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 June 24, 2026 has been entered. Claims 1 and 3-20 remain pending in the application.
Response to Arguments
Applicant’s 35 U.S.C. § 112 arguments, see (II.) in page 7 of Applicant’s Remarks, filed June 24, 2026, with respect to Claims have been fully considered and are persuasive. The 112(b) rejections of Claims have been withdrawn.
Applicant's 35 U.S.C. § 103 arguments, see (III.) in pages 7-13, with respect to Claims 1-6 and 16-19 (Waldhauser in view of Turovskiy), Claims 7-20 (Waldhauser in view of Turovskiy and Kordis), Claims 13-15 (Waldhauser in view of Turovskiy and Haissaguerre), and Claim 20 (Waldhauser in view Turovskiy and Sirhan), have been fully considered but they are not persuasive.
Regarding Claims 1-6 and 16-19 (Waldhauser in view of Turovskiy):
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). While Waldhauser does not explicitly teach “a spine intersection disposed distal of the first plurality of spines in an expanded configuration”, Turovskiy does suggest a spine configuration where the spines intersect on a distal side of the basket when expanded (see Fig. 36A) and further suggests using distal-facing electrodes [3603] to target areas for treatment (see col. 37, lines 3-11 and col. 41, lines 5-19). Modifying Waldhauser with such a suggestion in mind would result in a spine intersection of the second plurality of spines disposed distal of the first plurality of spines in an expanded configuration as claimed. A person having ordinary skill in the art could would have been able to do this, for example, by simply modifying the spines of Waldhauser to intersect more orthogonally (like they do in Turovskiy) so that the basket is able to more easily expand in a way that is similarly distal-facing. Examiner agrees with Applicant’s assertion that neither Waldhauser or Turovskiy, alone, explicitly teach the inversion of the spines between the two configurations. However, Examiner disagrees that Waldhauser and Turovskiy in combination would not suggest that inversion as described above.
In response to applicant’s argument that there is no obvious way to combine Waldhauser and Turovskiy to arrive at the elements of the amended claims, Examiner respectfully disagrees. It is true that there are no electrodes on the second plurality of spines in Waldhauser, but the proposed combination would have electrodes there in view of Turovskiy, which has distal-facing electrodes. As such, when the combined device is in its expanded configuration, it would be able to target tissue at the distal side of the basket in a way that would resemble Turovskiy. In a collapsed configuration, these electrodes would likely be brought inside a cage just as Applicant claims, but it would not be necessary for the electrodes to target tissue while being advanced in the collapsed state; they need only target tissue when in the expanded configuration.
In response to applicant's argument that the examiner's motivation to combine is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Turovskiy, for example, teaches a wide range of possible electrode configurations based on diverse geometric needs (see e.g. col. 21, lines 44-50, suggesting “front-facing” or “side-facing” electrodes; see also the “distal-facing” electrode approach of Fig. 36A). The motivation to modify Waldhauser to expand further in order to target areas at the distal side of the catheter would not be hindsight reasoning because the need for electrodes on a catheter to have different orientations depending on location and intended use was well-known in the art, and modifying the shape of a catheter to have electrodes face a specific way to target a specific area was within what would have been of ordinary skill in the art at the time of the claimed invention.
Regarding Claims 7-12 (Waldhauser in view of Turovskiy and Kordis), Claims 13-15 (Waldhauser in view of Turovskiy and Haissaguerre), and Claim 20 (Waldhauser in view of Turovskiy and Sirhan), applicant argues that combining each of these third references also fails to remedy the alleged deficiencies of the combination of Waldhauser and Turovskiy. However, as described above, Examiner finds the alleged deficiencies unpersuasive, making this argument moot.
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(s) 1-6, and 16-19 are rejected under 35 U.S.C 103 as being unpatentable over Waldhauser et al. (11,077,298 B2) in view of Turovskiy et al. (12,408,976 B2).
Regarding Claim 1, Waldhauser discloses a medical probe (see Annotated Fig. 22E below) comprising a tubular shaft [2226] including a proximal end [Opposite to DE] and a distal end [DE], the tubular shaft extending along a longitudinal axis [LA], an expandable basket assembly coupled to the distal end of the tubular shaft, the expandable basket assembly comprising: a first plurality of spines [2210] coupled to the distal end of the tubular shaft [2226] and forming a proximal portion of the expandable basket (see Annotated Fig. 22E below), a second plurality of spines [2204], each spine of the second plurality of spines [2204] rotatably coupled to a respective spine of the first plurality of spines [2210] (See column 18, lines 12-13, “Each of the first plurality of splines is coupled to one spline of the second plurality of splines”), a push rod [2224] connected to a distal end of the second plurality of spines [2204], the push rod [2224] configured to slide longitudinally between a proximal position and a distal position to transition the expandable basket assembly between the expanded configuration and the collapsed configuration (see column 143, lines 1-6, “proximal retraction of the cannula 2226 and/or distal advancement of the inner member 2224 can cause the splines 2210 to flex radially outward, proximal retraction of the inner member 2210 and/or distal advancement of the cannula 2226 can cause the splines 2210 to flex radially inward”; see also Fig. 22F). Waldhauser also discloses a spine intersection of the second plurality of spines [2204] on a proximal end of the second plurality of spines in a collapsed configuration (see Annotated Fig. 22E below).
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This embodiment of Waldhauser, however, is silent on a plurality of electrodes attached to the second plurality of spines and does not explicitly disclose a spine intersection disposed distal of the first plurality of spines in an expanded configuration. Waldhauser also does not explicitly teach the second plurality of spines forming a distal portion of the expandable basket assembly in the expanded configuration.
Turovskiy discloses an expandable basket assembly comprising a plurality of spines [3609] and a plurality of distal facing electrodes [3603] attached to the spines (See Fig. 36A). Although Turovskiy does not explicitly disclose a second plurality of spines rotatably coupled to a respective spine of the first plurality of spines, the plurality of spines bends inwards to form the proximal and distal side of the basket assembly. The plurality of spines of Turovskiy intersect at a more orthogonal angle compared to Waldhauser, allowing for an expanded configuration where the spine intersection of the plurality of spines is at the distal end of the spine plurality. The electrodes are also located on the distal side of the plurality of spines, which is the section of the spines that would be analogous to where a second plurality of spines would be located should the single plurality of spines be replaced by two rotatably coupled pluralities.
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Waldhauser and Turovskiy to arrive at the claimed invention. A combination of the teachings of Turovskiy and Waldhauser would provide for an expandable basket assembly composed of two spine pluralities with electrodes attached to the second plurality of spines and the overall shape of the basket resembling Waldhauser in its collapsed configuration and Turovskiy in its expanded configuration. For example, a person having ordinary skill in the art could have modified the second plurality of spines of Waldhauser to intersect at a more orthogonal angle and attached electrodes to them so the basket is able to expand to a shape similar to that of Fig. 36A of Turovskiy. This would result in the second plurality of spines forming a distal portion of the expandable basket assembly in the expanded configuration with the intersection disposed distal of the first plurality of spines. Doing so would allow the basket catheter to target areas at the distal side of the expanded basket.
Claim 3 is likewise rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy. Claim 3 has the additional limitation of the second plurality of spines configured to rotate outwardly with respect to the first plurality of spines to transition to an expanded configuration. This limitation is disclosed in Waldhauser. Advancement of the push rod [2224] causes inward rotation of the second plurality of spines [2204] with respect to the first plurality [2210] see column 143, lines 1-6, “proximal retraction of the cannula 2226 and/or distal advancement of the inner member 2224 can cause the splines 2210 to flex radially outward”; compare Fig. 22E to Fig. 22G). As seen in Fig. 22G, this rotation causes the basket to expand.
Claim 4 is likewise rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy. Claim 4 has the additional limitation of the plurality of the second plurality of spines being configured to rotate inwardly with respect to the first plurality of spines such that distal portion of the expandable basket assembly nests at least partially within the proximal portion of the expandable basket assembly. This limitation is disclosed in Waldhauser. Retraction of the push rod [2224] causes inward rotation of the second plurality of spines [2204] with respect to the first plurality [2210] (see column 143, lines 1-6, “proximal retraction of the inner member 2210 and/or distal advancement of the cannula 2226 can cause the splines 2210 to flex radially inward”; compare Fig. 22E to Fig. 22G). As seen in Annotated Fig. 22E above, the second plurality of spines [2204] (forming the distal portion of the expandable basket assembly) nests within the proximal portion of the expandable basket assembly formed by the first plurality [2210].
Claim 5 is likewise rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of a second embodiment of Waldhauser. Claim 5 has the additional limitation of the second plurality of spines being attached to each other to form a unitary spine assembly. This limitation is disclosed in another embodiment in Waldhauser. As seen in Fig. 22A, Waldhauser teaches the spines of the second plurality of spines [2214] all extending from the same hypotube [2212] as a unitary spine assembly. It would have been obvious for a person having ordinary skill in the art to modify the embodiment of Waldhauser as seen in Fig. 22E to comprise a unitary spine assembly in view of the embodiment as seen in Fig. 22A of Waldhauser. Doing so would couple the second plurality of spines while enabling the inner hypotube to be used as a push rod.
Claim 6 is likewise rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of a second embodiment of Waldhauser. Claim 6 has the additional limitation of the second plurality of spines comprising a single piece of continuous biocompatible material. This limitation is disclosed in Waldhauser. As seen in Fig. 22A, Waldhauser teaches the plurality of spines all extending from a hypotube [2212] as a single piece of continuous material. (see Waldhauser column 141, lines 58-59). It would have been obvious for a person having ordinary skill in the art to modify the embodiment of Waldhauser as seen in Fig. 22E to comprise a single piece of continuous material in view of the embodiment seen in Fig. 22A of Waldhauser. Doing so would couple the second plurality of spines and enable the inner hypotube to be used as a push rod. Waldhauser also teaches the plurality of spines comprise Nitinol, a biocompatible material (see Waldhauser column 145, lines 11-13).
Claim 16 is likewise rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy. Claim 16 has the additional limitation of the plurality of electrodes being configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V). Waldhauser discloses electrodes being configured to deliver electrical pulses for adjuvant cardiac therapy (see Waldhauser column 2, lines 16-22), but does not explicitly disclose the peak voltage range. Turovskiy, however, discloses electrical pulses having a peak voltage of more than 900 volts for irreversible electroporation (see Turovskiy column 1 lines 431-441). It would have been obvious for a person having ordinary skill in the art to configure the plurality of electrodes in Waldhauser to deliver electrical pulses for irreversible electroporation with a peak voltage of at least 900 volts. Doing so would trigger the desired apoptosis in the target areas.
Claims 17 is likewise rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy. Claim 17 has the additional limitation of the expandable basket assembly being configured to form an approximately spherically-shaped basket assembly when in the expanded form. Turovskiy discloses a plurality of spines [3609] bending perpendicularly towards a distal center [3605] to form an expandable basket assembly (See Fig. 36A). It would have been obvious to a person having ordinary skill in the art to have modified Waldhauser to incorporate the teachings of Turovskiy to provide for the second plurality of spines to join at the push rod at a more orthogonal angle and thereby be able to rotate outwards further than as disclosed in Fig. 22G of Waldhauser, creating an approximately spherical shape when expanded. Doing so would allow the basket catheter to target areas at the distal side of the expanded basket at a different angle than at the proximal side.
Claims 18 is likewise rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy. Claim 18 has the additional limitation of the expandable basket assembly being configured to form an approximately oblate-spheroid basket assembly when in the expanded form. Turovskiy discloses a plurality of spines [3609] bending towards a distal center [3605] to form an expandable basket assembly (See Fig. 36A). It would have been obvious to a person having ordinary skill in the art to have modified Waldhauser to incorporate the teachings of Turovskiy to provide for the second plurality of spines to join at the push rod at a more orthogonal angle and thereby be able to rotate outwards further than as disclosed in Fig. 22G of Waldhauser, creating an approximately oblate-spheroid shape when expanded. Doing so would allow the basket catheter to target areas at the distal side of the expanded basket at a different angle than at the proximal side.
Regarding Claim 19, Waldhauser discloses a medical probe (See Annotated Fig. 22E above) comprising a tubular shaft [2226] including a proximal end [Opposite to DE] and a distal end [DE], the tubular shaft extending along a longitudinal axis [LA], an expandable basket assembly coupled to the distal end of the tubular shaft, the expandable basket assembly comprising: a first plurality of spines [2210] coupled to the distal end of the tubular shaft [2226] and forming a proximal portion of the expandable basket assembly (See Annotated Fig. 22E above), a second plurality of spines [2204], each spine of the second plurality of spines [2204] rotatably coupled to a respective spine of the first plurality of spines [2210] (See column 18, lines 12-13, “Each of the first plurality of splines is coupled to one spline of the second plurality of splines”). Waldhauser also discloses a spine intersection of the second plurality of spines [2204] on a proximal end of the second plurality of spines in a collapsed configuration (see Annotated Fig. 22E above).
This embodiment of Waldhauser, however, does not explicitly disclose a spine intersection of disposed distal of the first plurality of spines in an expanded configuration. Waldhauser also does not explicitly teach the second plurality of spines forming a distal portion of the expandable basket assembly in the expanded configuration.
Although Turovskiy does not explicitly disclose a second plurality of spines rotatably coupled to a respective spine of the first plurality of spines, the plurality of spines bends inwards to form the proximal and distal side of the basket assembly. The plurality of spines of Turovskiy intersect at a more orthogonal angle compared to Waldhauser, allowing for an expanded configuration where the spine intersection of the plurality of spines is at the distal end of the spine plurality. Turovskiy also teaches that Nitinol, as a shape memory alloy, can bias the spines to be in either the expanded or collapsed configuration (See Turovskiy column 33, lines 60-63 "the ribs may be formed of a shape memory alloy … that is shape-set to be in the expanded configuration or alternatively the collapsed configuration”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Waldhauser and Turovskiy to arrive at the claimed invention. A combination of the teachings of Turovskiy and Waldhauser would provide for an expandable basket assembly composed of two spine pluralities with the overall shape of the basket resembling Waldhauser in its collapsed configuration and Turovskiy in its expanded configuration. For example, a person having ordinary skill in the art could have modified the second plurality of spines of Waldhauser to intersect at a more orthogonal angle so the basket is able to expand to a shape similar to Fig. 36A of Turovskiy. This would result in the second plurality of spines forming a distal portion of the expandable basket assembly in the expanded configuration with their intersection disposed distal of the first plurality of spines. This combination would allow the basket catheter to target areas at the distal side of the expanded basket. It would have also been obvious to a person having ordinary skill in the art to bias the second plurality of spines (which Waldhauser discloses may comprise Nitinol) to bow distally with respect to the first plurality of spines to cause the expandable basket assembly to transition to an expanded configuration. Doing so would bias the expandable basket assembly into an expanded configuration to more easily target areas away from the center of the basket assembly.
Claims 7-12 are rejected under 35 U.S.C 103 as being unpatentable over Waldhauser et al. (11,077,298 B2) in view of Turovskiy et al. (12,408,976 B2) and further in view of Kordis (5,823,189).
Claim 7 is rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of Kordis. Claim 7 has the additional limitation of each spine of the first plurality of spines comprising a first aperture extending therethrough at its distal end, each spine of the second plurality of spines comprising a second aperture extending therethrough at its proximal end, and the medical probe further comprising a plurality of pins, each pin of the plurality of pins configured to extend through a respective first aperture and a respective second aperture to rotatably couple the first plurality of spines to the second plurality of spines. Waldhauser discloses a rotatably coupled first and second plurality of spines, but it does not specifically disclose coupling the two pluralities via an aperture and pins mechanism. However, methods to mechanically couple spines together are known in the art, and it would have been obvious for a person having ordinary skill in the art to substitute any substantially equivalent known method of coupling two arms together to couple the spines of Waldhauser.
Kordis discloses a method of rotatably coupling spines [22] through the use of an aperture [84] at the ends of the spines whereby a pin [86] extends to hold the spines together (See Fig. 22). A person having ordinary skill in the art would have been motivated to use the teachings of Kordis to rotatably couple the first plurality of spines to the second plurality of spines of Waldhauser, with each of the resulting spines of the first plurality of spines thereby comprising a first aperture extending therethrough at its distal end, each spine of the second plurality of spines comprising a second aperture extending therethrough at its proximal end, and the plurality of pins configured to extend through a respective first aperture and a respective second aperture. Doing so would achieve the coupling necessary to cause the basket to expand as the second plurality of spines rotates outwards.
Claim 8 is rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of Kordis. Claim 8 has the additional limitation of the pin forming a snap-fit with the first plurality of spines and the second plurality of spines to secure the first plurality of spines to the second plurality of spines. Waldhauser does not explicitly disclose a snap-fit. However, Kordis also discloses a protrusion [46] in a spine [22] to snap-fit the spine [22] to an end cap [48] (See Fig. 8 and column 7, lines 12-13, “The detent 46 snaps into the bore 54 to lock the body 42 to the end cap 48”). It would have been obvious to modify the coupling mechanism for the two pluralities in Waldhauser with the pin described above forming a snap-fit with the first plurality of spines and the second plurality of spines. Doing so would secure the spine pluralities together while eliminating the need for fasteners.
Claim 9 is rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of Kordis. Claim 9 has the additional limitation of each spine of the first plurality of spines comprising a protrusion, each spine of the second plurality of spines comprising an aperture extending therethrough, the aperture configured to receive the protrusion to rotatably couple the first plurality of spines to the second plurality of spines. Waldhauser discloses a rotatably coupled first and second plurality of spines, but it does not specifically disclose coupling the two pluralities via an aperture and protrusion mechanism. However, methods to mechanically couple spines together are known in the art, and it would have been obvious for a person having ordinary skill in the art to substitute any substantially equivalent known method of coupling two arms together to couple the spines of Waldhauser.
Kordis discloses a protrusion [46] in a spine [22] to snap-fit the spine [22] to an end cap [48] (See Fig. 8 and column 7, lines 12-13, “The detent 46 snaps into the bore 54 to lock the body 42 to the end cap 48”). A person having ordinary skill in the art would have been motivated to use the teachings of Kordis to rotatably couple the first plurality of spines to the second plurality of spines of Waldhauser, with each spine of the first plurality of spines comprising a protrusion, each spine of the second plurality of spines comprising an aperture extending therethrough configured to receive the protrusion to rotatably couple the first plurality of spines to the second plurality of spines. Doing so would also achieve the coupling necessary to cause the basket to expand as the second plurality of spines rotates outwards.
Claim 10 is rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of Kordis. Claim 10 has the additional limitation of the protrusion forming a snap-fit with the aperture to secure the first plurality of spines to the second plurality of spines. However, Kordis also discloses a protrusion [46] in a spine [22] to snap-fit the spine [22] to an end cap [48] (See Fig. 8 and column 7, lines 12-13, “The detent 46 snaps into the bore 54 to lock the body 42 to the end cap 48”). It would have been obvious to modify the coupling mechanism for the two pluralities in Waldhauser with the protrusion described above forming a snap-fit with the aperture. Doing so would also secure the spine pluralities together while eliminating the need for fasteners.
Claim 11 is rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of Kordis. Claim 11 has the additional limitation of each spine of the second plurality of spines comprising a protrusion, each spine of the first plurality of spines comprising an aperture extending therethrough, the aperture configured to receive the protrusion to rotatably couple the first plurality of spines to the second plurality of spines. As mentioned in the discussion of Claim 9 above, Waldhauser discloses a rotatably coupled first and second plurality of spines, but it does not specifically disclose coupling the two pluralities via an aperture and protrusion mechanism. However, methods to mechanically couple spines together are known in the art, and it would have been obvious for a person having ordinary skill in the art to substitute any substantially equivalent known method of coupling two arms together to couple the spines of Waldhauser.
As mentioned in the discussion of Claim 9 above, a person having ordinary skill in the art would have been motivated to use the teachings of Kordis to rotatably couple the first plurality of spines to the second plurality of spines of Waldhauser using an aperture and protrusion mechanism. Although in Claim 11 the protrusion is in the second plurality of spines and the aperture in the first plurality, this does not substantially change the coupling mechanism compared to Claim 9 and as such a person having ordinary skill in the art would be motivated in the same way to modify the coupling mechanism with each spine of the second plurality of spines instead comprising a protrusion and each spine of the first plurality of spines comprising an aperture extending therethrough configured to receive the protrusion to rotatably couple the first plurality of spines to the second plurality of spines. Doing so would also achieve the coupling necessary to cause the basket to expand as the second plurality of spines rotates outwards.
Claim 12 is rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of Kordis. Claim 12 has the additional limitation of the protrusion forming a snap-fit with the aperture to secure the first plurality of spines to the second plurality of spines. However, as mentioned in the analysis of Claim 10, Kordis also discloses a protrusion [46] in a spine [22] to snap-fit the spine [22] to an end cap [48] (See Fig. 8 and column 7, lines 12-13, “The detent 46 snaps into the bore 54 to lock the body 42 to the end cap 48”). It would have been obvious to modify the coupling mechanism for the two pluralities in Waldhauser with the protrusion described above forming a snap-fit with the aperture. Doing so would also secure the spine pluralities together while eliminating the need for fasteners.
Claims 13-15 are rejected under 35 U.S.C 103 as being unpatentable over Waldhauser et al. (11,077,298 B2) in view of Turovskiy et al. (12,408,976 B2) and further in view of Haissaguerre et al. (5,916,213 A).
Claim 13 is rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of Haissaguerre. Claim 13 has the additional limitation of further comprising a plurality of hinge members, each hinge member of the plurality of hinge members being coupled to a distal end of a respective spine of the first plurality of spines and to a proximal end of a respective spine of the second plurality of spines. Waldhauser discloses a rotatably coupled first and second plurality of spines, but it does not specifically disclose coupling the two pluralities via hinges. However, methods to mechanically couple spines together are known in the art, and it would have been obvious for a person having ordinary skill in the art to substitute any substantially equivalent known method of coupling two arms together to couple the spines of Waldhauser.
Haissaguerre discloses a plurality of hinge members [250] each hinge member of the plurality of hinge members being coupled to a first plurality of spines [252] and to a second plurality of spines [255], each hinge member further comprising a proximal aperture [PA] and a distal aperture [DA], the proximal aperture [PA] configured to receive a protrusion [PP] of a respective spine of the first plurality of spines and the distal aperture [DA] configured to receive a protrusion [DP] of a respective spine of the second plurality of spines [255] to rotatably attach the first plurality of spines, the second plurality of spines, and the plurality of hinge members [250] to each other (see annotated Figs. 16A-16B). A person having ordinary skill in the art would have been motivated to use the teachings of Haissaguerre to rotatably couple the first plurality of spines to the second plurality of spines of Waldhauser, with each hinge member being coupled to a distal end of a respective spine of the first plurality of spines and to a proximal end of a respective spine of the second plurality of spines. Doing so would also achieve the coupling necessary to cause the basket to expand as the second plurality of spines rotates outwards.
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Claims 14-15 are rejected under 35 U.S.C 103 as being unpatentable over Waldhauser in view of Turovskiy and further in view of Haissaguerre. Claim 14 has the additional limitation of each hinge member comprising a proximal aperture and a distal aperture, the proximal aperture configured to receive a protrusion of a respective spine of the first plurality of spines and the distal aperture configured to receive a protrusion of a respective spine of the second plurality of spines to rotatably attach the first plurality of spines, the second plurality of spines, and the plurality of hinge members to each other. Claim 15 is also dependent on Claim 13 and is substantially equivalent to Claim 14, with the limitation instead being that the protrusions be in the hinges and the apertures be in the spines as opposed to the other way around.
As described in the discussion of Claim 13 above, Haissaguerre discloses hinge members with such apertures and spines with protrusions rotatably coupled to each other. Having the protrusions be in the hinge members and the apertures in the spines (as per Claim 15) or the reverse (as per Claim 14) would be obvious variants that achieve the same result of coupling the spines in a way that allows the basket to expand outwards upon rotation of the spines.
Claim 20 is rejected under 35 U.S.C 103 as being unpatentable over Waldhauser et al. (11,077,298 B2) in view of Turovskiy et al. (12,408,976 B2) and further in view of Sirhan et al. (EP 3861961 A1).
Waldhauser discloses a medical probe (See Annotated Fig. 22E above) comprising a tubular shaft [2226] including a proximal end [Opposite to DE] and a distal end [DE], the tubular shaft extending along a longitudinal axis [LA], an expandable basket assembly coupled to the distal end of the tubular shaft, the expandable basket assembly comprising: a first plurality of spines [2210] coupled to the distal end of the tubular shaft [2226] and forming a proximal portion of the expandable basket assembly (See Annotated Fig. 22E above), a second plurality of spines [2204], each spine of the second plurality of spines [2204] rotatably coupled to a respective spine of the first plurality of spines [2210] (See column 18, lines 12-13, “Each of the first plurality of splines is coupled to one spline of the second plurality of splines”). Waldhauser also discloses a spine intersection of the second plurality of spines [2204] on a proximal end of the second plurality of spines in a collapsed configuration (see Annotated Fig. 22E above).
This embodiment of Waldhauser, however, does not explicitly disclose a spine intersection of disposed distal of the first plurality of spines in an expanded configuration. Waldhauser also does not explicitly teach the second plurality of spines forming a distal portion of the expandable basket assembly in the expanded configuration.
Although Turovskiy does not explicitly disclose a second plurality of spines rotatably coupled to a respective spine of the first plurality of spines, the plurality of spines bends inwards to form the proximal and distal side of the basket assembly. The plurality of spines of Turovskiy intersect at a more orthogonal angle compared to Waldhauser, allowing for an expanded configuration where the spine intersection of the plurality of spines is at the distal end of the spine plurality.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Waldhauser and Turovskiy to arrive at the claimed invention. A combination of the teachings of Turovskiy and Waldhauser would provide for an expandable basket assembly composed of two spine pluralities with the overall shape of the basket resembling Waldhauser in its collapsed configuration and Turovskiy in its expanded configuration. For example, a person having ordinary skill in the art could have modified the second plurality of spines of Waldhauser to intersect at a more orthogonal angle so the basket is able to expand similar to Fig. 36A of Turovskiy. This would result in the second plurality of spines forming a distal portion of the expandable basket assembly in the expanded configuration with their intersection disposed distal of the first plurality of spines. This combination would allow the basket catheter to target areas at the distal side of the expanded basket.
Waldhauser also does not disclose a first plurality of spines comprising a hook member or a second plurality of spines comprising an aperture to couple the two together. However, methods to mechanically couple spines together are known in the art, and it would have been obvious for a person having ordinary skill in the art to substitute any substantially equivalent known method of coupling two arms together to couple the spines of Waldhauser.
Sirhan discloses a hook [H] and aperture [A] to couple two strut elements [1789 and 1786] (see annotated Fig 62b below). A person having ordinary skill in the art would have been motivated to use the teachings of Sirhan to rotatably couple the first plurality of spines to the second plurality of spines of Waldhauser, with the first plurality of spines comprising a hook that hooks into the aperture of the corresponding spine of the second plurality. Doing so would also achieve the coupling necessary to cause the basket to expand as the second plurality of spines rotates outwards.
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Conclusion
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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