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 .
Response to Amendment
The amendment filed April 1st, 2026 has been entered. Claims 1, 4, 9, 11, & 20 are amended. Claims 5, 12, & 14 are canceled. Claims 1-4, 6-11, 13, & 15-23 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6-11, 13, & 15-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 & 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “a gap of at least one millimeter”; independent claim 1 introduces “a gap”; it is unclear if the gap, of claim 3, is the same or different than the gap, as introduced in claim 1, which renders the claim indefinite. For examination purposes the examiner is considering them to be the same and “a gap of at least one millimeter” to be – the gap of at least one millimeter—.
Claim 23 recites the limitation “a gap of at least one millimeter”; independent claim 20 introduces “a gap”; it is unclear if the gap, of claim 23, is the same or different than the gap, as introduced in claim 20, which renders the claim indefinite. For examination purposes the examiner is considering them to be the same and “a gap of at least one millimeter” to be – the gap of at least one millimeter—.
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.
Claim 1-4, 9-11, & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan et al. (US 20190231421 A1), hereinafter “Viswanathan”.
Regarding claim 1, Viswanathan discloses a catheter apparatus comprising: an elongated deflectable element including a distal end that extends along a central longitudinal axis ([0272]; Figures 39A-39D—element 3910), the distal end comprising a proximal coupler ([0273]; Figures 39A-39D—elements 3910 & 3930; the examiner is considering the proximal coupler to be the distal portion of the elongated deflectable 3910 element which coupled to the proximal portion of the set of splines 3930) and an irrigation channel that extends through the proximal coupler ([0272], [0287], & [0288]; 39A-39D—elements 3910 & 3920; fluid (e.g., distilled or deionized water, saline) may be delivered through a lumen of shaft 3920, which extends through the proximal coupler (e.g. distal portion of the elongated deflectable 3910)); an expandable basket assembly disposed proximate the distal end of the elongated deflectable element ([0272]; Figures 39A-39D—element 3930) and comprising: a distal spline connector ([0273]; Figures 39A-39D—element 3922); a plurality of splines extending from the proximal coupler of the distal end of the elongated deflectable element to the distal spline connector ([0273]; Figures 39A-39D—element 3930), each spline comprising an inner surface facing inwardly toward the central longitudinal axis and an outer surface facing outwardly away from the central longitudinal axis ([0272] & [0273]; Figures 39A-39D—element 3930; with the inner surface being the surface of the splines 3930 facing the balloon 3950 and the outer surface being the surface of the splines 3930 facing away from the balloon 3950); and a plurality of electrodes disposed on the plurality of splines ([0275] & [0276]; Figures 39A-39D—element 3932 & 3934), each spline of the plurality of splines being affixed to the distal spline connector at a distal end of the spline ([0273]; Figures 39A-39D—element 3922), the central longitudinal axis intersecting and passing through the distal spline connector ([0273] & [0274]; Figures 39A-39D—elements 3922 & 3924); an inflatable balloon disposed in the expandable basket assembly ([0272] & [0273]; Figures 39A-39D—element 3950), the inflatable balloon including: a proximal balloon portion coupled to the distal end of the elongated deflectable element ([0272] & [0273]; Figures 39A-39D—element 3950; the proximal portion being the proximal end of the balloon 3950) and a distal balloon portion disposed proximate the distal spline connector ([0272] & [0273]; Figures 39A-39D—element 3950; the distal portion being the portion of the balloon 3950 that is distal to the proximal end of the balloon), the distal balloon portion comprising: an axial region of the inflatable balloon that is freely uncoupled from the distal spline connector such that a portion of the freely uncoupled axial region can conform to an internal boundary of the plurality of splines and such that the axial region can move towards and away from the inner surface of each spline ([0272], [0273], & [0284]; Figures 39A-39D—element 3950; the axial region being the portion of the balloon that extends between the proximal end and the distal end of the balloon 3950 that is configured to transform between a deflated and inflated configuration); and a distalmost end distal to the axial region and connected to the distal spline connector ([0273]; Figures 39A-39D—element 3922).
Viswanathan is silent to “the distal spline connector being configured to maintain, when the inflatable balloon is fully inflated, a gap between an outer surface of the inflatable balloon and the inner surfaces of the splines”; However, Viswanathan discloses in ([0007], [0247], & [0273]; Figures 39A-39D—element 3922) that the inflatable member in the inflated configuration may form a shape with an outer diameter at a largest portion of between about 6 mm to about 24 mm and the set of splines in the expanded configuration at its largest portion may have a diameter of between 6 mm and 24 mm, and further there appears to be a gap between the splines 3930 and balloon 3950 in the expanded and inflated configuration, as shown in Figures 39A & 39D; therefore it is the examiners position that a diameter of the balloon in the inflated configuration (e.g. 6 mm to about 24 mm) and a diameter of the splines in the expanded configuration (e.g. 6 mm to about 24 mm) could be selected so as to provide a gap between the two and that it would have been an obvious matter of design choice to select a diameter of the balloon in the inflated configuration and a diameter of the splines in the expanded configuration (within the range of 6 mm to about 24 mm) to achieve the gap between an outer surface of the inflatable balloon and the inner surfaces of the splines, since such a modification would have involved a mere change in the size of a component; A change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 2, Viswanathan discloses all of the limitations of claim 1, as described above.
Viswanathan further discloses the plurality of splines being disposed circumferentially around the inflatable balloon ([0273]; Figures 39A-39D—elements 3930 & 3950).
Regarding claim 3, as best understood in view of the 112(b) rejection above, Viswanathan discloses all of the limitations of claim 1, as described above.
Viswanathan is silent to “the inflatable balloon being configured to fully inflate so that there is a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon”; however, Viswanathan discloses in ([0007], [0247], & [0273]; Figures 39A-39D—element 3922) that the inflatable member in the inflated configuration may form a shape with an outer diameter at a largest portion of between about 6 mm to about 24 mm and the set of splines in the expanded configuration at its largest portion may have a diameter of between 6 mm and 24 mm, and further there appears to be a gap between the splines 3930 and balloon 3950 in the expanded and inflated configuration, as shown in Figures 39A & 39D; therefore it is the examiners position that a diameter of the balloon in the inflated configuration (e.g. 6 mm to about 24 mm) and a diameter of the splines in the expanded configuration (e.g. 6 mm to about 24 mm) could be selected so as to provide a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon and that it would have been an obvious matter of design choice to select a diameter of the balloon in the inflated configuration and a diameter of the splines in the expanded configuration (within the range of 6 mm to about 24 mm) to achieve a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon, since such a modification would have involved a mere change in the size of a component; A change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 4, Viswanathan discloses all of the limitations of claim 3, as described above.
Viswanathan further discloses the electrodes being disposed on at least one of the inner surface or the outer surface of respective ones of the plurality of splines ([0276]; Figures 39A-39B—elements 3932 & 3934; the electrodes may each encircle a circumference of its spline; therefore the electrodes are disposed on both the inner and outer surfaces of the plurality of splines).
Regarding claim 9, Viswanathan discloses a catheter apparatus comprising: an elongated deflectable element including a distal end ([0272]; Figures 39A-39D—element 3910), the distal end comprising a proximal coupler ([0273]; Figures 39A-39D—elements 3910 & 3930; the examiner is considering the proximal coupler to be the distal portion of the elongated deflectable 3910 element which coupled to the proximal portion of the set of splines 3930) and an irrigation channel that extends through the proximal coupler ([0272], [0287], & [0288]; 39A-39D—elements 3910 & 3920; fluid (e.g., distilled or deionized water, saline) may be delivered through a lumen of shaft 3920, which extends through the proximal coupler (e.g. distal portion of the elongated deflectable 3910)); an expandable basket assembly disposed at the distal end and comprising a plurality of splines extending from the proximal coupler ([0272]; Figures 39A-39D—element 3930) and a plurality of electrodes disposed on the plurality of splines ([0275] & [0276]; Figures 39A-39D—element 3932 & 3934); an inflatable balloon coupled to the distal end of the elongated deflectable element and disposed in the expandable basket assembly ([0272] & [0273]; Figures 39A-39D—element 3950), the inflatable balloon comprising a distal balloon portion ([0272] & [0273]; Figures 39A-39D—element 3950; the distal portion being the portion of the balloon 3950 that is distal to the proximal end of the balloon) that comprises an axial region of the inflatable balloon ([0272], [0273], & [0284]; Figures 39A-39D—element 3950; the axial region being the portion of the balloon that extends between the proximal end and the distal end of the balloon 3950 that is configured to transform between a deflated and inflated configuration) and a distalmost end extending from the axial region ([0273]; Figures 39A-39D—elements 3922 & 3950; the distalmost end being the distal tip of the balloon 3950 connected to connector 3922); and a distal spline connector positioned at a distal end of the expandable basket assembly and distal to the inflatable balloon, each spline of the plurality of splines being affixed to the distal spline connector at a distal end, the distalmost end of the inflatable balloon being connected to the distal spline connector ([0273]; Figures 39A-39D—element 3922) such that (i) the inflatable balloon and the distal spline connector are configured to define the spacing between the fully inflated balloon and the plurality of splines ([0273]; Figures 39A-39B—element 3922; as both the balloon 3950 and the splines 3930 are coupled to the distal spline connector 3922 it is the examiners position that the distal spline connector would aid in defining the separation/spacing of the balloon and the splines) and (ii) the axial region of the distal balloon portion can move towards and away from an inner surface of each spline ([0272], [0273], & [0284]; Figures 39A-39D—element 3950).
Viswanathan is silent to “the inflatable balloon configured to fully inflate so that there is a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon and (i) the inflatable balloon and the distal spline connector are configured to define the gap between the fully inflated balloon and the plurality of splines”; however, Viswanathan discloses in ([0007], [0247], & [0273]; Figures 39A-39D—element 3922) that the inflatable member in the inflated configuration may form a shape with an outer diameter at a largest portion of between about 6 mm to about 24 mm and the set of splines in the expanded configuration at its largest portion may have a diameter of between 6 mm and 24 mm, and further there appears to be a gap between the splines 3930 and balloon 3950 in the expanded and inflated configuration, as shown in Figures 39A & 39D; therefore it is the examiners position that a diameter of the balloon in the inflated configuration (e.g. 6 mm to about 24 mm) and a diameter of the splines in the expanded configuration (e.g. 6 mm to about 24 mm) could be selected so as to provide a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon and that it would have been an obvious matter of design choice to select a diameter of the balloon in the inflated configuration and a diameter of the splines in the expanded configuration (within the range of 6 mm to about 24 mm) to achieve a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon, since such a modification would have involved a mere change in the size of a component; A change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 10, Viswanathan discloses all of the limitations of claim 9, as described above.
Viswanathan further discloses the plurality of splines being disposed circumferentially around the inflatable balloon ([0273]; Figures 39A-39D—elements 3930 & 3950).
Regarding claim 11, Viswanathan discloses all of the limitations of claim 9, as described above.
Viswanathan further discloses each of the splines of the plurality of splines including a respective inner surface and a respective outer surface, the electrodes being disposed on at least one of the inner surface or the outer surface of respective ones of the plurality of splines ([0276]; Figures 39A-39B—elements 3932 & 3934; the electrodes may each encircle a circumference of its spline; therefore the electrodes are disposed on both the inner and outer surfaces of the plurality of splines).
Regarding claim 19, Viswanathan discloses all of the limitations of claim 9, as described above.
Viswanathan further discloses the distal spline connector comprising a tube or a slug ([0275]; Figures 39A-39D—element 3922; the distal spline connector 3922 comprises a flat, circular shape and/or a rounded and blunt profile and may comprise a cap; under the broadest reasonable interpretation of “slug” (e.g. a lump, disk, or cylinder of material) the examiner is considering the cap comprising a flat, circular shape and/or a rounded and blunt profile to be a slug; the examiner notes the rest are in the alternative).
Claim 6-8, 13, 16-18, 20, & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan in view of Kordis et al. (previously presented-US 20120271140 A1), hereinafter “Kordis”.
Regarding claim 6, Viswanathan discloses all of the limitations of claim 1, as described above.
Viswanathan does not disclose each spline of the plurality of splines being affixed to the distal spline connector by an adhesive or epoxy layer.
Kordis teaches an expandable basket assembly comprising a plurality of splines connected to a distal spline connector ([0103] & [0104]; Figure 1—elements 14 & 16), each spline of the plurality of splines being affixed to the distal spline connector by an adhesive or epoxy layer ([0143]-[0145]; Figures 30A & 30B; the splines 14 may be adhesively bonded to the distal tip 16; the examiner notes the rest are in the alternative).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the connection of each spline to the distal spline connector, as disclosed by Viswanathan, to include each spline of the plurality of splines being affixed to the distal spline connector by an adhesive or epoxy layer, as taught by Kordis, as both references and the claimed invention are directed toward ablation device comprising expandable basket assemblies and distal spline connectors. As disclosed by Viswanathan, each spline of the plurality of splines are coupled to the distal spline connector ([0273]). As disclosed by Kordis, each spline of the plurality of splines may be adhesively bonded to the distal spline connector in order to secure the splines to the distal spline connector ([0143] & [0144]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connection of each spline to the distal spline connector, as disclosed by Viswanathan, to include each spline of the plurality of splines being affixed to the distal spline connector by an adhesive or epoxy layer, as taught by Kordis, as such a modification would provide for a known and secure connection between the distal end of the plurality of splines and the distal spline connector and further would produce the predictable result of providing a connection between the splines and distal spline connector.
Regarding claim 7, Viswanathan discloses all of the limitations of claim 1, as described above.
Viswanathan does not disclose a distal securing ring surrounding the distal spline connector, each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring to affix each spline of the plurality of splines to the distal spline connector.
Kordis teaches an expandable basket assembly comprising a plurality of splines ([0103]; Figure 1—elements 14), the plurality of splines connected to a distal spline connector ([0126] & [0127]; Figure 26A—element 108), a distal securing ring surrounding the distal spline connector, each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring to affix each spline of the plurality of splines to the distal spline connector ([0126]-[0129]; Figure 26A—element 104).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include a distal securing ring surrounding the distal spline connector and each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring, as taught by Kordis, as both references and the claimed invention are directed toward catheters comprising expandable basket assemblies and distal spline connectors. As disclosed by Viswanathan, each spline of the plurality of splines are coupled to the distal spline connector ([0273]). As disclosed by Kordis, the distal spline connector may include two parts such that the splines are securably disposed and held between the distal spline connector and the distal securing ring ([0126]-[0129]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include a distal securing ring surrounding the distal spline connector and each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring, as taught by Kordis, as such a modification would provide for a known and secure connection between the distal end of the splines and the distal spline connector and would produce the predictable result of providing a connection between the splines and the distal spline connector.
Regarding claim 8, Viswanathan discloses all of the limitations of claim 1, as described above.
Viswanathan does not disclose each distal end of the plurality of splines being folded over to be affixed to the distal spline connector.
Kordis teaches an expandable basket assembly comprising a plurality of splines ([0103]; Figure 1—elements 14), the plurality of splines connected to a distal spline connector ([0104]; Figure 1—element 16), each distal end of the plurality of splines being folded over to be affixed to the distal spline connector ([0138]; Figures 28A & 28B—elements 14 & 16).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include each distal end of the plurality of splines being folded over to be affixed to the distal spline connector, as taught by Kordis, as both references and the claimed invention are directed toward catheters comprising expandable basket assemblies. As disclosed by Viswanathan, each spline of the plurality of splines are coupled to the distal spline connector ([0273]). As disclosed by Kordis, the distal spline connector may comprise a space or detent such that the spline distal ends may be inserted therein and securely affixed thereto ([0138] & [0139]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include each distal end of the plurality of splines being folded over to be affixed to the distal spline connector, as taught by Kordis, as such a modification would provide for a known and secure connection between the distal end of the splines and the distal spline connector and would produce the predictable result of providing a connection between the splines and the distal spline connector.
Regarding claim 13, Viswanathan discloses all of the limitations of claim 1, as described above.
Viswanathan does not disclose respective ones of the plurality of splines including Nitinol.
Kordis teaches an expandable basket assembly comprising a plurality of splines ([0103]; Figure 1—elements 14), respective ones of the plurality of splines including Nitinol ([0152]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the material of the splines, as disclosed by Viswanathan, to include respective ones of the plurality of splines including Nitinol, as taught by Kordis, as both references and the claimed invention are directed toward expandable basket catheters comprising a plurality of splines. As disclosed by Kordis, the splines desirably are made of a super-elastic material so that the splines bow outwardly into the basket shape, preferably the splines are made of nitinol ([0152]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the material of the splines, as disclosed by Viswanathan, to include respective ones of the plurality of splines including Nitinol, as taught by Kordis, as such a modification would provide for a known and material for the splines of a basket assembly and further it would have been obvious to one having ordinary skill in the art at the time the invention was made to include respective ones of the plurality of splines including Nitinol, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 16, Viswanathan discloses all of the limitations of claim 9, as described above.
Viswanathan does not disclose each spline of the plurality of splines being affixed to the distal spline connector by an adhesive or epoxy layer.
Kordis teaches an expandable basket assembly comprising a plurality of splines connected to a distal spline connector ([0103] & [0104]; Figure 1—elements 14 & 16), each spline of the plurality of splines being affixed to the distal spline connector by an adhesive or epoxy layer ([0143]-[0145]; Figures 30A & 30B; the splines 14 may be adhesively bonded to the distal tip 16; the examiner notes the rest are in the alternative).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the connection of each spline to the distal spline connector, as disclosed by Viswanathan, to include each spline of the plurality of splines being affixed to the distal spline connector by an adhesive or epoxy layer, as taught by Kordis, as both references and the claimed invention are directed toward ablation device comprising expandable basket assemblies and distal spline connectors. As disclosed by Viswanathan, each spline of the plurality of splines are coupled to the distal spline connector ([0273]). As disclosed by Kordis, each spline of the plurality of splines may be adhesively bonded to the distal spline connector in order to secure the splines to the distal spline connector ([0143] & [0144]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connection of each spline to the distal spline connector, as disclosed by Viswanathan, to include each spline of the plurality of splines being affixed to the distal spline connector by an adhesive or epoxy layer, as taught by Kordis, as such a modification would provide for a known and secure connection between the distal end of the plurality of splines and the distal spline connector and further would produce the predictable result of providing a connection between the splines and distal spline connector.
Regarding claim 17, Viswanathan discloses all of the limitations of claim 9, as described above.
Viswanathan does not disclose a distal securing ring surrounding the distal spline connector, each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring to affix each spline of the plurality of splines to the distal spline connector.
Kordis teaches an expandable basket assembly comprising a plurality of splines ([0103]; Figure 1—elements 14), the plurality of splines connected to a distal spline connector ([0126] & [0127]; Figure 26A—element 108), a distal securing ring surrounding the distal spline connector, each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring to affix each spline of the plurality of splines to the distal spline connector ([0126]-[0129]; Figure 26A—element 104).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include a distal securing ring surrounding the distal spline connector and each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring, as taught by Kordis, as both references and the claimed invention are directed toward catheters comprising expandable basket assemblies and distal spline connectors. As disclosed by Viswanathan, each spline of the plurality of splines are coupled to the distal spline connector ([0273]). As disclosed by Kordis, the distal spline connector may include two parts such that the splines are securely disposed and held between the distal spline connector and the distal securing ring ([0126]-[0129]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include a distal securing ring surrounding the distal spline connector and each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring, as taught by Kordis, as such a modification would provide for a known and secure connection between the distal end of the splines and the distal spline connector and would produce the predictable result of providing a connection between the splines and the distal spline connector.
Regarding claim 18, Viswanathan discloses all of the limitations of claim 9, as described above.
Viswanathan does not disclose each distal end of the plurality of splines being folded over to be affixed to the distal spline connector.
Kordis teaches an expandable basket assembly comprising a plurality of splines ([0103]; Figure 1—elements 14), the plurality of splines connected to a distal spline connector ([0104]; Figure 1—element 16), each distal end of the plurality of splines being folded over to be affixed to the distal spline connector ([0138]; Figures 28A & 28B—elements 14 & 16).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include each distal end of the plurality of splines being folded over to be affixed to the distal spline connector, as taught by Kordis, as both references and the claimed invention are directed toward catheters comprising expandable basket assemblies. As disclosed by Viswanathan, each spline of the plurality of splines are coupled to the distal spline connector ([0273]). As disclosed by Kordis, the distal spline connector may comprise a space or detent such that the spline distal ends may be inserted therein and securely affixed thereto ([0138] & [0139]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include each distal end of the plurality of splines being folded over to be affixed to the distal spline connector, as taught by Kordis, as such a modification would provide for a known and secure connection between the distal end of the splines and the distal spline connector and would produce the predictable result of providing a connection between the splines and the distal spline connector.
Regarding claim 20, Viswanathan discloses a catheter apparatus comprising: an elongated deflectable element including a distal end ([0272]; Figures 39A-39D—element 3910), the distal end comprising a proximal coupler ([0273]; Figures 39A-39D—elements 3910 & 3930; the examiner is considering the proximal coupler to be the distal portion of the elongated deflectable 3910 element which coupled to the proximal portion of the set of splines 3930) and an irrigation channel that extends through the proximal coupler ([0272], [0287], & [0288]; 39A-39D—elements 3910 & 3920; fluid (e.g., distilled or deionized water, saline) may be delivered through a lumen of shaft 3920, which extends through the proximal coupler (e.g. distal portion of the elongated deflectable 3910)); an expandable basket assembly disposed at the distal end and comprising a plurality of splines extending from the proximal coupler ([0272]; Figures 39A-39D—element 3930) and a plurality of electrodes disposed on the plurality of splines ([0275] & [0276]; Figures 39A-39D—element 3932 & 3934); a distal spline connector positioned at a distal end of the expandable basket assembly ([0273]; Figures 39A-39D—element 3922); and an inflatable balloon coupled to the distal end of the elongated deflectable element and disposed in the expandable basket assembly ([0272] & [0273]; Figures 39A-39D—element 3950), the inflatable balloon including: a proximal balloon portion coupled to the distal end of the elongated deflectable element ([0272] & [0273]; Figures 39A-39D—element 3950; the proximal portion being the proximal end of the balloon 3950) and a distal balloon portion disposed proximate the distal spline connector ([0272] & [0273]; Figures 39A-39D—element 3950; the distal portion being the portion of the balloon 3950 that is distal to the proximal end of the balloon), the distal balloon portion comprising: an axial region of the inflatable balloon that is freely uncoupled from the distal spline connector such that a portion of the freely uncoupled axial region can conform to an internal boundary of the plurality of splines and such that the axial region can move towards and away from inner surfaces of the splines ([0272], [0273], & [0284]; Figures 39A-39D—element 3950; the axial region being the portion of the balloon that extends between the proximal end and the distal end of the balloon 3950 that is configured to transform between a deflated and inflated configuration); and a distalmost end extending from the axial region and connected to the distal spline connector ([0273]; Figures 39A-39D—element 3922).
Viswanathan is silent to “the distal spline connector being configured to maintain, when the inflatable balloon is fully inflated, a gap between an outer surface of the inflatable balloon and the inner surfaces of the splines”; however, Viswanathan discloses in ([0007], [0247], & [0273]; Figures 39A-39D—element 3922) that the inflatable member in the inflated configuration may form a shape with an outer diameter at a largest portion of between about 6 mm to about 24 mm and the set of splines in the expanded configuration at its largest portion may have a diameter of between 6 mm and 24 mm, and further there appears to be a gap between the splines 3930 and balloon 3950 in the expanded and inflated configuration, as shown in Figures 39A & 39D; therefore it is the examiners position that a diameter of the balloon in the inflated configuration (e.g. 6 mm to about 24 mm) and a diameter of the splines in the expanded configuration (e.g. 6 mm to about 24 mm) could be selected so as to provide a gap between the two and that it would have been an obvious matter of design choice to select a diameter of the balloon in the inflated configuration and a diameter of the splines in the expanded configuration (within the range of 6 mm to about 24 mm) to achieve the gap between an outer surface of the inflatable balloon and the inner surfaces of the splines, since such a modification would have involved a mere change in the size of a component; A change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Viswanathan does not disclose a distal securing ring surrounding the distal spline connector, each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring to affix each spline of the plurality of splines to the distal spline connector and the distal securing ring.
Kordis teaches an expandable basket assembly comprising a plurality of splines ([0103]; Figure 1—elements 14), the plurality of splines connected to a distal spline connector ([0126] & [0127]; Figure 26A—element 108), a distal securing ring surrounding the distal spline connector, each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring to affix each spline of the plurality of splines to the distal spline connector and the distal securing ring ([0126]-[0129]; Figure 26A—element 104).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include a distal securing ring surrounding the distal spline connector, each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring to affix each spline of the plurality of splines to the distal spline connector and the distal securing ring, as taught by Kordis, as both references and the claimed invention are directed toward catheters comprising expandable basket assemblies and distal spline connectors. As disclosed by Viswanathan, each spline of the plurality of splines are coupled to the distal spline connector ([0273]). As disclosed by Kordis, the distal spline connector may include two parts such that the splines are securably disposed and held between the distal spline connector and the distal securing ring ([0126]-[0129]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connection of the plurality of splines to the distal spline connector, as disclosed by Viswanathan, to include a distal securing ring surrounding the distal spline connector, each spline of the plurality of splines being secured between the distal spline connector and the distal securing ring to affix each spline of the plurality of splines to the distal spline connector and the distal securing ring, as taught by Kordis, as such a modification would provide for a known and secure connection between the distal end of the splines and the distal spline connector and would produce the predictable result of providing a connection between the splines and the distal spline connector.
Regarding claim 23, as best understood in view of the 112(b) rejection above, Viswanathan in view of Kordis discloses all of the limitations of claim 20, as described above.
Viswanathan is silent to “the inflatable balloon being configured to fully inflate so that there is a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon”; however, Viswanathan discloses in ([0007], [0247], & [0273]; Figures 39A-39D—element 3922) that the inflatable member in the inflated configuration may form a shape with an outer diameter at a largest portion of between about 6 mm to about 24 mm and the set of splines in the expanded configuration at its largest portion may have a diameter of between 6 mm and 24 mm, and further there appears to be a gap between the splines 3930 and balloon 3950 in the expanded and inflated configuration, as shown in Figures 39A & 39D; therefore it is the examiners position that a diameter of the balloon in the inflated configuration (e.g. 6 mm to about 24 mm) and a diameter of the splines in the expanded configuration (e.g. 6 mm to about 24 mm) could be selected so as to provide a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon and that it would have been an obvious matter of design choice to select a diameter of the balloon in the inflated configuration and a diameter of the splines in the expanded configuration (within the range of 6 mm to about 24 mm) to achieve a gap of at least one millimeter between the fully inflated balloon and at least thirty percent of an inner surface area of the plurality of splines facing the inflatable balloon, since such a modification would have involved a mere change in the size of a component; A change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 15 & 21 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan in view of Basu et al. (previously presented-US 20180184982 A1), hereinafter “Basu”.
Regarding claim 15, Viswanathan discloses all of the limitations of claim 9, as described above.
Viswanathan does not disclose respective ones of the plurality of splines including respective polymer flex circuits.
Basu teaches a catheter comprising an expandable basket assembly comprising a plurality of splines ([0046]; Figure 1—element 18), the plurality of splines comprising a plurality of electrodes ([0046]; Figure 1—element 20), respective ones of the plurality of splines including respective polymer flex circuits ([0013], [0059], & [0060]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the plurality of splines, as disclosed by Viswanathan, to include respective ones of the plurality of splines including respective polymer flex circuits, as taught by Basu, as both references and the claimed invention are directed toward catheters comprising basket assemblies for ablating tissue. As disclosed by Basu, the splines may include flex circuits, by employing flex circuit techniques any number of electrodes may be readily positioned at any location on the splines, and the flex circuits allow for significant design freedom ([0059] & [0060]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the plurality of splines, as disclosed by Viswanathan, to include respective ones of the plurality of splines including respective polymer flex circuits, as taught by Basu, as such a modification would allow for any number of electrodes to be readily positioned at any location on the splines, and allow for significant design freedom.
Regarding claim 21, Viswanathan discloses all of the limitations of claim 1, as described above.
Viswanathan does not disclose respective ones of the plurality of splines including respective elongated flex circuits.
Basu teaches a catheter comprising an expandable basket assembly comprising a plurality of splines ([0046]; Figure 1—element 18), the plurality of splines comprising a plurality of electrodes ([0046]; Figure 1—element 20), respective ones of the plurality of splines including respective elongated flex circuits ([0013], [0059], & [0060]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the plurality of splines, as disclosed by Viswanathan, to include respective ones of the plurality of splines including respective elongated flex circuits, as taught by Basu, as both references and the claimed invention are directed toward catheters comprising basket assemblies for ablating tissue. As disclosed by Basu, the splines may include flex circuits, by employing flex circuit techniques any number of electrodes may be readily positioned at any location on the splines, and the flex circuits allow for significant design freedom ([0059] & [0060]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the plurality of splines, as disclosed by Viswanathan, to include respective ones of the plurality of splines including respective elongated flex circuits, as taught by Basu, as such a modification would allow for any number of electrodes to be readily positioned at any location on the splines, and allow for significant design freedom.
Claim 22 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan in view of Kordis and Basu.
Regarding claim 22, Viswanathan in view of Kordis discloses all of the limitations of claim 20, as described above.
Viswanathan does not disclose respective ones of the plurality of splines including respective elongated flex circuits
Basu teaches a catheter comprising an expandable basket assembly comprising a plurality of splines ([0046]; Figure 1—element 18), the plurality of splines comprising a plurality of electrodes ([0046]; Figure 1—element 20), respective ones of the plurality of splines including respective elongated flex circuits ([0013], [0059], & [0060]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the plurality of splines, as disclosed by Viswanathan, to include respective ones of the plurality of splines including respective elongated flex circuits, as taught by Basu, as both references and the claimed invention are directed toward catheters comprising basket assemblies for ablating tissue. As disclosed by Basu, the splines may include flex circuits, by employing flex circuit techniques any number of electrodes may be readily positioned at any location on the splines, and the flex circuits allow for significant design freedom ([0059] & [0060]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the plurality of splines, as disclosed by Viswanathan, to include respective ones of the plurality of splines including respective elongated flex circuits, as taught by Basu, as such a modification would allow for any number of electrodes to be readily positioned at any location on the splines, and allow for significant design freedom.
Conclusion
According, claims 1-4, 6-11, 13, & 15-23 are rejected.
THIS ACTION IS MADE FINAL. 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.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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