DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3 December 2025 has been entered in light of the RCE filed 17 December 2025.
Notice of 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 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 Arguments
In the response filed 3 December 2025, Applicant argues Valdez’279, Primeaux’410 and Alvarez’167 do not the shunting element shaft has a curved and straight portion extending out of the catheter shaft in the second state such that the expandable element is supported by the straight portion. As discussed in the interview conducted on 18 November 2025, Examiner agrees. However, upon further search and consideration, a new reference, Heuser’665 is relied upon to teach this feature. See the updated rejection below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-9, 14-17, 19-23, 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Valdez et al (US Patent Publication 2022/0273279) in view of Primeaux (US Patent Publication 2023/0099410) in view of Heuser et al. (US Patent 6,464,665) in view of Alvarez et al. (US Patent Publication 2013/0006167).
Claim 1, 2, 14: Valdez’279 teaches a shunting catheter (100), comprising:
a catheter shaft (202) having a distal end (210) and a proximal end (end opposite from 210, shown in Figure 7), the catheter shaft including a shaft lumen (paragraph [0076]);
a shunting element (300) disposed in the shaft lumen at a first state (paragraph [0076] discloses 300 is slidably disposed within catheter 200) and extended from the catheter shaft at a second state (Figure 3);
a shunting element shaft (302) configured to support the shunting element, the shunting element shaft (302) disposed within the shaft lumen at the first state (paragraph [0076]) and extended from the catheter shaft at the second state (Figure 3), the shunting element shaft being configured to form an angle with respect to the catheter shaft at the second state (Figure 3).
a puncture element (408) disposed proximate to a distal end (310) of the shunting element shaft (302);
wherein the catheter shaft defines a first axis (longitudinal axis of 200), the shunting element defines a second axis at the second state (longitudinal axis of 300 when it is extending from catheter 200, as shown in Figure 3), and the second axis and the first axis form an angle (Figure 3).
Valdez’279 teaches the shunting element can be configured to provide dilation of the opening provided by the puncture element (see shunt opening formed in Figures 14-16; paragraph [0088]) but does not teach the shunting element includes an expandable element.
Like Valdez’279, Primeaux’410 teaches a catheter shaft (140), a shunting element (108) including a shunting element shaft (152) disposed in the catheter shaft lumen and having a puncturing element (154) at the distal end.
Primeaux’410 further teaches providing the shunting element (108) with an expandable member (110) near its distal end to provide dilation of a puncture opening for a shunt (162 in Figures 6d, 6e) (paragraph [0062]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the shunting element shaft taught by Valdez’279 with an expandable member near its distal end, as taught by Primeaux’410, in order to provide further dilation of the opening in order to create an opening of a desired size.
Valdez’279 in view of Primeaux’410 does not teach the shunting element has a curved portion and straight portion extending out of the catheter shaft. For example, Figure 15 of Valdez’279 only shows the shunting element only has a curved portion extending from the shaft. The curved portion used to dilate the opening does extend a distance from the catheter shaft (see Figure 15).
However, like Valdez’279, Heuser’665 teaches a device (Figures 4, 5) including a catheter shaft (46), a shunting element having an expandable member (92), a shunting element shaft (84) and a puncturing element (column 6, lines 32-33) for creating a connection between two vessels. The shunting element shaft (84) has a first state disposed within the catheter lumen (Figure 4) and a second state in which the shunting element shaft (84) is extended from the catheter shaft at an angle with respect to the catheter shaft (Figure 5).
In the second state, Heuser’665’s shunting element shaft (84) has a curved portion (adjacent to the catheter opening in Figure 5) and a straight portion (more distal to the curved portion, i.e. portion of shaft 84 inside balloon 92). The expandable element (92) is supported by the straight portion of the shunting element shaft (Figure 5). The expandable element is a distance from the catheter shaft (Figure 5).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention in the art to modify the device taught by Valdez’279 such that the shunting element shaft has a curved portion and a straight portion, as taught by Heuser’665, to create a linear passage between the two vessels. The linear passage means the punctures in the two vessels creating the passage will be at a predictable location since they will be aligned with the distal tip of the shunting element (i.e. the puncture element) instead of being offset, as with a curved shunting element shaft. The linear connection further reduces the amount of stress on tissue because a linear shunt (e.g. 350 in Valdez or 100 in Heuser) is placed in the tissue.
Valdez’279 discloses the claimed invention except that the shunting element shaft forms an angle of greater than 20 degrees relative to the catheter shaft (claim 1) or between 60 and 120 degrees (claim 2).
Instead, Valdez’279 sets forth that angle between the shunting element shaft and the catheter shaft is a result effective variable, wherein the angle can be modified to facilitate accessing and proper positioning relative to the target tissue site while the device is positioned in the vessel, channel, chamber and/or organ (paragraph [0096]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the angle between the shunting element shaft and the catheter, for the purpose of accessing a particular target tissue site, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Valdez’279 does not teach the shunting element comprises a pull wire assembly functionally coupled to the shunting element.
Like Valdez’279, Alvarez’167 teaches a catheter shaft (100) having a side opening (110) through which a shunting element shaft (112; paragraph [0059]) passes. The shunting element shaft (112) element is in the catheter shaft lumen in a first state (Figure 1) and extended from the catheter in a second state (Figure 6b, for example). The shunting element shaft (112) can have a pre-curved shape (paragraph [0040]) such that it extends at an angle from the catheter shaft.
Alvarez’167 teaches the shunting element (112) element can include a pull wire assembly (130; Figure 4a, 4b) functionally coupled to the distal end portion of shunting element (paragraphs [0063], [0065]). The pull wire assembly (130) is configured to adjust the angle of the shunting element shaft (112) relative to the catheter shaft (100) (i.e., the angle between the first axis of the catheter shaft and the second axis of the shunting element) when the shunting element is extended from the catheter shaft at the second state (Figure 4a, 4b; paragraph [0062]- [0066]). Alvarez’167 teaches the angle can range from between 0 and 180 degrees relative to the longitudinal axis of the catheter (paragraph [0065] teaches the shunting element 112 can bend from an orientation parallel to the vessel wall to 180 degrees relative to the vessel wall. Paragraph [0065] teaches the shunting element 112 extends parallel with the vessel wall; when the shunting element is inside the catheter, the shunting element is parallel with the catheter; therefore, Alvarezn’167 teaches the shunting element 112 can bend from 0 to 180 degrees relative to the catheter).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the shunting element (which carries the puncture element) of Valdez’279, with a pull wire, as taught by Alvazrez’167 to aid in controlling the shunting element shaft (paragraph [0041]).
In the resulting device of Valdez’279 in view of Primeaux’410 in view of Heuser’665 in view of Alvazrez’167:
Valdez’279’s shunting catheter (302) has a balloon on its outer surface near the distal end (as rendered obvious by Primeaux’410) and the shunting catheter (302) includes a pull wire extending through its inner lumen to the distal end portion (as rendered obvious by Alvazrez’167). In this resulting device, the pull wire assembly is partially disposed in the expandable element, as required by claim 1. Further, the pull wire assembly is configured to adjust the angle between the first axis of the catheter shaft and the second axis of the shunting element after the shunting element is extended from the catheter shaft (Valdez’279 shows a space/void between the shunting catheter and puncture element after it extends outside of the catheter shaft because the side opening of the shaft is not in contact with the vessel wall – see Figures 12, 13 and paragraph [0206]. Valdez’279 further teaches the apposition element 250 is optional – see paragraph [0117] and the puncture element can be advanced from the shunting element shaft 300 after the shunting element 300 is at a desired location – see paragraph [0086]; Alvarez’167 teaches the pull wire can change the angle of the shunting element by 0 to 180 degrees relative to the catheter).
Claim 3: Primeaux’410 teaches the expandable element (110) is expanded at the second state (Figures 6d, 6e).
Heuser’665 teaches the expandable element is expanded at the second state (Figure 5).
Claim 4: Valdez’279 teaches the shunting element (302) includes a tube (it is a catheter with a lumen).
Further, Primeaux’410 teaches the shunting element (108) includes a tube (152; it is a catheter with a lumen) to support the expandable element 110.
Heuser’665 teaches the shunting element (92) includes a tube (it is attached to a catheter 84 with a lumen).
Claim 6: Valdez’279 teaches the catheter shaft (202) has a shaft opening (214), wherein the shunting element extends from the catheter shaft through the shaft opening (Figure 3).
Heuser’665 teaches the catheter shaft (46) has a shaft opening (distal opening) wherein the shunting element extends from the catheter shaft through the shaft opening (Figure 5).
Claim 7: Valdez’279 teaches the shaft opening (214) is not at the distal end of the catheter shaft (Figure 3).
Claim 8, 15: Valdez’279 teaches a portion (204) of the catheter shaft (202) between the shaft opening (214) and the distal end (210) has a curve (Figure 4; paragraph [0091]).
Claim 9: Valdez’279 teaches the shunting element includes a guidewire (paragraph [0119] discloses the shaft 404 can be a guidewire).
Claim 16: Valdez’279 teaches an opposition element (250) including a compressible structure [0079]) disposed proximal to the shunting element (Figure 3), the compressible structure of the apposition element being decompressed and protruded from the catheter shaft at the second state (paragraph [0079]).
Claim 17: Valdez’279 teaches A shunting catheter system, comprising:
a shunting catheter (100) comprising:
a catheter shaft (202) having a distal end (210) and a proximal end (end opposite from 210, shown in Figure 7), the catheter shaft including a shaft lumen (paragraph [0076]);
a shunting element (300) disposed in the shaft lumen at a first state (paragraph [0076] discloses 302 is slidably disposed within catheter 200) and extended from the catheter shaft at a second state (Figure 3);
a shunting element shaft (302) configured to support the shunting element, the shunting element shaft (302) disposed within the shaft lumen at the first state (paragraph [0076]) and extended from the catheter shaft at the second state (Figure 3), the shunting element shaft being configured to form an angle with respect to the catheter shaft at the second state (Figure 3).
a puncture element (408) disposed proximate to a distal end (310) of the shunting element (302);
wherein the catheter shaft defines a first axis (longitudinal axis of 200), the shunting element defines a second axis at the second state (longitudinal axis of 300 when it is extending from catheter 200, as shown in Figure 3), and the second axis and the first axis form an angle when the shunting element is extended from the catheter shaft in the second state (Figure 3);
Valdez’279 teaches the shunting element can be configured to provide dilation of the opening provided by the puncture element (see shunt opening formed in Figures 14-16; paragraph [0088]) but does not teach the shunting element includes an expandable element.
Like Valdez’279, Primeaux’410 teaches a shunting catheter system (100) including a catheter shaft (140), a shunting element (108) disposed in the catheter shaft lumen with a puncturing element (154) at the distal end.
Primeaux’410 further teaches providing the shunting element (108) including a shunting element shaft (152) with an expandable member (110) near its distal end to provide dilation of a puncture opening for a shunt (162 in Figures 6d, 6e) (paragraph [0062]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the shunting element shaft taught by Valdez’279 with an expandable member near its distal end, as taught by Primeaux’410, in order to provide further dilation of the opening in order to create an opening of a desired size.
Valdez’279 does not teach an energy source coupled to the shunting catheter or a controller connected to the energy source.
Like Valdez’279, Primeaux’410 teaches a shunting catheter (100) including a catheter shaft (140), a shunting element (108) including a shunting element shaft (152) disposed in the catheter shaft lumen and having a puncturing element (154) at the distal end.
Primeaux’410 further teaches connecting an energy source to the shunting element (108) (paragraph [0045] states the dilation element can be part of ablation device 102) to enhance cutting and puncturing. There is a controller connected to the energy source comprising one or more processors in order to control, monitor, supply and otherwise support operation of the energy for delivery to ablation device (paragraphs [0045], [0056]- [0058]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Valdez’279 by connecting an energy source to the shunting catheter and providing the energy source with a controller to provide an ablation tool to enhance cutting of tissue during creation of the shunt.
Valdez’279 in view of Primeaux’410 does not teach the shunting element has a curved portion and straight portion extending out of the catheter shaft. For example, Figure 15 of Valdez’279 only shows the shunting element only has a curved portion extending from the shaft. The curved portion used to dilate the opening does extend a distance from the catheter shaft (see Figure 15).
However, like Valdez’279, Heuser’665 teaches a device (Figures 4, 5) including a catheter shaft (46), a shunting element having an expandable member (92), a shunting element shaft (84) and a puncturing element (column 6, lines 32-33) for creating a connection between two vessels. The shunting element shaft (84) has a first state disposed within the catheter lumen (Figure 4) and a second state in which the shunting element shaft (84) is extended from the catheter shaft at an angle with respect to the catheter shaft (Figure 5).
In the second state, Heuser’665’s shunting element shaft (84) has a curved portion (adjacent to the catheter opening in Figure 5) and a straight portion (more distal to the curved portion, i.e. portion of shaft 84 inside balloon 92). The expandable element (92) is supported by the straight portion of the shunting element shaft (Figure 5). The expandable element is a distance from the catheter shaft (Figure 5).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention in the art to modify the device taught by Valdez’279 such that the shunting element shaft has a curved portion and a straight portion, as taught by Heuser’665, to create a linear passage between the two vessels. The linear passage means the punctures in the two vessels creating the passage will be at a predictable location since they will be aligned with the distal tip of the shunting element (i.e. the puncture element) instead of being offset, as with a curved shunting element shaft. The linear connection further reduces the amount of stress on tissue because a linear shunt (e.g. 350 in Valdez or 100 in Heuser) is placed in the tissue.
Valdez’279 discloses the claimed invention except that the shunting element shaft forms an angle of greater than 20 degrees relative to the catheter shaft.
Valdez’279 sets forth that angle between the shunting element shaft and the catheter shaft is a result effective variable, wherein the angle can be modified to facilitate accessing and proper positioning relative to the target tissue site while the device is positioned in the vessel, channel, chamber and/or organ (paragraph [0096]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the angle between the shunting element shaft and the catheter, for the purpose of accessing a particular target tissue site, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Valdez’279 does not teach the shunting element comprises a pull wire assembly functionally coupled to the shunting element.
Like Valdez’279, Alvarez’167 teaches a catheter shaft (100) having a side opening (110) through which a shunting element shaft (112; paragraph [0059]) passes. The shunting element shaft (112) is in the catheter shaft lumen in a first state (Figure 1) and extended from the catheter in a second state (Figure 6b, for example). The shunting element shaft (112) can have a pre-curved shape (paragraph [0040]) such that it extends at an angle from the catheter shaft.
Alvarez’167 teaches the shunting element (112) element can include a pull wire assembly (130; Figure 4a, 4b) functionally coupled to the distal end portion of shunting element (paragraphs [0063], [0065]). The pull wire assembly (130) is configured to adjust the angle of the shunting element shaft (112) relative to the catheter shaft (100) (i.e., the angle between the first axis of the catheter shaft and the second axis of the shunting element) when the shunting element is extended from the catheter shaft at the second state (Figure 4a, 4b; paragraph [0062]- [0066]). Alvarez’167 teaches the angle can range from between 0 and 180 degrees relative to the longitudinal axis of the catheter (paragraph [0065] teaches the shunting element 112 can bend from an orientation parallel to the vessel wall to 180 degrees relative to the vessel wall. Paragraph [0065] teaches the shunting element 112 extends parallel with the vessel wall; when the shunting element is inside the catheter, the shunting element is parallel with the catheter; therefore, Alvarez’167 teaches the shunting element 112 can bend from 0 to 180 degrees relative to the catheter).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the shunting element (which carries the puncture element) of Valdez’279, with a pull wire, as taught by Alvazrez’167 to aid in controlling the shunting element shaft (paragraph [0041]).
In the resulting device of Valdez’279 in view of Primeaux’410 in view of Heuser’665 in view of Alvazrez’167:
Valdez’279’s shunting catheter (302) has a balloon on its outer surface near the distal end (as rendered obvious by Primeaux’410) and the shunting catheter (302) includes a pull wire extending through its inner lumen to the distal end portion (as rendered obvious by Alvazrez’167). In this resulting device, the pull wire assembly is partially disposed in the expandable element, as required by claim 17. Further, the pull wire assembly is configured to adjust the angle between the first axis of the catheter shaft and the second axis of the shunting element after the shunting element is extended from the catheter shaft (Valdez’279 shows a space/void between the shunting catheter and puncture element after it extends outside of the catheter shaft because the side opening of the shaft is not in contact with the vessel wall – see Figures 12, 13 and paragraph [0206]. Valdez’279 further teaches the apposition element 250 is optional – see paragraph [0117] and the puncture element can be advanced from the shunting element shaft 300 after the shunting element 300 is at a desired location – see paragraph [0086]; Alvarez’167 teaches the pull wire can change the angle of the shunting element by 0 to 180 degrees relative to the catheter).
Claim 19: Valdez’279 teaches a method for creating a shunt (Figures 11-16), comprising:
deploying a shunting catheter (100) in a first state (Figure 12), the shunting catheter comprising:
a catheter shaft (202) having a distal end (210) and a proximal end (end opposite from 210, shown in Figure 7), the catheter shaft including a shaft lumen (paragraph [0076]);
a shunting element (300) having a proximal end (opposite end 310) and a distal end (towards 310), wherein the shunting element is disposed in the shaft lumen at the first state (Figure 12);
a shunting element shaft (302) configured to support the shunting element, the shunting element shaft (302) disposed within the shaft lumen at the first state (paragraph [0076]) and extended from the catheter shaft at the second state (Figure 3), the shunting element shaft being configured to form an angle with respect to the catheter shaft at the second state (Figure 3);
a puncture element (408) disposed proximate to a distal end (310) of the shunting element (302);
disposing the shunting catheter approximate to a target location of a patient (Figure 12); operating the shunting catheter to a second state (Figure 13-15), wherein the shunting element extends from the catheter shaft at an angle greater than zero degree at the proximal end of the shunting element at the second state (Figures 13-15),
puncturing, using the puncture element, an opening at the target location (Figure 14); and
expanding the opening using the shunting element (Figure 15).
Valdez’279 teaches the shunting element can be configured to provide dilation of the opening provided by the puncture element (see shunt opening formed in Figures 14-16; paragraph [0088]) but does not teach the shunting element includes an expandable element.
Like Valdez’279, Primeaux’410 teaches a shunting catheter (100) including a catheter shaft (140), a shunting element (108) disposed in the catheter shaft lumen and having a puncturing element (154) at the distal end.
Primeaux’410 further teaches providing the shunting element (108) including a shunting element shaft (152) with an expandable member (110) near its distal end in order to provide dilation of a puncture opening for a shunt (162 in Figures 6d, 6e) (paragraph [0062]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the shunting element taught by Valdez’279 with an expandable member near its distal end, as taught by Primeaux’410, to provide further dilation of the opening to create an opening of a desired size.
Valdez’279 in view of Primeaux’410 does not teach the shunting element has a curved portion and straight portion extending out of the catheter shaft in the second state. For example, Figure 15 of Valdez’279 only shows the shunting element only has a curved portion extending from the shaft. The curved portion used to dilate the opening does extend a distance from the catheter shaft (see Figure 15).
However, like Valdez’279, Heuser’665 teaches a device (Figures 4, 5) including a catheter shaft (46), a shunting element having an expandable member (92), a shunting element shaft (84) and a puncturing element (column 6, lines 32-33) for creating a connection between two vessels. The shunting element shaft (84) has a first state disposed within the catheter lumen (Figure 4) and a second state in which the shunting element shaft (84) is extended from the catheter shaft at an angle with respect to the catheter shaft (Figure 5).
In the second state, Heuser’665’s shunting element shaft (84) has a curved portion (adjacent to the catheter opening in Figure 5) and a straight portion (more distal to the curved portion, i.e. portion of shaft 84 inside balloon 92). The expandable element (92) is supported by the straight portion of the shunting element shaft (Figure 5). The expandable element is a distance from the catheter shaft (Figure 5).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention in the art to modify the device taught by Valdez’279 such that the shunting element shaft has a curved portion and a straight portion, as taught by Heuser’665, to create a linear passage between the two vessels. The linear passage means the punctures in the two vessels creating the passage will be at a predictable location since they will be aligned with the distal tip of the shunting element (i.e. the puncture element) instead of being offset, as with a curved shunting element shaft. The linear connection further reduces the amount of stress on tissue because a linear shunt (e.g. 350 in Valdez or 100 in Heuser) is placed in the tissue.
Valdez’279 does not teach the shunting element shaft forms an angle of greater than 20 degrees relative to the catheter.
Valdez’279 discloses the claimed invention except that the shunting element shaft forms an angle of greater than 20 degrees relative to the catheter shaft. Valdez’279 sets forth that angle between the shunting element shaft and the catheter shaft is a result effective variable, wherein the angle can be modified to facilitate accessing and proper positioning relative to the target tissue site while the device is positioned in the vessel, channel, chamber and/or organ (paragraph [0096]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the angle between the shunting element shaft and the catheter, for the purpose of accessing a particular target tissue site, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Valdez’279 does not teach the shunting element comprises a pull wire assembly functionally coupled to the shunting element.
Like Valdez’279, Alvarez’167 teaches a catheter shaft (100) having a side opening (110) through which a shunting element shaft (112; paragraph [0059]) passes. The shunting element shaft (112) is in the catheter shaft lumen in a first state (Figure 1) and extended from the catheter in a second state (Figure 6b, for example). The shunting element shaft (112) can have a pre-curved shape (paragraph [0040]) such that it extends at an angle from the catheter shaft.
Alvarez’167 teaches the shunting element (112) element can include a pull wire assembly (130; Figure 4a, 4b) functionally coupled to the distal end portion of shunting element (paragraphs [0063], [0065]). The pull wire assembly (130) is configured to adjust the angle of the shunting element shaft (112) relative to the catheter shaft (100) (i.e., the angle between the first axis of the catheter shaft and the second axis of the shunting element) when the shunting element is extended from the catheter shaft at the second state (Figure 4a, 4b; paragraph [0062]- [0066]). Alvarez’167 teaches the angle can range from between 0 and 180 degrees relative to the longitudinal axis of the catheter (paragraph [0065] teaches the shunting element 112 can bend from an orientation parallel to the vessel wall to 180 degrees relative to the vessel wall. Paragraph [0065] teaches the shunting element 112 extends parallel with the vessel wall; when the shunting element is inside the catheter, the shunting element is parallel with the catheter; therefore, Alvarez’167 teaches the shunting element 112 can bend from 0 to 180 degrees relative to the catheter).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the shunting element (which carries the puncture element) of Valdez’279, with a pull wire extending to the distal end portion, as taught by Alvazrez’167 in order to aid in controlling the shunting element shaft (paragraph [0041]).
In the resulting device of Valdez’279 in view of Primeaux’410 in view of Heuser’665 in view of Alvazrez’167:
Valdez’279’s shunting catheter (302) has a balloon on its outer surface near the distal end (as rendered obvious by Primeaux’410) and the shunting catheter (302) includes a pull wire extending through its inner lumen to the distal end portion (as rendered obvious by Alvazrez’167). In this resulting device, the pull wire assembly is partially disposed in the expandable element, as required by claim 17. Further, the pull wire assembly is configured to adjust the angle between the first axis of the catheter shaft and the second axis of the shunting element after the shunting element is extended from the catheter shaft (Valdez’279 shows a space/void between the shunting catheter and puncture element after it extends outside of the catheter shaft because the side opening of the shaft is not in contact with the vessel wall – see Figures 12, 13 and paragraph [0206]. Valdez’279 further teaches the apposition element 250 is optional – see paragraph [0117] and the puncture element can be advanced from the shunting element shaft 300 after the shunting element 300 is at a desired location – see paragraph [0086]; Alvarez’167 teaches the pull wire can change the angle of the shunting element by 0 to 180 degrees relative to the catheter).
Claim 20: Valdez’279 teaches an apposition element (250) including a compressible structure [0079]) disposed proximal to the shunting element (Figure 3), the compressible structure of the apposition element being decompressed and protruded from the catheter shaft at the second state (paragraph [0079]; Figure 13).
Claim 21: Valdez’279 teaches the catheter shaft (202) has a shaft opening (214), wherein the shunting element extends from the catheter shaft through the shaft opening (Figure 3).
Heuser’665 teaches the catheter shaft (46) has a shaft opening (distal opening) wherein the shunting element extends from the catheter shaft through the shaft opening (Figure 5).
Claim 22, 23: Valdez’279 teaches providing the distal portion of the catheter (which is carrying the shunting element 302 – see Figure 3) with a visualization element (“radiopaque marker”) to facilitate visualization of the catheter at the target location within the vessel (paragraph [0077]; radiopaque markers are well known to be viewable inside the body using imaging devices).
Claim 25: Valdez’279 teaches treating tissue surrounding the opening using the shunting element (Figures 15-16 teach a step of delivering an implant 350 using the shunting element to maintain the newly created opening).
Primeaux’410 further teaches using the expandable member (110) on the shunting element shaft (152) to provide dilation of a puncture opening for a shunt (162 in Figures 6d, 6e) (paragraph [0062]).
Claim 26: Valdez’279 teaches the target location is at a coronary sinus of the patient (paragraphs [0092], [0110]).
Claim 27: Valdez’279 teaches inserting the catheter into the right atrium via the inferior or superior vena cava (paragraph [0069]). From the right atrium, the catheter is advanced into the coronary sinus to create an opening between the coronary sinus and the left atrium (Figure 12-16).
Claim 28: Valdez’279 teaches removing the shunting catheter from the patient (Figure 16; paragraph [0121]).
Claim 29: Valdez’279 teaches generating the shunt using the shunting element (Figure 15; paragraph [0120]);
Wherein the shunt includes an expanded opening between the coronary sinus (18) and a left atrium (2) of a patient (Figure 15, 16).
Primeaux’410 further teaches using the expandable member (110) on the shunting element shaft (152) in order to provide dilation of a puncture opening for a shunt (162 in Figures 6d, 6e) (paragraph [0062]).
Claim 30: Valdez’279 teaches the shunt includes an implant.
However, Primeaux’491 teaches a method of creating a shunt between the coronary sinus and the left atrium without an implant because this avoids the permanent implantation of a foreign object and leads to better patient outcomes (paragraph [0044]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Valdez’279, by creating the opening in the coronary sinus without deploying an implant, as taught by Primeaux’491, in order to avoid the permanent implantation of a foreign object and lead to better patient outcomes (paragraph [0044]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Valdez’279 in view of Primeaux’491 in view of Heuser’665 in view of Alvarez’167, as applied to claim 4, further in view of Rosenman et al. (US Patent Publication 2006/0135961).
Valdez’279, as modified, teaches the limitations of claim 5 except that the tube has a plurality of cuts that are perpendicular to the second axis.
Like Valdez’279, Rosenman’961 teaches a tube (2) with a bend at the distal end
(Figure 2). Rosenman’961 teaches the tube (2) can have a plurality of cuts generally perpendicular to the longitudinal axis of the tube in order to control the shape of the bend (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the tubular element taught by Valdez’279 with a plurality of cuts, as taught by Rosenman’961, in order to control the shape of the bend (paragraph [0036]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Valdez’279 in view of Primeaux’491 in view of Heuser’665 in view of Alvarez’167, as applied to claim 1, further in view of Hall et al. (WO 2022/246158).
Valdez’279, as modified, teaches the limitations of claim 11 including an apposition element (250) having a compressible structure (paragraph [0079]) on the catheter shaft (202), but fails to disclose an outer shaft disposed outside a part of the catheter shaft.
Like Valdez’279, Hall’158 teaches a device for creating an opening between the coronary sinus and the left atrium (paragraph [0025]). Hall’158 teaches a device including a catheter (22) which carries a shunting element (34) and directing it to a target location (Figure 4c). Hall’158 teaches passing the catheter through an outer shaft (“introducer sheath”, paragraph [0029]) in order to aid in preventing blood loss (paragraph [0029]). Further, the use of an introducer sheath to insert a catheter into the vasculature is well known in the art.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to provide Valdez’279 with an introducer sheath (which is an “outer shaft disposed outside of at least a part of the catheter shaft”), as taught by Hall’158, in order to aid in preventing blood loss during the procedure and to aid in inserting the catheter into the vasculature.
In the resulting device of Valdez’279 in view of Hall’158, the apposition element on the outside of Valdez’279 catheter 202 will be disposed in the introducer sheath because the catheter carries the apposition element and passes through the introducer sheath to enter the vasculature.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Valdez’279 in view of Primeaux’491 in view of Heuser’665 in view of Alvarez’167 in view of Hall’158, as applied to claim 11, further in view of Zheng et al. (WO 2020/242491) as evidenced by Porter et al. (US Patent Publication 2012/0123466).
Claim 12, 13: Valdez’279, as modified, teaches the limitations of claim 12 except that the apposition element is a nickel titanium braided element.
Zhang’491 teaches a catheter (700) having a shaft (702) with an apposition element (712) that protrudes from the side of the catheter in the form of a nickel titanium wire cage (Figure 9; paragraph [0152]).
Zhang’491 does not explicitly the wire cage is braided, but this is a well-known method of forming a cage in medical devices. For example, Porter’466 teaches an expandable cage (100) formed of nitinol wire that is braided (paragraph [0076]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute the inflatable apposition element taught by Valdez’279 with a braided nitinol cage, as taught by Zhang’491, because both mechanisms would perform the same function of pressing the catheter into the vessel wall and substituting one mechanism for the other would have predictable results since both mechanisms perform the same function. For example, the nickel titanium cage could be preferred by a physician because it automatically self-expands without needing the physician to perform another step.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Valdez’279 in view of Primeaux’491 in view of Heuser’665 in view of Alvarez’167, as applied to claim 17, further in view of Matsubara et al. (US Patent Publication 2015/0209526).
Claim 18: Valdez’279 providing the distal end of the catheter shaft (202) which is proximate the shunting element 302 -see Figure 3) with a visualization element (“radiopaque markers”, paragraph [0077]) to allow the catheter to be viewed via imaging to ensure proper positioning of the device relative to the target (paragraph [0077]).
Valdez’279 does not teach a display for visualizing the location.
The use of an imaging device in combination with a display is well known in the art. For example, similar to Valdez’279, Matsubara’526 teaches a catheter for forming an opening between two vessels (10; paragraph [0034]). Matsubara’526 teaches a catheter (12), a shunting element (18; paragraph [0041], [0042]) which passes through a side opening (16) in the catheter.
Matsubara’526 further teaches providing the system with a radiopaque marker (paragraph [0055]) and an imaging device within the catheter (paragraph [0055]) which is connected to a display (30) for showing the radiopaque marker to aid the surgeon in properly positioning the catheter prior to creating the opening between the vessels (paragraph [0055]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Valdez’279 with an imaging device for capturing images and a display for viewing those images, as taught by Matsubara’526 in order to aid the surgeon in properly positioning the device prior to creating an opening between vessels.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Wednesday 9am-5pm and alternating Thursdays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Lindsey Bachman
/L.B./Examiner, Art Unit 3771 16 September 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights