 5, lines 47-53).
Regarding Claim 3, Kassab as modified discloses the method of claim 2, wherein the area of the balloon is determined based on the monitored pressure (see paragraph [0102] the area also being measured once the balloon is inflated, the pressure causing the inflation and therefore being a basis on the area measurement), the monitored pressure being determined by measuring pressure within a fluid line through which the fluid is advanced (see paragraphs [0092] and [0093] denoting that the pressure can be measured inside of the balloon, proximal to the balloon, and distal to the balloon).
Regarding Claim 4, Kassab as modified discloses the method of claim 2, wherein the area of the balloon is estimated based on a volume of fluid advanced through the delivery device (see claim 2 rejection above).
Regarding Claim 5, Kassab as modified discloses the method of claim 2, wherein the area of the balloon is determined based on a strain gauge mounted on the balloon (see paragraph [0094] denoting that the cross sectional area can be measured by electrodes, see also paragraph [0092] denoting that strain gauges can be used to sense the pressure of the balloon, see also see paragraph [0102] showing connection between pressure and area).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150366485 A1 (hereafter --Kassab--), US 5752522 A (hereafter --Murphy--), and US 20090312740 A1 (hereafter --Kim--) as applied to claim 2 above, in even further view of US 20020143294 A1 (hereafter –Duchon--).
Regarding Claim 6, Kassab as modified discloses the method of claim 2.
Kassab as modified fails to disclose further comprising displaying on the display device a reference curve of pressure as function of balloon area.
Duchon discloses a method of inflating a balloon inflation system that is able to monitor the expansion of the balloon in the vessel and the pressure of the balloon (see Abstract, see paragraphs [0064] and [0065]). Duchon teaches displaying graphs of volume and pressure as a function of time on a display monitor of the balloon, as well as teaches displaying a reference, target, or “baseline” curve (see paragraphs [0066], [0073], [0022], see also Figure 8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the display of Kassab as modified further include a reference curve of pressure as function of balloon area, allowing monitoring of both the reference and the procedural curves on the display, as by doing so would enable the physician to know the baseline pressure characteristics of the balloon catheter as well as the real time data, allowing the physician to view the difference between the actual, loaded pressure plot and the baseline graph as taught by Duchon (see paragraph [0073]).
Regarding Claim 7, Kassab as modified discloses the method of claim 6.
Kassab as modified fails to disclose wherein the reference curve is based on an expected relation of pressure of the balloon to area of the balloon when the balloon is being expanded in free space.
Duchon further teaches wherein the reference curve is based on an expected relation of pressure of the balloon to area of the balloon when the balloon is being expanded in free space (see paragraphs [0021], [0022], and [0073], see also Figure 8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the display of Kassab as modified further include wherein the reference curve is based on an expected relation of pressure of the balloon to area of the balloon when the balloon is being expanded in free space, as by doing so would allow the physician to see the difference between the actual data and baseline pressure data, and therefore see the effect of the patient on the balloon catheter as taught by Duchon (see paragraph [0021]).
Regarding Claim 8, Kassab as modified discloses the method of claim 7, further comprising monitoring a difference between the procedural curve and the reference curve while advancing fluid through the delivery device to expand the prosthetic heart valve (see claim 6 rejection above, see also paragraph [0021] of Duchon).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150366485 A1 (hereafter --Kassab--), US 5752522 A (hereafter --Murphy--), and US 20090312740 A1 (hereafter --Kim--), as applied to claim 2 above, in even further view of US 20220105319 A1 (hereafter --Salerno--).
Regarding Claim 9, Kassab as modified discloses the method of claim 2, wherein advancing fluid through the delivery device includes actuating an actuator (see paragraphs [0145] denoting that the fluid is injected via a suction and infusion port, the actuator being the injector, see also paragraph [0146]).
Kassab as modified fails to disclose actuating an actuator on a handle of the delivery device.
Salerno discloses a balloon inflating catheter device that comprises of a syringe, a plunger, and a handle (see Abstract, see also paragraph [0194]). Salerno teaches actuating an actuator on a handle of the delivery device to press the syringe (see paragraph [0194] denoting that pressing a plunger 53 of a syringe, which is performed by pressing a supply actuation control, preferably by means of a control interface located on the casing 15 of said catheter handle 10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the step of advancing fluid through the delivery device includes actuating an actuator on a handle of the delivery device, since 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 (actuating an actuator on a handle to advance the fluid) with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention, i.e., one skilled in the art would have recognized that the actuator being on the handle of the device would allow the device to effectively actuate filling the balloon.
Regarding Claim 10, Kassab as modified discloses the method of claim 9.
Kassab as modified fails to disclose wherein actuating the actuator on the handle of the delivery device sends a signal to a motorized housing having a syringe containing the fluid, the signal causing the motorized housing to depress a plunger of the syringe.
Salerno teaches wherein actuating the actuator on the handle of the delivery device (supply actuation control on a control interface located on the casing 15 of said catheter handle 10) (see paragraph [0194]) sends a signal to a motorized housing (60) having a syringe (53) containing the fluid, the signal (79) causing the motorized housing to depress a plunger of the syringe (see paragraphs [0026], [0106], [0107], [0114], [0118], and [0135]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the step of advancing fluid through the delivery device includes actuating the actuator on the handle of the delivery device sends a signal to a motorized housing having a syringe containing the fluid, the signal causing the motorized housing to depress a plunger of the syringe, since 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 (actuator sends a signal to a motorized housing having a syringe containing the fluid, the signal causing the motorized housing to depress a plunger of the syringe) with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention, i.e., one skilled in the art would have recognized that having an actuator that connects to a motorized housing with the syringe would enable the device to effectively depress the syringe and deliver fluid to the balloon for inflation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20160287260 A1: This reference discloses a balloon inflation device with sensors and inflation monitoring.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774