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 May 18th, 2026 has been entered. Claims 1-5 and 7-15
have been amended. Claims 6 and 16-20 are cancelled. Claims 1-5 and 7-15 are now pending in the application.
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
In response to arguments that Ikeda et al. (US 20090082621 A1) does not disclose “the amended handle/ shaft arrangement” the examiner respectfully disagrees. As detailed below, the examiner has updated the rejection to provide more clarity and better reject the claims as amended. The functional language for modifying the grip part of the handle, “configured to be grasped by an operating physician” is intended use and the identified handle of Ikeda would be capable of being grasped by an operating physician as would be any handle. Moreover, the examiner has provided more details in the rejection below regarding how the disclosure of Ikeda specifically discloses this feature, as well as, the side port feature.
Therefore, the examiner is maintaining the rejection under 35 U.S.C 102(a)(1) with Ikeda et al. (US 20090082621 A1).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: (First or Second) Deflection Mechanism in claims 1, 3, 11. The broadest reasonable interpretation of a deflection mechanism, based on the description in the disclosure, is a rotatable member and/or articulation wire(s) that directly causes articulation of the distal tip.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: homing feature and speed control feature in claim 10. The broadest reasonable interpretation of a homing feature, based on the description in the disclosure, is a device or interface that upon receiving an input, will straightens the distal tip. The broadest reasonable interpretation of a speed control feature, based on the description in the disclosure, is a device or interface that upon receiving an input, will adjust the speed of the distal tip articulation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Examiner Comments
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”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikeda et al. (US 20090082621 A1, hereinafter Ikeda).
Regarding Claim 1, Ikeda discloses
A steerable medical system (electric bending endoscope apparatus 1, FIG. 1), comprising:
an endoscope (electric bending endoscope 11, FIG. 1), comprising:
a handle (proximal portion of elongated insertion portion 13, i.e. the part encompassing forceps insertion port 13g and connected to bending drive unit 12, FIGS. 1-2),
the handle including a grip area (attaching and detaching region A, FIG. 1 + proximal portion of elongated insertion portion 13, FIGS. 1-2) configured to be grasped by an operating physician and a side port (tube port 16a, FIG. 1; Abstract, par. 11 disclose user capable of physically operating endoscope, i.e. via proximal portion/ handle); and
an elongate shaft (bending portion 13b, FIG. 1) extending distally from the handle to a distal tip (distal end rigid portion 13a, depicted in FIG. 1-2),
the elongate shaft including a working lumen (air and water supply pipeline 16b, FIG. 1) in fluid communication with the side port (par. 38 discloses tube is in fluid communication with air and water pipeline);
a detachable motor controller (bending drive unit 12, FIG. 1-2), comprising:
a motor control housing (endoscope holding device 40, FIG. 2-3, par. 23 disclose bending drive unit inside of endoscope holding device) configured to detachably interface with the handle (par. 24 discloses attachment and detachment of insertion portion and bending drive unit at an attaching and detaching region A, depicted in FIG. 1);
a first motor (electric motor 27a, FIG. 3) disposed within the motor control housing (depicted in FIG. 3);
a first gear assembly (Drive gear 27aa + reduction gear 29a, FIG. 3) disposed within the motor control housing (depicted in FIG. 3), and
a user input mechanism (operation portion 19 + system controller 17, FIG. 2) extending from the motor control housing (FIG. 2, par. 23 discloses operation portion connected to bending drive unit via system controller); and
a first drive axle (rotary shaft 25c + UD clutch 25a, FIG. 3) configured to engage the first gear assembly with a first deflection mechanism (UD drum 35a, FIG. 3) disposed within the handle (FIG. 3, par. 52 disclose drums inside of casing of insertion portion, the first deflection mechanism being configured to deflect the distal tip in a first plane (par. 48 discloses UD components contribute to bending in the vertical direction).
Regarding Claim 2, Ikeda discloses
The steerable medical system of claim 1,
wherein the detachable motor controller further includes a second motor (electric motor 27b, FIG. 3) disposed within the motor control housing (depicted in FIG. 3) and
a second gear assembly (Drive gear 27bb + reduction gear 29b, FIG. 3) disposed within the motor control housing (depicted in FIG. 3).
Regarding Claim 3, Ikeda discloses
The steerable medical system of claim 2, further including
a second drive axle (rotary shaft 25c + RL clutch 25b, depicted in FIG. 3) configured to engage the second gear assembly with a second deflection mechanism (UD drum 35b, FIG. 3) disposed within the handle (FIG. 3, par. 52 disclose drums inside of casing of insertion portion),
the second deflection mechanism being configured to deflect the distal tip in a second plane different from the first plane (par. 48 discloses RL components contribute to bending in the lateral/ horizontal direction).
Regarding Claim 4, Ikeda discloses
The steerable medical system of claim 3, wherein the first drive axle is coaxial with the second drive axle (depicted in FIG. 3).
Regarding Claim 5, Ikeda discloses
The steerable medical system of claim 3, wherein the first drive axle is parallel with the second drive axle (depicted in FIG. 3).
Regarding Claim 7, Ikeda discloses
The steerable medical system of claim 1,
wherein the user input mechanism includes a joystick control (operation stick 19a, FIG. 1) configured to operate the first motor (par. 26 discloses operation portion sends bending operation instruction to system controller, par. 36 discloses motor control part receives signals from the system controller, par. 31 discloses motor control part performs control of motor for bending operation, i.e. via instructions from operation portion).
Regarding Claim 8, Ikeda discloses
The steerable medical system of claim 2,
wherein the user input mechanism includes a joystick control (operation stick 19a, FIG. 1) configured to operate the first motor and the second motor (par. 26 discloses operation portion sends bending operation instruction to system controller, par. 36 discloses motor control part receives signals from the system controller, par. 31 discloses motor control part performs control of motor for bending operation, i.e. via instructions from operation portion).
Regarding Claim 9, Ikeda discloses
The steerable medical system of claim 8, wherein the joystick control is configured to operate the first motor and the second motor simultaneously ((par. 26 discloses operation portion sends bending operation instruction to system controller, par. 36 discloses motor control part receives signals from the system controller, par. 31 discloses motor control part performs control of electric motor, which encompasses both motors, for bending operation, i.e. via instructions from operation portion, par. 53 discloses simultaneous transmittal of drive force from both motors).
Regarding Claim 10, Ikeda discloses
The steerable medical system of claim 1, further comprising a homing feature (parallel link 40Ca, FIG. 7) configured to return the distal tip to a home position when activated (par. 70 discloses parallel link is configured to move the endoscope and bending drive unit in a predetermined direction, i.e. capable of returning the distal tip to a home position) and/or a speed control feature (encoder 28, FIG. 1) configured to control speed and/or responsiveness of movement of the distal tip (par. 49 discloses encoder converts operation states such as the respective rotation speeds and rotation amounts of the motors into output data, i.e. capable of resulting in speed control).
Regarding Claim 11, Ikeda discloses
A steerable medical system (electric bending endoscope apparatus 1, FIG. 1), comprising:
an endoscope (electric bending endoscope 11, FIG. 1), comprising:
a handle (proximal portion of elongated insertion portion 13, i.e. the part encompassing forceps insertion port 13g and connected to bending drive unit 12, FIGS. 1-2),
the handle including a grip area (attaching and detaching region A, FIG. 1 + proximal portion of elongated insertion portion 13, FIGS. 1-2) configured to be grasped by an operating physician and a side port (tube port 16a, FIG. 1; Abstract, par. 11 disclose user capable of physically operating endoscope, i.e. via proximal portion/ handle); and
an elongate shaft (bending portion 13b, FIG. 1) extending distally from the handle to a distal tip (distal end rigid portion 13a, depicted in FIG. 1-2),
the elongate shaft including a working lumen (air and water supply pipeline 16b, FIG. 1) in fluid communication with the side port (par. 38 discloses tube is in fluid communication with air and water pipeline);
a detachable motor controller (bending drive unit 12, FIG. 1-2) including;
a motor control housing (endoscope holding device 40, FIG. 2-3) configured to detachably interface with the handle (par. 24 discloses attachment and detachment of insertion portion and bending drive unit at an attaching and detaching region A, depicted in FIG. 1);
a user input mechanism (operation portion 19 + system controller 17, FIG. 2) extending from the motor control housing (FIG. 2, par. 23 discloses operation portion connected to bending drive unit via system controller);
a first motor (electric motor 27a, FIG. 3) disposed within the motor control housing (depicted in FIG. 3);
a first gear assembly (Drive gear 27aa + reduction gear 29a, FIG. 3) disposed within the motor control housing (depicted in FIG. 3);
a second motor (electric motor 27b, FIG. 3) disposed within the motor control housing (depicted in FIG. 3);
a second gear assembly (Drive gear 27bb + reduction gear 29b, FIG. 3) disposed within the motor control housing (depicted in FIG. 3); and
a first drive axle (rotary shaft 25c + UD clutch 25a, FIG. 3) coaxially disposed within a lumen of a second drive axle (rotary shaft 25c + RL clutch 25b, depicted in FIG. 3);
wherein the first drive axle is configured to engage the first gear assembly with a first deflection mechanism (UD drum 35a, FIG. 3) disposed within the handle (FIG. 3, par. 52 disclose drums inside of casing of insertion portion), the first deflection mechanism being configured to deflect the distal tip in a first plane (par. 48 discloses UD components contribute to bending in the vertical direction); and
wherein the second drive axle is configured to engage the second gear assembly with a second deflection mechanism (UD drum 35b, FIG. 3) disposed within the handle (FIG. 3, par. 52 disclose drums inside of casing of insertion portion), the second deflection mechanism being configured to deflect the distal tip in a second plane different from the first plane (par. 48 discloses RL components contribute to bending in the lateral/ horizontal direction).
Regarding Claim 12, Ikeda discloses
The steerable medical system of claim 11, wherein the first drive axle is fixedly secured to the first deflection mechanism (par. 52 discloses drums fixed to rotary shaft).
Regarding Claim 13, Ikeda discloses
The steerable medical system of claim 12, wherein the first drive axle is configured to slidably engage the first gear assembly (par. 24 discloses attachment and detachment carried out via clutch, i.e. clutch is movable/ slidable, par. 31 discloses clutch is an engaging means which engages the reduction gear and is attachable/ detachable, i.e. capable of slidable engagement).
Regarding Claim 14, Ikeda discloses
The steerable medical system of claim 11, wherein the second drive axle is fixedly secured to the second deflection mechanism (par. 52 discloses drums fixed to rotary shaft).
Regarding Claim 15, Ikeda discloses
The steerable medical system of claim 14, wherein the second drive axle is configured to slidably engage the second gear assembly (par. 24 discloses attachment and detachment carried out via clutch, i.e. clutch is movable/ slidable, par. 31 discloses clutch is an engaging means which engages the reduction gear and is attachable/ detachable, i.e. capable of slidable engagement).
Claim(s) 1, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ueno et al. (US 20070238927 A1, hereinafter Ueno).
Regarding Claim 1, Ueno discloses
A steerable medical system (endoscope system 1, FIG. 1), comprising:
an endoscope (power driven bending endoscope 2, FIG. 1), comprising:
a handle (insertion portion engagement portion 3D, FIGS. 2-3),
the handle including a grip area configured to be grasped by an operating physician and a side port (tubes port 13, FIG. 1; par. 71 operator brings the separated insertion body towards the motor unit for assembly/ attachment, i.e. by grasping the endoscope at a proximal end/ grip area); and
an elongate shaft (distal rigid portion 3A + a bending portion 3B + a flexible tube 3C, FIGS. 1-3) extending distally from the handle to a distal tip (depicted in FIGS. 1-3),
the elongate shaft including a working lumen (front water supply conduit 3a1, FIG. 1) in fluid communication with the side port (FIG. 1, par. 36 disclose fluid communication of tube and water supply conduit);
a detachable motor controller (motor unit 4, FIGS. 1-3), comprising:
a motor control housing (motor unit housing 4, FIG. 3) configured to detachably interface with the handle (FIGS. 1-3, par. 39 disclose insertion body and motor unit are detachably coupled);
a first motor (electric motor 23, FIG. 6) disposed within the motor control housing (depicted in FIG. 6);
a first gear assembly (motor pinion 23A + gear 32b, FIG. 6) disposed within the motor control housing (depicted in FIG. 6), and
a user input mechanism (engagement/disengagement buttons 34) extending from the motor control housing (depicted in FIG. 6); and
a first drive axle (shaft 32, FIG. 6) configured to engage the first gear assembly with a first deflection mechanism (sprocket 38, FIG. 1) disposed within the handle (FIGS. 1, 6, par. 77 disclose rotating power of the electric motor is transmitted to the sprocket via the motor pinion and the gear provided to the shaft),
the first deflection mechanism being configured to deflect the distal tip in a first plane (par. 77 discloses rotation of sprocket causes angle wire to pull or loosen bending portion, par. 32 discloses bending portion is bent in vertical and lateral directions).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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.
/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights