DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This action is responsive to the Supplemental Response to Restriction Requirement filed on 12/30/2025. Claims 1-13 & 21-25 are pending, and have been examined on the merits.
Election/Restriction
3. Applicant’s election without traverse of Group I (claims 1-13) in the reply filed on 12/30/25 is acknowledged. Non-elected claims 14-20 were cancelled in the 12/30/25 Amendment.
Claim Objections
4. Claims 2, 4-7, & 10 are objected to because of the following informalities:
a. In claim 2, line 2, the recitation of “the flexible circuit” should instead recite --the one or more flexible circuits-- to be consistent with the prior recitations of claim 1 (from which claim 2 depends).
b. In claim 2, line 3, the recitation of “the flexible circuit” should instead recite --the one or more flexible circuits--.
c. In claim 2, lines 3-4, the recitation of “respective ones of the ones of the one or more contact pads” should instead recite --respective ones of the one or more contact pads--.
d. In claim 4, line 1, the recitation of “the contact pad” should instead recite --the one or more contact pads-- to be consistent with the prior recitations of claim 1 (from which claim 4 depends).
e. In claim 5, line 2, the recitation of “the flexible circuit” should instead recite --the one or more flexible circuits--.
f. In claim 5, lines 2-3, the recitation of “the flexible circuit” should instead recite --the one or more flexible circuits--.
g. In claim 6, line 2, the recitation of “the flexible circuit” should instead recite --the one or more flexible circuits--.
h. In claim 7, line 2, the recitation of “the flexible circuit” should instead recite --the one or more flexible circuits--.
i. In claim 10, lines 2-3, the recitation of “the flexible circuit” should instead recite --the one or more flexible circuits--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 3, 6, 7, 9, 10, 21, 22, & 24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
7. Claim 3 recites the limitation “substantially parallel, flexible surfaces” in line 2. The term “substantially” in claim 3 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
8. Claim 6 recites the limitation “the flexible circuit is disposed generally parallel to the first surface” in line 2. The term “generally” in claim 6 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
9. Claim 7 recites the limitation “the flexible circuit is disposed generally perpendicular to the first surface” in line 2. The term “generally” in claim 7 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
10. Claim 9 recites the limitation “a third surface disposed generally perpendicular to the first surface” in line 4. The term “generally” in claim 9 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
11. Claim 10 is rejected as ultimately depending from a claim (claim 9) rejected under 35 U.S.C. 112(b).
12. Claim 21 recites the limitation “a third surface disposed generally perpendicular to the first surface” in lines 2-3. The term “generally” in claim 21 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
13. Claim 22 is rejected as ultimately depending from a claim (claim 21) rejected under 35 U.S.C. 112(b).
14. Claim 24 recites the limitation “aligned along a longitudinal axis” in lines 2-3. This recitation renders the claim indefinite, as it is not clear whether the recited “a longitudinal axis” is intended to be the same “longitudinal axis” previously recited in claim 1 (from which claim 24 depends), or a different longitudinal axis. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required
15. Claim 24 recites the limitation “a generally circular shape” in lines 3-4. The term “generally” in claim 24 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claim Rejections - 35 USC § 103
16. 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.
17. 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.
18. Claims 1, 4-7, 11, 12, 21, 23, & 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0205737 to Beeckler ("Beeckler") [made of record in Applicant’s 11/9/23 IDS] in view of U.S. Patent Application Publication No. 2021/0177355 to Govari ("Govari").
19. Regarding claim 1, Beeckler teaches a medical end effector, comprising:
one or more spines [splines (24) - ¶[0050]; FIG. 1A] extending along a longitudinal axis [the splines extend along the longitudinal axis of probe (29) - see FIG. 1], the spines [(24)] comprising:
a first surface being outward from the longitudinal axis [each spine (24) has a first outer surface that faces outward toward tissue to be contacted - FIG. 1A];
one or more contact pads [cover (44) - ¶[0056]; FIG. 2B] affixed to a portion of the first surface [outer surface] of the spine [(24)] [see ¶[0056] (“a cover 44, which covers the inner surface of the substrate, may bond the electrode unit to the spline”)]; and
one or more flexible circuits [flexible printed circuit with traces (40), electrodes (36a, 36b), and substrate (30) [see ¶[0050] (“at least one electrode unit 22 may be coupled to each spline. As shown in FIG. 1A, each pair of electrodes 36a and 36b for the basket catheter of FIG. 1 are in the form of flexible printed circuit with traces 40 connecting to remaining respective electrodes 36a and 36b”); and ¶[0052] (“Electrode unit 22 comprises a flexible electrically-insulative single-layer or multilayer substrate 30, comprising, for example, a flexible polymer, such as a polyimide”)] disposed over respective ones of the one or more contact pads [(44)] [¶[0056]; FIG. 2B], the one or more flexible circuits each comprising an electrode [either sensing electrode (36a, 36b), or ablation electrode (54) - see ¶[0052] (“Each coating (36a or 36b) functions as a sensing electrode, by sensing electrophysiological signals as described above with reference to FIG. 1; hence, the coatings may be alternatively referred to herein as ‘electrodes’”); and ¶[0062] (“each electrode unit comprises one or more ablation electrodes 54 that coat the outer surface of substrate 30 proximally and/or distally to the nested electrodes”)]…
INDUCTIVE COIL
Beeckler does not, however, teach the following emphasized claim limitation:
the one or more flexible circuits each comprising an electrode and an inductive coil as one unit.
Govari, in a similar field of endeavor, teaches that it was known in the art to co-locate both an electrode and an inductive coil on a single flexible circuit. For example, with reference to FIG. 2 of Govari (reproduced below), a flexible circuit substrate (60) is provided comprising both electrode(s) (55) and a magnetic sensing coil (62) comprising a spiral conductive trace (66) deposited on to substrate (60) [¶’s [0028], [0029], [0030]].
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FIG. 2 of Govari
NOTE: it is the Examiner’s position that an electrode and coil provided on a single flexible circuit are considered “one unit,” as this interpretation is consistent with Applicant’s configuration depicted in FIG. 2B, and described in Applicant’s published Specification (U.S. 2024/0216075), at, e.g., ¶[0042] (“FIG. 2B illustrates a plan view of a flexible circuit 200. The flexible circuit 200 can include both an electrode 210 and an inductive coil 220. For example, the electrode 210 can be an ablation electrode and the inductive coil 220 can be configured to sense magnetic fields, such as magnetic fields generated by magnetic field generator pads located under a patient”)].
Govari further teaches that, based on the signals that are output by sensing coils (62) in response to magnetic fields produced by magnetic field generators (36), a processor can derive both location and orientation coordinates of the expandable assembly (40) in the heart (26) [see, e.g., ¶’s [0024], [0025], [0029], [0030]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Beeckler such that each flexible circuit comprises both an electrode and an inductive coil as one unit, as taught by Govari, since addition of an inductive coil (for purposes of position determination) would provide the benefit/advantage of aiding a physician in properly positioning the probe during a procedure, thereby facilitating the procedure for the physician, and improving patient outcomes.
20. Regarding claim 4, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Beeckler was modified above (in the rejection of claim 1) to include the inductive coil of Govari. Beeckler further teaches wherein the contact pad [cover (44)] comprises a long side [length dimension - FIG. 2B (parallel to the length of the spline)] along the first surface and a short side [width dimension] perpendicular to the long side [the width dimension is perpendicular to the length dimension] and the inductive coil is disposed solely on at least one of the long side and the short side [NOTE: Govari depicts the coil (62) disposed along the short side (or width dimension) - as seen in FIG. 2; it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Beeckler and Govari such that the inductive coil be similarly placed on/in the flexible circuit over the width dimension of the contact pad].
21. Regarding claim 5, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Beeckler was modified above (in the rejection of claim 1) to include the inductive coil of Govari. Beeckler, as modified, further teaches wherein the electrode [either sensing electrode (36a, 36b), or ablation electrode (54)] is disposed on a first side [broadly, the left side] of the flexible circuit [comprising substrate (30) and the components mounted thereon] and the inductive coil is disposed on a second side [the right side] of the flexible circuit [comprising substrate (30) and the components mounted thereon (in a layout similar to FIG. 2 of Govari)].
22. Regarding claim 6, the combination of Beeckler and Govari teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
Beeckler further teaches wherein at least a portion of the first side of the flexible circuit is disposed generally parallel to the first surface of the spine [both the left/right sides of the flexible circuit in Beeckler are parallel to the first (outer or outward-facing) surface of the spine (24) as the flexible circuit is disposed on the outer-facing surface of the spine - FIG. 2B].
23. Regarding claim 7, the combination of Beeckler and Govari teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
Beeckler further teaches wherein at least a portion of the second side [broadly, a width dimension is a “portion” of the right side] of the flexible circuit is disposed generally perpendicular to the first surface [perpendicular to a length dimension of the outer surface of the spine].
24. Regarding claim 11, Beeckler teaches a system comprising:
a medical probe [probe (29) - ¶[0048]; FIG. 1] comprising a medical end effector [basket of splines (24) - ¶[0050]; FIG. 1A] comprising one or more spines [splines (24) - ¶[0050]; FIG. 1A] extending along a longitudinal axis [the splines extend along the longitudinal axis of probe (29) - see FIG. 1], the spines [(24)] comprising:
a first surface being outward from the longitudinal axis [each spine (24) has a first outer surface that faces outward toward tissue to be contacted - FIG. 1A];
one or more contact pads [cover (44) - ¶[0056]; FIG. 2B] affixed to a portion of the first surface [outer surface] of the spine [(24)] [see ¶[0056] (“a cover 44, which covers the inner surface of the substrate, may bond the electrode unit to the spline”)]; and
one or more flexible circuits [flexible printed circuit with traces (40), electrodes (36a, 36b), and substrate (30) [see ¶[0050] (“at least one electrode unit 22 may be coupled to each spline. As shown in FIG. 1A, each pair of electrodes 36a and 36b for the basket catheter of FIG. 1 are in the form of flexible printed circuit with traces 40 connecting to remaining respective electrodes 36a and 36b”); and ¶[0052] (“Electrode unit 22 comprises a flexible electrically-insulative single-layer or multilayer substrate 30, comprising, for example, a flexible polymer, such as a polyimide”)] disposed over respective ones of the one or more contact pads [(44)] [¶[0056]; FIG. 2B], the one or more flexible circuits each comprising an electrode [either sensing electrode (36a, 36b), or ablation electrode (54) - see ¶[0052] (“Each coating (36a or 36b) functions as a sensing electrode, by sensing electrophysiological signals as described above with reference to FIG. 1; hence, the coatings may be alternatively referred to herein as ‘electrodes’”); and ¶[0062] (“each electrode unit comprises one or more ablation electrodes 54 that coat the outer surface of substrate 30 proximally and/or distally to the nested electrodes”)]… [and]
an ablation power generator configured to be connected to the medical probe, and apply an electrical signal to at least one of the electrodes to ablate a tissue of a body part [ablation signal generator - see ¶[0046] (“Advantageously, each pair of nested electrodes may also be used as an ablation electrode, by connecting both the inner and outer electrode to the same terminal of an ablation signal generator”)].
INDUCTIVE COIL AND POSITION MODULE
Beeckler does not, however, teach the following emphasized claim limitations:
the one or more flexible circuits each comprising an electrode and an inductive coil as one unit; [and]
a position module configured to receive position signals from at least one of the inductive coils.
Govari, in a similar field of endeavor, teaches that it was known in the art to co-locate both an electrode and an inductive coil on a single flexible circuit. For example, with reference to FIG. 2 of Govari (reproduced below), a flexible circuit substrate (60) is provided comprising both electrode(s) (55) and a magnetic sensing coil (62) comprising a spiral conductive trace (66) deposited on to substrate (60) [¶’s [0028], [0029], [0030]].
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FIG. 2 of Govari
NOTE: it is the Examiner’s position that an electrode and coil provided on a single flexible circuit are considered “one unit,” as this interpretation is consistent with Applicant’s configuration depicted in FIG. 2B, and described in Applicant’s published Specification (U.S. 2024/0216075), at, e.g., ¶[0042] (“FIG. 2B illustrates a plan view of a flexible circuit 200. The flexible circuit 200 can include both an electrode 210 and an inductive coil 220. For example, the electrode 210 can be an ablation electrode and the inductive coil 220 can be configured to sense magnetic fields, such as magnetic fields generated by magnetic field generator pads located under a patient”)].
Govari further teaches that, based on the signals that are output by sensing coils (62) in response to magnetic fields produced by magnetic field generators (36), a processor can derive both location and orientation coordinates of the expandable assembly (40) in the heart (26) [see, e.g., ¶’s [0024], [0025], [0029], [0030]].
Govari further teaches a position module configured to receive position signals from at least one of the inductive coils [software of processor (41) - see ¶[0030] (“As explained above, processor 41 receives and processes the signals that are output by sensing coils 62 in response to the magnetic fields produced by magnetic field generators 36, and thus derives both location and orientation coordinates of the distal side of inflated balloon 40 in heart 26. In the pictured embodiment, sensing coils 62 are formed on multiple different substrates 60 at different locations around balloon 40. Processor 41 processes the respective signals that are output by sensing coils 62 on in combination, for example, by finding a directional average of the position coordinates of the multiple sensing coils. Processor 41 is thus able to derive position coordinates of the inflated balloon with enhanced accuracy”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Beeckler such that each flexible circuit comprises both an electrode and an inductive coil as one unit, as well as to include a position module configured to receive position signals from at least one of the inductive coils, all as taught by Govari, since addition of an inductive coil (for purposes of position determination) and a position module to process signals therefrom would provide the benefit/advantage of aiding a physician in properly positioning the probe during a procedure, thereby facilitating the procedure for the physician, and improving patient outcomes.
25. Regarding claim 12, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Beeckler further teaches wherein the one or more spines [(24)] are configured to form an expandable basket assembly [¶[0050]; FIG. 1A] comprising the one or more spines [(24)] extending along the longitudinal axis [along the longitudinal axis of probe (29) - see FIG. 1] and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form [¶[0050]; FIG. 1A].
26. Regarding claim 21, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
With reference to annotated FIG. 2B of Beeckler (provided below), Beeckler further teaches wherein the spines [(24)] further comprise:
a second surface [bottom surface] opposite the first surface [top surface];
a third surface [left surface] disposed generally perpendicular to the first surface [top surface];
a fourth surface [right surface] opposite the third surface [left surface].
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Annotated FIG. 2B of Beeckler
27. Regarding claim 23, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Beeckler was modified above (in the rejection of claim 1) to include the inductive coil of Govari. Govari further teaches wherein the inductive coil is configured to function as a single-axis sensor [¶[0029]; FIG. 2].
28. Regarding claim 24, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Beeckler further teaches wherein the one or more spines further comprise:
a distal portion [distal portion of splines (24) - FIG. 1A];
a delivery configuration in which the distal portion is aligned along a longitudinal axis [the longitudinal axis of probe (29)] [during insertion - ¶[0048]]; and
a deployed configuration [expansion of basket - ¶[0050]; FIG. 1A] in which the distal portion comprises a generally circular shape generally orthogonal to the longitudinal axis [clearly shown in FIG. 1A].
29. Claims 2, 3, & 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Beeckler and Govari, and further in view of U.S. Patent Application Publication No. 2018/0192959 to Mou et al. ("Mou").
30. Regarding claim 2, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Beeckler was modified above (in the rejection of claim 1) to include the inductive coil of Govari. Govari further teaches that the inductive coil comprises a first inductive coil embedded in the flexible circuit [Govari, ¶[0029] (broadly, the coil is deposited on the substrate, and then covered with a coating, thereby being “sandwiched” or embedded in the overall substrate)].
Beeckler does not teach that the flexible circuit bulges over the one or more contact pads. As such, the combination of Beeckler and Govari does not, however, teach:
the first inductive coil conforms to a curvature of the flexible circuit bulging over respective ones of the ones of the one or more contact pads.
Mou, in a similar field of endeavor, teaches electrophysiology catheters having electrodes mounted on splines of an expandable member [Abstract]. Mou teaches that it was known to provide electrodes on flex circuits that are wrapped over an outer surface of the spline (or around half of a circumference of the outer surface of the spline) to allow for endocardiac electrode contact on either side of the spline [e.g., ¶[0034]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Beeckler and Govari such that the flexible circuit be wrapped over an outer surface of the spine (such that it bulges over the one or more contact pads) in order to allow for endocardiac electrode contact on either side of the spine. As modified, the first inductive coil being a part of the flexible circuit would flex/curve with the flexible surface.
31. Regarding claim 3, the combination of Beeckler, Govari, & Mou teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Beeckler was modified above (in the rejection of claim 1) to include the inductive coil of Govari. Govari further teaches the first inductive coil being confined between two substantially parallel, flexible surfaces [Govari, e.g., ¶[0029] (between the substrate and coating)].
32. Regarding claim 8, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Beeckler and Govari does not, however, teach:
wherein each respective one of the one or more flexible circuits extends around the respective spine.
Mou, in a similar field of endeavor, teaches electrophysiology catheters having electrodes mounted on splines of an expandable member [Abstract]. Mou teaches that it was known to provide electrodes on flex circuits that are wrapped over an outer surface of the spline (or around half of a circumference of the outer surface of the spline) to allow for endocardiac contact on either side of the spline [e.g., ¶[0034]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Beeckler and Govari such that each respective one of the one or more flexible circuits extends around the respective spine in order to allow for endocardiac electrode contact on either side of the spine.
33. Regarding claim 9, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
With reference to annotated FIG. 2B of Beeckler (provided below), Beeckler further teaches wherein the spines [(24)] further comprise:
a second surface [bottom surface] opposite the first surface [top surface];
a third surface [left surface] disposed generally perpendicular to the first surface [top surface];
a fourth surface [right surface] opposite the third surface [left surface].
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Annotated FIG. 2B of Beeckler
The combination of Beeckler and Govari does not, however, teach:
wherein the one or more flexible circuits each extend around the first surface, third surface, fourth surface, and at least a portion of the second surface of the spine.
Mou, in a similar field of endeavor, teaches electrophysiology catheters having electrodes mounted on splines of an expandable member [Abstract]. Mou teaches that it was known to provide electrodes on flex circuits that are wrapped over an outer surface of the spline (or around half of a circumference of the outer surface of the spline) to allow for endocardiac contact on either side of the spline [e.g., ¶[0034]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Beeckler and Govari such that the one or more flexible circuits extend around the respective spine in order to allow for endocardiac electrode contact on either side of the spine. As modified, the one or more flexible circuits would each extend around the first surface [top surface, third surface [left surface], fourth surface [right surface], and at least a portion of the second surface [bottom surface] of the spine.
34. Regarding claim 10, the combination of Beeckler, Govari, & Mou teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Beeckler further teaches wherein the one or more flexible circuits extending around at least a portion of the second surface of the spine defines a gap in the flexible circuit through which one or more wires are routed [as modified, and as broadly as claimed, the flexible circuits of Beeckler, Govari, & Mou include vias [gaps] through which one or more wires are routed [e.g., ¶[0053]].
35. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Beeckler and Govari, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2018/0180684 to Govari ("Govari ‘684").
36. Regarding claim 13, the combination of Beeckler and Govari teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Beeckler further teaches wherein the one or more spines (24) comprises a distal end [the splines (24) in Beeckler are connected to (joined at) a curved/rounded tip at their respective distal ends - see FIG. 1A] and a proximal end [the end emerging from the distal end of probe body (29) - see FIG. 1A].
The combination of Beeckler and Govari does not, however, teach:
a three-axis sensor coupled to the one or more spines wherein the one or more spines comprises a distal end and a proximal end and the three-axis sensor is disposed proximate the distal end.
Govari ‘684, in a similar field of endeavor, teaches a navigation sensor which includes three coil arrangements aligned along three orthogonal axes to determine position and orientation of the navigation sensor in three dimensions within a known, induced magnetic field [e.g., ¶’s [0075], [0082], [0083]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Beeckler and Govari to include a known, art-recognized three-axis sensor, such as that of Govari ‘684, coupled to the one or more spines in order to determine position and orientation of the navigation sensor (and therefore the spline) in three dimensions, since such a modification would provide the benefit/advantage of aiding a physician in properly positioning/maneuvering the probe during a procedure, thereby facilitating the procedure for the physician, and improving patient outcomes. As modified, placement of the three-axis sensor anywhere proximal of a distal-most end of a spline would constitute the three-axis sensor being disposed proximate the distal end.
37. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Beeckler and Govari, as applied to claim 21 above, and further in view of U.S. Patent Application Publication No. 2017/0354364 to Bar-Tal et al. ("Bar-Tal") [made of record in Applicant’s 11/9/23 IDS].
38. Regarding claim 22, the combination of Beeckler and Govari teaches all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
While Beeckler teaches the use of wires (31) extending from the flexible circuits to the proximal end of the probe [e.g., ¶[0053]], the combination of Beeckler and Govari does not explicitly teach:
one or more wires disposed proximate the second surface and routed along a length of the spine.
Bar-Tal, in a similar field of endeavor, relates to catheters for recording intracardiac electrocardiogram (ECG) signals and/or ablating cardiac tissue [e.g., ¶[0002]]. More particularly, Bar-Tal teaches a basket catheter (22) comprising a basket (20) of splines (28) that is connected to a console (36) [¶[0041]; FIG. 1]. Bar-Tal further teaches that it was known to connect conducting elements (24) disposed on the surface of each of the splines to the console (36) via a wire (42) which passes through the interior of the spline [¶[0043]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Beeckler and Govari such that the one or more wires disposed proximate [broadly, “near”] the second surface [be] routed along a length of the spine, since such a particular known, wire routing technique was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Bar-Tal, and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Beeckler/Govari, and the results (routing a wire from a component disposed on a spline to a proximal location (e.g., to a console)) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
39. Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Beeckler, Govari, & Govari ‘684, as applied to claim 13 above, and further in view of U.S. Patent Application Publication No. 2013/0102869 to Kordis et al. ("Kordis").
40. Regarding claim 25, the combination of Beeckler, Govari, and Govari ‘684 teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Beeckler teaches that the splines (24) are connected to (joined at) a curved/rounded tip at their respective distal ends [see FIG. 1A].
The combination of Beeckler, Govari, and Govari ‘684 does not, however, explicitly teach:
an atraumatic tip disposed distal the three-axis sensor.
Kordis, in a similar field of endeavor, teaches a mapping catheter assembly (8) including a spline basket (12) having splines (14) with electrodes disposed thereon [¶[0103]]. Kordis further teaches that the distal portions of the splines (14) are securably disposed within a distal, atraumatic tip [see ¶[0127] (“distal tip 16 may include a top part 104 and a bottom part 108. The distal portions 66 of the splines 14 are securably disposed within the distal tip 16. The top surface 106 of the top part 104 may have any suitable shape, such as a substantially flat surface 106 with rounded edges so that the distal tip 16 is an atraumatic tip, i.e., a tip that will not cause damage to atrial tissue”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Beeckler, Govari, & Govari ‘684 such that the splines (24) bet connected to (or joined at) an atraumatic tip at their distal ends, since such a tip design would provide the benefit/advantage of not causing damage to atrial tissue, as explicitly taught by Kordis. Further, as modified, since the splines are connected to (or joined at) an atraumatic tip at their distal ends, the atraumatic tip will be distal to any components mounted on the splines, including, e.g., the three-axis sensor.
Conclusion
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/Bradford C. Blaise/Examiner, Art Unit 3794