DETAILED ACTION
This action is pursuant to the claims filed on November 9, 2023. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 and 16-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Spector (U.S. PGPub. No. 2023/0190166).
In regards to independent claim 1, Spector discloses an end effector for a catheter (an electrode array 103 labeled in Fig. 4 of a cardiac mapping catheter 100 of Figs. 1-4, [0031]), the end effector comprising:
a flexible circuit layer extending along a longitudinal axis from a proximal portion to a distal portion (a plurality of tines 105 or splines extending from the catheter shaft through the electrode array as shown in Figs. 1-4), the flexible circuit layer comprising a first surface and a second surface opposite the first surface ([0038]-[0039]: each of the two flat sides of the tines may contain a plurality of electrodes and its respective flexible printed circuit);
a framework extending generally parallel to the flexible circuit layer along the longitudinal axis from the proximal to the distal portion (flexible support frame 115 disposed along the tines 105 visibly shown in Figs. 1-3, [0032], [0037]); and
a flexible polymer layer encapsulating both the framework and the flexible circuit layer (deformable surface 107 is a flexible membrane where the tines 105, electrode 113 and support frame 115 are retained within as shown in Figs. 1-4, [0035] ,[0037]).
In regards to claim 2, Spector further discloses one or more first electrodes affixed to the first surface of the flexible circuit layer within its contact surface exposed through the flexible polymer layer to the ambient environment ([0038], [0057]: electrodes on the first side, i.e. the top side of the tine or spline 105 are exposed via opening 207; the electrodes 113 are disposed along a copper trace 201 and a copper pad which are part of the tine’s 105 flexible printed circuit as shown in Fig. 2).
In regards to claim 3, Spector further discloses one or more second electrodes affixed to the second surface of the flexible circuit layer within its contact surface exposed through the flexible polymer layer to the ambient environment ([0038], [0057]: electrodes on the second side, i.e. the bottom side of the tine or spline 105 are exposed via opening 207; the electrodes 113 are disposed along a copper trace 201 and a copper pad which are part of the tine’s 105 flexible printed circuit as shown in Fig. 2).
In regards to claim 4, Spector further discloses the first electrodes are axially aligned with the second electrodes to define pairs of opposite facing electrodes ([0038], [0048]-[0050]: the electrodes are disposed along a top surface and a bottom surface of the tines 105 to form a stacked electrode arrangement).
In regards to claim 5, Spector further discloses pairs of opposite facing electrodes are aligned generally parallel to the longitudinal axis ([0038], [0048]-[0050]: the two stacked electrodes extend along the tine which are parallel to the longitudinal axis of the electrode array 103).
In regards to claim 6, Spector further discloses the pairs of opposite facing electrodes are aligned generally transverse to the longitudinal axis ([0038], [0048]-[0050]: the stacked electrode arrangement along the tines 105 are aligned perpendicular/transverse to the longitudinal axis).
In regards to claim 7, Spector further discloses a plurality of pairs of first electrodes disposed on the first surface, the electrodes of each pair of first electrodes being spaced apart over a minimum gap and each pair of first electrodes spaced apart from adjacent pairs of first electrodes over a predetermined distance ([0048]: each of the individual sensing electrodes of the electrode array are arranged in an ordered series and are separated by a known distance along the top surface of the tines via the opening 207 of the flexible membrane of the deformable surface).
In regards to claim 8, Spector further discloses a plurality of pairs of second electrodes disposed on the second surface, the electrodes of each pair of second electrodes being spaced apart over a minimum gap and each pair of second electrodes spaced apart from adjacent pairs of second electrodes over a predetermined distance ([0048]: each of the individual sensing electrodes of the electrode array are arranged in an ordered series and are separated by a known distance along the bottom surface of the tines via the opening 207 of the flexible membrane of the deformable surface).
In regards to claim 9, Spector further discloses the framework is coupled to the flexible circuit layer (the flexible support frame 115 is disposed on the tines 105 as best shown in Fig. 3), the framework comprises a proximal end that divides into two symmetrical side members extending along the longitudinal axis (the flexible support frame 115 is divided into two symmetrical sides about the longitudinal axis of the end effector 110) and no framework is disposed on an area over the longitudinal axis from the proximal portion through the distal portion of the flexible circuit layer (Figs. 1-4 shows that no tines 105 extend over the longitudinal axis of the end effector 105, therefore, no frame 115 disposed on the tines 105 extend from proximal portion through the distal portion of the tine 105).
In regards to claim 10-11, Spector further discloses the end effector remains in contact against a generally planar surface with a force applied to the proximal portion of the end effector in a vertical axis with respect to the generally planar surface and a force applied generally parallel to the generally planar surface (the array 103 defines a planar surface which is configured to remain in contact with a generally planar surface tissue; [0017]: “Exemplary methods include providing an electrode array comprising a flexible support frame such that, upon deployment from a sheath, the electrode array conforms to the shape of a tissue and lies substantially flat when deployed against the tissue.”).
In regards to claim 16, Spector further discloses the framework comprises a proximal end that divides into two symmetrical side members extending along the longitudinal axis (the flexible support frame 115 is divided from distal to proximal ends into two symmetrical sides about the longitudinal axis of the end effector 110) so that no framework is disposed on an area over the longitudinal axis from the proximal portion through a central portion of the flexible circuit layer (Figs. 1-4 shows that no tines 105 extend over the longitudinal axis of the end effector 105, therefore, no frame 115 disposed on the tines 105 extend from proximal portion through a central portion of the tine 105).
In regards to claims 17-18, Spector further discloses the framework comprises a proximal portion that divides into a plurality of meandering members extending along the longitudinal axis towards the distal portion of the flexible circuit layer (the flexible support frame 115 comprises meandering members in Fig. 1-4), in which the meandering members comprise a sinusoidal member extending along the longitudinal axis on a plane (the flexible support frame 115 comprises meandering members which have sinusoidal shape in Fig. 1-4).
In regards to claim 19, Spector further discloses a plurality of coils disposed on the flexible circuit layer ([0046]: the cardiac mapping catheter may include two or more magnetic coils, (e.g., magnetic tracking sensors or magnetic location sensors 123). The magnetic sensors may be positioned on opposing ends of the deformable surface”).
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Spector as applied to claim 9/1 above.
In regards to claim 12-15, Spector discloses the invention substantially as claimed in claim 9/1 and discussed above. Spector discloses that each side member [of the framework] comprises two curvilinear members (the flexible support frame 115 are divided equally into symmetrical two members, each of the two members comprises two curvilinear members or sinusoidal shape of the support frame 115 extending longitudinally along the tines 105).
However, Spector does not disclose that each side member [of the framework] comprises a proximal portion that divides into three, four or five curvilinear members extending along the longitudinal axis to rejoin proximate the distal end of the flexible circuit layer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide additional curvilinear members to each side member of the framework of Spector, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Furthermore, dividing the plurality of curvilinear members into different groups (e.g. outer side member and inner side member) would involve routine skilled in the art. Adding additional inner and outer members, each comprising groups of curvilinear members along the flexible circuit layer provides for additional mechanical support to lie flat when deployed against tissue ([0034], [0037]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Spector as applied to claim 19/1 above, and further in view of Rao et al. (hereinafter ‘Rao’, U.S. PGPub. No. 2020/0030024).
In regards to claim 20, Spector discloses the invention substantially as claimed in claim 19/1 and discussed above. Spector discloses a plurality of elongate coil on either side of the longitudinal axis (elongate magnetic coils 123 extending along either side of the longitudinal axis of the electrode array 100; [0046]: “The magnetic coils in the opposing positions allow for shape detection of the array and identification of each electrode's position in 3D space”).
However, Spector does not disclose the plurality of elongate coils are coplanar with the first surface and a rectangular coil disposed proximate the distal portion of the flexible circuit and coplanar with the first surface.
Rao discloses providing a plurality of planar location coils (coils 424, 422, 442, and 440 in Fig. 6) on a substrate to provide along a catheter ([0057]). The planar coils or traces comprises a rectangular coil (see the rectangular shape of the coils 424, 422, 442, and 440). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plurality of elongate coils of Spector and incorporate planar coils along a distal portion of the flexible circuit along the flexible circuit as taught by Rao, as doing so provides location measurement of the distal portion of the catheter when the device is inserted into the body ([0057]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 12/8/2025