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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/03/2026 has been entered.
Response to Amendment
The Amendment filed February 04, 2026 has been entered. Currently, claims 1, 12, 14, 16-18, 20, and 22 have been amended, claims 23-24 have been newly added, and claims 1-3, 6-12, 14, 16-24 are pending in the application.
Claim Objections
Claim 2 is objected to because of the following informalities: the phrase “the first magnetic field sensing coil” on line 2 should be amended to read “the first magnetic field sensing coil trace” as similarly amended claim 18. Appropriate correction is required. Claim 3 is also objected to because it is dependent on claim 2.
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 16 is 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 16 recites the limitation "the magnetic file sensing coil wire" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 6-8, 10, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Honour (U.S. Application No. 20070219551 A1), in view of Bonner (U.S. Application No. 20030093104 A1), and further in view of Christian (U.S. Application No. 20140163548 A1).
Regarding independent claim 1, Honour discloses an electrophysiology catheter (Figs. 3, 21-22) having:
an elongated catheter body (40, pa. 0101);
a deflection section (42, portion of the catheter distal to the elongated catheter body) distal of the catheter body (pa. 0024, 0067);
a distal electrode section (pa. 0098, portion of the catheter distal to the deflection section) having:
a housing (portion of catheter which includes the distal electrode section which contains the multiple electrodes 44) with a generally-cylindrical, hollow housing body (pa. 0101) with an outer surface, the housing body defining a lumen (pa. 0019, 0066) and an opening (92, pa. 0105) in a sidewall allowing access into the lumen; and the housing body comprising:
a distal portion (pa. 0094, a middle portion of the distal electrode section as illustrated in Fig. 21) having a distal outer diameter, and a distal end portion (a distalmost portion of the distal electrode section) having a distal end diameter, and
a proximal portion (a proximal-most portion of the distal electrode section) having a proximal outer diameter;
the opening in the sidewall of the housing having a proximal edge (see border of the opening in the sidewall of the catheter body in Fig. 22). Examiner is interpreting “edge” as the line where an object or area begins or ends; a border.
a flex circuit (34) having a first portion (distalmost portion located on the distal portion of the housing body) wrapped generally circumferentially around the outer surface of the distal portion of the housing body (pa. 0103, 0105) and a second portion (proximal-most portion located on the proximal portion of the housing body) extending into the lumen via the opening in the housing body (see Fig. 22);
a tip electrode (64) distal of the housing body (pa. 0078 & Figs. 8-9), the tip electrode having a shell portion, the tip electrode having a proximal end (a proximal-most structure of the tip electrode) attached (at least, indirectly attached) to a border/structure between the distal end portion and the distal portion of the housing body (See Figs. 8-9, 17) such that a distal end (a distal end of conductive traces 36 as seen in Fig. 8) of the flex circuit is proximal of the proximal end of the tip electrode (see Figs. 8-9).
Examiner is interpreting a shell as any protective outer case/body structure; therefore, the outer body structure of the tip electrode meets the claim limitation. Furthermore, given the absent use of the term "attach" in the filed Specification, Examiner will interpret the claim term in light of the plain meaning as two components being directly or indirectly connected to each other. This definition is supported by Figures 4 and 6 of the filed Drawings which shows the tip electrode having a proximal end at least indirectly attached to the distal neck of the housing, and further supported by paragraph [0062] of the filed Specification which describes the tip electrode as being "mounted on an extended distal end 63D of the stem 63", wherein the stem is not part of the distal neck of the housing (i.e., implying the indirect attachment style).
Lastly, Honour discloses a control handle (e.g., steering mechanism) proximal of the catheter body (pa. 0024, 0067-0068). Examiner is using the broad interpretation of a control handle to mean any controlling mechanism that allows a user to manipulate the catheter, such as for example a steering mechanism.
However, Honour does not disclose:
element A: the distal outer diameter being smaller than the proximal outer diameter such that the housing body has a first step at a junction between the distal portion and the proximal portion,
element B: the distal end diameter of the distal end portion being smaller than the distal outer diameter of the distal portion such that the housing body has a second step distal of the first step that defines a distal neck of the housing body,
element C: the opening in the sidewall having a proximal edge along the first step, or
element D: the flex circuit is supported between the first step and the second step.
Regarding element A: Bonner, in the same field of endeavor teaches a catheter with an elongated tubular body (10, pa. 0044 & Figs. 1-2) and a distal electrode section (portion of the catheter distal to the tubular body) comprising:
the distal outer diameter (32, proximal portion, pa. 0044-0045) being smaller than the proximal outer diameter (30) such that the housing body has a first step at a junction between the distal portion and the proximal portion. Examiner is interpreting “step” as a surface that lies at a higher level compared to the level of the adjacent/distal surface. Therefore, a first proximal-most step can be seen between the different diameters/surface levels as shown in Fig. 2 to help anchor the distal portion of the catheter (pa. 0044).
Regarding element B: Bonner teaches the distal end diameter of the distal end portion (32, distal portion, pa. 0045) being smaller than the distal outer diameter of the distal portion such that the housing body has a second step distal of the first step. Examiner is pointing to the distalmost second step (tapered section between the stylet 28 and distal end portion) seen between the different diameters as shown in Fig. 2 to create a more atraumatic tip configuration for the housing body (pa. 0045). Furthermore, the second step defines a distal neck (i.e., the surface of 28, as seen in in Figs. 1-2) of the housing body.
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 have modified the housing body of Honour to include the structural stepped configuration of Bonner for the purpose of creating a stable distal electrode section.
Regarding element C: Honour already discloses the proximal edge being located along the proximal section of the distal electrode section, and Bonner already teaches the first step to be located on the proximal-most section of the distal electrode section. Therefore, the combination of Honour/Bonner would lead the device to have the proximal edge along the first step.
Regarding element D: Honour already discloses the flex circuit having a first portion wrapped around the distal portion (which includes the distal outer diameter) of the housing body, and Bonner already teaches the first step to be located on the proximal-most section of the catheter housing body and the second step to be located on the distalmost section of the hollow-housing body. Therefore, the combination of Honour and Bonner would lead to configuration of the distal electrode section comprising the flex circuit being supported between the first step and the second step.
However, Honour/Bonner combination do not teach the tip electrode comprising a plug portion and an internal chamber configured to receive fluid.
Christian, in the same field of endeavor, teaches the tip electrode (10, pa. 0033 & Figs. 2-3, 7-8), distal of the housing body (16), having a shell portion (46, pa. 0058) for deformation and/or deflection of the electrode section (pa. 0046-0047), a plug portion (88, pa. 0058, 0067) to prevent ingress of blood and/or fluids (pa. 0058), and an internal chamber (60, pa. 0067) configured to receive fluid.
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 have modified the distal tip electrode of Honour to include a plug in order to prevent ingress of blood and/or fluids into the volume defined by the electrode shell.
Regarding claim 6, Honour/Bonner/Christian combination discloses the distal electrode assembly includes a ring electrode (44) and a ring spacer (72) on the outer surface of the housing body (Honour, pa. 0023, 0076, 0088 & Figs. 9-13).
Regarding claim 7, Honour/Bonner/Christian combination discloses wherein the housing body has a ridge (66) at its proximal end, and the ring electrode abuts the ridge (pa. 0083 & Fig. 8), and the ring spacer (72) abuts the ring electrode (Honour, pa. 0086 & Fig. 9).
Examiner is interpreting a “ridge” as an elevated structural feature. Honour discloses circumferential depressions, or ridges, adapted to receive the electrode rings. Moreover, Examiner is interpreting the word “abutting” as to be next to or have a common boundary with; touch or lean on. Therefore, the ring spacer of Honour satisfy the abutting definition.
Regarding claim 8, Honour/Bonner/Christian combination discloses wherein the housing body has a ridge at its proximal end, and the ring spacer abuts the ridge, and the ring electrode abuts the ring spacer (Honour, pa. 0083, 0086 & Figs. 8-9).
Regarding claim 10, Honour discloses the invention substantially as claimed in claim 1 and discussed above.
However, Honour/Christian combination do not disclose an annular ridge at its proximal end, the annular ridge having an outer ridge diameter greater than the proximal outer diameter of the proximal portion of the housing body.
Bonner, in the same field of endeavor, teaches an annular ridge (the stepped/elevated structure that is located proximal to the proximal outer diameter 30, pa. 0044 & Fig. 2) at its proximal end, the annular ridge having an outer ridge diameter greater than the proximal outer diameter of the proximal portion of the housing body (see Fig. 2) for the purpose of allowing two sections of the catheter body to fit with each other (pa. 0044).
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 have modified the housing body of Honour to add the annular ridge of Bonner for the purpose of connecting two body sections.
Regarding claims 17 and 20, Honour discloses the flex circuit has a T-configuration in which the first portion is generally rectangular and wrapped around the outer surface of the distal portion of the housing body, and the second portion is elongated and extends from the first portion into the lumen via the opening in the sidewall of the housing body (pa. 0098, 0105 & Figs. 17-18, 21-22).
Examiner is interpreting the “L-configuration” as half of a “T-configuration”. Therefore, as seen in Fig. 18 of Honour, an imaginary line can be drawn in the middle of the T-configuration to form two L-configurations. Therefore, Honour discloses the flex circuit having an L-configuration.
However, Honour/Christian combination do not disclose the flex circuit being supported between the first and the second step.
Honour already discloses the flex circuit having a first portion wrapped around the distal portion (which includes the distal outer diameter) of the housing, and as seen in claim 1, Bonner already teaches the first step to be located on the proximal-most section of the housing and the second step to be located on the distalmost section of the housing. Therefore, the combination of Honour and Bonner would lead to configuration of the catheter body comprising the flex circuit to be supported between the first step and the second step.
Regarding claim 19, Honour/Bonner/Christian combination discloses the second portion of the flex circuit comprises connection pads that connect to one or more electrical components and are configured to pass electrical signals arising in the first and second magnetic field sensing coil traces toward the control handle (Honour, pa. 0064).
Claims 2-3, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Honour, Bonner, and Christian as applied to claim 1 above, and further in view of Nevo (U.S. Application No. 20030187347 A1).
Regarding claim 2, Honour/Bonner/Christian combination disclose the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose the flex circuit having a first magnetic field sensing coil trace, and a second magnetic field sensing coil trace generally perpendicular to the first magnetic field sensing coil.
Nevo, in the same field of endeavor, teaches the flex circuit has a first magnetic field sensing coil trace (
T
C
x
,
T
C
1
,
T
C
3
)
, and a second magnetic field sensing coil trace (
T
C
y
,
T
C
2
,
T
C
4
)
, generally perpendicular to the first magnetic field sensing coil (pa. 0070 & Fig. 5) to sense and indicate the location and orientation of the catheter (pa. 0027).
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 have added magnetic field sensing coil traces to the flex circuit of Honour in order to allow the user to sense and indicate the location and orientation of the catheter within the body cavity.
Regarding claim 3, Honour/Bonner/Christian combination disclose the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose the first and second magnetic field sensing coil traces are electrically connected to one or more cables extending through the catheter body and the deflection section.
Nevo, in the same field of endeavor, teaches the first and second magnetic field sensing coil traces are electrically connected to one or more cables extending through the catheter body and the deflection section (pa. 0073) to sense and indicate the location and orientation of the catheter (pa. 0027).
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 have added magnetic field sensing coil traces to the flex circuit of Honour in order to allow the user to sense and indicate the location and orientation of the catheter within the body cavity.
Regarding claim 18, Honour/Bonner/Christian combination disclose the invention substantially as claimed in claims 1 and 17 and discussed above.
However, they do not disclose the first portion of the flex circuit comprises a first magnetic field sensing coil trace, and a second magnetic field sensing coil trace generally perpendicular to the first magnetic field sensing coil trace.
Nevo, in the same field of endeavor, teaches the first portion of the flex circuit has a first magnetic field sensing coil trace (
T
C
x
,
T
C
1
,
T
C
3
)
, and a second magnetic field sensing coil trace (
T
C
y
,
T
C
2
,
T
C
4
)
, generally perpendicular to the first magnetic field sensing coil trace (pa. 0070 & Fig. 5) to sense and indicate the location and orientation of the catheter (pa. 0027).
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 have added the magnetic field sensing coil traces to the flex circuit of Honour in order to sense and indicate the location and orientation of the catheter within the body cavity.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Honour, Bonner, and Christian as applied to claim 1 above, and further in view of Ku (U.S. Application No. 20150073514 A1).
Regarding claim 9, Honour/Bonner/Christian combination disclose the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose proximal edge having an arcuate configuration.
Ku, in the same field of endeavor, teaches the opening in the housing body (112a) comprises a proximal edge (172a, 172b) having an arcuate configuration (pa. 0082 & Fig. 12A) to act as anchoring regions to secure internal members (pa. 0082-0083).
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 have modified the shape of the opening in the housing body for the purpose of having a configuration that preferrable to act as anchoring regions to secure internal members.
Claims 11-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Honour, Bonner, and Christian as applied to claim 1 above, and further in view of Jimenez (U.S. Patent No. 9433752 B2).
Regarding claim 11, Honour/Bonner/Christian combination disclose the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose the lumen is partially occluded at least at its distal end by a partial peripheral lip that projects inwardly into the lumen.
Jimenez, in the same field of endeavor, teaches the lumen (19) is partially occluded at least at its distal end by a partial peripheral lip (created by the puller wires 28A, 28B) that projects inwardly into the lumen (Col. 8, lines 7-11; Col. 11, lines 58-67 – Col. 12, lines 1-2 & Fig. 2-2B).
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 have substituted the puller member of Honour with the structural configuration of the puller member of Jimenez, which in turn creates the partial peripheral lip) because it requires less actuation force by a user and imposes less shear stress on the puller wire.
Regarding claim 12, Honour discloses a puller member (e.g., a pull wire) having a proximal portion (pa. 0067).
However, Honour/Bonner/Christian combination do not disclose:
element A: the puller member having first and second proximal portions and a U-bend portion connecting the first and second proximal portions, wherein the partial peripheral lip comprises first and second axial through holes connected by a curved elongated recess on a distal face of the lip,
element B: the first and second axial through holes configured to receive the first and second proximal portions of the puller member, and
element C: the curved elongated recess configured to receive the U-bend portion of the puller member.
Regarding the features of element A: Jimenez, in the same field of endeavor, teaches a puller member (28) having first (28A) and second proximal (28B) portions and U-bend portion (28M) connecting the first and second proximal portions (Col. 9, lines 51-57 & Fig. 5A), wherein the partial peripheral lip comprises first and second axial through holes (the two vertically aligned holes which accept the first and second proximal portions of the puller member) connected by a curved elongated recess on a distal face of the lip (Col. 9, lines 55-67 & Figs. 5A-5) because it requires less actuation force by a user and imposes less shear stress on the puller wire ( Col. 9, lines 51-55).
Regarding the features of element B: Jimenez teaches the first and second axial through holes (37) configured to receive the first and second proximal portions of the puller member (Col. 10, lines 65-67 – Col. 11, lines 1-3).
Regarding the features of element C: the curved elongated recess configured to receive the U-bend portion of the puller member (Col. 9, lines 50-67; Col. 11, lines 37-38 & Figs. 4C-5).
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 have substituted the puller member of Honour with the structural configuration of the puller member of Jimenez because it requires less actuation force by a user and imposes less shear stress on the puller wire.
Regarding claim 14, Honour/Bonner/Christian combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose a fluid tubing extending through the catheter body and the deflection section and into the distal electrode section, the fluid tubing having a distal end configured to pass fluid into the internal chamber of the tip electrode.
Jimenez, in the same field of endeavor, teaches the catheter (10, Fig. 2) including a fluid tubing (150, Col. 15, lines 21-28) extending through the catheter body (12, Col. 6, lines 18-22) and the deflection section (14) and into the distal electrode section, the fluid tubing having a distal end configured to pass fluid into the internal chamber of the tip electrode (Col. 15, lines 21-28) to help cool the electrodes.
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 have added a fluid tubing for the purpose of cooling the electrodes.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Honour, Bonner, Christian as applied to claim 1 above, and further in view of Hartmann (U.S. Application No. 2012019710 A1).
Regarding claim 16, Honour/Bonner/Christian combination disclose the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose the magnetic field sensing coil wire is wound on the outer surface of the housing body proximal the opening in the sidewall.
Hartmann, in the same field of endeavor, teaches a navigation system (10) used to track the location of an instrument (100) relative to a patient (pa. 0021) using a tracking system (30) that utilizes a tracking device (52) which includes one or more coils that can either transmit an EM field or sense an EM field to generate a tracking signal to allow the navigation system to determine the location of the tracked instrument in the navigation space (pa. 0040 & Fig. 1). The tracking device is formed as a plurality of wires (110) wound around an exterior or on an exterior wall (112) of the instrument to form a coil (pa. 0042 & Fig. 2).
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 have added magnetic field sensing coil wire to be wound on the outer surface of the housing body proximal the opening in the sidewall of the catheter of Honour in order to allow a user to sense and indicate the location/orientation of the catheter within the body cavity.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Honour, Bonner, Christian as applied to claim 1 above, and further in view of Salahieh (U.S. Patent No. 8295902 B2).
Regarding claim 21, Honour/Bonner/Christian combination disclose the invention substantially as claimed in claims 1 and 20 and discussed above.
However, they do not disclose the flex circuit comprising a third portion on a same side of the flex circuit as the distal leg and spaced proximally from the distal leg, the third portion wrapped around the outer surface of the proximal portion of the housing body.
Salahieh, in the same field of endeavor, teaches a flex circuit (89, Col. 6, lines 44-53 & Figs. 13A-13B) comprising a third portion (bottom-most horizontal branch spread out from the main vertical base) on a same side of the flex circuit as the distal leg and spaced proximally from the distal leg (upper-most horizontal branch spread out from the main vertical base), the third portion wrapped around the outer surface of the proximal portion of the housing body (Col. 8, lines 15-18; Col. 8, lines 49-54 & Figs. 2A-3B) to help connect to the outer surface of electrodes located on varying distances/locations across a device.
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 have substituted one known branching pattern of the flex circuit of Honour for another branching pattern because both configurations would lead to predictable results of allowing the flex circuit to connect to the multiple electrodes located on the housing.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Honour, Bonner, Christian as applied to claim 1 above, and further in view of Selkee (U.S. Patent No. 9101734 B2).
Regarding claim 22, Honour/Bonner/Christian combination disclose the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose a force sensor comprising a proximal end connected to the distal neck of the housing body, and a distal end extending into the plug portion of the tip electrode.
Selkee, in the same field of endeavor, teaches a catheter (100) having integrated force sensors (490), having a proximal and distal end, for measuring the force on the tip of the catheter as well as providing information regarding deflection of the catheter body (Col. 2, lines 24-27 & Figs. 1A-4). Furthermore, Selkee teaches the catheter comprising the proximal end of the force sensor being mounted on a center strut (80; analogous to the distal neck of the housing body), wherein the center strut contains a snap-fit wedge (441b) that is used to connect it to the distal portion of the catheter (438, 442) (Col. 8, lines 1-13), and also allowing the distal end of the force sensor to extend to the distal portion of the catheter. Examiner is interpreting the word “extending” as to occupy a specified area or stretch to a specified point. In this case, the distal portion of the force sensor are able to reach/occupy a specified point near the proximal region of the tip electrode.
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 have incorporated the force sensor of Selkee for the purpose of allowing the user to determine the forces applied to the outer diameter of the catheter tip (Selkee, Col. 8, lines 33-37).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Honour (U.S. Application No. 20070219551 A1), in view of Bonner (U.S. Application No. 20030093104 A1), in view of Christian (U.S. Application No. 20140163548 A1), in view of Nevo (U.S. Application No. 20030187347 A1), and further in view of Hartmann (U.S. Application No. 2012019710 A1).
Regarding independent claim 23, Honour discloses an electrophysiology catheter (Figs. 3, 21-22) having:
an elongated catheter body (40, pa. 0101);
a deflection section (42, portion of the catheter distal to the elongated catheter body) distal of the catheter body (pa. 0024, 0067);
a distal electrode section (pa. 0098, portion of the catheter distal to the deflection section) having:
a housing (portion of catheter which includes the distal electrode section which contains the multiple electrodes 44) with a generally-cylindrical, hollow housing body (pa. 0101) with an outer surface, the housing body defining a lumen (pa. 0019, 0066) and an opening (92, pa. 0105) in a sidewall allowing access into the lumen; and the housing body comprising:
a distal portion (pa. 0094, a middle portion of the distal electrode section as illustrated in Fig. 21) having a distal outer diameter, and a distal end portion (a distalmost portion of the distal electrode section) having a distal end diameter, and
a proximal portion (a proximal-most portion of the distal electrode section) having a proximal outer diameter;
the opening in the sidewall of the housing having a proximal edge (see border of the opening in the sidewall of the catheter body in Fig. 22). Examiner is interpreting “edge” as the line where an object or area begins or ends; a border.
a flex circuit (34) having a first portion (distalmost portion located on the distal portion of the housing body) wrapped generally circumferentially around the outer surface of the distal portion of the housing body (pa. 0103, 0105) and a second portion (proximal-most portion located on the proximal portion of the housing body) extending into the lumen via the opening in the housing body (see Fig. 22);
a tip electrode (64) distal of the housing body (pa. 0078 & Figs. 8-9), the tip electrode having a shell portion, the tip electrode being connected to (at least, indirectly connected) to and extending distally from a border/structure between the distal end portion and the distal portion of the housing body (See Figs. 8-9, 17) such that a distal end (a distal end of conductive traces 36 as seen in Fig. 8) of the first portion of the flex circuit is proximal of a proximal end (a proximal-most structure) of the tip electrode (see Figs. 8-9).
Examiner is interpreting a shell as any protective outer case/body structure; therefore, the outer body structure of the tip electrode meets the claim limitation. Furthermore, Examiner will interpret the claim term “connected to” in light of the plain meaning as two components being directly or indirectly connected to each other. This definition is supported by Figures 4 and 6 of the filed Drawings which shows the tip electrode having a proximal end at least indirectly attached to the distal neck of the housing, and further supported by paragraph [0062] of the filed Specification which describes the tip electrode as being "mounted on an extended distal end 63D of the stem 63", wherein the stem is not part of the distal neck of the housing (i.e., implying the indirect attachment style).
Lastly, Honour discloses a control handle (e.g., steering mechanism) proximal of the catheter body (pa. 0024, 0067-0068). Examiner is using the broad interpretation of a control handle to mean any controlling mechanism that allows a user to manipulate the catheter, such as for example a steering mechanism.
However, Honour does not disclose:
element A: the distal outer diameter being smaller than the proximal outer diameter such that the housing body has a first step at a junction between the distal portion and the proximal portion,
element B: the distal end diameter of the distal end portion being smaller than the distal outer diameter of the distal portion such that the housing body has a second step distal of the first step that defines a distal neck of the housing body,
element C: the opening in the sidewall having the proximal edge along the first step, or
element D: the flex circuit is supported between the first step and the second step.
Regarding element A: Bonner, in the same field of endeavor teaches a catheter with an elongated tubular body (10, pa. 0044 & Figs. 1-2) and a distal electrode section (portion of the catheter distal to the tubular body) comprising:
the distal outer diameter (32, proximal portion, pa. 0044-0045) being smaller than the proximal outer diameter (30) such that the housing body has a first step at a junction between the distal portion and the proximal portion. Examiner is interpreting “step” as a surface that lies at a higher level compared to the level of the adjacent/distal surface. Therefore, a first proximal-most step can be seen between the different diameters/surface levels as shown in Fig. 2 to help anchor the distal portion of the catheter (pa. 0044).
Regarding element B: Bonner teaches the distal end diameter of the distal end portion (32, distal portion, pa. 0045) being smaller than the distal outer diameter of the distal portion such that the housing body has a second step distal of the first step. Examiner is pointing to the distalmost second step (tapered section between the stylet 28 and distal end portion) seen between the different diameters as shown in Fig. 2 to create a more atraumatic tip configuration for the housing body (pa. 0045). Furthermore, the second step defines a distal neck (i.e., the surface of 28, as seen in in Figs. 1-2) of the housing body.
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 have modified the housing body of Honour to include the structural stepped configuration of Bonner for the purpose of creating a stable distal electrode section.
Regarding element C: Honour already discloses the proximal edge being located along the proximal section of the distal electrode section, and Bonner already teaches the first step to be located on the proximal-most section of the distal electrode section. Therefore, the combination of Honour/Bonner would lead the device to have the proximal edge along the first step.
Regarding element D: Honour already discloses the flex circuit having a first portion wrapped around the distal portion (which includes the distal outer diameter) of the housing body, and Bonner already teaches the first step to be located on the proximal-most section of the catheter housing body and the second step to be located on the distalmost section of the hollow-housing body. Therefore, the combination of Honour and Bonner would lead to configuration of the distal electrode section comprising the flex circuit being supported between the first step and the second step.
However, Honour/Bonner combination do not teach the tip electrode comprising a plug portion and an internal chamber configured to receive fluid.
Christian, in the same field of endeavor, teaches the tip electrode (10, pa. 0033 & Figs. 2-3, 7-8), distal of the housing body (16), having a shell portion (46, pa. 0058) for deformation and/or deflection of the electrode section (pa. 0046-0047), a plug portion (88, pa. 0058, 0067) to prevent ingress of blood and/or fluids (pa. 0058), and an internal chamber (60, pa. 0067) configured to receive fluid.
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 have modified the distal tip electrode of Honour to include a plug in order to prevent ingress of blood and/or fluids into the volume defined by the electrode shell.
However, Honour/Bonner/Christian combination do not teach the flex circuit having one or more magnetic field sensing coil traces.
Nevo, in the same field of endeavor, teaches the flex circuit having a first magnetic field sensing coil trace (
T
C
x
,
T
C
1
,
T
C
3
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and a second magnetic field sensing coil trace (
T
C
y
,
T
C
2
,
T
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4
)
(pa. 0070 & Fig. 5) to sense and indicate the location and orientation of the catheter (pa. 0027).
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 have added the magnetic field sensing coil traces taught by Nevo to the flex circuit of Honour in order to allow the user to sense and indicate the location and orientation of the catheter within the body cavity.
However, Honour/Bonner/Christian/Nevo combination do not teach a magnetic field sensing coil wire distinct from the flex circuit and wound around the outer surface of the housing body.
Hartmann, in the same field of endeavor, teaches a navigation system (10) used to track the location of an instrument (100) relative to a patient (pa. 0021) using a tracking system (30) that utilizes a tracking device (52) which includes one or more coils that can either transmit an EM field or sense an EM field to generate a tracking signal to allow the navigation system to determine the location of the tracked instrument in the navigation space (pa. 0040 & Fig. 1). The tracking device is formed as a plurality of wires (110) wound around an exterior or on an exterior wall (112) of the instrument to form a coil (pa. 0042 & Fig. 2).
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 have added magnetic field sensing coil wire to be wound on the outer surface of the housing body of the catheter of Honour in order to allow a user to more accurately sense and indicate the location/orientation of the catheter within the body cavity based on the magnetic measurements.
Regarding claim 24, Honour/Bonner/Christian/Nevo combination disclose the invention substantially as claimed in claim 23 discussed above.
However, they do not teach wherein the outer surface of the housing body has a circumferential recess proximal of the opening in the sidewall of the housing body, and the magnetic field sensing coil wire is situated in the circumferential recess.
Hartmann, in the same field of endeavor, teaches the wire (110) is formed around the exterior wall (112) of the instrument (100) to form a coil. The winds or turns of wire are formed between a plurality of guide posts (114) that are formed at selected positions on the external wall of the instrument (pa. 0042 & Figs. 2-3). The posts are formed as a single piece with the outer wall via a machining manufacturing process (pa. 0044).
Examiner notes that machining is a subtractive process where material is cut away from a solid block to achieve the desired shape. Therefore, since the posts are manufacturing using this technique, then each groove/channel between the posts can be considered a circumferential recess.
Therefore, 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 have substituted the manufacturing process used to make the housing body of Honour with the machining manufacturing process taught by Hartmann for the purpose of creating at least one circumferential recess proximal of the opening in the sidewall of the housing body in order to provide a guiding feature that is able to hold a magnetic field sensing coil wire. Furthermore, it would have been obvious to have added the magnetic field sensing coil wire of Hartmann to be wound on the outer surface of the housing body of the catheter of Honour in order to allow a user to more accurately sense and indicate the location/orientation of the catheter within the body cavity based on the magnetic measurements.
Response to Arguments
Applicant's arguments filed 02/04/2026, with respect to claim 1 under Honour, Bonner, and Christian have been considered but are not persuasive.
With regards to newly amended independent claim 1, Applicant argues that none of the cited references appears to disclose or suggest a configuration with a proximal housing body that supports a flex circuit, and a distal tip electrode attached at its proximal end to the distal neck of the housing body such that a distal end of the flex circuit is proximal of the proximal end of the tip electrode. However, Examiner, respectfully, disagrees.
Examiner notes that the claim language of claim 1 requires that the flex circuit has a first portion wrapped generally circumferentially around the outer surface of the distal portion of the housing body and supported between the first step and the second step, and a second portion extending into the lumen via the opening in the housing body. The claim language is silent on the flex circuit being supported by the “a proximal housing body”. This term “proximal housing body” is not supported at all by any of the language of claim 1, given that the housing body comprises a proximal portion having a proximal outer diameter. Therefore, it is unclear to Examiner as to which portion of the housing body the Applicant is arguing about. Nevertheless, the combination of references provided in the rejection still read on the limitations of independent claim 1. As described above, Honour discloses the flex circuit having a first portion wrapped around the distal portion of the housing body, and Bonner teaches the first step to be located on the proximal-most section of the catheter housing body and the second step to be located on the distalmost section of the hollow-housing body. Therefore, the combination of Honour and Bonner would lead to configuration of the distal electrode section comprising the flex circuit being supported between the first step and the second step. Furthermore, Honour discloses a tip electrode (64) distal of the housing body (pa. 0078 & Figs. 8-9), the tip electrode being connected to (at least, indirectly connected) to and extending distally from a border/structure between the distal end portion and the distal portion of the housing body (i.e., where a distal neck structure will be located) (See Figs. 8-9, 17) such that a distal end (a distal end of conductive traces 36 as seen in Fig. 8) of the first portion of the flex circuit is proximal of a proximal end (a proximal-most structure) of the tip electrode (see Figs. 8-9). Examiner will interpret the claim term “connected to” in light of the plain meaning as two components being directly or indirectly connected to each other. This definition is supported by Figures 4 and 6 of the filed Drawings which shows the tip electrode having a proximal end at least indirectly attached to the distal neck of the housing, and further supported by paragraph [0062] of the filed Specification which describes the tip electrode as being "mounted on an extended distal end 63D of the stem 63", wherein the stem is not part of the distal neck of the housing (i.e., implying the indirect attachment style). Therefore, the rejection based on the combination of references is maintained for the reasonings set-forth above.
With regards to newly added independent claim 23, Applicant argues that the Nevo reference fails to teach a flex circuit carrying one or more magnetic field sensing traces while the housing carries a distinct magnetic field sensing coil wire. Examiner finds this argument to be partially persuasive.
While Examiner concedes that the Nevo reference does not teach a magnetic field sensing coil wire, the Nevo reference does teach one or more magnetic field sensing traces. As evidenced by paragraph 0068, the magnetic coils are made by printed circuit techniques, wherein electrically-conductive deposits are applied to a planar dielectric substrate, which is then formed into an annular shape. One of ordinary skill in the art will recognize that a coil trace is a flat, 2D conductive path printed directly onto a circuit board (PCB) or flexible substrate, as described in the Nevo reference. Therefore, the prior art meets the claim limitation of a flex circuit carrying one or more magnetic field sensing traces.
In regards to the claim limitation of “a magnetic field sensing coil wire distinct from the flex circuit and wound around the outer surface of the housing body”, Examiner utilized the Hartmann reference which teaches a navigation system (10) used to track the location of an instrument (100) relative to a patient (pa. 0021) using a tracking system (30) that utilizes a tracking device (52) which includes one or more coils that can either transmit an EM field or sense an EM field to generate a tracking signal to allow the navigation system to determine the location of the tracked instrument in the navigation space (pa. 0040 & Fig. 1). The tracking device is formed as a plurality of wires (110) wound around an exterior or on an exterior wall (112) of the instrument to form a coil (pa. 0042 & Fig. 2).
Lastly, with regards to newly added claim 24, Applicant argues that none of the references cited contemplates or implies any reason or motivation to provide a wire wound in a recess on the outer surface of probe or housing. Examiner agrees and therefore introduces the Hartmann reference to ameliorate such shortcomings.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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