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.
Response to Amendment
The amendment filed 04/26/2026 has been entered. Claims 1, 3-5, and 8-10 remain pending in the application. Claims 11-21 have been cancelled. New claims 22-25 have been added.
Response to Arguments
Applicant's arguments filed 04/26/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Kassab does not consist of delivering a heart valve, the Examiner respectfully disagrees. Kassab discloses a delivery balloon catheter for use of delivery of a stent to a vessel of a patient (see Figure 7A, see also paragraphs [0134], [0144], and [0151], see also paragraph [0152]). Furthermore, Applicant’s argument that Duchon does not disclose the reference curve being a function of pressure and area, the Examiner has applied additional clarity with respect to how the prior art reads on the reference, as Duchon discloses that the “reference curve” could be pressure as a function of volume. Furthermore, Murphy is then brought in to teach that the area of the balloon is estimated based on a volume of fluid advanced through the delivery device (see column 5, lines 47-53) and that 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 and the reference data (baseline dataset) to calculate the cross-sectional area of the balloon at each value, further allowing the curves 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). In response to applicant's arguments against the references individually (only criticizing Duchon with respect to the reference curve being a function of pressure and area), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the argument that the motivation previously applied for the device of Kassab to include a reference curve of pressure as function of balloon volume, being that the modification 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]), the Examiner has further clarified the previous rejection and added that the modification would also enable the system to have the information to determine the effectiveness of the balloon catheter and may also be used to trigger certain actions by the computer; said actions including a shut down or aspiration if the data seems to indicate that there is a safety issue, such as a balloon rupture (see paragraph [0021]). Similarly, the argument that Kassab and Duchon’s mechanisms are used for different reasons, Duchon’s being to understand when the balloon is pressing against plaque and Kassab’s to be to size the valve annulus, Kassab relates to a device capable of delivering an implant to a heart, and Duchon is only brought into the rejection to teach the limitation of using a balloon catheter in tangent with a display device that has a display of 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, an option for the baseline curve being pressure as a function of volume. Therefore, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding Applicant’s argument that the only use of pressure measurements disclosed within Kassab relating to native heart valves or prosthetic heart valves is for measuring the size of the native heart valve or the size of the prosthetic heart valve and that, therefore, there would be no motivation to modify the methods of Kassab to monitor the actual pressure curve as a function of area compared to any baseline pressure curve, the Examiner respectfully disagrees. The claim language is “monitoring a pressure within the delivery device,” and “displaying the monitored pressure on a display device in real time during monitoring the pressure” which the Kassab reference reads on (see paragraphs [0092], [0093], [0115], and [0148]). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the pressure readings not being to size the vessel the valve is being delivered in, or the pressure readings not being used to understand when the balloon is pressing against plaque) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Duchon is solely bring brought in to teach the presence of a reference curve on the display of pressure with respect to volume, as well as the other components of the computer of Duchon that enables the device to control the inflation of the balloon based on reference data, desired deviation data (set data point ranges), and actual deviation data for safety of the patient’s vessel.
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 1, 3-5, 8, and 22-25 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--), in even further view of US 20020143294 A1 (hereafter –Duchon--).
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], see also paragraph [0148]); and simultaneously displaying the monitored pressure on a display device in real time during monitoring the pressure (see paragraph [0115]).
Kassab as modified fails to disclose further comprising displaying a reference pressure curve on the display device, wherein the reference pressure curve is displayed as a function of area of the balloon and 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 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, an option for the baseline curve being pressure as a function of volume (see paragraphs [0066], [0073], [0021], [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 volume, 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]), as well as would enable the system to have the information to determine the effectiveness of the balloon catheter and may also be used to trigger certain actions by the computer; said actions including a shut down or aspiration if the data seems to indicate that there is a safety issue, such as a balloon rupture (see paragraph [0021]).
Kassab as modified 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, wherein the reference pressure curve is displayed as a function of area of the balloon and 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.
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]; Fig. 14).
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 balloon pressure drops or increases, 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 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, wherein the reference pressure curve is displayed as a function of area of the balloon and 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, 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), and Kassab as modified by Duchon discloses a reference curve of pressure as a function of volume (see paragraph [0022] of Duchon).
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 and the reference data (baseline dataset) to calculate the cross-sectional area of the balloon at each value, further allowing the curves 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 1, 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 1, 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 1, 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).
Regarding Claim 8, Kassab as modified discloses the method of claim 1, further comprising monitoring an actual deviation between the procedural curve and the reference curve while advancing fluid through the delivery device to expand the prosthetic heart valve (see claim 1 rejection above, see also paragraphs [0021], [0071], and [0074] of Duchon).
Regarding Claim 22, Kassab as modified discloses the method of claim 8.
Kassab as modified fails to disclose further comprising comparing the actual deviation between the procedural curve and the reference curve to a desired deviation between the procedural curve and the reference curve.
Duchon discloses further comprising comparing the actual deviation between the procedural curve and the reference curve to a desired deviation between the procedural curve and the reference curve (see paragraph [0071] denoting that the program segment allows the device to be used in a manual mode, with safety limits set on pressure and volume, which would in turn set a range for pressure and volume that is acceptable for implantation, said range being the “desired deviation”, see also paragraph [0021] denoting the information can be used to determine the effectiveness of the balloon catheter and may also be used to trigger certain actions by the computer, meaning that anything outside of said range (being the desired deviation) would trigger intervention).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Kassab as modified to further include determining that the actual deviation is near or equal to the desired deviation and, as a result, determining that the prosthetic heart valve has been appropriately implanted, as by doing so would allow the device to set safety limits on pressure and volume (see paragraph [0071]).
Regarding Claim 23, Kassab as modified discloses the method of claim 22.
Kassab as modified fails to disclose wherein the desired deviation between the procedural curve and the reference curve is determined based on data from a plurality of implantations of prosthetic heart valves.
Duchon teaches wherein the desired deviation between the procedural curve and the reference curve is determined based on data from a plurality of procedures (see paragraph [0022] denoting that the computer can also be used to record the balloon pressure during implantations as a function of time or volume, baseline pressure as a function of time or volume, injection rate as a function of time, and any other data that the computer may be programmed to use or record so that each procedure, or case, can be recorded as a computer file and used later for analysis or as a record to be inserted into the patient's file, see also paragraph [0071] denoting that a program segment may be provided that allows a physician to inflate the balloon manually, while "recording" flow rates, volumes and pressures used, so that the computer 106 may "learn" how the physician inflated the balloon. The physician may then instruct the computer 106 to repeat the inflation techniques he or she just performed. There are many instances where multiple inflations must be performed and this feature allows the physician to replicate a desired inflation automatically).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Kassab as modified to further include wherein the desired deviation between the procedural curve and the reference curve is determined based on data from a plurality of implantations of prosthetic heart valves, as by doing so would enable the device of Kassab, which delivers stent valves, to have a that is able computer to learn how the physician inflated the balloon (see paragraph [0071]), as well as would enable the system to be programmed to use or record so that each procedure, or case, can be recorded as a computer file and used later for analysis or as a record to be inserted into the patient's file (see paragraph [0022]).
Regarding Claim 24, Kassab as modified discloses the method of claim 22.
Kassab as modified fails to disclose further comprising: determining that the actual deviation is near or equal to the desired deviation and, as a result, determining that the prosthetic heart valve has been appropriately implanted.
Duchon teaches further comprising: determining that the actual deviation is near or equal to the desired deviation and, as a result, determining that the prosthetic heart valve has been appropriately implanted (see paragraph [0071] denoting that the program segment allows the device to be used in a manual mode, with safety limits set on pressure and volume, which would in turn set a range for pressure and volume that is acceptable for implantation being the “desired deviation,” and determining whether or not intervention needs to occur, as denoted in paragraph [0022] would be the system comparing the desired deviation and the actual deviation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Kassab as modified to further include determining that the actual deviation is near or equal to the desired deviation and, as a result, determining that the prosthetic heart valve has been appropriately implanted, as by doing so would enable the device of Kassab, which would be delivering a stent valve, to follow a pressure versus time algorithm previously inputted into the computer, control the balloon volume, regardless of, or in addition to, balloon pressure, all whilst using the available data to determine if there is a safety issue during the balloon inflation as taught by Duchon (see paragraph [0021]).
Regarding Claim 25, Kassab as modified discloses the method of claim 22.
Kassab as modified fails to disclose further comprising: determining that the actual deviation is greater than the desired deviation and, as a result, slowing or pausing inflation of the balloon.
Duchon teaches further comprising: determining that the actual deviation is greater than the desired deviation and, as a result, slowing or pausing inflation of the balloon (see paragraph [0021] denoting the information can be used to determine the effectiveness of the balloon catheter and may also be used to trigger certain actions by the computer. Such actions might include a shut down or aspiration if the data seems to indicate that there is a safety issue, such as a balloon rupture. Another action might be to hold the balloon pressure at a predetermined level for a period of time after a pop has been detected).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Kassab as modified to further include determining that the actual deviation is greater than the desired deviation and, as a result, slowing or pausing inflation of the balloon, as by doing so would enable the system to interfere if the data seems to indicate that there is a safety issue, as taught by Duchon (see paragraph [0021]).
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 1 above, in even further view of US 20020143294 A1 (hereafter –Duchon--), and in even further view of US 20220105319 A1 (hereafter --Salerno--).
Regarding Claim 9, Kassab as modified discloses the method of claim 21, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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