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 December 16, 2025 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 December 16, 2026, with respect to Claims 17-18 have been fully considered and are persuasive. The 112(b) rejections of Claims 17-18 have been withdrawn.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 of 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).
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. A person having ordinary skill in the art would be able to take the teachings of Turovskiy and Waldhauser to arrive at the claimed invention by adding electrodes to the second plurality of spines of Waldhauser and having the spines intersect in a more orthogonal direction. This would allow the shape of the expandable basket to resemble that of Turovskiy in its expanded state. A person having ordinary skill in the art could also take the teachings of Turovskiy and Waldhauser to arrive at the claimed invention by replacing the single plurality of spines of Turovskiy with the two rotatably coupled spines of Turovskiy. Either approach would meet the limitations of the amended claims, as will be further shown in the discussion of the 103 rejections below.
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). Applicant states that one of ordinary skill in the art could simply advance the catheter rather than seek a combination with Turovskiy; however, a combination with Turovskiy would allow for an expanded configuration with a distal side of the basket that is able to target a wider range of points than would be possible from just advancing the catheter of Waldhauser.
Regarding 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 of Sirhan), applicant argues that combining each of these third references also fail to remedy the alleged deficiencies of the combination of Waldhauser and Turovskiy. However, Examiner finds the alleged deficiencies unpersuasive, making this argument moot.
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.
Claim 1, and by virtue of their dependency, Claims 3-18, 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 1 recites the limitation “a spine intersection of the second plurality of spines disposed distal of the first plurality of spines in an expanded configuration and proximal of the second plurality of spines in a collapsed configuration” in lines 11-13. Because the spine intersection would be part of the second plurality of spines being used as reference, the limitation essentially limits the intersection of spines to be proximal of itself, rendering it indefinite. Additionally, Claim 1 recites the limitation "the expanded configuration" in line 9. There is insufficient antecedent basis for this limitation in the claim; instead, “an expanded configuration” is introduced in line 12. For purposes of examination, the limitations will be considered to read “an expanded configuration” in line 9 and “a spine intersection of the second plurality of spines disposed distal of the first plurality of spines in the expanded configuration and on a proximal end of the second plurality of spines in a collapsed configuration” in lines 11-13. Independent Claims 19 and 20 have limitations that mirror the language of Claim 1 discussed above and are likewise rejected for the same reason.
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 of the second plurality of spines 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 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 the second plurality of spines 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 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 Michel 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 Michel. 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.
Michel 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 Michel 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 Michel. 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, Michel 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 the second plurality of spines 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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