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 .
Status of Claims
The amendments and remarks filed on 03OCT2025 have been entered and considered.
Claims 1-20 are currently pending.
Claims 1-4, & 16 have been amended.
No claims have been added, withdrawn, or canceled.
New matter has been added to claim 3.
Claims 1-20 are under examination.
Response to Arguments
Applicant's amendments filed 03OCT2025 regarding the claim objections have been fully considered and have been found to overcome the objections. Therefore, the claim objections have been withdrawn.
Applicant's amendments filed 03OCT2025 regarding the rejections under 35 USC 112(b) have been fully considered and have been found obviate the rejections. Therefore, the 112(b) rejections have been withdrawn.
Applicant's arguments filed 03OCT2025 regarding the rejections under 35 USC 102(a)(1)/ 103 have been fully considered and have been found to be persuasive. Therefore, the rejection shave been withdrawn. A new ground for rejection has been provided below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites limitation “approximately rectangular shape”. As stated in ¶0063 of the Specification, “As used herein, the terms "about" or "approximately" for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.”. The specification does not provide support for this approximately rectangular shape, only stating a substantially rectangular shape in ¶0011. There is no written description for the approximately rectangular shape which would define the shape that this may take on, and the disclosure of ¶0063 does not further define this in a meaningful way. Therefore, the limitation lacks a written description.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Olson (US Publication No. 20190282116; Previously Cited) in view of Postma et al. (EP Publication No. 3082936).
Regarding claim 1, Olson discloses an apparatus comprising: an elongated shaft comprising a proximal portion and a distal portion, the elongated shaft configured to be manipulated at the proximal portion to position the distal portion into a heart of a patient (Olson ¶0065 “For example, after conducting an initial global electrophysiology mapping of a cardiac chamber, a clinician may further refine the resolution of the electrophysiology map in a region of interest by moving additional splines into the interest region (see, e.g., FIG. 1B).”), the elongated shaft defining a longitudinal axis of the apparatus (Olson ¶0009 “"The elongated catheter shaft includes a proximal end and a distal end, and defines a longitudinal axis.”); a handle affixed to the proximal portion of the shaft (Olson ¶0067 “extends proximally to a catheter handle at a proximal end of the catheter shaft 105.”); and an end effector disposed proximate to the distal portion of the elongated shaft (Olson ¶0008 “In particular, the instant disclosure relates to both planar and basket type end effectors coupled to a distal end of a catheter shaft.”; Figure 2A End Effector 201), the end effector comprising a plurality of spine pairs wherein each spine includes electrodes disposed thereon (Olson ¶0062 “In various embodiments, electrode bipole pairs may extend between adjacent splines 110,”), the plurality of spine pairs comprising an outer pair of spines and an inner pair of spines (Olson Figure 2B showing the inner spines in line with a set of outer spines) such that in a first configuration, the outer pair of spines are contiguous to a plane with the inner pair of spines (Olson ¶0009 “The planar array conforms to tissue, and includes two or more struts extending substantially parallel with the longitudinal axis and lying in a common plane.”; Figure 2A; Figure 4A; ¶0078) where the spines are rotated about the longitudinal axis (Olson ¶0033 “Aspects of the present disclosure facilitate clinician controlled rotation of one or more of the splines within a basket catheter about a longitudinal axis.”).
Olson discloses embodiments for a basket catheter and planar mapping catheter with improvements to the adjustability of each type of catheter. Olson further discloses in ¶0123 that “Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.”. Therefore, one of ordinary skill in the art would think that based on the disclosure of Olson ¶0123 that the improvements shown in reference to the basket catheter designs may be applicable to the embodiments involving the planar configurations. Therefore, one would be reasonably motivated to have a planar catheter configuration as seen in Olson with the rotational manipulation of the spines about a longitudinal axis (Olson ¶0033) for the purpose of further conforming the catheter array to a tissue for improved functionality (See for example, Olson ¶0078 discussing the planar array being adapted to conform to a tissue).
Olson does not disclose in a second configuration, one of the inner pair of spines or the outer pair of spines are rotated from a planar configuration so that the inner pair of spines is non-coplanar to the outer pair of spines. Postma in a similar field of endeavor of catheter design teaches an elongated shaft comprising a proximal portion and a distal portion, the elongated shaft configured to be manipulated at the proximal portion to position the distal portion into a heart of a patient (Postma ¶0257) the end effector comprising a plurality of spine pairs wherein each spine includes electrodes disposed thereon (Postma Figure 3B showing electrodes 315 as a part of the elongate members 304, which equate to spines for the catheter) such that in a second configuration, one of the inner pair of spines or the outer pair of spines are manipulated from a planar configuration so that the inner pair of spines is non-coplanar to the outer pair of spines (Postma; Figure 5L-2 showing the action of flattening the spines into a planar configuration (flattened, a fully planar configuration is not provided, but support for the manipulation to such is found in ¶0061 “According to some embodiments, the catheter system 500 includes several different types of motions to control the deployment, retraction, positioning, size, and shape of the manipulable portion 502. These different types of motions may include coiling, uncoiling, fanning, un-fanning, bifurcated doming, flattening, clam shelling, or a combination of some or all of these motions. In some embodiments, these motions facilitate accommodation of different bodily cavity sizes (e.g., different atrium sizes), as well as proper positioning of the manipulable-portion within the bodily cavity (e.g., atrium) and contact with one or more tissue walls of the bodily cavity.”).
Olson teaches adjustability of various types of mapping catheters (Olson ¶0032 “Various embodiments of the present disclosure are directed to flexible, mapping catheters with adjustable electrode array densities.”) further disclosing that the adjustability of beneficial for enhancing mapping (Olson ¶0032 “Various embodiments of the present disclosure are directed to flexible, mapping catheters with adjustable electrode array densities. The variable electrode array density facilitates variable granularity of an electrophysiology map.”). Therefore, before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Olson such that in a second configuration, one of the inner pair of spines or the outer pair of spines are manipulated from a planar configuration so that the inner pair of spines is non-coplanar to the outer pair of spines, as taught in Postma for the purpose of facilitating accommodation of different bodily cavity sizes (Postma ¶0061) since Olson has already disclosed that increased adjustability to the catheter design facilitates enhanced mapping capabilities (Olson ¶0033 “By moving an additional spline therebetween, mapping fidelity is greatly improved. Moreover, such basket catheter adjustability may further benefit advanced electrophysiology mapping implementations such as orientation independent sensing/omnipolar technology”; ¶0085 “The change in electrode spacing between adjacent struts facilitates variable granularity electrophysiology mapping of target tissue. The deflection of the struts facilitates a more global mapping of target tissue, at least laterally relative to a longitudinal axis of the catheter.”).
Regarding claim 2, claim 1 is obvious over Olson combined with Postsma. Olson further discloses wherein each pair of spines includes a connecting member to define a spine loop so that the plurality of spine pairs define a plurality of spine loops, (Olson Figures 2A-2B showing distal tip 215 which is shown as being the connecting member which defines one or more spine loops in the system) at least one of the plurality of spine loops being rotatable about the longitudinal axis (Olson ¶0033 “Aspects of the present disclosure facilitate clinician controlled rotation of one or more of the splines within a basket catheter about a longitudinal axis.”).
Olson discloses embodiments for a basket catheter and planar mapping catheter with improvements to the adjustability of each type of catheter. Olson further discloses in ¶0123 that “Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.”. Therefore, one of ordinary skill in the art would think that based on the disclosure of Olson ¶0123 that the improvements shown in reference to the basket catheter designs may be applicable to the embodiments involving the planar configurations. Therefore, one would be reasonably motivated to have a planar catheter configuration as seen in Olson with the rotational manipulation of the spines about a longitudinal axis (Olson ¶0033) for the purpose of further conforming the catheter array to a tissue for improved functionality (See for example, Olson ¶0078 discussing the planar array being adapted to conform to a tissue).
Regarding claim 3, claims 1-2 are obvious over Olson combined with Postma. Olson further discloses wherein each of the spine loops comprising an approximately rectangular shape. (Olson Figures 2A and 4B showing spine loops in a rectangular form).
Regarding claim 4, claims 1-2 are obvious over Olson combined with Postma. Olson further discloses wherein each of the spine loops comprising a distal width wider than a proximal width. (Olson Figures 2B).
Regarding claim 5, claims 1-2 are obvious over Olson combined with Postma. Olson further discloses wherein the plurality of spine loops comprising three spine loops (Olson ¶0075 “Although the planar array 201 in FIG. 2A depicts five struts 210.sub.1-5, the catheter may comprise more or less struts, with spacing between each respective strut based on a desired electrode spacing for a given electrophysiology application.” Showing that the spine loops (formed by the struts) may be equal to three based on the intended use of the device) at least two of the three spine loops being rotatable about the longitudinal axis by manipulation of the handle. (Olson ¶0033 “Aspects of the present disclosure facilitate clinician controlled rotation of one or more of the splines within a basket catheter about a longitudinal axis.”).
Olson discloses embodiments for a basket catheter and planar mapping catheter with improvements to the adjustability of each type of catheter. Olson further discloses in ¶0123 that “Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.”. Therefore, one of ordinary skill in the art would think that based on the disclosure of Olson ¶0123 that the improvements shown in reference to the basket catheter designs may be applicable to the embodiments involving the planar configurations. Therefore, one would be reasonably motivated to have a planar catheter configuration as seen in Olson with the rotational manipulation of the spines about a longitudinal axis (Olson ¶0033) for the purpose of further conforming the catheter array to a tissue for improved functionality (See for example, Olson ¶0078 discussing the planar array being adapted to conform to a tissue).
Regarding claim 6, claims 1-2 are obvious over Olson combined with Postma. Olson further discloses wherein the end effector further comprises a flexible linkage affixed to the plurality of spine loops at a distal end of the end effector along the longitudinal axis. (Olson ¶0081 “As also seen in FIG. 2A, there may be a distal tip 215 where one or more of the struts 210.sub.1-5 come together. This distal tip 215 may be constructed from metal or some other radiopaque material to provide fluoroscopy visualization. The distal tip 215 may further facilitate (semi-) independent planar movement between the struts 210.sub.1-5.” Showing that distal tip 215 affixes the spine loops and is flexible to allow for planar movement of the spines which provides supportive manipulation control between the spine loops through the handle).
Regarding claim 7, claims 1-2 are obvious over Olson combined with Postma. Olson further discloses wherein the end effector further comprises a linkage affixed to a distal end of at least one of the spine loops of the plurality of spine loops, extending along the longitudinal axis, and affixed to the distal portion of the elongated shaft. (Olson ¶0073 “Each of the struts is precisely, laterally separated from each other to facilitate exact spacing between electrodes 211.sub.1-N on adjacent struts 210.sub.1-5, and the struts are coupled to one another at distal and proximal ends (e.g., at a distal tip 215 and bushing 208).”; Figure 2A).
Regarding claim 8, claim 1 is obvious over Olson combined with Postma. Olson further discloses the end effector comprising: a first spine loop comprising the outer pair of spines, the first spine loop defining an outer perimeter of the end effector when the plurality of spines are in the first configuration (Olson Figures 2A-2B where the outer Spine loop is being interpreted as being defined by Strut 2101 & 2105), a second spine loop comprising the inner pair of spines, the inner pair of spines being positioned between the outer pair of spines when the plurality of spines are in the first configuration (Olson Figures 2A-2B where the second Spine loop is being interpreted as being defined by Strut 2102 & 2104 ),
Olson does not explicitly disclose a third spine loop comprising a central pair of spines of the plurality of spines, the central pair of spines being positioned between the inner pair of spines when the plurality of spines are in the first configuration. Olson ¶0075 discloses that “Although the planar array 201 in FIG. 2A depicts five struts 210.sub.1-5, the catheter may comprise more or less struts, with spacing between each respective strut based on a desired electrode spacing for a given electrophysiology application. “. Therefore, one of ordinary skill in the art would think to have a third spine loop composed of the struts, comprising a central pair as the addition of more spine loops facilitates a more detailed mapping application as well as increased tissue conformity since the increased amount of spines allows for more tissue area to be mapped. One would further understand that the central pair of spines being positioned between the inner pair of spines when the plurality of spines are in the first configuration is a design choice made based on the electrophysical mapping application. Olson Figure 2A-2B shows the spine loops being nested, and therefore one of ordinary skill in the art would understand that any extra spine loops being added for the purpose of a given application may also be nested similar to that of the two loop configuration found in Olson Figures 2A-2B.
Regarding claim 9, claims 1 & 8 are obvious over Olson combined with Postma. Olson further discloses the first spine loop being configured to rotate about the longitudinal axis and the second spine loop being configured to rotate about the longitudinal axis (Olson ¶0033 “Aspects of the present disclosure facilitate clinician controlled rotation of one or more of the splines within a basket catheter about a longitudinal axis.”).
Olson discloses embodiments for a basket catheter and planar mapping catheter with improvements to the adjustability of each type of catheter. Olson further discloses in ¶0123 that “Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.”. Therefore, one of ordinary skill in the art would think that based on the disclosure of Olson ¶0123 that the improvements shown in reference to the basket catheter designs may be applicable to the embodiments involving the planar configurations. Therefore, one would be reasonably motivated to have a planar catheter configuration as seen in Olson with the rotational manipulation of the spines about a longitudinal axis (Olson ¶0033) for the purpose of further conforming the catheter array to a tissue for improved functionality (See for example, Olson ¶0078 discussing the planar array being adapted to conform to a tissue).
Neither Olson not Postma teach wherein the first spine loop being configured to rotate between 30° and 90° about the longitudinal axis, and the second spine loop being configured to rotate between -30° and -45° about the longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a first spine loop being configured to rotate between 30° and 90° about the longitudinal axis, and the second spine loop being configured to rotate between -30° and -45° about the longitudinal axis, for the purpose of increasing the configurability of the device, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 10, claims 1 & 8 are obvious over Olson combined with Postma. Olson discloses wherein in the second configuration, the first spine loop being at an angle of approximately 60° to the second spine loop, the second spine loop being at an angle of approximately 60° to the third spine loop, and the third spine loop being at an angle of approximately 60° to the first spine loop. (Olson ¶0071 “After a total of approximately 60° of motion, the first keying feature 130 contacts a stop 134 on first intermediate shaft 106, which prevents any further rotational motion of the inner shaft and second intermediate shaft. In the present embodiment, the splines on both outer shaft 105 and first intermediate shaft 106, and the shafts themselves, do not rotate. Accordingly, the rotation of the splines coupled to inner shaft 109 and second intermediate shaft 107 facilitates the reconfiguration of the basket catheter between a regional and global electrophysiology mapping configuration.”).
Regarding claim 11, claim 1 is obvious over Olson combined with Postma. Olson does not further disclose wherein the spines being positioned in the second configuration when the end effector is in free space, and the spines being movable to the first configuration when the end effector is pressed against a planar surface. Postma further teaches wherein the spines being positioned in the second configuration when the end effector is in free space, and the spines being movable to the first configuration when the end effector is pressed against a planar surface. (Postma; Figure 5L-2 showing the action of flattening the spines into a planar configuration (flattened, a fully planar configuration is not provided, but support for the manipulation to such is found in ¶0061 “According to some embodiments, the catheter system 500 includes several different types of motions to control the deployment, retraction, positioning, size, and shape of the manipulable portion 502. These different types of motions may include coiling, uncoiling, fanning, un-fanning, bifurcated doming, flattening, clam shelling, or a combination of some or all of these motions. In some embodiments, these motions facilitate accommodation of different bodily cavity sizes (e.g., different atrium sizes), as well as proper positioning of the manipulable-portion within the bodily cavity (e.g., atrium) and contact with one or more tissue walls of the bodily cavity.”). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Olson such that the spines being positioned in the second configuration when the end effector is in free space, and the spines being movable to the first configuration when the end effector is pressed against a planar surface, as taught in Postma for the purpose of facilitating accommodation of different bodily cavity sizes (Postma ¶0061).
Regarding claim 12, claim 1 is obvious over Olson combined with Postma. Olson does not further discloses a pull wire extending from the handle to the distal portion of the elongated shaft such that manipulation of the handle moves the pull wire causes the plurality of spines to move between the second configuration and the first configuration. Postma teaches a pull wire extending from the handle to the distal portion of the elongated shaft such that manipulation of the handle moves the pull wire causes the plurality of spines to move between the second configuration and the first configuration (Postma ¶0086 “In some embodiments, sleeve 513a and cable 513b form part of a Bowden cable. A Bowden cable is a generally flexible cable used to transmit force by the movement of an inner cable relative to a hollow outer cable housing (also sometimes referred to as a sleeve or sheath). The housing may be generally of composite construction, for example a tightly helically wound metallic wire sometimes lined with a friction reducing polymer. Typically, a first part of the cable extends outwardly from a first end of the sleeved housing, and a second part of the cable extends outwardly from a second end of the sleeved housing. The translational movement of the inner cable is most often used to transmit a pulling force, although push/pull cables are also employed. The cable housing provides the Bowden cable with compressive strength to resist buckling during a tensioning of the inner cable. “). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Olson to include a pull wire extending from the handle to the distal portion of the elongated shaft such that manipulation of the handle moves the pull wire causes the plurality of spines to move between the second configuration and the first configuration, as taught in Postma for the purpose of facilitating accommodation of different bodily cavity sizes (Postma ¶0061), where Olson ¶0036 further discloses the use of a pull wire for manipulating the struts. By combining the embodiments of Olson and Postma, one can configure a system with an advanced range of motion of manipulation such that is controlled by a pull wire.
Regarding claim 13, claims 1 & 12 are obvious over Olson combined with Postma. Olson further discloses the spines being rotatable about the longitudinal axis. (Olson ¶0033 “Aspects of the present disclosure facilitate clinician controlled rotation of one or more of the splines within a basket catheter about a longitudinal axis.”).
Olson discloses embodiments for a basket catheter and planar mapping catheter with improvements to the adjustability of each type of catheter. Olson further discloses in ¶0123 that “Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.”. Therefore, one of ordinary skill in the art would think that based on the disclosure of Olson ¶0123 that the improvements shown in reference to the basket catheter designs may be applicable to the embodiments involving the planar configurations. Therefore, one would be reasonably motivated to have a planar catheter configuration as seen in Olson with the rotational manipulation of the spines about a longitudinal axis (Olson ¶0033) for the purpose of further conforming the catheter array to a tissue for improved functionality (See for example, Olson ¶0078 discussing the planar array being adapted to conform to a tissue).
Olson does not further disclose a first rotating frame disposed in the distal portion of the elongated shaft and affixed to a first spine of the plurality of spines, and manipulatable in response to movement of the pull wire./ Postma teaches a first rotating frame disposed in the distal portion of the elongated shaft and affixed to a first spine of the plurality of spines, and manipulatable in response to movement of the pull wire (Postma ¶0073 “For example, in some embodiments, manipulable portion 502 includes a structure 502a (e.g., the same or similar to structure or frame 308) “). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Olson to include a first rotating frame disposed in the distal portion of the elongated shaft and affixed to a first spine of the plurality of spines, and manipulatable in response to movement of the pull wire, as taught in Postma for the purpose of facilitating reinforcement of the manipulation portions of the device.
Regarding claim 14, claims 1 & 12-14 are obvious over Olson combined with Postma. Olson further discloses the spines being rotatable about the longitudinal axis. (Olson ¶0033 “Aspects of the present disclosure facilitate clinician controlled rotation of one or more of the splines within a basket catheter about a longitudinal axis.”).
Olson discloses embodiments for a basket catheter and planar mapping catheter with improvements to the adjustability of each type of catheter. Olson further discloses in ¶0123 that “Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.”. Therefore, one of ordinary skill in the art would think that based on the disclosure of Olson ¶0123 that the improvements shown in reference to the basket catheter designs may be applicable to the embodiments involving the planar configurations. Therefore, one would be reasonably motivated to have a planar catheter configuration as seen in Olson with the rotational manipulation of the spines about a longitudinal axis (Olson ¶0033) for the purpose of further conforming the catheter array to a tissue for improved functionality (See for example, Olson ¶0078 discussing the planar array being adapted to conform to a tissue).
Olson does not further disclose a second rotating frame disposed in the distal portion of the elongated shaft and affixed to proximal ends of a second spine loop, the first rotating frame being affixed to proximal ends of a first spine loop, the first spine loop comprising the first spine and a second spine of the outer pair of spines, the first rotating frame and the first spine loop being manipulatable in response to movement of the pull wire, the second spine loop comprising the inner pair of spines, the second rotating frame and the second spine loop being manipulatable in response to movement of the pull wire, and the first rotating frame and the first spine loop being configured to rotate oppositely about annal axis in relation to rotation of the second rotating frame and the second spine loop about the axis.
Postma teaches a second rotating frame disposed in the distal portion of the elongated shaft and affixed to proximal ends of a second spine loop, the first rotating frame being affixed to proximal ends of a first spine loop, the first spine loop comprising the first spine and a second spine of the outer pair of spines, the first rotating frame and the first spine loop being manipulatable in response to movement of the pull wire, the second spine loop comprising the inner pair of spines, the second rotating frame and the second spine loop being manipulatable in response to movement of the pull wire (Postma ¶0073 where the frame defines the plurality of spines which are manipulatable through a cable to perform a plurality of deflection motions) and the first rotating frame and the first spine loop being configured to rotate oppositely about annal axis in relation to rotation of the second rotating frame and the second spine loop about the axis (Postma Figures 5L-2 through 5M-2 which show that the rotating portions may rotate in opposite directions such as to change configurations).
Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Olson such that a second rotating frame disposed in the distal portion of the elongated shaft and affixed to proximal ends of a second spine loop, the first rotating frame being affixed to proximal ends of a first spine loop, the first spine loop comprising the first spine and a second spine of the outer pair of spines, the first rotating frame and the first spine loop being manipulatable in response to movement of the pull wire, the second spine loop comprising the inner pair of spines, the second rotating frame and the second spine loop being manipulatable in response to movement of the pull wire, and the first rotating frame and the first spine loop being configured to rotate oppositely about annal axis in relation to rotation of the second rotating frame and the second spine loop about the axis, as taught in Postma for the purpose of facilitating reinforcement of the manipulation portions of the device while maintaining an extensive range of motion and control to each spine to create a articulated system which can conform to any space.
Regarding claim 15, claims 1 & 12-14 are obvious over Olson combined with Postma. Olson does not further disclose the first spine loop comprising a first support frame affixed to the first rotating frame, and the second spine loop comprising a second support frame affixed second rotating frame. Postma further teaches the first spine loop comprising a first support frame affixed to the first rotating frame, and the second spine loop comprising a second support frame affixed second rotating frame. (Postma ¶0073 “For example, in some embodiments, manipulable portion 502 includes a structure 502a (e.g., the same or similar to structure or frame 308) “). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Olson to include the first spine loop comprising a first support frame affixed to the first rotating frame, and the second spine loop comprising a second support frame affixed second rotating frame, as taught in Postma for the purpose of facilitating reinforcement of the manipulation portions of the device.
Regarding claim 16, claims 1 & 12-14 are obvious over Olson combined with Postma. Olson further discloses a distal cap affixed at the distal portion of the elongated shaft , distal of the first rotating frame and the second rotating frame, wherein a distal end of the pull wire is affixed to the distal cap, (Olson Figure 1A; ¶0054 “The deployment member 120 in some embodiments may be a pull-wire which extends between a catheter handle and a distal cap 115. Actuation of the pull-wire causes expansion/contraction of the basket.” Where the examiner is interpreting the pullwire and cap assembly of figure 1A to be equivalent to the distal portion 215 of Figure 2A such that distal portion 215 can serve as a “cap” as it is the most distal end portion with connects all of the struts.) wherein the pull wire is threaded through a first pull wire lumen of the first rotating frame, wherein the pull wire is threaded through a second pull wire lumen of the second rotating frame, and wherein tension in the pull wire moves the first pull wire lumen to align with the second pull wire lumen. (Olson ¶0082 “In some embodiments of the present disclosure, the mapping catheter 201 may include steering wires which extend a length of catheter shaft 205. Prior to reaching a bushing 208 that couples the catheter shaft 205 to struts 210.sub.1-5 of planar array 201, the steering wires may be coupled to one or more steering rings which receive a force from a proximal end of the steering wires and facilitates steering the catheter shaft 205 and the planar array 201 through a patient's vasculature. “).
Regarding claim 17, claims 1, 12-14, & 16 are obvious over Olson combined with Postma. Olson further discloses a plurality of pull wires each affixed to the distal cap and each threaded through a first respective pull wire lumen of the first rotating frame and a second respective pull wire lumen of the second rotating frame, wherein the plurality of pull wires are configured to move the plurality of spines from the first configuration to the second configuration and from the second configuration to the first configuration. (Olson ¶0082).
Regarding claim 18, claims 1, & 12-14 are obvious over Olson combined with Postma. Olson does not further disclose a center column disposed in the distal portion of the elongated shaft and affixed to proximal ends of a third spine loop, the third spine loop comprising a central pair of spines, the first rotating frame and/or the second rotating frame being movable to rotate about the center column in response to movement of the pull wire. Postma teaches a center column disposed in the distal portion of the elongated shaft and affixed to proximal ends of a third spine loop, the third spine loop comprising a central pair of spines, the first rotating frame and/or the second rotating frame being movable to rotate about the center column in response to movement of the pull wire. (Postma ¶0207 “For example, actuator 572 may include a mechanism that converts an input movement (e.g., an input movement of cover 520a) into an output movement of various control elements 573 (shown in Figure 5M-1 ) in a manner suitable for additionally fanning of the elongate members 504.” Where the examiner is interpreting the control elements 573 as functioning as a central column as they extend through the flexible elements 502 which articulate in reference to parts 573). Before the effective filing date, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Olson to include a center column disposed in the distal portion of the elongated shaft and affixed to proximal ends of a third spine loop, the third spine loop comprising a central pair of spines, the first rotating frame and/or the second rotating frame being movable to rotate about the center column in response to movement of the pull wire, as taught in Postma for the purpose of facilitating reinforcement of the manipulation portions of the device.
Regarding claim 19, claims 1, 12-14, & 18 are obvious over Olson combined with Postma. Olson further discloses a plurality of electrical conductors extending through the elongated shaft, through the center column, and electrically connected to the electrodes. (Olson ¶0082).
Regarding claim 20, claim 1 is obvious over Olson combined with Postma. Olson further discloses wherein the distal portion of the elongated shaft being configured to deflect in relation to longitudinal axis in response to manipulation of the handle. (Olson ¶0077 “The catheter shaft 205 may be made of a flexible material, such that it can be threaded through a tortuous vasculature of a patient. “ where ¶0082 states “Prior to reaching a bushing 208 that couples the catheter shaft 205 to struts 210.sub.1-5 of planar array 201, the steering wires may be coupled to one or more steering rings which receive a force from a proximal end of the steering wires and facilitates steering the catheter shaft 205 and the planar array 201 through a patient's vasculature.” Showing that the elongated shaft 205 can deflect along an axis to facilitate steering through vasculature).
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 extension fee 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 date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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