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 .
This Office Action is in response to the amendments dated February 17, 2026.
Claims 1-20 are pending.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the feature of “the electrical connector of the shaft is rotatable relative to a housing of the shaft”, as claimed in Claims 8, 10, and 18, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
FIG. 4A, as shown in US PGPUB 2024/0245286 of the present patent application, shows an electrical connector 306, within the shaft housing 300, that mates with the handle electrical connector 414 of the handle body 400. This allows the shaft housing 300 and handle body 400 to rotate relative to one another. Paragraph [0061] of the present patent application states that “the shaft housing 300 and the handle body 400 are rotatable with respect to one another, thus the electrical connection is also rotatable”, rather than the shaft’s electrical connection being rotatable relative to the shaft housing 300. As such, Applicant’s interpretation of “the electrical connector of the shaft is rotatable relative to a housing of the shaft” presented in Applicant’s February 17, 2026 response is not supported by the figures.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8, 10, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Specifically, Claims 8, 10, and 18 claim the feature of “the electrical connector of the shaft is rotatable relative to a housing of the shaft”.
FIG. 4A, as shown in US PGPUB 2024/0245286 of the present patent application, shows an electrical connector 306, within the shaft housing 300, that mates with the handle electrical connector 414 of the handle body 400. This allows the shaft housing 300 and handle body 400 to rotate relative to one another. Paragraph [0061] of the present patent application states that “the shaft housing 300 and the handle body 400 are rotatable with respect to one another, thus the electrical connection is also rotatable”, rather than the shaft’s electrical connection being rotatable relative to the shaft housing 300. As such, Applicant’s interpretation of “the electrical connector of the shaft is rotatable relative to a housing of the shaft” presented in Applicant’s February 17, 2026 response is not supported by the present specification. That is, although the present specification states in paragraph [0017] and Claims 8, 10, and 18 state “the first electrical connector is rotatable with respect to the shaft housing”, the present specification provides no guidance or explanation for how this can occur, since such guidance/explanation/teaching is not shown or described in the specification. As such, the feature of “the electrical connector of the shaft is rotatable relative to a housing of the shaft” is not enabled by the present patent application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Okamoto et al. (US PGPUB 2014/0309625 – “Okamoto”).
Regarding Claim 1, Harhen discloses:
A medical device (Harhen FIG. 1, probe 100) comprising:
a shaft (Harhen FIG. 3, flexible shaft 62) extending from a proximal end to a distal end; and
a handle body (Harhen FIG. 4, actuator assembly 80) removably couplable to and detachable from the shaft (Harhen FIG. 4, showing actuator assembly 80 removably couplable to and detachable from flexible shaft 62 by coupling/decoupling transducer assembly 60 to actuator assembly 80), the handle body including:
an electrical connector (Harhen, FIG. 4, first connector 90, which includes first electrical interface 94, extending from handle/actuator 80) couplable to and detachable from an electrical connector of the shaft (Harhen, FIG. 6, second electrical interface 74 attached to shaft 62; Harhen paragraph [0030] "second connector 70 contains a second electrical interface 74 that lines up the first electrical interface 94 of the first connector 90"); and
an actuator (Harhen FIG. 3, actuator 82) for deflecting a distal end of the shaft (Harhen FIG. 3, transducer assembly 60 and actuator assembly 80; Harhen paragraph [0022], “transducer assembly 60 includes a bending mechanism that is actuatable by the actuator 82 when the actuator assembly 80 and the transducer assembly 60 are connected together”), wherein the actuator is coupled to a first wheel (Harhen FIG. 9, pulley 73) and a wire (Harhen FIG. 9, pull wires 65), and wherein the actuator is configured to pull the wire proximally to deflect the distal end of the shaft (Harhen paragraph [0035], “actuation of the user operated actuator 82 (shown in FIGS. 3 and 4) will cause the output actuator 92 to rotate. Since the control actuator 72 is being urged up against the output actuator 92, the control actuator 72 will follow the rotation of the output actuator 92. Rotation of the control actuator 72 turns the pulley 73 which operates the pull wires 65 that extend distally through the flexible shaft 62, and cause a bending mechanism (not shown) located in the bending section (shown in FIG. 3) to bend.”).
Although Harhen shows in Harken FIG. 9 control pull wires 65 stretched over grooved supports, Harken does not explicitly disclose the control wire being coupled to a wire attachment, wherein a second wheel supports the wire between the first wheel and the wire attachment.
Okamoto teaches the control wire (Okamoto FIG. 12, proximal portion of control wire 23) being coupled to a wire attachment (Okamoto FIG. 12, spring 21), wherein a second wheel (Okamoto FIG. 12, idler wheel 25) supports the wire between the first wheel and the wire attachment.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Okamoto’s wire attachment spring and idler wheel with the medical device disclosed by Harhen. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a steerable insertion portion that has control wire with predetermined tensile force (see Okamoto paragraph [0095]).
Regarding Claim 3, Harhen in view of Okamoto teach the features of Claim 1, as described above.
Okamoto further teaches wherein the wire attachment (Okamoto FIG. 12, spring 21) couples the wire of the handle body (Okamoto FIG. 12, proximal portion of wire 23) to a wire of the shaft (Okamoto FIG. 12, wire 22).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Okamoto et al. (US PGPUB 2014/0309625 – “Okamoto”) and Haraguchi et al. (US PGPUB 2018/0071040 – “Haraguchi”).
Regarding Claim 2, Harhen in view of Okamoto teach the features of Claim 1, as described above.
Harhen in view of Okamoto do not explicitly teach wherein the wire extends about the first wheel and is fixed to the first wheel at an attachment point.
Haraguchi teaches wherein the wire (Haraguchi FIG. 2, control wire 61 or 62) extends about the first wheel (Haraguchi FIG. 2, pulley 52) and is fixed to the first wheel at an attachment point (Haraguchi FIG. 2, protrusions 53A or 53B; Haraguchi paragraph [0027], “The pair of wires 61 and 62 are respectively wound on the protrusions 53A and 53B, and a part of the wound portion is connected to the pulley 52 by soldering, adhesion, welding or the like.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Haraguchi’s attachment points on the control wheel with the medical device taught by Harhen in view of Okamoto. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of medical device having bending control wires that a secured to the control wheel, in order to ensure continuity of contact by the control wire between the control wheel and the bendable portion of the medical device.
Claim 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Okamoto et al. (US PGPUB 2014/0309625 – “Okamoto”) and Shin et al. (US PGPUB 2021/0068619 – “Shin").
Regarding Claim 4, Harhen in view of Okamoto teach the features of Claim 1, as described above.
Harhen in view of Okamoto do not explicitly teach wherein the handle body includes a stop block distal to the wire attachment, and wherein the wire attachment is configured to abut the stop block.
PNG
media_image1.png
296
446
media_image1.png
Greyscale
Shin teaches wherein the handle (Shin FIG. 1, handle/operation part 20) body includes a stop block (Examiner-annotated Shin FIG. 7b shown above, stop block shown at the termination of guide rail 531 or 532) distal to the wire attachment (Shin FIG. 7b, connection blocks 511 and/or 512), and wherein the wire attachment is configured to abut the stop block (Shin paragraph [0057], “by disposing a first guide rail 531 having a predetermined length disposed parallel to the upper chain and contacting one side surface of each of the first and third connection blocks vertically located at predetermined intervals in the figure between the first connection block 511 and the third connection block 523, the first guide rail guides the first and third connection blocks to be pulled”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Shin’s stop block/guide rails with the medical device taught by Harhen in view of Okamoto. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a bending system having limited movement of a bending portion while also preventing a collision between the wire attachment and the pulley.
Regarding Claim 5, Harhen in view of Okamoto and Shin teach the features of Claim 4, as described above.
Shin further teaches wherein the stop block is fixed to a housing of the handle body and the wire attachment is movable relative to the housing of the handle body (Shin FIGs. 7b and 7c, showing direction conversion module 500 of handle 20 in Shin FIG. 1, where the termination of guide rail 531 or 532 are part of the handle 20, and the connection block 511 or 512 move within the handle 20).
Regarding Claim 6, Harhen in view of Okamoto and Shin teach the features of Claim 4, as described above.
Shin further teaches wherein a spring (Shin FIG. 7b, coil spring 501) surrounds a portion of the wire attachment (Shin FIG. 7b, protrusion from connection block 511, which together with connection block 512 forms a wire attachment for control wire pair 21/22), and wherein the spring biases the wire attachment towards the stop block (Shin FIG. 7b, showing coil spring 511 pushing/biasing connection block 512 towards distal termination of guide rail 532).
Regarding Claim 7, Harhen in view of Okamoto and Shin teach the features of Claim 4, as described above.
Shin further teaches wherein the wire attachment (Shin FIG. 7b, block 511 and connection wire 21) extends through a wall fixed to a housing of the handle body, and wherein the wall is proximal to the stop block (Shin FIG. 7b, showing connection wire 21 of wire attachment extending through a wall of the module 500 that is within handle 20 in Shin FIG. 1).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Okamoto et al. (US PGPUB 2014/0309625 – “Okamoto”) and Ulmschneider et al. (US PGPUB 2020/0397232 – “Ulmschneider”).
Regarding Claim 8, Harhen in view of Okamoto teach the features of Claim 1, as described above.
Harhen in view of Okamoto do not explicitly teach wherein the electrical connector of the shaft is rotatable relative to a housing of the shaft.
Ulmschneider teaches wherein the electrical connector of the shaft (Ulmschneider FIG. 1, sockets 30 in handle 12 for connecting to pins 32 in the shaft 18) is rotatable relative to a housing of the shaft (Ulmschneider, FIG. 1, longitudinal axis 24 of shaft 18; Ulmschneider paragraph [0060], “shaft 18 is rotatable about its longitudinal axis 24 relative to the housing 14 of the handle 12”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make the shaft/handle connection taught by Harhen in view of Okamoto to be relatively rotatable using the rotatable pins/sockets taught in FIG. 1 of Ulmschneider. One skilled in the art would be motivated to make this connection rotatable in order for it to be "possible for a user to rotate the shaft relative to the housing of the handle and thereby, for example, to adjust a viewing direction of the endoscope while holding the handle in a fixed orientation" (see paragraph [0021] of Ulmschneider).
Regarding Claim 9, Harhen in view of Okamoto teach the features of Claim 1, as described above.
Harhen in view of Okamoto do not explicitly teach wherein the shaft includes a ramp configured to align the electrical connector of the handle body with the electrical connector of the shaft when the handle body is coupled to the shaft.
Ulmschneider teaches wherein the shaft (Ulmschneider FIG. 2 shown above, shaft 18) includes a ramp (Ulmschneider FIG. 2, coupling plate 19 held by claws 15) configured to align the electrical connector of the handle body (Ulmschneider FIG. 2, sockets 30) with the electrical connector (Ulmschneider FIG. 1, pins 32) of the shaft when the handle body is coupled to the shaft.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make the shaft/handle connection taught by Harhen in view of Okamoto to be relatively rotatable using the rotatable pins/sockets taught in FIG. 1 of Ulmschneider and coupling plate 19 shown in FIG. 2 of Ulmschneider. One skilled in the art would be motivated to make this guided connection in order for the pins and sockets to align during assembly.
Regarding Claim 10, Harhen discloses:
A medical device (Harhen FIG. 1, probe 100) comprising:
a handle body (Harhen FIG. 3, control handle 84) including an actuator (Harhen FIG. 3, actuator 82), a wheel (Harhen FIG. 9, pulley 73), and a wire (Harhen FIG. 9, pull wires 65) within a housing of the handle body; and
a shaft (Harhen FIG. 3, flexible shaft 62) couplable to the handle body, the shaft extending from a proximal end to a distal end and including:
an electrical connector (Harhen, FIG. 4, first connector 90, which includes first electrical interface 94, extending from handle/actuator 80) couplable to an electrical connector of the handle body.
Harhen does not explicitly disclose wherein the electrical connector of the shaft is rotatable relative to a housing of the shaft.
Ulmschneider teaches wherein the electrical connector of the shaft (Ulmschneider FIG. 1, sockets 30 in handle 12 for connecting to pins 32 in the shaft 18) is rotatable relative to a housing of the shaft (Ulmschneider, FIG. 1, longitudinal axis 24 of shaft 18; Ulmschneider paragraph [0060], “shaft 18 is rotatable about its longitudinal axis 24 relative to the housing 14 of the handle 12”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make the shaft/handle connection disclosed by Harhen to be relatively rotatable using the rotatable pins/sockets taught in FIG. 1 of Ulmschneider. One skilled in the art would be motivated to make this connection rotatable in order for it to be "possible for a user to rotate the shaft relative to the housing of the handle and thereby, for example, to adjust a viewing direction of the endoscope while holding the handle in a fixed orientation" (see paragraph [0021] of Ulmschneider).
Harhen in view of Ulmschneider do not explicitly teach an actuator coupled to a wire attachment, a wire extending through the shaft to the distal end of the shaft, wherein the wire of the shaft is coupled to the wire of the handle body via the wire attachment, and wherein the actuator is configured to pull the wire of the handle body proximally to deflect the distal end of the shaft.
Okamoto teaches:
an actuator (Okamoto FIG. 12, rotating shaft portion 82) coupled to a wire attachment (Okamoto FIG. 12, spring 21),
a wire (Okamoto FIG. 12, wire 22 extending through insertion portion 3) extending through the shaft to the distal end of the shaft, wherein the wire of the shaft is coupled to the wire of the handle body via the wire attachment (Okamoto FIG. 12, spring 21), and wherein the actuator is configured to pull the wire of the handle body proximally to deflect the distal end of the shaft (Okamoto paragraph [0097], “a surgeon tilts the manipulator 70 as indicated by the alternate long and two short dashes lines, the up transmission wire 24U is pulled and the down transmission wire 24D is slackened with the tilting of the manipulator 70. As a result, the straightened bending portion 3b is bent upward”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Okamoto’s wire attachment spring with the medical device taught by Harhen in view of Ulmschneider. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a steerable insertion portion that has control wire with predetermined tensile force (see Okamoto paragraph [0095]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Ulmschneider et al. (US PGPUB 2020/0397232 – “Ulmschneider”), Okamoto et al. (US PGPUB 2014/0309625 – “Okamoto”), and Weitzner et al. (US PGPUB 2008/0221391 – “Weitzner”).
Regarding Claim 11, Harhen in view of Ulmschneider and Okamoto teach the features of Claim 10, as described above.
Harhen in view of Ulmschneider and Okamoto do not explicitly teach wherein the shaft includes a sheath that surrounds the wire of the shaft, and wherein the wire of the shaft is configured to move relative to the sheath when the wire of the handle body is moved proximally.
Weitzner teaches wherein the shaft includes a sheath that surrounds the wire of the shaft, and wherein the wire of the shaft is configured to move relative to the sheath when the wire of the handle body is moved proximally (Weitzner FIG. 3A, strands 60 controlling the bending of articulating portion 56; Weitzner, paragraph [0159] "strands 60 extend from the proximal portion of the guide tube to the articulation body member 58 to control the articulation body member. Strands 60 can comprise one or more filaments formed of a flexible material including, for example, a variety of wires and cables. In one aspect, strands 60 include an inner filament positioned within an outer casing. For example, strands 60 can be defined by Bowden cables").
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Weitzner's sheathed/Bowden pull wires for Harhen's distal bare/unsheathed pull wires in the medical device taught by Harhen in view of Ulmschneider and Okamoto. One skilled in the art would have been motivated to make such a substitution in order to "reduce power losses along the length of the guide tube" (Weitzner, paragraph [0159]).
Regarding Claim 12, Harhen in view of Ulmschneider, Okamoto, and Weitzner teach the features of Claim 11, as described above.
Weitzner further teaches wherein the sheath and the wire of the shaft are coupled to the wire attachment via a fitting (Weitzner FIG. 80E, showing Bowden-type cable 346 having an outer sheath 348 with one end secured to a cable stop 350 positioned on the collar 324 that is fitted over the shaft 314; see also Weitzner paragraph [0349]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Weitzner's fitting with the medical device taught by Harhen in view of Ulmschneider and Okamoto. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical device that limits movement of a sheath/cable (see Weitzner paragraph [0349]).
Regarding Claim 13, Harhen in view of Ulmschneider and Okamoto teach the features of Claim 10, as described above.
Harhen in view of Ulmschneider and Okamoto do not explicitly teach wherein a spring surrounds a portion of the wire attachment.
Weitzner teaches wherein a spring surrounds a portion of the wire attachment (Weitzner FIG. 80E, Bowden-type cable 346; Weitzner paragraph [0349], “the cable 346 is a Bowden-type cable having an outer sheath 348 with one end secured to a cable stop 350 positioned on the collar 324 that is fitted over the shaft 314”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Weitzner's sheathed/Bowden pull wires for Harhen's distal bare/unsheathed pull wires in the medical device taught by Harhen in view of Ulmschneider and Okamoto. One skilled in the art would have been motivated to make such a substitution in order to "reduce power losses along the length of the guide tube" (Weitzner, paragraph [0159]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Ulmschneider et al. (US PGPUB 2020/0397232 – “Ulmschneider”), Okamoto et al. (US PGPUB 2014/0309625 – “Okamoto”), and Shin et al. (US PGPUB 2021/0068619 – “Shin").
Regarding Claim 14, Harhen in view of Ulmschneider and Okamoto teach the features of Claim 10, as described above.
Harhen in view of Ulmschneider and Okamoto do not explicitly teach wherein the handle body includes a stop block distal to the wire attachment.
Shin teaches wherein the handle (Shin FIG. 1, handle/operation part 20) body includes a stop block (Examiner-annotated Shin FIG. 7b shown above, stop block shown at the termination of guide rail 531 or 532) distal to the wire attachment (Shin FIG. 7b, connection blocks 511 and/or 512).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Shin’s stop block/guide rails with the medical device taught by Harhen in view of Ulmschneider and Okamoto. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a bending system having limited movement of a bending portion while also preventing a collision between the wire attachment and the pulley.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Ulmschneider et al. (US PGPUB 2020/0397232 – “Ulmschneider”), Okamoto et al. (US PGPUB 2014/0309625 – “Okamoto”), and Haraguchi et al. (US PGPUB 2018/0071040 – “Haraguchi”).
Regarding Claim 15, Harhen in view of Ulmschneider and Okamoto teach the features of Claim 10, as described above.
Harhen in view of Ulmschneider and Okamoto do not explicitly teach wherein the wire of the handle body is fixed to the wheel at an attachment point.
Haraguchi teaches wherein the wire (Haraguchi FIG. 2, control wire 61 or 62) of the handle body is fixed to the wheel (Haraguchi FIG. 2, pulley 52) at an attachment point (Haraguchi FIG. 2, protrusions 53A or 53B; Haraguchi paragraph [0027], “The pair of wires 61 and 62 are respectively wound on the protrusions 53A and 53B, and a part of the wound portion is connected to the pulley 52 by soldering, adhesion, welding or the like.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Haraguchi’s attachment points on the control wheel with the medical device taught by Harhen in view of Ulmschneider and Okamoto. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of medical device having bending control wires that a secured to the control wheel, in order to ensure continuity of contact by the control wire between the control wheel and the bendable portion of the medical device.
Claims 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Shin et al. (US PGPUB 2021/0068619 – “Shin").
Regarding Claim 16, Harhen discloses:
A medical device (Harhen FIG. 1, probe 100) comprising:
a shaft (Harhen FIG. 3, flexible shaft 62) extending from a proximal end to a distal end; and
a handle body (Harhen FIG. 4, actuator assembly 80) removably couplable to and detachable from the shaft (Harhen FIG. 4, showing actuator assembly 80 removably couplable to and detachable from flexible shaft 62 by coupling/decoupling transducer assembly 60 to actuator assembly 80), the handle body including:
an electrical connector (Harhen, FIG. 4, first connector 90, which includes first electrical interface 94, extending from handle/actuator 80) couplable to and detachable from an electrical connector of the shaft (Harhen, FIG. 6, second electrical interface 74 attached to shaft 62; Harhen paragraph [0030] "second connector 70 contains a second electrical interface 74 that lines up the first electrical interface 94 of the first connector 90");
a wheel (Harhen FIG. 9, pulley 73);
an actuator coupled to the wheel (Harhen FIG. 3, actuator 82); and
a wire (Harhen FIG. 9, wire 65) fixed to the wheel, and wherein the actuator is configured to pull the wire attachment proximally to deflect the distal end of the shaft.
Harhen does not explicitly disclose:
a wire attachment;
a spring surrounding a portion of the wire attachment; and
the wire coupled to the wire attachment, wherein the wire attachment couples the wire of the handle body to a wire extending through the shaft.
Shin teaches
a wire attachment (Shin FIG. 7b, protrusion from connection block 511);
a spring (Shin FIG. 7b, coil spring 501) surrounding a portion of the wire attachment; and
the wire coupled to the wire attachment (Shin FIG. 7b, protrusion from connection block 511, which together with connection block 512 forms a wire attachment for control wire pair 21/22), wherein the wire attachment couples the wire of the handle body to a wire (Shin FIG. 7b, wire 21) extending through the shaft.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Shin’s wire attachment and spring with the medical device disclosed by Harhen. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical device having control wires that are spring-biased to reduce slack in the control wires.
Regarding Claim 17, Harhen in view of Shin teach the features of Claim 16, as described above.
Shin further teaches wherein the handle body includes a fixed stop block (Examiner-annotated Shin FIG. 7b shown above, stop block shown at the termination of guide rail 531 or 532), and wherein the wire attachment is configured to abut the fixed stop block (Shin paragraph [0057], “by disposing a first guide rail 531 having a predetermined length disposed parallel to the upper chain and contacting one side surface of each of the first and third connection blocks vertically located at predetermined intervals in the figure between the first connection block 511 and the third connection block 523, the first guide rail guides the first and third connection blocks to be pulled”).
Regarding Claim 20, Harhen in view of Shin teach the features of Claim 16, as described above.
Shin further teaches wherein the wire (Shin FIG. 6, wire 21) of the shaft is coupled to the wire attachment (Shin FIG. 6, connection block 511) via a fitting (Shin FIG. 6, locking groove 511a connected to locking member 21a).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Shin et al. (US PGPUB 2021/0068619 – “Shin") and Ulmschneider et al. (US PGPUB 2020/0397232 – “Ulmschneider”).
Regarding Claim 18, Harhen in view of Shin teach the features of Claim 16, as described above.
Harhen further discloses wherein the electrical connector of the handle body is fixed to a housing of the handle body (Harhen FIG. 4, showing first connector 90 fixed to the housing of actuator assembly 80).
Harhen in view of Shin do not explicitly teach wherein the electrical connector of the shaft is rotatable relative to a housing of the shaft.
Ulmschneider teaches wherein the electrical connector of the shaft (Ulmschneider FIG. 1, sockets 30 in handle 12 for connecting to pins 32 in the shaft 18) is rotatable relative to a housing of the shaft (Ulmschneider, FIG. 1, longitudinal axis 24 of shaft 18; Ulmschneider paragraph [0060], “shaft 18 is rotatable about its longitudinal axis 24 relative to the housing 14 of the handle 12”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to make the shaft/handle connection taught by Harhen in view of Shin to be relatively rotatable using the rotatable pins/sockets taught in FIG. 1 of Ulmschneider. One skilled in the art would be motivated to make this connection rotatable in order for it to be "possible for a user to rotate the shaft relative to the housing of the handle and thereby, for example, to adjust a viewing direction of the endoscope while holding the handle in a fixed orientation" (see paragraph [0021] of Ulmschneider).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Harhen (US PGPUB 2009/0118618 – “Harhen") in view of Shin et al. (US PGPUB 2021/0068619 – “Shin") and Macnamara et al. (US PGPUB 2007/0232858 – “Macnamara”).
Regarding Claim 19, Harhen in view of Shin teach the features of Claim 17, as described above.
Harhen in view of Shin do not explicitly teach wherein the spring is configured to compress when the wire attachment is pulled proximally.
Macnamara teaches wherein the spring (Macnamara FIG. 2, compression spring 128) is configured to compress when the wire attachment (Macnamara FIG. 2, slide block 122 connected to outer sheath 104a of control cable 102a) is pulled proximally (Macnamara paragraph [0016], “When one or both outer sheaths 104a and 104b are under compression (due to looping or significant bending of the shaft) sufficient to overcome the counteracting force of the spring 128, the slide block 122 will give and slide to compress the spring 128.”.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Macnamara’s slide/compression spring with the medical device taught by Harhen in view of Shin. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical device having control cables that are easy to move (see Macnamara paragraph [0016]).
Response to Arguments
Applicant’s arguments, see pages 11-12, filed February 17, 2026, with respect to the nonstatutory double patenting rejection of Claims 1-20 have been fully considered and are persuasive, in view of the Terminal Disclaimer against Parent Patent 11,974,722 filed on February 17, 2026. The nonstatutory double patenting rejection of Claims 1-20 has been withdrawn.
Applicant's arguments, see pages 7-9, filed February 17, 2026, with respect to the rejection of Claims 1 and 16 and their respective dependent claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
On pages 8-9, Applicant asserts that a person of ordinary skill in the art would not have been motivated to modify control handle 84 of Harhen (US PGPUB 2009/0118618 – “Harhen") to include pulley 73 and pull wires 65 shown in Harhen FIG. 9. Examiner is unclear as to what Applicant is asserting. Control handle 84, pulley 73, and pull wires 65 are all part of the same embodiment disclosed by Harhen. Thus, there is no modification being performed. Furthermore, Applicant’s cited Harhen paragraph [0023] merely teaches that the connector 70, which connects to the shaft 62, is removable from the actuator assembly 80 (as shown in Harhen FIG. 3). This passage explicitly discloses the attachable/detachable nature of the handle from the shaft.
On pages 9-11, Applicant asserts that that the cited prior art fails to teach or suggest the features claimed in Claim 10.
Specifically, on page 9, Applicant asserts that Examiner has failed to point to a specific structure of Harhen as teaching “an electrical connector of the handle body”. Examiner respectfully disagrees. The present final rejection, as well as the November 17, 2025 non-final rejection, explicitly identifies the electrical connector in Harhen as a first connector 90, which includes first electrical interface 94, extending from handle/actuator 80, as shown in Harhen FIG. 4.
On pages 10, Applicant asserts that Ulmschneider et al. (US PGPUB 2020/0397232 – “Ulmschneider”) fails to teach wherein the electrical connector of the shaft is rotatable relative to a housing of the shaft. FIG. 1 of Ulmschneider shows electrical pins 32 coupled to shaft 18. Ulmschneider paragraph [0060] states that “shaft 18 is rotatable about its longitudinal axis 24 relative to the housing 14 of the handle 12”. Therefore, Ulmschneider’s electrical pins 32 rotate as the shaft 18 rotates.
Applicant then further asserts that the phrase “the electrical connector of the shaft is rotatable relative to a housing of the shaft” in Claim 10, and presumably Claims 8 and 18, is intended to be interpreted as the electrical connector rotates while the shaft housing remains at a relatively fixed location. If it is Applicant’s intent to interpret this phrase in this manner, rather than Examiner’s interpretation that the electrical connects and shaft housing rotate together relative to one another, then Examiner has now rejected Claims 8, 10, and 18 under 35 U.S.C. 112(a) and objected to the figures, as shown above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure includes:
Truckai et al. (US PGPUB 2018/0184892 – “Truckai”) teaches in Truckai FIG. 7 an introducer shaft 510 that is attachable to handle 514 via a hub 540. The hub 540 includes a first electrical connector 545a that couples with a second electrical connector 545b in the handle 514.
Weitzner et al. (US PGPUB 2017/0209024 – “Weitzner”) teaches in Weitzner FIG. 1 a shaft 30 that couples to a handle 10. Weitzner FIG. 3 shows a bayonet mount between handle 10 and shaft body 31, which includes electrical contacts 18C for electrically connecting the shaft body 31 to the handle 10.
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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
5/12/26
Prosecution Insights