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.
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(s) 1-7, 10, and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pageard et al., (US 20110144637; hereinafter Pageard).
Regarding claim 1, Pageard (Figures 2-4b) discloses a cryogenic balloon catheter system (100), comprising: a balloon catheter (110) including a shaft (element 115 starting at the distal end of handle 111 and ending at the connection with the proximal end of balloon 130), ([0036]), an expandable balloon (130) attached to a distal portion of the shaft (element 115 starting at the distal end of handle 111 and ending at the connection with the proximal end of balloon 130), ([0038]-[0039]), and a pressure sensor (120a) coupled to the balloon catheter (110) at a location distal to the expandable balloon (130), ([0043]); a pump (60) coupled to and configured to inflate the expandable balloon (130) with a fluid ([0037]); a graphical display (171) configured to display a complication of data relating to the balloon catheter (110), ([0049]); and a control system (output module 170 + control unit of console 60) adapted to (a) selectively inflate the expandable balloon (130) and (b) detect and display on the graphical display (171) a pressure waveform sensed by the pressure sensor (120a), ([0037]-[0038], [0049]).
Regarding claim 2, Pageard (Figures 2-4b) further discloses a fluid source (fluid supply/exhaust) and a fluid control system (control unit) for controlling delivery of the fluid to an interior of the expandable balloon (130), ([0037]).
Regarding claim 3, Pageard (Figures 2-4b) further discloses a handle assembly (111) attached to the shaft (element 115 starting at the distal end of handle 111 and ending at the connection with the proximal end of balloon 130) and operable by a user to control the balloon catheter (110) and a connection component (connector connecting handle 111 to control system output module 170 + control unit of console 60, shown in Figure 2) adapted to communicatively couple with the control system (output module 170 + control unit of console 60), ([0036]-[0037]).
Regarding claim 4, Pageard (Figures 2-4b) further discloses wherein the balloon catheter (110) further includes an injection tube (one or more lumens inside element 115 for releasing coolant into element 130) for conveying the fluid along the balloon catheter (110) to an interior of the expandable balloon (130), ([0038]).
Regarding claim 5, Pageard (Figures 2-4b) further discloses wherein the balloon catheter (110) further includes a guide component (116) coupled to a distal end of the shaft (element 115 starting at the distal end of handle 111 and ending at the connection with the proximal end of balloon 130) and extending through an interior of the expandable balloon (130) and distal to the expandable balloon (130), ([0036]-[0039]).
Regarding claim 6, Pageard (Figures 2-4b) further discloses wherein the pressure sensor (120a) is coupled to (integrated into) the guide component (116), ([0043]).
Regarding claim 7, Pageard (Figures 2-4b) further discloses wherein the pressure sensor (120a) is integrated into (coupled to) the guide component (116), ([0043]).
Regarding claim 10, Pageard (Figures 2-4b) further discloses wherein the control system (output module 170 + control unit of console 60) is configured to further display a plurality of operating parameters (numerical representations of the pressure) associated with the cryogenic balloon catheter system (100), ([0056]).
Regarding claim 12, Pageard (Figures 2-4b) further discloses wherein the control system (output module 170 + control unit of console 60) is configured to monitor the pressure waveform during an inflation procedure and determine whether an occlusion has occurred based on a change in the pressure waveform ([0071]-[0075]).
Regarding claim 13, Pageard (Figures 2-4b) further discloses wherein the pressure waveform is based on a pulmonary vein pressure ([0040], [0071]).
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 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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pageard as applied to claim 1 above, and further in view of Carignan et al., (US 11007001; hereinafter Carignan).
Regarding claim 8, Pageard discloses the cryogenic balloon catheter system of claim 1, but fails to disclose wherein the pressure sensor is coupled to a distal portion of the expandable balloon. However, Carignan teaches a cryogenic balloon catheter system (Col. 31, lines 26-29), wherein a pressure sensor is coupled to a distal portion of an expandable balloon (Col. 19, lines 4-8). It would have been an obvious matter of design choice to modify Pageard to include the pressure sensor coupled to a distal portion of the expandable balloon since applicant has not disclosed that having the pressure sensor coupled to a distal portion of the expandable balloon solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the pressure sensor being coupled to a distal portion of the expandable balloon, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pageard as applied to claim 2 above, and further in view of Ingle et al., (US 20110190751; hereinafter Ingle).
Regarding claim 9, Pageard discloses the cryogenic balloon catheter system of claim 2, but fails to disclose wherein the expandable balloon includes an inner balloon disposed inside an outer balloon and further wherein the inner balloon is adapted to receive the fluid. However, Ingle (Figure 1) teaches a cryogenic balloon catheter system (101) wherein the expandable balloon (102) includes an inner balloon (104) disposed inside an outer balloon (106) and further wherein the inner balloon (104) is adapted to receive the fluid ([0030]-[0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pageard to include a nested balloon configuration with the inner balloon adapted to receive the fluid, as taught by Ingle, because the modification would enable cryotherapy to be applied to a target tissue region while insulating and protecting surrounding non-target tissues (Ingle; [0006], [0045]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pageard as applied to claim 1 above, and further in view of Shen et al., (US 20230097773; hereinafter Shen).
Regarding claim 11, Pageard further discloses wherein the control system (output module 170 + control unit of console 60) is configured to display the pressure waveform during an inflation procedure ([0049], [0071]-[0075]), but fails to disclose upon initiation of an ablation procedure, to replace the pressure waveform with a temperature display. However, Shen teaches a cryogenic balloon catheter system (1-3) in which a control system (2) is configured to display (on display 3) the pressure waveform during an inflation procedure ([0078]), and upon initiation of an ablation procedure, to replace the pressure waveform with a temperature display ([0079]-[0080]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pageard to include the control system configured to, upon initiation of an ablation procedure, replace the pressure waveform with a temperature display, as taught by Shen, because the modification would provide a display specific to each operation (inflation/ablation) performed at the moment in order to aid with that specific operation only.
Claim(s) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pageard in view of Shen.
Regarding claim 14, Pageard (Figures 2-4b) discloses a method of performing a cryoablation procedure on a heart of a patient, the method comprising: advancing a balloon catheter (110) to a target location adjacent the heart, the balloon catheter (110) including a shaft (element 115 starting at the distal end of handle 111 and ending at the connection with the proximal end of balloon 130) ([0036], [0071]), an expandable balloon (130) attached to a distal portion of the shaft (element 115 starting at the distal end of handle 111 and ending at the connection with the proximal end of balloon 130), ([0038]-[0039]), and a pressure sensor (120a) coupled to the balloon catheter (110) at a location distal to the expandable balloon (130), ([0043]); initiating an inflation procedure including delivering a cryogenic fluid to an interior of the expandable balloon (130) and generating a pressure waveform sensed by the pressure sensor (120a) during the inflation procedure; generating a display including a panel (171) showing at least a portion of the pressure waveform during the inflation procedure ([0071]-[0075]).
Pageard fails to disclose upon completion of the inflation procedure, replacing the panel showing the pressure waveform with a temperature panel. However, Shen teaches a cryogenic balloon catheter method (1-3) in which a control system (2) is configured to display (on display 3) the pressure waveform during an inflation procedure ([0078]), and upon completion of the inflation procedure, replacing the panel showing the pressure waveform with a temperature panel ([0079]-[0080]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pageard to include, upon completion of the inflation procedure, replacing the panel showing the pressure waveform with a temperature panel, as taught by Shen, because the modification would provide a display specific to each operation (inflation/ablation) performed at the moment in order to aid with that specific operation only.
Regarding claim 15, Pageard (Figures 2-4b) further discloses determining an occlusion based on a change in the pressure waveform ([0071]-[0075]).
Regarding claim 16, Pageard (Figures 2-4b) further discloses wherein the pressure waveform is based on the pulmonary vein pressure and the occlusion is based on the pulmonary vein ([0040], [0071]).
Regarding claim 17, Pageard (Figures 2-4b) further discloses, following completion of the inflation procedure, initiating an ablation procedure ([0073]).
Regarding claim 18, Pageard (Figures 2-4b) further discloses wherein the delivering step includes using a fluid source (fluid supply/exhaust) and a fluid control system (control unit) for controlling delivery of the fluid to an interior of the expandable balloon (130), ([0037]).
Regarding claim 19, Pageard (Figures 2-4b) further discloses wherein the balloon catheter (110) further includes a guide component (116) coupled to a distal end of the shaft (element 115 starting at the distal end of handle 111 and ending at the connection with the proximal end of balloon 130) and extending through an interior of the expandable balloon (130) and distal to the expandable balloon (130), ([0036]-[0039]).
Regarding claim 20, Pageard (Figures 2-4b) further discloses wherein the pressure sensor (120a) is disposed within the pulmonary vein ([0040], [0071]).
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794