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 .
Response to Amendment
The amendment filed 05 September 2025 has been entered. Claim(s) 1-8 remain pending in the application. Applicant’s amendments to the drawings and claims have overcome each and every objection to the drawings and claims previously set forth in the Office Action mailed 09 June 2025. The double patenting rejection has been overcome in view of the accepted terminal disclaimer.
Terminal Disclaimer
The terminal disclaimer filed on 15 September 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of application number 17/840,699 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda (US 20170281270) in view of Schultz (US 20190111238 A1 ).
Regarding claim 1, Masuda discloses a catheter device (Handle 12 and internal components described in Paragraph 0069-0070) to be applied to a catheter (1),
the catheter including a catheter shaft (11), and a plurality of temperature sensors (temperature measuring rings 111-115, temperature sensors 51-55) provided in a region in vicinity of a tip end of the catheter shaft (Paragraph 0055-- The tip-flexible part 11A of the catheter tube 11 is provided therein with five temperature sensors 51 to 55 that are respectively disposed near the metal rings 111 to 115) and configured to measure an internal temperature of a hollow organ inside a body (Paragraph 0010, 0027, 0071-- The catheter 1 may measure information on the internal temperature of a hollow organ inside the body, such as the esophagus, of a patient), and a first handle provided on a base end of the catheter shaft (intermediate segment between catheter shaft 11 and portion 122/rotary plate 41 of the handle; see the segment labeled A below in Fig. 1),
the catheter device comprising:
a tube member (61) extending in an axial direction, and configured to be inserted through a lumen provided in the catheter shaft (Paragraph 0043-- The first tube 61 serving as an inner tube may be disposed on inner circumference side of the tip-flexible part 11A, whereas the second tube 62 serving as an outer tube may be disposed on outer circumference side of the first tube 61); and
a second handle (12) provided on a base end of the tube member (Paragraph 0069-0070-- each of the operating wires 40a and 40b having the foregoing configurations may be disposed inside the first tube 61…the base ends of the respective conduction wires L1 to L5 each may be so extended as to be led from the inside of the catheter tube 11 to the inside of the handle 12. The base ends of the respective operating wires 40a and 40b each may also be fixed by the unillustrated fastener inside the handle 12), and the second handle including a deformation operating member (41a/41b is part of handle portion 122, part of handle 12; paragraph 0037) configured to receive an operation that causes a region in vicinity of a tip end of the tube member to be subjected to bending deformation (Paragraph 0073-- the operator may grab the handle 12 with his/her one hand and operate the knob 41a with its fingers to rotate the rotary plate 41 in a direction denoted by the arrow d1a of FIG. 1, i.e., in a clockwise direction. This pulls the foregoing operating wire 40a toward the base end within the catheter tube 11, thereby causing the region near the tip of the catheter tube 11 to be curved or “deflected” in a direction denoted by the arrow d2a of FIG. 1), the second handle being provided separately from a first handle (intermediate segment between catheter shaft 11 and portion 122/rotary plate 41 of the handle; see the segment labeled A below in Fig. 1) provided on a base end of the catheter shaft (Fig. 1, intermediate segment is provided at the base end of the catheter shaft 11),
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wherein, upon the bending deformation of the region in the vicinity of the tip end of the tube member in response to the operation of the deformation operating member, the tube member to be subjected to the bending deformation is configured to be pressed against a wall surface of the lumen of the catheter shaft to displace the region in the vicinity of the tip end of the catheter shaft (Paragraph 0030-0031, 0043, 0073-0074; Fig. 4—deflection of the tube 61 via the wires 40a and 40b would necessarily cause the tube to be pressed against a wall surface in a corresponding direction), and
the first handle and the second handle are configured to be integrated (Fig. 1).
However, Masuda fails to explicitly disclose the first handle and the second handle are configured to be separated from each other. Schultz, in the same field of endeavor of a steerable catheter system (Abstract), discloses a device including a first handle (segment 46) and a second handle (12), wherein the first handle and second handle are configured to be integrated with each other and are configured to be separated from each other (paragraph 0042--fitting 46 with external threads that is configured to mate with threaded housing 48 that is rotatably mounted to handle 12 and features complementary internal threads…In other embodiments, any suitable releasable attachment between handle 12 and catheter body 14 may be employed, such as a snap fit connection, a pneumatic push-in connection or the like).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Masuda with the separable first and second handles of Schultz in order to predictably allow for a reversible attachment between the catheter body and the catheter device which would allow for the disposal or replacement of components as needed in order to reduce waste and cost of the system by providing an alternative to replacing the entire system.
Regarding claim 2, the combination of Masuda and Schultz discloses the catheter device of claim 1. However, Masuda fails to explicitly disclose wherein the second handle has a projection, and the projection of the second handle is configured to be fitted with a recess provided on the first handle. Schultz, in the same field of endeavor of a steerable catheter system (Abstract), discloses a device including a first handle (segment 46) and a second handle (12), wherein the second handle has a projection (raised portion of threads of threaded housing 48 which is mounted to handle 12, Fig. 4), and the projection of the second handle is configured to be fitted with a recess provided on the first handle (see recessed portions of threads of segment 46, Fig. 4; paragraph 0042--fitting 46 with external threads that is configured to mate with threaded housing 48 that is rotatably mounted to handle 12 and features complementary internal threads…In other embodiments, any suitable releasable attachment between handle 12 and catheter body 14 may be employed, such as a snap fit connection, a pneumatic push-in connection or the like).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Masuda with the attachment details of Schultz in order to predictably allow for a reversible attachment between the catheter body and the catheter device which would allow for the disposal or replacement of components as needed in order to reduce waste and cost of the system by providing an alternative to replacing the entire system.
Regarding claim 3, the combination of Masuda and Schultz discloses the catheter device of claim 1. Masuda additionally discloses wherein an orientation of deformation upon the bending deformation of the region in the vicinity of the tip end of the tube member is adjustable, on a basis of an angle of integration, within a plane orthogonal to the axial direction, upon the integration of the first handle and the second handle with each other (Paragraph 0040, 0075-- adjustment knob 42 may be a member that is rotatable in the Z-X plane, and fixes or keeps a position at which the rotary plate 41 is rotated. In other words, the adjustment knob 42 may fix or keep a state in which the region near the tip of the catheter tube 11 is curved. More specifically, the operator may twist the adjustment knob 42 to fix the rotary plate 41 to the handle body 121. This allows for fixation of the position at which the rotary plate 41 is rotated).
Regarding claim 4, Masuda discloses a catheter body (Area encompassed between distal tip 110 and first handle area A, marked above) of a catheter (1), the catheter being configured to measure an internal temperature of a hollow organ inside a body (Paragraph 0010, 0027, 0071-- The catheter 1 may measure information on the internal temperature of a hollow organ inside the body, such as the esophagus, of a patient), the catheter body comprising:
a catheter shaft (11) having a lumen (Paragraphs 0043-0044; Fig. 3-4—see outer tube 62);
a plurality of temperature sensors (temperature measuring rings 111-115, temperature sensors 51-55) provided in a region in vicinity of a tip end of the catheter shaft (Paragraph 0055-- The tip-flexible part 11A of the catheter tube 11 is provided therein with five temperature sensors 51 to 55 that are respectively disposed near the metal rings 111 to 115) and configured to measure the internal temperature of the hollow organ inside the body (Paragraph 0010, 0027, 0071); and
the catheter device comprising:
a first handle (intermediate segment between catheter shaft 11 and portion 122/rotary plate 41 of the handle; see the segment labeled A below in Fig. 1) provided on a base end of the catheter shaft (Fig. 1, intermediate segment is provided at the base end of the catheter shaft 11),
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wherein, upon bending deformation of a region in vicinity of a tip end of a tube member (61) of a catheter device in response to an operation of a deformation operating member (41a/41b) of the catheter device (Paragraph 0073-- the operator may grab the handle 12 with his/her one hand and operate the knob 41a with its fingers to rotate the rotary plate 41 in a direction denoted by the arrow d1a of FIG. 1, i.e., in a clockwise direction. This pulls the foregoing operating wire 40a toward the base end within the catheter tube 11, thereby causing the region near the tip of the catheter tube 11 to be curved or “deflected” in a direction denoted by the arrow d2a of FIG. 1), the tube member to be subjected to the bending deformation is configured to be pressed against a wall surface of the lumen of the catheter shaft to displace the region in the vicinity of the tip end of the catheter shaft (Paragraph 0030-0031, 0043, 0073-0074; Fig. 4—deflection of the tube 61 via the wires 40a and 40b would necessarily cause the tube to be pressed against a wall surface in a corresponding direction), the catheter device including the tube member (61) extending in an axial direction, and configured to be inserted through the lumen of the catheter shaft (Paragraph 0043-- The first tube 61 serving as an inner tube may be disposed on inner circumference side of the tip-flexible part 11A, whereas the second tube 62 serving as an outer tube may be disposed on outer circumference side of the first tube 61), and
a second handle (12) provided on a base end of the tube member (Paragraph 0069-0070-- each of the operating wires 40a and 40b having the foregoing configurations may be disposed inside the first tube 61…the base ends of the respective conduction wires L1 to L5 each may be so extended as to be led from the inside of the catheter tube 11 to the inside of the handle 12. The base ends of the respective operating wires 40a and 40b each may also be fixed by the unillustrated fastener inside the handle 12), the second handle including the deformation operating member configured to receive the operation that causes the region in the vicinity of the tip end of the tube member to be subjected to the bending deformation (41a/41b is part of handle portion 122, part of handle 12; paragraph 0037), the second handle being provided separately from the first handle (see Fig. 1), and
the first handle and the second handle are configured to be integrated (see Fig. 1).
However, Masuda fails to explicitly disclose the first handle and the second handle are configured to be separated from each other. Schultz, in the same field of endeavor of a steerable catheter system (Abstract), discloses a device including a first handle (segment 46) and a second handle (12), wherein the first handle and second handle are configured to be integrated with each other and are configured to be separated from each other (paragraph 0042--fitting 46 with external threads that is configured to mate with threaded housing 48 that is rotatably mounted to handle 12 and features complementary internal threads…In other embodiments, any suitable releasable attachment between handle 12 and catheter body 14 may be employed, such as a snap fit connection, a pneumatic push-in connection or the like).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Masuda with the separable first and second handles of Schultz in order to predictably allow for a reversible attachment between the catheter body and the catheter device which would allow for the disposal or replacement of components as needed in order to reduce waste and cost of the system by providing an alternative to replacing the entire system.
Regarding claim 5, the combination of Masuda and Schultz discloses the catheter body of claim 4. However, Masuda fails to explicitly disclose wherein the first handle has a recess, and the recess of the first handle is configured to be fitted with a projection provided on the second handle. Schultz, in the same field of endeavor of a steerable catheter system (Abstract), discloses a device including a first handle (segment 46) and a second handle (12), wherein the first handle has a recess (see recessed portions of threads of segment 46, Fig. 4), and the recess of the first handle is configured to be fitted with a projection provided on the second handle (Corresponding raised portion, Fig. 4; paragraph 0042--fitting 46 with external threads that is configured to mate with threaded housing 48 that is rotatably mounted to handle 12 and features complementary internal threads…In other embodiments, any suitable releasable attachment between handle 12 and catheter body 14 may be employed, such as a snap fit connection, a pneumatic push-in connection or the like).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Masuda with the attachment details of Schultz in order to predictably allow for a reversible attachment between the catheter body and the catheter device which would allow for the disposal or replacement of components as needed in order to reduce waste and cost of the system by providing an alternative to replacing the entire system.
Regarding claim 6, the combination of Masuda and Schultz discloses the catheter body of claim 4. Masuda additionally discloses that electrical leads electrically coupled to the temperature sensors extend through some portion of the handle (Paragraph 0057-- The conduction wires L1 to L5 each may be inserted through the lumen provided in the catheter tube 11 and led to the inside of the handle 12 as described previously), wherein the tube member is configured to be inserted through the lumen of the catheter shaft, with the tube member being inserted linearly through the first handle (Paragraph 0043-- The first tube 61 serving as an inner tube may be disposed on inner circumference side of the tip-flexible part 11A, whereas the second tube 62 serving as an outer tube may be disposed on outer circumference side of the first tube 61; Paragraph 0069-0070-- each of the operating wires 40a and 40b having the foregoing configurations may be disposed inside the first tube 61…the base ends of the respective conduction wires L1 to L5 each may be so extended as to be led from the inside of the catheter tube 11 to the inside of the handle 12. The base ends of the respective operating wires 40a and 40b each may also be fixed by the unillustrated fastener inside the handle 12).
However, Masuda fails to explicitly disclose a connector provided on a side face of the first handle at a position that is off the axial direction, and configured to allow electrical leads electrically coupled to the temperature sensors to be coupled to outside. Schultz, in the same field of endeavor of a steerable catheter system (Abstract), discloses a device including a first handle (segment 46) comprising a connector provided on a side face of the first handle at a position that is off the axial direction, and configured to allow electrical leads electrically coupled to the temperature sensors to be coupled to outside (paragraph 0041-0042--lumen 32 may carry lead wires and thermocouple wires 34 for communicating electrical signals to and from ring electrodes 22 and tip electrode 24…the couplings associated with lead and thermocouple wires 34, sensor cables 38 and irrigation tubing 42 are not shown, but any suitable fluidic or electrical connector system may be employed as desired. For example, edge connectors provided in fitting 46 and threaded housing may be used to couple electrode lead and thermocouple wires 34 and/or sensor cables 38 with PCB 25). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Masuda to include an electrical connector as disclosed by Schultz in order to predictably improve the ability of the device to be connected to external devices which may allow for the display of values from the device, such as temperatures measured by the temperature sensors.
Regarding claim 7, Masuda discloses a catheter (1) configured to measure an internal temperature of a hollow organ inside a body (Paragraph 0010, 0027, 0071-- The catheter 1 may measure information on the internal temperature of a hollow organ inside the body, such as the esophagus, of a patient), the catheter comprising:
a catheter body (Area encompassed between distal tip 110 and first handle area 122); and
a catheter device (Handle 12 and internal components described in Paragraph 0069-0070), the catheter body including a catheter shaft (11) having a lumen (Paragraphs 0043-0044; Fig. 3-4—see outer tube 62), a plurality of temperature sensors (temperature measuring rings 111-115, temperature sensors 51-55) provided in a region in vicinity of a tip end of the catheter shaft (Paragraph 0055-- The tip-flexible part 11A of the catheter tube 11 is provided therein with five temperature sensors 51 to 55 that are respectively disposed near the metal rings 111 to 115) and configured to measure the internal temperature of the hollow organ inside the body (Paragraph 0010, 0027, 0071);, and
a first handle (intermediate segment between catheter shaft 11 and portion 122/rotary plate 41 of the handle; see the segment labeled A below in Fig. 1) provided on a base end of the catheter shaft (Fig. 1, intermediate segment is provided at the base end of the catheter shaft 11),
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the catheter device including a tube member (61) extending in an axial direction, and inserted through the lumen of the catheter shaft (Paragraph 0043-- The first tube 61 serving as an inner tube may be disposed on inner circumference side of the tip-flexible part 11A, whereas the second tube 62 serving as an outer tube may be disposed on outer circumference side of the first tube 61), and
a second handle (12) provided on a base end of the tube member (Paragraph 0069-0070-- each of the operating wires 40a and 40b having the foregoing configurations may be disposed inside the first tube 61…the base ends of the respective conduction wires L1 to L5 each may be so extended as to be led from the inside of the catheter tube 11 to the inside of the handle 12. The base ends of the respective operating wires 40a and 40b each may also be fixed by the unillustrated fastener inside the handle 12), the second handle including the deformation operating member (41a/41b) configured to receive the operation that causes the region in the vicinity of the tip end of the tube member to be subjected to the bending deformation (41a/41b is part of handle portion 122, part of handle 12; paragraph 0037), wherein, upon the bending deformation of the region in the vicinity of the tip end of the tube member in response to the operation of the deformation operating member, the tube member to be subjected to the bending deformation is configured to be pressed against a wall surface of the lumen of the catheter shaft to displace the region in the vicinity of the tip end of the catheter shaft (Paragraph 0030-0031, 0043, 0073-0074; Fig. 4—deflection of the tube 61 via the wires 40a and 40b would necessarily cause the tube to be pressed against a wall surface in a corresponding direction); and
the first handle and the second handle are configured to be integrated with each other (see Fig. 1).
However, Masuda fails to explicitly disclose the first handle and the second handle being provided separately from one another and are configured to be separated from each other. Schultz, in the same field of endeavor of a steerable catheter system (Abstract), discloses a device including a first handle (segment 46) and a second handle (12), wherein the first handle and second handle are configured to be integrated with each other and are configured to be separated from each other (paragraph 0042--fitting 46 with external threads that is configured to mate with threaded housing 48 that is rotatably mounted to handle 12 and features complementary internal threads…In other embodiments, any suitable releasable attachment between handle 12 and catheter body 14 may be employed, such as a snap fit connection, a pneumatic push-in connection or the like).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Masuda with the separable first and second handles of Schultz in order to predictably allow for a reversible attachment between the catheter body and the catheter device which would allow for the disposal or replacement of components as needed in order to reduce waste and cost of the system by providing an alternative to replacing the entire system.
Regarding claim 8, the combination of Masuda and Schultz discloses the catheter of claim 7. Masuda additionally discloses wherein the hollow organ inside the body comprises esophagus, and the catheter is configured to measure an internal temperature of the esophagus upon surgical ablation of left atrium of a patient (Paragraph 0010, 0027, 0071-- The catheter 1 may measure information on the internal temperature of a hollow organ inside the body, such as the esophagus, of a patient when being used for a medical treatment of arrhythmia, etc., of the patient, e.g., when being used for surgical ablation of the left atrium).
Response to Arguments
Applicant's arguments filed 05 September 2025 have been fully considered but they are not persuasive.
In particular, the applicant argues that the claimed “tube member” is not taught by Masuda as the first tube 61 of Masuda “constitutes a component of the catheter shaft 11 itself” while the claimed tube member is not part of the claimed catheter shaft.
However, as noted in the cited paragraph 0043 of Masuda, the first tube 61 may be a tube which is separated from the second tube 62, such that it is inserted into the second tube 62 of the catheter tube 11 and thus is inserted into a lumen of the catheter shaft as claimed. The current claim language does not preclude this first tube 61 from serving as the tube member as claimed.
The claims remain rejected under 35 U.S.C. 103.
It is recommended that the claims be amended to further clarify the arrangement of the tube member in order to overcome the Masuda reference. In particular, it appears that various details of the insertion of the tube member described in the final two paragraphs of page 14 of the specification, specifically regarding an insertion path guide and an insertion hole, are not disclosed by Masuda and would thus overcome at least the existing prior art rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791